3646 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

(b) If the owner, operator, or agent in 

charge of a farm appeals the order and 

requests an informal hearing: 

(1) If FDA grants the request for a 

hearing and the hearing is held, the 

presiding officer must provide a 2 

calendar day opportunity for the hearing 

participants to review and submit 

comments on the report of the hearing 

under § 112.208(c)(4), and must issue a 

final decision within 10 calendar days 

after the hearing is held; or 

(2) If FDA denies the request for a 

hearing, the presiding officer must issue 

a final decision on the appeal 

confirming or revoking the withdrawal 

within 10 calendar days after the date 

the appeal is filed. 

§ 112.211 When is an order to withdraw a 

qualified exemption applicable to a farm 

revoked? 

An order to withdraw a qualified 

exemption applicable to a farm under 

§ 112.5 is revoked if: 

(a) The owner, operator, or agent in 

charge of the farm appeals the order and 

requests an informal hearing, FDA 

grants the request for an informal 

hearing, and the presiding officer does 

not confirm the order within the 10 

calendar days after the hearing, or issues 

a decision revoking the order within 

that time; or 

(b) The owner, operator, or agent in 

charge of the farm appeals the order and 

requests an informal hearing, FDA 

denies the request for an informal 

hearing, and FDA does not confirm the 

order within the 10 calendar days after 

the appeal is filed, or issues a decision 

revoking the order within that time; or 

(c) The owner, operator, or agent in 

charge of the farm appeals the order 

without requesting an informal hearing, 

and FDA does not confirm the order 

within the 10 calendar days after the 

appeal is filed, or issues a decision 

revoking the order within that time. 

(d) Confirmation of a withdrawal 

order by the presiding officer is 

considered a final Agency action for 

purposes of 5 U.S.C. 702. 

Dated: January 3, 2013. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2013–00123 Filed 1–4–13; 11:15 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 1, 16, 106, 110, 114, 117, 

120, 123, 129, 179, and 211 

[Docket No. FDA–2011–N–0920] 

RIN 0910–AG36 

Current Good Manufacturing Practice 

and Hazard Analysis and Risk-Based 

Preventive Controls for Human Food 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

amend its regulation for Current Good 

Manufacturing Practice In 

Manufacturing, Packing, or Holding 

Human Food (CGMPs) to modernize it 

and to add requirements for domestic 

and foreign facilities that are required to 

register under the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) to 

establish and implement hazard 

analysis and risk-based preventive 

controls for human food. FDA also is 

proposing to revise certain definitions 

in FDA’s current regulation for 

Registration of Food Facilities to clarify 

the scope of the exemption from 

registration requirements provided by 

the FD&C Act for ‘‘farms.’’ FDA is taking 

this action as part of its announced 

initiative to revisit the CGMPs since 

they were last revised in 1986 and to 

implement new statutory provisions in 

the FD&C Act. The proposed rule is 

intended to build a food safety system 

for the future that makes modern, 

science-, and risk-based preventive 

controls the norm across all sectors of 

the food system. 

DATES: Submit either electronic or 

written comments on the proposed rule 

by May 16, 2013. Submit comments on 

information collection issues under the 

Paperwork Reduction Act of 1995 by 

February 15, 2013, (see the ‘‘Paperwork 

Reduction Act of 1995’’ section of this 

document). 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2011–N– 

0920 and/or RIN 0910–AG36, by any of 

the following methods, except that 

comments on information collection 

issues under the Paperwork Reduction 

Act of 1995 must be submitted to the 

Office of Regulatory Affairs, Office of 

Management and Budget (OMB) (see the 

‘‘Paperwork Reduction Act of 1995’’ 

section of this document). 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

Docket No. for this rulemaking. All 

comments received may be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

With regard to the proposed rule: Jenny 

Scott, Center for Food Safety and 

Applied Nutrition (HFS–300), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 240– 

402–2166. 

With regard to the information 

collection: Domini Bean, Office of 

Information Management, Food and 

Drug Administration, 1350 Picard Dr., 

PI50–400T, Rockville, MD 20850, 

domini.bean@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

Executive Summary 

Purpose and Coverage of the Proposed Rule 

Summary of the Major Provisions of the 

Proposed Rule 

Costs and Benefits 

I. Introduction 

II. Background 

A. Regulatory Framework for Human Food 

B. FDA Food Safety Modernization Act 

C. Preventive Controls and Hazard 

Analysis and Critical Control Points 

(HACCP) Systems 

D. Food Safety Problems Associated With 

Manufacturing, Processing, Packing, and 

Holding Food for Human Consumption 

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Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 3647 

E. The Role of Testing as a Verification 

Measure in a Food Safety System 

F. The Role of Supplier Approval and 

Verification Programs in a Food Safety 

System 

III. Legal Authority 

A. Changes to Current 21 CFR Part 1, 

Subparts H, I, and J 

B. Changes to Current 21 CFR Part 110 

C. Hazard Analysis and Risk-Based 

Preventive Controls 

IV. Public Meeting and Preliminary 

Stakeholder Comments 

A. Introduction 

B. Comments on Allergen Control 

C. Comments on Accredited Laboratories 

D. Comments on Environmental 

Monitoring and Product Testing 

E. Comments on Flexibility of Regulations 

and Guidance 

F. Comments on Food Defense 

G. Comments on Guidance and Outreach 

H. Comments on Preventive Controls 

I. Comments on Small and Very Small 

Business 

J. Comments on Submission of Food Safety 

Plan to FDA 

K. Comments on Modified Requirements 

for Warehouses 

V. Placement of Regulatory Requirements 

VI. Highlights of the Proposed Rule 

A. Overview 

B. Proposed Revisions to 21 CFR Part 1, 

Subparts H, I, and J 

C. Proposed Revisions to General 

Provisions of 21 CFR Part 110 (Part 110) 

(Proposed Part 117, Subpart A) 

D. Proposed Revisions to Current Good 

Manufacturing Practice Requirements of 

Part 110 (Proposed Part 117, Subpart B) 

E. Proposed New Requirements for Hazard 

Analysis and Risk-Based Preventive 

Controls (Proposed Part 117, Subpart C) 

F. Proposed New Provisions for Modified 

Requirements (Proposed Part 117, 

Subpart D) 

G. Proposed New Provisions for 

Withdrawal of an Exemption Applicable 

to a Qualified Facility (Proposed Part 

117, Subpart E) 

H. Proposed New Recordkeeping 

Requirements (Proposed Part 117, 

Subpart F) 

VII. Compliance Dates 

VIII. Rulemaking Required by Section 103(c) 

of FSMA: On-Farm Activities 

A. Section 103(c) of FSMA 

B. The Current Legal and Regulatory 

Framework Under Sections 415 and 418 

of the FD&C Act and Regulations 

Implementing Section 415 of the FD&C 

Act 

C. Why This Rulemaking Is Needed 

D. Organizing Principles for How the 

Status of a Food As a Raw Agricultural 

Commodity or As a Processed Food 

Affects the Requirements Applicable to a 

Farm Under Sections 415 and 418 of the 

FD&C Act 

E. Proposed Revisions to 21 CFR Part 1 

F. Impact of Proposed Revisions to the 

Definitions in 21 CFR Part 1 

G. Qualitative Risk Assessment of On-Farm 

Activities Outside of the Farm Definition 

H. Results of the Qualitative Risk 

Assessment 

I. Tentative Conclusions Regarding OnFarm Low-Risk Activity/Food 

Combinations Under Section 418 of the 

FD&C Act 

J. Tentative Conclusions Regarding OnFarm Low-Risk Activity/Food 

Combinations Under Section 421 of the 

FD&C Act 

IX. Proposed General Revisions to Current 

Part 110 

A. Title 

B. Proposed Redesignations 

C. Proposed Revisions for Consistency of 

Terms 

D. Proposed Additions Regarding CrossContact 

E. Proposed Revisions for Consistency 

With the Definition of ‘‘Food’’ 

F. Proposed Revisions To Address 

Guidance in Current Part 110 

G. Proposed Editorial Changes 

X. Proposed Revisions to General Provisions 

of Part 110 (Proposed Part 117, Subpart 

A) 

A. Proposed § 117.1—Applicability and 

Status 

B. Proposed § 117.3—Definitions 

C. Proposed § 117.5—Exemptions 

D. Proposed § 117.7—Applicability of Part 

117 to a Facility Solely Engaged in the 

Storage of Packaged Food That is Not 

Exposed to the Environment 

XI. Proposed Revisions to Current Good 

Manufacturing Practice Requirements of 

Part 110 (Proposed Part 117, Subpart B) 

A. Proposed Deletion of Guidance From 

Current Part 110 

B. Other Potential Revisions to Current 

Guidance 

C. Proposed Revisions for Consistency of 

Terms 

D. Proposed Revisions To Address CrossContact 

E. Proposed and Potential Revisions to 

Current § 110.10—Personnel (Proposed 

§ 117.10) 

F. Proposed Revisions to Current 

§ 110.20—Plant and Grounds (Proposed 

§ 117.20) 

G. Proposed Revisions to Current 

§ 110.35—Sanitary Operations (Proposed 

§ 117.35) 

H. Proposed Revisions to Current 

§ 110.37—Sanitary Facilities and 

Controls (Proposed § 117.37) 

I. Proposed Revisions to Current § 110.40— 

Equipment and Utensils (Proposed 

§ 117.40) 

J. Proposed Revisions to Current § 110.80— 

Processes and Controls (Proposed 

§ 117.80) 

K. Proposed Revisions to Current 

§ 110.93—Warehousing and Distribution 

(Proposed § 117.93) 

L. Proposed Revisions to Current 

§ 110.110—Natural or Unavoidable 

Defects in Food for Human Use That 

Present No Health Hazard (Proposed 

§ 117.110) 

M. Potential Revisions to Establish 

Requirements in Place of Current 

Guidance 

N. Request for Comment on Additional 

CGMP Requirements 

XII. Proposed New Requirements for Hazard 

Analysis and Risk-Based Preventive 

Controls (Proposed Part 117, Subpart C) 

A. Proposed § 117.126—Requirement for a 

Food Safety Plan 

B. Proposed § 117.130—Hazard Analysis 

C. Proposed § 117.135—Preventive 

Controls for Hazards That Are 

Reasonably Likely To Occur 

D. Proposed § 117.137—Recall Plan for 

Food With a Hazard That Is Reasonably 

Likely To Occur 

E. Proposed § 117.140—Monitoring 

F. Proposed § 117.145—Corrective Actions 

G. Proposed § 117.150—Verification 

H. Proposed § 117.155—Requirements 

Applicable to a Qualified Individual 

I. Proposed § 117.175—Records Required 

for Subpart C 

J. Request for Comment on Additional 

Preventive Controls and Verification 

Procedures Not Being Proposed 

K. Request for Comment on Other Potential 

Provisions Not Explicitly Included in 

Section 418 of the FD&C Act 

XIII. Proposed New Provisions for Modified 

Requirements (Proposed Part 117, 

Subpart D) 

A. Proposed § 117.201—Modified 

Requirements That Apply to a Qualified 

Facility 

B. Proposed § 117.206—Modified 

Requirements That Apply to a Facility 

Solely Engaged in the Storage of 

Packaged Food That Is Not Exposed to 

the Environment 

XIV. Proposed New Provisions for 

Withdrawal of an Exemption Applicable 

to a Qualified Facility (Proposed Part 

117, Subpart E) 

A. Requirements of Section 418 of the 

FD&C Act 

B. Proposed § 117.251—Circumstances 

That May Lead FDA To Withdraw an 

Exemption Applicable to a Qualified 

Facility 

C. Proposed § 117.254—Issuance of an 

Order To Withdraw an Exemption 

Applicable to a Qualified Facility 

D. Proposed § 117.257—Contents of an 

Order To Withdraw an Exemption 

Applicable to a Qualified Facility 

E. Proposed § 117.260—Compliance With, 

or Appeal of, an Order To Withdraw an 

Exemption Applicable to a Qualified 

Facility 

F. Proposed § 117.264—Procedure for 

Submitting an Appeal 

G. Proposed § 117.267—Procedure for 

Requesting an Informal Hearing 

H. Proposed § 117.270—Requirements 

Applicable to an Informal Hearing 

I. Proposed § 117.274—Presiding Officer 

for an Appeal and for an Informal 

Hearing 

J. Proposed § 117.277—Time Frame for 

Issuing a Decision on an Appeal 

K. Proposed § 117.280—Revocation of an 

Order To Withdraw an Exemption 

Applicable to a Qualified Facility 

L. Proposed § 117.284—Final Agency 

Action 

M. Conforming Amendments to 21 CFR 

Part 16 

XV. Proposed New Recordkeeping 

Requirements (Proposed Part 117, 

Subpart F) 

A. Relevant Statutory Provisions 

B. Proposed § 117.301—Records Subject to 

the Requirements of this Subpart F 

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3648 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

C. Proposed § 117.305—General 

Requirements Applying to Records 

D. Proposed § 117.310—Additional 

Requirements Applying to the Food 

Safety Plan 

E. Proposed § 117.315—Requirements for 

Record Retention 

F. Proposed § 117.320—Requirements for 

Official Review 

G. Proposed § 117.325—Public Disclosure 

XVI. FSMA’s Rulemaking Provisions 

A. Requirements in Section 418(n)(3) of the 

FD&C Act Regarding Content 

B. Requirements in Section 418(n)(5) of the 

FD&C Act Regarding Review of Hazard 

Analysis and Preventive Controls 

Programs in Existence on the Date of 

Enactment of FSMA 

XVII. Proposed Removal of 21 CFR Part 

110—Current Good Manufacturing 

Practice In Manufacturing, Packing, Or 

Holding Human Food 

XVIII. Proposed Conforming Amendments 

XIX. Preliminary Regulatory Impact Analysis 

A. Overview 

B. Regulatory Flexibility Act 

C. Small Business Regulatory Enforcement 

Fairness Act of 1996 

D. Unfunded Mandates Reform Act of 1995 

E. Paperwork Reduction Act of 1995 

F. Public Access to the Analyses 

XX. Analysis of Environmental Impact 

XXI. Federalism 

XXII. Comments 

XXIII. References 

Appendix 

I. The Role of Testing as a Verification 

Measure in a Modern Food Safety 

System 

A. Verification of Preventive Controls 

B. Scientifically Valid Sampling and 

Testing 

C. Verification Testing of Raw Materials 

and Ingredients 

D. Verification of Sanitation Controls to 

Significantly Minimize or Prevent the 

Potential for an Environmental Pathogen 

to Contaminate Food 

E. Role of Environmental Monitoring in 

Verifying the Implementation and 

Effectiveness of Sanitation Controls in 

Significantly Minimizing or Preventing 

the Potential for an Environmental 

Pathogen to Contaminate Food 

F. The Role of Finished Product Testing in 

Verifying the Implementation and 

Effectiveness of Preventive Controls 

G. Metrics for Microbiological Risk 

Management 

II. The Role of Supplier Approval and 

Verification Programs in a Food Safety 

System 

III. References 

Executive Summary 

Purpose and Coverage of the Proposed 

Rule 

The proposed rule would revise 

FDA’s current good manufacturing 

practice (CGMP) regulations regarding 

the manufacturing, processing, packing, 

or holding of human food in two 

fundamental ways. First, it would add 

new preventive controls provisions as 

required by the FDA Food Safety 

Modernization Act (FSMA). In general, 

with some exceptions the new 

preventive controls provisions would 

apply to facilities that are required to 

register with FDA under FDA’s current 

food facility registration regulations. 

These preventive controls would 

include requirements for covered 

facilities to maintain a food safety plan, 

perform a hazard analysis, and institute 

preventive controls for the mitigation of 

those hazards. Facilities would also be 

required to monitor their controls, verify 

that they were effective, take any 

appropriate corrective actions, and 

maintain records documenting these 

actions. Second, the proposed rule 

would update, revise, or otherwise 

clarify certain requirements of our 

CGMP regulations, which were last 

updated in 1986. 

In addition, this proposed rule would 

clarify the scope of the exemption for 

‘‘farms’’ in FDA’s current food facility 

registration regulations and make 

corresponding clarifications to FDA’s 

current regulations for the 

establishment, maintenance, and 

availability of records. These 

clarifications would affect who would 

be subject to the current regulations for 

registration and recordkeeping as well 

as the new preventive controls 

requirements that would be established 

by this proposed rule. 

To put these changes in context, and 

to provide legal, regulatory, scientific, 

and technical information relevant to 

the new provisions, we provide several 

sections of background. This 

background discusses the history of 

food regulation and current regulatory 

framework, provides an overview of the 

provisions of FSMA applicable to this 

proposed rule, explains the principles 

and history of the use of Hazard 

Analysis and Critical Control Point 

(HACCP) systems, and describes a 

variety of hazards that have been 

associated with foods and food safety 

problems (including outbreaks of 

foodborne illness) that have resulted 

from these hazards. An Appendix also 

describes the role of testing as a 

verification measure in a food safety 

system, and the role of supplier 

approval and verification programs in a 

food safety system. 

Summary of the Major Provisions of the 

Proposed Rule 

The proposed rule would implement 

the requirements of FSMA for covered 

facilities to establish and implement a 

food safety system that includes a 

hazard analysis and risk-based 

preventive controls. Specifically, the 

proposed rule would establish 

requirements for: 

• A written food safety plan; 

• Hazard analysis; 

• Preventive controls for hazards that 

are reasonably likely to occur; 

• Monitoring; 

• Corrective actions; 

• Verification; and 

• Associated records. 

The application of the preventive 

controls would be required only in cases 

where facilities determine that hazards 

are reasonably likely to occur. We do 

not expect that all possible preventive 

measures and verification procedures 

would be applied to all foods at all 

facilities. 

The proposed rule would also 

establish a series of exemptions 

(including modified requirements in 

some cases) from the requirements for 

hazard analysis and preventive controls. 

Facilities that manufacture, process, 

pack or hold food and that are required 

to register with FDA under section 415 

of the FD&C Act would be required to 

comply with the proposed regulation 

unless they are covered by an 

exemption. The table immediately 

below summarizes these proposed 

exemptions in general terms. 

Importantly, the table in this Executive 

Summary does not include all the 

details that you must consider to 

determine whether an exemption 

applies to you. We provide those details 

in the proposed regulation (proposed 

§ 117.5) and explain them in section X.C 

of this document. 

PROPOSED EXEMPTIONS FROM THE NEW REQUIREMENTS FOR HAZARD ANALYSIS AND RISK-BASED PREVENTIVE

CONTROLS

Who or what would be exempt from the requirements for hazard analysis and risk-based preventive controls Notes 

‘‘Qualified Facility’’ as defined by FSMA: FDA is proposing three options for defining ‘‘very small business’’ and 

requests comment on which to adopt in a final rule. 

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Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 3649 

PROPOSED EXEMPTIONS FROM THE NEW REQUIREMENTS FOR HAZARD ANALYSIS AND RISK-BASED PREVENTIVE

CONTROLS—Continued 

Who or what would be exempt from the requirements for hazard analysis and risk-based preventive controls Notes 

• Business with average annual sales of < $500,000 and at least 

half the sales to consumers or local retailers or restaurants 

(within the same state or within 275 miles); or.

Modified requirements would apply—i.e., a qualified facility would be 

required to: 

• Notify FDA about its status; and 

• Either: 

Æ Notify FDA that it is addressing hazards through preventive controls and monitoring; or 

Æ Notify FDA that it complies with applicable local regulations, and 

notify consumers of the name and complete business address of 

the facility where the food was manufactured or processed. 

• Very small business.

• Option 1: Average annual sales of < $250,000.

• Option 2: Average annual sales of < $500,000.

• Option 3: Average annual sales of <$1,000,000.

• Low risk, on farm activities performed by small business (< 500 

employees).

Small and very small on-farm businesses conducting these low risk activities would be exempt from most of the rule’s requirements. 

-or- 

• Low-risk, on-farm activities performed by a very small business We would define the low-risk activities that qualify for the exemption, 

including the specific foods to which they relate (such as re-packing 

intact fruits and vegetables, or grinding/milling/cracking/crushing 

grains) 

Æ Option 1: very small = <$250,000.

Æ Option 2: very small = <$500,000.

Æ Option 3: very small = <$1,000,000.

Activities that are subject to the seafood HACCP requirements of part 

123 (21 CFR part 123).

The facility must be in compliance with part 123. 

Activities that are subject to the juice HACCP requirements of part 120 

(21 CFR part 120).

The facility must be in compliance with part 120. 

Activities that are subject to the ‘‘low-acid canned food’’ requirements 

of part 113 (21 CFR part 113).

• The exemption applies only with respect to microbiological hazards. 

• The facility must be in compliance with part 113. 

The manufacturing, processing, packing, or holding of a dietary supplement that is subject to the CGMP requirements of part 111 (21 CFR 

part 111).

• The facility must be in compliance with part 111. 

• The facility must be in compliance with requirements for serious adverse event reporting for dietary supplements 

Activities of a facility that are subject to section 419 of the FD&C Act 

(Standards for Produce Safety).

Elsewhere in this issue of the Federal Register, FDA is proposing 

standards for produce safety. 

Alcoholic beverages at a facility that is required to obtain a permit from, 

register with, or obtain approval of a notice or application from the 

Secretary of the Treasury as a condition of doing business in the 

United States.

The exemption also would apply to food other than alcoholic beverages 

at such a facility, provided that the food is in prepackaged form and 

constitutes not more than 5 percent of the overall sales of the facility. 

Facilities that are solely engaged in the storage of raw agricultural 

commodities (other than fruits and vegetables) intended for further 

distribution or processing.

A facility that stores raw agricultural commodities that are fruits and 

vegetables would not be exempt. 

A facility solely engaged in the storage of packaged food that is not exposed to the environment.Modified requirements would apply for the storage of refrigerated packaged food. 

The proposed rule also would 

establish the conditions under which an 

exemption granted to a ‘‘qualified 

facility’’ could be withdrawn, and the 

procedures that would be followed to 

withdraw such an exemption. The 

proposed rule would establish 

requirements that would apply to all 

records that would be required by the 

various proposed provisions. The 

proposed recordkeeping provisions 

would implement specific requirements 

of FSMA regarding records associated 

with the new provisions for hazard 

analysis and risk-based preventive 

controls and would allow facilities to 

show, and FDA to determine, 

compliance with the regulatory 

requirements. 

The proposed rule would require that 

a qualified individual prepare the food 

safety plan, validate preventive controls, 

review records for implementation and 

effectiveness of preventive controls and 

the appropriateness of corrective 

actions, and perform the required 

reanalysis of a food safety plan. The 

proposed rule also would establish 

minimum requirements for the 

‘‘qualified individual,’’ who would be 

required to successfully complete 

training with a standardized curriculum 

or be otherwise qualified through job 

experience to develop and apply a food 

safety system. Only a trained individual 

or individual qualified by job 

experience is capable of effectively 

executing these activities. 

FDA is requesting comment on when 

and how other elements of a preventive 

controls system are an appropriate 

means of implementing the statutory 

directives, including: a product testing 

program, an environmental monitoring 

program, and a supplier approval and 

verification program, as appropriate. 

Costs and Benefits 

We summarize the domestic 

annualized costs of the three options for 

the proposed rule in the table 

immediately below. We are unable to 

estimate the benefits of the proposed 

rule. Instead we show the Breakeven 

Illness Percentage for each of the three 

options for the proposed rule. This is 

calculated by dividing the number of 

illnesses that would have to be 

prevented annually under each option 

by the total estimated number of 

illnesses attributable to FDA-regulated 

food products under the scope of each 

option of the proposed rule. This 

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3650 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

ignores the costs to foreign firms and 

benefits to foreign consumers. 

Total domestic costs annualized at 7 

per cent over 7 years 

Annual breakeven illness percentage 

Proposed Rule with Very Small Business Defined as Less Than or Equal to 

$250,000 in Annual Revenue.

$475 million ......................................... 24 

Proposed Rule with Very Small Business Defined as Less Than or Equal to 

$500,000 in Annual Revenue.

$395 million ......................................... 20 

Proposed Rule with Very Small Business Defined as Less Than or Equal to 

$1,000,000 in Annual Revenue.

$319 million ......................................... 16 

I. Introduction 

Each year, about 48 million 

Americans (1 in 6) get sick, 128,000 are 

hospitalized, and 3,000 die from foodborne diseases, according to recent 

estimates from the Centers for Disease 

Control and Prevention (CDC). This is a 

significant public health burden that is 

largely preventable. While many 

illnesses are the result of improper food 

handling practices in the home and food 

service settings, which would not be 

addressed by this proposed rule, FDA 

believes that improvements to its 

current good manufacturing practice 

(CGMP) regulations in part 110 (21 CFR 

part 110), including those prescribed by 

the FDA Food Safety Modernization Act 

(FSMA) (Pub. L. 111–533), can play an 

important role in reducing foodborne 

illness. 

FSMA, signed into law by President 

Obama on January 4, 2011, enables FDA 

to better protect public health by 

helping to ensure the safety and security 

of the food supply. FSMA enables us to 

focus more on preventing food safety 

problems rather than relying primarily 

on reacting to problems after they occur. 

The law also provides us with new 

enforcement authorities to help achieve 

higher rates of compliance with riskbased, prevention-oriented safety 

standards and to better respond to and 

contain problems when they do occur. 

In addition, the law gives us important 

new tools to better ensure the safety of 

imported foods and directs us to build 

an integrated national food safety 

system in partnership with State, local, 

tribal, and territorial authorities. 

This new law continues efforts by the 

food industry and government to protect 

and improve the safety of the nation’s 

food supply. At the Federal level, these 

efforts go back to the Pure Food and 

Drug Act of 1906, the United States’ first 

national food safety law. FSMA carries 

forward the basic principle embodied in 

the 1906 law that food establishments 

have the primary responsibility and 

capacity to make food safe and that 

government’s role is to set standards for 

food safety and provide oversight to 

help ensure standards are met. 

Since passage of the 1906 Act, and the 

most recent revision of its basic food 

safety provisions in the Federal Food, 

Drug, and Cosmetic Act of 1938, the 

combined efforts of the food industry 

and government have produced a set of 

standards and practices that make the 

U.S. food supply among the safest in the 

world. These efforts include the 

development and adoption by FDA of 

CGMP standards that have long 

provided the regulatory foundation for 

food safety. They also include, in more 

recent years, the adoption for some 

elements of the food supply of more 

targeted, risk-based approaches, such as 

the Hazard Analysis and Critical Control 

Points (HACCP) approach to food safety. 

HACCP was pioneered by the food 

industry and reflects the understanding 

that food safety is best assured if each 

producer and processor understands the 

hazards that are reasonably likely to 

occur in their particular product and 

operation and puts in place 

scientifically sound preventive controls 

to significantly minimize or eliminate 

the hazard. FDA has by regulation 

required seafood and juice processors to 

implement the HACCP approach to 

preventive controls. The U.S. 

Department of Agriculture (USDA) has 

also mandated HACCP for meat and 

poultry processors, and many food 

companies have implemented such 

modern preventive control systems for 

other commodities. 

While these efforts have contributed 

to progress on food safety, and the 

United States has one of the safest food 

supplies in the world, significant food 

safety challenges persist in today’s 

complex, dynamic, and global food 

system. Today’s food supply is highly 

diverse and increasingly complex, with 

many new foods in the marketplace that 

pose new food safety challenges. New 

pathogens are emerging, and we are 

seeing commonly known pathogens 

appear in foods where they have not 

been traditionally seen. The population 

of individuals at greater risk for 

foodborne illness, such as those who are 

immune-compromised, is increasing. 

When illness outbreaks occur, they can 

have devastating impacts on public 

health and impose substantial economic 

disruption and cost on the food 

industry. The food safety challenge is 

only compounded by globalization, 

which has resulted in approximately 15 

percent of the U.S. food supply being 

imported, including 80 percent of our 

seafood, 50 percent of our fresh fruit, 

and 20 percent of our vegetables. 

Congress responded to today’s food 

safety challenges by enacting FSMA. 

FSMA builds on past experience and 

the strong foundation provided by the 

current food safety system, but it also 

marks an historic turning point for food 

safety. FSMA directs FDA to build a 

food safety system for the future that 

makes modern, science- and risk-based 

preventive controls the norm across all 

sectors of the food system; meets the 

food safety challenges of the global food 

system; and establishes stronger 

partnerships for food safety across all 

levels of government and with the 

private sector to ensure optimal use of 

public and private resources. FDA has 

embarked on a comprehensive effort to 

build the food safety system mandated 

by Congress, as described on its FSMA 

implementation web page at http:// 

www.fda.gov/fsma. 

A top priority for FDA are those 

FSMA-required regulations that provide 

the framework for industry’s 

implementation of preventive controls 

and FDA’s ability to oversee their 

implementation for both domestic and 

imported food. These include, among 

others, regulations establishing 

preventive control standards for human 

food and animal food facilities, produce 

safety standards, standards that define 

the accountability of importers to verify 

the safety of food produced overseas, 

and a new program for accrediting 

public and private bodies to provide 

credible certifications that regulated 

entities are meeting U.S. safety 

standards. A proposed rule on foreign 

supplier verification is closely 

interconnected to this rule on 

preventive controls for human food, and 

is expected to publish soon. 

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In this document, we propose 

standards to implement the requirement 

in section 103 of FSMA for the adoption 

of preventive controls in human food 

facilities. The preamble that follows 

provides critical background on FDA’s 

previous efforts in establishing and 

implementing CGMPs and preventive 

controls, because these past efforts are 

the critical starting point and 

foundation for FSMA implementation. 

The preamble then explains and 

provides background on the rationale 

for our proposed updating of current 

CGMP requirements and for the new 

rules implementing FSMA’s preventive 

controls requirement. We are seeking 

comments on all aspects of this 

proposal. 

II. Background 

A. Regulatory Framework for Human 

Food 

1. Current Good Manufacturing Practice 

in Manufacturing, Packing or Holding 

Human Food 

In the Federal Register of April 26, 

1969, FDA issued a final rule to 

establish in 21 CFR part 128 CGMP 

requirements for the manufacturing, 

processing, packing, or holding of 

human food (34 FR 6977). The CGMP 

regulation established criteria for 

effective sanitation control in the 

manufacture, processing, packing, or 

holding of human foods to effect 

compliance with section 402(a)(4) of the 

FD&C Act (21 U.S.C. 342(a)(4)), under 

which food is adulterated if it has been 

prepared, packed, or held under 

insanitary conditions whereby it may 

have become contaminated with filth, or 

whereby it may have been rendered 

injurious to health (33 FR 19023, 

December 20, 1968). In 1973, we 

amended the CGMP regulation by 

adding a new section regarding natural 

or unavoidable defect levels in foods. 

(38 FR 854, January 5, 1973). In 1977, 

we redesignated the CGMP regulation as 

part 110 (21 CFR part 110) (42 FR 14301 

at 14338, March 5, 1977). 

In the Federal Register of June 19, 

1986, FDA issued a final rule to revise 

the CGMP regulation in part 110 

(hereinafter current part 110) (51 FR 

22458). That final rule established new, 

updated, and more detailed CGMP 

requirements for food industry 

personnel; plants and grounds; sanitary 

facilities, controls, and operations; 

equipment and utensils; processes and 

controls; warehousing and distribution; 

and natural or avoidable defect levels 

(51 FR 22458). During the rulemaking to 

establish current part 110, we clarified 

that the CGMP regulations also identify 

the applicable criteria for implementing 

the requirements of section 402(a)(3) of 

the FD&C Act (21 U.S.C. 342(a)(3)), such 

that compliance with the CGMP 

requirements is also required to ensure 

that food does not consist in whole or 

in part of any filthy, putrid, or 

decomposed substance, or are otherwise 

unfit for food (51 FR 22458 at 22462). 

In addition, we noted that the CGMP 

requirements in part 110 serve two 

purposes: (1) To provide guidance on 

how to reduce insanitary manufacturing 

practices and on how to protect against 

food becoming contaminated; and (2) to 

state explicit, objective requirements 

that enable industry to know what FDA 

expects when an investigator visits one 

of its plants (51 FR 22458 at 22459). 

In the rulemaking to establish current 

part 110, we also invoked section 361 of 

the Public Health Service Act (PHS Act) 

(42 U.S.C. 264), which authorizes FDA 

to issue regulations for any 

requirements that, in the 

Commissioner’s judgment, are necessary 

to prevent the introduction, 

transmission, or spread of food-borne 

communicable diseases from one State 

to another (44 FR 33238 at 33239, June 

8, 1979). As we noted in that 

rulemaking, ‘‘[b]ecause this authority is 

designed to eliminate the introduction 

of diseases * * * from one State to 

another, this authority must of necessity 

be exercised upon the disease-causing 

substance within the State where the 

food is manufactured, processed, or 

held,’’ and that ‘‘[d]ue to the 

nationwide, interrelated structure of the 

food industry, communicable diseases 

may, without proper intrastate food 

controls, easily spread interstate’’ (44 FR 

33238 at 33239). 

Current part 110 serves as an 

‘‘umbrella’’ regulation applicable to the 

manufacturing, processing, packing, or 

holding of all human food, with the 

exception that it does not apply to 

establishments engaged solely in the 

harvesting, storage, or distribution of 

raw agricultural commodities (RACs) 

which are ordinarily cleaned, prepared, 

treated, or otherwise processed before 

being marketed to consumers 

(§ 110.19(a)). 

In 2002, FDA convened a CGMP 

Modernization Working Group (the 

CGMP Working Group) to determine 

whether part 110 is in need of further 

revision. The CGMP Working Group 

initiated research programs, presented 

preliminary findings, and solicited 

public comments, data, and scientific 

information through three public 

meetings (69 FR 40312, July 2, 2004). In 

2005, the CGMP Working Group issued 

a report (hereinafter the CGMP Working 

Group Report) summarizing the oral and 

written comments we received in 

response to the Federal Register notice 

announcing the public meetings, as well 

as our key findings (Ref. 1). 

The CGMP Working Group Report 

presented seven ‘‘opportunities’’ for 

CGMP modernization. The report called 

for: 

• Requiring appropriate training for 

food production supervisors and 

workers, including the maintenance of 

personnel training records; 

• Requiring the creation and 

implementation of a written food 

allergen control plan for food processing 

establishments that handle major food 

allergens; 

• Requiring a written environmental 

pathogen control program, including the 

maintenance of appropriate 

implementation records, for food 

processors that produce ready-to-eat 

foods that support the growth of the 

pathogenic microorganism Listeria 

monocytogenes; 

• Requiring food processors to 

develop and maintain written cleaning 

and sanitation procedures, at a 

minimum for all food-contact 

equipment and food-contact surfaces, 

that define the scope, cleaning or 

sanitation objective, management 

responsibility, monitoring, corrective 

action, and recordkeeping associated 

with the cleaning or sanitation 

procedure; 

• Considering whether to remove the 

current exemption for facilities solely 

engaged in the harvesting, packing, 

storage, and distribution of RACs by 

requesting further public comment on 

this issue; 

• Requiring food processors to 

maintain certain critical records that 

document that controls and systems that 

ensure food safety are being properly 

implemented and requiring that FDA be 

given access to such documents to 

verify compliance with the CGMP 

requirements; and 

• Requesting further public 

comments and suggestions regarding 

how the use of time-temperature 

relationships can be incorporated into 

CGMP regulations or guidances for 

proper refrigerated storage or hot 

holding (Ref. 1). 

2. Other Food Safety Regulations 

Established by FDA 

Although the umbrella CGMP 

requirements of current part 110 apply 

to the full range of human food, FDA 

concluded over time that they do not 

directly address unique safety issues 

associated with the manufacturing, 

processing, packing, or holding of 

certain specific types of food products. 

We therefore promulgated additional 

food safety regulations to provide for 

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specific process controls for the 

manufacturing, processing, packing, or 

holding of certain specific foods that are 

not captured by the more general part 

110 CGMP requirements. Currently, 

such specific food safety regulations 

include those for: 

• Thermally processed low-acid foods 

packaged in hermetically sealed 

containers (i.e., ‘‘low-acid canned 

foods,’’ hereinafter referred to as LACF) 

(part 113 (21 CFR part 113)) (Although 

some hermetically sealed containers 

(e.g., pouches and glass bottles) used to 

package thermally processed low-acid 

foods generally would not be viewed as 

‘‘cans,’’ the term ‘‘low-acid canned 

foods’’ has been used for decades as a 

shorthand description for ‘‘thermally 

processed low-acid foods packaged in 

hermetically sealed containers,’’ and we 

continue to use that term and its 

abbreviation, LACF, for the purposes of 

this document); 

• Acidified food (part 114 (21 CFR 

part 114)); 

• Bottled drinking water (part 129 (21 

CFR part 129)); 

• Infant formula (parts 106 and 107 

(21 CFR parts 106 and 107)); 

• Fish and fishery products (part 123 

(21 CFR part 123)); 

• Juice (part 120 (21 CFR part 120)); 

• Dietary supplements (part 111 (21 

CFR part 111)); 

• Refrigeration of shell eggs held for 

retail distribution (§ 115.50 (21 CFR 

115.50); and 

• Production, storage, and 

transportation of shell eggs (part 118) 

(21 CFR part 118)). 

We discuss these food safety 

regulations immediately below. 

a. Acidified food and LACF. In the 

Federal Register of January 24, 1973, 

FDA issued a final rule (the canned food 

CGMP regulation) to establish specific 

CGMP requirements to address safety 

issues unique to the manufacturing, 

processing, packing, and holding of 

thermally processed foods packaged in 

hermetically sealed containers (38 FR 

2398). In the Federal Register of May 

14, 1973, we issued a final rule to 

establish an emergency permit control 

regulation, in accordance with section 

404 of the FD&C Act (21 U.S.C. 344), to 

serve as an enforcement mechanism for 

the canned food regulation (38 FR 

12716). In the Federal Register of 

January 29, 1974, we issued a final rule 

to establish procedures to implement 

the emergency permit control 

enforcement mechanism (39 FR 3748). 

The emergency permit control 

regulation is currently codified in 21 

CFR part 108. 

In 1979, we issued a final rule to 

revise the canned food CGMP regulation 

and separate it into two distinct 

regulations. One of these regulations, 

established in part 113, is directed to 

the safe manufacturing, processing, 

packing, and holding of LACF (44 FR 

16209, March 16, 1979). The second 

regulation, established in part 114, is 

directed to the safe manufacturing, 

processing, packing, and holding of 

acidified foods (44 FR 16230, March 16, 

1979). Acidified foods are low-acid 

foods to which acid(s) or acid food(s) 

are added; they have a water activity 

greater than 0.85 and have a finished 

equilibrium pH of 4.6 or below; and 

certain foods are excluded from the 

coverage of part 114 (21 CFR 114.3(b)). 

In the Federal Register of March 16, 

1979, we also issued an emergency 

permit control regulation to serve as an 

enforcement mechanism for the new 

acidified foods regulation (44 FR 

16204). 

In establishing the regulations for 

LACF and acidified foods, FDA 

determined that CGMP regulations 

specific to LACFs and acidified foods 

are necessary to control the presence of 

Clostridium botulinum (C. botulinum), a 

bacterium commonly found in soil that 

can form spores that are capable of 

prolonged survival under adverse 

conditions and produce a botulinum 

toxin under anaerobic conditions, such 

as those in canned foods (41 FR 30442, 

July 23, 1976). Botulinum toxin can 

cause botulism, a rare but serious 

paralytic illness that can be fatal and is 

considered a medical emergency (Ref. 

2). The primary factors that determine 

the formation and growth of C. 

botulinum in food are pH, water 

activity, and storage conditions, and 

LACFs and acidified foods can pose a 

risk of botulism if these critical factors 

are not carefully controlled (44 FR 

16209). 

Part 113 establishes requirements for 

equipment; control of components, food 

product containers, closures, and inprocess material; production and 

process controls; and records and 

reports for LACF. Part 114 establishes 

requirements for production and 

process controls and records and reports 

for acidified foods. In light of the 

severity of the hazard presented by 

botulinum toxin, parts 113 and 114 

require that supervisory personnel be 

trained at schools approved by FDA 

(§§ 113.10 and 114.10, respectively). 

The enforcement regulations in 

§§ 108.25 and 108.35 require 

manufacturers, processors, and packers 

of acidified foods and LACF, 

respectively, to file food canning 

establishment registration information 

with FDA. The registration information 

must include, among other things: the 

name, principal place of business, and 

the location of the establishment 

engaged in the manufacturing, 

processing, or packing of acidified foods 

or LACF; processing methods; and a list 

of the foods prepared at the 

establishment (§§ 108.25(c) and 

108.35(c), respectively). Under the 

procedural enforcement regulations of 

subpart A of part 108, if after an 

investigation we determine that a 

manufacturer, processor, or packer of 

acidified foods or LACF is not in 

compliance with the requirements of 

§§ 108.25 or 108.35, respectively, we 

may issue an order requiring that the 

entity apply for and obtain a temporary 

emergency permit from us, which we 

might or might not issue, before 

introducing any acidified food or LACF 

into interstate commerce. Subpart A of 

part 108 also establishes the criteria and 

procedures related to a determination of 

the need for an emergency permit, 

revocation of the determination of need 

for an emergency permit, issuance or 

denial of an emergency permit, and 

suspension and reinstatement of an 

emergency permit. 

b. Bottled drinking water. In the 

Federal Register of November 26, 1973, 

FDA issued a final rule to establish 

quality standard regulations establishing 

allowable levels for microbiological, 

physical, chemical, and radiological 

contaminants in bottled drinking water 

(38 FR 32558). The quality standard 

regulation is codified at 21 CFR 

§ 165.110(b). In the Federal Register of 

March 12, 1975, we issued a final rule 

to establish CGMP requirements for the 

processing and bottling of bottled 

drinking water (40 FR 11566). The 

bottled water CGMP regulation is 

codified in part 129 (21 CFR part 129). 

FDA promulgated part 129 in light of 

surveys and analyses of field 

investigations that we and the U.S. 

Environmental Protection Agency (EPA) 

conducted in 1971 and 1972. The 

surveys and analyses revealed, among 

other things, that some bottled water 

failed to meet some of the prevailing 

regulatory criteria for non-bottled, 

public drinking water (38 FR 1019 at 

1019, January 8, 1973), some of the 

bottling plants surveyed did not 

conduct adequate bacteriological and 

chemical analyses of their products, and 

in other cases, bottling was not 

performed under sanitary conditions (38 

FR 32563). 

Part 129 requires that bottled water be 

safe and that it be processed, bottled, 

held, and transported under sanitary 

conditions. Processing practices 

addressed in part 129 include the 

protection of the water source from 

contamination, sanitation at the bottling 

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facility, and quality control to ensure 

the safety of the water. Part 129 also 

establishes certain analytical testing 

requirements for chemical, physical, 

radiological, and microbiological 

contaminants. 

c. Infant formula. The Infant Formula 

Act of 1980 (the 1980 infant formula act) 

(Pub. L. 96–359) amended the FD&C Act 

to include section 412 (21 U.S.C. 350a) 

and was intended to improve protection 

of infants consuming infant formula 

products by establishing greater 

regulatory control over the formulation 

and production of infant formula. 

Enactment of the law resulted largely 

from the emergence of a substantial 

number of cases involving a serious 

medical disorder known as 

hypochloremic metabolic alkalosis, 

which is most frequently characterized 

by an infant’s inability to thrive. The 

illnesses were found to be associated 

with prolonged exclusive use of soy 

protein-based infant formulas that 

lacked adequate amounts of the 

essential nutrient, chloride (45 FR 

86362 at 86362, December 30, 1980). 

In response to the 1980 act, FDA 

issued final rules to establish the 

following regulations regarding infant 

formula: 

• Subpart B of part 106 (21 CFR part 

106, subpart B) regarding infant formula 

quality control procedures (47 FR 

17016, April 20, 1982); 

• Subpart D of part 107 (21 CFR part 

107, subpart D) regarding infant formula 

recalls (47 FR 18832, April 30, 1982); 

• Subpart B of part 107 (21 CFR part 

107, subpart B) regarding the labeling of 

infant formula (50 FR 1833, January 4, 

1985); 

• Subpart C of part 107 (21 CFR part 

107, subpart C) regarding exempt infant 

formula (50 FR 48183, November 22, 

1985); 

• Subpart D of part 107 (21 CFR part 

107, subpart D) regarding nutrient 

requirements for infant formulas (50 FR 

45106, October 30, 1985). 

In 1986, Congress amended section 

412 of the FD&C Act as part of the AntiDrug Abuse Act of 1986 (Pub. L. 99– 

570) (the 1986 infant formula 

amendments) to address concerns 

regarding the sufficiency of quality 

control testing, CGMP, recordkeeping, 

and recall requirements. In 1989, FDA 

issued revised recall regulations in 

subpart E of part 107 (54 FR 4006, 

January 27, 1989), and in 1991, FDA 

issued regulations in § 106.100 to 

implement the provisions of the 1986 

infant formula amendments for records 

and record retention (56 FR 66566, 

December 24, 1991). 

In the Federal Register of July 9, 

1996, FDA issued a proposed rule to 

implement the remaining provisions of 

the 1986 infant formula amendments 

(61 FR 36154). Specifically, we 

proposed to amend the existing infant 

formula regulations in parts 106 and 107 

to: (1) Establish CGMPs, including 

microbiological testing; (2) revise the 

quality control procedures in part 106 to 

ensure that an infant formula contains 

the level of nutrients necessary to 

support infant growth and development; 

(3) specify audit procedures to ensure 

compliance with CGMP and quality 

control procedure regulations; (4) 

establish requirements for quality 

factors to ensure that required nutrients 

will be in a bioavailable form; (5) 

establish batch and CGMP 

recordkeeping requirements; (6) specify 

submission requirements for registration 

and notification to FDA before the 

introduction of an infant formula into 

interstate commerce; and (7) update 21 

CFR part 107 to reflect the 1986 

amendments. In 2002 and 2003, FDA 

held three Food Advisory Committee 

meetings (67 FR 12571, March 19, 2002; 

67 FR 63933; October 16, 2002; 68 FR 

8299; February 20, 2003). FDA reopened 

the comment period for the proposed 

rule twice (68 FR 22341, April 28, 2003; 

and 71 FR 43393, August 1, 2006). FDA 

is developing a final rule. 

d. Fish and fishery products. In the 

Federal Register of December 18, 1995, 

FDA issued a final rule to establish in 

part 123 procedures for the safe and 

sanitary processing and importing of 

fish and fishery products (60 FR 65096). 

Part 123 requires seafood processors to 

develop, implement, and document 

sanitation control procedures and 

mandates the application of HACCP 

procedures. In the remainder of this 

document, the phrases ‘‘seafood HACCP 

regulation’’ and ‘‘HACCP regulation for 

seafood’’ refer to part 123. We discuss 

the HACCP concept in more detail in 

section II.C of this document. We 

describe the seafood HACCP regulation 

in more detail in section II.C.5.a of this 

document. 

e. Juice. In the Federal Register of 

January 19, 2001, FDA issued a final 

rule to establish in part 120 (21 CFR part 

120) requirements to ensure the safe and 

sanitary processing and importation of 

fruit and vegetable juices and juice 

products by mandating the application 

of HACCP principles to the processing 

of these foods (66 FR 6138). In the 

remainder of this document, the phrases 

‘‘juice HACCP regulation’’ and ‘‘HACCP 

regulation for juice’’ refer to part 120. 

We describe the juice HACCP regulation 

in more detail in section II.C.5.c of this 

document. 

f. Dietary supplements. The Dietary 

Supplement Health and Education Act 

of 1994 (DSHEA) (Pub. L. 103–417) 

among other things added section 402(g) 

to the FD&C Act (21 U.S.C. 342(g)). 

Section 402(g)(2) in part authorizes the 

Secretary of HHS to promulgate 

regulations to prescribe CGMPs for 

dietary supplements. Section 402(g)(2) 

also stipulates that such regulations 

must be modeled after existing CGMP 

regulations for food. 

In the Federal Register of June 25, 

2007, FDA issued a final rule to 

establish in part 111 (21 CFR part 111) 

CGMP requirements for the 

manufacturing, packaging, labeling, and 

holding of dietary supplements to 

ensure their quality (72 FR 34752). FDA 

established part 111 because the 

umbrella food CGMP provisions of part 

110 alone do not adequately address the 

unique characteristics of dietary 

supplements (72 FR 34752 at 34761). 

For example, unlike most foods, the 

majority of dietary supplements are 

packaged into tablets, gel caps, and 

capsules; some dietary supplements 

may contain bioactive ingredients for 

which specific, controlled amounts are 

intended to be in each tablet or capsule; 

vitamins can present a concentrated 

source of biologically active 

components that have adverse health 

consequences at high doses; and herbal 

and botanical dietary supplements are 

often complex mixtures that can vary in 

composition and be contaminated with 

substances having adverse health 

consequences depending on factors 

such as the part of the plant used, the 

location of harvesting and growing 

conditions that can vary from year-toyear (72 FR 34752 at 34761). 

Part 111 includes those requirements 

of part 110 that are common to the 

manufacturing, packaging, labeling and 

holding of dietary supplements, such as 

requirements for personnel, physical 

plant and grounds, and equipment and 

utensils. Part 111 also establishes 

requirements such as for the use of 

written procedures for certain 

operations; a production and process 

control system that includes the 

establishment of specifications for 

incoming ingredients and finished 

product; certain requirements for testing 

of incoming ingredients and finished 

product; the establishment and 

implementation of quality control 

operations; the preparation and use of a 

written master manufacturing record for 

each unique formulation and for each 

batch size of a given dietary 

supplement; the preparation of an 

individual batch production record 

every time a dietary supplement batch 

is produced; the establishment and use 

of certain laboratory control processes; 

the investigation of any product 

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complaint that involves the possibility 

of a failure to meet any CGMP 

requirement; and the establishment and 

retention of records associated with the 

manufacture, packaging, labeling, or 

holding of a dietary supplement for 

specified periods of time. 

g. Refrigeration of shell eggs held for 

retail distribution. In the Federal 

Register of December 5, 2000, FDA 

issued a final rule that established in 

§ 115.50 (21 CFR 115.50) refrigeration 

requirements for shell eggs held for 

retail distribution (the shell egg 

refrigeration regulation) (65 FR 76092). 

FDA promulgated the shell egg 

refrigeration regulation to prevent 

foodborne illnesses and deaths resulting 

from the contamination of shell eggs 

with Salmonella Enteritidis (SE), a 

specific Salmonella serotype. As 

discussed in the proposed rule to 

establish the shell egg refrigeration 

regulation (64 FR 36492, July 6, 1999), 

the disease salmonellosis results from 

an intestinal infection with Salmonella 

microorganisms and is characterized by 

diarrhea, fever, abdominal cramps, 

headache, nausea, and vomiting. Most 

healthy people recover, but the infection 

can spread to the bloodstream, and then 

to other areas of the body, leading to 

severe and fatal illness, which is more 

likely to occur in children, the elderly, 

and persons with weakened immune 

systems. Salmonella spp. is among the 

leading bacterial causes of foodborne 

illness in the United States, and shell 

eggs are the predominant source of SE 

related cases of salmonellosis in the 

United States where a food vehicle is 

identified for the illness (64 FR 36492 

at 36493). 

The shell egg refrigeration regulation 

requires that shell eggs held at retail 

establishments be stored and displayed 

under refrigeration at a temperature of 

7.2 °C (45 °F) or less to help prevent the 

growth of Salmonella spp., except for 

shell eggs that have been specifically 

processed to destroy all viable 

Salmonella spp. that might be present. 

The shell egg refrigeration regulation 

includes administrative procedures with 

which refrigeration requirements may 

be enforced, including providing for the 

diversion or destruction of shell eggs 

that have been held in violation of the 

refrigeration requirements. 

h. Production, storage, and 

transportation of shell eggs. In the 

Federal Register of July 9, 2009 (74 FR 

33030), FDA issued a final rule to 

establish in part 118 (21 CFR part 118) 

requirements for shell egg producers to 

register with FDA, implement measures 

to prevent SE from contaminating eggs 

on the farm and from further growth 

during storage and transportation, and 

maintain records related to their 

compliance with the requirements of the 

regulation. As with the shell egg 

refrigeration rule, FDA promulgated part 

118 to reduce SE-associated illnesses 

and deaths by reducing the risk that 

shell eggs are contaminated with SE (74 

FR 33030). 

3. Food Safety Guidance to Industry 

FDA has issued numerous guidance 

documents (hereinafter, ‘‘guidance’’ or 

‘‘guidances’’) to assist the food industry 

in implementing food safety regulatory 

requirements under FDA’s jurisdiction. 

We issue guidances, in accordance with 

our regulations in § 10.115 (21 CFR 

10.115) for ‘‘good guidance practices,’’ 

to describe our interpretation of or 

policy on a regulatory issue. Guidances 

do not establish legally enforceable 

rights or responsibilities and do not 

legally bind the public or FDA 

(§ 10.115(d)(1)). Accordingly, regulated 

industry is not required to employ the 

approaches contained in a guidance and 

instead may choose to use an alternative 

approach, provided that the alternative 

approach complies with the relevant 

statutes and regulations (§ 10.115(d)(2)). 

Although guidances do not legally bind 

FDA, they represent our current 

thinking on a particular interpretation of 

or policy regarding a given regulatory 

issue (§ 10.115(d)(3)). Under 

§§ 10.115(c)(1) and (g), we publish a 

guidance in draft form for public 

comment before issuing the guidance in 

final form, except where prior public 

participation is not feasible or 

appropriate, if the guidance (1) sets 

forth initial interpretations of statutory 

or regulatory requirements, (2) sets forth 

changes in interpretation or policy that 

are of more than a minor nature; (3) 

includes complex scientific issues, or 

(4) covers highly controversial issues. 

FDA generally issues guidance to 

industry for the purpose of 

communicating our policy decisions 

and interpretations of our regulatory 

requirements so that regulated industry 

better understands how to comply with 

those requirements. In some cases, we 

issue guidance specifically targeted to 

assisting industry in complying with a 

particular food safety regulation. For 

example, we have issued guidances to 

assist industry in complying with the 

seafood HACCP regulation (Ref. 3) and 

the juice HACCP regulation (Ref. 4). In 

other cases, we issue guidance that is 

more narrowly focused in scope or is 

not directly targeted to assisting 

industry in complying with a particular 

food safety regulation. For example, we 

have issued guidance that addresses the 

chemical contamination of candy with 

lead (Ref. 5) and guidance on measures 

to address the risk for contamination by 

Salmonella spp. in food containing a 

peanut-derived product as an ingredient 

(Ref. 6). 

4. Food Safety Compliance Policy 

Guides 

FDA issues guidance to its staff in the 

form of compliance policy guides 

(CPGs). The primary purpose of a CPG 

is to explain FDA’s policy on regulatory 

issues related to the statutes and 

regulations that we are responsible for 

implementing. CPGs advise FDA field 

inspection and compliance personnel as 

to FDA’s standards and procedures to be 

applied when determining industry 

compliance with our regulatory 

requirements. FDA issues CPGs in 

accordance with our regulation for good 

guidance practices in § 10.115 and 

makes the CPGs available to the public, 

thereby providing regulated industry 

with additional insight into how we 

interpret the statutes and regulations we 

are responsible for implementing for 

purposes of assessing compliance with 

our regulatory requirements. In general, 

our food safety CPGs are relatively 

focused in scope. For example, we have 

issued a CPG regarding microbial 

contaminants in dairy products (Ref. 7 

Ref. 7), and a CPG that sets forth the 

criteria that are to be used by FDA 

personnel to determine whether foods 

other than dairy products will be 

considered adulterated because of the 

presence of Salmonella spp. (Ref. 8). 

5. Current Inspection System 

Section 704 of the FD&C Act 

authorizes FDA to enter and inspect 

establishments in which food is 

manufactured, processed, packed, or 

held and to inspect all pertinent 

equipment, finished and unfinished 

materials, containers, and labeling 

located in such establishments (21 

U.S.C. 374). We inspect food 

establishments both for cause, for 

example as part of foodborne illness 

outbreak investigations, and as a matter 

of routine practice. Section 421 of the 

FD&C Act (21 U.S.C. 350j), which was 

added to the FD&C Act by section 201 

of FSMA, directs FDA to ‘‘identify high 

risk-facilities and * * * allocate 

resources to inspect facilities according 

to the known safety risks of the 

facilities’’ as determined by several 

factors, including among other things 

‘‘[t]he known safety risks of the food 

manufactured, processed, packed, or 

held at the facility’’ and ‘‘[t]he 

compliance history of a facility’’ 

(Section 421(a)(1)). In addition, Section 

421 requires FDA to: immediately 

‘‘increase the frequency of inspection of 

all facilities,’’ and includes schedules 

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for the increased frequency with which 

‘‘domestic high-risk facilities,’’ 

‘‘domestic non-high risk facilities,’’ and 

‘‘foreign facilities’’ must be inspected 

over time (Section 421(a)(2)). Section 

421 also directs FDA to ‘‘allocate 

resources to inspect any article of food 

imported into the United States 

according to the known safety risks of 

the article of food’’ as determined by a 

number of factors, including among 

other things ‘‘[t]he known safety risks of 

the countries or regions’’ from which 

the food originates or through which it 

is transported, and ‘‘[t]he compliance 

history of the importer’’ (Section 

421(b)). 

FDA inspectors, or inspectors from 

other Federal agencies or the States 

authorized to conduct inspections on 

our behalf, inspect food establishments 

to determine whether the 

establishments are in compliance with 

the requirements of the FD&C Act and 

other applicable laws and regulations, 

and document their findings in 

Establishment Inspection Reports. 

Following an inspection, FDA may 

decide that: (1) No further action is 

required because no objectionable 

conditions or practices were found 

during the inspection; (2) voluntary 

action on the part of the food 

establishment is appropriate to correct 

violations that are serious enough to 

document but not serious enough to 

warrant a regulatory action, or (3) the 

practices and conditions discovered 

during the inspection are significant 

enough to require regulatory action by 

FDA (Ref. 9). 

If we decide to initiate a regulatory 

action against a food establishment, we 

may elect to take an advisory action, 

such as issuing a Warning Letter, an 

Untitled Letter, or scheduling a 

regulatory meeting (Ref. 10). If we 

determine that the conditions and 

practices found at a food establishment 

constitute serious violations of the law 

that cannot be, or have not been, 

resolved by voluntary compliance, we 

may decide to initiate an administrative 

or judicial action, such as an 

administrative detention, an order to 

cease distribution and give notice under 

section 423(b) of the FD&C Act (21 

U.S.C. 3501), a seizure of violative 

products, an injunction, or a criminal 

prosecution (Ref. 11) (Ref. 12). 

6. Systems for Identifying Food Safety 

Problems 

a. Contamination of food and 

foodborne illness. Food can become 

contaminated (e.g., with biological, 

chemical, physical, or radiological 

hazards) at many different steps in the 

farm-to-table continuum: on the farm; in 

packing, manufacturing/processing, or 

distribution facilities; during storage or 

transit; at retail establishments; in 

restaurants; and in the home. As 

discussed more fully in section II.D of 

this document, consumption of 

contaminated food can lead to acute or 

long term illness or injury. Early 

detection of contamination enables food 

establishments to prevent contaminated 

food from entering commerce. When 

contamination is not detected in time to 

prevent contaminated food from 

entering commerce, the contamination 

may be detected while the food is in 

storage or in transit; at retail 

establishments; in restaurants; or in the 

home. This often necessitates a recall to 

retrieve the contaminated product from 

commerce. 

We learn about contaminated food 

through a variety of mechanisms, 

including required reporting by 

industry; investigations of outbreaks of 

foodborne illness; recalls; and state 

surveillance and reporting programs. 

We discuss these mechanisms 

immediately below. 

b. Required reporting by industry. In 

some cases, a firm that manufactures, 

processes, packs, or holds food, or a 

regulatory official, detects 

contamination of a food in the market. 

This may occur even when there is no 

known or suspected association 

between the food and reports of 

foodborne illness. The Food and Drug 

Administration Amendments Act of 

2007 (Pub. L. 110–085) established, 

among other things, section 417 of the 

FD&C Act (21 U.S.C. 350f), which 

requires FDA to establish a Reportable 

Food Registry (RFR). A ‘‘reportable 

food’’ is an article of food (other than 

dietary supplements or infant formula) 

for which there is a reasonable 

probability that the use of, or exposure 

to, such article of food will cause 

serious adverse health consequences or 

death to humans or animals (Section 

417(a)(2) of the FD&C Act). Under 

section 417(d)(1) of the FD&C Act, food 

firms that are ‘‘responsible parties’’ as 

defined in the statute are required to 

notify FDA electronically with certain 

information within 24 hours of 

determining that a food they 

manufactured, processed, packed, or 

held is a reportable food. On September 

8, 2009, FDA launched the electronic 

portal for submission of these required 

reports. Information about reportable 

foods becomes part of the RFR. 

Infant formula and dietary 

supplements are excluded from the 

requirements of the RFR. Infant formula 

manufacturers must comply with 

notification requirements for violative 

infant formula as established in 21 CFR 

107.240. Manufacturers, packers and/or 

distributors whose names appear on the 

label of a dietary supplement marketed 

in the United States must submit to FDA 

any report received of a serious adverse 

event associated with that dietary 

supplement when used in the United 

States, accompanied by a copy of the 

dietary supplement’s label, under 

section 761 of the FD&C Act (21 U.S.C. 

379aa–1). 

When contamination of food could 

cause illness or injury, quick action is 

necessary to remove the food from the 

market. FDA evaluates the information 

submitted to the RFR and that submitted 

by infant formula and dietary 

supplement firms and takes regulatory 

action when appropriate. Often this 

information can be used to determine 

the distribution of contaminated (and 

potentially contaminated) food, 

including raw agricultural commodities, 

food ingredients, and single- or multiingredient processed foods. 

c. Outbreaks of foodborne illness. In 

some cases, contaminated food goes 

undetected until it is associated with an 

outbreak of foodborne illness. (An 

outbreak of foodborne illness is the 

occurrence of two or more cases of a 

similar illness resulting from the 

ingestion of a common food.) When an 

outbreak of foodborne illness occurs, 

quick action is critical to prevent 

additional illness. The CDC of HHS, and 

State, local, territorial and/or tribal 

health departments conduct 

epidemiologic investigations to identify 

the food(s) that may be involved in an 

outbreak. Many outbreaks are reported 

to the National Outbreak Reporting 

System (NORS) by the State, local, 

territorial, or tribal health department 

that conducted the outbreak 

investigation. Outbreak reporting is 

voluntary. Multi-state outbreaks are 

generally reported to NORS by CDC 

(Ref. 13). The Foodborne Outbreak 

Online Database (FOOD) allows the 

public direct access to information on 

foodborne outbreaks reported to CDC 

(Ref. 14). 

In July 1995, the Foodborne Diseases 

Active Surveillance Network (FoodNet) 

was established as a collaborative 

program among CDC, 10 state health 

departments, USDA’s Food Safety and 

Inspection Service (FSIS), and FDA. 

FoodNet conducts surveillance for 

infections caused by specific pathogenic 

microorganisms as diagnosed by 

laboratory testing of samples from 

patients. The surveillance area includes 

approximately 15 percent of the United 

States population (approximately 46 

million persons). The objectives of 

FoodNet are to determine the burden of 

foodborne illness in the United States; 

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monitor trends in the burden of specific 

foodborne illness over time; attribute 

the burden of foodborne illness to 

specific foods and settings; and 

disseminate information that can lead to 

improvements in public health practice 

and the development of interventions to 

reduce the burden of foodborne illness 

(Ref. 15). Information from FoodNet is 

used to assess the impact of food safety 

initiatives on the burden of foodborne 

illness (Ref. 16). 

FDA works closely with CDC to 

monitor those outbreaks in which there 

is some indication or early information 

to suggest that an FDA regulated 

product may be implicated in an 

outbreak of foodborne illness. In some 

cases (e.g., when it appears unlikely that 

an implicated food was contaminated at 

the point of sale, such as at a 

restaurant), FDA works closely with 

multidisciplinary Federal, State, local, 

territorial, and tribal investigators 

during the investigation of the outbreak. 

Depending on the circumstances, such 

multidisciplinary investigations may 

involve a traceback investigation (i.e., 

an investigation to determine and 

document the production chain and the 

source(s) of contaminated or potentially 

contaminated food); a traceforward 

operation (i.e., an operation to 

determine the distribution of 

contaminated or potentially 

contaminated food); regulatory 

inspections; and, in some cases, root 

cause investigations (to try and 

determine the specific causes of 

contamination and contributing factors). 

PulseNet is another collaborative 

program for the surveillance and 

detection of foodborne illness that is 

coordinated by the CDC, with laboratory 

participants from state health 

departments, local health departments, 

and Federal agencies, including FDA 

and FSIS. Using pulsed-field gel 

electrophoresis (PFGE), PulseNet 

participants perform standardized 

molecular subtyping (or fingerprinting) 

of foodborne disease causing bacteria. 

The patterns are then submitted 

electronically to PulseNet, which is a 

dynamic database that allows for the 

rapid comparison of patterns and 

facilitates identification of common 

source outbreaks. PulseNet is 

considered to be a powerful intelligence 

network that allows for the collection 

and analysis of state and local 

epidemiological surveillance data for 

the identification of outbreaks that may 

otherwise go unnoticed. In addition, 

PulseNet helps food regulatory agencies 

identify areas where the implementation 

of new measures and enhanced 

surveillance are likely to increase the 

safety of our food supply. 

The Food Emergency Response 

Network (FERN) is a network 

coordinated by the FDA and USDA to 

integrate the nation’s food testing 

laboratory (Ref. 17). The FERN supports 

all four phases of incident 

management—prevention, 

preparedness, response, and recovery— 

and coordinates the testing activities of 

Federal, state, and local laboratories. As 

of April 2011, FERN has 172 laboratory 

members (39 Federal, 116 State, and 17 

local), located in all 50 States and 

Puerto Rico. FERN member laboratories 

represent the large majority of food 

testing laboratories in the U.S., 

including public health, agriculture, 

veterinary diagnostic and environmental 

laboratories. At this point, it is 

estimated that the FERN membership 

represents about 85% of all eligible food 

regulatory laboratories in the U.S. 

FERN members use a web-based 

information network (the Electronic 

Laboratory Exchange Network, or 

eLEXNET) (Ref. 18) as their primary, 

real-time data exchange and 

communication system. Many 

participating laboratories conduct food 

surveillance testing programs for 

microbial pathogens (e.g., E. coli 

O157:H7, Salmonella spp., Listeria 

monocytogenes,), aflatoxin, antibiotics, 

undeclared allergens, heavy metals, and 

other threats to the food supply. 

Laboratory results can be uploaded into 

eLEXNET for the early identification of 

threats to the food supply. For example, 

overlaying laboratory results with 

distribution and epidemiological data 

can assist in identifying the source of 

the outbreak. The system also allows 

officials to analyze risks and identify 

trends for future surveillance efforts. In 

addition, the eLEXNET serves as a 

method repository for laboratories to 

rapidly search, access, review, and print 

methods. 

d. Recalls. In 1978, we established a 

program regarding recalls, including 

guidance on policy, procedures, and 

industry responsibilities (43 FR 26202, 

June 16, 1978). Our regulations in part 

7, subpart C (21 CFR part 7, subpart C) 

address recall policy; health hazard 

evaluation and recall classification; 

recall strategy; FDA-requested recall; 

firm-initiated recall; recall 

communications; public notification of 

recall; recall status reports; termination 

of a recall; and general industry 

guidance. In addition, under authority 

in section 412(f) of the FD&C Act (21 

U.S.C. 350a(f)), we have issued 

regulations establishing specific 

requirements for infant formula recalls 

(21 CFR part 107, subpart E). More 

recently, FSMA amended the FD&C Act 

by establishing section 423 of the FD&C 

Act (21 U.S.C. 350l), which provides 

FDA with mandatory recall authority for 

food (other than infant formula, which 

remains subject to section 412(f) of the 

FD&C Act). 

Section 7.41 (Health hazard 

evaluation and recall classification) 

describes how we evaluate the health 

hazard presented by a product being 

recalled by considering whether any 

disease or injuries have already 

occurred from the use of the product; 

whether any existing conditions could 

contribute to a clinical situation that 

could expose consumers to a health 

hazard; how the hazard could impact 

various segments of the population (e.g., 

children, surgical patients), with 

particular attention paid to the hazard to 

those individuals who may be at 

greatest risk; the degree of seriousness of 

the health hazard to which the 

populations at risk would be exposed; 

the likelihood of occurrence of the 

hazard; and the potential consequences 

(immediate or long-range) of occurrence 

of the hazard. On the basis of this 

evaluation, we classify the recall (i.e., 

Class I, Class II, or Class III) to indicate 

the relative degree of health hazard of 

the product being recalled or considered 

for recall. A Class I recall is a situation 

in which there is a reasonable 

probability that the use of, or exposure 

to, a violative product will cause serious 

adverse health consequences or death 

(§ 7.3(m)(1)). A Class II recall is a 

situation in which use of, or exposure 

to, a violative product may cause 

temporary or medically reversible 

adverse health consequences or where 

the probability of serious adverse health 

consequences is remote (§ 7.3(m)(2)). A 

Class III recall is a situation in which 

use of, or exposure to, a violative 

product is not likely to cause adverse 

health consequences (§ 7.3(m)(3)). 

In recent years, recalls of food 

ingredients have highlighted the 

potentially large impact that 

contamination (or potential 

contamination) of a single food 

ingredient can have on thousands of 

food products containing that ingredient 

(Ref. 19) (Ref. 20) (Ref. 21) (Ref. 22) (Ref. 

23) (Ref. 24), with correspondingly 

significant disruption and cost for 

industry and consumers. 

e. State surveillance and reporting 

programs. State food safety agencies are 

involved in identifying contaminated 

food by conducting surveillance testing 

(Ref. 25). Communication of 

surveillance testing results by state food 

safety agencies to FDA is essential for 

identifying contaminated food. State 

food safety agencies also conduct 

thousands of inspections and collect 

and analyze food samples at food 

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manufacturers/processors every year 

under contract to FDA. The states 

perform inspections of food 

manufacturers, processors, packers and 

holders to determine compliance with 

the FD&C Act, state law, or both. Such 

inspections focus on identifying 

significant CGMP violations and 

insanitary conditions which may render 

the food injurious to health, particularly 

those involving the introduction of, lack 

of controls for, and/or growth promotion 

of pathogenic organisms. State 

inspections also focus on identifying 

practices or other conditions that may 

have caused food to become filthy, 

putrid, decomposed, or contaminated 

with foreign objects (Ref. 26). FDA 

coordinates eLEXNET), which is a webbased information network that allows 

state food safety officials to share 

laboratory analysis findings with FDA 

and other Federal, state and local food 

safety agencies (Ref. 18). FDA also 

participates in FERN, which is an FDA/ 

FSIS joint initiative to integrate the 

nation’s food-testing laboratories at the 

local, state, and Federal levels into a 

network that is able to respond to 

emergencies involving biological, 

chemical, or radiological contamination 

of food (Ref. 17). 

7. Outreach to Consumers and 

Educators 

As part of its efforts to protect the 

public health, FDA engages in outreach 

efforts to provide consumers and 

educators with information regarding 

the safe handling, preparation, and 

consumption of food to reduce the 

incidence of foodborne illness. 

We conduct some of our consumer 

and educator outreach initiatives in 

cooperation with other Federal 

departments and agencies. For example, 

HHS, USDA, and their constituent 

agencies maintain the Internet site 

FoodSafety.gov. FoodSafety.gov, which 

provides consumers and health 

educators with the most current 

information regarding, among other 

things, food recalls and alerts, health 

risks posed by particular food safety 

hazards, instructions for the safe 

handling and preparation of food, and 

the most current news and information 

released by FDA and the other 

participating Federal departments and 

agencies regarding food safety issues 

(Ref. 27). 

We also engage in consumer outreach 

in partnership with non-governmental 

entities. Most prominently, HHS, USDA, 

and the U.S. Department of Education 

work with industry associations, 

academic institutions, consumer and 

public health organizations, and 

professional societies in the food 

sciences to support the Partnership for 

Food Safety Education. This 

partnership, among other things, 

educates consumers about the 

importance of safe food handling and 

health risks posed by specific foodborne 

illnesses, prepares and disseminates 

food safety curricula for use by 

educators, and provides information 

regarding how consumers can be aware 

of and respond to food recalls (Ref. 28). 

FDA also conducts its own 

independent informational outreach 

efforts specifically designed for 

consumers (Ref. 29) and for educators 

(Ref. 30). 

B. FDA Food Safety Modernization Act 

1. Requirements for Food Facilities 

On January 4, 2011, the FDA Food 

Safety Modernization Act (FSMA) (Pub. 

L. 111–353) was signed into law. 

Section 103 of FSMA, Hazard Analysis 

and Risk-Based Preventive Controls, 

amends the FD&C Act to create a new 

section 418 with the same name. Many 

of the provisions in section 103 of 

FSMA that are relevant to this 

rulemaking are codified in section 418 

of the FD&C Act. 

a. General requirements. Section 418 

of the FD&C Act contains requirements 

applicable to food facilities and 

mandates agency rulemaking. Section 

418(a) is a general provision that 

requires the owner, operator, or agent in 

charge of a facility to evaluate the 

hazards that could affect food 

manufactured, processed, packed, or 

held by the facility, identify and 

implement preventive controls, monitor 

the performance of those controls, and 

maintain records of the monitoring. 

Section 418(a) specifies that the purpose 

of the preventive controls is to ‘‘prevent 

the occurrence of such hazards and 

provide assurances that such food is not 

adulterated under section 402 [of the 

FD&C Act] or misbranded under section 

403(w) [of the FD&C Act] * * *.’’ 

In addition to those areas specified in 

section 418(a) of the FD&C Act, sections 

418(b)–(i) contain more specific 

requirements applicable to facilities. 

These include corrective actions 

(§ 418(e)), verification (§ 418(f)), a 

written plan and documentation 

(§ 418(h)), and reanalysis of hazards 

(§ 418(i)). Section 103(e) of FSMA 

creates a new section 301(uu) in the 

FD&C Act (21 U.S.C. 331(uu)) to 

prohibit ‘‘[t]he operation of a facility 

that manufactures, processes, packs, or 

holds food for sale in the United States 

if the owner, operator, or agent in charge 

of such facility is not in compliance 

with section 418 [of the FD&C Act].’’ In 

section XII of this document, we discuss 

proposed requirements (proposed 

subpart C) that would implement these 

provisions of section 418 of the FD&C 

Act. 

b. Qualified facilities. Section 418(l) 

of the FD&C Act (Modified 

Requirements for Qualified Facilities) 

establishes criteria for a facility to be a 

qualified facility, establishes an 

exemption for qualified facilities, 

establishes modified requirements for 

qualified facilities, and provides that the 

Secretary may withdraw the exemption 

otherwise granted to qualified facilities 

in specified circumstances. Under 

section 418(l)(1) of the FD&C Act, a 

facility is a qualified facility if (1) it is 

a very small business as the term would 

be defined by this rulemaking or (2) it 

falls within specified limitations on the 

average annual monetary value of its 

sales and types of customers. Section 

418(l)(2)(A) of the FD&C Act exempts a 

qualified facility from the requirements 

for hazard analysis and risk-based 

preventive controls as set forth in 

sections 418(a)–(i) of the FD&C Act, as 

well as the requirements issued under 

section 418(n) of the FD&C Act. Section 

418(l)(2)(B) of the FD&C Act requires a 

qualified facility to submit 

documentation to the Secretary related 

to its qualified status and also submit 

either documentation of the facility’s 

implementation and monitoring of 

preventive controls or documentation of 

its compliance with other appropriate 

non-Federal food safety laws. Section 

418(l)(3) of the FD&C Act authorizes the 

Secretary to withdraw the exemption 

from a qualified facility in specified 

circumstances. In section X.C.1 of this 

document, we discuss a proposed 

exemption for qualified facilities 

(proposed § 117.5(a)). In section XIV of 

this document, we discuss a proposed 

process for withdrawing an exemption 

for a qualified facility (proposed subpart 

E). In section XIII.A of this document, 

we discuss proposed modified 

requirements for qualified facilities 

(proposed § 117.201). 

c. Exemptions and exceptions. In 

addition to the exemption for qualified 

facilities in section 418(l)(2)(A) of the 

FD&C Act, there are several other 

exemptions and exceptions to the 

requirements specified in section 418 of 

the FD&C Act. Section 418(j) of the 

FD&C Act provides an exemption for 

facilities that are required to comply 

and are in compliance with the 

regulations for seafood HACCP, juice 

HACCP, or thermally processed lowacid foods packed in hermetically 

sealed containers. Section 418(k) of the 

FD&C Act provides an exception for 

activities of facilities subject to section 

419 of the FD&C Act (Standards for 

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Produce Safety). Section 103(g) of 

FSMA provides an exemption for 

certain activities regarding a dietary 

supplement that is in compliance with 

sections 402(g)(2) and 761 of the FD&C 

Act (21 U.S.C. 342(g)(2), 379aa–1). In 

sections X.C.2 through X.C.4 of this 

document, we discuss proposed 

exemptions for activities that are subject 

to part 123 (proposed § 117.5(b)), part 

120 (proposed § 117.5(c)), part 113 

(proposed § 117.5(d)), section 419 of the 

FD&C Act (proposed § 117.5(f)), or the 

manufacturing, processing, packing, and 

holding of dietary supplements 

(proposed § 117.5(e)). 

As discussed in section II.B.2.e of this 

document, section 418(m) of the FD&C 

Act also authorizes the Secretary to 

create exemptions or modifications to 

the requirements with respect to certain 

facilities. 

d. Rule of construction regarding 

alcohol-related facilities. As discussed 

in more detail in section X.C.7 of this 

document, section 116 of FSMA (21 

U.S.C. 2206) (Alcohol-Related Facilities) 

provides a rule of construction for 

certain facilities engaged in the 

manufacturing, processing, packing, or 

holding of alcoholic beverages and other 

food. In section X.C.7 of this document, 

we discuss proposed exemptions related 

to such facilities (proposed § 117.5(i)). 

2. Requirements for Agency Rulemaking 

Section 103 of FSMA contains two 

separate rulemaking provisions. Section 

103(a) of FSMA requires rulemaking 

related to the hazard analysis and riskbased preventive controls required by 

section 418 of the FD&C Act. In 

addition, section 103(c) of FSMA 

requires rulemaking in two areas: (1) 

Clarification of certain aspects of the 

definition of the term ‘‘farm’’ under 

section 415 of the FD&C Act (21 U.S.C. 

350d) (Registration of Food Facilities) 

and (2) possible exemption from or 

modification of requirements of section 

418 and section 421 of the FD&C Act (21 

U.S.C. 350j) (Targeting of Inspection 

Resources for Domestic Facilities, 

Foreign Facilities, and Ports of Entry; 

Annual Report) for certain facilities as 

the Secretary deems appropriate and as 

further specified in section 103(c)(1)(D) 

of FSMA. 

a. General rulemaking requirements. 

Section 418(n)(1)(A) of the FD&C Act 

requires that not later than 18 months 

after the date of FSMA’s enactment, the 

Secretary issue regulations ‘‘to establish 

science-based minimum standards for 

conducting a hazard analysis, 

documenting hazards, implementing 

preventive controls, and documenting 

the implementation of the preventive 

controls * * *.’’ 

b. Definition of small and very small 

business. Section 418(l)(5) of the FD&C 

Act requires the Secretary, in 

consultation with the Secretary of 

Agriculture, to conduct a study of the 

food processing sector regulated by the 

Secretary and to make determinations in 

five areas. These areas include, in part, 

(1) distribution of food production by 

type and size of operation, (2) the 

proportion of food produced by each 

type and size of operation, (3) the 

number and types of food facilities colocated on farms, (4) the incidence of 

foodborne illness originating from each 

size and type of operation, and (5) the 

effect on foodborne illness risk 

associated with certain activities 

regarding food. 

Section 418(n)(1)(B) of the FD&C Act 

requires that the regulations define the 

terms ‘‘small business’’ and ‘‘very small 

business,’’ taking into consideration the 

study of the food processing sector 

required by section 418(l)(5) of the 

FD&C Act. These terms are significant 

because section 103 of FSMA contains 

several provisions specific to such 

entities. 

• Small and very small businesses are 

subject to modifications or exemptions 

from requirements under section 418 or 

421 of the FD&C Act for facilities 

engaged only in specific types of onfarm activities and involving foods that 

the Secretary determines to be low risk 

(§ 103(c)(1)(D) of FSMA). 

• Small and very small businesses are 

not subject to section 418 of the FD&C 

Act until 6 months (small businesses) or 

18 months (very small businesses) after 

the effective date of FDA’s final rule 

(§ 103(i) of FSMA). 

• A very small business is deemed a 

‘‘qualified facility’’ and would, 

therefore, qualify for the exemptions as 

discussed in section X.C.1 of this 

document. (§ 418(l)(1)(B) of the FD&C 

Act). 

Consistent with section 418(l)(5) of 

the FD&C Act, FDA has consulted with 

USDA during its study of the food 

processing sector (Ref. 31). The study is 

available in the docket established for 

this proposed rule (Ref. 32). We request 

comment on that study. In section X.B.4 

of this document, we discuss our 

proposed definitions for small business 

and very small business. We will 

consider comments regarding the study, 

as well as comments regarding our 

proposed definitions for small and very 

small business, in any final rule based 

on this proposed rule. 

c. Clarification of the term ‘‘facility.’’ 

Generally, section 418 of the FD&C Act 

applies to the owner, operator, or agent 

in charge of a ‘‘facility.’’ Section 

418(o)(2) of the FD&C Act defines 

‘‘facility’’ as ‘‘a domestic facility or a 

foreign facility that is required to 

register under section 415.’’ Section 415 

of the FD&C Act, in turn, requires any 

facility engaged in manufacturing, 

processing, packing, or holding food for 

consumption in the United States to 

register with the Secretary. 

The requirement in section 415 of the 

FD&C Act that a facility must register 

does not apply to farms. FDA’s 

implementing regulations for section 

415 (see part 1, subpart H) (21 CFR part 

1, subpart H; hereinafter the section 415 

registration regulations) define ‘‘farm,’’ 

in relevant part, as ‘‘a facility in one 

general physical location devoted to the 

growing and harvesting of crops, the 

raising of animals (including seafood), 

or both’’ (§ 1.227(b)(3)) (21 CFR 

1.227(b)(3)). The term ‘‘farm’’ includes a 

facility that packs or holds food, 

provided that all food used in such 

activities is grown, raised, or consumed 

on that farm or another farm under the 

same ownership (§ 1.227(b)(3)(i)). Under 

that same definition, the term ‘‘farm’’ 

also includes a facility that 

manufactures/processes food, provided 

that all food used in such activities is 

consumed on that farm or another farm 

under the same ownership 

(§ 1.227(b)(3)(ii)). 

Section 103(c)(1)(A) of FSMA requires 

that not later than 9 months after the 

date of enactment, the Secretary publish 

a notice of proposed rulemaking in the 

Federal Register to issue regulations for 

purposes of section 415 of the FD&C Act 

with respect to ‘‘activities that 

constitute on-farm packing or holding of 

food that is not grown, raised, or 

consumed on such farm or another farm 

under the same ownership’’ and 

‘‘activities that constitute on-farm 

manufacturing or processing of food that 

is not consumed on that farm or on 

another farm under common 

ownership.’’ The regulation is intended 

to ‘‘enhance the implementation’’ of 

section 415 and ‘‘clarify the activities 

that are included within the definition 

of the term ‘facility’ ’’ (§ 301(c)(1)(B) of 

FSMA). In section VIII.E of this 

document, we discuss our proposal to 

revise the section 415 registration 

regulations to enhance the 

implementation of section 415 and to 

clarify the definition of the term 

‘‘facility.’’ 

d. Science-based risk analysis and 

requirements under sections 418 and 

421 of the FD&C Act. Section 

103(c)(1)(C) of FSMA requires that in 

issuing the proposed rule the Secretary 

conduct a science-based risk analysis of: 

• ‘‘Specific types of on-farm packing 

or holding of food that is not grown, 

raised, or consumed on such farm or 

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another farm under the same ownership, 

as such packing and holding relates to 

specific foods; and 

• Specific on-farm manufacturing and 

processing activities as such activities 

relate to specific foods that are not 

consumed on that farm or on another 

farm under common ownership.’’ 

As part of the rulemaking, the 

Secretary is required to consider the 

results of the science-based risk analysis 

and exempt certain facilities from the 

requirements in sections 418 and 421 of 

the FD&C Act or modify those 

requirements, as the Secretary 

determines appropriate, if such facilities 

are only engaged in specific types of onfarm manufacturing, processing, 

packing, or holding activities the 

Secretary determines to be low risk, and 

involving specific foods that the 

Secretary determines to be low risk 

(§ 103(c)(1)(D)(i) of FSMA). Any 

exemption or modification is limited to 

small and very small businesses 

(§ 103(c)(1)(D)(ii) of FSMA). 

In section VIII.G of this document, we 

discuss our approach to the requirement 

in FSMA section 103(c) for a sciencebased risk analysis of the types of onfarm manufacturing, processing, 

packing, or holding operations that can 

involve food that is not consumed on 

that farm or on another farm under 

common ownership for purposes of 

section 415 of the FD&C Act and request 

comment on that approach. The final 

approach will consider comments 

received to this proposed rule. 

In sections VIII.I and X.C of this 

document, we discuss proposed 

exemptions for small and very small 

businesses that are solely engaged in 

certain types of ‘‘low risk’’ activities 

involving the on-farm manufacturing, 

processing, packing, and holding of 

certain ‘‘low risk’’ foods from the 

requirements of section 418 of the FD&C 

Act (proposed § 117.5(g) and (h)). In 

section VIII.J of this document, we 

discuss our tentative conclusion that we 

should not exempt or modify the 

frequency requirements under 421 

based solely upon whether a facility 

only engages in such low-risk activity/ 

food combinations and is a small or very 

small business and we seek comment on 

this proposal. 

e. Exemption or modification of 

requirements for certain facilities. 

Under section 418(m) of the FD&C Act, 

the Secretary may exempt or modify the 

requirements for compliance of section 

418 of the FD&C Act for hazard analysis 

and preventive controls for facilities 

that are solely engaged in the storage of 

RACs (other than fruits and vegetables) 

intended for further distribution or 

processing. As discussed in section 

X.C.8 of this document, in accordance 

with the discretionary language of 

section 418(m), FDA tentatively 

concludes that facilities solely engaged 

in the storage of RACs, other than fruits 

and vegetables, intended for further 

distribution or processing should be 

exempt from the requirements for 

hazard analysis and preventive controls 

that we are proposing to establish in 

subpart C of part 117. 

Section 418(m) of the FD&C Act also 

authorizes the Secretary to exempt or 

modify the requirements for compliance 

with section 418 for facilities that are 

solely engaged in the storage of 

packaged foods that are not exposed to 

the environment. In section X.D of this 

document, we describe our proposal for 

how the requirements of part 117 would 

apply to such facilities (proposed 

§ 117.7). In section X.D.4 of this 

document, we propose modified 

requirements for such facilities, directed 

at the storage of packaged foods that are 

not exposed to the environment and that 

require time/temperature control to 

limit the growth of, or toxin formation 

by, microorganisms of public health 

significance (proposed § 117.206). 

f. Animal food and intentional 

adulteration. FDA proposes to 

implement section 103 of FSMA in 

several regulations, rather than a single 

regulation that covers all food and 

hazards subject to preventive controls. 

This proposal is applicable to certain 

hazards that may be associated with a 

food facility that manufactures, 

processes, packs or holds human food. 

Section 103 of FSMA applies to ‘‘food,’’ 

which is not limited to human food. 

Section 201(f) of the FD&C Act defines 

‘‘food’’ to include ‘‘articles used for food 

or drink for man or other animals’’ (21 

U.S.C. 321(f)). FDA tentatively 

concludes that the differences between 

human and animal food are best 

addressed through separate regulations. 

FDA plans to propose a separate 

regulation applicable to certain hazards 

that may be associated with a food 

facility that manufactures, processes, 

packs or holds animal food. 

Establishments that manufacture, 

process, pack, or hold food for both 

humans and animals should consider 

this proposed rule as well as the future 

proposed rule directed to CGMPs and 

hazard analysis and risk-based 

preventive controls for food for animals, 

as there may be differences in the 

requirements that would be applicable 

to such establishments under the two 

proposed rules. 

In addition, this rulemaking is not 

intended to address ‘‘hazards that may 

be intentionally introduced, including 

by acts of terrorism.’’ (§ 418(b)(2) of the 

FD&C Act). FDA plans to implement 

section 103 of FSMA regarding such 

hazards in a separate rulemaking in the 

future. FDA tentatively concludes that 

intentional hazards, which are not 

addressed in traditional HACCP or other 

food safety systems, likely will require 

different kinds of controls and would be 

best addressed in a separate rulemaking. 

However, we also recognize that some 

kinds of intentional adulterants could 

be viewed as reasonably likely to occur, 

e.g., in foods concerning which there is 

a widely recognized risk of 

economically motivated adulteration in 

certain circumstances. An example of 

this kind of hazard is the addition of 

melamine to certain food products 

apparently to enhance perceived quality 

and/or protein content. We request 

comment on whether to include 

potential hazards that may be 

intentionally introduced for economic 

reasons. We also request comment on 

when an economically motivated 

adulterant can be considered reasonably 

likely to occur. 

C. Preventive Controls and Hazard 

Analysis and Critical Control Points 

(HACCP) Systems 

1. HACCP Systems 

HACCP is a preventive strategy for 

food safety that involves a systematic 

approach to the identification and 

assessment of the risk (likelihood of 

occurrence and severity) of hazards 

from a particular food or food 

production process or practice and the 

control of those hazards. HACCP has 

been endorsed by the National Advisory 

Committee on Microbiological Criteria 

for Foods (NACMCF) as an effective and 

rational means of ensuring food safety. 

NACMCF is an advisory committee 

chartered under USDA (Ref. 33). 

NACMCF includes participants from 

USDA’s FSIS, HHS (FDA and CDC), the 

Department of Commerce (National 

Marine Fisheries Service), the 

Department of Defense (Office of the 

Army Surgeon General), academia, 

industry, state employees and consumer 

groups. NACMCF provides guidance 

and recommendations to the Secretaries 

of USDA and HHS, as well as other 

Federal agencies, regarding the 

microbiological safety of foods. 

Although HACCP was first introduced 

in 1971 at the National Conference for 

Food Protection, it was not widely used 

by the food industry until the concept 

was more fully developed by NACMCF. 

In 1989 NACMCF adopted ‘‘HACCP 

Principles for Food Production,’’ which 

was revised in 1992; in 1997, NACMCF 

adopted its current version, ‘‘Hazard 

Analysis and Critical Control Point 

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Principles and Application Guidelines’’ 

(Ref. 34). Revisions in both the 1992 and 

1997 NACMCF HACCP documents were 

patterned after changes made in HACCP 

documents issued by the Codex 

Alimentarius Commission (Codex). (The 

Codex Alimentarius Commission was 

formed in 1963 by the Food and 

Agriculture Organization and the World 

Health Organization of the United 

Nations to develop food standards, 

guidelines, and related texts such as 

codes of practice, and is recognized 

under the World Trade Organization 

Agreement on the Application of 

Sanitary and Phytosanitary Measures as 

the international standards organization 

for food safety.) (See the discussion of 

Codex HACCP documents in section 

II.C.5.e of this document). 

HACCP is designed for use in all 

segments of the food industry from 

growing, harvesting, processing, 

manufacturing, distributing, and 

merchandising to preparing food for 

consumption (Ref. 34). Under HACCP, a 

food operation develops a plan that 

identifies food hazards applicable to the 

food and production process, and the 

points in the production process where 

a food hazard could be introduced, 

controlled or enhanced. A failure at 

these points would likely result in a 

food hazard being created or allowed to 

persist. These points are referred to as 

critical control points (CCPs). Under 

HACCP, identified CCPs are 

systematically monitored to ensure that 

critical limits are not exceeded, and 

records are kept of that monitoring. 

Corrective actions are taken when 

control of a CCP is lost, including 

proper disposition of the food produced 

during that period, and these actions are 

documented. The effectiveness of 

HACCP is also systematically verified 

by the food operation. 

2. Section 103 of FSMA and HACCP 

FDA tentatively concludes for several 

reasons that HACCP is the appropriate 

framework to reference in interpreting 

and implementing section 103 of FSMA. 

As discussed in section II.B of this 

document, section 103 of FSMA 

amended the FD&C Act by adding 

section 418. Section 418 of the FD&C 

Act and section 103 of FSMA are both 

titled ‘‘Hazard Analysis and Risk-Based 

Preventive Controls.’’ This title 

identifies two critical elements of 

HACCP—hazard analysis and 

preventive controls. As discussed in 

section II.C.4.a of this document, a 

hazard analysis is the first of the seven 

principles of HACCP, and is key to an 

effective food safety system. Further, 

establishment of a system of preventive 

controls for these hazards is the central 

purpose of HACCP. (See 66 FR 6138 and 

60 FR 65096 stating that FDA issued the 

juice and seafood HACCP regulations 

because a system of preventive controls 

is the most effective and efficient way 

to ensure that these products are safe.) 

In addition, section 418(n)(5) of the 

FD&C Act requires that in promulgating 

the regulations to implement preventive 

controls, ‘‘the Secretary shall review 

regulatory hazard analysis and 

preventive control programs in 

existence * * * to ensure that such 

regulations are consistent, to the extent 

practicable, with applicable domestic 

and internationally-recognized 

standards * * *.’’ (See section XVI.B of 

this document for a discussion of this 

review.) The hazard analysis and 

preventive control systems in existence 

are all based on HACCP principles. 

Further, section 418 uses HACCP 

terminology throughout, including 

hazard analysis, monitoring, corrective 

actions, and verification. The close 

relationship of section 418 to HACCP is 

further illustrated by an exemption 

created in section 418(j) for ‘‘seafood, 

juice, and low-acid canned food 

facilities subject to HACCP.’’ 

At the same time, FDA notes that not 

every provision in section 418 of the 

FD&C Act is identical to HACCP as 

described in current literature. For 

example, as discussed in section II.C.4.b 

of this document, HACCP systems focus 

on determining CCPs, whereas section 

418(c) requires that the owner, operator, 

or agent in charge of a facility identify 

and implement preventive controls, 

including at critical control points, if 

any (emphasis added). As another 

example, as discussed in section II.C.4.c 

of this document, HACCP systems focus 

on establishing critical limits for CCPs, 

whereas section 418(c) of the FD&C Act 

requires that the owner, operator, or 

agent in charge of a facility identify and 

implement preventive controls, 

including at CCPs, if any, without 

specifying that the preventive controls 

establish critical limits. In fact, section 

418 of the FD&C Act does not use the 

term ‘‘critical limit.’’ Although the 

approach in section 418 and this 

proposed rule aligns well with HACCP, 

it differs in part in that preventive 

controls may be required at points other 

than at critical control points and 

critical limits would not be required for 

all preventive controls. 

As another example, as discussed in 

section II.C.4.a of this document, 

HACCP systems refer to hazards as 

‘‘biological, chemical and physical 

agents’’ whereas section 418(b)(1)(A) of 

the FD&C Act requires that the owner, 

operator, or agent in charge of a facility 

identify and evaluate known or 

reasonably foreseeable hazards that may 

be associated with the facility, including 

‘‘biological, chemical, physical, and 

radiological hazards’’ (emphasis added). 

Although radiological hazards are not 

common, the consequences to 

consumers of exposure to radiological 

hazards may be severe (e.g., cancer). As 

discussed in section II.C.4.a of this 

document, under HACCP systems the 

hazard analysis includes a written 

assessment of the likelihood that the 

hazard will occur and its severity if it 

does occur (emphasis added). Thus, 

section 418(b)(1)(A) of the FD&C Act is 

consistent with the framework for 

HACCP even though it lists an 

additional type of hazard that must be 

considered and controlled as necessary. 

Throughout this document, we 

identify the sections of FSMA 

applicable to specific proposed 

provisions and describe how the 

proposed provisions relate to HACCP 

principles as established by NACMCF in 

the NACMCF HACCP guidelines, by 

Federal agencies in HACCP regulations, 

and by Codex in the HACCP Annex in 

the Codex General Principles of Food 

Hygiene (Ref. 35). 

3. Five Preliminary Tasks of HACCP/ 

Preventive Controls 

The NACMCF HACCP guidelines 

recommend a process for developing a 

HACCP system, or the implementation 

of a HACCP plan (Ref. 34). The ‘‘five 

preliminary tasks’’ of HACCP include: 

(1) Assembling a HACCP team; (2) 

describing the food and its distribution; 

(3) identifying the intended use and 

consumers of the food; (4) developing a 

flow diagram; and (5) verifying the flow 

diagram. The NACMCF HACCP 

guidelines advise that these preliminary 

tasks be accomplished before the 

application of HACCP principles to 

developing a HACCP plan for a specific 

food and process. Although FDA is not 

proposing to mandate that the owner, 

operator, or agent in charge of a facility 

conduct these preliminary tasks, 

facilities will greatly benefit from 

completing these preliminary tasks in 

developing their hazard analysis and 

risk-based preventive control systems. 

4. The Seven Principles of HACCP 

NACMCF has developed and adopted 

seven principles that describe the 

HACCP concept: (1) Conduct a hazard 

analysis; (2) Determine the CCPs; (3) 

Establish the critical limits; (4) Establish 

monitoring procedures; (5) Establish 

corrective actions; (6) Establish 

verification procedures; and (7) 

Establish recordkeeping and 

documentation procedures (Ref. 34). We 

discuss these immediately below. 

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a. Principle 1: Conduct a hazard 

analysis. The first HACCP principle is 

the identification of the hazards 

associated with the product and 

process. The NACMCF HACCP 

guidelines define a hazard as a 

biological, chemical, or physical agent 

that is reasonably likely to cause illness 

or injury in the absence of its control 

(Ref. 34). The hazard analysis includes 

an identification of the hazard, an 

assessment of the likelihood that the 

hazard will occur and its severity if it 

does occur, and identification of control 

measures for each identified hazard, all 

of which should be documented. 

b. Principle 2: Determine the CCPs. 

The second HACCP principle is 

identification of CCPs. The NACMCF 

HACCP guidelines define a CCP as a 

step at which control can be applied 

and is essential to prevent or eliminate 

a food safety hazard or reduce it to an 

acceptable level (Ref. 34). Steps in the 

manufacturing process that may be 

CCPs include heat treatment, chilling, 

product formulation, and metal 

detection. 

c. Principle 3: Establish the critical 

limits. The third HACCP principle is 

establishing the critical limits, which 

involves establishing values for 

parameters that must be met for each 

control measure associated with a CCP. 

The NACMCF HACCP guidelines define 

a critical limit as a maximum and/or 

minimum value to which a biological, 

chemical or physical parameter must be 

controlled at a CCP to prevent, eliminate 

or reduce to an acceptable level the 

occurrence of a food safety hazard (Ref. 

34). Critical limits can be thought of as 

boundaries of safety for each CCP 

(Codex defines a critical limit as a 

criterion which separates acceptability 

from unacceptability (Ref. 35)) and may 

be set for control measures such as 

temperature, time, physical dimensions, 

moisture level, water activity, pH, and 

available chlorine. A critical limit is 

used to distinguish between safe and 

unsafe operating conditions at a CCP. 

For example, the minimum temperature 

and the minimum time at that 

temperature in a heat treatment step that 

will kill specific pathogens identified as 

hazards for a food are the critical limits 

for that CCP. 

d. Principle 4: Establish monitoring 

procedures. The fourth HACCP 

principle is establishing monitoring 

procedures. The NACMCF HACCP 

guidelines define monitoring to mean 

conducting a planned sequence of 

observations or measurements to assess 

whether a CCP is under control and to 

produce an accurate record of the 

monitoring for use in future verification 

procedures (Ref. 34). For example, 

monitoring can assess whether a CCP is 

operating within its critical limit. An 

unsafe food may result if a process is 

not properly controlled and a deviation 

occurs. Because of the potentially 

serious consequences of a deviation 

from a critical limit, monitoring 

procedures must be effective. 

Depending on the circumstances, 

monitoring may be on a continuous or 

a non-continuous basis. Continuous 

monitoring of a critical limit is possible 

with many types of physical and 

chemical methods. When it is not 

possible to monitor a critical limit on a 

continuous basis, monitoring intervals 

must be established that are frequent 

enough to determine whether the 

measure designed to control the hazard 

is consistently being met. 

e. Principle 5: Establish corrective 

actions. The fifth HACCP principle is 

establishing corrective actions. The 

NACMCF HACCP guidelines define 

corrective actions as procedures 

followed when a deviation occurs (Ref. 

34). While the HACCP system is 

intended to prevent deviations in a 

planned process from occurring, total 

prevention can rarely, if ever, be 

achieved. Therefore, procedures need to 

be in place to fix or correct the cause of 

the deviation to ensure that the CCP is 

brought under control, there is 

appropriate disposition of any food 

produced during a deviation, and 

records are made of the corrective 

actions taken. Out-of-control situations 

should be used to identify opportunities 

for improvement of the process to 

prevent future occurrences. 

f. Principle 6: Establish verification 

procedures. The sixth HACCP principle 

is establishing verification procedures. 

The NACMCF HACCP guidelines define 

verification as those activities, other 

than monitoring, that determine the 

validity of the HACCP plan and that the 

system is operating according to the 

plan (Ref. 34). These activities may 

involve the application of methods, 

procedures, tests, and evaluations, other 

than monitoring. Verification activities, 

particularly those directed to validation, 

may be very scientific and technical in 

nature. For additional information about 

verification activities, see the discussion 

in section XII.G of this document. For 

additional information about the 

specific verification activity of 

‘‘validation,’’ see the discussion in 

section XII.G.2 of this document. 

g. Principle 7: Establish recordkeeping 

and documentation procedures. The 

seventh HACCP principle is establishing 

recordkeeping and documentation 

procedures. Written HACCP records list 

the hazards, CCPs, and critical limits 

identified by the facility, as well as the 

procedures that the facility intends to 

use to implement the system. Written 

HACCP records also include those 

generated during the operation of the 

HACCP system. 

5. History of the Use of HACCP 

a. HACCP regulation for fish and 

fishery products. In 1995, FDA issued a 

final rule to establish in part 123 

procedures for the safe and sanitary 

processing and importing of fish and 

fishery products (60 FR 65096). Part 123 

requires, among other things, that 

seafood processors apply HACCP 

principles to the processing of seafood. 

In the proposed rule to establish part 

123, FDA identified several food safety 

hazards specific to the processing of fish 

and fishery products that warranted the 

promulgation of the seafood HACCP 

regulation, including microbiological 

hazards, naturally occurring toxins, 

chemical contaminants that might be 

present in the aquatic environment, and 

decomposition of fish and fishery 

products that might result from 

improper product handling and produce 

the toxin, histamine (59 FR 4142 at 

4143–4144, January 28, 1994). 

The HACCP regulation for seafood 

incorporated the seven HACCP 

principles as established in the 1992 

revision of NACMCF’s HACCP 

Principles for Food Production (‘‘Hazard 

Analysis and Critical Control Point 

System’’) (Ref. 36). The HACCP 

regulation for seafood also requires that 

individuals assigned the tasks of 

developing, reassessing, or modifying a 

HACCP plan, and conducting required 

records review must be adequately 

trained in the application of HACCP 

principles to fish and fishery products, 

evidenced either by the successful 

completion of the equivalent of a 

standardized curriculum recognized as 

adequate by FDA or by sufficiently 

adequate work experience (§ 123.10). 

The HACCP regulation for seafood does 

not require the use of NACMCF’s five 

preliminary tasks as prerequisites to 

conducting a hazard analysis or 

developing a HACCP plan. We believe, 

however, that processors greatly benefit 

from using these preliminary steps in 

developing their HACCP systems (60 FR 

65096 at 65117). 

The HACCP regulation for seafood 

also requires that processors of seafood 

products monitor the conditions and 

practices of a sanitation standard 

operating procedure (SSOP); correct, in 

a timely manner, those conditions and 

practices that are not met; and 

document the monitoring and 

corrections (§ 123.11). In addition, the 

HACCP regulation for seafood is explicit 

that the general, umbrella CGMP 

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requirements for human food of part 110 

apply to processors of fish and fishery 

products in determining whether the 

facilities, methods, practices, and 

controls used are safe, and whether the 

products have been processed under 

sanitary conditions (§ 123.5(a)). 

In section XII of this document, we 

describe provisions of the HACCP 

regulation for seafood in more detail 

when we compare the proposed 

requirements for hazard analysis and 

risk-based preventive controls that are 

the subject of this document to 

provisions of current HACCP systems, 

including the HACCP regulation for 

seafood. 

b. HACCP regulation for meat and 

poultry. In 1996, FSIS issued a final rule 

to establish in 9 CFR part 417 a 

regulation that, among other things, 

requires each meat and poultry 

establishment to develop and 

implement a system of HACCP controls 

designed to improve the safety of their 

products (61 FR 38806, July 25, 1996). 

In the remainder of this document, the 

phrase ‘‘FSIS HACCP regulation for 

meat and poultry’’ refers to 9 CFR part 

417. FSIS issued its HACCP regulation 

for meat and poultry in light of 

outbreaks of foodborne illness and 

studies (conducted by the National 

Academy of Sciences, the U.S. General 

Accounting Office, and FSIS) that 

established the need for fundamental 

change in the FSIS meat and poultry 

inspection program to improve food 

safety, reduce the risk of foodborne 

illness in the United States, and make 

better use of FSIS’ resources (61 FR 

38806 at 38807). 

The FSIS HACCP regulation for meat 

and poultry incorporates the seven 

HACCP principles as established in the 

1992 revision of NACMCF’s HACCP 

Principles for Food Production (Ref. 36). 

Unlike our HACCP regulations for 

seafood and for juice, the FSIS HACCP 

regulation for meat and poultry requires 

two of the NACMCF preliminary tasks— 

i.e., that a flow chart describing the 

steps of each process and product flow 

in the establishment be prepared and 

that the intended use and consumers of 

the finished product be identified (9 

CFR 417.2(a)(2)). 

The FSIS HACCP regulation for meat 

and poultry requires the establishment 

to develop, implement and maintain 

written SSOPs that describe the 

procedures an establishment will 

conduct daily, before and during 

operations, to prevent direct 

contamination or adulteration of 

products (9 CFR 416.11 and 416.12(a)). 

Establishments must monitor the 

implementation of the SSOPs (9 CFR 

416.13(c)), take appropriate corrective 

actions (9 CFR 416.15), and maintain 

records that document the 

implementation and monitoring of the 

SSOPs (9 CFR 416.16). 

In section XII of this document, we 

describe provisions of the FSIS HACCP 

regulation for meat and poultry in more 

detail when we compare the proposed 

requirements for hazard analysis and 

risk-based preventive controls that are 

the subject of this document to 

provisions of current HACCP systems, 

including the FSIS HACCP regulation 

for meat and poultry. 

c. HACCP regulation for juice. In 

2001, FDA issued a final rule to 

establish in part 120 requirements to 

ensure the safe and sanitary processing 

and importation of fruit and vegetable 

juices for beverages (66 FR 6138). Part 

120 requires, among other things, that 

processors of juice products apply 

HACCP principles to the processing of 

juice. We issued the juice HACCP 

regulation in light of a number of food 

safety hazards associated with juice 

products, including microbiological 

hazards that led to outbreaks of 

foodborne illness associated with juice 

products (63 FR 20449, at 20450–20451, 

April 24, 1998). 

The HACCP regulation for juice 

incorporated the seven HACCP 

principles as established in the 

NACMCF HACCP guidelines adopted in 

1997 and published in 1998 (Ref. 34). 

As with the HACCP regulation for 

seafood, the HACCP regulation for juice 

requires that individuals assigned the 

tasks of developing the hazard analysis, 

developing a HACCP plan, and verifying 

and modifying the HACCP plan must be 

adequately trained in the application of 

HACCP principles to juice products, 

evidenced either by the successful 

completion of the equivalent of a 

standardized curriculum recognized as 

adequate by FDA or by sufficiently 

adequate work experience (§ 120.13). As 

with the HACCP regulation for seafood, 

the HACCP regulation for juice does not 

require the use of NACMCF’s five 

preliminary tasks as prerequisites to 

conducting a hazard analysis or 

developing a HACCP plan. 

As with the HACCP regulation for 

seafood, the HACCP regulation for juice 

requires that processors of juice 

products monitor the conditions and 

practices of a sanitation standard 

operating procedure (SSOP); correct, in 

a timely manner, those conditions and 

practices that are not met; and 

document the monitoring and 

corrections (§ 120.6). In addition, the 

HACCP regulation for juice is explicit 

that the umbrella CGMP requirements of 

part 110 apply in determining whether 

the facilities, methods, practices, and 

controls used to process juice are safe, 

and whether the juice products have 

been processed under sanitary 

conditions (§ 120.5). 

Unlike the HACCP regulation for 

seafood, the HACCP regulation for juice, 

with certain exceptions, establishes 

requirements for process controls for 

pathogen reduction (§ 120.24). The 

HACCP regulation for juice also 

establishes requirements for process 

verification for juice processors, under 

certain circumstances, to analyze their 

finished juice products for the presence 

of E. coli using specified sampling and 

analytical methodologies (§ 120.25). 

In section XII of this document, we 

describe provisions of the HACCP 

regulation for juice in more detail when 

we compare the proposed requirements 

for hazard analysis and risk-based 

preventive controls that are the subject 

of this document to provisions of 

current HACCP systems, including the 

HACCP regulation for juice. 

d. Dairy HACCP pilot program. The 

Pasteurized Milk Ordinance (PMO) is a 

model milk regulation recommended by 

the U.S. Public Health Service/FDA for 

voluntary adoption by State and local 

milk control agencies. This model milk 

regulation includes provisions 

governing the processing, packaging and 

sale of Grade ‘‘A’’ milk and milk 

products and provides administrative 

and technical details on how to obtain 

satisfactory compliance. It is published 

to assist States and municipalities in 

initiating and maintaining effective 

programs for the prevention of 

milkborne disease. Currently all fifty 

states, the District of Columbia, and 

Puerto Rico have adopted the PMO by 

reference or have codified the PMO in 

state requirements. At its biennial 

conferences, the National Conference on 

Interstate Milk Shipments (NCIMS) 

considers changes and modifications to 

the Grade ‘‘A’’ PMO. 

Appendix K of the PMO (the PMO 

HACCP Appendix) describes a 

voluntary, NCIMS HACCP Program 

alternative to the traditional inspection 

system. No milk plant, receiving station 

or transfer station may participate in the 

voluntary NCIMS HACCP Program 

unless the Regulatory Agency 

responsible for the oversight of the 

facility agrees to participate with the 

dairy plant(s), receiving station(s) and 

transfer station(s) in the NCIMS HACCP 

Program (Ref. 37). 

The PMO HACCP Appendix 

incorporates the seven HACCP 

principles established in the 1998 

NACMCF HACCP guidelines and 

essentially follows the same 

requirements as described in the 

HACCP regulation for juice (part 120). 

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SSOPs are referred to as ‘‘required 

prerequisite programs (PPs).’’ In contrast 

to the HACCP regulations for seafood 

and juice, the PMO HACCP Appendix 

requires that, in addition to the required 

PPs, any other PPs that the hazard 

analysis is relying upon to reduce the 

likelihood of hazards such that they 

would not be reasonably likely to occur 

also be monitored, audited, and 

documented. In this respect, the PMO 

HACCP Appendix is broader in scope 

than HACCP, in that it emphasizes the 

importance of monitoring, auditing, and 

documentation for the complete food 

safety system rather than focusing 

monitoring, auditing, and 

documentation solely on critical control 

points. 

e. HACCP in the international food 

safety community. HACCP is recognized 

in the international food safety 

community as the state-of-the-art means 

to ensure the safety and integrity of 

food. In particular, the Committee on 

Food Hygiene of Codex has endorsed 

the HACCP concept as a worldwide 

guideline incorporated as an Annex into 

the Codex General Principles of Food 

Hygiene (GPFH) (Ref. 35). The European 

Union (EU) and other countries around 

the world have begun to require that 

foods be processed using a HACCP 

system. A discussion on the comparison 

of hazard analysis and preventive 

controls standards in section XVI.B 

includes those in Regulation (EC) No 

852/2004 of the European Parliament 

and Council of the European Union 

Regulation (Ref. 38) (the EU Regulation), 

the Australia-New Zealand Food 

Standards Code (Ref. 39), and the 

Canadian Food Inspection Agency’s 

Food Safety Enhancement Program (Ref. 

40), all of which are based on the Codex 

HACCP Annex. 

The HACCP reference documents 

from NACMCF and Codex have changed 

over the years as experience has been 

gained from the application of the 

concept in food production. These 

reference documents remain consistent 

with each other. This harmonization is 

critical, as these documents serve as the 

basis for hazard analysis and preventive 

controls standards internationally, thus 

providing for harmonized food safety 

standards among countries. Such 

harmonization facilitates trade by 

establishing a framework for ensuring 

safety. In addition to these standards 

serving as the basis for requirements by 

governments, there has been widespread 

international adoption of HACCP/ 

preventive controls by industry at the 

company level, and as the foundation 

for food safety in third-party auditing 

schemes and certification efforts for 

companies, such as those benchmarked 

through the Global Food Safety 

Initiative (GFSI) (Ref. 41). (See section II 

of the Appendix to this document for 

more information on GFSI.) 

The proposed rule would require that 

a food safety system similar to HACCP 

be implemented in food facilities and 

would harmonize our requirements with 

the recommendations and requirements 

of internationally recognized food safety 

experts/authorities, such as experts/ 

authorities in NACMCF (Ref. 34), Codex 

(Ref. 35), FSANZ (Ref. 39), CFIA (Ref. 

40), and the European Union (Ref. 38). 

The World Health Organization has 

recognized the importance of the 

HACCP system for prevention of 

foodborne diseases for more than 30 

years and has played an important role 

in its development and promotion (Ref. 

42). FAO likewise emphasizes the 

importance of HACCP and promotes it 

through international training and food 

safety manuals, e.g., for mycotoxin 

prevention and control (Ref. 43). 

The Final Act of the Uruguay Round 

of the General Agreement on Tariffs and 

Trade (GATT), particularly the 

Agreement on the Application of 

Sanitary and Phytosanitary Measures 

(the ‘‘SPS Agreement’’) and the 

Agreement on Technical Barriers to 

Trade, had significant implications for 

Codex standards. Specifically, the SPS 

Agreement identifies Codex standards, 

guidelines and other recommendations 

as the baseline for consumer protection. 

As a result, the work of Codex 

(including the Codex HACCP Annex 

(Ref. 35) has become the reference for 

international food safety requirements. 

The Codex GPFH recommends a HACCP 

approach wherever possible to enhance 

food safety (Ref. 44). The international 

recognition of the HACCP approach as 

essential to ensuring the safety and 

suitability of food for human 

consumption enhances the potential for 

international trade as well as food safety 

(Ref. 43). 

D. Food Safety Problems Associated 

With Manufacturing, Processing, 

Packing, and Holding of Food for 

Human Consumption 

1. Contamination of Food 

Food can become contaminated (e.g., 

with biological, chemical, physical, or 

radiological hazards) at many different 

steps in the farm-to-table continuum: on 

the farm; in packing, manufacturing/ 

processing, or distribution facilities; 

during storage or transit; at retail 

establishments; in restaurants; and in 

the home. Consumption of 

contaminated food can lead to acute or 

long term illness or injury. CDC 

estimates that each year approximately 

48 million illnesses, 128,000 

hospitalizations, and 3,000 deaths are 

food related (Ref. 45) (Ref. 46). These 

numbers include all illnesses that CDC 

estimates are attributable to food, 

including those illnesses caused by 

unspecified agents. These estimates also 

include a correction factor to account 

for the fact that foodborne illness is 

under-reported (Ref. 47). Focusing only 

on the foodborne illnesses attributable 

to particular pathogens, a recent CDC 

report estimated that consumption of 

food contaminated with pathogenic 

bacteria (such as Campylobacter spp., 

Clostridium perfringens, Shiga toxinproducing Escherichia coli (STEC) 

O157, STEC non-O157, Listeria 

monocytogenes, Salmonella spp., Vibrio 

species, Yersinia enterocolitica), 

parasites (such as Cryptosporidium spp. 

and Giardia intestinalis) and viruses 

(such as norovirus) cause more than 9 

million episodes of foodborne illness, 

nearly 56,000 hospitalizations, and 

more than 1,300 deaths in the United 

States each year (Ref. 45). (A pathogenic 

microorganism is a microorganism 

capable of causing illness or injury.) 

Other food-related problems are caused 

by chemicals, allergens, and other 

harmful substances, such as glass (see 

sections II.D.2.b through II.D.2.d of this 

document for a discussion of these 

problems). 

Early detection of contamination 

enables food establishments to prevent 

contaminated food from leaving their 

premises. When contamination is not 

detected in time to prevent 

contaminated food from leaving an 

establishment, the contamination may 

be detected while the food is in storage 

or in transit; at retail establishments; in 

restaurants; or in the home and often 

results in the need for a recall. 

Contamination after the food leaves the 

establishment may be detected during 

an investigation of an outbreak of 

foodborne illness or may be detected by 

end users (e.g., restaurants and 

consumers may identify physical 

hazards such as metal fragments or 

pieces of glass). 

In recent years, we have taken a 

number of actions to prevent 

contamination of food at each step in 

the farm-to-table continuum. We have 

worked with other Federal, State, local, 

territorial, tribal, and foreign 

counterpart food safety agencies to 

strengthen the Nation’s food safety 

systems across the entire distribution 

chain. This cooperative work has 

resulted in a greater awareness of 

potential vulnerabilities, the creation of 

more effective prevention programs, 

new or better surveillance systems, and 

the ability to respond more quickly to 

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outbreaks of foodborne illness. (An 

outbreak of foodborne illness is the 

occurrence of two or more cases of a 

similar illness resulting from the 

ingestion of a common food.) However, 

changes in consumer preferences, 

changes in industry practices, and the 

rising volume of imports continue to 

pose significant challenges for FDA (72 

FR 8750, February 27, 2007; 73 FR 

55115, September 24, 2008). There are 

also many foodborne illnesses 

associated with unknown agents, which 

presents challenges in outbreak 

investigations (Ref. 46). In addition, 

microorganisms can change their 

characteristics by acquiring genes, 

including those for virulence, from 

other microorganisms (Ref. 48). 

2. Microbiological, Chemical, Physical, 

and Radiological Hazards 

In the following discussion of 

hazards, we highlight four categories: 

microbial, chemical (including 

allergens), physical, and radiological. Of 

the four types of hazards, there is far 

more information and data on 

microbiological problems associated 

with foods than with the others. 

a. Microbiological hazards. 

Foodborne illness can have very serious 

consequences, including death. Below, 

we discuss several microorganisms 

commonly associated with foodborne 

illness. 

Salmonella spp. 

Salmonella contamination has been 

associated with eggs, milk and dairy 

products, fish, shrimp, frog legs, yeast, 

coconut, sauces and salad dressing, cake 

mixes, cream-filled desserts and 

toppings, dried gelatin, peanut butter, 

cocoa, and chocolate (Ref. 49). In a 

recent report tracking trends in 

foodborne illness, CDC reported that in 

2010 Salmonella spp. was the most 

common foodborne pathogen and the 

most common cause of hospitalization 

and death (Ref. 50). The incidence of 

foodborne illness due to Salmonella 

spp. has not declined significantly in 

the last 15 years (Ref. 50). Salmonella 

spp. can cause serious and sometimes 

fatal infections in young children, frail 

or elderly people, and others with 

weakened immune systems (Ref. 49) 

(Ref. 51). Healthy persons infected with 

Salmonella spp. often experience fever, 

diarrhea (which may be bloody), nausea, 

vomiting, and abdominal pain. In rare 

circumstances, infection with 

Salmonella spp. can result in the 

organism getting into the blood stream 

and producing more severe illnesses 

such as arterial infections (i.e., infected 

aneurysms), endocarditis, and arthritis 

(Ref. 49) (Ref. 51). 

Listeria Monocytogenes 

Listeria monocytogenes is another 

pathogen often implicated in foodborne 

illness. In 2011, CDC reported that of all 

the foodborne pathogens tracked by 

CDC through FoodNet, L. 

monocytogenes had the highest case 

fatality rate (12.8 percent) and the 

highest hospitalization rate (89.6 

percent) (Ref. 50). L. monocytogenes is 

a bacterium that occurs widely in both 

agricultural (soil, plants and water) and 

food processing environments. L. 

monocytogenes can multiply slowly at 

refrigeration temperatures, thereby 

challenging an important defense 

against foodborne pathogens—i.e., 

refrigeration (Ref. 52) (Ref. 53). Ingestion 

of L. monocytogenes can cause 

listeriosis, which can be a lifethreatening human illness. Serious 

illness almost always occurs in people 

considered to be at higher risk, such as 

the elderly and those who have a 

preexisting illness that reduces the 

effectiveness of their immune system 

(Ref. 54). In addition, perinatal 

listeriosis results from foodborne 

exposure of the pregnant mother leading 

to in utero exposure of the fetus, 

resulting in fetal infection that leads to 

fetal death, premature birth, or neonatal 

illness and death. L. monocytogenes also 

causes listerial gastroenteritis, a 

syndrome typically associated with 

mild gastrointestinal symptoms in 

healthy individuals (Ref. 54) (Ref. 55). 

The risk of illness from L. 

monocytogenes associated with a 

particular food is dependent on five key 

factors (Ref. 52) (Ref. 53): 

• Amount and frequency of 

consumption of a food; 

• Frequency and extent of 

contamination of a food with L. 

monocytogenes; 

• Ability of the food to support the 

growth of L. monocytogenes; 

• Temperature of refrigerated/chilled 

food storage; and 

• Duration of refrigerated/chilled 

storage. 

In 2003, FDA and FSIS, in 

consultation with CDC, released a 

quantitative assessment (the FDA/FSIS 

Lm RA) of relative risk associated with 

consumption of 23 categories of readyto-eat (RTE) foods that had a history of 

contamination with L. monocytogenes, 

or that were implicated 

epidemiologically with an outbreak or a 

sporadic case of listeriosis (Ref. 53). The 

FDA/FSIS Lm RA shows that the risk of 

illness from L. monocytogenes increases 

with the number of cells ingested and 

that there is greater risk of illness from 

RTE foods that support growth of L. 

monocytogenes than from those that do 

not (Ref. 56). FAO/WHO released a risk 

assessment on L. monocytogenes in RTE 

foods in 2004. A key finding of that risk 

assessment was that the models 

developed predict that nearly all cases 

of listeriosis result from the 

consumption of high numbers of the 

pathogen (Ref. 54). Refrigerated foods 

present a greater risk from L. 

monocytogenes because some 

refrigerated foods that support growth 

may be held for an extended period of 

time, thus increasing the risk if L. 

monocytogenes is present in a food. 

Growth of L. monocytogenes does not 

occur if the food is frozen, but the 

organism may survive. If a frozen food 

contaminated with L. monocytogenes is 

thawed and held at temperatures that 

support growth, e.g., under refrigeration, 

the risk of illness from L. 

monocytogenes in that food increases. 

Escherichia Coli O157:H7 

One of the most serious foodborne 

pathogens in terms of symptoms is 

Escherichia coli O157:H7, one of the 

enterohemorrhagic strains of E. coli. 

While the incidence of E. coli O157:H7 

infection has been declining in recent 

years, it is still among the top five 

pathogens causing hospitalization as a 

result of foodborne illness (Ref. 45). 

E. coli is a normal inhabitant of the 

intestines of all animals, including 

humans. However, E. coli O157:H7 is a 

rare variety of E. coli that, among other 

virulence factors, produces one or more 

related, potent toxins that cause severe 

damage to the lining of the intestine. 

Hemorrhagic colitis is the name of the 

acute disease caused by E. coli O157:H7. 

The illness is characterized by severe 

cramping (abdominal pain) and 

diarrhea, which often becomes bloody. 

Occasionally vomiting occurs. The 

illness is usually self-limited and lasts 

for an average of 8 days. Some victims, 

particularly the very young, develop 

hemolytic uremic syndrome (HUS), 

characterized by renal failure and 

hemolytic anemia. From 0 to 15 percent 

of hemorrhagic colitis victims may 

develop HUS. The disease can lead to 

permanent loss of kidney function and 

death (Ref. 49). 

Noroviruses 

Noroviruses are a group of related, 

single-stranded RNA, non-enveloped 

viruses that cause acute gastroenteritis 

in humans. Norovirus is the official 

genus name for the group of viruses 

previously described as ‘‘Norwalk-like 

viruses’’ (NLV) or small round 

structured viruses (SRSVs) because of 

their morphologic features. Norovirus 

infection usually presents as acute-onset 

vomiting, watery non-bloody diarrhea 

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with abdominal cramps, and nausea. 

Low-grade fever also occasionally 

occurs, and diarrhea is more common 

than vomiting in children. Dehydration 

is the most common complication, 

especially among the young and elderly, 

and may require medical attention. 

Symptoms usually last 24 to 72 hours. 

Recovery is usually complete and there 

is no evidence of any serious long-term 

sequelae (i.e., chronic conditions 

resulting from the illness) (Ref. 57). 

Noroviruses are transmitted primarily 

through the fecal-oral route, either by 

consumption of fecally contaminated 

food or water or by direct person-toperson spread. Noroviruses are highly 

contagious and as few as 10 viral 

particles may be sufficient to infect an 

individual. During outbreaks of 

norovirus gastroenteritis, more than one 

mode of transmission has been 

documented—e.g., initial foodborne 

transmission in a restaurant by a 

contaminated food, followed by 

secondary person-to-person 

transmission to household contacts. 

CDC recently estimated that there are 

5.4 million cases of domesticallyacquired foodborne illness each year 

due to norovirus infection, and more 

than 58 percent of all foodborne 

illnesses can be attributed to norovirus 

(Ref. 45). 

As part of the work of the CGMP 

Working Group, FDA reviewed its food 

recall records for recall actions that 

were classified I or II for fiscal years 

1999 through 2003 to identify those 

recalls that took place because of 

problems that could have been 

prevented by CGMP-type preventive 

measures such as proper equipment 

sanitation, adequate training of 

employees, review of product labels for 

accuracy and agreement with the 

product formulation, and adequate 

preventive maintenance of equipment 

(Ref. 58). The review did not include 

Class III recalls because these recalled 

products are not likely to have caused 

adverse health consequences. FDA 

repeated this type of review 5 years 

later, for the period 2008–2009 (Ref. 59). 

In these two reports, the second most 

common reason for such recalls was 

microbiological contamination (Ref. 58) 

(Ref. 59). Approximately 17 percent of 

such recalls during 1999–2003 and 24 

percent of such recalls during 2008– 

2009 were linked to microbiological 

hazards. During 2008–2009, the two 

most commonly implicated pathogens 

in such recalls were L. monocytogenes 

(9.9 percent) and Salmonella spp. (7.6 

percent). In the first annual report on 

the Reportable Food Registry, the three 

main pathogens associated with the 229 

primary reports received by the RFR 

were Salmonella spp. (37.6 percent), L. 

monocytogenes (14.4 percent), and E. 

coli O157:H7 (2.6 percent) (Ref. 60). In 

the second annual report on the 

Reportable Food Registry, the three 

main pathogens associated with the 225 

primary reports received by the RFR 

were Salmonella spp. (38.2 percent), L. 

monocytogenes (17.8 percent), and E. 

coli O157:H7 (0.4 percent) (Ref. 61). 

There are many other pathogens 

associated with foodborne illness; 

however the four described above have 

been implicated in many recent 

outbreaks of foodborne illness as 

demonstrated by the examples below. 

• In 2006–2007, a commercial brand 

peanut butter contaminated with 

Salmonella enterica serotype Tennessee 

(usually shortened to Salmonella 

Tennessee) caused 715 confirmed cases 

of illness, including 129 

hospitalizations (Ref. 62). (Salmonella 

spp. are grouped into serotypes (also 

called serovars) based on cell surface 

antigens, which are determined by 

serologic testing. The serotype is often 

named after the location where it was 

isolated.) This was the first outbreak 

associated with peanut butter in the 

United States (Ref. 63). Investigators 

detected Salmonella spp. in 

environmental samples collected at the 

manufacturer’s facility as well as in 

finished product (Ref. 64) (Ref. 65). Two 

years later, in 2008–2009, another large 

Salmonella outbreak was linked to 

peanut butter and peanut paste (Ref. 66) 

(Ref. 67). Implicated products included 

contaminated peanut butter consumed 

at institutional settings and peanut 

crackers made with the contaminated 

peanut butter as an ingredient (Ref. 66). 

This single outbreak resulted in 714 

confirmed cases of illnesses, including 

166 hospitalizations, and 9 deaths (Ref. 

67). Inspections conducted by FDA at 

the manufacturing facilities revealed 

lack of controls to prevent product 

contamination from pests, from an 

insanitary air-circulation system, from 

insanitary food-contact surfaces, and 

from the processing environment (Ref. 

68) (Ref. 69). 

• In 2007, a puffed snack food was 

implicated in a Salmonella Wandsworth 

and Salmonella Typhimurium outbreak. 

There were 87 confirmed reports of 

illnesses, including 8 hospitalizations. 

The likely source of contamination was 

a contaminated ingredient—i.e., 

imported dried vegetable powder that 

was applied to the puffed snack food 

after the cooking step (Ref. 51) (Ref. 70). 

• From October 2008 to March 2009, 

a multistate L. monocytogenes outbreak 

was linked to Mexican-style cheese that 

was contaminated post-pasteurization. 

There were 8 confirmed cases of illness 

in 5 states (Ref. 71). An investigation at 

the plant revealed the potential for 

product contamination due to 

deficiencies in cleaning and plant and 

equipment maintenance (Ref. 72). 

• In 2008–2009, white pepper was 

implicated in a Salmonella Rissen 

outbreak that resulted in a 87 confirmed 

cases of illness, including 8 

hospitalizations and 1 death (Ref. 73) 

(Ref. 74). During the investigation, FDA 

isolated the outbreak strain from raw 

whole white pepper, in-process 

samples, finished products, and 

environmental samples taken at various 

locations throughout the processing 

areas (Ref. 75). 

• In 2009, a prepackaged, refrigerated 

cookie dough was implicated in an E. 

coli O157:H7 outbreak that caused 76 

confirmed cases of illness, including 35 

hospitalizations (Ref. 76) (Ref. 77). E. 

coli O157:H7 was found in unopened 

packages of cookie dough in the 

production facility, although it was not 

the outbreak strain (Ref. 77) (Ref. 78). 

• In 2011, an outbreak of listeriosis 

from cantaloupes was attributed to 

insanitary conditions at a facility that 

washed, packed, cooled, and stored 

intact cantaloupes (Ref. 79) (Ref. 80). 

The outbreak appears to have occurred 

due to a combination of factors, 

including pooled water on the floor of 

the facility (which was also difficult to 

clean), poorly designed equipment (not 

easily cleaned and sanitized) that was 

previously used for a different 

commodity, no pre-cool step, a truck 

parked near the packing area that had 

visited a cattle operation, and possible 

low level contamination from the 

growing/harvesting operation (Ref. 79). 

b. Chemical hazards other than food 

allergens. There are a variety of 

‘‘chemical’’ hazards that may be 

associated with food, including 

pesticide and drug residues, natural 

toxins, decomposition resulting in the 

production of toxins such as histamine, 

unapproved food or color additives, and 

food allergens. (We discuss food 

allergens in more detail in the next 

section of this document). Under the 

FD&C Act, certain products, such as 

food additives, color additives, new 

animal drugs, and pesticides require 

premarket approval before they may be 

legally used. (In the case of pesticides, 

EPA ‘‘registers’’ (i.e., approves) the use 

of pesticides and establishes tolerances 

(the maximum amounts of residues that 

are permitted in or on a food) if the use 

of a particular pesticide may result in 

residues in or on food. FDA enforces 

those tolerances, except for meat, 

poultry, and certain egg products, which 

are the responsibility of FSIS (Ref. 81). 

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Moreover, this approval can be limited 

so that the product may only be used 

legally on or with specific foods, or for 

specific purposes, for which approval 

has been obtained. This limitation 

reflects a longstanding recognition that 

the safety of these types of products is 

variable and must be established on a 

use-by-use basis. Whether an additive, 

drug, or pesticide is safe for a particular 

use, in a particular food, at a particular 

level, depends on factors such as the 

amount of the food that is consumed 

and, if the additive, drug, or pesticide is 

ingested by a living animal before 

slaughter, how the product is 

metabolized in that animal. 

Therefore, an additive, drug, or 

pesticide that has been approved for use 

in some foods, but not other foods, is 

deemed by the FD&C Act to be unsafe 

for use with those other foods. By 

specifically identifying pesticides, drug 

residues, and unapproved food and 

color additives as potential known or 

reasonably foreseeable hazards that a 

facility must consider and evaluate in 

its hazard analysis, section 418(b) of the 

FD&C Act emphasizes the current 

provisions of the FD&C Act regarding 

substances that require premarket 

review. 

Natural toxins (such as aflatoxin in 

foods such as peanuts and tree nuts and 

patulin in apple juice products) are well 

recognized as hazards (Ref. 82) (Ref. 83) 

(Ref. 84) (Ref. 85). Decomposition 

products such as histamine, produced 

from the amino acid histidine when 

certain bacteria grow, can pose a risk to 

health. Biogenic amines other than 

histamine have been associated with 

illnesses, and these may also be formed 

when bacteria grow in some foods. 

Although certain fish species are the 

most common source of illness from 

histamine and other biogenic amines, 

illness from histamine has been 

reported from consumption of other 

foods, in particular cheese (Ref. 86) (Ref. 

87). Heavy metals (such as lead) can 

lead to adverse health consequences 

(such as impaired cognitive 

development in children) (Ref. 88). 

Depending on the particular chemical 

hazard and its level in the food, 

contamination of food with a chemical 

hazard may lead to immediate or nearterm onset of illness (e.g., 

gastrointestinal illness), or may more 

commonly be associated with chronic 

exposure and long-term effects. 

Industrial chemicals (such as caustic 

cleaning compounds) can cause an 

acute reaction. Examples of long-term 

effects include impaired cognitive 

development in children exposed over 

time to relatively low levels of lead in 

contaminated candy (Ref. 88) and liver 

cancer as the result of chronic exposure 

to the mycotoxin aflatoxin (Ref. 89 (Ref. 

90). 

c. Chemical hazards—food allergens. 

Food allergies are immune-mediated 

adverse reactions to proteins. It has been 

estimated that food allergies affect four 

to six percent of children and two to 

three percent of adults (Ref. 91) (Ref. 92) 

(Ref. 93). A recent study by CDC 

estimates that approximately 3 million 

children in the United States (3.9 

percent) have food allergies (Ref. 94). 

This study also reported that the 

prevalence of food allergies increased by 

18 percent in this age group between 

1997 and 2007 (Ref. 94). 

The severity of a food allergic reaction 

varies depending on factors such as the 

amount of allergen ingested, the type of 

allergen, and the presence of other 

underlying medical conditions. 

Sensitive individuals may experience 

reactions to allergen doses as low as a 

few micrograms of food protein (Ref. 95) 

(Ref. 96) (Ref. 97). As high as one-third 

of sensitive individuals can experience 

severe reactions at the minimal eliciting 

dose of an allergen. 

Allergic reactions from food result in 

an estimated 125,000 emergency room 

visits in the United States each year 

(Ref. 98), and as many as 100–150 

deaths in the United States each year 

(Ref. 99) (Ref. 100). For children under 

18 years of age, CDC estimates that there 

are approximately 9,500 food allergyrelated hospitalizations per year (Ref. 

101). The signs and symptoms 

associated with allergic reactions can 

range from oral irritation and swelling 

to cardiovascular collapse (Ref. 102). 

Although more than 170 different 

foods have been reported to cause 

allergic reactions, most severe reactions 

are caused by the major food allergens 

defined in the Food Allergen Labeling 

and Consumer Protection Act (FALCPA) 

(21 U.S.C. 321(qq)): milk, egg, fish, 

crustacean shellfish, tree nuts, wheat, 

peanuts, and soybeans. These eight 

allergens account for 90 percent of 

allergic reactions in affected individuals 

(Ref. 101). FALCPA amended the FD&C 

Act to prescribe the manner in which 

food labels must disclose that a food is, 

or contains an ingredient that bears or 

contains, a major food allergen (one of 

the eight listed above). 

The most common CGMP related 

problem we have identified that 

resulted in a recall, both before and after 

FALCPA was passed, is labeling 

problems (i.e., undeclared allergen). In 

conjunction with the work of the CGMP 

Working Group, FDA reviewed CGMPrelated food recalls during the period 

1999–2003 (Ref. 58). Labeling problems 

accounted for 68 percent of food recalls, 

including 34 percent of recalls due to 

undeclared major food allergens. FDA 

followed up with a similar review of 

CGMP-related food recalls during the 

period 2008–2009, with a focus on 

primary recalls. (A primary recall is a 

recall initiated by a firm where the food 

safety problem first occurred. A 

subsequent recall is triggered by a 

primary recall. In a subsequent recall, 

the recalling firm is a recipient of an 

ingredient that is implicated in a 

primary recall.) In that follow-up 

review, labeling problems accounted for 

62 percent of primary food recalls, 

including 43 percent of recalls due to 

undeclared major food allergens (Ref. 

59). Thus, although FALCPA was 

passed in 2004, we continue to see 

problems with undeclared allergens in 

foods, as evidenced by recalls. 

Some of the problems with 

undeclared allergens come to light only 

after consumers experience allergic 

reactions. For example, in August 2010, 

a prepared food with undeclared milk 

was recalled after a consumer complaint 

of an allergic reaction. It was discovered 

that the ‘‘natural flavors’’ used might 

have contained a milk product, but milk 

was not listed as an allergen on the 

product label (Ref. 103). In December 

2010, a snack product with undeclared 

egg was recalled after a consumer 

complaint of an allergic reaction. The 

egg-containing product was mistakenly 

packaged in packaging designed for a 

similar product that did not contain egg 

(Ref. 104). 

d. Physical hazards. Physical hazards 

include stones, glass, or metal fragments 

that could inadvertently be introduced 

into food. Physical hazards may be 

associated with raw materials, 

especially raw agricultural 

commodities. The facility and 

equipment can also be a source of 

physical hazards, e.g., container glass 

and metal fragments such as nuts and 

bolts from equipment used in 

manufacturing/processing. 

The first RFR Annual Report issued in 

January 2011 identified only three 

primary RFR entries for ‘‘foreign 

objects’’ (which were physical hazards 

that could have resulted in serious 

adverse health consequences or death), 

and all of these were in animal feed or 

pet food (Ref. 60). However, there have 

been recalls of human foods due to 

contamination or potential 

contamination with physical hazards. In 

October 2010, several types of frozen 

vegetables were recalled after shards of 

broken glass were found in some 

packages (Ref. 105) and in May 2011 

several types of English muffins and 

bread products were recalled due to 

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possible contamination with small 

pieces of metal (Ref. 106). 

e. Radiological hazards. Radiological 

contamination of foods is a rare event. 

Examples of radiological hazards 

include radionuclides such as radium226, radium-228, uranium-235, 

uranium-238, plutonium-239, 

strontium-90, iodine-131, and cesium137. The most common way these 

radionuclides are incorporated into 

foods is through use of water that 

contains a radionuclide to manufacture 

a food. For example, in certain locations 

in the United States, high 

concentrations of radium-226, radium228 and uranium have been detected in 

private wells (Ref. 107) (Ref. 108). 

Radiological hazards also may result 

from accidental contamination, e.g., 

contamination arising from accidental 

release from a nuclear facility or from 

damage to a nuclear facility from a 

natural disaster. In 2011, following the 

damage to a nuclear power plant during 

an earthquake and tsunami in Japan, 

radioactivity was subsequently detected 

in foods, particularly milk, vegetables, 

and seafood produced in areas 

neighboring the plant (Ref. 109). 

Consuming food contaminated with 

radioactive material will increase the 

amount of radioactivity a person is 

exposed to, which could have adverse 

health effects. The health effect depends 

upon the radionuclide and the amount 

a person is exposed to. For instance, 

exposure to certain levels of radioactive 

iodine is associated with increased risk 

of thyroid cancer (Ref. 109). 

f. Summary. As discussed above, food 

safety problems associated with 

microbiological, chemical, physical, and 

radiological hazards continue to cause 

illnesses and deaths and result in 

significant recalls. In its reviews of 

CGMP-related food recalls, FDA 

summarized key factors that contributed 

to the food safety problems that initiated 

the recalls. For recalls during 1999– 

2003, FDA concluded that the 

contributing factors (there could be 

more than one for a single recall) 

included incorrect packaging/labeling 

(68 percent), ineffective employee 

training (32 percent), failure to follow 

processing standard operation 

procedures (26 percent), excess/ 

mistaken addition of chemicals/ 

ingredients (9 percent), contamination 

of raw materials (8 percent), ineffective 

use of sanitation principles (8 percent), 

and unknown (4 percent). For recalls 

during 2008–2009, FDA used a slightly 

different methodology to categorize the 

contributing factors; the contributing 

factors included lack of label controls 

(57 percent), lack of supplier controls 

(37 percent), deficiencies in employee 

training (24 percent), lack of sanitation 

controls (17 percent), poor processing 

controls (13 percent), lack of 

environmental monitoring (9 percent), 

and unknown (1 percent). The findings 

from the two recall analyses 

demonstrate that over the past decade, 

similar types of food safety problems 

caused by similar types of contributing 

factors continue to challenge the food 

industry (Ref. 58) (Ref. 59). 

3. Preventing Food Safety Problems 

As discussed in section II.C of this 

document, HACCP is a preventive food 

safety strategy that is a systematic 

approach to the identification and 

assessment of the risk of hazards from 

a particular food or food production 

process or practice and the control of 

those hazards that are reasonably likely 

to occur. The HACCP system aims to 

identify the points in the manufacturing 

process at which hazards might occur 

and to continuously monitor and 

control those points in an attempt to 

ensure that products meet pre-specified 

performance criteria (Ref. 34). The 

HACCP system is universally endorsed 

by international bodies such as Codex, 

the Food and Agriculture Organization, 

and the World Health Organization. 

During the last few years, HACCP 

systems have been mandated by U.S. 

Federal regulations established by FDA 

for seafood and juice, and established by 

FSIS for meat and poultry. (In the 

remainder of this document, we use the 

term ‘‘Federal HACCP regulations’’ to 

refer to these HACCP regulations for 

seafood, juice, and meat and poultry.) 

Codex has issued guidelines for HACCP 

systems (Ref. 35), and several 

industrialized nations or unions have 

mandated HACCP for part or all of their 

food industries (Ref. 38) (Ref. 39) (Ref. 

40). 

As discussed in sections II.C.1 

through II.C.4 of this document, HACCP 

is a preventive system made up of 

interdependent activities including 

hazard analysis, preventive controls, 

monitoring, corrective actions, 

verification, and record keeping 

associated with these activities. These 

activities work together to prevent food 

safety problems; the individual 

activities, by themselves, are not as 

effective as the combination of these 

activities in the complete HACCP 

system. For example, a facility may 

determine that certain pathogens are 

reasonably likely to occur in a food 

product and establish and implement a 

heat treatment, for a specified 

combination of time and temperature, as 

a control to prevent the pathogens from 

contaminating finished food products. 

Unless the facility monitors the 

temperature and time during the heat 

treatment, the facility will not be able to 

determine whether its preventive 

control was, in fact, implemented. 

Moreover, the monitoring, by itself, 

would provide less value if the 

temperature was not documented 

during the monitoring and the 

documentation was not reviewed so that 

the facility can verify that the proper 

temperature was achieved for sufficient 

time. If the proper temperature or time 

is not achieved, corrective actions 

would be necessary to ensure that the 

food is reprocessed, diverted to a use 

that does not raise a food safety concern, 

or disposed. For the heat treatment to be 

effective, the level of any pathogens 

contaminating ingredients or other raw 

materials used to make the food must 

not exceed the level of pathogens that 

the heat treatment is validated to 

eliminate. 

As discussed in section III of this 

document, FDA tentatively concludes 

that a modern food safety system based 

on HACCP principles can address the 

food safety problems discussed in 

sections II.D.1 through II.D.2 of this 

document. 

E. The Role of Testing as a Verification 

Measure in a Food Safety System 

The safety of food is principally 

ensured by the effective implementation 

of scientifically valid preventive control 

measures throughout the food chain 

(Ref. 34) (Ref. 110). Prevention of 

hazards in food is much more effective 

than trying to differentiate safe from 

unsafe food using testing. Although 

testing is rarely considered a control 

measure, it plays a very important role 

in ensuring the safety of food. An 

important purpose of testing is to verify 

that control measures, including those 

related to suppliers and those verified 

through environmental monitoring, are 

controlling the hazard (Ref. 111) (Ref. 

112). Testing is used in conjunction 

with other verification measures in the 

food safety system, such as audits of 

suppliers, observations of whether 

activities are being conducted according 

to the food safety plan, and reviewing 

records to determine whether process 

controls are meeting specified limits for 

parameters established in the food 

safety plan. As discussed in the 

Appendix to this document (see 

sections I.C, I.E, and I.F of the 

Appendix), microbial testing may 

include: 

• Testing raw materials and 

ingredients to verify that suppliers have 

significantly minimized or prevented 

hazards reasonably likely to occur in the 

raw materials and ingredients; 

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• Testing the environment to verify 

that sanitation controls have 

significantly minimized or prevented 

the potential for environmental 

pathogens to contaminate RTE food; and 

• Testing finished product to verify 

that preventive controls have 

significantly minimized or prevented 

hazards reasonably likely to occur in the 

food. 

Each type of testing provides 

information applicable to managing 

hazards in foods, depending on the food 

and process. We discuss the role of 

testing as a verification measure in a 

food safety system in section I of the 

Appendix to this document. 

F. The Role of Supplier Approval and 

Verification Programs in a Food Safety 

System 

The development of a supplier 

approval and verification program can 

be part of a preventive approach. 

Because many facilities acting as 

suppliers procure their raw materials 

and ingredients from other suppliers, 

there is often a chain of suppliers before 

a raw material or other ingredient 

reaches the manufacturer/processor. 

Using a preventive approach, a facility 

receiving raw materials or ingredients 

from a supplier can help ensure that the 

supplier (or a supplier to the supplier) 

has implemented preventive controls to 

significantly minimize or prevent 

hazards that the receiving facility has 

identified as reasonably likely to occur 

in that raw material or other ingredient 

unless the receiving facility will itself 

control the identified hazard. 

A supplier approval and verification 

program is a means of ensuring that raw 

materials and ingredients are procured 

from those suppliers that can meet 

company specifications and have 

appropriate programs in place, 

including those related to the safety of 

the raw materials and ingredients. A 

supplier approval program can ensure a 

methodical approach to identifying such 

suppliers. A supplier verification 

program can help provide initial and 

ongoing assurance that suppliers are 

complying with practices to achieve 

adequate control of hazards in raw 

materials or ingredients. We discuss 

supplier approval and verification 

programs in more detail in section II of 

the Appendix to this document. 

III. Legal Authority 

FDA is proposing changes to the 

Current Good Manufacturing Regulation 

under the FD&C Act and the Public 

Health Service Act. FDA is proposing 

changes to 21 CFR Part 1, Subparts H, 

I, and J under the FDA Food Safety 

Modernization Act and the FD&C Act. 

FDA is proposing all other new 

requirements under the FDA Food 

Safety Modernization Act, the FD&C Act 

and the Public Health Service Act. 

A. Changes to Current 21 CFR Part 1, 

Subparts H, I, and J 

Section 103(c)(1)(A) of FSMA requires 

that the Secretary publish a notice of 

proposed rulemaking in the Federal 

Register to issue regulations for 

purposes of section 415 of the FD&C Act 

(Registration of Food Facilities) with 

respect to ‘‘activities that constitute onfarm packing or holding of food that is 

not grown, raised, or consumed on such 

farm or another farm under the same 

ownership’’ and ‘‘activities that 

constitute on-farm manufacturing or 

processing of food that is not consumed 

on that farm or on another farm under 

common ownership.’’ In section VIII.E 

of this document, we discuss our 

proposal to revise the section 415 

registration regulations (21 CFR subpart 

H) to clarify the types of activities that 

are included as part of the definition of 

the term ‘‘facility’’ under section 415 of 

the FD&C Act and the scope of the 

exemption for ‘‘farms’’ provided by 

section 415 of the FD&C Act. The 

proposed rule also would make 

corresponding changes in part 1, 

subpart I (Prior Notice of Imported 

Food) and in part 1, subpart J 

(Establishment, Maintenance, and 

Availability of Records). FDA’s legal 

authority to modify these regulations is 

derived from section 103(c) of FSMA 

and 21 U.S.C. 414, 415, 381(m) and 

371(a). 

B. Changes to Current 21 CFR Part 110 

FDA’s legal authority to require 

Current Good Manufacturing Practices 

derives from sections 402(a)(3), (a)(4) 

and 701(a) of the FD&C Act (21 U.S.C. 

342(a)(3), 342(a)(4), and 371(a)). Section 

402(a)(3) of the FD&C Act provides that 

a food is adulterated if it consists in 

whole or in part of any filthy, putrid, or 

decomposed substance, or if it is 

otherwise unfit for food. Section 

402(a)(4) of the FD&C Act provides that 

a food is adulterated if it has been 

prepared, packed, or held under 

insanitary conditions whereby it may 

have become contaminated with filth, or 

whereby it may have been rendered 

injurious to health. Under section 701(a) 

of the FD&C Act, FDA is authorized to 

issue regulations for the efficient 

enforcement of the FD&C Act. The 

changes to the current CGMP regulation 

proposed in this document clarify the 

existing requirements of the regulation 

and update existing requirements to 

reflect changes in the food industry and 

in scientific understanding of food 

safety since issuance of the current 

regulation. In addition to the FD&C Act, 

FDA’s legal authority for the proposed 

changes to current CGMP requirements 

derives from the PHS Act to the extent 

such measures are related to 

communicable disease. Authority under 

the PHS Act for the proposed 

regulations is derived from the 

provisions of sections 311, 361, and 368 

(42 U.S.C. 243, 264, and 271) that relate 

to communicable disease. The PHS Act 

authorizes the Secretary to make and 

enforce such regulations as ‘‘are 

necessary to prevent the introduction, 

transmission, or spread of 

communicable diseases from foreign 

countries into the States * * * or from 

one State * * * into any other State’’ 

(section 361(a) of the PHS Act). (See sec. 

1, Reorg. Plan No. 3 of 1966 at 42 U.S.C. 

202 for transfer of authority from the 

Surgeon General to the Secretary.) 

C. Hazard Analysis and Risk-Based 

Preventive Controls 

Section 103 of FSMA, Hazard 

Analysis and Risk-Based Preventive 

Controls, amends the FD&C Act to 

create a new section 418, which 

mandates rulemaking. Section 

418(n)(1)(A) of the FD&C Act requires 

that the Secretary issue regulations ‘‘to 

establish science-based minimum 

standards for conducting a hazard 

analysis, documenting hazards, 

implementing preventive controls, and 

documenting the implementation of the 

preventive controls * * *.’’ Section 

418(n)(1)(B) of the FD&C Act requires 

that the regulations define the terms 

‘‘small business’’ and ‘‘very small 

business,’’ taking into consideration the 

study of the food processing sector 

required by section 418(l)(5) of the 

FD&C Act. Further, section 103(e) of 

FSMA creates a new section 301(uu) in 

the FD&C Act (21 U.S.C. 331(uu)) to 

prohibit ‘‘[t]he operation of a facility 

that manufactures, processes, packs, or 

holds food for sale in the United States 

if the owner, operator, or agent in charge 

of such facility is not in compliance 

with section 418 [of the FD&C Act].’’ 

In addition to rulemaking 

requirements, section 418 contains 

requirements applicable to the owner, 

operator, or agent in charge of a facility 

required to register under section 415. 

Section 418(a) is a general provision 

that requires the owner, operator, or 

agent in charge of a facility to evaluate 

the hazards that could affect food 

manufactured, processed, packed, or 

held by the facility, identify and 

implement preventive controls, monitor 

the performance of those controls, and 

maintain records of the monitoring. 

Section 418(a) specifies that the purpose 

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of the preventive controls is to ‘‘prevent 

the occurrence of such hazards and 

provide assurances that such food is not 

adulterated under section 402 [of the 

FD&C Act] or misbranded under section 

403(w) [of the FD&C Act] * * *.’’ In 

addition to the general requirements in 

section 418(a) of the FD&C Act, sections 

418(b)–(i) contain more specific 

requirements applicable to facilities. 

These include hazard analysis 

(§ 418(b)), preventive controls (§ 418(c)), 

monitoring (§ 418(d)), corrective actions 

(§ 418(e)), verification (§ 418(f)), 

recordkeeping (§ 418(g)), a written plan 

and documentation (§ 418(h)), and 

reanalysis of hazards (§ 418(i)). In 

sections XII and XV of this document, 

we discuss proposed requirements 

(proposed subparts C and F) that would 

implement these provisions of section 

418 of the FD&C Act. 

Sections 418(j)–(m) of the FD&C Act 

and sections 103(c)(1)(D) and (g) of 

FSMA provide authority for certain 

exemptions and modifications to the 

requirements of section 418 of the FD&C 

Act. These include provisions related to 

seafood and juice HACCP, and low-acid 

canned food (§ 418(j)); activities of 

facilities subject to section 419 of the 

FD&C Act (Standards for Produce 

Safety) (§ 418(k)); qualified facilities 

(§ 418(l)); facilities that are solely 

engaged in the production of food for 

animals other than man, the storage of 

raw agricultural commodities (other 

than fruits and vegetables) intended for 

further distribution or processing, or the 

storage of packaged foods that are not 

exposed to the environment (§ 418(m)); 

facilities engaged only in certain lowrisk on-farm activities on certain foods 

conducted by small or very small 

businesses (§ 103(c)(1)(D) of FSMA), and 

dietary supplements (§ 103(g) of FSMA). 

In sections X.C, XIII, and XIV of this 

document, we discuss proposed 

provisions (proposed § 117.5(a)–(j), and 

proposed subparts D and E) that would 

implement these provisions of section 

418 of the FD&C Act and section 103 of 

FSMA. 

FDA tentatively concludes that the 

provisions in subpart C and related 

requirements in subparts A, D, and F 

should be applicable to activities that 

are intrastate in character. Facilities are 

required to register under section 415 of 

the FD&C Act regardless of whether the 

food from the facility enters interstate 

commerce (§ 1.225(b)). The plain 

language of Section 418 of the FD&C Act 

applies to facilities that are required to 

register under section 415 (§ 418(o)(2) of 

the FD&C Act) and does not exclude a 

facility because food from such a facility 

is not in interstate commerce. Section 

301(uu) of the FD&C Act provides that 

‘‘the operation of a facility that 

manufactures, processes, packs, or holds 

food for sale in the United States if the 

owner, operator, or agent in charge of 

such facility is not in compliance with 

section 418’’, or the causing thereof, is 

a prohibited act. 

FDA also is proposing the provisions 

in subpart C and related requirements in 

Subparts A, D, and F, under sections 

402(a)(3), 402(a)(4), 403(w), and 701(a) 

of the FD&C Act to the extent such 

requirements are necessary to prevent 

food from being held under insanitary 

conditions whereby it may become 

contaminated with filth or rendered 

injurious to health, or being unfit for 

food; and to the extent necessary to 

prevent food from being misbranded 

under section 403(w). FDA is also 

proposing those provisions under 

sections 311, 361, and 368 of the PHS 

Act relating to communicable disease to 

the extent those provisions are 

necessary to prevent the interstate 

spread of communicable disease. FDA 

tentatively concludes that a modern 

food safety system based on HACCP 

principles can address the food safety 

problems discussed in section II.D of 

this document. The food safety system 

that we are proposing would require a 

facility to conduct a hazard analysis to 

determine those hazards that are 

reasonably likely to occur and establish 

and implement preventive controls for 

those hazards. To ensure that controls 

are properly implemented and 

effectively controlling the hazards, the 

proposed food safety system would 

establish requirements for monitoring, 

corrective actions, and verification, 

including validation that the preventive 

controls are adequate to control the 

identified hazards. Certain activities 

would be required to be conducted (or 

overseen) by a qualified individual and 

certain activities would be required to 

be documented. A written food safety 

plan would include the hazard analysis, 

the preventive controls that would be 

established and implemented to address 

those hazards determined to be 

reasonably likely to occur, procedures 

for monitoring, corrective actions, and 

verification, and a recall plan. The 

written plan and other documentation 

would be required to be made promptly 

available to FDA upon oral or written 

request. 

FDA tentatively concludes that, taken 

as a whole, the food safety system 

described here is necessary to help 

prevent food safety problems associated 

with microbiological, chemical, 

physical, and radiological hazards in 

foods. Therefore, the proposed system is 

necessary to prevent food from being 

adulterated because it is unfit for food 

or because it has been held under 

insanitary conditions whereby it may 

become contaminated with filth or may 

be rendered injurious to health; to 

prevent food from becoming 

misbranded under section 403(w) of the 

FD&C Act; and to prevent the spread of 

communicable disease. 

IV. Public Meeting and Preliminary 

Stakeholder Comments 

A. Introduction 

On April 20, 2011, FDA held a public 

meeting entitled ‘‘FDA Food Safety 

Modernization Act: Focus on Preventive 

Controls for Facilities’’ (Federal 

Register of April 13, 2011, 71 FR 

20588). The purpose of the public 

meeting was to provide interested 

persons with an opportunity to discuss 

implementation of the provisions in 

section 418 of the FD&C Act. Although 

the meeting included introductory 

presentations by FDA, the primary 

purpose of the meeting was to listen to 

our stakeholders. In order to meet that 

goal, FDA provided multiple 

opportunities for individuals to express 

their views, including by providing 

opportunities for individuals to make 

presentations at the meeting during an 

open public and webcast comment 

session, whereby participants could 

make presentations in person or via 

webcast, and during another listening 

session that was held at the end of the 

day. Various stakeholders made 

presentations during these public 

sessions, including presentations made 

by representatives from consumer 

groups, industry trade associations, food 

companies, and state agencies. The 

major topics discussed in these 

comments included food allergens and 

the importance of allergen controls, 

verification and the importance of 

testing, submission of food safety plans 

to FDA, education and training on 

preventive controls, the need for 

flexibility in the regulations, modified 

requirements for certain packaged food 

items not exposed to the environment, 

on-farm manufacturing, processing, 

packing and holding activities, and 

states partnering with FDA to conduct 

inspections. 

Stakeholders were given additional 

opportunities to express their views 

during break-out sessions focused on 

specific topics. Topics for the break-out 

sessions included preventive controls 

guidance, on-farm manufacturing and 

small business, preventive controls and 

the relationship to CGMPs, product 

testing and environmental monitoring, 

and training and technical assistance. A 

transcript of FDA’s remarks at the 

opening session, the open public and 

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webcast comment session, and the 

listening session is available on FDA’s 

Web site (Ref. 113). In addition, webcast 

videos were prepared for the public 

meeting and subsequently provided on 

FDA’s Web site, including webcast 

videos of the opening session, open 

public comment session, listening 

session, and several breakout sessions 

(Ref. 114). 

The notice announcing the public 

meeting also requested written 

comments. In response to this request, 

FDA received 30 written comment 

letters. The major issues presented in 

the written comment letters included 

the following: allergen control, 

accredited laboratories, environmental 

monitoring and product testing, 

flexibility of regulations and guidance, 

food defense, guidance and outreach, 

preventive controls, small businesses 

and exempted facilities, submission of 

the food safety plans to FDA, and 

modified requirements for warehouses. 

In the remainder of this section, we 

summarize each of the major issues 

raised in the written comments and 

identify the key proposed provisions 

applicable to the comments. 

B. Comments on Allergen Control 

Comments state that FDA should 

address the evaluation of allergens as a 

food hazard and the need for preventive 

controls for allergens in its 

implementation of section 418 of the 

FD&C Act. One comment notes that an 

effective allergen control plan is critical 

to protecting the health and confidence 

of consumers. Comments recommend 

that any required allergen control 

programs be limited to ‘‘major food 

allergens,’’ as defined in the FD&C Act. 

We propose a definition of ‘‘food 

allergen’’ (proposed § 117.3) in section 

X.B.4 of this document and discuss 

proposed requirements for preventive 

controls directed to food allergens 

(proposed § 117.135(d)(2)) in section 

XII.C.6 of this document. 

C. Comments on Accredited 

Laboratories 

Several comments urge FDA to 

require use of accredited laboratories 

only when there is a known or 

suspected food safety problem and not 

in the routine course of business (testing 

raw/ingredient, in-process, or finished 

product). Some comments state it would 

be inconsistent with its statutory 

authority for FDA to require use of 

accredited laboratories beyond limited 

‘‘for cause’’ circumstances, e.g., testing 

for ‘‘identified or suspected food safety 

problems’’ or imports. 

Section 202 of FSMA creates a new 

section 422 in the FD&C Act addressing 

laboratory accreditation for the analyses 

of foods, including use of accredited 

laboratories in certain circumstances. 

This document does not propose 

additional requirements for the use of 

accredited laboratories and does not 

include a discussion of section 422 of 

the FD&C Act. 

D. Comments on Environmental 

Monitoring and Product Testing 

Many comments assert that the role 

and need for product testing and 

environmental monitoring varies 

depending on the type of products and 

processing operation and that it should 

be the facility’s responsibility to 

determine the testing needed to verify 

that its preventive controls are effective. 

Others state that environmental and 

product testing may be appropriate in 

certain instances as verification 

activities, but they do not constitute a 

control step. A number of comments 

assert that finished product testing is 

extremely costly and cannot establish 

safety. As such, they recommend that 

industry and FDA should focus on 

ensuring that preventive measures are 

properly designated and effective 

instead of relying on finished product 

testing. One comment mentions that 

effective testing programs use aggressive 

and robust environmental testing and 

recognize the limited value of finished 

product testing. A few comments point 

out that finished product testing is 

particularly important for RTE products, 

and others suggest that environmental 

monitoring should be required only in 

the part of the facility that handles 

exposed RTE product. Some comments 

maintain that FDA should require 

verification testing when any food has 

an identified hazard for which a facility 

has implemented a preventive control, 

and others state that high-risk plants 

should be required to do microbial 

sampling to a standard and frequency 

set by FDA. A few comments encourage 

FDA to require plants to conduct both 

environmental sampling and testing of 

finished products to provide assurances 

that product coming off the end of the 

line has been produced in accordance 

with the plant’s preventive control plan. 

Section I in the Appendix to this 

document discusses a number of issues 

associated with environmental 

monitoring and product testing. 

Although we are not including 

provisions for environmental 

monitoring or product testing in this 

proposed rule, in section XII.J of this 

document, we request comment on 

these issues. 

E. Comments on Flexibility of 

Regulations and Guidance 

The majority of comments addressing 

this topic state that regulations and 

guidance should be science and riskbased, non-prescriptive, and flexible 

because of the wide variety of facilities 

that will be subject to the regulations. 

One notes that regulations should not 

require companies to hire outside 

consultants either explicitly or in 

practical terms because of their 

complexity. 

As discussed in section XVI.A of this 

document, section 418(n)(3) of the 

FD&C Act requires that the content of 

the regulations promulgated under 

§ 418(n)(1) of the FD&C Act provide 

sufficient flexibility to be practicable for 

all sizes and types of facilities; comply 

with chapter 35 of title 44, United States 

code (commonly known as the 

‘‘Paperwork Reduction Act’’); 

acknowledge differences in risk and 

minimize, as appropriate, the number of 

separate standards that apply to separate 

foods; and not require a facility to hire 

a consultant or other third party to 

identify, implement, certify, or audit 

preventative controls. Section XVI.A of 

this document also addresses how this 

proposed rule complies with the 

requirements in section 418(n)(3) of the 

FD&C Act. 

F. Comments on Food Defense 

Numerous comments reiterate the 

need for food defense to be treated 

distinctly from food safety, because they 

address separate issues and often 

involve different types of expertise 

within companies. They recommend 

that FDA allow manufacturers to 

develop and maintain two distinct sets 

of documents on these separate issues. 

One comment suggests that FDA 

consider implementing the food and 

feed defense-related provisions of 

FSMA through guidance, rather than 

regulation. 

FDA discusses its tentative decision 

not to address ‘‘hazards that may be 

intentionally introduced, including by 

acts of terrorism’’ in section II.B.2.f of 

this document. As stated there, FDA 

plans to implement section 103 

regarding such hazards in a separate 

rulemaking in the future. 

G. Comments on Guidance and 

Outreach 

Comments urge FDA to focus on 

education and outreach for farms, 

facilities, distributors, inspectors, and 

state departments of agriculture. They 

support guidance that would include 

information on conducting valid hazard 

analyses and risk assessments, 

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implementing preventive controls, and 

what constitutes a valid food safety 

plan. They also support guidance that 

would provide access to background 

resources, such as scientific studies, risk 

analyses and risk-based modeling. They 

state that guidance should include 

examples of food safety plans, both 

acceptable and unacceptable ones. One 

comment envisions several different 

types of guidance: how to identify 

hazards and how to distinguish 

preventive controls associated with 

HACCP plans from those falling outside 

HACCP plans; preventive controls that 

should be considered for certain 

categories of food (e.g., high risk food); 

and what constitutes a hazard and how 

you determine its likely occurrence. 

Section 103(b) of FSMA requires FDA 

to issue a guidance document related to 

the ‘‘regulations promulgated under 

subsection (b)(1) with respect to the 

hazard analysis and preventive controls 

under section 418’’ of the FD&C Act. In 

addition, section 103(d) of FSMA 

requires, within 180 days after the 

issuance of the regulations, that FDA 

issue a small entity compliance policy 

guide setting forth in plain language the 

requirements of the regulations 

established under section 418(n) of the 

FD&C Act and section 103 of FSMA to 

assist small entities in complying with 

the hazard analysis and other activities 

required under section 418 of the FD&C 

Act and section 103 of FSMA. On May 

23, 2011, FDA published a Federal 

Register notice announcing the opening 

of a docket [Docket No. FDA–2011–N– 

0238] to obtain information about 

preventive controls and other practices 

used by facilities to identify and address 

hazards associated with specific types of 

food and specific processes (76 FR 

29767). FDA established this docket to 

provide an opportunity for interested 

parties to provide information and share 

views that will inform the development 

of guidance on preventive controls for 

food facilities that manufacture, process, 

pack, or hold human food. FDA 

anticipates issuing these required 

guidance documents in a timely manner 

in coordination with issuing the final 

regulations to assist our stakeholders in 

complying with the regulations. 

FDA did not conduct HACCP training 

for persons subject to our HACCP 

regulations for seafood or juice. 

However, when implementing those 

regulations, FDA worked with an 

alliance of representatives from Federal 

and State agencies, industry and 

academia, to create a uniform, core 

training program that serves as the 

standardized curriculum against which 

other course materials can be judged. 

FDA will be working with an alliance to 

develop such a standardized curriculum 

for any final rule establishing 

requirements for hazard analysis and 

risk-based preventive controls. 

H. Comments on Preventive Controls 

A number of comments point out that 

not all preventive controls need to be 

constructed as critical control points. 

Some urge FDA to work with each 

industry segment to develop a set of 

general preventive controls for that 

segment or to use existing preventive 

controls programs that may already exist 

for a segment of industry; those general 

preventive controls would be tailored to 

each situation, plant design, and 

product. One comment asserts that 

preventive controls must consider 

incoming water as a key risk and states 

that the risk assessment must be 

informed by current standards and 

methodologies and take into account 

resistance to traditional disinfectants. 

FDA is proposing requirements for 

preventive controls in proposed 

§ 117.135 (discussed in section XII.C of 

this document). 

I. Comments on Small and Very Small 

Businesses 

Several comments urge FDA to define 

a very small business. Many recommend 

that these businesses should be 

significantly smaller than those that 

gross $500,000 a year. One comment 

proposes that FDA define very small 

business as having fewer than 20 

employees, stating that the Small 

Business Administration has done so. 

Another suggests that ‘‘very small’’ 

business be defined by the volume of 

product that they put into commerce. 

For facilities that satisfy criteria for the 

‘‘qualified facility’’ exemption and 

therefore have the option of submitting 

documentation related to preventive 

controls or compliance with State, local, 

county, or other applicable non-Federal 

food safety law, several comments urge 

FDA to require that such facilities 

submit documentation of one option or 

the other. One comment disagrees that 

small processors should be exempt, 

since small processors frequently pose a 

risk to the public precisely because of 

their lack of sophistication and 

availability of trained technical staff. 

We discuss our proposed definitions 

for small and very small businesses 

(proposed § 117.3) in section X.B.4 of 

this document. We discuss our 

proposed definition for ‘‘qualified 

facility’’ (proposed § 117.3) in section 

X.B.4 of this document; our proposed 

exemption from subpart C for a 

‘‘qualified facility’’ (proposed § 117.5(a)) 

in section X.C.1 of this document; 

proposed modified requirements for a 

‘‘qualified facility’’ (proposed § 117.201) 

in section XIII.A of this document; and 

a proposed process that would govern 

withdrawal of an exemption from 

subpart C for a ‘‘qualified facility’’ 

(proposed Subpart E) in section XIV of 

this document. 

J. Comments on Submission of Food 

Safety Plan to FDA 

Most comments agree that FDA 

should not require electronic 

submission of food safety plans, 

pointing out that not only would it be 

impractical, but also that food safety 

plans are most appropriately reviewed 

by FDA during on-site facility 

inspections, with the support of people 

familiar with the system who can 

answer questions and show an inspector 

relevant equipment, operations, and 

procedures. They note that plans are of 

limited utility outside of the plant 

context. However, a few comments state 

that FDA should request all initial food 

safety plans, as this would give us an 

idea of any misunderstandings of the 

preventive control requirements. These 

comments also note that submission of 

plans could help FDA quickly 

determine if high-risk facilities are 

developing effective plans and might 

help FDA prioritize inspections. 

FDA is not proposing to require 

submission of food safety plans. We 

discuss this topic and request comment 

on alternate approaches in section XII.K 

of this document. 

K. Comments on Modified Requirements 

for Warehouses 

All comments submitted on the issue 

of warehouses urge FDA to modify the 

preventive controls requirements for 

facilities, such as warehouses, that are 

solely engaged in the storage of 

packaged foods that are not exposed to 

the environment, since no 

manufacturing or processing takes place 

at such food warehouses and the 

product is not exposed to the 

environment. Most state that the facility 

should have procedures in place 

addressing general controls, such as 

sanitation, pest control, storage, 

segregation, security, and 

recordkeeping. 

FDA is proposing modified 

requirements for warehouses solely 

engaged in the storage of packaged food 

that is not exposed to the environment 

in proposed § 117.7 (discussed in 

section X.D of this document) and 

proposed § 117.206 (discussed in 

section XIII.B of this document). 

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V. Placement of Regulatory 

Requirements 

We are proposing to establish the 

revised umbrella CGMP requirements, 

together with the new requirements for 

hazard analysis and risk-based 

preventive controls, in proposed part 

117. As discussed in section XVII of this 

document, we are proposing to remove 

current part 110 after the compliance 

date for all businesses to be in 

compliance with the requirements of 

new part 117. 

VI. Highlights of the Proposed Rule 

A. Overview 

The proposed rule would revise 

FDA’s current regulations in part 110 

regarding the manufacturing, 

processing, packing, or holding of 

human food in two fundamental ways. 

First, it would add new provisions to 

implement section 103 of FSMA. 

Second, it would update, revise, or 

otherwise clarify certain requirements of 

our current regulations in part 110. The 

new provisions and revisions to the 

current CGMP requirements would be 

established in part 117. Under the 

proposed rule, new part 117 would be 

divided into the following subparts: 

• Subpart A—General Provisions; 

• Subpart B—Current Good 

Manufacturing Practice; 

• Subpart C—Hazard Analysis and 

Risk-Based Preventive Controls; 

• Subpart D—Modified 

Requirements; 

• Subpart E—Withdrawal of an 

Exemption Applicable to a Qualified 

Facility; and 

• Subpart F—Requirements Applying 

to Records That Must Be Established 

and Maintained. 

• Subpart G would be reserved. 

In the remainder of this section, we 

highlight key provisions of the proposed 

rule. 

B. Proposed Revisions to 21 CFR Part 1, 

Subparts H, I, and J 

To implement section 103(c) of 

FSMA, the proposed rule would revise 

certain definitions in FDA’s current 

section 415 registration regulations. 

These revisions would clarify the types 

of activities that are included as part of 

the definition of the term ‘‘facility’’ 

under section 415 of the FD&C Act and 

the scope of the exemption for ‘‘farms’’ 

provided by section 415 of the FD&C 

Act. The proposed rule also would make 

corresponding changes in part 1, 

subpart I (Prior Notice of Imported 

Food) and in part 1, subpart J 

(Establishment, Maintenance, and 

Availability of Records). 

C. Proposed Revisions to General 

Provisions of 21 CFR Part 110 (Part 110) 

(Proposed Part 117, Subpart A) 

The proposed rule would both revise 

current provisions of subpart A of part 

110 and add new provisions to subpart 

A as it would be established in 

proposed part 117. The new provisions 

would include specified exemptions for 

certain facilities, or for certain activities 

conducted by facilities, from the 

proposed requirements for hazard 

analysis and preventive controls in 

proposed part 117, subpart C. The 

proposed exemptions would be 

consistent with requirements 

established by FSMA or discretion 

provided by FSMA. The subjects of the 

specified exemptions relate to: 

• A ‘‘qualified’’ facility; 

• Activities subject to our existing 

HACCP regulations for seafood and 

juice, our regulations governing 

microbiological hazards in low acid 

canned foods, and our dietary 

supplement CGMP regulations; 

• Activities of a facility that are 

subject to the Standards for Produce 

Safety in section 419 of the FD&C Act; 

• Certain low-risk packing or holding 

activity/food combinations conducted 

on a farm by a small or very small 

business; 

• Certain low-risk manufacturing/ 

processing activity/food combinations 

conducted on a farm by a small or very 

small business; 

• The receipt, manufacturing, 

processing, packing, holding, and 

distribution of alcoholic beverages and 

other prepackaged food sold in 

conjunction with alcoholic beverages 

(e.g., gift baskets); 

• Facilities that are solely engaged in 

the storage of RACs (other than fruits 

and vegetables) intended for further 

distribution or processing; and 

• Facilities solely engaged in the 

storage of packaged food that is not 

exposed to the environment, although 

the storage of such food that requires 

time/temperature control to prevent the 

growth of, or toxin formation by, 

pathogenic microorganisms would be 

subject to modified requirements that 

would be established in proposed 

subpart D. 

D. Proposed Revisions to Current Good 

Manufacturing Practice Requirements of 

Part 110 (Proposed Part 117, Subpart B) 

In order to modernize current CGMP 

requirements, the proposed rule would 

make revisions including: 

• Modernizing and updating the 

language throughout (e.g., by replacing 

the word ‘‘shall’’ with the word ‘‘must’’ 

and by using certain terms consistently 

throughout proposed part 117); 

• Deleting certain provisions 

containing recommendations, including 

the specific temperatures for 

maintaining refrigerated, frozen or hot 

foods; 

• Clarifying that certain CGMP 

provisions requiring protection against 

contamination require protection 

against cross-contact of food as well to 

address allergens; and 

• Proposing that provisions directed 

to preventing contamination of food and 

food-contact substances be directed to 

preventing contamination of foodpackaging materials as well. 

E. Proposed New Requirements for 

Hazard Analysis and Risk-Based 

Preventive Controls (Proposed Part 117, 

Subpart C) 

1. Written Food Safety Plan 

We propose to require that the owner, 

operator, or agent in charge of a facility 

have and implement a written food 

safety plan that includes as applicable: 

• A hazard analysis; 

• Preventive controls; 

• Monitoring procedures; 

• Corrective action procedures; 

• Verification procedures; and 

• A recall plan. 

2. Written Hazard Analysis 

We propose to require that the written 

hazard analysis identify and evaluate 

known or reasonably foreseeable 

hazards for each type of food 

manufactured, processed, packed, or 

held at the facility to determine whether 

there are hazards that are reasonably 

likely to occur, including biological, 

chemical, physical, and radiological 

hazards. The hazard analysis would 

include an evaluation of the identified 

hazards to determine whether the 

hazards are reasonably likely to occur, 

including an assessment of the severity 

of the illness or injury if the hazard 

were to occur. 

3. Written Preventive Controls 

We propose to require that the owner, 

operator, or agent in charge of a facility 

identify and implement preventive 

controls (including at critical control 

points, if any) to provide assurances that 

hazards that are reasonably likely to 

occur will be significantly minimized or 

prevented and that the food 

manufactured, processed, packed or 

held by such facility will not be 

adulterated under section 402 of the 

FD&C Act or misbranded under section 

403(w) of the FD&C Act. The preventive 

controls would include, as appropriate: 

• Parameters associated with the 

control of the hazard and the maximum 

or minimum value, or combination of 

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values, to which any biological, 

chemical, physical, or radiological 

parameter must be controlled to 

significantly minimize or prevent a 

hazard that is reasonably likely to occur; 

• Process controls; 

• Food allergen controls; 

• Sanitation controls; 

• A recall plan; and 

• Any other necessary controls. 

4. Written Recall Plan 

We propose to require that the written 

recall plan be developed for food with 

hazards that are reasonably likely to 

occur. 

5. Monitoring 

We propose to require the monitoring 

of the preventive controls to provide 

assurance that they are consistently 

performed, including requirements to 

establish and implement written 

monitoring procedures and establish 

and maintain records documenting the 

implementation of the monitoring 

procedures. 

6. Corrective Actions 

We propose to require that facilities 

establish and implement written 

corrective action procedures that would 

be used if preventive controls are not 

properly implemented and take 

corrective actions in the event of an 

unanticipated problem. 

7. Verification 

We propose to require that facilities 

conduct certain verification activities, 

including: 

• Validation of a subset of the 

preventive controls; 

• Verification that monitoring is 

being conducted; 

• Verification that appropriate 

decisions about corrective actions are 

being made; and 

• Verification that the preventive 

controls are consistently implemented 

and are effectively and significantly 

minimizing or preventing the hazards 

that are reasonably likely to occur. 

We also propose to require reanalysis 

of the food safety plan at least once 

every 3 years and more often when 

circumstances warrant. 

8. Qualified Individual 

We propose to establish qualification 

requirements for a ‘‘qualified 

individual,’’ who would be required to 

do or oversee the preparation of the food 

safety plan, validation of preventive 

controls, review of records for 

implementation and effectiveness of 

preventive controls and the 

appropriateness of corrective actions, 

and reanalysis of a food safety plan. A 

‘‘qualified individual’’ would be 

required to successfully complete 

training with a standardized curriculum 

or be otherwise qualified through job 

experience to develop and apply a food 

safety system. Job experience may 

qualify an individual to perform these 

functions if such experience has 

provided an individual with knowledge 

at least equivalent to that provided 

through the standardized curriculum. 

9. List of Required Records 

We propose to establish a list of 

records that would be required under 

proposed subpart C, including the 

written food safety plan and records 

documenting monitoring of preventive 

controls, corrective actions, verification, 

and applicable training for the qualified 

individual. 

F. Proposed New Provisions for 

Modified Requirements (Proposed Part 

117, Subpart D) 

Proposed subpart D would implement 

certain provisions in sections 418(l) and 

(m) of the FD&C Act for modified 

requirements with respect to: 

• Qualified facilities: Implementing 

the modified requirements specified in 

section 418(l) of the FD&C Act for 

facilities that satisfy the statutory 

criteria for a ‘‘qualified facility,’’ we 

propose to establish requirements that 

include: 

• Submission to FDA of 

documentation that the facility is a 

qualified facility; and 

• Submission to FDA of 

documentation demonstrating that the 

owner, operator, or agent in charge of 

the facility has identified the potential 

hazards associated with the food being 

produced, is implementing preventive 

controls to address the hazards, and is 

monitoring the performance of the 

preventive controls to ensure that such 

controls are effective; or 

• Submission to FDA of 

documentation that the facility is in 

compliance with State, local, county, or 

other applicable non-Federal food safety 

law, including relevant laws and 

regulations of foreign countries. 

• Facilities solely engaged in the 

storage of packaged food that is not 

exposed to the environment: Acting on 

the discretion provided to FDA by 

section 418(m) of the FD&C Act, we 

propose to require that the owner, 

operator, or agent in charge of a facility 

solely engaged in the storage of 

packaged food that is not exposed to the 

environment conduct certain activities 

for any such refrigerated packaged food 

that requires time/temperature control 

to significantly minimize or prevent the 

growth of, or toxin production by, 

microorganisms of public health 

significance, including: 

• Establishing and implementing 

temperature controls; 

• Monitoring the temperature 

controls; 

• Taking appropriate corrective 

actions when there is a problem with 

temperature controls; 

• Verifying that temperature controls 

are consistently implemented; and 

• Establishing and maintaining the 

following records: 

• Records documenting the 

monitoring of temperature controls; 

• Records of corrective actions; and 

• Records documenting verification 

activities. 

We seek comment on these proposed 

requirements. 

G. Proposed New Provisions for 

Withdrawal of an Exemption Applicable 

to a Qualified Facility (Proposed Part 

117, Subpart E) 

Proposed subpart E would implement 

the provisions of section 418(l)(3) of the 

FD&C Act and establish the conditions 

under which an exemption granted to a 

‘‘qualified facility’’ could be withdrawn, 

and the procedures that would be 

followed to withdraw such an 

exemption. 

H. Proposed New Recordkeeping 

Requirements (Proposed Part 117, 

Subpart F) 

Proposed subpart F would establish 

requirements that would apply to all 

records that would be required by the 

various proposed provisions of 

proposed part 117, including: 

• General requirements related to the 

content and form of records; 

• Additional requirements specific to 

the food safety plan; 

• Requirements for record retention; 

• Requirements for official review of 

records by FDA; and 

• Public disclosure. 

VII. Compliance Dates 

Section 103(i)(1) of FSMA, General 

Rule, provides that ‘‘[t]he amendments 

made by this section shall take effect 18 

months after the date of enactment’’ 

(i.e., by July 4, 2012). Section 103(i)(2) 

of FSMA, Flexibility for Small 

Businesses, provides that 

‘‘[n]otwithstanding paragraph (1),’’ the 

amendments made by this section ‘‘shall 

apply’’ to a small business and very 

small business beginning on the dates 

that are 6 months and 18 months, 

respectively, ‘‘after the effective date’’ of 

FDA’s final regulation. 

FDA is implementing the 

amendments made by section 103 to the 

FD&C Act through this rulemaking 

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(except as relates to animal food and 

intentional contamination). FDA 

tentatively concludes that it is 

appropriate to provide a sufficient time 

period following publication of the final 

regulation for facilities to come into 

compliance. The final regulation will 

contain provisions that affect which 

facilities are subject to section 418 and 

which provisions apply to particular 

facilities. Without these provisions of 

the regulation in effect, facilities would 

be uncertain as to the applicability of 

certain requirements to them. Further, 

FDA tentatively concludes that 

compliance with section 418 will be 

facilitated greatly by the detail and 

explanation that will be provided by the 

final regulation. 

The current practices of many 

businesses are sufficient to satisfy some 

of the proposed requirements. However, 

the majority of businesses will need to 

make at least some changes if the 

proposed regulations are adopted. FDA 

recognizes that it can take time to 

implement a food safety system that 

would require, among other things, 

performance of a hazard analysis, 

development of preventive controls, and 

monitoring of preventive controls. 

FDA is proposing that the final rule 

would be effective 60 days after 

publication in the Federal Register, 

with staggered compliance dates. 

However, we recognize that businesses 

of all sizes may need more time to 

comply with the new requirements 

established under FSMA. FDA believes 

that it is reasonable to allow for 1 year 

after the date of publication of the final 

rule for businesses other than small and 

very small businesses to come into 

compliance with the new requirements 

established under FSMA. FDA also 

believes that it is reasonable to allow for 

2 years after the date of publication of 

the final rule for small businesses to 

come into compliance with the new 

requirements established under FSMA, 

and 3 years after the date of publication 

of the final rule for very small 

businesses to come into compliance 

with the new requirements established 

under FSMA. FDA intends to work 

closely with the food industry, 

extension and education organizations, 

and state partners to develop the tools 

and training programs needed to 

facilitate implementation of this rule. 

FDA also is proposing to modernize 

the existing CGMP requirements, and 

businesses already subject to current 

part 110 will be subject to the 

modernized CGMPs that would be 

established in proposed part 117. FDA 

believes that it is reasonable to allow for 

the same compliance periods for the 

modernized CGMPs as for the other 

provisions in proposed part 117 so that 

a facility would be subject to all of the 

relevant provisions in proposed part 117 

at the same time. To provide for this 

staggered implementation of the 

modernized CGMPs, FDA is proposing 

to establish the revised regulations in a 

new part (i.e., part 117) so that current 

part 110 can remain unchanged and in 

effect for compliance purposes until all 

businesses have reached the date when 

they must be in compliance with new 

part 117. Thus, as discussed in section 

XVII of this document, we are proposing 

that current part 110 be removed on the 

date that is 3 years after the date of 

publication of the final rule. 

VIII. Rulemaking Required by Section 

103(c) of FSMA: On-Farm Activities 

A. Section 103(c) of FSMA 

1. Clarification of the Activities That 

Are Included as Part of the Definition of 

the Term ‘‘Facility’’ Under Section 415 

of the FD&C Act 

Section 103(c)(1)(A) of FSMA requires 

the Secretary to ‘‘publish a notice of 

proposed rulemaking in the Federal 

Register to promulgate regulations with 

respect to—(i) activities that constitute 

on-farm packing or holding of food that 

is not grown, raised, or consumed on 

such farm or another farm under the 

same ownership for purposes of section 

415 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C 350d), as 

amended by [FSMA]; and (ii) activities 

that constitute on-farm manufacturing 

or processing of food that is not 

consumed on that farm or on another 

farm under common ownership for 

purposes of such section 415.’’ Section 

103(c)(1)(B) of FSMA stipulates that 

such rulemaking ‘‘shall enhance the 

implementation of such section 415 and 

clarify the activities that are included as 

part of the definition of the term 

‘facility’ under such section.’’ Section 

415 of the FD&C Act, in turn, directs the 

Secretary to require by regulation that 

any facility engaged in manufacturing, 

processing, packing, or holding food for 

consumption in the United States be 

registered with the Secretary. The 

registration requirement in section 415 

of the FD&C Act does not apply to 

farms. Our regulations that implement 

section 415 and require food facilities to 

register with FDA are established in part 

1 (21 CFR part 1), subpart H 

(Registration of Food Facilities) (the 

section 415 registration regulations). 

To implement sections 103(c)(1)(A) 

and (B) of FSMA, in this document we 

are proposing to clarify the treatment of 

activities that are included as part of the 

definition of the term ‘‘facility’’ in 

section 415 of the FD&C Act in order to 

enhance the implementation of section 

415. By doing so, we also clarify the 

coverage of section 418 of the FD&C Act, 

because section 418 applies to domestic 

and foreign facilities that are required to 

register under section 415 (see section 

418(o)(2)) except where exemptions 

from section 418 apply. In the 

remainder of this section VIII of this 

document: 

• We discuss the current legal and 

regulatory framework for farms under 

sections 415 and 418 of the FD&C Act, 

including requirements for registration 

of food facilities in the section 415 

registration regulations. (See section 

VIII.B.) 

• We explain why we tentatively 

conclude that rulemaking is needed to 

implement sections 103(c)(1)(A) and (B) 

of FSMA. (See section VIII.C.) 

• We explain how the status of a food 

as a raw agricultural commodity (RAC) 

or a processed food affects the 

requirements applicable to a farm under 

sections 415 and 418 of the FD&C Act. 

We also articulate a comprehensive set 

of organizing principles that form the 

basis for proposed revisions to the 

section 415 registration regulations. (See 

section VIII.D.) 

• We describe our proposed revisions 

to the definitions in the section 415 

registration regulations, based on the 

organizing principles articulated in 

section VIII.D, to clarify the treatment of 

activities that are included as part of the 

definition of the term ‘‘facility’’ in those 

regulations and to enhance and clarify 

the application of those definitions. We 

also describe conforming changes to 

part 1, subpart I (Prior Notice of 

Imported Food) (hereinafter the prior 

notice regulations, established under 

section 307 of the Public Health 

Security and Bioterrorism Preparedness 

and Response Act of 2002 (Pub. L. 107– 

188) (hereinafter the ‘‘BT Act’’)) and 

part 1, subpart J (Establishment, 

Maintenance, and Availability of 

Records) (hereinafter the section 414 

recordkeeping regulations, established 

under section 414 of the FD&C Act). 

(See section VIII.E.) 

• We describe the impact of the 

proposed revisions to the definitions in 

the section 415 registration regulations 

on farms and on ‘‘farm mixed-type’’ 

facilities. A ‘‘farm mixed-type’’ facility 

conducts activities that are outside the 

scope of the definition of ‘‘farm’’ (e.g., 

slicing or chopping fruits or vegetables) 

even though it also conducts activities 

that are within the scope of the 

definition of farm (e.g., growing and 

harvesting crops or raising animals). 

Conducting activities outside the 

definition of ‘‘farm’’ triggers the 

requirements in the section 415 

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registration regulations and, thus, brings 

the facility within the scope of section 

418 of the FD&C Act. (See section 

VIII.F.) 

2. Science-Based Risk Analysis Covering 

Specific Types of On-Farm 

Manufacturing, Processing, Packing and 

Holding Activities 

Section 103(c)(1)(C) of FSMA directs 

the Secretary to conduct a science-based 

risk analysis as part of the section 103(c) 

rulemaking. The science-based risk 

analysis is to cover ‘‘(i) specific types of 

on-farm packing or holding of food that 

is not grown, raised, or consumed on 

such farm or another farm under the 

same ownership, as such packing and 

holding relates to specific foods; and (ii) 

specific on-farm manufacturing and 

processing activities as such activities 

relate to specific foods that are not 

consumed on that farm or on another 

farm under common ownership.’’ In 

section VIII.G of this document, we 

describe a draft Qualitative Risk 

Assessment (the section 103(c)(1)(C) 

draft RA) (Ref. 115) we performed to 

satisfy this requirement. 

3. Exemptions and Modified 

Requirements for Certain Facilities 

Section 103(c)(1)(D)(i) of FSMA 

requires that, as part of the section 

103(c) rulemaking, ‘‘the Secretary shall 

consider the results of the science-based 

risk analysis * * * and shall exempt 

certain facilities from the requirements 

in section 418 of the Federal Food, 

Drug, and Cosmetic Act (as added by 

[section 103 of FSMA]) including 

hazard analysis and preventive controls, 

and the mandatory inspection frequency 

in section 421 of such Act (as added by 

section 201 [of FSMA]), or modify the 

requirements in such sections 418 or 

421, as the Secretary determines 

appropriate, if such facilities are 

engaged only in specific types of onfarm manufacturing, processing, 

packing, or holding activities that the 

Secretary determines to be low risk 

involving specific foods the Secretary 

determines to be low risk.’’ Section 

103(c)(1)(D)(ii) of FSMA provides that 

the exemptions or modifications 

described in section 103(c)(1)(D)(i) 

‘‘shall not include an exemption from 

the requirement to register under 

section 415 of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 350d), as 

amended by [FSMA], if applicable, and 

shall apply only to small businesses and 

very small businesses, as defined in the 

regulation promulgated under section 

418(n) of the Federal Food, Drug, and 

Cosmetic Act[.]’’ In section VIII.H of this 

document, we discuss the results of the 

section 103(c)(1)(C) draft RA. In section 

VIII.I of this document, we set forth our 

tentative conclusions regarding 

combinations of on-farm manufacturing, 

processing, packing, and holding 

activities and foods determined to be 

low risk, considering the results of the 

section 103(c)(1)(C) draft RA. In section 

VIII.J of this document, we discuss a 

proposed approach to using the results 

of the section 103(c)(1)(C) draft RA for 

the purposes of section 421 of the FD&C 

Act. In section X.C.6 of this document, 

we discuss our proposal to exempt lowrisk combinations of activities and foods 

from the requirements of section 418 of 

the FD&C Act when performed by farm 

mixed-type facilities that are small or 

very small businesses as would be 

defined in proposed § 117.3 (see 

discussion of the proposed definitions 

of ‘‘small business’’ and ‘‘very small 

business’’ in section X.B.4 of this 

document). 

B. The Current Legal and Regulatory 

Framework Under Sections 415 and 418 

of the FD&C Act and Regulations 

Implementing Section 415 of the FD&C 

Act 

As noted in the previous section, 

section 415 of the FD&C Act directs the 

Secretary to require by regulation that 

any facility engaged in manufacturing, 

processing, packing, or holding food for 

consumption in the United States be 

registered with the Secretary. Section 

1.227 in the section 415 registration 

regulations includes definitions that are 

relevant to the scope of those 

regulations, including definitions for 

types of establishments (‘‘facility’’ and 

‘‘farm’’) and for types of activities 

(‘‘holding,’’ ‘‘manufacturing/ 

processing,’’ ‘‘packaging,’’ and 

‘‘packing’’). In relevant part, these 

definitions play a role in determining 

whether an establishment is a facility 

that must register with FDA and 

implement a provision (in section 

415(b)(1) of the FD&C Act) exempting 

‘‘farms’’ from the registration 

requirement in section 415. We have 

issued guidance to assist food facilities 

in complying with the section 415 

registration regulations (hereinafter 

‘‘Food Facility Registration Guidance’’) 

(Ref. 116). 

Section 418(n) of the FD&C Act 

directs the Secretary to establish 

regulations implementing the 

requirements of section 418 for hazard 

analysis and risk-based preventive 

controls applicable to the owner, 

operator, or agent in charge of a 

‘‘facility.’’ Section 418(o)(2) of the FD&C 

Act defines ‘‘facility’’ for the purpose of 

section 418 as ‘‘a domestic or foreign 

facility that is required to register under 

section 415.’’ 

Under the framework established by 

section 415 of the FD&C Act and the 

section 415 registration regulations, 

farms are establishments that do 

conduct activities described in the farm 

definition in § 1.227(b)(3) but do not 

conduct other activities (such as 

manufacturing/processing on food that 

is not consumed on that farm or another 

farm under the same ownership) that 

would trigger the requirements in the 

section 415 registration regulations. 

Because establishments that satisfy the 

definition of ‘‘farm’’ in § 1.227(b)(3) are 

not required to register under section 

415, they do not satisfy the definition of 

‘‘facility’’ in section 418(o)(2) of the 

FD&C Act and, thus, they are not subject 

to section 418 of the FD&C Act. 

The current legal and regulatory 

framework provided in sections 415 and 

418 of the FD&C Act, the section 415 

registration regulations, and the Food 

Facility Registration Guidance is 

relevant to the FSMA section 103(c) 

rulemaking and the FD&C Act section 

418(n) rulemaking that are the subjects 

of this document. That framework 

determines which establishments and 

activities are subject to the requirements 

of section 418 of the FD&C Act. We 

describe key provisions applicable to 

the current legal and regulatory 

framework in Table 1. 

TABLE 1—KEY PROVISIONS APPLICABLE TO THE CURRENT LEGAL AND REGULATORY FRAMEWORK UNDER SECTIONS 415 

AND 418 OF THE FD&C ACT

Provision of the Section 415 Registration 

Regulations or the FD&C Act Definition or Requirement 

§ 1.227(b)(2): Current definition of ‘‘facility’’ For the purposes of section 415 of the FD&C Act, a facility is, in relevant part, any establishment, 

structure, or structures under one ownership at one general physical location, or, in the case of a 

mobile facility, traveling to multiple locations, that manufactures/processes, packs, or holds food 

for consumption in the United States. 

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TABLE 1—KEY PROVISIONS APPLICABLE TO THE CURRENT LEGAL AND REGULATORY FRAMEWORK UNDER SECTIONS 415 

AND 418 OF THE FD&C ACT—Continued 

Provision of the Section 415 Registration 

Regulations or the FD&C Act Definition or Requirement 

§ 1.225: Requirement to register ............... The owner, operator, or agent in charge of either a domestic or foreign facility must register in accordance with the section 415 registration regulations if the facility is engaged in the manufacturing/processing, packing, or holding of food for consumption in the United States, unless the facility qualifies for one of the exemptions in § 1.226. 

§ 1.226(b): Exemption from registration for 

farms.

Farms are not subject to the registration requirement in § 1.225. 

§ 1.227(b)(3): Current definition of ‘‘farm’’ Farm means a facility in one general physical location devoted to the growing and harvesting of 

crops, the raising of animals (including seafood), or both. Washing, trimming of outer leaves of, 

and cooling produce are considered part of harvesting. The term ‘‘farm’’ includes facilities that 

pack or hold food, provided that all food used in such activities is grown, raised, or consumed on 

that farm or another farm under the same ownership; and facilities that manufacture/process food, 

provided that all food used in such activities is consumed on that farm or another farm under the 

same ownership. 

§ 1.227(b)(5): Current definition of ‘‘holding’’.Holding means storage of food. Holding facilities include warehouses, cold storage facilities, storage 

silos, grain elevators, and liquid storage tanks. 

§ 1.227(b)(6): Current definition of ‘‘manufacturing/processing’’.Manufacturing/processing means making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients. Examples of 

manufacturing/processing activities are cutting, peeling, trimming, washing, waxing, eviscerating, 

rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting juice, distilling, labeling, or packaging. 

§ 1.227(b)(8): Current definition of ‘‘packaging’’.Packaging (when used as a verb) means placing food into a container that directly contacts food 

and that the consumer receives. 

§ 1.227(b)(9): Current definition of ‘‘packing’’.Packing means placing food into a container other than packaging the food. 

Section 418(o)(2) of the FD&C Act ........... A facility that is subject to the requirements of section 418 of the FD&C Act is a domestic facility or 

a foreign facility that is required to register under section 415 of the FD&C Act. 

Together, the provisions described in 

Table 1 establish that a business 

qualifies as a ‘‘farm’’ that is exempt from 

the section 415 registration regulations 

if it satisfies the definition of ‘‘farm’’ in 

§ 1.227(b)(3), including the activities 

performed, where the activities take 

place, where the food used in the 

activities comes from, and where the 

food is consumed: 

• A farm is devoted to the growing 

and harvesting of crops. Washing, 

trimming of outer leaves of, and cooling 

produce are considered part of 

harvesting. 

• A farm can pack or hold food, 

provided that all food used in such 

activities is grown, raised, or consumed 

on that farm or another farm under the 

same ownership. 

• A farm can manufacture/process 

food, provided that all food used in 

such activities is consumed on that farm 

or another farm under the same 

ownership. 

We note that FDA established the 

same definitions of the terms ‘‘facility,’’ 

‘‘farm,’’ ‘‘holding,’’ ‘‘manufacturing/ 

processing,’’ ‘‘packaging,’’ and 

‘‘packing’’ in the section 414 

recordkeeping regulations (§ 1.328), 

because farms are excluded from FDA’s 

authority to establish recordkeeping 

requirements under section 414(b) of the 

FD&C Act. 

C. Why This Rulemaking Is Needed 

Farms are subject to many provisions 

of the FD&C Act and FDA’s authorities 

thereunder, such as FDA’s inspection 

authority under section 704 and the 

general adulteration provisions for food 

in section 402. FDA has long recognized 

that regulation of farms should be 

sensitive to the agricultural setting. As 

early as 1969, FDA exempted 

establishments ‘‘engaged solely in the 

harvesting, storage, or distribution’’ of 

raw agricultural commodities from 

certain regulatory requirements (34 FR 

6977 at 6980, April 26, 1969). The BT 

Act provided FDA with the authority to 

require domestic and foreign facilities 

that manufacture, process, pack, or hold 

food for consumption in the United 

States to register with FDA, and to issue 

regulations regarding the establishment 

and maintenance of certain records 

(codified as sections 415 and 414 of the 

FD&C Act, respectively). Sections 415 

and 414 explicitly exclude ‘‘farms,’’ but 

do not define that term. In notice and 

comment rulemaking implementing 

these provisions, FDA developed a 

definition of the term ‘‘farm.’’ FDA first 

proposed to define ‘‘farm’’ as a facility 

in one general physical location devoted 

to the growing of crops for food, the 

raising of animals for food (including 

seafood), or both. Under that proposed 

definition, the term ‘‘farm’’ would also 

have included (i) facilities that pack or 

hold food, provided that all food used 

in such activities is grown or raised on 

that farm or is consumed on that farm; 

and (ii) facilities that manufacture/ 

process food, provided that all food 

used in such activities is consumed on 

that farm or another farm under the 

same ownership (68 FR 5378 at 5418, 

February 3, 2003). 

FDA received comments stating that 

the proposed definition was too narrow 

because it would not include farms that 

engage in activities traditionally 

performed on farms for nearly all 

commodities, such as washing, 

trimming outer leaves, and cooling (68 

FR 58894 at 58905, October 10, 2003). 

Accordingly, to reflect the intent of 

Congress to exempt establishments 

engaging in activities farms traditionally 

perform from the section 415 

registration regulations, in the final rule 

FDA revised the first part of the farm 

definition in § 1.227(b)(3) to state that a 

farm is a facility in one general location 

that is devoted to the growing and 

harvesting of crops, the raising of 

animals (including seafood), or both, 

and that washing, trimming outer 

leaves, and cooling of food are 

considered part of harvesting (68 FR 

58894 at 58905) (emphasis added). FDA 

also established the same definition of 

‘‘farm’’ at § 1.328 for the purpose of 

exempting farms from the section 414 

recordkeeping regulations (69 FR 71652, 

December 9, 2004). In post-rulemaking 

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guidances implementing the section 415 

registration regulations and the section 

414 regulations, FDA further addressed 

and interpreted the farm definition with 

the goal of doing so in a manner 

recognizing the traditional activities of 

establishments commonly recognized to 

be farms (see the Food Facility 

Registration Guidance (Ref. 116) and 

‘‘Guidance for Industry: Questions and 

Answers Regarding Establishment and 

Maintenance of Records (Edition 4), 

September 2006 (hereinafter 

‘‘Recordkeeping Guidance’’ (Ref. 117)). 

Farm Mixed-Type Facilities 

Consistent with the current legal and 

regulatory framework under sections 

415 and 418 of the FD&C Act and the 

section 415 registration regulations, 

activities within the farm definition in 

§ 1.227(b)(3) would not be subject to the 

requirements of this proposed rule. 

Activities that are not within the farm 

definition and that trigger the section 

415 registration regulations would be 

subject to the requirements of section 

418 of the FD&C Act (and therefore to 

the relevant parts of this proposed rule), 

except where an exemption applies. 

(For a discussion of proposed 

exemptions, see section X.C of this 

document.) 

For the purposes of this document, a 

‘‘farm mixed-type facility’’ is an 

establishment that grows and harvests 

crops or raises animals and may 

conduct other activities within the farm 

definition, but that also conducts 

activities that trigger the section 415 

registration regulations (see the 

discussion of our proposed definition of 

‘‘farm mixed-type facility’’ in section 

VIII.E of this document). Section 418 of 

the FD&C Act does not explicitly 

address whether a farm mixed-type 

facility is subject to section 418 with 

respect to all of its activities or only 

with respect to its activities that trigger 

the section 415 registration regulations. 

Considering the text of section 103 of 

FSMA and the FD&C Act as a whole, 

FDA tentatively concludes that a farm 

mixed-type facility should be subject to 

section 418 only with respect to its 

activities that trigger the section 415 

registration regulations, and not with 

respect to its activities that are within 

the farm definition. Put another way, we 

would apply section 418 only to the 

‘‘non-farm’’ portion of the 

establishment’s activities, and not to the 

‘‘farm’’ portion of its activities. 

Because section 418(o)(2) of the FD&C 

Act defines the term ‘‘facility’’ for the 

purposes of section 418 to mean only 

those facilities required to register under 

section 415 of the FD&C Act, FDA 

tentatively concludes that Congress 

intended the exemptions from the 

section 415 registration regulations, 

including the farm exemption in 

§ 1.226(b), to be meaningful for the 

purposes of defining the applicability of 

section 418. Section 418(a) requires the 

owner, operator, or agent in charge of a 

facility that is required to register under 

section 415 to ‘‘evaluate the hazards that 

could affect food manufactured, 

processed, packed, or held by such 

facility’’ and to take other steps 

discussed more fully in section XII of 

this document, including identifying 

and implementing preventive controls, 

monitoring preventive controls, and 

maintaining records. The use of the 

phrase ‘‘food manufactured, processed, 

packed, or held by the facility’’ in 

section 418(a) parallels the language in 

section 415(a)(1) providing that ‘‘[t]he 

Secretary shall by regulation require 

that any facility engaged in 

manufacturing, processing, packing, or 

holding food for consumption in the 

United States be registered with the 

Secretary.’’ Considering the text of 

FSMA and the FD&C Act as a whole, 

FDA tentatively concludes that only 

those manufacturing, processing, 

packing, or holding activities that trigger 

registration under the section 415 

registration regulations should be 

considered to be manufacturing, 

processing, packing, or holding of food 

by a facility for the purposes of section 

418. Put another way, FDA tentatively 

concludes that a mixed-type facility 

should only be subject to section 418 

with respect to its activities that actually 

trigger the section 415 registration 

regulations, and not with respect to its 

other activities, at the same location, 

that would not trigger the section 415 

registration regulations. To conclude 

otherwise would mean that, for 

example, the farm exemption from 

registration would be rendered 

irrelevant to the coverage of section 418, 

except for activities on farms that will 

be subject to requirements under section 

419 of the FD&C Act (see the discussion 

of the exemption provided by section 

418(k) of the FD&C Act to such farms in 

section X.C.5 of this document). Under 

such an interpretation many ‘‘farm’’ 

portions of farm mixed-type facilities 

would be subject to section 418, 

including, for example, dairies, egg 

farms, farms raising livestock for food, 

and farms growing produce that is not 

subject to requirements under section 

419. However, section 103(c)(1)(D) of 

FSMA, which directs FDA to consider 

exempting or modifying the 

requirements of section 418 for 

activities conducted by a farm mixedtype facility outside the farm 

exemption, seems to mean that Congress 

did not intend the ‘‘farm’’ portion of 

such a facility to be covered by section 

418, even though Congress intended the 

‘‘non-farm’’ portions of such a facility to 

be subject to section 418 (including 

under modified requirements) (provided 

that FDA concluded that it was 

appropriate to do so after conducting 

the science-based risk analysis required 

by section 103(c)(1)(C) of FSMA). (See 

section VIII.G for a discussion of the 

analysis FDA conducted and section 

VIII.H of this document for a discussion 

of FDA’s proposed actions in light of 

that analysis). 

Therefore, unless an exemption from 

section 418 of the FD&C Act applies, 

FDA tentatively concludes that a facility 

that is required to register under section 

415 of the FD&C Act should be subject 

to section 418 with respect to all its 

activities that trigger the section 415 

registration regulations, but not with 

respect to its activities that would not 

trigger the section 415 registration 

regulations (such as activities within the 

farm definition set forth in 

§ 1.227(b)(3)). Thus, it is particularly 

important to clarify the classification of 

various activities included in the 

‘‘facility’’ definition in section 415 as 

manufacturing, processing, packing, or 

holding—and in doing so to clarify the 

scope of the farm definition in 

§ 1.227(b)(3)—to make clear the extent 

to which a farm mixed-type facility 

must comply with section 418. 

Clarification of Activities Relevant to 

Farm Mixed-Type Facilities 

At the time FDA developed the farm 

definition and its interpretations of that 

definition, the practical impact of an 

activity’s classification as inside or 

outside that definition was limited to 

the potential to trigger the section 415 

registration regulations and the section 

414 recordkeeping regulations. With the 

advent of FSMA, the scope of the farm 

definition has taken on more 

importance because, for example and as 

discussed in this section, activities 

within the farm definition are not 

subject to section 418 of the FD&C Act, 

but activities outside the farm definition 

are subject to section 418. Therefore, it 

is important that FDA clarify the scope 

of the farm definition, including the 

classification of manufacturing, 

processing, packing and holding 

activities relevant to that definition, and 

adjust it if necessary and appropriate to 

enhance implementation of section 418 

of the FD&C Act, as well as section 415 

of the FD&C Act. Accordingly, in the 

remainder of this section VIII FDA 

articulates a comprehensive set of 

organizing principles that would form 

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the basis for our proposal for classifying 

activities to more accurately reflect the 

scope of activities traditionally 

conducted by farms and to allow for 

more certainty among industry with 

regard to how their activities will be 

regulated. We seek comment on this 

proposal. 

D. Organizing Principles for How the 

Status of a Food as a Raw Agricultural 

Commodity or as a Processed Food 

Affects the Requirements Applicable to 

a Farm Under Sections 415 and 418 of 

the FD&C Act 

1. Statutory Framework for Raw 

Agricultural Commodities and 

Processed Food 

To clarify the scope of the farm 

definition, FDA considered how the 

activities of farms relate to the statutory 

concepts of ‘‘raw agricultural 

commodity’’ and ‘‘processed food.’’ The 

FD&C Act defines ‘‘raw agricultural 

commodity’’ and ‘‘processed food’’ in 

relation to each other, and identifies 

certain activities that transform a RAC 

into a processed food and others that do 

not. Section 201(r) of the FD&C Act (21 

U.S.C. 321(r)) defines ‘‘raw agricultural 

commodity’’ to mean ‘‘any food in its 

raw or natural state, including all fruits 

that are washed, colored, or otherwise 

treated in their unpeeled natural form 

prior to marketing.’’ Section 201(gg) of 

the FD&C Act (21 U.S.C. 321(gg)) 

defines ‘‘processed food’’ to mean ‘‘any 

food other than a raw agricultural 

commodity and includes any raw 

agricultural commodity that has been 

subject to processing, such as canning, 

cooking, freezing, dehydration, or 

milling.’’ In addition, section 

201(q)(1)(B)(i)(II) of the FD&C Act 

(which defines pesticide chemicals) 

contains the following language 

regarding activities that do not 

transform a RAC into a processed food: 

‘‘the treatment [with pesticide 

chemicals] is in a manner that does not 

change the status of the food as a raw 

agricultural commodity (including 

treatment through washing, waxing, 

fumigating, and packing such 

commodities in such manner).’’ 

The status of a food as a RAC or 

processed food is relevant for many 

different purposes under the FD&C Act. 

For example, under section 403(q)(4) of 

the FD&C Act (21 U.S.C. 343(q)(4)), FDA 

has established a voluntary nutrition 

labeling program that applies to RACs 

but not to processed foods. Under 

403(w) of the FD&C Act (21 U.S.C. 

343(w)), labeling requirements related to 

major food allergens apply to processed 

foods but do not apply to RACs. Under 

sections 201(q), 403(k), 403(l), and 408 

of the FD&C Act (21 U.S.C. 321(q), 

343(k), 343(l), and 346a), the status of a 

food as a RAC has an impact on the 

manner in which pesticide chemicals 

and their residues are regulated. FSMA 

created more provisions in the FD&C 

Act and elsewhere that take status as a 

RAC or processed food into account, 

including section 417(f) of the FD&C Act 

(21 U.S.C. 350f(f)), establishing 

notification requirements for reportable 

foods that do not apply to fruits and 

vegetables that are RACs; section 418(m) 

of the FD&C Act, which authorizes FDA 

to exempt or modify the requirements 

for compliance under section 418 with 

respect to facilities that are solely 

engaged in the storage of RACs other 

than fruits and vegetables intended for 

further distribution or processing; 

section 419(a)(1)(A) of the FD&C Act (21 

U.S.C. 350h(a)(1)(A)), which authorizes 

FDA to establish minimum sciencebased standards applicable to certain 

fruits and vegetables that are RACs; and 

section 204(d)(6)(D) of FSMA (21 U.S.C. 

2223(d)(6)(D)), which contains special 

provisions for commingled RACs 

applicable to FDA’s authority under 

section 204 of FSMA to establish 

additional recordkeeping requirements 

for high risk foods. FDA has also 

established by regulation an exemption 

from the current CGMP requirements 

applicable to establishments engaged 

solely in the harvesting, storage, or 

distribution of one or more RACs 

(§ 110.19). (We discuss this exemption 

in detail in section X.C.9 of this 

document.) 

The term ‘‘raw agricultural 

commodity’’ and similar terms also 

appear in other Federal statutes. While 

these statutes are not implemented or 

enforced by FDA and do not directly 

impact the interpretation of the 

definitions in sections 201(r) and 

201(gg) of the FD&C Act, they do 

provide some suggestions about what 

‘‘raw agricultural commodity’’ and 

related concepts can mean in various 

circumstances. For example, the 

Secretary of Transportation may 

prescribe commercial motor vehicle 

safety standards under 49 U.S.C. 31136, 

but the Motor Carrier Safety 

Improvement Act of 1999 (Pub. L. 106– 

159, title II, Sec. 229, Dec. 9, 1999), as 

added and amended by the Safe, 

Accountable, Flexible, Efficient 

Transportation Equity Act: A Legacy for 

Users (Pub. L. 109–59, title IV, Sec. 

4115, 4130, Aug. 10, 2005), provided an 

exemption from maximum driving or 

on-duty times for drivers transporting 

‘‘agricultural commodities’’ or farm 

supplies within specific areas during 

planting and harvest periods. In that 

circumstance, ‘‘agricultural commodity’’ 

is defined as ‘‘any agricultural 

commodity, non-processed food, feed, 

fiber, or livestock * * * and insects’’ 

(49 U.S.C. 31136 note). Another 

example is 19 U.S.C. 1677(4)(E), which 

provides for certain circumstances in 

which producers or growers of raw 

agricultural products may be considered 

part of the industry producing 

processed foods made from the raw 

agricultural product for the purposes of 

customs duties and tariffs related to 

such processed foods. In that 

circumstance, ‘‘raw agricultural 

product’’ is defined as ‘‘any farm or 

fishery product’’ (19 U.S.C. 1677(4)(E)). 

These statutes are informative in that 

they suggest that the ‘‘raw agricultural 

commodity’’ concept describes and 

signifies the products of farms in their 

natural states, or, in other words, that 

which a farm exists to produce on a 

basic level. 

2. Interpretive Documents and Guidance 

Regarding Whether an Activity 

Transforms a Raw Agricultural 

Commodity Into a Processed Food 

Because the status of a food as a RAC 

or processed food is of great importance 

in defining the jurisdiction of FDA and 

EPA over antimicrobial substances, FDA 

and EPA have developed guidance 

regarding whether or not various 

activities transform RACs into processed 

foods. FDA and EPA jointly issued a 

legal and policy interpretation of the 

agencies’ jurisdiction under the FD&C 

Act over antimicrobial substances used 

in or on food (hereinafter the ‘‘1998 

Joint EPA/FDA Policy Interpretation’’) 

(63 FR 54532, October 9, 1998). In 1999, 

FDA issued guidance addressing several 

of the issues discussed in the 1998 Joint 

EPA/FDA Policy Interpretation. (See 

Guidance for Industry: Antimicrobial 

Food Additives, July 1999 (hereinafter 

‘‘Antimicrobial Guidance’’) (Ref. 118)). 

As discussed in these documents, FDA 

and EPA agreed that the following 

‘‘post-harvest’’ activities do not 

transform a RAC into processed food 

within the meaning of that term in 

section 201(gg) of the FD&C Act: 

‘‘washing, coloring, waxing, hydrocooling, refrigeration, shelling of nuts, 

ginning of cotton, and the removal of 

leaves, stems, and husks’’ (Ref. 118, 

section 7 and 63 FR 54532 at 54541). 

FDA and EPA also agreed that the 

following activities do transform a RAC 

into a processed food: ‘‘canning, 

freezing, cooking, pasteurization or 

homogenization, irradiation, milling, 

grinding, chopping, slicing, cutting, or 

peeling’’ (Ref. 118, section 7 and 63 FR 

54532 at 54541). In addition, these 

documents set forth the conclusion of 

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EPA and FDA that drying a RAC causes 

it to become a processed food, unless 

the drying is for the purpose of 

facilitating storage or transportation of 

the commodity (Ref. 118, section 7 and 

63 FR 54532 at 54541–2); this 

conclusion was based on EPA’s policy 

statement on the status of dried 

commodities as RACs (61 FR 2386, 

January 25, 1996). FDA and EPA also 

identified slaughter of animals for food 

and activities done to carcasses postslaughter as ‘‘processing’’ for the 

purposes of the processed food 

definition (Ref. 118, section 7 and 63 FR 

54532 at 54542). Table 2 summarizes 

activities that cause food RACs to 

become processed foods and activities 

that do not change the status of a food 

RAC, as provided in the FD&C Act and 

addressed in the 1998 Joint EPA/FDA 

Policy Interpretation and the 

Antimicrobial Guidance. 

TABLE 2—THE EFFECT OF ACTIVITIES ON RACS THAT ARE FOODS

Activities that change a RAC into a processed food Activities that do not change the status of a RAC. 

Canning. Application of pesticides (including by washing, waxing, fumigation, or 

packing). 

Chopping. Coloring. 

Cooking. Drying for the purpose of storage or transportation. 

Cutting. Hydro-cooling. 

Drying that creates a distinct commodity. Otherwise treating fruits in their unpeeled natural form. 

Freezing. Packing. 

Grinding. Refrigeration. 

Homogenization. Removal of leaves, stems, and husks. 

Irradiation. Shelling of nuts. 

Milling. Washing. 

Pasteurization. Waxing. 

Peeling. Activities designed only to isolate or separate the commodity from foreign objects or other parts of the plant. 

Slaughtering animals for food and activities done to carcasses postslaughter, including skinning, eviscerating, and quartering. 

Slicing. 

Activities that alter the general state of the commodity. 

The summary in Table 2 demonstrates 

that the activities that transform a RAC 

into a processed food (and are 

sometimes therefore referred to as 

‘‘processing’’ in the context of a food’s 

status as a RAC or processed food) are 

not coextensive with the definition of 

‘‘manufacturing/processing’’ that FDA 

established in §§ 1.227(b)(6) and 1.328 

for the purposes of the section 415 

registration regulations and the section 

414 recordkeeping regulations, 

respectively. The definition of 

‘‘Manufacturing/processing’’ in those 

regulations includes most food-handling 

activities because it is satisfied by any 

degree of ‘‘making food from one or 

more ingredients, or synthesizing, 

preparing, treating, modifying or 

manipulating food.’’ In contrast, 

transforming a RAC into a processed 

food seems to require meeting a 

threshold of altering the general state of 

the commodity (Ref. 118, section 7 and 

63 FR 54532 at 54541), sometimes 

referred to as transformation of the RAC 

into a new or distinct commodity (61 FR 

2386 at 2388). Because the activities that 

transform a RAC into a processed food 

are not coextensive with the definition 

of ‘‘manufacturing/processing’’ in 

§§ 1.227(b)(6) and 1.328, a given activity 

may be manufacturing/processing under 

the current definition in §§ 1.227(b)(6) 

and 1.328 without transforming a RAC 

into a processed food. Examples of such 

activities include coloring, washing, and 

waxing. 

3. The Organizing Principles 

The current section 415 registration 

regulations, section 414 recordkeeping 

regulations, and related guidances 

demonstrate that some activities may be 

classified differently on farms and off 

farms. For example, ‘‘washing’’ is an 

example of manufacturing/processing 

under the definition of that term in 

§§ 1.227(b)(6) and 1.328. However, 

‘‘washing’’ produce is identified as part 

of harvesting under the farm definition 

in §§ 1.227(b)(3) and 1.328, so washing 

on farms is harvesting rather than 

manufacturing/processing. To date, FDA 

has not articulated organizing principles 

explaining these differences. In this 

document, we are tentatively 

articulating the following organizing 

principles to explain and clarify the 

basis for our proposed revisions to the 

definitions that classify activities onfarm and off-farm in the section 415 

registration regulations and in the 

section 414 recordkeeping regulations, 

and that we interpret in guidances. In 

section VIII.E of this document, we 

propose to incorporate these organizing 

principles into the definitions, 

previously established in §§ 1.227 and 

1.328, that classify activities related to 

foods on farms and farm mixed-type 

facilities. FDA tentatively concludes 

that doing so would more accurately 

reflect which activities of these 

establishments should fall within the 

farm definition. 

a. First organizing principle. The 

statutes we describe in section VIII.D.1 

of this document, and previous 

interpretations of the concepts of RACs 

and processed food as set forth in the 

1998 Joint EPA/FDA Policy 

Interpretation and the Antimicrobial 

Guidance, lead FDA to tentatively 

conclude that the basic purpose of farms 

is to produce RACS and that RACs are 

the essential products of farms. This 

tentative conclusion is the first 

organizing principle that we would 

incorporate into the definitions that 

classify activities related to foods on 

farms and farm mixed-type facilities. 

b. Second organizing principle. In 

light of the first organizing principle 

(i.e., that the basic purpose of farms is 

to produce RACs, and that RACs are the 

essential products of farms), we also 

tentatively conclude that activities that 

involve RACs and that farms 

traditionally do for the purposes of 

growing their own RACs, removing 

them from the growing areas, and 

preparing them for use as a food RAC, 

and for packing, holding and 

transporting them, should all be within 

the definition of ‘‘farm’’ in §§ 1.227(b)(3) 

and 1.328. Doing so would 

appropriately implement the intent of 

Congress (under sections 415(b)(1) and 

414(b) of the FD&C Act) that FDA 

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3680 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

exempt ‘‘farms’’ from the section 415 

registration regulations and the section 

414 recordkeeping regulations. This is 

the case even if the same activities offfarm would be considered to be 

manufacturing/processing under the 

definition of that term in §§ 1.227(b)(6) 

and 1.328, because those activities 

involve ‘‘making food from one or more 

ingredients, or synthesizing, preparing, 

treating, modifying or manipulating 

food.’’ This tentative conclusion 

regarding a special classification for onfarm activities is the second organizing 

principle that we would incorporate 

into the definitions that classify 

activities related to foods on farms and 

farm mixed-type facilities. 

c. Third organizing principle. In light 

of the first organizing principle (i.e., that 

the basic purpose of farms is to produce 

RACs, and that RACs—but not 

processed foods—are the essential 

products of farms) FDA tentatively 

concludes that the second organizing 

principle (i.e., the special classification 

of on-farm activities) should only apply 

to RACs. Thus, the third organizing 

principle that we would incorporate 

into the definitions that classify 

activities related to foods on farms and 

farm mixed-type facilities is that 

activities should be classified based in 

part on whether the food operated on is 

a RAC or a processed food, and on 

whether the activity transforms a RAC 

into a processed food. A farm that 

chooses to transform its RACs into 

processed foods should be considered to 

have chosen to expand its business 

beyond the traditional business of a 

farm, thereby opting to become a farm 

mixed-type facility subject to the section 

415 registration regulations, section 414 

recordkeeping regulations, and other 

requirements linked to the registration 

requirement of section 415 of the FD&C 

Act by FSMA (such as compliance with 

section 418 of the FD&C Act). 

d. Fourth organizing principle. In 

light of the first organizing principle 

(i.e., that the essential purpose of a farm 

is to produce RACs, and that RACs are 

the essential products of farms), FDA 

also tentatively concludes that the 

second organizing principle (i.e., the 

special classification of on-farm 

activities) should only apply to RACs 

grown or raised on the farm itself or on 

other farms under the same ownership 

because the essential purpose of a farm 

is to produce its own RACs, not to 

handle RACs grown on unrelated farms 

for distribution into commerce. (For the 

purposes of this discussion, FDA refers 

to RACs grown or raised on a farm or 

another farm under the same ownership 

as a farm’s ‘‘own RACs,’’ in contrast to 

RACs grown on a farm under different 

ownership, which FDA refers to as 

‘‘others’ RACs.’’) Notably, when FDA 

first undertook to define ‘‘farm,’’ it 

received a comment implicitly 

recognizing this, urging the agency to 

define farms to include typical postharvesting operations, if all food is 

grown on the farm (emphasis added) (68 

FR 5378 at 5379). Therefore, activities 

farms may perform on others’ RACs 

should appropriately be classified as 

manufacturing/processing, packing, or 

holding in the same manner as these 

activities are classified off-farm when 

the RACs are to be distributed into 

commerce. In general, when a farm opts 

to perform activities outside the farm 

definition (and, thus, becomes a farm 

mixed-type facility), the establishment’s 

activities that are within the farm 

definition should be classified as 

manufacturing/processing, packing, or 

holding in the same manner as for a 

farm that is not a mixed-type facility, 

but the activities that are outside the 

farm definition should be classified in 

the same manner as for an off-farm food 

establishment. This is the fourth 

organizing principle that we would 

incorporate into the definitions that 

classify activities related to foods on 

farms and farm mixed-type facilities. 

e. Fifth organizing principle. FDA 

tentatively concludes that 

manufacturing/processing, packing, or 

holding food—whether RACs or 

processed foods, from any source—for 

consumption on the farm should remain 

within the farm definition because 

otherwise farms could not feed people 

and animals on the farm without being 

required to register under section 415 of 

the FD&C Act. This is the fifth 

organizing principle that we would 

incorporate into the definitions that 

classify activities related to foods on 

farms and farm mixed-type facilities. 

f. Summary of organizing principles. 

For the convenience of the reader, Table 

3 summarizes the organizing principles 

that FDA is articulating in this 

document to explain and clarify the 

basis for our proposed revisions to the 

definitions that classify activities onfarm and off-farm in the section 415 

registration regulations and in the 

section 414 recordkeeping regulations, 

and that we interpret in guidances. 

TABLE 3—SUMMARY OF ORGANIZING PRINCIPLES REGARDING CLASSIFICATION OF ACTIVITIES ON-FARM AND OFF-FARM

No. Organizing Principle 

1 .................. The basic purpose of farms is to produce RACs and RACs are the essential products of farms. 

2 .................. Activities that involve RACs and that farms traditionally do for the purposes of growing their own RACs, removing them from the 

growing areas, and preparing them for use as a food RAC, and for packing, holding and transporting them, should all be within 

the definition of ‘‘farm’’ in §§ 1.227 and 1.328. 

3 .................. Activities should be classified based in part on whether the food operated on is a RAC or a processed food, and on whether the 

activity transforms a RAC into a processed food. 

4 .................. Activities farms may perform on others’ RACs should appropriately be classified as manufacturing/processing, packing, or holding 

in the same manner as these activities are classified off-farm when the RACs are to be distributed into commerce. 

5 .................. Manufacturing/processing, packing, or holding food—whether RACs or processed foods, from any source—for consumption on 

the farm should remain within the farm definition. 

E. Proposed Revisions to 21 CFR Part 1 

1. Proposed Redesignation of the 

Definitions in § 1.227 

FDA is proposing to redesignate all 

definitions in the section 415 

registration regulations (i.e., current 

§ 1.227) to eliminate paragraph 

designations (such as (a), (b), (1), (2), 

and (3)). Paragraph designations are not 

necessary when definitions are 

presented in alphabetical order. New 

definitions that FDA is proposing to add 

to the section 415 registration 

regulations and the section 414 

recordkeeping regulations would be 

added in alphabetical order. 

2. Proposed Substantive Revisions to 

the Definitions in §§ 1.227 and 1.328 

FDA is proposing to revise the 

definitions in the section 415 

registration regulations (§ 1.227) and in 

the section 414 recordkeeping 

regulations (§ 1.328), and to add new 

definitions to those regulations, to 

reflect the organizing principles 

articulated in section VIII.D of this 

document and to clarify how those 

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definitions apply to specific activities 

depending on where the activities take 

place, the food used in the activities, 

where the food comes from, and where 

the food is consumed. 

FDA is proposing to add a new 

definition of the term ‘‘Mixed-type 

facility’’ to §§ 1.227 and 1.328. ‘‘Mixedtype facility’’ would mean an 

establishment that engages in both 

activities that are exempt from 

registration under section 415 of the 

FD&C Act and activities that require the 

establishment to be registered. This term 

and its definition were initially 

developed in the preamble to the 

proposed rule on food facility 

registration (68 FR 5378 at 5381) and in 

the interim final rule on food facility 

registration (68 FR 58894 at 58906–7, 

58914, 58934–8) and would be codified 

in our proposed revisions to §§ 1.227 

and 1.328 with the same meaning. The 

proposed definition would also provide, 

as an example of such a facility, a 

definition of a ‘‘farm mixed-type 

facility.’’ A ‘‘farm mixed-type facility’’ 

would be defined as an establishment 

that grows and harvests crops or raises 

animals and may conduct other 

activities within the farm definition, but 

also conducts activities that require the 

establishment to be registered. FDA 

tentatively concludes that it is necessary 

to define this term to satisfy the 

directives of FSMA section 103(c) to 

enhance the implementation of section 

415 of the FD&C Act, clarify the 

activities that are included as part of the 

term facility under section 415, and to 

conduct this rulemaking addressing 

activities that constitute on-farm 

packing or holding of food not grown, 

raised, or consumed on such farm or 

another farm under the same ownership 

and activities that constitute on-farm 

manufacturing or processing of food not 

consumed on that farm or another farm 

under common ownership. Because the 

specific classes of activities mentioned 

in FSMA section 103(c) are, by 

definition, on-farm activities that do not 

fall within the farm definition, Congress 

has explicitly directed FDA to engage in 

rulemaking addressing establishments 

that conduct activities that are outside 

the farm definition on farms. 

Accordingly, FDA is proposing to define 

the term ‘‘farm mixed-type facility’’ to 

refer to these establishments. 

FDA is proposing to add a new 

definition of the term ‘‘Harvesting’’ to 

§§ 1.227 and 1.328. Harvesting would 

apply to farms and farm mixed-type 

facilities and be defined as activities 

that are traditionally performed by 

farms for the purpose of removing raw 

agricultural commodities from the place 

they were grown or raised and preparing 

them for use as food. Harvesting would 

be limited to activities performed on 

raw agricultural commodities on the 

farm on which they were grown or 

raised, or another farm under the same 

ownership. Harvesting would not 

include activities that transform a raw 

agricultural commodity, as defined in 

section 201(r) of the FD&C Act, into a 

processed food as defined in section 

201(gg) of the FD&C Act. Gathering, 

washing, trimming of outer leaves of, 

removing stems and husks from, sifting, 

filtering, threshing, shelling, and 

cooling raw agricultural commodities 

grown on a farm or another farm under 

the same ownership would be listed as 

examples of harvesting. This proposed 

definition would include the same 

examples of ‘‘harvesting’’ that were 

previously part of the farm definition 

(washing, trimming of outer leaves, and 

cooling) and would add other examples 

to help clarify the scope of the 

definition of harvesting. FDA also 

proposes to make clear that these 

activities are ‘‘harvesting’’ when 

conducted on any of a farm’s own RACs, 

not just ‘‘produce.’’ For example, 

unpasteurized shell eggs are RACs, and 

washing such eggs on the farm on which 

the eggs were produced would be part 

of harvesting the eggs. ‘‘Harvesting’’ is a 

category of activities that is only 

applicable to farms and farm mixed-type 

facilities. Activities that would be 

‘‘harvesting’’ when performed on a farm 

on the farm’s own RACs would be 

classified differently under other 

circumstances, such as at a processing 

facility that is not on a farm, or when 

performed by a farm on others’ RACs. 

For example, at an off-farm processing 

facility that pasteurizes eggs, washing 

the unpasteurized shell eggs after they 

are received would not be ‘‘harvesting’’ 

because it is not being performed on the 

farm that produced the eggs (or another 

farm under the same ownership). 

Instead, washing eggs at the off-farm 

processing facility would be 

‘‘manufacturing/processing,’’ because it 

involves preparing, treating, modifying 

or manipulating food. 

FDA is proposing to revise the 

definition of ‘‘Holding’’ in current 

§§ 1.227(b)(5) and 1.328 by adding to 

the existing definition an expanded 

definition applicable to farms and farm 

mixed-type facilities. The proposed 

revision would state that, for farms and 

farm mixed-type facilities, holding 

would also include activities 

traditionally performed by farms for the 

safe or effective storage of RACs grown 

or raised on the same farm or another 

farm under the same ownership, but 

would not include activities that 

transform a RAC, as defined in section 

201(r) of the FD&C Act, into a processed 

food as defined in section 201(gg) of the 

FD&C Act. This would mean that more 

activities than just storage of food would 

be classified as ‘‘holding’’ when a farm 

or farm mixed-type facility performs 

those activities on its own RACs. For 

example, fumigating or otherwise 

treating a farm’s own RACs against pests 

for the purpose of safe and effective 

storage would be ‘‘holding’’ under this 

proposed definition. However, 

fumigating or otherwise treating food 

against pests under other circumstances 

(such as off-farm or by a farm handling 

others’ RACs) would not be ‘‘holding’’ 

food because it is not storage of food, 

which would remain the definition of 

holding applicable to most 

circumstances. 

FDA is proposing to revise the 

definition of ‘‘Manufacturing/ 

processing’’ in current §§ 1.227(b)(6) 

and 1.328 by adding to the existing 

definition a criterion applicable to farms 

and farm mixed-type facilities. The 

proposed revision would state that, for 

farms and farm mixed-type facilities, 

manufacturing/processing would not 

include activities that are part of 

harvesting, packing, or holding. Under 

this proposed revision, expanded 

definitions of ‘‘packing’’ and ‘‘holding,’’ 

and the extra category ‘‘harvesting’’ 

would apply to activities performed by 

farms and farm mixed-type facilities on 

their own RACs. These expanded and 

extra categories would not apply offfarm or to foods other than a farm’s own 

RACs or a farm mixed-type facility’s 

own RACs. Thus, some activities that 

would otherwise be manufacturing/ 

processing would instead be defined as 

packing, holding, or harvesting by virtue 

of being performed by a farm or farm 

mixed-type facility on its own RACs. 

Accordingly, these activities would not 

be manufacturing/processing because 

they would already be classified into the 

expanded definitions of packing or 

holding, or into the extra category of 

harvesting. 

FDA is proposing to revise the 

definition of ‘‘Packing’’ in current 

§§ 1.227(b)(9) and 1.328 by adding to 

the existing definition an expanded 

definition applicable to farms and farm 

mixed-type facilities. The proposed 

revision would state that, for farms and 

farm mixed-type facilities, packing 

would also include activities (which 

may include packaging) traditionally 

performed by farms to prepare RACs 

grown or raised on the same farm or 

another farm under the same ownership 

for storage and transport, but would not 

include activities that transform a RAC, 

as defined in section 201(r) of the FD&C 

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3682 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

Act, into a processed food as defined in 

section 201(gg) of the FD&C Act. This 

would mean that more activities than 

just placing food into a container other 

than packaging would be classified as 

‘‘packing’’ when a farm or farm mixedtype facility performs those activities on 

its own RACs. For example, packaging 

(placing food into a container that 

directly contacts the food and that the 

consumer receives) a farm’s own RACs 

would be ‘‘packing’’ under this 

definition because farms traditionally 

do this to provide greater protection for 

fragile RACs than would be possible if 

the RACs were placed in containers 

other than the consumer container, and 

because this activity does not transform 

a RAC into a processed food. However, 

packaging food under other 

circumstances would not be ‘‘packing’’ 

food because packaging is explicitly 

excluded from the definition of packing 

applicable to most circumstances 

(placing food into a container other than 

packaging). Other examples of activities 

that could be packing when performed 

by a farm or a farm mixed-type facility 

on its own RACs include packaging or 

packing a mix of RACs together (e.g., in 

a bag containing three different colored 

bell peppers, or a box of mixed produce 

for a community sponsored agriculture 

program farm share); coating RACs with 

wax, oil, or resin coatings used for the 

purposes of storage or transport; placing 

stickers on RACs; labeling packages 

containing RACs; sorting, grading, or 

culling RACs; and drying RACs for the 

purpose of storage or transport. 

Table 4 provides examples of how we 

would classify activities conducted offfarm and on-farm (including farm 

mixed-type facilities) using these 

proposed revisions to the definitions in 

the section 415 registration regulations 

and in the section 414 recordkeeping 

regulations. 

TABLE 4—CLASSIFICATION OF ACTIVITIES CONDUCTED OFF-FARM AND ON-FARM

[Including farm mixed-type facilities] 

Classification Off-Farm On-Farm (Including farm mixed-type facilities) 

Harvesting .................. Notes: Not applicable. Harvesting is a 

classification that only applies on 

farms and farm mixed-type facilities.

Notes: Activities traditionally performed by farms for the purpose of removing 

RACs from growing areas and preparing them for use as food. Harvesting is 

limited to activities performed on RACs on the farm on which they were 

grown or raised, or another farm under the same ownership. Harvesting 

does not include activities that change a RAC into processed food. Activities 

that are harvesting are within the farm definition. 

Harvesting .................. Examples: Not applicable ..................... Examples: Activities that fit this definition when performed on a farm’s ‘‘own 

RACs’’ (a term we use to include RACs grown or raised on that farm or another farm under the same ownership) include gathering, washing, trimming 

of outer leaves, removing stems and husks, sifting, filtering, threshing, shelling, and cooling. These activities, performed on a farm’s own RACs, are inside the farm definition. 

Packing ...................... Notes: Placing food in a container 

other than packaging the food 

(where packaging means placing 

food into a container that directly 

contacts the food and that the consumer receives).

Notes: Placing food in a container other than packaging the food (using the 

same definition of packaging), or activities (which may include packaging) 

traditionally performed by farms to prepare RACs grown or raised on that 

farm or another farm under the same ownership for storage or transport. 

Packing does not include activities that change a RAC into a processed 

food. Activities that are packing are within the farm definition when they are 

performed on food grown, raised, or consumed on that farm or another farm 

under the same ownership; under any other circumstances they are outside 

the farm definition. 

Packing ...................... Examples: Putting individual unit cartons into a larger box used for shipping, and putting articles of produce 

in non-consumer containers (such as 

shipping crates).

Examples: Activities that fit the definition of packing when performed on a 

farm’s own RACs include packaging, mixing, coating with wax/oil/resin for 

the purpose of storage or transport, stickering/labeling, drying for the purpose of storage or transport, and sorting/grading/culling. These activities, 

performed on a farm’s own RACs, are inside the farm definition. 

.......................................................... Activities that fit the definition of packing when performed on a farm on any 

other foods, including RACs grown or raised on a farm not under the same 

ownership, include putting individual unit cartons into a larger box used for 

shipping, and putting articles of produce in non-consumer containers (such 

as shipping crates)—the same activities that fit the definition of packing off 

farm. These activities, performed on food other than a farm’s own RACs, 

are outside the farm definition unless done on food for consumption on the 

farm. 

Holding ....................... Notes: Storage of food ......................... Notes: Storage of food, or activities traditionally performed by farms for the 

safe or effective storage of RACs grown or raised on that farm or another 

farm under the same ownership. Holding does not include activities that 

change a RAC into a processed food. Activities that are holding are within 

the farm definition when they are performed on food grown, raised, or consumed on that farm or another farm under the same ownership; under any 

other circumstances they are outside the farm definition. 

Holding ....................... Example: Storing food, such as in a 

warehouse.

Examples: activities that fit the definition of holding when performed on a 

farm’s own RACs include fumigating during storage, and storing food, such 

as in a warehouse. These activities, performed on a farm’s own RACs, are 

inside the farm definition. 

.......................................................... An activity that fits the definition of holding when performed on a farm on any 

other foods, including RACs grown or raised on a farm not under the same 

ownership, is storing food, such as in a warehouse—the same activity that 

fits the definition of holding off farm. This activity, performed on food other 

than a farm’s own RACs, is outside the farm definition unless done on food 

for consumption on the farm. 

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TABLE 4—CLASSIFICATION OF ACTIVITIES CONDUCTED OFF-FARM AND ON-FARM—Continued 

[Including farm mixed-type facilities] 

Classification Off-Farm On-Farm (Including farm mixed-type facilities) 

Manufacturing/ ...........

Processing .................

Notes: Making food from one or more 

ingredients, or synthesizing, preparing, treating, modifying, or manipulating food. Includes packaging 

(putting food in a container that directly contacts food and that the 

consumer receives).

Notes: Making food from one or more ingredients, or synthesizing, preparing, 

treating, modifying, or manipulating food; except for things that fall into the 

categories of harvesting, packing, or holding (see rows above). Activities 

that are manufacturing/processing are outside the farm definition unless 

done on food for consumption on the farm. 

Manufacturing/ ...........

Processing .................

Examples: Activities that fit this definition include washing, trimming of 

outer leaves, removing stems and 

husks, sifting, filtering, threshing, 

shelling, cooling, packaging, mixing, 

coating, stickering/labeling, drying, 

sorting/grading/culling not incidental 

to packing or holding, fumigating, 

slaughtering animals or post-slaughter operations, irradiation, cutting/ 

coring/chopping/slicing, canning, artificial ripening, cooking, pasteurizing/ 

homogenizing, infusing, distilling, 

salting, smoking, grinding/milling, 

and freezing.

Examples: Activities that fit the definition of manufacturing/processing when 

performed on a farm’s own RACs include slaughtering animals or postslaughter operations, irradiation, cutting/coring/chopping/slicing, canning, 

coating with things other than wax/oil/resin, drying that creates a distinct 

commodity, artificial ripening, cooking, pasteurizing/homogenizing, infusing, 

distilling, salting, smoking, grinding/milling, and freezing. These activities, 

performed on a farm’s own RACs, are outside the farm definition unless 

done on food for consumption on the farm. 

.......................................................... Activities that fit the definition of manufacturing/processing when performed on 

a farm on any other foods, including RACs grown or raised on a farm not 

under the same ownership include washing, trimming of outer leaves, removing stems and husks, sifting, filtering, threshing, shelling, cooling, packaging, mixing, coating, stickering/labeling, drying, sorting/grading/culling not 

incidental to packing or holding, fumigating, slaughtering animals or postslaughter operations, irradiation, cutting/coring/chopping/slicing, canning, artificial ripening, cooking, pasteurizing/homogenizing, infusing, distilling, salting, smoking, grinding/milling, and freezing—the same activities that fit the 

definition of manufacturing/processing off farm. These activities, performed 

on food other than a farm’s own RACs, are outside the farm definition unless done on food for consumption on the farm. 

3. Proposed Technical Amendments and 

Conforming Changes 

As a technical amendment for clarity 

and for consistency with our current 

approach to citing the FD&C Act in new 

regulations, FDA is proposing to delete 

the definition of ‘‘Act’’ in current 

§ 1.227 of the section 415 registration 

regulations and revise all remaining 

definitions in current § 1.227 to refer to 

‘‘the Federal Food, Drug, and Cosmetic 

Act’’ rather than ‘‘the act.’’ As a 

conforming change, FDA is proposing to 

revise current § 1.241 in the section 415 

registration regulations to refer to ‘‘the 

Federal Food, Drug, and Cosmetic Act’’ 

rather than ‘‘the act.’’ 

Likewise, as a technical amendment 

for clarity and for consistency with our 

current approach to citing the FD&C Act 

in new regulations, FDA is proposing to 

delete the definition of ‘‘Act’’ in current 

§ 1.328 of the section 414 recordkeeping 

regulations and revise all remaining 

definitions in current § 1.328 to refer to 

‘‘the Federal Food, Drug, and Cosmetic 

Act’’ rather than ‘‘the act.’’ As a 

conforming change, FDA is proposing to 

revise current §§ 1.361 and 1.363 in the 

section 414 registration regulations to 

refer to ‘‘the Federal Food, Drug, and 

Cosmetic Act’’ rather than ‘‘the act.’’ 

As a conforming change to the 

proposed definition of ‘‘harvesting,’’ 

FDA is proposing to revise the 

definition of ‘‘Farm’’ in current 

§§ 1.227(b)(3) and 1.328 to delete 

examples of harvesting that currently 

appear in that definition. With the 

proposed new, separate definition of 

harvesting, it would be redundant to 

retain the examples of harvesting within 

the definition of ‘‘Farm.’’ 

As a conforming change to the 

proposed redesignation of § 1.227 to 

eliminate paragraph designations, FDA 

is proposing to revise § 1.276(b)(9) in 

the prior notice regulations to crossreference § 1.227 (without any 

paragraph designations) rather than to 

cross-reference § 1.227(b)(6). 

F. Impact of Proposed Revisions to the 

Definitions in 21 CFR Part 1 

1. Approach 

FDA has previously addressed 

whether various activities fall within 

the farm definition or not and, as 

discussed more fully in sections VIII.F.2 

through VIII.F.5 of this document, has 

provided guidance on these issues in 

the rulemakings establishing the section 

415 registration regulations and the 

section 414 recordkeeping regulations 

and in accompanying guidance (Ref. 

116) (Ref. 117). For most of the activities 

FDA has previously addressed, applying 

the proposed definitions described in 

section VIII.E of this document would 

result in the same classification with 

respect to whether the activities are 

within the farm definition or not. 

However, because we have not 

previously articulated a comprehensive 

set of organizing principles that form 

the basis for classification of activities, 

in some cases the classification of an 

activity (e.g., packing, holding, or 

harvesting), or the rationale leading to 

the classification of an activity, may be 

different under the proposed revisions 

to the definitions in part 1 than under 

the current definitions in part 1. 

In sections VIII.F.2 through VIII.F.5 of 

this document, we discuss several 

examples of activities that we 

previously addressed and interpreted 

during the rulemakings to establish the 

section 415 registration regulations and 

the section 414 recordkeeping 

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3684 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

regulations, or in related guidances. We 

also explain what, if any, impact our 

proposed revisions to the definitions in 

part 1 would have on our interpretation 

of whether or how an activity conducted 

on a farm or a farm mixed-type facility 

would be within the farm definition or 

would be outside the farm definition 

(and, thus, trigger the section 415 

registration regulations and be within 

the scope of section 418 of the FD&C 

Act). We focus on examples of activities 

where we consider that the proposed 

revisions to the definitions in part 1 

would result in some change in 

outcome. For the convenience of the 

reader, in section VIII.F.6 of this 

document we provide a table 

summarizing these examples. 

In sections VIII.F.2 through VIII.F.5 of 

this document, for the sake of 

simplicity, we discuss activities that 

would be classified as manufacturing/ 

processing outside the farm definition 

under this proposal, without stating 

each time that such activities would still 

be within the farm definition if 

performed on food for a farm or farm 

mixed-type facility’s own consumption. 

The discussion below should not be 

read to suggest that the activities 

discussed could not be within the farm 

definition if they were performed on 

food for a farm or farm mixed-type 

facility’s own consumption. 

2. Application of Pesticides to a Farm or 

Farm Mixed-Type Facility’s Own Raw 

Agricultural Commodities 

The general term ‘‘treating’’ is part of 

the definition of manufacturing/ 

processing in current §§ 1.227(b)(6) and 

1.328, and would remain in the 

proposed revision to that definition. 

FDA previously addressed ‘‘treating 

against pests’’ on farms and farm mixedtype facilities in the preamble to the 

interim final rule on food facility 

registration (68 FR 58894 at 58905), the 

Food Facility Registration Guidance 

(Questions 2.5, 2.6, and 11.1) (Ref. 116), 

and the preamble to the Establishment 

and Maintenance of Records final rule 

(69 FR 71562, 71587, December 9, 

2004). In those documents, FDA 

previously concluded that treating crops 

against pests by applying pesticides 

prior to harvest is an integral part of 

growing crops and is therefore 

‘‘growing’’ within the farm definition. 

For other post-harvest pesticide 

applications FDA previously concluded 

that the applications are manufacturing/ 

processing outside the farm definition, 

because such applications are directed 

at the food rather than at the entire 

plant. However, for one specific 

postharvest pesticide application (i.e., 

applying wash water containing 

chlorine), FDA previously concluded 

both that some uses are washing within 

the farm definition and that another use 

is manufacturing/processing outside the 

farm definition. Specifically, FDA 

previously concluded that the following 

two uses of water containing chlorine 

are washing within the farm definition: 

(1) The application by a farm of 

chlorinated water from public or other 

water supplies that are chlorinated for 

other purposes and (2) the application 

by a farm of wash water containing 

chlorine added by the farm to wash 

water at levels below 200 parts per 

million (ppm) total chlorine. FDA also 

previously concluded that the 

application by a farm of wash water 

containing chlorine added by the farm 

to wash water at levels above 200 ppm 

is manufacturing/processing outside the 

farm definition because such levels 

constitute treating the crop against pests 

rather than washing. 

Some but not all of these previous 

conclusions regarding the application of 

a pesticide to a farm or farm mixed-type 

facility’s own RACs would change 

under the proposed revisions to part 1. 

Under both the current definitions in 

part 1 and the proposed revisions to 

those definitions, treatment of food 

crops against pests before harvest while 

the crop is still in the growing area has 

been, and would continue to be, 

considered an inherent part of the 

growing process and thus classified 

within the farm definition. Thus, the 

classification of such treatments would 

not be affected by the proposed 

revisions to part 1. 

However, under the proposed 

revisions to part 1 FDA would now 

classify pesticide treatments of a farm’s 

own RACs or a farm mixed-type 

facility’s own RACs for the purpose of 

safe or effective storage to be holding 

within the farm definition rather than 

manufacturing/processing outside the 

farm definition. An example of such 

activity is fumigating a farm’s own raw 

nuts to prevent insect infestation and 

damage during the potentially long 

storage period of the nuts. FDA is aware 

that such treatments are traditionally 

performed by farms and may be a 

practical necessity for the preservation 

of some crops during storage, and such 

treatments do not transform a RAC into 

a processed food. Thus, these treatments 

fit the proposed definition of ‘‘holding’’ 

applicable to farms and farm mixed-type 

facilities with respect to their own 

RACs. 

Likewise, under the proposed 

revisions to part 1 FDA would now 

classify pesticide treatment of a farm’s 

own RACs or a farm mixed-type 

facility’s own RACs for the purpose of 

removing the crop from the growing 

area and preparing it for use as food to 

be harvesting. An example of such 

activity is washing a crop in water 

containing an antimicrobial chemical 

after removing the crop from the 

growing area. Generally, antimicrobial 

chemicals are intended only to ensure 

the safety of the wash water. However, 

if an antimicrobial chemical was also 

intended to reduce the microbial load 

on the crop itself as a safety measure, 

under the proposed revisions to part 1 

addition of that antimicrobial chemical 

to reduce the microbial load on a farm’s 

own RACs or a farm mixed-type 

facility’s own RACs would now be 

classified within the farm definition 

rather than be classified as 

manufacturing/processing outside the 

farm definition. For example, the 

application of wash water containing 

chlorine added by the farm at levels 

above 200 ppm to its own RACs would 

now be classified as washing and/or 

treating (depending on the 

circumstances), either of which would 

be harvesting within the farm definition 

rather than as manufacturing/processing 

outside the farm definition. FDA is 

aware that such treatments are 

traditionally performed by farms and 

that they are part of preparing the crop 

for safe use as food, and such treatments 

do not transform a RAC into a processed 

food. Thus, these treatments fit the 

proposed definition of ‘‘harvesting’’ 

applicable to farms and farm mixed-type 

facilities with respect to their own 

RACs. Except for the two examples 

discussed above where FDA previously 

concluded that certain applications of 

water containing chlorine are washing 

within the farm definition, the 

classification of washing a crop in water 

containing an antimicrobial chemical as 

within the farm definition would 

represent a change from its previous 

classification as manufacturing/ 

processing outside the farm definition. 

Continuing to use the general term 

‘‘treating’’ in the proposed definition of 

manufacturing/processing in §§ 1.227 

and 1.328 is not in conflict with the 

tentative conclusions FDA is reaching in 

this document. First, the general term 

‘‘treating’’ refers broadly to treatments of 

any kind, and not specifically ‘‘treating 

against pests.’’ Under both the current 

definitions and the proposed revisions 

to the definitions, some ‘‘treating’’ (e.g., 

delivering a heat treatment) has been, 

and would continue to be, classified as 

manufacturing/processing outside the 

farm definition. Second, for a farm or 

farm mixed-type facility conducting 

operations on its own RACs, only those 

activities that do not satisfy either the 

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Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 3685 

expanded definition of packing or 

holding, or the new definition of 

harvesting, would be classified as 

manufacturing/processing outside the 

farm definition. Thus, although 

application of a pesticide treatment to a 

farm’s own RACs would now be 

classified within the farm definition 

when such treatment falls within the 

categories of holding or harvesting, 

application of a pesticide treatment offfarm has been, and would be continue 

to be, classified as manufacturing/ 

processing outside the farm definition, 

because the exclusion applicable to a 

farm or farm mixed-type facility 

operating on its own RACs would not 

apply. 

3. Coating a Farm or Farm Mixed-Type 

Facility’s Own Raw Agricultural 

Commodities for Storage or Transport 

(e.g., Wax, Oil, or Resin Coatings) 

FDA lists ‘‘waxing’’ as an example of 

a manufacturing/processing activity in 

the definition of that term in current 

§§ 1.227(b)(6) and 1.328, and waxing 

would remain as an example in the 

proposed revision to that definition. In 

addition, FDA has previously addressed 

‘‘waxing’’ on farms and farm mixed-type 

facilities in the preamble to the interim 

final rule on Food Facility Registration 

(68 FR 58894 at 58912) and the 

preamble to the Establishment and 

Maintenance of Records final rule (69 

FR 71562 at 71587). In those documents, 

FDA previously concluded that on-farm 

waxing was manufacturing/processing 

outside the farm definition. 

This previous conclusion that on-farm 

waxing was manufacturing/processing 

outside the farm definition would 

change for certain types of waxing 

under the proposed revisions to part 1. 

Under those proposed revisions, 

applying a coating to a farm or farm 

mixed-type facility’s own RACs for the 

purpose of protecting them during 

storage or transport, and not to create a 

distinct commodity, would now be 

within the expanded definition of 

packing and thus be classified within 

the farm definition rather than be 

classified as manufacturing/processing 

outside the farm definition. Examples of 

such coatings are waxes, oils, and resins 

applied to fresh produce such as 

cucumbers, apples, and avocados. FDA 

is aware that such treatments are 

traditionally performed by farms to 

prepare crops for storage or transport. 

These coatings do not transform a RAC 

into a processed food. Thus, these 

treatments fit the proposed definition of 

‘‘packing’’ applicable to farms and farm 

mixed-type facilities with respect to 

their own RACs. By contrast, if a farm 

or a farm mixed-type facility applies a 

coating to its own RACs in a manner 

that creates a distinct commodity (e.g., 

coating nuts in chocolate or coating 

apples in caramel), that activity would 

create a processed food and would not 

fit the expanded definition of packing. 

Thus, the act of applying the coating 

would continue to be classified as 

manufacturing/processing outside the 

farm definition. 

Continuing to use ‘‘waxing’’ as an 

example in the proposed definition of 

manufacturing/processing in §§ 1.227 

and 1.328 is not in conflict with these 

tentative conclusions. As explained 

with respect to pesticide treatments, 

activities that are conducted on a farm 

or farm mixed-type facility and are 

within the expanded definitions of 

packing and holding, or the new 

definition of harvesting, would be 

classified within the farm definition 

rather than classified as manufacturing/ 

processing outside the farm definition. 

The current definition of 

manufacturing/processing in 

§§ 1.227(b)(6) and 1.328 and the 

examples of harvesting within the 

definition of farm in §§ 1.227(b)(3) and 

1.328 demonstrate that FDA has 

consistently cited some activities as 

examples of manufacturing/processing 

as a general matter, but classified them 

differently in specific situations based 

on relevant circumstances. Washing, 

trimming, and cooling are all examples 

of manufacturing/processing in current 

§§ 1.227(b)(6) and 1.328, but washing, 

trimming outer leaves of, and cooling 

produce are part of harvesting in the 

farm definition in current §§ 1.227(b)(3) 

and 1.328. Use of an activity as an 

example of manufacturing/processing in 

current §§ 1.227(b)(6) and 1.328, or the 

proposed revision of that definition, 

does not represent a conclusion that the 

activity is always classified as 

manufacturing/processing under all 

circumstances. FDA expects that its 

proposed revisions to part 1 will clarify 

this. 

4. Drying a Farm or Farm Mixed-Type 

Facility’s Own Raw Agricultural 

Commodities To Create a Distinct 

Commodity 

FDA has previously addressed drying 

RACs on farms and farm mixed-type 

facilities in the Food Facility 

Registration Guidance (Ref. 116) and the 

Recordkeeping Guidance (Ref. 117). In 

those documents, FDA previously 

reached three conclusions relevant to 

drying: (1) Drying peppermint naturally 

during storage in a barn would not be 

manufacturing/processing; (2) drying 

hay naturally or artificially is an 

essential part of harvesting hay to 

prevent spontaneous combustion and is 

therefore not manufacturing/processing; 

and (3) drying alfalfa would be part of 

harvesting if it was an activity 

traditionally performed during the 

removing of the crop from the field 

through the safe storage of the crop. 

One of these previous conclusions 

regarding drying (i.e., the previous 

conclusion regarding drying herbs) 

would change under the proposed 

revisions to part 1. As discussed in 

section VIII.D of this document, FDA 

tentatively concludes that the question 

of whether an activity transforms a RAC 

into a processed food should be part of 

defining what activities are within the 

farm definition, because RACs are 

essential products of farms and 

processed foods are not. Thus, activities 

that transform foods from RACs into 

processed foods would not be within 

the expanded definitions of packing or 

holding, or the new definition of 

harvesting, that apply to farms and farm 

mixed-type facilities conducting 

activities on their own RACs. Instead, 

anything that transforms a RAC into a 

processed food would be classified as 

manufacturing/processing outside the 

farm definition (unless it is done only 

for consumption on the farm or farm 

mixed-type facility). 

In the Antimicrobial Guidance (Ref. 

118), FDA approved of and referenced 

the 1996 EPA interpretive ruling 

entitled ‘‘Pesticides; Status of Dried 

Commodities as Raw Agricultural 

Commodities’’ (61 FR 2386). As 

discussed briefly in section VIII.D of 

this document, in the 1998 EPA/FDA 

Joint Policy Interpretation and the 

Antimicrobial Guidance, FDA and EPA 

concluded that a RAC becomes a 

processed food when it is dried, unless 

the purpose of the drying is to facilitate 

transportation or storage of the 

commodity prior to processing. As a 

practical matter, this means that some 

RACs become processed foods when 

they are dried, because the drying 

creates a distinct commodity from the 

RAC. An example of this kind of drying 

is drying grapes to create raisins; raisins 

are processed foods (61 FR 2386 at 

2388). When the drying is for the 

purpose of storage or transport and does 

not create a distinct commodity, 

however (such as for grains, nuts, 

legumes, hays, other grasses, hops, rice, 

beans, and corn), the dried commodity 

remains a RAC (61 FR 2386 at 2388). 

Accordingly, under the proposed 

revisions to part 1 drying hay and alfalfa 

would now be classified within the 

expanded definitions of packing or 

holding, depending on how the drying 

is conducted (before storage or during 

storage, respectively), because these 

crops are traditionally dried by farms for 

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3686 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

the purpose of preparing for storage or 

transport (for packing) or for safe and 

effective storage (for holding), and 

because drying these crops does not 

create a distinct commodity (so the 

dried commodity is still a RAC). Drying 

hay and alfalfa in the manner FDA 

previously discussed would continue to 

be classified within the farm definition. 

In contrast, drying herbs such as 

peppermint would now be classified as 

manufacturing/processing outside the 

farm definition, because drying an herb 

creates a distinct commodity and 

therefore a processed food, just as 

drying a fruit creates a distinct 

commodity and therefore a processed 

food. 

5. Off-Farm Packaging of Raw 

Agricultural Commodities 

Current §§ 1.227(b)(8) and 1.328 

define ‘‘packaging’’ (when used as a 

verb) as placing food into a container 

that directly contacts the food and that 

the consumer receives, and that 

definition of ‘‘packaging’’ would remain 

unchanged under the proposed 

revisions to the definitions in part 1. 

Packaging is listed as an example of 

manufacturing/processing in current 

§§ 1.227(b)(6) and 1.328 (as well as in 

§ 1.226(a)), and would continue to be 

listed as an example of manufacturing/ 

processing under the proposed revisions 

to part 1. As discussed in section 

VIII.E.2 of this document, current 

§§ 1.227(b)(9) and 1.328 distinguish 

‘‘packaging’’ from ‘‘packing’’ and define 

‘‘packing’’ as placing food into a 

container other than packaging the food. 

Under the proposed revisions to the 

definitions in part 1, that definition of 

‘‘packing’’ would be expanded to 

include activities traditionally 

performed by farms for the safe or 

effective storage of RACs grown or 

raised on the same farm or another farm 

under the same ownership, but would 

not include activities that transform a 

RAC, as defined in section 201(r) of the 

FD&C Act, into a processed food as 

defined in section 201(gg) of the FD&C 

Act. 

FDA has previously addressed 

packaging on farms and farm mixedtype facilities, and off-farm, in the Food 

Facility Registration Guidance (Ref. 

116), the preamble to the Establishment 

and Maintenance of Records final rule 

(69 FR 71562 at 71587), and the 

Recordkeeping Guidance (Ref. 117). In 

those documents, FDA previously 

reached four conclusions relevant to 

‘‘packaging’’ and ‘‘packing’’ activities on 

farms and farm mixed-type facilities: (1) 

Placing RACs into consumer-ready 

containers (e.g., placing strawberries in 

clamshell packages, and placing eggs in 

a carton) both on the farm that grew 

them and at off-farm packing houses is 

‘‘more akin to packing’’ than packaging 

(despite meeting the definition of 

packaging) because it does not alter the 

form of the food, so it is not 

manufacturing/processing; (2) bottling 

wine (placing it in a container that 

touches the food and that the consumer 

receives) is packaging and therefore 

manufacturing/processing because it 

preserves the manufactured condition of 

the wine; (3) placing cereal in a plastic 

cereal box liner is packaging and 

therefore manufacturing/processing; and 

(4) placing apples received from 

elsewhere in bulk into plastic bags is 

packaging and therefore manufacturing/ 

processing. 

Most of these conclusions would 

remain the same under the proposed 

revisions to part 1, although the 

reasoning for those conclusions would 

instead be based on the organizing 

principles articulated in the proposed 

revisions to the definitions in part 1. 

Specifically, bottling wine and placing 

cereal in plastic box liners would 

continue to be classified as packaging 

and therefore manufacturing/processing, 

regardless of where such activities are 

performed, because those foods are 

processed foods to which the expanded 

proposed definition of packing would 

not be applicable. Placing apples 

received from elsewhere in bulk into 

plastic bags would continue to be 

classified as packaging and therefore 

manufacturing/processing, because the 

activity is conducted on others’ RACs. 

Under the proposed revisions to the 

definitions in part 1, a farm or farm 

mixed-type facility that places its own 

RACs in consumer containers that 

contact the food would now be 

classified as packing because farms 

traditionally do this to prepare their 

RACs for storage or transport, and this 

activity does not transform the RACs 

into a processed food. Examples of this 

kind of activity include an egg farm 

putting its own eggs in cartons, a 

strawberry farm placing its own 

strawberries in clamshell packages, or 

an apple farm placing its own apples 

into plastic bags. Such packing activities 

would continue to be classified within 

the farm definition. 

Under the proposed revisions to part 

1, there would be a change in how FDA 

considers the act of placing RACs into 

consumer containers (1) off-farm and (2) 

on a farm or farm mixed-type facility 

with respect to others’ RACs. Off-farm, 

the expanded definition of packing 

would not apply, so this activity would 

be now be classified as packaging (and, 

therefore, manufacturing/processing). 

Off-farm, as a practical matter this 

change should have no practical impact 

because off-farm establishments that 

conduct this activity are already 

required to register under section 415 of 

the FD&C Act, and therefore already are 

subject to section 418 of the FD&C Act, 

whether this activity is classified as 

packing or manufacturing/processing. 

However, on a farm or farm mixed-type 

facility that places others’ RACs into 

consumer containers, this activity 

would now be classified as packaging 

and therefore manufacturing/processing, 

because the expanded definition of 

packing would only apply to a farm’s 

own RACs. This change in classification 

would impact a farm or farm mixed-type 

facility that conducts such activities if it 

is not currently required to register. This 

classification result is consistent with 

the organizing principles articulated in 

section VIII.D of this document because, 

while it may be a practical necessity for 

a farm to place its own fragile RACs in 

consumer packages to protect them 

during storage and transport, packaging 

others’ RACs is not part of the essential 

purpose of a farm (producing the farm’s 

own RACs). Farms that conduct such 

activities are acting as distributors for 

another farm’s products and FDA 

considers that the activities they 

conduct on others’ RACs should be 

classified as manufacturing/processing, 

packing, or holding in the same manner 

as are activities performed by off-farm 

distributors of RACs. Therefore FDA 

tentatively concludes that these 

activities should now be outside the 

farm definition. We seek comment on 

this proposal. 

6. Summary of Examples of the Impact 

of the Proposed Revisions to the 

Definitions in 21 CFR Part 1 on a Farm 

or Farm Mixed-Type Facility 

For the convenience of the reader, 

Table 5 summarizes the examples 

discussed in sections VIII.F.2 through 

VIII.F.5 of this document. 

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TABLE 5—SUMMARY OF THE EXAMPLES OF THE IMPACT OF THE PROPOSED REVISIONS TO THE DEFINITIONS IN 21 CFR 

PART 1 ON A FARM OR FARM MIXED-TYPE FACILITY

Activity 

How does FDA classify the activity under 

the current definitions 

in §§ 1.227 and 

1.328? 

Using FDA’s current 

classification, would 

conducting the activity trigger the section 

415 registration regulations? 

How would FDA classify the activity under 

the proposed revisions to the definitions in §§ 1.227 and 

1.328? 

Using the classification under the proposed revised definitions, would conducting the activity 

trigger the section 

415 registration regulations? 

Would the classification under the proposed revised definitions represent a 

change? 

Application of Pesticide 

Applying pesticides to 

own RACs prior to 

harvest.

Growing within the 

farm definition (because it is an integral part of growing 

crops).

No ............................. Growing within the 

farm definition (because it is an integral part of growing 

crops).

No ............................. No. 

Fumigating own raw 

nuts to prevent insect infestation and 

damage during the 

potentially long storage period of the 

nuts.

Manufacturing/processing outside the 

farm definition (because application 

of pesticides after 

harvest is necessarily directed at 

the food, not the 

entire plant).

Yes ............................ Holding within the 

farm definition (for 

the purpose of safe 

or effective storage).

No ............................. Yes. 

Use of pesticides in 

wash water applied 

to own RACs.

Harvesting within the 

farm definition if 

water is from a 

public or other supply chlorinated for 

other purposes, or 

if chlorine is added 

at 200 ppm or less 

(washing that does 

not treat the crop); 

manufacturing/processing outside the 

farm definition if 

chlorine is added at 

levels above 200 

ppm.

Depends on source 

and level of chlorine in water; FDA 

has not previously 

addressed chemicals other than 

chlorine.

Harvesting within the 

farm definition 

(washing and/or 

treating against 

pests for the purpose of removing 

the crop from the 

growing area and 

preparing it for use 

as food).

No ............................. Yes. 

Coating 

Applying coatings to 

own RACs (e.g., applying waxes, oils, 

and resins to fresh 

produce; coating 

raw nuts in chocolate; coating apples 

in caramel).

Manufacturing/processing outside the 

farm definition 

(waxing generally, 

not specific to fresh 

produce).

Yes, for waxing generally; FDA has not 

previously addressed other coatings.

Waxes, oils, and resins on fresh 

produce: Packing 

within the farm definition (for the purpose of protecting 

them during storage or transport, 

and not to create a 

distinct commodity); 

Waxes, oils, and resins on fresh 

produce: No.

Chocolate on nuts or 

caramel on apples: 

Yes 

Yes. 

Chocolate on nuts or 

caramel on apples: 

Manufacturing/processing outside the 

farm definition (creates a distinct commodity and thus 

creates a processed food). 

Drying 

Drying peppermint naturally during storage 

in a barn.

Storage within the 

farm definition.

No ............................. Manufacturing/processing outside the 

farm definition 

(transforms a RAC 

into a processed 

food).

Yes ............................ Yes. 

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TABLE 5—SUMMARY OF THE EXAMPLES OF THE IMPACT OF THE PROPOSED REVISIONS TO THE DEFINITIONS IN 21 CFR 

PART 1 ON A FARM OR FARM MIXED-TYPE FACILITY—Continued 

Activity 

How does FDA classify the activity under 

the current definitions 

in §§ 1.227 and 

1.328? 

Using FDA’s current 

classification, would 

conducting the activity trigger the section 

415 registration regulations? 

How would FDA classify the activity under 

the proposed revisions to the definitions in §§ 1.227 and 

1.328? 

Using the classification under the proposed revised definitions, would conducting the activity 

trigger the section 

415 registration regulations? 

Would the classification under the proposed revised definitions represent a 

change? 

Drying hay naturally or 

artificially.

Harvesting within the 

farm definition (an 

essential part of 

harvesting hay to 

prevent spontaneous combustion).

No ............................. Packing or holding 

within the farm definition (depending 

on whether the drying is before storage or during storage).

No ............................. No. 

Drying alfalfa .............. Harvesting within the 

farm definition (traditionally performed 

during the removing of the crop from 

the field through 

the safe storage of 

the crop).

No ............................. Packing within the 

farm definition 

(done before storage to prepare a 

RAC for storage or 

transport and does 

not create a distinct 

commodity).

No ............................. No. 

Drying grapes to create raisins.FDA has not previously addressed 

this activity.

FDA has not previously addressed 

this activity.

Manufacturing/processing outside the 

farm definition 

(transforms a RAC 

into a processed 

food).

Yes ............................ Yes (because FDA is 

addressing this activity for the first 

time). 

Packing/Packaging 

Bottling wine ............... Packaging, which is 

manufacturing/processing outside the 

farm definition (because it preserves 

the manufactured 

condition of the 

wine).

Yes ............................ Packaging, which is 

manufacturing/processing outside the 

farm definition (because the food is a 

processed food so 

the expanded definition of packing 

does not apply).

Yes ............................ No. 

Placing cereal in a 

plastic cereal box 

liner.

Packaging, which is 

manufacturing/processing outside the 

farm definition.

Yes ............................ Packaging, which is 

manufacturing/processing outside the 

farm definition (because the food is a 

processed food so 

the expanded definition of packing 

does not apply).

Yes ............................ No. 

Placing a farm’s or 

farm mixed-type facility’s own RACs 

into consumer-ready 

containers (e.g., 

placing strawberries 

in clamshell packages, and placing 

eggs in a carton).

Packing within the 

farm definition (because it does not 

alter the form of the 

food).

No ............................. Packing within the 

farm definition (because farms traditionally do this to 

prepare their RACs 

for storage or 

transport, and this 

activity does not 

transform the RACs 

into a processed 

food).

No ............................. No. 

Placing others’ RACs 

into consumer-ready 

packages on a farm 

or farm mixed-type 

facility (e.g., placing 

others’ apples received in bulk into 

plastic bags).

Packaging, which is 

manufacturing/processing outside the 

farm definition.

Yes ............................ Packaging, which is 

manufacturing/processing outside the 

farm definition (because the activity is 

conducted on others’ RACS).

Yes ............................ No. 

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TABLE 5—SUMMARY OF THE EXAMPLES OF THE IMPACT OF THE PROPOSED REVISIONS TO THE DEFINITIONS IN 21 CFR 

PART 1 ON A FARM OR FARM MIXED-TYPE FACILITY—Continued 

Activity 

How does FDA classify the activity under 

the current definitions 

in §§ 1.227 and 

1.328? 

Using FDA’s current 

classification, would 

conducting the activity trigger the section 

415 registration regulations? 

How would FDA classify the activity under 

the proposed revisions to the definitions in §§ 1.227 and 

1.328? 

Using the classification under the proposed revised definitions, would conducting the activity 

trigger the section 

415 registration regulations? 

Would the classification under the proposed revised definitions represent a 

change? 

Placing others’ RACs 

into consumer-ready 

containers off-farm 

(e.g., placing strawberries in clamshell 

packages, and placing eggs in a carton 

at a facility not colocated on a farm or 

farm mixed-type facility).

Packing (because it 

does not alter the 

form of the food), 

but not within the 

farm definition because conducted 

off-farm.

Yes ............................ Packaging, which is 

manufacturing/processing (because 

the activity is conducted off-farm, so 

the expanded definition of packing 

does not apply).

Yes ............................ Yes, but while the 

classification of the 

activity changes 

from packing to 

manufacturing/processing, under both 

the current and 

proposed revised 

definitions, the activity would trigger 

registration. 

G. Qualitative Risk Assessment of OnFarm Activities Outside of the Farm 

Definition 

As discussed in section VIII.A.2 of 

this document, section 103(c)(1)(C) of 

FSMA directs the Secretary to conduct 

a science-based risk analysis as part of 

the section 103(c) rulemaking. The 

science-based risk analysis is to cover 

‘‘(i) specific types of on-farm packing or 

holding of food that is not grown, 

raised, or consumed on such farm or 

another farm under the same ownership, 

as such packing and holding relates to 

specific foods; and (ii) specific on-farm 

manufacturing and processing activities 

as such activities relate to specific foods 

that are not consumed on that farm or 

on another farm under common 

ownership.’’ 

As used in section 103(c)(1) of FSMA, 

the term ‘‘risk analysis’’ is ambiguous. 

One interpretation is that the common 

meaning of the term is intended—a 

simple evaluation of whether activity/ 

food combinations are likely to result in 

the consumer becoming ill. Another 

interpretation is that the ‘‘risk analysis’’ 

should be consistent with the formal 

definition and related terms used by 

Codex with respect to food safety (Ref. 

119): 

• Risk is a function of the probability 

of an adverse health effect and the 

severity of that effect, consequential to 

a hazard(s) in food. 

• Risk analysis is a process consisting 

of three components: risk assessment, 

risk management and risk 

communication. 

• Risk assessment is a scientificallybased process consisting of hazard 

identification, hazard characterization, 

exposure assessment, and risk 

characterization. 

• Risk management is the process, 

distinct from risk assessment, of 

weighing policy alternatives, in 

consultation with interested parties, 

considering risk assessment and other 

factors relevant for the health protection 

of consumers and for the promotion of 

fair trade practices, and, if needed, 

selecting appropriate prevention and 

control options. 

• Risk communication is the 

interactive exchange of information and 

opinions throughout the risk analysis 

process concerning risk, risk-related 

factors and risk perceptions, among risk 

assessors, risk managers, consumers, 

industry, the academic community and 

other interested parties, including the 

explanation of risk assessment findings 

and the basis of risk management 

decisions. 

Because section 103(c)(1)(C) of FSMA 

calls for a science-based risk analysis, 

we are applying the Codex definitions to 

the extent possible. It is not clear 

whether the requirement of section 

103(c)(1)(C) of FSMA to conduct a 

science-based risk analysis was 

intended to encompass all three 

components of risk analysis. Section 

103(c)(1)(D) of FSMA requires the 

Secretary to consider the results of the 

science-based risk analysis and exempt 

certain facilities from the requirements 

in section 418 of the FD&C Act, 

including hazard analysis and 

preventive controls, and the mandatory 

inspection frequency of section 421, or 

to modify those requirements for 

facilities engaged in on-farm 

manufacturing, processing, packing or 

holding activities determined to be low 

risk involving foods determined to be 

low risk. Thus, section 103(c)(1)(D) of 

FSMA is focused on ensuring that the 

agency’s risk management decisions 

with respect to exempting or modifying 

requirements applicable to low-risk onfarm activity/food combinations under 

sections 418 and 421 are science-based, 

as determined by an analysis of the risk 

of specific types of on-farm activity/food 

combinations required by section 

103(c)(1)(C). We therefore tentatively 

conclude that the analysis required by 

section 103(c)(1)(C) should be limited to 

an assessment of the risk of specific 

types of on-farm activity/food 

combinations for the purposes of 

making the risk management decisions 

required by section 103(c)(1)(D). The 

risk communication component of the 

risk analysis is accomplished through 

the discussion of that assessment in this 

document, the opportunities for public 

comment (on the risk assessment and on 

this proposed rule), and our evaluation 

of, and response to, comments in a final 

rule. 

Consistent with this approach, we 

conducted a qualitative risk assessment 

(Ref. 115) (‘‘Section 103(c)(1)(C) draft 

RA’’) related to activity/food 

combinations for the purpose of 

determining which activity/food 

combinations would be considered low 

risk. We focused on activity/food 

combinations that we identified as being 

conducted on farms (and, thus, might be 

conducted by farm mixed-type 

facilities), but we did not consider 

activity/food combinations that would 

be solely within the farm definition 

(such as growing fruits and vegetables) 

and, thus, are not relevant to the 

requirements of section 103 of FSMA. 

We focused on considering the risk of 

activity/food combinations rather than 

separately considering the risk of 

specific food categories because doing 

so better enabled us to focus on whether 

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a specific manufacturing, processing, 

packing, or holding activity conducted 

on food by a farm mixed-type facility 

warranted an exemption from, or 

modified requirements for, the 

provisions of section 418 of the FD&C 

Act. 

Elsewhere in this issue of the Federal 

Register, FDA is making the section 

103(c)(1)(C) draft RA available for 

public comment. We will consider 

comments regarding the section 

103(c)(1)(C) draft RA in preparing a final 

version of the RA and will announce the 

availability of the final version of the 

RA when it is available. The final 

preventive controls rule will take into 

account the final version of the section 

103(c)(1)(C) RA. 

H. Results of the Qualitative Risk 

Assessment 

In this section, we report the results 

of the section 103(c)(1)(C) draft RA, 

arranged in three lists. References to 

‘‘farms’’ in these lists should be 

understood to include farm mixed-type 

facilities. The lists are shaped by the 

proposed definitions for harvesting, 

manufacturing/processing, packing, or 

holding in the section 415 registration 

regulations (discussed in section VIII.E 

of this document), the organizing 

principles (discussed in section VIII.D 

of this document) that form the basis for 

those proposed definitions, and the 

examples of activity classifications 

(discussed in section VIII.F of this 

document). As discussed in section 

VIII.E of this document, the same 

activity may be classified differently 

(among the categories of harvesting, 

manufacturing/processing, packing, or 

holding) depending on whether the food 

being operated upon is a RAC and 

whether the RAC was grown or raised 

on the farm or farm mixed-type facility 

performing the activity or a farm under 

the same ownership. We request 

comment on the lists in sections 

VIII.H.1 through VIII.H.3. 

For the purposes of this document, a 

fruit is the edible reproductive body of 

a seed plant or tree nut (such as apple, 

orange, and almond) such that fruit 

means the harvestable or harvested part 

of a plant developed from a flower. For 

the purposes of this document, a 

vegetable is the edible part of an 

herbaceous plant (such as cabbage or 

potato) or fleshy fruiting body of a 

fungus (such as white button or 

shiitake) grown for an edible part such 

that vegetable means the harvestable or 

harvested part of any plant or fungus 

whose fruit, fleshy fruiting bodies, 

seeds, roots, tubers, bulbs, stems, leaves, 

or flower parts are used as food and 

includes mushrooms, sprouts, and herbs 

(such as basil or cilantro). Examples of 

fruits and vegetables are apples, 

apricots, avocados, bananas, berries, 

broccoli, cabbage, cantaloupe, carrots, 

cauliflower, celery, cherries, citrus, 

cucumbers, garlic, grapes, green beans, 

herbs (such as basil, chives, cilantro, 

mint, oregano, and parsley), honeydew, 

kiwifruit, lettuce, mangos, mushrooms, 

onions, papaya, peaches, pears, peas, 

peppers, pineapple, plums, radish, 

scallions, snow peas, spinach, sprouts, 

squash, tomatoes, and watermelon. For 

the purposes of this document, grains 

means the small, hard fruits or seeds of 

arable crops, or the crops bearing these 

fruits or seeds, that are grown and 

processed for use as meal, flour, baked 

goods, cereals and oils rather than for 

fresh consumption (including cereal 

grains, pseudo cereals, oilseeds and 

other plants used in the same fashion). 

Examples of food grains include barley, 

dent- or flint-corn, sorghum, oats, rice, 

rye, wheat, amaranth, quinoa, 

buckwheat, cotton seed, and soybeans. 

For the purpose of the section 

103(c)(1)(C) draft RA, ‘‘intact fruits and 

vegetables’’ refers only to fruits and 

vegetables other than cocoa beans, 

coffee beans, peanuts, sugar beets, 

sugarcane, and tree nuts. Cocoa beans, 

coffee beans, peanuts, sugar beets, 

sugarcane, and tree nuts can be 

considered part of ‘‘fruits and 

vegetables’’ as a general matter, but we 

addressed those foods separately for the 

purpose of section 103(c)(1)(C) draft RA 

in order to accurately reflect differences 

in activity/food combinations likely to 

be performed on farm mixed-type 

facilities on those foods as compared to 

other fruits and vegetables, as well as 

specific hazards associated with certain 

of those foods. 

1. List of Low-Risk On-Farm Packing 

and Holding Activity/Food 

Combinations When Conducted on 

Food Not Grown, Raised, or Consumed 

on That Farm or Another Farm Under 

the Same Ownership 

The section 103(c)(1)(C) draft RA 

identified the following low-risk 

packing and holding activity/food 

combinations when conducted on a 

farm on food not grown, raised, or 

consumed on that farm or another farm 

under the same ownership—i.e., 

packing or re-packing (including 

weighing or conveying incidental to 

packing or re-packing); sorting, culling, 

or grading incidental to packing or 

storing; and storing (ambient, cold and 

controlled atmosphere) of: 

• Hard candy, fudge, taffy, and toffee; 

• Cocoa products; 

• Cocoa beans and coffee beans (raw 

or roasted); 

• Grains and grain products; 

• Honey (raw and pasteurized); 

• Intact fruits and vegetables; 

• Jams, jellies and preserves; 

• Maple sap for syrup and maple 

syrup; 

• Peanuts and tree nuts; 

• Soft drinks and carbonated water; 

and 

• Sugar beets, sugarcane, and sugar. 

We note that the same activities 

performed on a farm’s own RACs, or 

food consumed on the farm or another 

farm under the same ownership, would 

be within the farm definition and 

therefore were outside the scope of the 

section 103(c)(1)(C) draft RA. 

2. List of Low-Risk On-Farm 

Manufacturing/Processing Activity/ 

Food Combinations When Conducted 

on the Farm’s Own Raw Agricultural 

Commodities for Distribution Into 

Commerce 

The section 103(c)(1)(C) draft RA 

identified the following low-risk 

manufacturing/processing activity/food 

combinations when conducted on a 

farm on the farm’s own RACs for 

distribution into commerce: 

• Artificial ripening of intact fruits 

and vegetables; 

• Boiling/evaporation of maple sap to 

make maple syrup; 

• Chopping raw peanuts and raw tree 

nuts; 

• Coating (with coatings other than 

wax, oil, or resin used for the purpose 

of storage or transportation) intact fruits 

and vegetables (e.g., caramel apples) and 

raw peanuts and raw tree nuts (e.g., 

adding seasonings); 

• Drying/dehydrating intact fruits and 

vegetables (without the addition of 

sulfites) where the drying creates a 

distinct commodity (e.g., drying fruits or 

herbs); 

• Extracting oil from grains; 

• Grinding/milling/cracking/crushing 

grains (e.g., making grain products such 

as corn meal) and raw peanuts or raw 

tree nuts (e.g., making ground peanuts); 

• Making jams, jellies and preserves 

from acid foods (e.g., acid fruits); 

• Making sugar from sugarcane and 

sugar beets; and 

• Salting raw peanuts and raw tree 

nuts. 

3. List of Low-Risk On-Farm 

Manufacturing/Processing Activity/ 

Food Combinations When Conducted 

on Food Other Than the Farm’s Own 

Raw Agricultural Commodities, for 

Distribution Into Commerce 

The section 103(c)(1)(C) draft RA 

identified the following low-risk 

manufacturing/processing activity/food 

combinations when conducted on a 

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farm on food other than the farm’s own 

RACs, for distribution into commerce. 

• Artificial ripening of intact fruits 

and vegetables; 

• Chopping peanuts and tree nuts; 

• Coating (with coatings other than 

wax, oil, or resin used for the purpose 

of storage or transportation) intact fruits 

and vegetables (e.g., caramel apples) and 

peanuts and tree nuts (e.g., adding 

seasonings); 

• Cooling intact fruits and vegetables 

using cold air; 

• Drying/dehydrating (whether for 

storage/transport or for creating a 

distinct commodity) intact fruits and 

vegetables (without sulfiting), cocoa 

beans, coffee beans, grains and grain 

products, and peanuts and tree nuts; 

• Extracting oils from grains (e.g., 

corn, oilseeds, soybeans); 

• Fermenting cocoa beans and coffee 

beans; 

• Grinding/milling/cracking/crushing 

cocoa beans, coffee beans, grains (e.g., 

making grain products such as corn 

meal), and peanuts and tree nuts (e.g., 

making ground peanuts); 

• Labeling (including stickering) hard 

candy, cocoa beans, cocoa products 

from roasted cocoa beans (other than 

milk chocolate), coffee beans, intact 

fruits and vegetables, grain and grain 

products (other than those containing 

wheat in a form that would not be 

recognized as containing wheat without 

a label declaration), honey, jams/jellies/ 

preserves, maple sap, maple syrup, 

intact single-ingredient peanuts or tree 

nuts (shelled and unshelled), soft drinks 

and carbonated beverages, sugar beets, 

sugarcane, and sugar; 

• Making hard candy, fudge, taffy, 

and toffee; 

• Making cocoa products from 

roasted cocoa beans; 

• Making honey; 

• Making jams, jellies and preserves 

from acid foods (e.g., acid fruits); 

• Making maple syrup; 

• Making soft drinks and carbonated 

water; 

• Making sugar from sugar beets and 

sugarcane; 

• Mixing cocoa beans, coffee beans, 

intact fruits and vegetables, grain and 

grain products, honey, maple sap and 

maple syrup, and peanuts and tree nuts; 

• Packaging hard candy, fudge, taffy, 

and toffee; cocoa beans; cocoa products; 

coffee beans; intact fruits and vegetables 

(other than modified atmosphere or 

vacuum packaging); grain and grain 

products; honey; jams, jellies and 

preserves; maple syrup; peanuts and 

tree nuts (including modified 

atmosphere or vacuum packaging); soft 

drinks and carbonated water; and sugar 

beets, sugarcane, and sugar; 

• Salting peanuts and tree nuts; 

• Shelling/hulling cocoa beans (i.e., 

winnowing), intact fruits and vegetables 

(e.g., dried beans and peas), and peanuts 

and tree nuts; 

• Sifting grains and grain products; 

• Sorting, culling and grading (other 

than when incidental to packing or 

storage) hard candy, fudge, taffy, and 

toffee; cocoa beans; cocoa products; 

coffee beans; intact fruits and 

vegetables; grain and grain products; 

honey; jams, jellies and preserves; 

maple sap; maple syrup; peanuts and 

tree nuts; soft drinks and carbonated 

water; and sugar beets and sugarcane; 

• Treating cocoa beans, coffee beans, 

intact fruits and vegetables, grain and 

grain products, and peanuts and tree 

nuts against pests (other than during 

growing) (e.g., fumigation); and 

• Waxing (wax, oil, or resin used for 

the purpose of storage or transportation) 

intact fruits and vegetables. 

We note that the list in this section 

(i.e., section VIII.H.3) for low-risk 

manufacturing/processing activity/food 

combinations for foods other than a 

farm’s own RACs is longer than the 

corresponding list in the previous 

section (i.e., section VIII.H.2) for lowrisk manufacturing/processing activity/ 

food combinations for a farm’s own 

RACs. This relates to the fact that some 

activities that would be manufacturing/ 

processing when performed on foods 

other than a farm’s own RACs are not 

manufacturing/processing when 

performed on a farm’s own RACs. As 

discussed in sections VIII.E and VIII.F of 

this document, when some activities are 

performed on the farm’s own RACs, 

those activities are classified as packing, 

holding, or harvesting and are within 

the farm definition, making them 

outside the scope of the section 

103(c)(1)(C) draft RA and resulting in a 

shorter list of low-risk activity/food 

combinations for the purpose of the 

rulemaking required by section 103(c) of 

FSMA. 

I. Tentative Conclusions Regarding OnFarm Low-Risk Activity/Food 

Combinations Under Section 418 of the 

FD&C Act 

Based on the results of the section 

103(c)(1)(C) draft RA regarding on-farm 

low-risk activity/food combinations, we 

are proposing in § 117.5(g) and (h) to 

exempt farm mixed-type facilities that 

are small or very small businesses (as 

defined in proposed § 117.3) from 

requirements under section 418 of the 

FD&C Act if the only activities subject 

to section 418 that the business 

conducts are low-risk activity/food 

combinations (see the discussion of 

these proposed exemptions in section 

X.C.6 of this document). The proposed 

exemptions would not exempt eligible 

facilities from the requirement to 

register under section 415 of the FD&C 

Act. 

J. Tentative Conclusions Regarding OnFarm Low-Risk Activity/Food 

Combinations Under Section 421 of the 

FD&C Act 

We tentatively conclude that FDA 

should consider the low-risk on-farm 

activity/food combinations identified in 

the section 103(c)(1)(C) draft RA as a 

factor in identifying high-risk facilities 

that are small and very small businesses 

and allocating inspection resources 

under Section 421 of the FD&C Act, 

Targeting of Inspectional Resources for 

Domestic Facilities. However, at this 

time, FDA tentatively concludes that it 

should not exempt or modify the 

frequency requirements under 421 

based solely upon whether a facility 

only engages in such low-risk activity/ 

food combinations and is a small or very 

small business. Current data limitations 

impact our ability to accurately identify 

such facilities, and we must be able to 

identify such facilities in order to 

implement an exempted or modified 

inspection frequency schedule. We 

request comment on whether we should 

establish data submission requirements 

that would allow us to identify these 

types of facilities in order to exempt 

them from the inspection frequencies, or 

modify the inspection frequencies that 

apply to them, under section 421 of the 

FD&C Act. Examples of data elements 

that we might need in order to identify 

these facilities include: Identification of 

a facility as a farm mixed-type facility, 

annual monetary value of sales, number 

of employees, food category/activity 

type. We also request comment on these 

possible data elements and any other 

criteria that may be appropriate for the 

purposes of allocating inspection 

resources to these facilities. 

IX. Proposed General Revisions to 

Current Part 110 

A. Title 

FDA is proposing to revise the title of 

current subpart B from ‘‘Current Good 

Manufacturing Practice in 

Manufacturing, Packing, or Holding 

Human Food’’ to ‘‘Current Good 

Manufacturing Practice and Hazard 

Analysis and Risk-Based Preventive 

Controls for Human Food.’’ The 

proposed title would reflect that 

proposed part 117 would include both 

CGMP requirements (including those 

established prior to the enactment of 

FSMA) and requirements for risk-based 

preventive controls for domestic and 

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3692 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

foreign facilities that are required to 

register under section 415 of the FD&C 

Act. As proposed, the title of proposed 

part 117 would no longer identify 

specific activities (i.e., manufacturing, 

packing, and holding). The activities 

covered by the CGMP requirements 

would be identified within the 

requirements themselves and are not 

necessary to include in the title of 

proposed part 117. We request comment 

on the proposed title for part 117. 

B. Proposed Redesignations 

FDA is proposing to redesignate the 

subparts of current part 110 and to 

include in proposed part 117, subpart B 

the CGMP provisions already 

established in part 110. The proposed 

redesignation will clearly separate 

current CGMP requirements, and any 

newly proposed CGMP requirements, 

from newly proposed requirements that 

would implement section 418 of the 

FD&C Act. The proposed redesignation 

is intended to make it easy for persons 

who would be exempt from 

requirements established under section 

418 of the FD&C Act to identify the 

CGMP requirements that apply to them. 

FDA also is proposing a general 

reorganization and redesignation of the 

provisions currently in part 110 as they 

would be established in proposed part 

117. The proposed revisions are 

intended to enhance the clarity of 

proposed part 117 as a whole. Table 6 

shows the proposed reorganization and 

redesignation of current provisions. In 

sections X and XI of this document, we 

discuss proposed changes to the current 

provisions of part 110 in the order in 

which they would appear in a final rule 

based on this proposed rule. Provisions 

that we do not propose to delete or 

revise would be re-established in part 

117 unchanged. 

TABLE 6—PROPOSED REARRANGEMENT OF PROVISIONS AND SUBPARTS OF CURRENT PART 110 

Current designation Current subpart location Proposed 

redesignation 

Proposed subpart 

location 

§ 110.3—Definitions ............................................................ Subpart A ............................. Proposed § 117.3 ................. Proposed Subpart A. 

§ 110.5—Current good manufacturing practice .................. Subpart A ............................. Proposed § 117.1 ................. Proposed Subpart A. 

§ 110.10—Personnel ........................................................... Subpart A ............................. Proposed § 117.10 ............... Proposed subpart B. 

§ 110.19—Exclusions .......................................................... Subpart A ............................. Proposed § 117.5(k) ............ Proposed subpart A. 

§ 110.20—Plant and grounds .............................................. Subpart B ............................. Proposed § 117.20 ............... Proposed subpart B. 

§ 110.35—Sanitary operations ............................................ Subpart B ............................. Proposed § 117.35 ............... Proposed subpart B. 

§ 110.37—Sanitary facilities and controls ........................... Subpart B ............................. Proposed § 117.37 ............... Proposed subpart B. 

§ 110.40—Equipment and utensils ..................................... Subpart C ............................ Proposed § 117.40 ............... Proposed subpart B. 

§ 110.80—Processes and controls ..................................... Subpart E ............................. Proposed § 117.80 ............... Proposed subpart B. 

§ 110.93—Warehousing and distribution ............................ Subpart E ............................. Proposed § 117.93 ............... Proposed subpart B. 

§ 110.110—Natural or unavoidable defects in food for 

human use that present no health hazard.

Subpart G ............................ Proposed § 117.110 ............. Proposed subpart B. 

C. Proposed Revisions for Consistency of 

Terms 

1. Activities Subject to Proposed Part 

117 

FDA is proposing to revise provisions 

of current part 110 to make clear that 

the activities that would be subject to 

proposed part 117 include 

manufacturing, processing, packing and 

holding. We describe each of these 

proposed revisions elsewhere in this 

document, in an order consistent with 

the placement of the current or revised 

provision. Section 418 of the FD&C Act 

uses this group of terms to broadly 

identify activities that take place in food 

facilities. In addition, we have 

previously described activities that may 

be considered ‘‘manufacturing, 

processing, packing, or holding’’ by 

establishing definitions for 

‘‘manufacturing/processing’’ in current 

§§ 1.227(b)(6) and 1.328, ‘‘packing’’ in 

current §§ 1.227(b)(9) and 1.328, and 

‘‘holding’’ in current §§ 1.227(b)(5) and 

1.328. This proposed rule proposes 

certain revisions to these existing 

definitions (see section VIII.E of this 

document) and would incorporate the 

revised definitions of manufacturing/ 

processing, packing, and holding in 

proposed part 117. We tentatively 

conclude there is no meaningful 

distinction between ‘‘manufacturing/ 

processing,’’ ‘‘packing,’’ and ‘‘holding’’ 

as defined in our proposed revisions to 

§§ 1.227 and 1.328 and those terms as 

they have been used in current part 110. 

We also tentatively conclude that 

consistent use of these terms throughout 

proposed part 117, in reference to 

activities taking place in food facilities, 

establishments, or plants, would make 

the regulations more clear and have no 

substantive effect on the current 

requirements. We request comment on 

this proposed revision. 

2. The Term ‘‘Facility’’ 

FDA is proposing to replace the term 

‘‘facility’’ or ‘‘facilities’’ in current part 

110 with the term ‘‘establishment’’ or 

‘‘plant’’ in proposed part 117 whenever 

the term ‘‘facility’’ or ‘‘facilities’’ could 

be confused with the firms that are 

subject to the proposed requirements for 

hazard analysis and risk-based 

preventive controls required by section 

418 of the FD&C Act. FDA is proposing 

this change to distinguish between the 

requirements of current part 110 

(Current Good Manufacturing Practices) 

and requirements that we are proposing 

to establish under section 103 of FSMA. 

The term ‘‘facility’’ as used in current 

part 110 reflects the common meaning 

of that term as something designed, 

built, or installed to serve a specific 

function. However, after issuance of 

current part 110, in our regulation 

implementing section 415 of the FD&C 

Act, ‘‘Registration of Food Facilities’’ 

(§ 1.227(b)(2) in part 1, subpart H), we 

defined the term ‘‘facility’’ to have a 

very specific meaning for the purpose of 

that regulation as follows: 

Current section 1.227(b)(2) provides 

in part that ‘‘[f]acility means any 

establishment, structure, or structures 

under one ownership at one general 

physical location, or, in the case of a 

mobile facility, traveling to multiple 

locations, that manufactures/processes, 

packs, or holds food for consumption in 

the United States.’’ Part 1, subpart H 

broadly defines the term ‘‘facility’’ for 

the purposes of that subpart, and 

provides that facilities must register 

unless they qualify for one of the 

exemptions in that subpart. For 

example, current § 1.227(b)(3) defines 

‘‘farm’’ as a type of facility, and 

§ 1.226(b) provides that farms do not 

need to register. 

Section 418(o)(2) of the FD&C Act 

defines ‘‘facility’’ for the purposes of 

section 418 to mean ‘‘a domestic facility 

or a foreign facility that is required to 

register under section 415’’ of the FD&C 

Act, and proposed § 117.3 would define 

‘‘facility’’ to incorporate this statutory 

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definition. Under proposed § 117.3, the 

term ‘‘facility’’ would have a meaning 

for the purposes of proposed part 117 

that is more narrow than the common 

meaning of the term or the definition of 

facility in current § 1.227(b)(2), in that it 

would encompass only those facilities 

that are required to register under 

section 415 of the FD&C Act (and part 

1, subpart H). Our proposal to replace 

the term ‘‘facility’’ in current part 110 

with ‘‘establishment’’ or ‘‘plant’’ in 

proposed part 117 is intended to avoid 

confusion about the applicability of 

proposed part 117 to plants or 

establishments that satisfy the definition 

of the term ‘‘facility’’ in current 

§ 1.227(b) but are exempt from the 

requirement to register. We describe 

each of these proposed revisions 

elsewhere in this document, in an order 

consistent with the placement of the 

current or revised provision. We request 

comment on this proposed revision. 

We are not proposing to replace the 

use of the term ‘‘facilities’’ in current 

requirements directed to specific 

functional parts of a plant or 

establishment, such as ‘‘toilet facilities’’ 

and ‘‘hand-washing facilities.’’ We 

tentatively conclude that the use of the 

term ‘‘facilities’’ in these contexts would 

not create confusion. We request 

comment on whether there is potential 

for confusion such that we should 

eliminate all use of the term ‘‘facility’’ 

or ‘‘facilities’’ as it is used in current 

part 110 irrespective of context. 

3. Owner, Operator, or Agent in Charge 

Section 418 of the FD&C Act 

establishes requirements applicable to 

the ‘‘owner, operator, or agent in 

charge’’ of a facility. Current part 110 

establishes requirements for persons not 

explicitly identified as ‘‘owner, 

operator, or agent in charge’’ of a food 

plant or establishment. For example, 

current § 110.10 establishes 

requirements applicable to ‘‘plant 

management’’ and current § 110.20(a) 

establishes requirements for the 

‘‘operator’’ of a food plant. We request 

comment on whether there is any 

meaningful difference between the 

persons identified in current part 110 

and the ‘‘owner, operator, or agent in 

charge’’ identified in section 418 of the 

FD&C Act. We also request comment on 

whether it would be appropriate to refer 

to the ‘‘owner, operator, or agent in 

charge’’ of a plant, establishment, or 

facility throughout proposed part 117 

and, if so, whether the requirements 

would be clear if we revise the proposed 

rule to use pronouns (such as ‘‘you’’ and 

‘‘your’’) within proposed part 117. 

Pronouns are commonly used in 

contemporary regulations and simplify 

the presentation of the requirements. 

4. Food-Packaging Materials 

Most provisions of current part 110 

directed to preventing contamination of 

food and food-contact substances also 

are directed to preventing 

contamination of food-packaging 

materials. Because food-packaging 

materials come in contact with food, if 

they become contaminated this could 

lead to contamination of the food. FDA 

is proposing that provisions of current 

part 110 directed to preventing 

contamination of food and food-contact 

substances consistently be directed to 

preventing contamination of foodpackaging materials as well. We 

describe each of these proposed 

revisions elsewhere in this document, in 

an order consistent with the placement 

of the current or revised provision. 

D. Proposed Additions Regarding CrossContact 

Proposed § 117.3 would define the 

term ‘‘cross-contact’’ to mean the 

unintentional incorporation of a food 

allergen into a food. ‘‘Food allergen’’ 

would be defined as a major food 

allergen as defined in section 201(qq) of 

the Federal Food, Drug, and Cosmetic 

Act. As discussed in section X.B.4 of 

this document, it has been estimated 

that food allergies affect four to six 

percent of children and two to three 

percent of adults in the U.S. Food 

allergies can cause life threatening 

reactions to foods. Because there is no 

cure for food allergy, sensitive 

consumers and their families must 

practice avoidance to prevent reactions. 

To do so they must rely on food labels 

to be complete, clear, and accurate. 

Manufacturers can provide consumers 

with the food labels they need by using 

controls to ensure that labels declare all 

the food allergens that are intended to 

be present, controls to ensure that the 

correct label is applied to the product, 

and controls that prevent the 

unintended presence of food allergens 

through cross-contact. 

Comments submitted to the Food 

CGMP Modernization Working Group 

emphasized the importance of controls 

to prevent cross-contact (Ref. 1). After 

considering the comments, the CGMP 

Working Group report recommended 

that food processing establishments that 

handle any of the major food allergens 

be required to develop and adopt a food 

allergen control plan that addresses six 

areas of control, one of which is 

‘‘[p]revention of cross-contact during 

processing’’ (Ref. 1). FDA interprets 

current part 110 to require protection 

against cross-contact, which can 

constitute insanitary conditions that 

may cause a food to be adulterated 

under section 402(a)(4) of the FD&C Act 

if the food may have been rendered 

injurious to health. Consistent with this 

interpretation, FDA issued a Notice to 

Manufacturers titled ‘‘Allergy Warning 

Letter’’ on June 10, 1996, advising with 

regard to cross-contact that adhering to 

CGMPs is essential for effective 

reduction of adverse reactions, and 

urging manufacturers to take all steps 

necessary to eliminate cross 

contamination and to ensure the 

absence of unintended food allergens 

(Ref. 120). In the past, inadvertent 

incorporation of an allergen into a food 

was referred to as ‘‘contamination’’ or 

‘‘cross contamination’’ (Ref. 121), and in 

many instances these terms are still 

used (Ref. 122). More recently, the term 

‘‘cross-contact’’ (rather than 

‘‘contamination’’ or ‘‘cross 

contamination’’) has been applied with 

respect to unintentional transfer of 

allergenic proteins from a food 

containing the proteins to one that does 

not (Ref. 123) (Ref. 124), because an 

allergen is a normal component of food, 

and not itself a contaminant. Given this 

shift in the scientific literature 

distinguishing ‘‘cross-contact’’ from 

‘‘contamination’’ and ‘‘cross 

contamination,’’ FDA tentatively 

concludes that it should begin using the 

term ‘‘cross-contact’’ to describe 

inadvertent incorporation of an allergen 

into food, rather than the general term 

‘‘contamination,’’ for purposes of 

clarity. To make it clear that CGMPs 

require protection against cross-contact, 

and to ensure that CGMPs continue to 

address health concerns related to 

allergens, FDA is proposing to revise 

several provisions of current part 110 to 

explicitly address cross-contact in 

proposed part 117. 

We describe each of these proposed 

additions elsewhere in this document, 

in an order consistent with the 

placement of the current or revised 

provision. We request comment on this 

proposed revision to the CGMPs. 

E. Proposed Revisions for Consistency 

With the Definition of ‘‘Food’’ 

Current § 110.3 defines ‘‘food’’ to 

mean food as defined in section 201(f) 

of the FD&C Act and includes raw 

materials and ingredients. We are 

proposing to retain that definition in 

this proposed rule. There is an overlap 

between raw materials and ingredients. 

Not all raw materials are ingredients. 

For example, under section 201(f) of the 

FD&C Act, a food additive is food and, 

thus, the manufacture of a food additive 

is subject to current part 110. An 

example of a food additive is sucrose 

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fatty acid esters. Under § 172.859, 

sucrose fatty acid esters are the mono- 

, di-, and tri-esters of sucrose with fatty 

acids and are derived from sucrose and 

edible tallow or hydrogenated edible 

tallow or edible vegetable oils. The only 

solvents which may be used in the 

preparation of sucrose fatty acid esters 

are those generally recognized as safe in 

food or regulated for such use by an 

appropriate section in this part. Ethyl 

acetate or methyl ethyl ketone or 

dimethyl sulfoxide and isobutyl alcohol 

(2-methyl-1-propanol) may be used in 

the preparation of sucrose fatty acid 

esters. The regulation for sucrose fatty 

acid esters identifies a number of raw 

materials used in the production of 

sucrose fatty acid esters. Because the 

production process transforms those 

raw materials into the substance 

‘‘sucrose fatty acid esters,’’ those raw 

materials generally would not be viewed 

as ‘‘ingredients’’ of the final chemical 

product. Likewise, if a facility adds the 

food additive ‘‘sucrose fatty acid esters’’ 

to a food product, the facility would 

view that food additive as an ingredient 

of its food product, but would not view 

the chemicals used to produce sucrose 

fatty acid esters as ingredients of its 

food product. 

The title of current § 110.80(a) and 

several provisions within current 

§ 110.80 refer to ‘‘raw materials and 

other ingredients’’ rather than to ‘‘raw 

materials and ingredients’’ as in the 

definition of ‘‘food.’’ For consistency 

with the definition of food, we are 

proposing to change the title of current 

§ 110.80(a) (which would be proposed 

§ 117.80(b)) to ‘‘Raw materials and 

ingredients.’’ As a companion change to 

this change in title, we are proposing to 

substitute ‘‘ingredients’’ for ‘‘other 

ingredients’’ throughout provisions in 

current § 110.80 that refer to both raw 

materials and ingredients. We do not list 

every instance where this proposed 

revision would apply in proposed 

§ 110.80. 

F. Proposed Revisions To Address 

Guidance in Current Part 110 

In 2000, we codified our policies and 

procedures for the development, 

issuance, and use of guidance 

documents in § 10.115 (21 CFR 10.115) 

(65 FR 56468, September 19, 2000). 

Under § 10.115(b), guidance documents 

are documents prepared for FDA staff, 

applicants/sponsors, and the public that 

describe our interpretation of or policy 

on a regulatory issue. They include 

documents that relate to the design, 

production, labeling, promotion, 

manufacturing, and testing of regulated 

products; the processing, content, and 

evaluation or approval of submissions; 

and inspection and enforcement 

policies. Under § 10.115(d), guidance 

documents do not establish legally 

enforceable rights or responsibilities 

and do not legally bind the public or 

FDA. 

Comments submitted to the Food 

CGMP Modernization Working Group 

noted that several provisions of current 

part 110 use non-binding language such 

as ‘‘should’’ and recommended that we 

revise part 110 to express all provisions 

using binding language (e.g., ‘‘shall’’ in 

place of ‘‘should’’) (Ref. 1). Consistent 

with these comments and with 21 CFR 

10.115, we are proposing to delete some 

non-binding provisions of current part 

110 (e.g., provisions using ‘‘should’’ or 

‘‘compliance may be achieved by’’). We 

request comment on this proposal. In 

section XI.M of this document, we 

request comment on whether to revise 

other non-binding provisions to 

establish new requirements in proposed 

part 117 or to simply retain them as 

useful provisions of a comprehensive 

CGMP. We describe each of these in 

more detail elsewhere in this document. 

G. Proposed Editorial Changes 

FDA is proposing to revise current 

part 110 to make several changes that 

are editorial in nature. These editorial 

changes have no substantive effect on 

the current requirements of part 110 

and, thus, we do not list every instance 

where these proposed editorial changes 

would apply. We are proposing to: 

• Refer to the ‘‘Federal Food, Drug, 

and Cosmetic Act’’ rather than to ‘‘the 

act’’ for clarity and for consistency with 

our current approach to citing the FD&C 

Act in new regulations; 

• Replace the term ‘‘shall’’ with the 

term ‘‘must.’’ The term ‘‘must’’ is a more 

common word than ‘‘shall,’’ and we are 

using ‘‘must’’ in new regulations. 

• Replace the phrase ‘‘includes, but is 

not limited to’’ with ‘‘includes,’’ 

because the use of the word ‘‘includes’’ 

indicates that the specified list that 

follows is not exclusive. The phrase 

‘‘but is not limited to’’ is unnecessary. 

(72 FR 34752 at 34765, June 25, 2007) 

• Replace the phrase ‘‘adulteration 

within the meaning of the act’’ with the 

single term ‘‘adulteration’’ because 

‘‘within the meaning of the act’’ is not 

needed for the term ‘‘adulteration’’ to 

have the meaning assigned by section 

402 of the FD&C Act (21 U.S.C. § 342 

(Adulterated food). 

• Replace the term ‘‘whenever’’ with 

‘‘when’’ for grammatical simplicity. 

X. Proposed Revisions to General 

Provisions of Part 110 (Proposed Part 

117, Subpart A) 

A. Proposed § 117.1—Applicability and 

Status 

FDA is proposing to redesignate 

current § 110.5(a) as proposed § 117.1(a) 

with associated editorial changes 

described in section IX.G of this 

document. Current § 110.5(a) establishes 

that the criteria and definitions in part 

110 apply in determining whether a 

food is adulterated (1) within the 

meaning of section 402(a)(3) of the act 

in that the food has been manufactured 

under such conditions that it is unfit for 

food; or (2) within the meaning of 

section 402(a)(4) of the FD&C Act in that 

the food has been prepared, packed, or 

held under insanitary conditions 

whereby it may have become 

contaminated with filth, or whereby it 

may have been rendered injurious to 

health. Current § 110.5(a) also 

establishes that the criteria and 

definitions in part 110 apply in 

determining whether a food is in 

violation of section 361 of the Public 

Health Service Act (42 U.S.C. 264). FDA 

is proposing to retain the provisions of 

current § 110.5(a) in proposed 

§ 117.1(a). The provisions of current 

§ 110.5(a) as re-established in proposed 

§ 117.1(a) would continue to apply to all 

provisions that currently are established 

in part 110 and would be re-established 

in proposed part 117. Under this 

proposed rule, proposed § 117.1 also 

would apply to new provisions of 

proposed part 117, including provisions 

that would be added under the authority 

of sections 402(a)(3), 402(a)(4), or 418 of 

the FD&C Act, section 361 of the PHS 

Act, or a combination of those 

authorities. We note that section 418(a) 

of the FD&C Act provides that facilities 

subject to that section must ‘‘identify 

and implement preventive controls to 

* * * provide assurances that * * * 

food is not adulterated under section 

402 [of the FD&C Act]’’ and that similar 

references to preventing adulteration 

under section 402 of the FD&C Act also 

appear in section 418(c) and (e). In 

section III of this document, we explain 

how the proposed provisions are 

necessary to protect against 

contamination with hazards that may 

adulterate food. We tentatively conclude 

that the link between the proposed 

provisions and the potential for 

adulteration provides a basis for 

applying the criteria and definitions in 

proposed part 117 in determining 

whether, under particular 

circumstances, a food is adulterated 

under section 402(a)(3) or (a)(4) or in 

violation of section 361 of the PHS Act. 

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Section 103(e) of FSMA amends 

section 301 of the FD&C Act (21 U.S.C. 

331) by adding a new section—(uu)—to 

the list of acts and the causing thereof 

that are prohibited. Under section 

301(uu), the following act, and the 

causing thereof, is prohibited: ‘‘[t]he 

operation of a facility that manufactures, 

processes, packs, or holds food for sale 

in the United States if the owner, 

operator, or agent in charge of such 

facility is not in compliance with 

section 418 [of the FD&C Act].’’ To 

clearly communicate that failure to 

comply with regulations established 

under section 418 is a prohibited act, 

proposed § 117.1(b) would establish that 

the operation of a facility that 

manufactures, processes, packs, or holds 

food for sale in the United States if the 

owner, operator, or agent in charge of 

such facility is required to comply with, 

and is not in compliance with, section 

418 of the FD&C Act or subparts C, D, 

E, or F of part 117 is a prohibited act 

under section 301(uu) of the FD&C Act 

(21 U.S.C. 331(uu)). 

FDA is proposing to redesignate 

current § 110.5(b) as proposed § 117.1(c) 

with no changes. Current § 110.5(b) 

establishes that food covered by specific 

current good manufacturing practice 

regulations also is subject to the 

requirements of those regulations. As 

discussed in sections II.A.1 and II.A.2 of 

this document, following the 

establishment of the umbrella CGMPs in 

1969 (34 FR 6977), FDA established 

additional CGMP requirements, 

including CGMP requirements for 

thermally processed low-acid foods 

packaged in hermetically sealed 

containers (proposed rule, 41 FR 30444, 

July 23, 1976; final rule, 44 FR 16209, 

March 16, 1979; currently established in 

part 113) and CGMP requirements for 

acidified foods (proposed rule, 41 FR 

30457, July 23, 1976; final rule, 44 FR 

16230, March 16, 1979; currently 

established in part 114). In the preamble 

to the proposed rule to establish current 

§ 110.5(b), we explained that this 

provision was intended to communicate 

that foods covered by such specific 

CGMPs are still subject to part 110 (44 

FR 33238, at 33239, June 8, 1979). Since 

current § 110.5(b) was established, we 

have established additional food safety 

regulations, such as the 1995 HACCP 

regulations in part 123 for fish and 

fishery products (60 FR 65096, 

December 18, 1995) and the 2001 

HACCP regulations in part 120 for juice 

(66 FR 6138, January 19, 2001). As with 

foods that are subject to part 113 or part 

114, foods that are subject to part 123 

or part 120 are subject to the 

requirements of part 123 or 120 even 

though they are foods covered by the 

current good manufacturing practice 

requirements that are currently 

established in part 110 and would be reestablished in part 117. See section II.A 

of this document for a discussion of 

other food safety regulations for specific 

foods to which this would also apply. 

Importantly, section 418 of the FD&C 

Act requires that we establish 

regulations to implement requirements 

for hazard analysis and risk-based 

preventive controls for human food. As 

discussed in section V of this document, 

we tentatively conclude that it is 

appropriate to establish these 

requirements for hazard analysis and 

risk-based preventive controls within 

the framework of current part 110, as 

would be re-established in proposed 

part 117. As discussed in section IX.A 

of this document, we are proposing that 

the title of proposed part 117 reflect the 

addition of these new requirements. As 

discussed more fully in section X.C of 

this document, section 418 of the FD&C 

Act establishes several exemptions from 

the proposed requirements for hazard 

analysis and risk-based preventive 

controls. For example, section 418(j)(1) 

of the FD&C Act provides that section 

418 of the FD&C Act ‘‘shall not apply to 

a facility if the owner, operator, or agent 

in charge of such facility is required to 

comply with, and is in compliance with 

* * * (A) [t]he Seafood Hazard Analysis 

Critical Control Points Program * * *’’ 

(We interpret ‘‘Seafood Hazard Analysis 

Critical Control Points Program’’ to 

mean the requirements of part 123 for 

fish and fishery products.) As discussed 

below, consistent with section 

418(j)(1)(A), proposed § 117.5(b) would 

provide that proposed subpart C of 

proposed part 117 would not apply with 

respect to activities that are subject to 

part 123 at a facility, if the owner, 

operator, or agent in charge of the 

facility is required to comply with, and 

is in compliance with part 123. 

However, under current § 110.5(b) and 

proposed § 117.1(c), all activities at that 

facility have been, and would continue 

to be, subject to the CGMP requirements 

in proposed subpart B and the 

requirements of part 123. The same 

would be true for establishments and 

facilities that are subject to other food 

safety regulations, consistent with the 

exemptions that would be established in 

proposed § 117.5. 

B. Proposed § 117.3—Definitions 

1. Redesignation 

FDA is proposing to redesignate all 

definitions in current § 110.3(a) through 

(r) as proposed § 117.3, eliminate 

paragraph designations (such as (a), (b), 

and (c)), and add new definitions in 

alphabetical order. Paragraph 

designations are not necessary when the 

definitions are presented in alphabetical 

order. Proposed § 117.3 would remain 

within subpart A. 

2. Current Definitions That FDA Is 

Proposing To Delete 

Current § 110.3(p) defines ‘‘shall’’ to 

be used to state mandatory 

requirements. FDA is proposing to 

delete the definition of ‘‘shall’’ and use 

‘‘must’’ instead, as discussed in section 

IX.G of this document. 

3. Current Definitions That FDA Is 

Proposing To Revise 

Current § 110.3(e) defines ‘‘critical 

control point’’ to mean a point in a food 

process where there is a high probability 

that improper control may cause, allow, 

or contribute to a hazard or to filth in 

the final food or decomposition of the 

final food. Current § 110.3(e) was 

established in 1986. Current § 110.3(e) 

preceded various currently used 

definitions of ‘‘critical control point’’ 

(CCP)—e.g., in the NACMCF HACCP 

guidelines (Ref. 34), the Codex HACCP 

Annex (Ref. 35), and Federal HACCP 

regulations for seafood (part 123), juice 

(part 120), and meat and poultry (9 CFR 

part 417). Proposed § 117.3 would revise 

the current definition of ‘‘critical control 

point’’ to match the statutory definition 

in section 418(o)(1) of the FD&C Act and 

to be consistent with definitions in the 

NACMCF HACCP guidelines, the Codex 

HACCP Annex, and Federal HACCP 

regulations for seafood, juice, and meat 

and poultry. Proposed § 117.3 would 

define ‘‘critical control point’’ to mean 

a point, step, or procedure in a food 

process at which control can be applied 

and is essential to prevent or eliminate 

a food safety hazard or reduce such 

hazard to an acceptable level. 

A non-substantive difference between 

the definition of CCP in proposed 

§ 117.3 and the definition of CCP in 

§ 120.3(d) is that proposed § 117.3 

would incorporate the phrase ‘‘food 

safety hazard’’ into the definition of 

CCP, whereas § 120.3(d) uses the phrase 

‘‘food hazard.’’ We see no meaningful 

difference between ‘‘food safety hazard’’ 

and ‘‘food hazard,’’ whether comparing 

proposed § 117.3 to § 120.3(d) or 

whether comparing § 120.3(d) to 

§ 123.3(b) (which uses the phrase ‘‘food 

safety hazard’’ in its definition of CCP). 

In fact, we see no meaningful difference 

between ‘‘food safety hazard’’ and 

‘‘hazard’’ and are proposing to define 

the term ‘‘hazard’’ rather than ‘‘food 

safety hazard’’ for the purpose of 

proposed part 117 (see the discussion of 

our definition of the term ‘‘hazard’’ in 

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section X.B.4 of this document). Section 

418 of the FD&C Act largely refers to 

‘‘hazards’’ and the single reference to 

‘‘food safety hazard’’ is in the statutory 

definition of CCP. Because the phrase 

‘‘food safety hazard’’ appears in so many 

current definitions of CCP, we 

tentatively conclude it is appropriate to 

propose to establish the statutory 

definition of CCP into the proposed 

rule, even though this will be the only 

place in the proposed rule where we use 

the term ‘‘food safety hazard.’’ 

There are slight differences in 

wording among the various currently 

used definitions of CCP—e.g., whether 

the definition uses the term ‘‘control’’ or 

the phrase ‘‘control measure’’ and in 

how the definition incorporates 

concepts such as ‘‘essential,’’ 

‘‘preventing,’’ eliminating’’ or ‘‘reducing 

to acceptable level’’ hazards. Part 123 

preceded the 1998 NACMCF guidelines 

and, thus, has the most differences. For 

the purpose of this proposed rule, we do 

not see these differences as meaningful 

and tentatively conclude that the 

statutory definition of CCP in section 

418(o)(1) of the FD&C Act is, for 

practical purposes, consistent with 

existing definitions and that our 

proposed definition of CCP would 

present no conflict with existing 

recommendations. 

The definition of CCP in proposed 

§ 117.3 would also differ from the 

definition of CCP in current § 110.3(e) in 

that the definition of CCP would no 

longer explicitly address filth. Deleting 

filth from the definition of CCP is 

consistent with section 418(o)(1) of the 

FD&C Act, and with the various current 

definitions of CCP, to emphasize food 

safety hazards generally rather than 

specifically identifying filth, which may 

or may not present a food safety hazard, 

depending on the circumstances. 

Similarly, the definition of CCP in 

proposed § 117.3 also would no longer 

explicitly address decomposition of the 

final food. However, section 418(b)(1) of 

the FD&C Act refers to decomposition 

among the hazards to be identified and 

evaluated and, thus, decomposition is 

considered within the term ‘‘hazard’’ 

when it affects the safety of the product. 

Current § 110.3(g) defines ‘‘foodcontact surfaces’’ as those surfaces that 

contact human food and those surfaces 

from which drainage onto the food or 

onto surfaces that contact the food 

ordinarily occurs during the normal 

course of operations. Current § 110.3(g) 

also specifies that ‘‘food-contact 

surfaces’’ includes utensils and foodcontact surfaces of equipment. FDA is 

proposing to revise the definition for 

‘‘food-contact surfaces’’ to include the 

phrase ‘‘or other transfer’’ after 

‘‘drainage.’’ FDA is proposing this 

revision to clarify that surfaces from 

which any transfer involving liquids or 

non-liquids onto the food or onto 

surfaces that contact the food are foodcontact surfaces. Proposed § 117.3 

would define ‘‘food-contact surfaces’’ to 

mean those surfaces that contact human 

food and those surfaces from which 

drainage, or other transfer, onto the food 

or onto surfaces that contact the food 

ordinarily occurs during the normal 

course of operations. Proposed § 117.3 

would also specify that ‘‘food-contact 

surfaces’’ includes utensils and foodcontact surfaces of equipment. 

Current § 110.3(i) defines 

‘‘microorganisms’’ to mean yeasts, 

molds, bacteria, and viruses and 

includes, but is not limited to, species 

having public health significance. 

Current § 110.3(i) also specifies that the 

term ‘‘undesirable microorganisms’’ 

includes those microorganisms that are 

of public health significance, that 

subject food to decomposition, that 

indicate that food is contaminated with 

filth, or that otherwise may cause food 

to be adulterated within the meaning of 

the act. Current § 110.3(i) also states 

that, occasionally in these regulations, 

FDA used the adjective ‘‘microbial’’ 

instead of using an adjectival phrase 

containing the word microorganism. 

FDA is proposing to revise the 

definition for ‘‘microorganisms’’ to also 

include protozoa and microscopic 

parasites. FDA is proposing this revision 

to clarify that FDA considers not only 

yeasts, molds, bacteria and viruses, but 

also protozoa and microscopic parasites, 

to be microorganisms of importance in 

the safe and sanitary production of 

foods. As discussed in section IX.G of 

this document, FDA is proposing to 

delete the phrases ‘‘but is not limited 

to,’’ and ‘‘within the meaning of the 

act.’’ FDA also is proposing to delete the 

last sentence in the definition because it 

is not needed. Proposed § 117.3 would 

define ‘‘microorganisms’’ to mean 

yeasts, molds, bacteria, viruses, 

protozoa, and microscopic parasites and 

includes species having public health 

significance. Proposed § 117.3 would 

also specify that the term ‘‘undesirable 

microorganisms’’ includes those 

microorganisms that are of public health 

significance, that subject food to 

decomposition, that indicate that food is 

contaminated with filth, or that 

otherwise may cause food to be 

adulterated. 

Current § 110.3(k) defines ‘‘plant’’ to 

mean the building or facility or parts 

thereof, used for or in connection with 

the manufacturing, packaging, labeling, 

or holding of human food. FDA is 

proposing to revise the definition for 

‘‘plant’’ by adding ‘‘processing’’ and 

‘‘packing’’ and deleting ‘‘labeling’’ and 

‘‘packaging’’ so that activities listed in 

the definition are consistent with 

activities covered by proposed part 117. 

As discussed in section IX.C.2 of this 

document, FDA is proposing to 

consistently use the terms 

‘‘manufacturing, processing, packing 

and holding’’ to reflect the group of 

terms used in section 418(a) of the 

FD&C Act to broadly identify activities 

that take place in food facilities. As 

discussed later in this section, 

‘‘labeling’’ and ‘‘packaging’’ would be 

included in the definition of 

manufacturing/processing and do not 

need to be repeated in the definition of 

‘‘plant.’’ As discussed above in section 

IX.C.2 of this document, FDA also is 

proposing to replace the term ‘‘facility’’ 

with the term ‘‘establishment.’’ 

Proposed § 117.3 would define ‘‘plant’’ 

to mean the building or establishment or 

parts thereof, used for or in connection 

with the manufacturing, processing, 

packing, or holding of human food. 

Current § 110.3(n) defines ‘‘safemoisture level’’ as a level of moisture 

low enough to prevent the growth of 

undesirable microorganisms in the 

finished product under the intended 

conditions of manufacturing, storage, 

and distribution. Current § 110.3(n) also 

specifies that the maximum safe 

moisture level for a food is based on its 

water activity (aw), and that an aw will 

be considered safe for a food if adequate 

data are available that demonstrate that 

the food at or below the given aw will 

not support the growth of undesirable 

microorganisms. FDA is proposing to 

revise the definition for ‘‘safe-moisture 

level’’ to: 

• Delete the hyphen between ‘‘safe’’ 

and ‘‘moisture.’’ The hyphen is not 

necessary. 

• Remove the word ‘‘maximum’’ 

before ‘‘safe moisture level.’’ FDA 

tentatively concludes that this word is 

not needed, since the word ‘‘maximum’’ 

is implicit when referring to ‘‘safe’’ with 

respect to moisture level. 

• Replace the phrase ‘‘based on’’ with 

‘‘related to.’’ FDA tentatively concludes 

that the term ‘‘related to’’ is more 

appropriate because moisture level is 

not the only factor that determines 

water activity. 

• Replace the phrase ‘‘manufacturing, 

storage, and distribution’’ with the 

phrase ‘‘manufacturing, processing, 

packing, and holding.’’ As discussed in 

section IX.C.1 of this document, we are 

proposing to use this group of terms to 

broadly identify activities that take 

place in food facilities. 

With these proposed changes, 

proposed § 117.3 would define ‘‘safe 

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moisture level’’ to mean a level of 

moisture low enough to prevent the 

growth of undesirable microorganisms 

in the finished product under the 

intended conditions of manufacturing, 

processing, packing, and holding. 

Proposed § 117.3 would also specify 

that the safe moisture level for a food is 

related to its water activity (aw), and that 

an aw will be considered safe for a food 

if adequate data are available that 

demonstrate that the food at or below 

the given aw will not support the growth 

of undesirable microorganisms. 

Current § 110.3(o) defines ‘‘sanitize’’ 

to mean to adequately treat food-contact 

surfaces by a process that is effective in 

destroying vegetative cells of 

microorganisms of public health 

significance, and in substantially 

reducing numbers of other undesirable 

microorganisms, but without adversely 

affecting the product or its safety for the 

consumer. FDA is proposing to revise 

the definition for ‘‘sanitize’’ to include 

the term ‘‘cleaned’’ before ‘‘food-contact 

surfaces.’’ It is well established that 

sanitizers can be inactivated by organic 

material and, thus, are not effective 

unless used on clean surfaces (Ref. 125). 

Proposed § 117.3 would define 

‘‘sanitize’’ to mean to adequately treat 

cleaned food-contact surfaces by a 

process that is effective in destroying 

vegetative cells of microorganisms of 

public health significance, and in 

substantially reducing numbers of other 

undesirable microorganisms, but 

without adversely affecting the product 

or its safety for the consumer. 

4. New Definitions 

FDA is proposing to define the term 

‘‘affiliate’’ to mean any facility that 

controls, is controlled by, or is under 

common control with another facility. 

The proposed definition would 

incorporate the definition in section 

418(l)(4)(A) of the FD&C Act and would 

make the meaning of the term clear 

when used in the proposed definition of 

‘‘qualified facility.’’ 

FDA is proposing to define ‘‘calendar 

day’’ to mean every day shown on the 

calendar. 

FDA is proposing to define the term 

‘‘cross-contact’’ to mean the 

unintentional incorporation of a food 

allergen into a food. We discuss crosscontact in more detail in section IX.D of 

this document. 

FDA is proposing to define the term 

‘‘environmental pathogen’’ to mean a 

microorganism that is of public health 

significance and is capable of surviving 

and persisting within the 

manufacturing, processing, packing, or 

holding environment. Examples of 

environmental pathogens include 

Salmonella spp. and Listeria 

monocytogenes. FDA requests comment 

on this definition and the types of 

organisms that should be considered 

environmental pathogens, including 

whether spores of pathogens such as 

Clostridium perfringens or Bacillus 

cereus should be considered 

environmental pathogens. 

FDA is proposing to define the term 

‘‘facility’’ to mean a domestic facility or 

a foreign facility that is required to 

register under section 415 of the FD&C 

Act in accordance with the 

requirements of 21 CFR part 1, subpart 

H. The proposed definition would 

incorporate the definition in section 

418(o)(2) of the FD&C Act. 

FDA is proposing to define the term 

‘‘farm’’ by reference to the definition of 

that term in proposed § 1.227. See 

section VIII of this document for 

detailed discussion of farms and mixedtype facilities. We are proposing to 

cross-reference the definition of ‘‘farm’’ 

rather than to define it in proposed part 

117 because the definition of ‘‘farm,’’ 

under both current § 1.227(b)(3) and 

proposed § 1.227, includes the word 

‘‘facility’’ with a meaning that is broader 

than the meaning of ‘‘facility’’ in section 

418(o)(2) of the FD&C Act. Under part 

I, subpart H, the term ‘‘facility’’ is not 

limited to entities that are required to 

register under section 415 of the FD&C 

Act. We are proposing to cross-reference 

the definition to reduce the potential 

confusion that could result if we used 

the term ‘‘facility’’ to have two different 

meanings within proposed part 117. 

FDA is proposing to define the term 

‘‘FDA’’ to mean the Food and Drug 

Administration. Defining this term 

within the definitions applicable to part 

117 would eliminate the need to define 

the term within each distinct section of 

the regulation and would provide for 

the substitution of ‘‘Food and Drug 

Administration’’ with ‘‘FDA’’ each time 

‘‘Food and Drug Administration appears 

in current part 110. 

FDA is proposing to define the term 

‘‘food allergen’’ to mean a major food 

allergen as defined in section 201(qq) of 

the FD&C Act. Section 201(qq) defines 

the term ‘‘major food allergen’’ to mean 

any of the following: Milk, egg, fish 

(e.g., bass, flounder, or cod), Crustacean 

shellfish (e.g., crab, lobster, or shrimp), 

tree nuts (e.g., almonds, pecans, or 

walnuts), wheat, peanuts, and soybeans, 

or a food ingredient that contains 

protein derived from one of these foods, 

with certain exceptions. The proposed 

definition would be consistent with the 

requirement in section 418(a) of the 

FD&C Act that the owner, operator, or 

agent in charge of a facility ‘‘identify 

and implement preventive controls to 

significantly minimize or prevent the 

occurrence of * * * hazards and 

provide assurances that [food 

manufactured, processed, packed, or 

held by the facility] is not * * * 

misbranded under section 403(w) [of the 

FD&C Act].’’ Section 403(w) of the 

FD&C Act provides certain labeling 

requirements for foods that bear or 

contain a major food allergen, with 

certain exceptions. 

FDA is proposing to define the term 

‘‘harvesting’’ as applicable to farms and 

farm mixed-type facilities and meaning 

activities that are traditionally 

performed by farms for the purpose of 

removing raw agricultural commodities 

from the place they were grown or 

raised and preparing them for use as 

food. The proposed definition would 

also specify that harvesting is limited to 

activities performed on raw agricultural 

commodities on the farm on which they 

were grown or raised, or another farm 

under the same ownership; and that 

harvesting does not include activities 

that transform a raw agricultural 

commodity, as defined in section 201(r) 

of the FD&C Act, into a processed food 

as defined in section 201(gg) of the 

FD&C Act. The proposed definition 

would state that gathering, washing, 

trimming of outer leaves of, removing 

stems and husks from, sifting, filtering, 

threshing, shelling, and cooling raw 

agricultural commodities grown on a 

farm or another farm under the same 

ownership are examples of harvesting. 

We are proposing to use the same 

definition of ‘‘harvesting’’ as would be 

established in proposed § 1.227. See 

section VIII.E of this document for a 

detailed discussion of ‘‘harvesting.’’ 

FDA is proposing to define ‘‘hazard’’ 

to mean any biological, chemical, 

physical, or radiological agent that is 

reasonably likely to cause illness or 

injury in the absence of its control. The 

proposed definition is consistent with 

the NACMCF HACCP guidelines, the 

Codex HACCP Annex, and Federal 

HACCP regulations for seafood, juice, 

and meat and poultry. The NACMCF 

HACCP guidelines (Ref. 34) and our 

HACCP regulation for juice (§ 120.3(g)) 

define ‘‘hazard’’ and ‘‘food hazard,’’ 

respectively as a biological, chemical, or 

physical agent that is reasonably likely 

to cause illness or injury in the absence 

of its control. The Codex HACCP Annex 

defines ‘‘hazard’’ as a biological, 

chemical or physical agent in, or 

condition of, food with the potential to 

cause an adverse health effect (Ref. 35). 

Our HACCP regulation for seafood 

(§ 123.3(f)) and the FSIS HACCP 

regulation for meat and poultry (9 CFR 

417.1) define ‘‘food safety hazard’’ as 

any biological, chemical, or physical 

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property that may cause a food to be 

unsafe for human consumption. A 

difference between the proposed 

definition of ‘‘hazard’’ and the 

definitions established in the NACMCF 

HACCP guidelines, the Codex HACCP 

Annex, and Federal HACCP regulations 

for seafood, juice, and meat and poultry 

is that the proposed definition would 

include radiological agents whereas the 

various definitions of ‘‘hazard,’’ ‘‘food 

hazard’’ and ‘‘food safety hazard’’ under 

these HACCP systems do not. We are 

proposing to include radiological agents 

to implement section 418(b)(1)(A) of the 

FD&C Act, which includes radiological 

hazards as an example of known or 

reasonably foreseeable hazards that may 

be associated with the facility. We 

describe biological, chemical, 

radiological, and physical hazards in 

sections II.D and XII.B.3 of this 

document. 

FDA is proposing to define the term 

‘‘hazard that is reasonably likely to 

occur’’ to mean a hazard for which a 

prudent person who manufactures, 

processes, packs, or holds food would 

establish controls because experience, 

illness data, scientific reports, or other 

information provides a basis to 

conclude that there is a reasonable 

possibility that the hazard will occur in 

the type of food being manufactured, 

processed, packed, or held in the 

absence of those controls. The proposed 

definition is consistent with Federal 

HACCP regulations for seafood, juice, 

and meat and poultry. Our HACCP 

regulation for seafood describes a food 

safety hazard that is reasonably likely to 

occur as one for which a prudent 

processor would establish controls 

because experience, illness data, 

scientific reports, or other information 

provide a basis to conclude that there is 

a reasonable possibility that it will 

occur in the particular type of fish or 

fishery product being processed in the 

absence of those controls (§ 123.6(a)). 

Our HACCP regulation for juice 

describes a food hazard that is 

reasonably likely to occur as one for 

which a prudent processor would 

establish controls because experience, 

illness data, scientific reports, or other 

information provide a basis to conclude 

that there is a reasonable possibility 

that, in the absence of those controls, 

the food hazard will occur in the 

particular type of product being 

processed (§ 120.7(a)(2)). The FSIS 

HACCP regulation for meat and poultry 

describes a food safety hazard that is 

reasonably likely to occur as one for 

which a prudent establishment would 

establish controls because it historically 

has occurred, or because there is a 

reasonable possibility that it will occur 

in the particular type of product being 

processed, in the absence of those 

controls (9 CFR 417.2(a)). In section 

XII.B.4 of this document, we explain 

how the term ‘‘hazard that is reasonably 

likely to occur’’ would implement 

section 418(b)(1) of the FD&C Act and 

relate this term to the NACMCF HACCP 

guidelines and the Codex HACCP 

Annex. 

FDA is proposing to define the term 

‘‘holding’’ to mean the storage of food. 

The proposed definition would also 

state that holding facilities include 

warehouses, cold storage facilities, 

storage silos, grain elevators, and liquid 

storage tanks; and that, for farms and 

farm mixed-type facilities, holding also 

includes activities traditionally 

performed by farms for the safe or 

effective storage of raw agricultural 

commodities grown or raised on the 

same farm or another farm under the 

same ownership, but does not include 

activities that transform a raw 

agricultural commodity, as defined in 

section 201(r) of the FD&C Act, into a 

processed food as defined in section 

201(gg) of the FD&C Act. We are 

proposing to use the same definition of 

‘‘holding’’ as would be established in 

proposed § 1.227. See section VIII.E of 

this document for a detailed discussion 

of ‘‘holding.’’ 

FDA is proposing to define the term 

‘‘manufacturing/processing’’ to mean 

making food from one or more 

ingredients, or synthesizing, preparing, 

treating, modifying or manipulating 

food, including food crops or 

ingredients. The proposed definition 

would also state that examples of 

manufacturing/processing activities are 

cutting, peeling, trimming, washing, 

waxing, eviscerating, rendering, 

cooking, baking, freezing, cooling, 

pasteurizing, homogenizing, mixing, 

formulating, bottling, milling, grinding, 

extracting juice, distilling, labeling, or 

packaging. The proposed definition 

would also specify that, for farms and 

farm mixed-type facilities, 

manufacturing/processing does not 

include activities that are part of 

harvesting, packing, or holding. We are 

proposing to use the same definition of 

‘‘manufacturing/processing’’ as would 

be established in proposed § 1.227. See 

section VIII.E of this document for a 

detailed discussion of ‘‘manufacturing/ 

processing.’’ 

FDA is proposing to define the term 

‘‘mixed-type facility’’ to mean an 

establishment that engages in both 

activities that are exempt from 

registration under section 415 of the 

FD&C Act and activities that require the 

establishment to be registered. The 

proposed definition would also state 

that an example of such a facility is a 

‘‘farm mixed-type facility,’’ which is an 

establishment that grows and harvests 

crops or raises animals and may 

conduct other activities within the farm 

definition, but also conducts activities 

that require the establishment to be 

registered. We are proposing to use the 

same definition as would be established 

in proposed § 1.227. See section VIII.E 

of this document for a detailed 

discussion of ‘‘mixed-type facilities.’’ 

FDA is proposing to define the term 

‘‘monitor’’ to mean to conduct a 

planned sequence of observations or 

measurements to assess whether a 

process, point, or procedure is under 

control and to produce an accurate 

record for use in verification. The 

proposed definition is consistent with 

the NACMCF HACCP guidelines, the 

Codex HACCP Annex, and Federal 

HACCP regulations for seafood, juice, 

and meat and poultry. The proposed 

definition is the same as the definition 

in our HACCP regulation for juice 

(§ 120.3(i)). The NACMCF guidelines 

define ‘‘monitor’’ to mean to conduct a 

planned sequence of observations or 

measurements to assess whether a CCP 

is under control and to produce an 

accurate record for future use in 

verification (Ref. 34). The Codex HACCP 

Annex defines ‘‘monitor’’ to mean the 

act of conducting a planned sequence of 

observations or measurements of control 

parameters to assess whether a CCP is 

under control (Ref. 35). Our HACCP 

regulation for seafood, and the FSIS 

HACCP regulation for meat and poultry 

were each established before the current 

NACMCF HACCP guidelines and do not 

define the term ‘‘monitor.’’ However, as 

discussed in section XII.E of this 

document, both of these regulations 

establish requirements that are 

consistent with the definition of 

‘‘monitor’’ in proposed § 117.3 and in 

the NACMCF HACCP guidelines, the 

Codex HACCP Annex, and our HACCP 

regulation for juice. 

FDA is proposing to define the term 

‘‘packaging’’ to mean (when used as a 

verb) placing food into a container that 

directly contacts the food and that the 

consumer receives. FDA is proposing to 

use the same definition of ‘‘packaging’’ 

as would be established in proposed 

§ 1.227. See section VIII.E of this 

document for a detailed discussion of 

‘‘packaging.’’ 

FDA is proposing to define the term 

‘‘packing’’ to mean placing food into a 

container other than packaging the food. 

The proposed definition would also 

specify that, for farms and farm mixedtype facilities, packing also includes 

activities traditionally performed by 

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farms to prepare raw agricultural 

commodities grown or raised on the 

same farm or another farm under the 

same ownership for storage and 

transport, but does not include activities 

that transform a raw agricultural 

commodity, as defined in section 201(r) 

of the FD&C Act, into a processed food 

as defined in section 201(gg) of the 

FD&C Act. We are proposing to use the 

same definition of ‘‘packing’’ as would 

be established in proposed § 1.227. See 

section VIII.E of this document for a 

detailed discussion of ‘‘packing.’’ 

FDA is proposing to define the term 

‘‘preventive controls’’ to mean those 

risk-based, reasonably appropriate 

procedures, practices, and processes 

that a person knowledgeable about the 

safe manufacturing, processing, packing, 

or holding of food would employ to 

significantly minimize or prevent the 

hazards identified under the hazard 

analysis that are consistent with the 

current scientific understanding of safe 

food manufacturing, processing, 

packing, or holding at the time of the 

analysis. The proposed definition would 

incorporate the definition in section 

418(o)(3) of the FD&C Act. 

FDA is proposing to define the term 

‘‘qualified end-user’’ to mean, with 

respect to a food, the consumer of the 

food (where the term consumer does not 

include a business); or a restaurant or 

retail food establishment (as those terms 

are defined in § 1.227) that (1) is located 

(a) in the same State as the qualified 

facility that sold the food to such 

restaurant or establishment; or (b) not 

more than 275 miles from such facility; 

and (2) is purchasing the food for sale 

directly to consumers at such restaurant 

or retail food establishment. The 

proposed definition would incorporate 

the definition in section 418(l)(4)(B) of 

the FD&C Act. 

FDA is proposing to define the term 

‘‘qualified facility’’ to mean (when 

including the sales by any subsidiary; 

affiliate; or subsidiaries or affiliates, 

collectively, of any entity of which the 

facility is a subsidiary or affiliate) a 

facility that is a very small business as 

defined in this part, or a facility as to 

which both of the following apply: 

• During the 3-year period preceding 

the applicable calendar year, the average 

annual monetary value of the food 

manufactured, processed, packed or 

held at such facility that is sold directly 

to qualified end-users (as defined in this 

part) during such period exceeded the 

average annual monetary value of the 

food sold by such facility to all other 

purchasers; and 

• The average annual monetary value 

of all food sold during the 3-year period 

preceding the applicable calendar year 

was less than $500,000, adjusted for 

inflation. 

The proposed definition would 

incorporate the description of ‘‘qualified 

facility’’ in section 418(l)(1) of the FD&C 

Act with editorial changes to improve 

clarity. 

FDA is proposing to define the term 

‘‘qualified individual’’ to mean a person 

who has successfully completed 

training in the development and 

application of risk-based preventive 

controls at least equivalent to that 

received under a standardized 

curriculum recognized as adequate by 

the FDA or is otherwise qualified 

through job experience to develop and 

apply a food safety system. FDA is 

proposing to define the term ‘‘qualified 

individual’’ to have a concise term to 

use in proposed provisions that would 

require that an activity be performed by 

such an individual. We are proposing to 

establish requirements for a qualified 

individual in proposed section 

§ 117.155 (see section XII.H of this 

document). 

FDA is proposing to define the term 

‘‘ready-to-eat food (RTE food)’’ to mean 

any food that is normally eaten in its 

raw state or any other food, including 

processed food, for which it is 

reasonably foreseeable that the food 

would be eaten without further 

processing that will significantly 

minimize biological hazards. Our 

proposed definition is consistent with 

the definition in the Codex Guidelines 

on the Application of General Principles 

of Food Hygiene to the Control of 

Listeria Monocytogenes in Foods (Ref. 

52), which defines an RTE food as any 

food which is normally eaten in its raw 

state or any food handled, processed, 

mixed, cooked, or otherwise prepared 

into a form which is normally eaten 

without further listericidal steps. By 

referring to ‘‘any other food, including 

processed food,’’ our proposed 

definition for RTE food, in combination 

with our proposed definition of 

‘‘manufacturing/processing,’’ would 

incorporate the concepts in the Codex 

guidelines for control of Listeria that 

RTE food includes foods that have been 

processed, mixed, cooked, or otherwise 

prepared into a form that can be eaten 

without processing in a manner that 

adequately reduces pathogens. Our 

proposed definition would generalize 

the Codex definition established for the 

purpose of guidelines directed to a 

single hazard—i.e., the environmental 

pathogen L. monocytogenes—to any 

biological hazard that would be 

addressed under section 418 of the 

FD&C Act. In so doing, our proposed 

definition would state that RTE foods 

are normally eaten without further 

‘‘processing that will significantly 

minimize biological hazards,’’ rather 

than ‘‘listericidal steps.’’ In a draft 

guidance directed to the control of L. 

monocytogenes in refrigerated or frozen 

RTE foods (Ref. 126), we defined RTE 

food to mean ‘‘a food that is customarily 

consumed without cooking by the 

consumer, or that reasonably appears to 

be suitable for consumption without 

cooking by the consumer.’’ We are 

proposing a definition of RTE food that 

is more closely aligned to the definition 

in the Codex guidelines on the control 

of Listeria than the definition in our 

draft guidance regarding the control of 

Listeria to emphasize that RTE foods 

include foods that are already processed 

to some degree but have reached the 

point at which no further steps to 

significantly minimize biological 

hazards will be applied before it is 

eaten. This emphasis is needed for 

clarity with respect to proposed 

requirements that would be directed to 

control of environmental pathogens at a 

facility. As discussed in section 

XII.B.4.b of this document, proposed 

§ 117.130(c)(2) would require that a 

hazard analysis include an evaluation of 

whether environmental pathogens are 

reasonably likely to occur whenever a 

RTE food is exposed to the environment 

prior to packaging. As discussed in 

section XII.G.7 of this document, under 

proposed § 117.135(d)(3) preventive 

controls must include, as appropriate 

and where necessary to significantly 

minimize or prevent hazards that are 

reasonably likely to occur (including 

any environmental pathogen that is 

reasonably likely to occur in a ready-toeat food that is exposed to the 

environment prior to packaging, any 

microorganism of public health 

significance that is reasonably likely to 

occur in a ready-to-eat food due to 

employee handling, and any food 

allergen hazard) sanitation controls that 

include procedures for the (A) 

Cleanliness of food-contact surfaces, 

including food-contact surfaces of 

utensils and equipment; and (B) 

Prevention of cross-contact and crosscontamination from insanitary objects 

and from personnel to food, food 

packaging material, and other foodcontact surfaces and from raw product 

to processed product. 

Our proposal to include in the 

proposed definition of RTE food the 

concept that it includes food that ‘‘is 

reasonably foreseeable that the food 

would be eaten without further 

processing to significantly minimize 

biological hazards’’ would retain the 

concept, in the draft guidance directed 

to the control of L. monocytogenes in 

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3700 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

refrigerated or frozen RTE foods, that an 

RTE food includes food that ‘‘reasonably 

appears to be suitable for consumption 

without cooking by the consumer.’’ For 

example, it is well known that 

consumers eat raw cookie dough; an 

outbreak of foodborne illness caused by 

E. coli O157:H7 has been linked to 

consumption of raw cookie dough (Ref. 

77). It also is well known that 

consumers use dried soup mix in RTE 

form as a component of a dip; multiple 

dried soup mix products were recalled 

due to the potential for contamination 

with Salmonella spp. from an ingredient 

(hydrolyzed vegetable protein) (Ref. 24). 

FDA is proposing to define the term 

‘‘reasonably foreseeable hazard’’ to 

mean a potential biological, chemical, 

physical, or radiological hazard that 

may be associated with the facility or 

the food. The term ‘‘reasonably 

foreseeable hazard’’ is not used in 

NACMCF HACCP guidelines, the Codex 

HACCP Annex, or Federal HACCP 

regulations for seafood, juice, or meat 

and poultry. However, the term is used 

in FSMA and, as discussed in section 

XII.B.2.a of this document, the concept 

is grounded in the hazard evaluation 

process in HACCP systems. 

FDA is proposing to define the term 

‘‘significantly minimize’’ to mean to 

reduce to an acceptable level, including 

to eliminate. The specific terms 

‘‘significantly minimize’’ and 

‘‘preventive control’’ are not used in the 

NACMCF HACCP guidelines, the Codex 

HACCP Annex, or Federal HACCP 

regulations for seafood, juice, or meat 

and poultry. However, these terms are 

used in FSMA and are consistent with 

the definition of ‘‘control measure’’ in 

the NACMCF HACCP guidelines, the 

Codex HACCP Annex, and our HACCP 

regulation for juice. The NACMCF 

HACCP guidelines define ‘‘control 

measure’’ as any action or activity that 

can be used to prevent, eliminate or 

reduce a significant hazard (Ref. 34). 

The Codex HACCP Annex defines 

‘‘control measure’’ as any action or 

activity that can be used to prevent or 

eliminate a food safety hazard or reduce 

it to an acceptable level (Ref. 35). Our 

HACCP regulation for juice defines 

‘‘control measure’’ as any action or 

activity to prevent, reduce to acceptable 

levels, or eliminate a hazard (§ 120.3(c)). 

Our HACCP regulation for seafood, and 

the FSIS HACCP regulation for meat and 

poultry, which were established prior to 

the current NACMCF HACCP 

guidelines, do not define ‘‘control 

measure.’’ However, these Federal 

HACCP regulations nonetheless reflect 

the same concept that would be 

established in the proposed definition of 

‘‘significantly minimize’’ in the 

definition of ‘‘critical control point,’’ 

which is defined in the HACCP 

regulation for seafood as a point, step, 

or procedure in a food process at which 

control can be applied, and a food safety 

hazard can as a result be prevented, 

eliminated, or reduced to acceptable 

levels (§ 123.3(b)) and in the FSIS 

HACCP regulation for meat and poultry 

as a point, step, or procedure in a food 

process at which control can be applied 

and, as a result, a food safety hazard can 

be prevented, eliminated, or reduced to 

acceptable levels (9 CFR 417.1). 

FDA is proposing to define the term 

‘‘small business’’ to mean, for the 

purposes of part 117, a business 

employing fewer than 500 persons. See 

section X.B.5 for additional discussion 

of the definition of small business. 

FDA is proposing to define the term 

‘‘subsidiary’’ to mean any company 

which is owned or controlled directly or 

indirectly by another company. The 

proposed definition would incorporate 

the definition in section 418(l)(4)(D) of 

the FD&C Act. 

FDA is proposing to define the term 

‘‘validation’’ to mean that element of 

verification focused on collecting and 

evaluating scientific and technical 

information to determine whether the 

food safety plan, when properly 

implemented, will effectively control 

the identified hazards. The proposed 

definition is consistent with the 

NACMCF HACCP guidelines, the Codex 

HACCP Annex, and our HACCP 

regulation for juice. The NACMCF 

guidelines (Ref. 34) and our HACCP 

regulation for juice (§ 120.3(p)) define 

validation as that element of verification 

focused on collecting and evaluating 

scientific and technical information to 

determine whether the HACCP plan, 

when properly implemented, will 

effectively control the identified food 

hazards. The Codex HACCP Annex 

defines validation as obtaining evidence 

that the elements of the HACCP plan are 

effective (Ref. 35). Another Codex 

document (i.e., ‘‘Guidelines for the 

Validation of Food Safety Control 

Measures’’ (Codex validation 

guidelines)) defines validation more 

broadly than in the realm of HACCP 

systems as obtaining evidence that a 

control measure or combination of 

control measures, if properly 

implemented, is capable of controlling 

the hazard to a specified outcome (Ref. 

127). Our HACCP regulation for seafood, 

and the FSIS HACCP regulation for meat 

and poultry, do not define the term 

‘‘validation.’’ We discuss our proposed 

requirements for validation (proposed 

§ 117.150(a)), and their relationship to 

HACCP systems, in section XII.G.2.a of 

this document. 

FDA is proposing to define the term 

‘‘verification’’ to mean those activities, 

other than monitoring, that establish the 

validity of the food safety plan and that 

the system is operating according to the 

plan. The proposed definition is 

consistent with the NACMCF HACCP 

guidelines, the Codex HACCP Annex 

and validation guidelines, and our 

HACCP regulation for juice. The 

NACMCF guidelines (Ref. 34), and our 

HACCP regulation for juice (§ 120.3(q)) 

define verification as those activities, 

other than monitoring, that determine 

the validity of the HACCP plan and that 

the system is operating according to the 

plan. The Codex HACCP Annex defines 

verification as the application of 

methods, procedures, tests and other 

evaluations, in addition to monitoring to 

determine compliance with the HACCP 

plan (Ref. 35). The Codex validation 

guidelines define verification as the 

application of methods, procedures, 

tests and other evaluations, in addition 

to monitoring to determine whether a 

control measure is or has been operating 

as intended (Ref. 127). Our HACCP 

regulation for seafood, and the FSIS 

HACCP regulation for meat and poultry, 

do not define the term ‘‘verification.’’ 

FDA is proposing to define the term 

‘‘very small business’’ to mean, for the 

purposes of proposed part 117, a 

business that has less than $250,000 in 

total annual sales of foods, adjusted for 

inflation (Option 1 of co-proposal). As 

one co-proposal, we are proposing to 

define the term ‘‘very small business’’ to 

mean a business that has less than 

$500,000 in total annual sales of foods, 

adjusted for inflation (Option 2). As 

another co-proposal, we are proposing 

to define the term ‘‘very small business’’ 

to mean a business that has less than 

$1,000,000 in total annual sales of 

foods, adjusted for inflation (Option 3). 

See section X.B.5 for additional 

discussion of the definition of very 

small business. 

5. Food Processing Sector Study and the 

Definitions of ‘‘Small Business’’ and 

‘‘Very Small Business’’ 

FDA conducted a Food Processing 

Sector Study as required by section 

418(l)(5) of the FD&C Act (Ref. 32) . The 

purpose of that study was to make 

determinations in five areas as required 

by section 418(l)(5)(A) of the FD&C Act 

and to use the results of the study in 

defining the terms ‘‘small business’’ and 

‘‘very small business.’’ These areas 

include, in part, (1) distribution of food 

production by type and size of 

operation, (2) the proportion of food 

produced by each type and size of 

operation, (3) the number and types of 

food facilities co-located on farms, (4) 

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the incidence of foodborne illness 

originating from each size and type of 

operation, and (5) the effect on 

foodborne illness risk associated with 

certain activities regarding food. The 

Food Processing Sector Study provides 

information on the number of 

establishments and average sales per 

establishment by industry and size of 

operation. FDA’s proposed definitions 

are informed by that study. The food 

processing sector study is available in 

the docket established for this proposed 

rule (Ref. 32). We request comment on 

that study. We will consider comments 

regarding the study, as well as 

comments regarding our proposed 

definitions ‘‘small business’’ and ‘‘very 

small business,’’ in any final rule based 

on this proposed rule. 

Section 418(l)(5)(B) of the FD&C Act 

required consideration of harvestable 

acres, income, the number of 

employees, and the volume of product 

in defining the terms ‘‘small business’’ 

and ‘‘very small business.’’ The Food 

Processing Sector Study (Ref. 32) 

concluded that there was no consistent 

pattern across food categories in terms 

of which sizes of establishments 

contribute most to foodborne illness 

risk. ‘‘Harvestable acres,’’ ‘‘income,’’ 

‘‘the number of employees,’’ and ‘‘the 

volume of food harvested’’ are all ways 

to measure the size of an operation. 

Income does not appear to be the most 

relevant measure, since facility income 

may be derived from multiple sources, 

many of which are not food-related. 

‘‘Harvestable acres’’ and ‘‘volume of 

food harvested’’ are similar measures 

that appear primarily relevant to the 

growing and harvesting of crops, which 

are activities not subject to this 

regulation. Harvestable acres and 

volume of food harvested do not 

provide a meaningful measure with 

respect to the risk from food produced 

by a farm mixed-type facility (a food 

facility co-located on a farm subject to 

this regulation); our qualitative risk 

assessment of manufacturing, 

processing, packing and holding 

activities conducted in a facility colocated on a farm showed that risk was 

related to activity/food combinations; 

these foods could be harvested from 

large or small farms (see section VIII.G 

of this document for a discussion of that 

qualitative risk assessment). A high risk 

activity/food combination could be 

conducted on a farm with many 

harvestable acres or very few 

harvestable acres. For example, an onfarm facility producing bagged salads 

(which would not be considered a lowrisk activity/food combination) could be 

one that has very few acres, or the 

bagged salads production could be a 

small component of a large vegetable 

growing farm. FDA has previously used 

both number of employees and annual 

sales as criteria for defining small and 

very small businesses, e.g., in 21 CFR 

120.1(b)(1) and (b)(2). We have limited 

data on number of employees, income, 

and annual sales upon which to base 

our definitions of small and very small 

business, but no data for ‘‘harvestable 

acres’’ or ‘‘the volume of food 

harvested.’’ 

a. Definition of ‘‘Small Business.’’ 

FDA is proposing to define the term 

‘‘small business’’ to mean, for the 

purposes of part 117, a business 

employing fewer than 500 persons. The 

proposed limit of 500 employees would 

include all employees of the business 

rather than be limited to the employees 

at a particular facility. We are proposing 

to establish the same definition for 

small business as that which has been 

established by the U.S. Small Business 

Administration under 13 CFR 121 for 

most food manufacturers. This is also 

the same definition for small business as 

we used to define a small business in 

our juice HACCP regulation 

(§ 120.1(b)(1)). The definition of small 

business is relevant to two provisions in 

the proposed rule. It would affect which 

facilities qualify for the exemption in 

§ 117.5(g) for on-farm packing or 

holding, and the exemption in 

§ 117.5((h) for on-farm manufacturing/ 

processing, of food by a small business 

if the only activities subject to section 

418 of the FD&C Act are the specific 

low-risk activity/food combinations 

listed in those sections. It would also 

affect what the compliance date is for 

such facilities. 

Effect on proposed § 117.5(g) and 

proposed § 117.5(h). 

Under proposed § 117.5(g) a farm 

mixed-type facility that meets the 

definition of a small business and only 

conducts specific packing or holding 

activity/food combinations would be 

eligible for an exemption from subpart 

C. Similarly, under proposed § 117.5(h) 

a farm mixed-type facility that meets the 

definition of a small business and only 

conducts specific manufacturing/ 

processing activity/food combinations 

would be eligible for an exemption from 

subpart C. Based on the Food Processing 

Sector Study, we estimate that 

approximately 97,169 facilities would 

be part of a small business under the 

proposed definition and thus satisfy the 

size requirement of the exemption in 

proposed § 117.5(g) and proposed 

§ 117.5(h). Of those facilities, we 

estimate that approximately 1,661 

would be co-located on farms. A subset 

of those facilities would qualify for the 

exemption from Subpart C based on 

their manufacturing/processing and 

packing and holding activities. 

Other Effects. 

Based on the Food Processing Sector 

Study we estimate that businesses 

employing fewer than 500 employees 

produce approximately 18 percent 

(based on sales) of all manufactured 

food produced in the United States. As 

discussed in section VII of this 

document, the compliance date for a 

small business would be 2 years after 

the date of publication of the final rule. 

Under our proposed definition, 97,169 

facilities would be subject to this 

compliance date. 

b. Definition of ‘‘Very Small 

Business.’’ In addition to defining 

‘‘small business,’’ FDA is required to 

define ‘‘very small business.’’ FDA has 

not reached a tentative conclusion on 

how best to define ‘‘very small 

business’’ for the purposes of this rule. 

Consequently, we are proposing three 

possible definitions based on annual 

sales of $250,000, $500,000, or 

$1,000,000 and requesting comment on 

which of these three options to include 

in a final rule. All three proposed 

definitions are informed by the findings 

of the Food Processing Sector Study 

(Ref. 32). We request comment on 

whether a dollar amount of sales that is 

more than, or less than, the $250,000, 

$500,000, or $1,000,000 dollar amounts 

we are proposing would be appropriate. 

We also request comment on how a 

particular dollar amount of sales would 

be in keeping with Congressional 

intent—i.e., in light of the provisions in 

section 418(l) regarding qualified 

facilities, including the statutory 

limitations on sales to qualified endusers. 

The definition of very small business 

is relevant to 3 provisions of the 

proposed rule. It would affect which 

facilities qualify for the exemption in 

§ 117.5(g) for on-farm packing or 

holding, and the exemption in 

§ 117.5((h) for on-farm manufacturing/ 

processing, of food by a very small 

business if the only activities subject to 

section 418 of the FD&C Act are the 

specific low-risk activity/food 

combinations listed in those sections. It 

would also affect which facilities are 

automatically ‘‘qualified’’ facilities 

subject to the modified requirements in 

§ 117.201 and what the compliance date 

is for such facilities. 

i. Effect on proposed § 117.5(g) and 

proposed § 117.5(h). The definition of 

very small business affects which 

facilities qualify for the exemption in 

§ 117.5(g) for on-farm packing or 

holding, and the exemption in 

§ 117.5((h) for on-farm manufacturing/ 

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3702 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

processing, of food by a very small 

business if the only activities subject to 

section 418 of the FD&C Act are the 

specific low-risk activity/food 

combinations listed in those sections, 

ii. Other Effects. The definition of 

very small business affects which 

facilities are automatically ‘‘qualified’’ 

facilities subject to the modified 

requirements in § 117.201, and the 

applicable compliance dates for such 

facilities. There are two ways a facility 

may be ‘‘qualified’’ and thus subject to 

the modified requirements in proposed 

§ 117.201. The first, limited annual 

monetary value of sales, is based on 

fixed criteria set out in FSMA 

§ 418(l)(1)(C). The second, as provided 

by § 418(l)(1)(B), is to be a very small 

business as defined by FDA. Therefore, 

we discuss the affect of the proposed 

definitions for very small business in 

relation to the existing requirements for 

qualified facilities in § 418(l)(1)(C). 

Less than $250,000 in Total Annual 

Sales—Effect on proposed § 117.5(g) 

and proposed § 117.5(h). 

One possible definition of the term 

‘‘very small business,’’ for the purposes 

of proposed part 117, would be a 

business that has less than $250,000 in 

total annual sales of foods, adjusted for 

inflation (Option 1 of the co-proposal). 

From the Food Processing Sector Study 

it is apparent that the number of colocated facilities is concentrated at the 

smaller end of the size spectrum. Using 

data from Dun & Bradstreet, FDA 

estimates that 736 facilities would meet 

the size requirement for the exemptions 

in proposed § 117.5(g) and proposed 

§ 117.5(h). A subset of those facilities 

would then qualify for the exemption 

from Subpart C based on their 

manufacturing/processing, packing or 

holding activities. 

Less than $250,000 in Total Annual 

Sales—Effect on number of qualified 

facilities. 

The proposed definition of $250,000 

uses a dollar amount for sales that is, 

essentially, the same as the maximum 

dollar amount of sales by a qualified 

facility to end-users other than those 

that would satisfy the definition of 

‘‘qualified end-users,’’ except unlike 

with § 418(l)(1)(C), there would be no 

requirement that more than half of sales 

must be to qualified end-users. The 

$250,000 definition of very small 

business would add approximately 

34,600 domestic facilities to the number 

of qualified facilities beyond the 

approximately 11,500 domestic facilities 

that are qualified facilities under section 

418(l)(1)(C) of the FD&C Act, leading to 

a total of 46,100 domestic qualified 

facilities. These 46,100 domestic 

qualified facilities would have a 3 year 

compliance date. As a group, businesses 

with less than $250,000 in total annual 

sales of foods produce less than one-half 

of one percent of all food produced in 

the United States when measured by 

dollar value. 

Less than $500,000 in Total Annual 

Sales—Effect on proposed § 117.5(g) 

and proposed § 117.5(h). 

One possible definition of the term 

‘‘very small business,’’ for the purposes 

of proposed part 117, would be a 

business that has less than $500,000 in 

total annual sales of foods, adjusted for 

inflation (Option 2 of the co-proposal). 

From the Food Processing Sector Study 

it is apparent that the number of colocated facilities is concentrated at the 

smaller end of the size spectrum. Using 

data from Dun & Bradstreet, FDA 

estimates that 903 facilities would meet 

the size requirement for the exemptions 

in proposed § 117.5(g) and proposed 

§ 117.5(h). A subset of those facilities 

would then qualify for the exemption 

from Subpart C based on their 

manufacturing/processing, packing or 

holding activities. 

Less than $500,000 in Total Annual 

Sales—Effect on number of qualified 

facilities. 

Defining very small business to mean 

a business that has less than $500,000 

in total annual sales of foods would add 

approximately 45,900 domestic facilities 

to the number of qualified facilities 

beyond the approximately 11,500 

domestic facilities that are qualified 

facilities under section 418(l)(1)(C) of 

the FD&C Act, leading to a total of 

57,400 domestic qualified facilities. 

These 57,400 domestic qualified 

facilities would have a 3 year 

compliance date. As a group, businesses 

with less than $500,000 in total annual 

sales of foods produce less than one 

percent of all food produced in the 

United States when measured by dollar 

value. 

Less than $1,000,000 in Total Annual 

Sales—Effect on proposed § 117.5(g) 

and proposed § 117.5(h). 

One possible definition of the term 

‘‘very small business,’’ for the purposes 

of proposed part 117, would be a 

business that has less than $1,000,000 in 

total annual sales of foods, adjusted for 

inflation (Option 3 of the co-proposal). 

From the Food Processing Sector Study 

it is apparent that the number of colocated facilities is concentrated at the 

smaller end of the size spectrum. Using 

data from Dun & Bradstreet, FDA 

estimates that 1,227 facilities would 

meet the size requirement for the 

exemption in proposed § 117.5(g) and 

proposed § 117.5(h). A subset of those 

facilities would then qualify for the 

exemption from Subpart C based on 

their manufacturing/processing, packing 

or holding activities. 

Less than $1,000,000 in Total Annual 

Sales—Effect on number of qualified 

facilities. 

As compared to option two, defining 

very small business to mean a business 

that has less than $1,000,000 in total 

annual sales of foods would add 

approximately 63,500 domestic facilities 

to the number of qualified facilities 

beyond the approximately 11,500 

domestic facilities that are qualified 

facilities under section 418(l)(1)(C) of 

the FD&C Act, leading to a total of 

75,000 domestic qualified facilities. 

These 75,000 domestic qualified 

facilities would have 3 year compliance 

date. As a group, businesses with less 

than $1,000,000 in total annual sales of 

foods produce less than two percent of 

all food produced in the United States 

when measured by dollar value. 

C. Proposed § 117.5—Exemptions 

For a summary list of the exemptions 

in proposed § 117.5, see the table in the 

Executive Summary of this document. 

1. Proposed § 117.5(a)—Exemption 

Applicable to a Qualified Facility 

Section 418(l) of the FD&C Act 

establishes modified requirements for 

‘‘qualified facilities.’’ We describe what 

a qualified facility is in section XIII.A of 

this document, where we propose the 

modified requirements for such a 

facility (proposed § 117.201). We also 

define the term ‘‘qualified facility’’ in 

proposed § 117.3 (see the discussion of 

definitions in section X.B.4 of this 

document). Section 418(l)(2)(A) of the 

FD&C Act provides that a qualified 

facility ‘‘shall not be subject to the 

requirements under [sections 418(a) 

through (i) and (n) of the FD&C Act];’’ 

as a practical matter with respect to the 

provisions of this proposed rule, section 

418(l)(2)(A) of the FD&C Act provides 

that a qualified facility would be exempt 

from the proposed requirements of 

subpart C. Importantly, section 418(l)(3) 

of the FD&C Act provides that the 

Secretary of HHS may withdraw the 

exemption provided in section 

418(l)(2)(A) under certain 

circumstances. We discuss the 

withdrawal provisions of section 

418(l)(3), and our proposed provisions 

to implement section 418(l)(3) 

(proposed subpart E), in section XIV of 

this document. 

We tentatively conclude that we 

should include the exemption provided 

in section 418(l)(2)(A) of the FD&C Act 

in the proposed rule to establish by 

regulation the reach of the provision. 

Proposed § 117.5(a) would provide that 

subpart C would not apply to a qualified 

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facility, except as provided by subpart E 

(i.e., except as provided by the proposed 

provisions for withdrawal), and that 

qualified facilities are subject to the 

modified requirements in § 117.201. 

2. Proposed § 117.5(b) and (c)— 

Exemptions Applicable to Food Subject 

to HACCP Requirements for Fish and 

Fishery Products or for Juice 

Section 418(j)(1)(A) of the FD&C Act 

provides that section 418 of the FD&C 

Act shall not apply to a facility that is 

required to comply with, and is in 

compliance with, the Seafood Hazard 

Analysis Critical Control Points 

Program. Likewise, section 418(j)(1)(B) 

of the FD&C Act provides that section 

418 of the FD&C Act shall not apply to 

a facility if the owner, operator, or agent 

in charge of such facility is required to 

comply with, and is in compliance with, 

‘‘[t]he Juice Hazard Analysis Critical 

Control Points Program* * *.’’ (We 

interpret ‘‘Juice Hazard Analysis Critical 

Control Points Program’’ to mean the 

requirements of part 120 for juice.) 

The purpose of sections 418(j)(1)(A) 

and (B) appears clear—to exclude food 

covered by and in compliance with 

current HACCP requirements (parts 120 

and 123) from section 418 of the FD&C 

Act. The exclusion likely reflects a 

determination that the similarity of the 

existing HACCP requirements in parts 

120 and 123 to the preventive control 

requirements in section 418 makes 

application of section 418 unnecessary 

to foods currently subject to and in 

compliance with part 120 or 123. 

Although the purpose of the exemption 

appears clear, FDA considers the 

language of sections 418(j)(1)(A) and (B) 

to be ambiguous with regard to 

application of the exemption. The 

language of sections 418(j)(1)(A) and (B) 

premise exemption from section 418 on 

an owner, operator, or agent in charge 

of a facility being required to comply 

with, and being in compliance with, 

part 120 or 123 ‘‘with respect to such 

facility[.]’’ However, parts 120 and 123 

do not apply to ‘‘facilities,’’ 

establishments, or plants. Rather, they 

apply to the specified foods (juice and 

fish and fishery products, respectively) 

and to persons defined as ‘‘processors’’ 

who conduct certain activities involving 

those foods. See, e.g., § 120.1 (‘‘The 

requirements of this part shall apply to 

any juice * * *’’), § 120.3(k) (definition 

of ‘‘Processor’’), § 123.3(l) (definition of 

‘‘Processor’’), and § 123.6(b) (‘‘The 

purpose of this part is to set forth 

requirements specific to the processing 

of fish and fishery products’’). Thus, it 

is unclear for purposes of sections 

418(j)(1)(A) and (B) under what 

circumstances a juice or seafood 

processor is required to comply with 

parts 120 or 123 ‘‘with respect to [a] 

facility,’’ especially when such a person 

also conducts activities involving other 

foods not subject to parts 120 or 123 at 

the same facility. Because of this 

ambiguity, FDA considered three 

possible interpretations. 

First, we could interpret sections 

418(j)(1)(A) and (B) to exempt all food 

manufactured, processed, packed, or 

held by a facility from section 418 of the 

FD&C Act if the owner, operator, or 

agent in charge of the facility is required 

to comply with and is in compliance 

with part 123 or 120 with respect to any 

activities in the facility. Under this 

interpretation, food manufactured, 

processed, packed, or held by a facility 

that is not subject to part 120 or 123 

would be excluded from section 418 if 

the owner, operator, or agent in charge 

of the facility is required to comply 

with, and is in compliance with, part 

120 or 123 for any food manufactured, 

processed, packed, or held by the 

facility. For example, if a facility 

processes juice products and the owner, 

operator, or agent in charge is in 

compliance with the juice HACCP 

regulation (part 120), all food 

manufactured, processed, packed, or 

held by the facility—both the juice 

subject to part 120 and food not subject 

to part 120 (e.g., dairy products)—would 

be exempt from section 418. The 

exclusion for juice appears consistent 

with the purpose of section 418(j)(1)(B) 

because the juice is already subject to 

the HACCP requirements in part 120. 

The resulting exclusion for dairy 

products, however, does not serve the 

purpose of the exclusion because the 

dairy products are not subject to the 

HACCP requirements in parts 120 or 

123. Further, the exclusion of food not 

subject to part 120 or 123 (e.g., dairy 

products) would create a gap in the 

coverage of preventive controls, and 

therefore not be protective of public 

health. 

For example, there could be hazards 

reasonably likely to occur with regard to 

the dairy products, including 

environmental pathogens such as L. 

monocytogenes, but such hazards would 

not trigger any preventive control 

requirements because the facility would 

be excluded from section 418 of the 

FD&C Act. Finally, there is no apparent 

reason to regulate the same type of food 

not subject to part 120 or 123 (e.g., dairy 

products) differently depending on 

whether the food is manufactured, 

processed, packed, or held by a facility 

that manufactures, processes, packs, or 

holds other food that is subject to part 

120 or 123. Therefore, we tentatively 

conclude that this interpretation results 

in an exclusion that is too broad. 

Second, we could interpret sections 

418(j)(1)(A) and (B) to exempt an entire 

facility from section 418 only if the 

owner, operator, or agent in charge of 

the facility is subject to and in 

compliance with part 120 or 123 with 

regard to all food manufactured, 

processed, packed, or held by the 

facility. Under this interpretation, juice 

and seafood in a facility would, in 

addition to being subject to part 120 or 

123, be subject to the requirements in 

section 418 if the facility manufactures, 

processes, packs, or holds any food not 

subject to part 120 or 123. For example, 

juice processing activities subject to part 

120 at a facility that processes juice and 

dairy products would be subject to 

section 418 because the facility 

manufacturers, processes, packs, or 

holds food not subject to part 120 or 

123. The resulting application of section 

418 to the dairy products in the example 

is a logical outcome—the dairy products 

are not subject to any other preventive 

control-type requirements. Further, the 

coverage gap created by the first 

possible interpretation is avoided. The 

application of section 418 to the juice in 

the example, however, is problematic. 

The juice is subject to part 120, thus 

application of section 418 to the juice 

would result in a circumstance that the 

exclusion in sections 418(j)(1)(A) and 

(B) was likely intended to avoid— 

subjecting food covered by current 

HACCP requirements to additional 

preventive control requirements in 

section 418. Therefore, we tentatively 

conclude that this interpretation results 

in an exclusion that is too narrow. 

Finally, we considered a third 

interpretation. We could interpret 

sections 418(j)(1)(A) and (B) of the 

FD&C Act to exempt those activities of 

a facility that are subject to part 120 or 

123, and only those activities, regardless 

of whether the facility manufactures, 

processes, packs, or holds other food. 

This interpretation would fulfill the 

apparent goal of the exemption— to 

exclude food covered by and in 

compliance with current HACCP 

requirements (parts 120 and 123) from 

section 418. Further, this interpretation 

is neither too broad (because it does not 

exclude food that is not subject to part 

120 or 123) nor is it too narrow (because 

it does not result in overlapping 

requirements when food not subject to 

part 120 or 123 is processed in the same 

facility as food that is subject to part 120 

or 123). This is the interpretation that 

seems most reasonable and that we 

propose to adopt in this proposed rule. 

We request comment on our 

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3704 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

interpretation of sections 418(j)(1)(A) 

and (B). 

We tentatively conclude that we 

should include the exemptions 

provided in sections 418(j)(1)(A) and (B) 

of the FD&C Act in the proposed rule to 

establish by regulation the reach of the 

exemption as we have interpreted it. 

Proposed § 117.5(b) would provide that 

Subpart C would not apply with respect 

to activities that are subject to part 123 

(Fish and Fishery Products) at a facility 

if the owner, operator, or agent in charge 

of the facility is required to comply 

with, and is in compliance with, part 

123 with respect to such activities. 

Likewise, proposed § 117.5(c) would 

provide that Subpart C would not apply 

with respect to activities that are subject 

to part 120 (Hazard Analysis and 

Critical Control Point (HACCP) Systems) 

at a facility if the owner, operator, or 

agent in charge of the facility is required 

to comply with, and is in compliance 

with, part 120 with respect to such 

activities. Proposed § 117.5(b) and (c) 

would make clear that the exemptions 

provided by sections 418(j)(1)(A) and 

(B) of the FD&C Act would apply to 

particular activities at a facility rather 

than to the facility as a whole. For 

example, a facility producing juice and 

dairy beverages would be exempt only 

with respect to juices subject to, and in 

compliance, with part 120. Such a 

facility would be subject to subpart C 

with respect to its dairy beverages, 

unless it qualified for another 

exemption. 

We request comment on the criteria 

that should be used to determine 

whether a facility is in compliance with 

part 123 or part 120. 

3. Proposed § 117.5(d)—Exemption 

Applicable to Food Subject to Part 

113—Thermally Processed Low-Acid 

Foods Packaged In Hermetically Sealed 

Containers 

Section 418(j)(1)(C) of the FD&C Act 

provides that section 418 of the FD&C 

Act shall not apply to a facility if the 

owner, operator, or agent in charge of 

such facility is required to comply with, 

and is in compliance with, ‘‘[t]he 

Thermally Processed Low-Acid Foods 

Packaged in Hermetically Sealed 

Containers standards of the [FDA] (or 

any successor standards).’’ (We interpret 

‘‘Thermally Processed Low-Acid Foods 

Packaged in Hermetically Sealed 

Containers standards’’ to mean the 

requirements of part 113.) Importantly, 

section 418(j)(2) of the FD&C Act limits 

the express exemption associated with 

part 113 to microbiological hazards that 

are regulated under part 113 (or any 

successor regulations). FDA considers 

the language of section 418(j)(1)(C) of 

the FD&C Act to be ambiguous with 

regard to application of the exemption. 

As discussed with regard to sections 

418(j)(1)(A) and (B) above, the language 

of section 418(j)(1)(C) premises 

exemption from section 418 of the FD&C 

Act on an owner, operator, or agent in 

charge of a facility being required to 

comply with, and being in compliance 

with, part 113 ‘‘with respect to such 

facility[.]’’ However, part 113 does not 

apply to ‘‘facilities,’’ establishments, or 

plants. Rather, it applies to the specified 

foods (low-acid canned foods) and to 

persons defined as ‘‘commercial 

processors’’ who conduct certain 

activities involving those foods. See, 

e.g., § 113.3(d) (definition of 

‘‘Commercial processor’’), and section 

404 of the FD&C Act (21 U.S.C. 344), 

which provides FDA with legal 

authority to issue part 113 (‘‘[The 

Secretary] shall promulgate regulations 

providing for the issuance, to 

manufacturers, processors, or packers of 

such class of food [presenting specific 

risks defined in the section] in such 

locality of permits to which shall be 

attached such conditions governing the 

manufacture, processing, or packaging 

of such class of food * * *’’). Thus, it 

is unclear for purposes of section 

418(j)(1)(C) under what circumstances a 

low-acid canned food processor is 

required to comply with part 113 ‘‘with 

respect to [a] facility,’’ especially when 

such a person also conducts activities 

involving other foods not subject to part 

113 at the same facility. 

We considered the same three 

interpretations of section 418(j)(1)(C) of 

the FD&C Act as we considered for 

sections 418(j)(1)(A) and (B) of the 

FD&C Act for the purpose of proposed 

§ 117.5(b) and (c). We tentatively 

conclude that we should interpret 

section 418(j)(1)(C) in the same manner 

as we interpreted sections 418(j)(1)(A) 

and (B)—i.e., to exempt those activities 

of a facility that are subject to part 113, 

and only those activities. Such an 

interpretation would fulfill the apparent 

goal of the exemption without being too 

narrow or too broad. We also tentatively 

conclude that we should include the 

exemption provided in section 

418(j)(1)(C) of the FD&C Act in the 

proposed rule to establish by regulation 

the reach of the exemption as we have 

interpreted it. Proposed § 117.5(d)(1) 

would provide that Subpart C would not 

apply with respect to activities that are 

subject to part 113 (Thermally Processed 

Low-Acid Foods Packaged in 

Hermetically Sealed Containers) at a 

facility if the owner, operator, or agent 

in charge of the facility is required to 

comply with, and is in compliance with, 

part 113 with respect to such activities. 

For example, a facility producing both 

low-acid foods packaged in hermetically 

sealed containers and acidified foods 

subject to part 114 would be exempt 

only with respect to low-acid foods 

subject to, and in compliance with, part 

113. Consistent with section 418(j)(2) of 

the FD&C Act, proposed § 117.5(d)(2) 

would establish that the exemption in 

proposed § 117.5(d)(1) would be 

applicable only with respect to the 

microbiological hazards that are 

regulated under part 113. A facility that 

is required to comply with, and is in 

compliance with, part 113 would be 

subject to the requirements in proposed 

subpart C for hazards such as chemical 

hazards (e.g., pesticide residues), 

physical hazards (e.g., metal fragments 

that could be introduced from 

equipment) and radiological hazards 

(e.g., high concentrations of radium-226, 

radium-228 or uranium in well water 

used in product). A facility that is 

required to comply with, and is in 

compliance with, part 113 also would 

be subject to the requirements in 

proposed subpart C for biological 

hazards not regulated under part 113. 

For example, the heat-stable toxin 

produced by the Staphylococcus aureus 

is a biological hazard that would not be 

inactivated or destroyed by the 

processing required under part 113 (Ref. 

128) (Ref. 129). 

We request comment on the criteria 

that should be used to determine 

whether a facility is in compliance with 

part 113. 

4. Proposed § 117.5(e)—Exemption 

Applicable to a Facility That 

Manufactures, Processes, Packs, or 

Holds a Dietary Supplement 

Section 103(g) of FSMA provides that 

‘‘[n]othing in the amendments made by 

[section 103 of FSMA] shall apply to 

any facility with regard to the 

manufacturing, processing, packing, or 

holding of a dietary supplement that is 

in compliance with the requirements of 

sections 402(g)(2) and 761 of the [FD&C 

Act] (21 U.S.C. 342(g)(2), 379aa–1).’’ 

Section 402(g)(2) of the FD&C Act 

authorizes FDA to issue regulations to 

require good manufacturing practices 

for dietary supplements. FDA has issued 

such a regulation at part 111 (21 CFR 

111) (Current Good Manufacturing 

Practice in Manufacturing, Packaging, 

Labeling, or Holding Operations for 

Dietary Supplements). Section 761 of 

the FD&C Act requires serious adverse 

event reporting for dietary supplements. 

FDA has issued guidance implementing 

section 761 (Ref. 130). 

We interpret section 103(g) of FSMA 

in a manner analogous to our 

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interpretation of sections 418(j) and (k) 

of the FD&C Act—i.e., as an exemption 

from the requirements for hazard 

analysis and preventive controls that we 

are proposing to establish in subpart C 

of proposed part 117. We interpret the 

reference in section 103(g) of FSMA to 

‘‘compliance with section 402(g)(2)’’ to 

mean compliance with part 111 (i.e., the 

regulation authorized by section 

402(g)(2) of the FD&C Act). We 

tentatively conclude that Congressional 

intent regarding the reach of section 

103(g) of FSMA is unambiguous in that 

section 103(g) of FSMA directly limits 

the provision ‘‘with regard to the 

manufacturing, processing, packing, or 

holding of a dietary supplement * * *.’’ 

We also tentatively conclude that we 

should include a provision 

implementing section 103(g) of FSMA 

in the proposed rule to establish by 

regulation the reach of the provision. 

Proposed § 117.5(e) would provide that 

Subpart C would not apply to any 

facility with regard to the 

manufacturing, processing, packing, or 

holding of a dietary supplement that is 

in compliance with the requirements of 

Part 111 (Current good manufacturing 

practice in manufacturing, packing, 

labeling, or holding operations for 

dietary supplements) and section 761 of 

the FD&C Act (Serious Adverse Event 

Reporting for Dietary Supplements). 

We request comment on the criteria 

that should be used to determine 

whether a facility is in compliance with 

part 111 and with section 761 of the 

FD&C Act. 

5. Proposed § 117.5(f)—Exemptions 

Applicable to Activities Subject to 

Standards for Produce Safety in Section 

419 of the FD&C Act 

Section 418(k) of the FD&C Act 

provides that section 418 of the FD&C 

Act ‘‘shall not apply to activities of a 

facility that are subject to section 419 [of 

the FD&C Act]’’. Section 419, 

‘‘Standards for Produce Safety,’’ 

requires FDA to establish by regulation 

‘‘science-based minimum standards for 

the safe production and harvesting of 

those types of fruits and vegetables, 

including specific mixes or categories of 

fruits and vegetables, that are raw 

agricultural commodities for which 

[FDA] has determined that such 

standards minimize the risk of serious 

adverse health consequences or death.’’ 

Section 419(h) of the FD&C Act provides 

that section 419 of the FD&C Act ‘‘shall 

not apply to activities of a facility that 

are subject to section 418 [of the FD&C 

Act].’’ Elsewhere in this issue of the 

Federal Register, FDA is issuing a 

proposed rule to implement section 419. 

That proposed rule would apply section 

419 to (1) ‘‘farms’’ (as would be defined 

in proposed §§ 1.227 and 1.328) that are 

not required to register under section 

415 of the FD&C Act; and to (2) farms 

that conduct an activity (or activities) 

that triggers the section 415 registration 

requirement (‘‘farm mixed-type 

facilities’’), but only with respect to 

their activities that are within the farm 

definition and therefore do not trigger 

the registration requirement. See section 

VIII.E of this document for a discussion 

of our proposed revisions and additions 

to the definitions in current §§ 1.227(b) 

and 1.328. 

Establishments that are exempt from 

registration under section 415 of the 

FD&C Act as ‘‘farms’’ would not be 

subject to section 418 of the FD&C Act 

when conducting activities within the 

farm definition. Farm mixed-type 

facilities would be subject to section 418 

of the FD&C Act when conducting those 

activities that trigger the section 415 

registration requirement. We tentatively 

conclude that Congressional intent 

regarding the reach of section 418(k) of 

the FD&C Act is unambiguous in that 

section 418(k) directly limits the 

exemption to activities of the facility 

that are subject to section 419 of the 

FD&C Act. We also tentatively conclude 

that we should include a provision 

implementing section 418(k) of the 

FD&C Act in the proposed rule to 

establish by regulation the reach of the 

exemption. Proposed § 117.5(f) would 

provide that Subpart C would not apply 

to activities of a facility that are subject 

to section 419 of the FD&C Act 

(Standards for Produce Safety). 

As discussed immediately below in 

section X.C.6 of this document, 

proposed § 117.5(g) and (h) would 

provide for an exemption from the 

requirements of proposed subpart C for 

certain on-farm, low-risk manufacturing, 

processing, packing or holding activities 

by a small or very small business. 

6. Proposed § 117.5(g) and (h)— 

Exemption Applicable to Certain Onfarm Manufacturing, Processing, 

Packing or Holding Food by a Small or 

Very Small Business 

a. Requirements of section 103 of 

FSMA. As discussed in section VIII.A.1 

of this document, section 103(c)(1)(A) of 

FSMA requires that the Secretary 

publish a proposed rule to promulgate 

regulations with respect to ‘‘(i) activities 

that constitute on-farm packing or 

holding of food that is not grown, 

raised, or consumed on such farm or 

another farm under the same ownership 

for purposes of section 415 of the [FD&C 

Act]; and (ii) activities that constitute 

on-farm manufacturing or processing of 

food that is not consumed on that farm 

or on another farm under common 

ownership for purposes of section 415.’’ 

Section 103(c)(1)(B) of FSMA directs 

that the rulemaking ‘‘shall enhance the 

implementation of such section 415 [of 

the FD&C Act] and clarify the activities 

that are included as part of the 

definition of the term ‘‘facility’’ under 

such section 415.’’ In section VIII of this 

document, we discuss clarifications of 

certain on-farm activities and whether 

they trigger the section 415 registration 

requirement in order to enhance the 

implementation of section 415 by 

clarifying the treatment of various 

activities for purposes of section 415, 

including activities conducted on farms. 

As discussed in section VIII.A.2 of 

this document, section 103(c)(1)(C) of 

FSMA requires that the Secretary 

conduct a science-based risk analysis of 

‘‘(i) specific types of on-farm packing or 

holding of food that is not grown, 

raised, or consumed on such farm or 

another farm under the same ownership, 

as such packing and holding relates to 

specific foods; and (ii) specific on-farm 

manufacturing and processing activities 

as such activities relate to specific foods 

that are not consumed on that farm or 

on another farm under common 

ownership.’’ As discussed in section 

VIII.G of this document, consistent with 

the requirements of section 103(c)(1)(C) 

of FSMA we have conducted a 

qualitative risk assessment related to 

activity/food combinations for the 

purpose of determining which activity/ 

food combinations would be considered 

low risk. 

Section 103(c)(1)(D)(i) of FSMA 

requires that, in promulgating the 

regulations under Section 103(c)(1)(A), 

‘‘the Secretary shall consider the results 

of the science-based risk analysis 

conducted under [Section 103(c)(1)(C) 

of FSMA], and shall exempt certain 

facilities from the requirements in 

section 418 of the [FD&C Act] * * *, 

including hazard analysis and 

preventive controls, and the mandatory 

inspection frequency in section 421 of 

[the FD&C Act] * * * or modify the 

requirements in [sections 418 or 421 of 

the FD&C Act], as the Secretary 

determines appropriate, if such facilities 

are engaged only in specific types of onfarm manufacturing, processing, 

packing, or holding activities that the 

Secretary determines to be low risk 

involving specific foods the Secretary 

determines to be low risk.’’ Section 

103(c)(1)(D)(ii) of FSMA provides that 

‘‘[t]he exemptions or modifications 

under [section 103(c)(1)(D)(i) of FSMA] 

shall not include an exemption from the 

requirement to register under section 

415 of the [FD&C Act] * * * if 

applicable, and shall apply only to 

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small businesses and very small 

businesses, as defined in the regulation 

promulgated under section 418(n) of the 

[FD&C Act].’’ 

b. FDA’s interpretation of section 

103(c)(1)(D)(i) of FSMA. FDA considers 

the language of section 103(c)(1)(D)(i) of 

FSMA to be unambiguous with regard to 

the reach of the exemption. The 

language of section 103(c)(1)(D)(i) 

includes the requirement ‘‘if such 

facilities are engaged only in specific 

types of on-farm manufacturing, 

processing, packing, or holding 

activities that the Secretary determines 

to be low risk involving specific foods 

the Secretary determines to be low 

risk.’’ FDA tentatively concludes that 

this language is unambiguous and 

means that Congress intended us to 

exempt a facility from, or modify the 

requirements of, section 418 of the 

FD&C Act under this authority if the 

facility only conducts a limited set of 

low-risk activity/food combinations that 

would otherwise be subject to section 

418, that is, to the extent the facility is 

subject to section 418, it ‘‘is engaged 

only in’’ the identified activities 

involving the identified foods. This 

interpretation seems both protective of 

public health and consistent with the 

preventive purpose of section 418 of the 

FD&C Act. This interpretation would 

mean that a facility would be required 

to conduct a hazard analysis and 

establish and implement risk-based 

preventive controls for all activities 

conducted on all foods (including lowrisk activity/food combinations) if a 

facility conducts a single activity subject 

to section 418 of the FD&C Act that is 

not a low-risk activity/food 

combination, unless the facility 

qualifies for another exemption from 

subpart C. 

c. Proposed § 117.5(g)—Exemptions 

for on-farm low-risk packing or holding 

activity/food combinations. Proposed 

§ 117.5(g) would provide that subpart C 

would not apply to on-farm packing or 

holding of food by a small or very small 

business if the only packing and holding 

activities subject to section 418 of the 

FD&C Act that the business conducts are 

the following low-risk packing or 

holding activity/food combinations on 

food not grown, raised, or consumed on 

that farm mixed-type facility or another 

farm or farm mixed-type facility under 

the same ownership—i.e., packing or repacking (including weighing or 

conveying incidental to packing or repacking); sorting, culling, or grading 

incidental to packing or storing; and 

storing (ambient, cold and controlled 

atmosphere) of: 

(1) Hard candy, fudge, taffy, and 

toffee; 

(2) Cocoa beans and coffee beans (raw 

and roasted); 

(3) Cocoa products. 

(4) Grains and grain products; 

(5) Honey (raw and pasteurized); 

(6) Intact fruits and vegetables (for 

purposes of proposed §§ 117.5(g) and (h) 

only, ‘‘intact fruits and vegetables’’ 

refers only to fruits and vegetables other 

than cocoa beans, coffee beans, peanuts, 

sugar beets, sugarcane, and tree nuts); 

(7) Jams, jellies and preserves; 

(8) Maple sap for syrup and maple 

syrup; 

(9) Peanuts and tree nuts; 

(10) Sugar beets, sugarcane, and sugar; 

and 

(11) Soft drinks and carbonated water. 

The low-risk on farm packing and 

holding activity/food combinations on 

food not grown, raised, or consumed on 

that farm mixed-type facility or another 

farm or farm mixed-type facility under 

the same ownership reflect the findings 

of the analysis required by section 

103(c)(1)(C) of FSMA, discussed in 

sections VIII.G and VIII.H of this 

document. For purposes of proposed 

§ 117.5(g) and (h) only, ‘‘intact fruits 

and vegetables’’ refers only to fruits and 

vegetables other than cocoa beans, 

coffee beans, peanuts, sugar beets, 

sugarcane, and tree nuts. Cocoa beans, 

coffee beans, peanuts, sugar beets, 

sugarcane, and tree nuts can be 

considered part of ‘‘fruits and 

vegetables’’ as a general matter, but FDA 

has addressed those foods separately for 

the purpose of the analysis required by 

section 103(c)(1)(C) of FSMA and the 

proposed § 117.5(g) and (h) exemptions 

in order to accurately reflect differences 

in activity/food combinations likely to 

be performed on farm mixed-type 

facilities on those foods as compared to 

other fruits and vegetables, as well as 

differences in risk across those activity/ 

food combinations. 

d. Proposed § 117.5(h)—Exemptions 

for on-farm low-risk manufacturing/ 

processing activity/food combinations. 

Proposed § 117.5(h) would provide that 

subpart C would not apply to on-farm 

low-risk manufacturing/processing 

activities conducted by a small or very 

small business if the only 

manufacturing/processing activities 

subject to section 418 of the FD&C Act 

that the business conducts are the 

following: 

(1) When conducted on a farm mixedtype facility’s own raw agricultural 

commodities as defined in section 

201(r) of the Federal Food, Drug, and 

Cosmetic Act (those grown or raised on 

that farm mixed-type facility or another 

farm/farm mixed-type facility under the 

same ownership) for distribution into 

commerce: 

(i) Artificial ripening of intact fruits 

and vegetables; 

(ii) Boiling/evaporation of maple sap 

to make maple syrup; 

(iii) Chopping peanuts and tree nuts; 

(iv) Coating (with coatings other than 

wax, oil, or resin used for the purpose 

of storage or transportation) intact fruits 

and vegetables (e.g., caramel apples) and 

coating peanuts or tree nuts (e.g., adding 

seasonings); 

(v) Drying/dehydrating intact fruits 

and vegetables (without the addition of 

sulfites) where the drying creates a 

distinct commodity (e.g., drying fruits or 

herbs); 

(vi) Extracting oil from grains (e.g., 

corn, oilseeds, soybeans); 

(vii) Grinding/milling/cracking/ 

crushing grains (e.g., making grain 

products such as corn meal) and raw 

peanuts or raw tree nuts (e.g., making 

ground peanuts); 

(viii) Making jams, jellies and 

preserves from acid foods (e.g., acid 

fruits); 

(ix) Making sugar from sugar beets 

and sugarcane; and 

(x) Salting raw peanuts and raw tree 

nuts; 

(2) When conducted on food other 

than the farm mixed-type facility’s own 

raw agricultural commodities for 

distribution into commerce: 

(i) Artificial ripening of intact fruits 

and vegetables; 

(ii) Chopping peanuts and tree nuts; 

(iii) Coating (with coatings other than 

wax, oil, or resin used for the purpose 

of storage or transportation) intact fruits 

and vegetables (e.g., caramel apples), 

and peanuts and tree nuts (e.g., adding 

seasonings); 

(iv) Cooling intact fruits and 

vegetables using cold air; 

(v) Drying/dehydrating (whether for 

storage/transport or for creating a 

distinct commodity) intact fruits and 

vegetables (without sulfiting), cocoa 

beans, coffee beans, grains and grain 

products, and peanuts and tree nuts; 

(vi) Extracting oils from grains (e.g., 

corn, soybeans, oilseeds); 

(vii) Fermenting cocoa beans and 

coffee beans; 

(viii) Grinding/milling/cracking/ 

crushing cocoa beans, coffee beans, 

grains (e.g., making grain products such 

as corn meal), and peanuts and tree nuts 

(e.g., making ground peanuts); 

(ix) Labeling (including stickering) 

hard candy, cocoa beans, cocoa 

products from roasted cocoa beans 

(other than milk chocolate) coffee beans, 

intact fruits and vegetables, grain and 

grain products (other than those 

containing wheat in a form that would 

not be recognized as containing wheat 

without a label declaration), honey, 

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jams/jellies/preserves, maple sap, maple 

syrup, intact single-ingredient peanuts 

or tree nuts (shelled and unshelled), soft 

drinks and carbonated beverages, sugar 

beets, sugarcane, and sugar; 

(x) Making hard candy, fudge, taffy, 

and toffee; 

(xi) Making cocoa products from 

roasted cocoa beans; 

(xii) Making honey; 

(xiii) Making jams, jellies and 

preserves from acid foods (e.g., acid 

fruits); 

(xiv) Making maple syrup; 

(xv) Making soft drinks and 

carbonated water; 

(xvi) Making sugar from sugar beets 

and sugarcane; 

(xvii) Mixing cocoa beans, coffee 

beans, intact fruits and vegetables, grain 

and grain products, honey, maple sap 

and maple syrup, and peanuts and tree 

nuts; 

(xviii) Packaging hard candy, fudge, 

taffy, toffee; cocoa beans; cocoa 

products; coffee beans; intact fruits and 

vegetables (other than modified 

atmosphere or vacuum packaging); grain 

and grain products; honey; jams, jellies 

and preserves; and maple syrup; 

peanuts and tree nuts (including 

modified atmosphere or vacuum 

packaging); soft drinks and carbonated 

water; and sugar beets, sugarcane, and 

sugar; 

(xix) Salting peanuts and tree nuts; 

(xx) Shelling cocoa beans (i.e., 

winnowing), intact fruits and vegetables 

(e.g., dried beans and peas), and peanuts 

and tree nuts; 

(xxi) Sifting grains and grain 

products; 

(xxii) Sorting, culling and grading 

(other than when incidental to packing 

or storage) hard candy, fudge, taffy, and 

toffee; cocoa beans; cocoa products; 

coffee beans; intact fruits and 

vegetables; grain and grain products; 

honey; jams, jellies, and preserves; 

maple sap; maple syrup; peanuts and 

tree nuts; soft drinks and carbonated 

water; and sugar beets, sugarcane, and 

sugar; 

(xxiii) Treating cocoa beans, coffee 

beans, intact fruits and vegetables, grain 

and grain products, and peanuts and 

tree nuts against pests (other than 

during growing) (e.g., fumigation); 

(xxiv) Waxing (wax, oil, or resin used 

for the purpose of storage or 

transportation) intact fruits and 

vegetables. 

The low-risk on-farm manufacturing/ 

processing activity/food combinations 

reflect the findings of the analysis 

required by section 103(c)(1)(C) of 

FSMA, discussed in sections VIII.G and 

VIII.H of this document. 

7. Proposed § 117.5(i)— Exemptions 

Related to Alcoholic Beverages 

a. Requirements of FSMA. Section 

116(a) of FSMA (21 U.S.C 2206(a)) 

provides that, except as provided by 

certain listed sections in FSMA, nothing 

in FSMA, or the amendments made by 

FSMA, ‘‘shall be construed to apply to 

a facility that—(1) under the Federal 

Alcohol Administration Act (27 U.S.C. 

201 et seq.) or chapter 51 of subtitle E 

of the Internal Revenue Code of 1986 

(26 U.S.C. 5001 et seq.) is required to 

obtain a permit or to register with the 

Secretary of the Treasury as a condition 

of doing business in the United States; 

and (2) under section 415 of the [FD&C 

Act] is required to register as a facility 

because such facility is engaged in 

manufacturing, processing, packing, or 

holding 1 or more alcoholic beverages, 

with respect to the activities of such 

facility that relate to the manufacturing, 

processing, packing, or holding of 

alcoholic beverages.’’ 

Section 116(b) of FSMA (21 U.S.C. 

2206(b)) provides that section 116(a) of 

FSMA ‘‘shall not apply to a facility 

engaged in the receipt and distribution 

of any non-alcohol food, except that 

[section 116(a) of FSMA] shall apply to 

a facility described in [section 116(a) of 

FSMA] that receives and distributes 

non-alcohol food, provided such food is 

received and distributed—(1) in a 

prepackaged form that prevents any 

direct human contact with such food; 

and (2) in amounts that constitute not 

more than 5 percent of the overall sales 

of such facility, as determined by the 

Secretary of the Treasury.’’ 

Section 116(c) of FSMA (21 U.S.C. 

2206(c)) provides that, ‘‘[e]xcept as 

provided in [sections 116(a) and (b) of 

FSMA], [section 116] shall not be 

construed to exempt any food, other 

than alcoholic beverages, as defined in 

section 214 of the Federal Alcohol 

Administration Act (27 U.S.C. 214), 

from the requirements of [FSMA] 

(including the amendments made by 

[FSMA]).’’ 

b. FDA’s interpretation of Section 

116(a)(1) of FSMA. FDA is aware that 

some facilities that manufacture, 

process, pack, or hold alcoholic 

beverages are required to obtain what is 

technically called a ‘‘permit’’ from the 

Secretary of the Treasury (‘‘Treasury’’) 

and some are required to ‘‘register’’ 

(such as ‘‘dealers’’ under 26 U.S.C. 

5124) with Treasury. Others must 

adhere to functionally similar 

requirements by submitting a notice or 

application and obtaining approval from 

Treasury prior to commencing business. 

As examples, distilled spirits plants 

require a Federal Alcohol 

Administration Act (FAA Act) basic 

permit (27 U.S.C. 203–204) and must 

register under the Internal Revenue 

Code of 1986 (IRC) (26 U.S.C. 5171–72); 

wineries must obtain an FAA Act basic 

permit to produce or blend wine and as 

a bonded wine cellar must obtain 

approval of an application under the 

IRC (26 U.S.C. 5351 and 5356); and 

breweries must file a brewer’s notice 

under the IRC and must obtain approval 

of that notice from Treasury (26 U.S.C. 

5401). Because Treasury informs FDA 

that these are functionally similar 

requirements, and because FDA has not 

identified a public health basis or an 

indication that Congress intended for 

these various facilities to be treated 

differently for the purposes of section 

116 of FSMA, FDA tentatively 

concludes that the phrase ‘‘obtain a 

permit or register’’ is ambiguous and 

should be interpreted broadly, to 

include not only facilities that must 

obtain what is technically named a 

‘‘permit’’ or must ‘‘register’’ with 

Treasury, but also those facilities that 

must adhere to functionally similar 

requirements as a condition of doing 

business in the United States, namely, 

by submitting a notice or application to 

Treasury and obtaining Treasury 

approval of that notice or application. 

Proposed § 117.5(i)(1)(i) would provide 

that obtaining approval of a notice or 

application from the Secretary of the 

Treasury as a condition of doing 

business in the United States under the 

relevant statutes would be treated the 

same as obtaining a permit or registering 

with Treasury under those statutes for 

the purposes of section 418 of the FD&C 

Act. 

FDA understands that all of the 

facilities described in FSMA section 

116(a)(1) are located in the United 

States (including Puerto Rico under the 

FAA Act). In isolation, therefore, section 

116(a)(1) of FSMA appears to operate to 

exempt only certain domestic facilities 

from the requirements of section 418 of 

the FD&C Act. Under this interpretation, 

while domestic facilities would be 

exempt from section 418 of the FD&C 

Act if they met all of the required 

criteria, foreign facilities would not be 

exempt because they do not satisfy 

section 116(a)(1) of FSMA. 

This raises the question of whether 

such a construction of section 116(a)(1) 

of FSMA would be consistent with the 

risk-based public health principles 

underlying section 418 of the FD&C Act 

and FSMA generally; and raises 

concerns related to U.S. trade 

obligations, for example, those found in 

the World Trade Organization 

Agreements. See, e.g., The General 

Agreement on Tariffs and Trade 1994, 

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(GATT 1994) Art. III(4) (‘‘The products 

of the territory of any contracting party 

imported into the territory of any other 

contracting party shall be accorded 

treatment no less favorable than that 

accorded to like products of national 

origin in respect of all laws, regulations 

and requirements affecting their internal 

sale* * *.’’); Agreement on the 

Application of Sanitary and 

Phytosanitary Measures, (SPS 

Agreement), Art. 2(3) (‘‘Member shall 

ensure that their sanitary and 

phytosanitary measures do not 

arbitrarily or unjustifiably discriminate 

between Members where identical or 

similar conditions prevail, including 

between their own territory and that of 

other Members.’’). Importantly, section 

404 of FSMA provides that ‘‘Nothing in 

this Act * * * shall be construed in a 

manner inconsistent with the agreement 

establishing the World Trade 

Organization or any other treaty or 

international agreement to which the 

United States is a party.’’ 

As a result, FDA considers the 

language of section 116 of FSMA, read 

together with the language of section 

404 of FSMA, to be ambiguous with 

regard to foreign facilities that 

manufacture, process, pack, or hold 

alcoholic beverages. There are multiple 

possible interpretations of this 

provision. For example, section 116 of 

FSMA could be read to exempt only 

domestic facilities from the 

requirements of section 418 of the FD&C 

Act, or section 404 of FSMA could be 

read to make the section 116(a)(1) 

exemption inapplicable for all facilities 

for the purposes of section 418 of the 

FD&C Act. In considering sections 116 

and 404 together, FDA tentatively 

concludes that it is reasonable to 

construe section 116(a)(1) to refer not 

only to domestic firms, but also to 

foreign firms in order to be consistent 

with the risk-based public health 

principles underlying section 418 of the 

FD&C Act and FSMA generally, and to 

avoid any inconsistency with treaties or 

international agreements to which the 

United States is a party. Accordingly, 

proposed § 117.5(i)(1)(i) would apply 

the exemption not only to domestic 

facilities that are required to secure a 

permit, registration, or approval from 

Treasury under the relevant statutes, but 

also to foreign facilities of a type that 

would require such a permit, 

registration, or approval if they were 

domestic facilities. 

c. FDA’s interpretation of Section 

116(b) of FSMA. FDA also considers the 

language of section 116 of FSMA to be 

ambiguous with regard to the reach of 

the exemption for facilities that 

manufacture, process, pack, or hold 

alcoholic beverages and also receive, 

manufacture, process, pack, hold, or 

distribute non-alcohol food (for clarity 

FDA is using the term ‘‘food other than 

alcoholic beverages’’ rather than ‘‘nonalcohol food’’ in the codified and 

discussion that follows). Section 116(b) 

of FSMA provides that section 116(a) 

‘‘shall not apply to a facility engaged in 

the receipt and distribution of any nonalcohol food,’’ except when the nonalcohol food is ‘‘received and 

distributed—(1) in a prepackaged form 

that prevents any direct human contact 

with such food; and (2) in amounts that 

constitute not more than 5 percent of 

the overall sales of such facility, as 

determined by the Secretary of the 

Treasury.’’ 

In order to interpret the application of 

section 116 to food other than alcoholic 

beverages, FDA must interpret the 

meaning of the phrase ‘‘received and 

distributed * * * in a prepackaged form 

that prevents any direct human contact 

with such food’’ in section 116(b) of 

FSMA. FDA tentatively concludes that 

this phrase refers to food that is 

completely enclosed in packaging 

during the entire time it is under the 

facility’s direct control, such that direct 

human contact with such food is 

prevented. Under this interpretation, 

facilities that conduct activities using 

such packaged food without opening the 

packaging after receiving the food and 

before distributing it are receiving and 

distributing food in prepackaged form 

that prevents any direct human contact 

with such food. For example, a winery 

that assembles gift baskets containing 

bottles of its own wine and prepackaged 

boxes of crackers purchased from a 

supplier, without opening the boxes of 

crackers, would be receiving and 

distributing the food other than 

alcoholic beverages (crackers) in 

prepackaged form that prevents direct 

human contact with such food. 

Considering this interpretation and 

the fact that alcohol-related facilities 

also handle food other than alcoholic 

beverages in other ways, one 

interpretation of section 116(b) could be 

that facilities described in 116(a) that 

also receive and distribute any food 

other than alcoholic beverages would be 

entirely ineligible for the exemption, 

and therefore wholly subject to section 

418 of the FD&C Act, unless such food 

is received and distributed in 

prepackaged form and in amounts that 

constitute no more than 5 percent of a 

facility’s overall sales. For example, if a 

brewery receives grain and distributes 

spent grain as animal feed, the entire 

brewery and all of its activities, 

including the manufacturing, 

processing, packing, and holding of 

beer, would be subject to section 418 of 

the FD&C Act under this interpretation 

because it receives and distributes food 

other than alcoholic beverages that is 

not in prepackaged form. However, if 

the same brewery simply disposed of its 

spent grain as waste, the brewery’s 

manufacturing, processing, packing, and 

holding of beer would not be subject to 

section 418 of the FD&C Act. In other 

words, under this interpretation, 

whether the facility’s manufacturing, 

processing, packing, or holding of 

alcohol would be subject to section 418 

of the FD&C Act would depend on the 

facility’s activities relating to food other 

than alcoholic beverages. 

When considering the provision as a 

whole and in its statutory context, FDA 

tentatively concludes that another 

interpretation is more reasonable. The 

agency understands section 116 of 

FSMA, in general, to indicate that the 

manufacturing, processing, packing, or 

holding of alcoholic beverages at most 

alcohol-related facilities should not be 

subject to section 418 of the FD&C Act. 

FDA understands section 116(b) of 

FSMA to indicate that the receipt and 

distribution of food other than alcoholic 

beverages, including any manufacturing, 

processing, packing, or holding of such 

food occurring at the facility between 

receipt and distribution, should be 

subject to section 418 of the FD&C Act, 

unless that food is received and 

distributed in prepackaged form and in 

amounts that constitute 5 percent or less 

of the facility’s overall sales. Thus, 

activities related to alcoholic beverages 

(including the manufacturing, 

processing, packing, or holding of 

alcoholic beverages) at facilities within 

the scope of 116(a) of FSMA would not 

be subject to section 418 of the FD&C 

Act. Activities related to food other than 

alcoholic beverages (including the 

receiving, manufacturing, processing, 

packing, holding, and distributing of 

such foods) would be subject to section 

418 of the FD&C Act even if those 

activities occur at facilities that are 

otherwise within the scope of 116(a) 

(unless they qualify for another 

exemption or are in prepackaged form 

and constitute 5 percent or less of the 

facility’s overall sales). For example, if 

an alcoholic beverage distillery also 

makes non-alcoholic beverages, under 

this interpretation the alcoholic 

beverage distilling activities would be 

exempt from section 418 of the FD&C 

Act, but the activities related to nonalcoholic beverages would be subject to 

section 418 (assuming the non-alcoholic 

beverages are not in prepackaged form 

and constitute less than 5 percent of the 

facility’s overall sales) unless they 

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qualify for another exemption. This 

interpretation is also consistent with the 

rule of construction in section 116(c) of 

FSMA, which states, ‘‘except as 

provided in [sections 116(a) and (b) of 

FSMA], [section 116 of FSMA] shall not 

be construed to exempt any food, other 

than alcoholic beverages, * * * from 

the requirements of this Act.’’ 

When considering the statute as a 

whole, including its underlying 

purpose, this interpretation of section 

116 also provides a more consistent, 

risk-based approach supported by 

public health principles. FDA concludes 

that Congress must have considered 

identifying hazards and implementing 

preventive controls for the 

manufacturing, processing, packing, and 

holding of alcoholic beverages to 

warrant lower priority from a public 

health perspective than other foods. 

Congress may have made such a 

conclusion in light of the potential 

antimicrobial function of the alcohol 

content in such beverages and the 

concurrent regulation of alcoholic 

beverage-related facilities by both FDA 

and the Alcohol and Tobacco Tax and 

Trade Bureau (TTB). The definition of 

‘‘food’’ under the FD&C Act includes 

‘‘articles used for food or drink’’ and 

thus includes alcoholic beverages. See 

21 U.S.C. 321(f). As such, alcoholic 

beverages are subject to the FD&C Act 

adulteration provisions, and 

implementing regulations, related to 

food. For example, manufacturers of 

alcoholic beverages are responsible for 

adhering to the requirements of current 

part 110. In addition, alcoholic 

beverages are regulated by TTB under 

the Federal Alcohol Administration Act 

and Chapter 51 of the Internal Revenue 

Code, which together establish ‘‘a 

comprehensive system of controls of 

alcoholic beverages, including on-site 

inspections and procedures that require 

the advance approval of statements of 

process and of formulas showing each 

ingredient to be used in the product’’ 

(Ref. 131 at II.B). FDA tentatively 

concludes that Congress intended to 

exempt certain alcohol-related facilities 

from section 418 of the FD&C Act 

because it found that, in light of the 

relatively low public health risk 

presented by the manufacturing, 

processing, packing, and holding of 

alcoholic beverages and their joint 

regulation by both FDA and TTB, the 

current regulatory scheme was sufficient 

to control the hazards associated with 

the manufacturing, processing, packing, 

and holding of alcoholic beverages. At 

the same time, FDA tentatively 

concludes that Congress did not intend 

to exempt manufacturing, processing, 

packing, or holding of food other than 

alcoholic beverages from section 418 

except in the very limited circumstances 

set forth in section 116(b)(1) and (2) of 

FSMA. 

At times, the manufacturing, 

processing, packing, or holding of 

alcoholic beverages is inseparable from 

the manufacturing, processing, packing, 

or holding of food other than alcoholic 

beverages. For example, a brewery that 

sells its spent grains as animal feed may 

be manufacturing beer and animal feed 

simultaneously for at least part of the 

brewing process. FDA tentatively 

concludes that section 418 of the FD&C 

Act does not apply to such inseparable 

activities. FDA tentatively concludes 

that section 418 applies to the food 

other than alcoholic beverages starting 

at the point at which it becomes 

physically separate from the alcoholic 

beverage because section 116(c) 

demonstrates Congress’s intent to limit 

the reach of the exemption to alcoholic 

beverages. Thus, in the case of the 

brewery manufacturing animal feed, 

section 418 of the FD&C Act would 

apply to the spent grain sold as animal 

feed once the spent grain is physically 

separated from the beer, but not before 

that point. 

Proposed § 117.5(i)(1) would provide 

that subpart C would not apply with 

respect to alcoholic beverages at 

facilities meeting the criteria in 

proposed § 117.5(i)(1)(i) and (ii). 

Proposed § 117.5(i)(2) would provide 

that subpart C would not apply with 

respect to food other than alcoholic 

beverages at facilities described in 

proposed § 117.5(i)(1), provided such 

food is in prepackaged form that 

prevents direct human contact with the 

food and constitutes not more than 5 

percent of the overall sales of the 

facility, as determined by the Secretary 

of the Treasury. 

We tentatively conclude that we 

should include a provision 

implementing section 116 of FSMA in 

the proposed rule to establish by 

regulation the reach of the provision. 

We request comment on our 

interpretation of section 116 of FSMA. 

8. Proposed § 117.5(j)—Exemption 

Applicable to Facilities Solely Engaged 

in Storage of Raw Agricultural 

Commodities Other than Fruits and 

Vegetables Intended for Further 

Distribution or Processing 

Section 418(m) of the FD&C Act 

provides in relevant part that FDA may 

by regulation ‘‘exempt or modify the 

requirements for compliance under 

[section 418 of the FD&C Act] with 

respect to facilities that are solely 

engaged in * * * the storage of raw 

agricultural commodities (other than 

fruits and vegetables) intended for 

further distribution or processing’’. 

Proposed § 117.5(j) would exempt 

facilities that are solely engaged in the 

storage of raw agricultural commodities 

(other than fruits and vegetables) 

intended for further distribution or 

processing from the requirements of 

subpart C. This provision would 

exempt, for example, facilities that only 

store whole grains (such as corn, wheat, 

barley, rye, grain sorghum, oats, rice, 

wild rice, and soybeans), unpasteurized 

shell eggs, and unpasteurized milk from 

subpart C. This would include facilities 

such as grain elevators and silos, 

provided that such facilities do not 

conduct other activities subject to 

section 418 of the FD&C Act. Outbreaks 

of foodborne illness have not been 

traced back to storage facilities solely 

engaged in the storage of non-fruit or 

vegetable RACs. In addition, as 

discussed in section X.C.9 of this 

document, facilities that are solely 

engaged in the storage of RACs are 

exempt from the current CGMP 

regulation, and FDA proposes to 

maintain this exemption from the 

CGMPs. FDA tentatively concludes that 

there would not be significant public 

health benefit to be gained by subjecting 

facilities that solely store non-fruit and 

vegetable RACs intended for further 

distribution or processing to the 

requirements of subpart C. Such 

facilities would remain subject to the 

requirements of the FD&C Act. For 

example, if storage is done under 

insanitary conditions whereby the food 

may become contaminated with filth or 

rendered injurious to health, the food 

would be adulterated under section 

402(a)(4) of the FD&C Act. 

9. Proposed § 117.5(k)—Exemption 

Applicable to Farms, Activities of 

‘‘Farm Mixed-type Facilities’’ Within 

the Definition of ‘‘Farm,’’ and the 

Holding or Transportation of One or 

More Raw Agricultural Commodities 

Current § 110.19(a) provides that 

establishments engaged solely in the 

harvesting, storage, or distribution of 

one or more ‘‘raw agricultural 

commodities,’’ as defined in section 

201(r) of the FD&C Act, which are 

ordinarily cleaned, prepared, treated, or 

otherwise processed before being 

marketed to the consuming public, are 

exempt from the requirements of part 

110. The exemption in current 

§ 110.19(a) is commonly referred to as 

the ‘‘RAC exemption.’’ Current 

§ 110.19(b) states that we will issue 

special regulations if it is necessary to 

cover operations excluded under 

current § 110.19(a). In section VIII.D of 

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this document, we discuss the meaning 

of the term ‘‘raw agricultural 

commodity’’ (RAC). 

FDA is proposing a series of changes 

to current § 110.19. As discussed more 

fully below, FDA is proposing to 

redesignate current § 110.19(a) as 

proposed § 117.5(k) and revise the 

newly established provision as follows: 

• Delete current § 110.19(b); 

• Make clear that the exemption from 

requirements in proposed part 117 

remains limited to the current 

requirements (which presently are 

established in current part 110, subparts 

B, C, E, and G and would be reestablished in proposed part 117, 

subpart B under this proposed rule); and 

• Adjust and clarify what activities 

fall within this exemption based on 

experience and changes in related areas 

of the law since issuance of the CGMP 

regulation. 

Proposed § 117.5(k) would provide 

that Subpart B does not apply to 

‘‘farms’’ (as would be defined in 

proposed § 1.227), activities of farm 

mixed-type facilities (as would be 

defined in proposed § 1.227) that fall 

within the definition of ‘‘farm,’’ or the 

holding or transportation of one or more 

‘‘raw agricultural commodities,’’ as 

defined in section 201(r) of the FD&C 

Act. 

Redesignating current § 110.19(a) as 

proposed § 117.5(k) would simplify the 

rule by listing all exemptions in a single 

place. Deleting current § 110.19(b) 

would have no substantive effect, 

because current § 110.19(b) establishes 

no binding requirement on FDA or on 

persons that would be subject to part 

110 and is unnecessary to retain in part 

110. We may issue special regulations if 

it is necessary to do so irrespective of 

whether such a possibility is provided 

for in part 110. Making clear that the 

exemption remains limited to the 

requirements in current part 110 is 

necessary because establishments that 

previously qualified for the RAC 

exemption would be subject to section 

418 of the FD&C Act if they are required 

to register under section 415 of the 

FD&C Act, unless they otherwise qualify 

for an exemption from section 418 (in 

proposed § 117.5(a) through (j)). 

Based on FDA’s experience since 

issuance of the CGMP regulation and 

changes in related areas of the law since 

that time, FDA proposes to modify the 

existing language so that this exemption 

would apply to farms (as would be 

defined in proposed § 1.227), activities 

of farm mixed-type facilities that fall 

within the farm definition, and 

activities related to holding or 

transporting RACs. 

FDA proposes to explicitly apply this 

exemption to ‘‘farms’’ within the 

meaning of that term in proposed 

§ 1.227. In current § 110.19(a), FDA used 

the term ‘‘harvesting’’ to describe one 

type of activity that could qualify for the 

exemption. Current § 110.19(a) and its 

use of the term ‘‘harvesting’’ predated 

the BT Act of 2002, which exempted 

‘‘farms’’ from the new authorities in 

sections 414 and 415 of the FD&C Act. 

As discussed in section VIII.C of this 

document, FDA developed a definition 

of the term ‘‘farm’’ through notice and 

comment rulemaking implementing 

those authorities. Through those 

rulemakings, FDA learned that the terms 

‘‘growing’’ and ‘‘harvesting’’ were not 

enough to capture the scope of the 

activities traditionally done on farms, 

and expanded the farm definition 

accordingly. Further, in this rulemaking, 

FDA is proposing to further clarify the 

scope of the farm definition. FDA 

recognizes today that farms within the 

definition of ‘‘farm’’ in proposed § 1.227 

grow/raise and harvest their own RACs, 

pack and hold their own RACs or any 

food they may consume themselves, 

and/or manufacture food for their own 

consumption. The term ‘‘harvesting’’ in 

current § 110.19(a) is narrower than the 

current farm definition, but FDA 

concludes that the RAC exemption 

should apply to all activities within the 

farm definition and not merely to 

harvesting because other controls (such 

as those in the proposed produce safety 

rule under section 419 of the FD&C Act, 

and the statutory adulteration provision 

for food, section 402 of the FD&C Act) 

are more appropriate to apply to farms 

and their activities than is the CGMP 

regulation, which was developed and 

established for establishments other 

than farms. This is consistent with how 

FDA has interpreted the RAC exemption 

with respect to farms. For example, our 

‘‘Guide to Produce Farm Investigations’’ 

(Ref. 132) advises FDA staff that 

‘‘[f]arming operations, and subsequent 

operations in packing sheds and 

buildings, may not meet all 

requirements outlined in 21 CFR part 

110 or recommendations in the GAP 

Guide (Ref. 133). However these 

documents serve as a useful tool in 

assessing whether raw agricultural 

products are handled under conditions 

that may adulterate the food.’’ Farms 

within the proposed § 1.227 definition 

are also not covered by section 418 of 

the FD&C Act because they do not have 

to register under section 415 of the 

FD&C Act, so they are not covered by 

any of proposed part 117. Activities 

within the farm definition are addressed 

by the adulteration provisions of the 

FD&C Act and the requirements in part 

118 for egg producers (as applicable), 

and will also be addressed (as 

applicable) in the proposed rule to 

establish produce safety standards 

under section 419 of the FD&C Act. 

FDA also proposes to exclude 

activities of farm mixed-type facilities 

that fall within the farm definition in 

proposed § 1.227 from subpart B. See 

sections VIII.C and VIII.E of this 

document for a discussion of the term 

‘‘farm mixed-type facility.’’ FDA 

tentatively concludes that the portion of 

a farm mixed-type facility that is within 

the farm definition should be treated the 

same for the purposes of subpart B as 

are the same activities on farms that 

only conduct activities within the farm 

definition. FDA also proposes to 

exclude activities related to holding or 

transporting RACs, whether or not such 

activities are performed on farms. The 

term ‘‘holding’’ would have the same 

meaning here as in the revisions we are 

proposing to current § 1.227(b)(5). 

Current § 110.19(a) uses the term 

‘‘storage’’ to describe these activities. In 

proposed § 1.227, ‘‘holding’’ is defined 

as ‘‘storage of food’’ for establishments 

other than farms and farm mixed-type 

facilities. The term ‘‘transportation’’ 

would be used instead of the current 

term ‘‘distribution’’ to make clear that 

the scope of the activities exempted by 

that term is limited to movement of 

RACs in commerce by a motor vehicle 

or rail vehicle, and does not extend to 

other activities, such as packing, that 

might be considered to be part of the 

broader term ‘‘distribution.’’ Entities 

that would be entirely exempted by 

these terms in the proposed revised 

provision would include warehouses, 

silos, or other entities that only store 

RACs and transporters that only handle 

RACs. Because section 418 of the FD&C 

Act applies to any facility that is 

required to register under section 415 

unless an exemption from section 418 

applies, it is a separate question 

whether these entities would be subject 

to subpart C. Many of the 

establishments that are exempted from 

subpart B by this proposed provision are 

also likely to be exempt from subpart C 

or subject to modified requirements 

under section 418 of the FD&C Act, 

either because they do not have to 

register under section 415 (e.g., common 

carriers), or they qualify for an 

exemption or modified requirements 

under section 418 (e.g., modified 

requirements for certain warehouses 

under proposed § 117.7, exemption for 

small or very small businesses 

performing only on-farm low-risk 

activity/food combinations under 

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proposed § 117.5(g) and (h), exemption 

for facilities that are solely engaged in 

the storage of raw agricultural 

commodities (other than fruits and 

vegetables) intended for further 

distribution or processing under 

proposed § 117.5(j)). 

By removing the term ‘‘distribution’’ 

from current § 110.19(a), FDA proposes 

to exclude packing of RACs that does 

not fall within the farm definition from 

the revised exemption, i.e., to subject 

packing of RACs to the requirements of 

subpart B. As discussed in section II.A.1 

of this document, the CGMP working 

group recommended that the agency 

consider removing the RAC exclusion 

entirely, and recommended that the 

agency request further comments on the 

appropriate application of CGMP 

controls to raw agricultural product 

harvesting, packing, storage and 

distribution (Ref. 1). These concerns 

were based on investigations of 

outbreaks linked to fresh produce that 

had ‘‘identified contamination during 

production and harvest, initial 

processing and packing, distribution, 

and final processing as the likely source 

of product contamination.’’ (Ref. 1). 

Since issuance of the CGMP working 

group report, FDA has continued to 

investigate foodborne illness outbreaks 

and contamination events associated 

with fresh produce and other RACs, and 

continues to be concerned about 

sanitation practices at establishments 

that pack RACs. Packing of RACs has 

been implicated as a likely source of 

contamination in multi-state foodborne 

illness outbreaks associated with RACs 

(Ref. 134) (Ref. 135) (Ref. 136). 

Accordingly, FDA tentatively 

concludes that packing of RACs should 

be subject to the CGMP requirements in 

proposed subpart B, but that the other 

activities discussed above for RACs are 

sufficiently addressed, or will be 

addressed, by FDA in other ways. We 

seek comment on this proposal. 

Growing/raising and harvesting of 

RACs, and all activities within the farm 

definition, such as on-farm packing and 

holding of a farm’s own RACs, will 

continue to be addressed through the 

statutory adulteration provisions in the 

FD&C Act, the requirements of part 118 

for egg producers (as applicable), and 

the proposed rule to establish produce 

safety standards (as applicable) under 

section 419 of the FD&C Act. FDA 

tentatively concludes that it is 

appropriate to address food safety on 

farms in this fashion, rather than by 

requiring farms to comply with subpart 

B. Manufacturing/processing steps 

conducted on RACs are already subject 

to the current CGMP regulation and will 

continue to be subject to the 

requirements of subpart B, which 

applies to manufacturing/processing, 

including when such activities are 

performed on RACs. This includes 

manufacturing/processing steps that 

may occur at establishments that are 

commonly known as ‘‘packinghouses,’’ 

such as washing and treating fruits and 

vegetables. ‘‘Distribution’’ is a term that 

might include activities such as 

transportation and packing (including 

re-packing). For clarity, we now discuss 

those two steps separately. 

Transportation of non-RACs is subject to 

the CGMP requirements in current 

§ 110.93, and FDA further expects to 

address transportation of food in more 

detail in rulemaking to implement the 

Sanitary Food Transportation Act of 

2005 (Pub. L. 109–59) and section 416 

of the FD&C Act (75 FR 22713, April 30, 

2010). Section 416(b) of the FD&C Act 

requires FDA to promulgate regulations 

to ‘‘require shippers, carriers by motor 

vehicle or rail vehicle, receivers, and 

other persons engaged in the 

transportation of food to use sanitary 

transportation practices prescribed by 

the Secretary to ensure that food is not 

transported under conditions that may 

render the food adulterated.’’ In 

addition, FDA is not currently aware of 

foodborne illness outbreaks related to 

RACs that were likely to have been 

caused by insanitary conditions during 

transportation conditions. This leaves 

only packing as a step of concern that 

is not being sufficiently addressed, 

either through application of the CGMP 

requirements or in another way. 

Therefore, FDA tentatively concludes 

that packing of RACs that does not fall 

within the farm definition should be 

subject to the requirements in proposed 

subpart B. We request comment on this 

conclusion and on whether there any 

aspects of proposed subpart B that 

should not apply to the packing of 

RACs. 

Because the current exemption in 

§ 110.19(a) is limited to ‘‘establishments 

engaged solely in’’ the listed activities, 

it does not exempt establishments that 

conduct any activities relating to food 

for human consumption other than the 

specifically identified activities for 

RACs. FDA tentatively concludes that it 

would be reasonable to revise the 

exemption so that it would exempt the 

specifically identified activities when 

performed on RACs, regardless of 

whether the establishment that conducts 

those activities also conducts other 

activities that do not qualify for the 

exemption. This is because, as in the 

section 418(j)(1) exemptions discussed 

in sections X.C.2 and X.C.3 of this 

document (for activities covered by 

parts 120, 123, and 113), it is more 

appropriate to subject these activities to 

controls other than those in proposed 

subpart B, and these activities should be 

regulated in the same way whether or 

not other activities subject to proposed 

subpart B take place at the same 

establishment. If activities subject to 

proposed subpart B do take place at the 

same establishment, compliance with 

proposed subpart B with respect to 

those activities should provide the 

necessary protection for food subject to 

those activities regardless of whether 

RACs are also stored or transported by 

the same establishment, or if activities 

inside the farm definition are conducted 

at the same establishment. 

FDA also proposes to delete ‘‘which 

are ordinarily cleaned, prepared, 

treated, or otherwise processed before 

being marketed to the consuming 

public’’ from the current exemption. 

While this phrase captured FDA’s 

original reasoning for providing the 

RAC exemption, it is confusing because 

many RACs are not so processed (as is 

often the case for fresh produce, for 

example) and the operative part of the 

exemption is that it applies to RACs, not 

only some RACs depending on whether 

they receive later manipulation. 

D. Proposed § 117. 7—Applicability of 

Part 117 to a Facility Solely Engaged in 

the Storage of Packaged Food That Is 

Not Exposed to the Environment 

1. Requirements of Section 418 of the 

FD&C Act 

Section 418(m) of the FD&C Act 

provides, in relevant part, that ‘‘[t]he 

Secretary may, by regulation, exempt or 

modify the requirements for compliance 

under [section 418 of the FD&C Act] 

with respect to facilities that are solely 

engaged in * * * the storage of 

packaged foods that are not exposed to 

the environment.’’ 

2. Petition Relevant to Section 418(m) of 

the FD&C Act 

In a letter dated July 22, 2011, an 

industry coalition of the American 

Bakers Association, the American 

Frozen Food Institute, the Grocery 

Manufacturers Association, the 

International Bottled Water Association, 

the International Dairy Foods 

Association, the International 

Warehouse Logistics Association, the 

Peanut and Tree Nut Processors 

Association, and the Snack Food 

Association (the section 418(m) 

petitioners) submitted a citizen petition 

(Docket No. FDA–2011–P–0561). The 

petition requests that FDA promulgate 

regulations under section 418(m) of the 

FD&C Act ‘‘to exempt from compliance 

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3712 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

or modify the requirements for 

compliance under section 418 [of the 

FD&C Act] for facilities that are solely 

engaged in the storage of packaged foods 

that are not exposed to the environment, 

by allowing such facilities to satisfy the 

requirements of that section through 

compliance with the [CGMPs] mandated 

for such facilities by [current] § 110.93.’’ 

The section 418(m) petitioners assert 

that the food safety issues presented by 

facilities used only to store packaged 

foods that are not exposed to the 

environment are essentially the same, 

regardless of the type of food. As such, 

trade associations representing a variety 

of product sectors are signatories to the 

petition and are supportive of the 

request to exempt such facilities from 

the provisions of section 418 of the 

FD&C Act. In the remainder of this 

document, we refer to packaged food 

not exposed to the environment as 

‘‘unexposed packaged food.’’ We 

consider ‘‘not exposed to the 

environment’’ and ‘‘unexposed’’ to 

mean that the food is in a form that 

prevents any direct human contact with 

the food. 

The section 418(m) petitioners state 

that most of the potential hazards and 

preventive controls noted in section 418 

of the FD&C Act are not relevant to 

facilities solely engaged in the storage of 

unexposed packaged foods and that the 

foods handled in these facilities would 

have already been subjected to hazard 

analyses and preventive controls 

(including CGMPs) throughout the 

process of their manufacture and 

packaging for delivery to retailers and 

end-users. They further state that most 

of the preventive control activities 

carried out in food production settings 

(such as sanitation of food-contact 

surfaces and utensils) offer no benefit 

for a facility storing unexposed 

packaged foods and that controls such 

as supplier verification and recall plans 

would be addressed by the 

manufacturing facility from which the 

foods originated. 

The section 418(m) petitioners state 

that the ‘‘few hazards’’ that may arise in 

facilities solely engaged in the storage of 

unexposed packaged foods, ‘‘including 

those relating to environmental, climate, 

and pest controls, are already addressed 

under FDA’s existing CGMPs governing 

warehousing and distribution [in 

current § 110.93].’’ They state that 

storage facilities themselves pose ‘‘a 

very limited, if any, food-safety risk’’ 

and that they are not aware of any 

significant foodborne illness outbreaks 

attributable to storage at such facilities. 

The section 418(m) petitioners note 

that many packaged food warehouses 

contain a variety of foods that can come 

from many different manufacturing 

facilities or even different companies. 

According to the petitioners, warehouse 

operators work closely with the food 

manufacturers to understand the 

conditions and controls that need to be 

utilized to ensure the quality of the 

foods they store and distribute and, in 

many cases, those conditions and 

controls are formalized in written 

contracts. 

The section 418(m) petitioners assert 

that the warehouse operators themselves 

do not have access to product 

formulations and other relevant 

information that would be necessary for 

them to conduct a hazard analysis, 

develop preventive controls, and 

monitor them. They state that the food 

manufacturer, on the other hand, does 

understand the products it produces 

and factors in the storage and 

distribution parameters and 

considerations into the hazard analysis 

and appropriately instructs the 

warehouses to ensure unexposed 

packaged foods are being properly 

stored. The section 418(m) petitioners 

thus assert that responsibility for hazard 

analysis and risk-based preventive 

controls under section 418 of the FD&C 

Act is properly and best shouldered by 

the food manufacturer. 

The section 418(m) petitioners 

propose that FDA use the following 

language as part of its regulations 

implementing section 418 of the FD&C 

Act: ‘‘A facility that is engaged solely in 

the storage, holding, warehousing, or 

distribution of packaged foods that are 

not exposed to the environment shall be 

exempt from the requirements of section 

418 of the Federal Food, Drug, and 

Cosmetic Act if the facility complies 

with the requirements set forth at 21 

CFR 110.93.’’ 

FDA notes that petitioners also make 

arguments for their position relevant to 

‘‘hazards that may be intentionally 

introduced, including by acts of 

terrorism,’’ as described in § 418(b)(2). 

As discussed in sections II.B.2.f and 

XII.B.1, those hazards will be addressed 

in a future rulemaking so FDA is not 

addressing that aspect of the petition in 

this proposal. 

3. FDA’s Tentative Response to the 

Petition 

We tentatively agree in part, and 

disagree in part, with the section 418(m) 

petitioners. As discussed more fully 

below, we agree it is appropriate for 

facilities solely engaged in the storage of 

unexposed packaged food to be exempt 

from the requirements that would be 

established in proposed subpart C, 

provided that the food does not require 

time/temperature control for safety. For 

unexposed packaged food that requires 

time/temperature control for safety, we 

disagree that such an exemption is 

warranted, but tentatively conclude that 

unexposed packaged food that requires 

time/temperature control for safety 

could be subject to modified 

requirements rather than to the full 

requirements that would be established 

in proposed subpart C. 

We disagree that warehouse operators 

do not have access to information 

relevant to conducting a hazard analysis 

and establishing risk-based preventive 

controls. The principal hazard that 

would be identified in any hazard 

analysis for unexposed packaged food is 

the potential for the growth of, or toxin 

formation by, microorganisms of public 

health significance when an unexposed 

refrigerated packaged food requires 

time/temperature control for safety. 

Information about this hazard and 

appropriate preventive controls for this 

hazard is widely available (Ref. 137) 

(Ref. 138) (Ref. 139) (Ref. 140). For 

example, the 2009 Edition of FDA’s 

Food Code defines ‘‘Potentially 

Hazardous Food (Time/Temperature 

Control for Safety Food)’’ as a food that 

requires time/temperature control for 

safety to limit pathogenic 

microorganism growth or toxin 

formation (Ref. 137). Earlier editions 

(e.g., the 2001 Food Code) included a 

similar definition for ‘‘potentially 

hazardous food’’; since 2005, the 

definition jointly refers to ‘‘potentially 

hazardous food’’ and ‘‘time/temperature 

control for safety food’’ (commonly 

referred to as TCS food) to emphasize 

the importance of temperature control 

in keeping food safe. Although we 

disagree that warehouse operators do 

not have access to information relevant 

to conducting a hazard analysis and 

establishing risk-based preventive 

controls, we agree that it is not 

necessary for each facility solely 

engaged in the storage of unexposed 

packaged food to conduct its own 

hazard analysis to identify this hazard 

for unexposed refrigerated packaged 

food as reasonably likely to occur and 

for each such facility to determine that 

time/temperature control is the 

appropriate preventive control. 

We also disagree that current § 110.93 

alone is adequate for addressing 

environmental problems such as a flood 

in the facility and pest control 

problems, even though the food in 

question is not exposed to the 

environment and pest control problems 

with the container would likely be 

visible to the warehouse operator. 

However, we tentatively conclude that 

proposed § 117.93, along with other 

applicable provisions of proposed part 

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117, subpart B, such as pest control in 

proposed § 117.35, do adequately 

address most safety-related issues that 

may arise in facilities solely engaged in 

the storage of unexposed packaged food. 

We disagree that current § 110.93 or 

other provisions in proposed part 117, 

subpart B justifies the exemption from 

all preventive control requirements 

sought by the petitioners in the specific 

case of unexposed refrigerated packaged 

food that requires time/temperature 

control for safety (hereinafter unexposed 

refrigerated packaged TCS food). As 

discussed more fully in section XIII.B of 

this document, such food requires the 

implementation of an appropriate 

preventive control (temperature), 

monitoring that control, taking 

corrective actions when there is a 

problem with that control, verifying that 

the control is consistently implemented, 

and establishing and maintaining 

records documenting the monitoring, 

corrective actions, and verification. FDA 

tentatively concludes that it is 

appropriate for our response to the 

petition to distinguish between 

packaged food that requires such time/ 

temperature control and packaged food 

that does not. 

We also disagree that an exemption 

provided under section 418(m) of the 

FD&C Act should be established in a 

manner that has the potential to be 

interpreted more broadly than section 

418(m) provides. The section 418(m) 

petitioners request that we establish a 

provision that ‘‘A facility that is engaged 

solely in the storage, holding, 

warehousing, or distribution of 

packaged foods that are not exposed to 

the environment shall be exempt from 

the requirements of section 418 [of the 

FD&C Act]’’, whereas section 418(m) 

provides discretion for an exemption 

‘‘with respect to facilities that are solely 

engaged in * * * the storage of 

packaged foods that are not exposed to 

the environment.’’ Under proposed 

§ 117.3, ‘‘holding’’ would mean storage 

of food and holding facilities would 

include, relevant to unexposed 

packaged food, warehouses and cold 

storage facilities. To the extent that a 

facility that is engaged solely in 

‘‘warehousing’’ or ‘‘distribution’’ of 

unexposed packaged food is merely 

‘‘storing’’ or ‘‘holding’’ the food, an 

exemption established using the 

language provided by section 418(m) 

would apply to that facility. However, to 

the extent that a facility that is engaged 

solely in ‘‘warehousing’’ or 

‘‘distribution’’ of unexposed packaged 

food is not merely ‘‘storing’’ or 

‘‘holding’’ the food, an exemption 

established using the language provided 

by section 418(m) would not apply to 

that facility. 

In response to the petition, FDA is 

proposing to establish an exemption 

from subpart C for facilities solely 

engaged in the storage of unexposed 

packaged food (proposed § 117.7). FDA 

also is proposing to establish modified 

requirements at such facilities to require 

that the owner, operator, or agent in 

charge of such a facility comply with 

modified requirements for any 

unexposed refrigerated packaged TCS 

food (proposed § 117.206). See the 

discussion of proposed § 117.7 in the 

next section of this document and the 

discussion of proposed § 117.206 in 

section XIII.B of this document. 

4. Proposed § 117.7—Applicability of 

Part 117 to a Facility Solely Engaged in 

the Storage of Packaged Food That Is 

Not Exposed to the Environment 

Proposed § 117.7(a) would provide 

that subpart C does not apply to a 

facility solely engaged in the storage of 

packaged food that is not exposed to the 

environment. Proposed § 117.7(b) would 

establish that unexposed packaged food 

at such facilities is subject to modified 

requirements that would be established 

in proposed § 117.206. As discussed 

more fully in section XIII.B of this 

document, the modified requirements 

would mandate that such a facility 

establish and implement appropriate 

temperature controls, monitor the 

temperature controls, take corrective 

actions, verify that the temperature 

controls are consistently implemented, 

and establish and maintain records 

documenting the monitoring, corrective 

actions, and verification activities for 

unexposed refrigerated packaged TCS 

food. These modified requirements 

would be a subset of the proposed 

requirements that would be established 

in subpart C. 

There are limited routes of 

contamination for unexposed packaged 

food in a facility that solely stores 

unexposed packaged food (e.g., 

packaged food in containers in a 

warehouse). Contamination can occur, 

for example, if rodents gnaw through 

packages or if human waste from an 

improperly maintained toilet facility 

spills and seeps into paper-based 

packaging. However, with one 

exception, the CGMP requirements in 

proposed part 117, subpart B (e.g., 

proposed §§ 117.20, 117.35, 117.37, and 

117.93) would apply to the storage of 

unexposed packaged food and be 

adequate to prevent such contamination 

so that it would not be necessary for the 

owner, operator, or agent in charge of a 

facility to address these routes of 

contamination by applying the hazard 

analysis and risk-based preventive 

controls that would be established in 

proposed subpart C. The exception 

would be for the rare circumstance in 

which RACs are packaged in a manner 

in which the RACs are not exposed to 

the environment. Under current 

§ 110.19(a), an establishment solely 

engaged in storing RACs is exempt from 

CGMPs in current part 110; under 

proposed § 117.5(k), such an 

establishment would continue to be 

exempt from CGMPs. Such an 

establishment is now, and would 

continue to be, subject to section 

402(a)(4) of the FD&C Act. An 

establishment that is solely engaged in 

the storage of packaged RACs that are 

not exposed to the environment may 

find the provisions of proposed subpart 

B helpful in ensuring compliance with 

section 402(a)(4) of the FD&C Act. 

Many of the requirements that would 

be established in proposed subpart C 

would be directed to manufacturing, 

processing, and packing food and would 

not apply to the storage of unexposed 

packaged food that does not require 

time/temperature control for safety. This 

is the case for: 

• Process controls (proposed 

§ 117.135(d)(1)); 

• Food allergen controls (proposed 

§ 117.135(d)(2)); 

• Sanitation controls (proposed 

§ 117.135(d)(3)); 

• Monitoring of process controls, food 

allergen controls, and sanitation 

controls (proposed § 117.140); 

• Corrective actions (proposed 

§ 117.145); 

• Verification (including initial 

validation) of process controls 

(proposed § 117.150); and 

• A recall plan (proposed § 117.137) 

(recalls generally are initiated by the 

manufacturer, processor, or packer of 

the food). 

FDA tentatively concludes that the 

outcome of a hazard analysis for storage 

of unexposed packaged food that does 

not require time/temperature control for 

safety is that there are no hazards 

reasonably likely to occur. We also 

tentatively conclude that there would be 

little public health benefit to requiring 

the owner, operator, or agent in charge 

of each facility solely engaged in the 

storage of such food to conduct its own 

hazard analysis and document that 

outcome in its own food safety plan. 

Likewise, we tentatively conclude that 

there would be no need for the facility 

to establish and implement preventive 

controls, with corresponding 

monitoring, corrective actions, or 

verification (including validation), 

because there would be no hazards 

reasonably likely to occur to trigger such 

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activities. We also tentatively conclude 

that there would be no need for a 

qualified individual to conduct 

activities such as preparing the food 

safety plan (proposed § 117.126(c)); 

developing the hazard analysis 

(proposed § 117.130(a)(3)); validating 

the preventive controls (proposed 

§ 117.150(a)(1)); reviewing records for 

implementation and effectiveness of 

preventive controls and appropriateness 

of corrective actions (proposed 

§ 117.150(d)(2)); or performing 

reanalysis of the food safety plan 

(proposed § 117.150(e)(1)(iv)), because 

the facility would not need to conduct 

these activities. Thus, with the 

exception of the unexposed refrigerated 

packaged TCS food, we tentatively 

conclude that the food safety system 

that would be established in proposed 

subpart C is not needed to significantly 

minimize or prevent the occurrence of 

hazards that could affect unexposed 

packaged food at a facility solely 

engaged in the storage of such food. 

The purpose of proposed § 117.7(b) is 

to make clear that although a facility 

solely engaged in the storage of 

unexposed packaged food is exempt 

from subpart C, such a facility is subject 

to modified requirements that would be 

established in proposed § 117.206. 

These requirements would apply to the 

storage of unexposed refrigerated 

packaged TCS food. We explain the 

basis for those proposed requirements in 

section XIII.B of this document. 

XI. Proposed Revisions to Current Good 

Manufacturing Practice Requirements 

of Part 110 (Proposed Part 117, Subpart 

B) 

A. Proposed Deletion of Guidance From 

Current Part 110 

As discussed in section IX.F of this 

document, FDA is proposing a number 

of revisions to delete some guidance 

currently established in part 110 (e.g., 

provisions using ‘‘should’’ or 

‘‘compliance may be achieved by’’). 

Table 8 identifies each of the proposed 

deletions and either explains the 

deletion or, for deletions with longer 

explanations, refers to the section of the 

preamble where the deletion is 

explained. 

TABLE 8—PROPOSED DELETION OF GUIDANCE CURRENTLY ESTABLISHED IN PART 110 

Current designation of provision that includes guidance Guidance that FDA is proposing to delete Explanation 

§ 110.10(b)(5) (Cleanliness) Gloves should be of an impermeable material ............... We considered the diversity of food that is manufactured, processed, packed or held and would be subject to the requirements of proposed part 117. The 

use of an impermeable material may be important for 

handling a ready-to-eat food but may not be required 

for handling a food that will receive a validated heat 

treatment. Thus, we tentatively conclude that it would 

not be appropriate to require that gloves used for the 

handling of all foods be made of an impermeable 

material and that a discussion of gloves would be 

more appropriate in a guidance document, which 

could describe factors to consider in selecting and 

using gloves in the production of food. 

§ 110.35(b)(2) (Substances 

used in cleaning and sanitizing).

Follow all relevant regulations promulgated by other 

Federal, State, and local government agencies for 

the application, use, or holding of toxic cleaning compounds, sanitizing agents, and pesticide chemicals.

Although such a recommendation may be helpful and 

could be included in future guidance, FDA tentatively 

concludes that it is more properly addressed by the 

applicable Federal, State, and local government 

agencies and is outside the scope of proposed part 

117. 

§ 110.37(d) (Toilet facilities) Compliance with the requirements for toilet facilities 

may be accomplished by four specified mechanisms.

See explanation in section XI.H.2 of this document. 

§ 110.37(e) (Hand-washing 

facilities).

Compliance with the requirements for hand-washing facilities may be accomplished by six specified mechanisms.See explanation in section XI.H.3 of this document. 

§ 110.40(e) (Equipment and 

utensils).

Each freezer and cold storage compartment used to 

store and hold food capable of supporting growth of 

microorganisms should be fitted with an automatic 

control for regulating temperature or with an automatic alarm system to indicate a significant temperature change in a manual operation.

It is now very common for freezer and cold storage 

compartments to be fitted with an automatic control 

for regulating temperature. Thus, we tentatively conclude that it is not necessary to revise current 

§ 110.40(e) to require, rather than recommend, use 

of an automatic control for regulating temperature or 

an automatic alarm system, because the design of 

modern freezer and cold storage compartments has 

established this approach without the need for a Federal requirement. 

§ 110.80(a)(2) (Processes 

and controls—raw materials and ingredients).

Compliance with the requirements for the safety of raw 

materials and ingredients may be achieved by purchasing raw materials and ingredients under a supplier’s guarantee or certification.

We tentatively conclude that there are more mechanisms for achieving compliance than the single 

mechanism identified in current § 110.80(a)(2)—e.g., 

in some cases, compliance could be achieved by 

testing raw materials and ingredients. Rather than 

propose to require a subset of mechanisms to 

achieve compliance, FDA tentatively concludes that 

these recommendations would be more appropriate 

in a guidance document. 

§ 110.80(a)(3) (Processes 

and controls—raw materials and ingredients).

Compliance with action levels for poisonous or deleterious substances before these materials or ingredients are incorporated into finished food.See explanation in section XI.J.2 of this document. 

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TABLE 8—PROPOSED DELETION OF GUIDANCE CURRENTLY ESTABLISHED IN PART 110—Continued 

Current designation of provision that includes guidance Guidance that FDA is proposing to delete Explanation 

§ 110.80(a)(3) (Processes 

and controls—raw materials and ingredients).

Compliance with the requirement for raw materials and 

other ingredients susceptible to contamination with 

aflatoxin or other natural toxins to comply with current FDA regulations for poisonous or deleterious 

substances before these materials or ingredients are 

incorporated into finished food may be accomplished 

by purchasing raw materials and other ingredients 

under a supplier’s guarantee or certification, or may 

be verified by analyzing these materials and ingredients for aflatoxins and other natural toxins.

We tentatively conclude that there may be more mechanisms for achieving compliance than those mechanisms identified in current § 110.80(a)(3). Rather than 

propose to require a subset of mechanisms to 

achieve compliance, FDA tentatively concludes that 

these recommendations would be more appropriate 

in a guidance document. 

§ 110.80(a)(4) (Processes 

and controls—raw materials and ingredients).

Raw materials, other ingredients, and rework susceptible to contamination with pests, undesirable microorganisms, or extraneous material must comply with 

applicable FDA defect action levels for natural or unavoidable defects if a manufacturer wishes to use the 

materials in manufacturing food.

See explanation in section XI.J.2 of this document. 

§ 110.80(a)(4) (Processes 

and controls—raw materials and ingredients).

The requirement for raw materials, other ingredients, 

and rework susceptible to contamination with pests, 

undesirable microorganisms, or extraneous material 

to comply with applicable FDA regulations for natural 

or unavoidable defects if a manufacturer wishes to 

use the materials in manufacturing food may be 

verified by any effective means, including purchasing 

the materials under a supplier’s guarantee or certification, or examination of these materials for contamination.

We tentatively conclude that there may be more mechanisms for achieving compliance than those mechanisms identified in current § 110.80(a)(4). Rather than 

propose to require a subset of mechanisms to 

achieve compliance, FDA tentatively concludes that 

these recommendations would be more appropriate 

in a guidance document. 

§ 110.80(b)(2) (Manufacturing operations).One way to comply with the requirement for all food 

manufacturing, including packaging and storage, to 

be conducted under such conditions and controls as 

are necessary to minimize the potential for the 

growth of microorganisms, or for the contamination of 

food is careful monitoring of physical factors such as 

time, temperature, humidity, water activity, pH, pressure, flow rate, and manufacturing operations such 

as freezing, dehydration, heat processing, acidification, and refrigeration to ensure that mechanical 

breakdowns, time delays, temperature fluctuations, 

and other factors do not contribute to the decomposition or contamination of food.

We considered the diversity of food that is manufactured, processed, packed or held and would be subject to the requirements of proposed part 117 and the 

physical factors and manufacturing operations that 

could be monitored to minimize the growth of microorganisms. FDA tentatively concludes that this diversity does not make it appropriate to propose establishing these specific recommendations as requirements and that these recommendations would be 

more appropriate in a guidance document. 

§ 110.80(b)(3) (Manufacturing operations).Compliance with the requirement for food that can support the rapid growth of undesirable microorganisms 

to be held in a manner that prevents the food from 

becoming adulterated within the meaning of the 

FD&C Act may be accomplished by any effective 

means, including maintaining refrigerated foods at 

45°F (7.2°C) or below as appropriate for the particular food involved, maintaining frozen foods in a 

frozen state, maintaining hot foods at 140°F (60°C) 

or above, and heat treating acid or acidified foods.

We considered the diversity of food that is manufactured, processed, packed or held and would be subject to the requirements of proposed part 117, as well 

as the temperatures that are needed for the safe 

holding of foods. FDA tentatively concludes that this 

diversity does not make it appropriate to propose to 

establish these specific recommendations as requirements and that these recommendations would be 

more appropriate in a guidance document. In addition, we note that current § 110.80(b)(3)(iv) provides 

for heat treating acid or acidified foods to destroy 

mesophilic microorganisms when those foods are to 

be held in hermetically sealed containers at ambient 

temperatures. However, current § 110.80(b)(4) addresses measures, including heat treating, taken to 

destroy or prevent the growth of undesirable microorganisms. We tentatively conclude that proposing to 

revise current § 110.80(b)(3)(iv) would create a redundancy with current § 110.80(b)(4). 

§ 110.80(b)(8) (Manufacturing operations).Compliance with the requirement for effective measures 

to be taken to protect against the inclusion of metal 

or other extraneous material in food be accomplished 

by using sieves, traps, magnets, electronic metal detectors, or other suitable effective means.

We considered the diversity of food that is manufactured, processed, packed or held and would be subject to the requirements of proposed part 117 and the 

methods that could be used to protect against the inclusion of metal or other extraneous material in food. 

FDA tentatively concludes that it would not be appropriate to establish such specific recommendations as 

requirements and that such recommendations would 

be more appropriate in a guidance document. 

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TABLE 8—PROPOSED DELETION OF GUIDANCE CURRENTLY ESTABLISHED IN PART 110—Continued 

Current designation of provision that includes guidance Guidance that FDA is proposing to delete Explanation 

§ 110.80(b)(10) (Manufacturing operations).Protection may be provided during manufacturing steps 

such as washing, peeling, trimming, cutting, sorting 

and inspecting, mashing, dewatering, cooling, shredding, extruding, drying, whipping, defatting, and forming by adequate cleaning and sanitizing of all foodcontact surfaces.

We considered that the cleaning and sanitizing of foodcontact surfaces would already be addressed in proposed § 117.35(d), which would require that all foodcontact surfaces, including utensils and food-contact 

surfaces of equipment, be cleaned as frequently as 

necessary to protect against cross-contact and contamination of food, and in proposed § 117.80(c)(1), 

which would require, in relevant part, that equipment 

and utensils be maintained in an acceptable condition through appropriate cleaning and sanitizing, as 

necessary. 

§ 110.80(b)(10) (Manufacturing operations).Protection may be provided during manufacturing steps 

such as washing, peeling, trimming, cutting, sorting 

and inspecting, mashing, dewatering, cooling, shredding, extruding, drying, whipping, defatting, and forming by using time and temperature controls at and 

between each manufacturing step.

We considered the diversity of food that is manufactured, processed, packed or held and would be subject to the requirements of proposed part 117 and 

that use of time and temperature controls at and between each manufacturing step may not be required 

for all foods. For example, the use of time and temperature controls would not be necessary for shelfstable foods used as ingredients in another product. 

FDA tentatively concludes that this recommendation 

would be more appropriate in a guidance document. 

§ 110.80(b)(12) (Manufacturing operations).Recommendations for how to comply with requirements 

for batters, breading, sauces, gravies, dressings, and 

other similar preparations to be treated or maintained 

in such a manner that they are protected against 

contamination.

Recommendations to comply by using ingredients free 

of contamination, employing adequate heat processes where applicable, and providing adequate 

physical protection of components from contaminants 

that may drip, drain, or be drawn into them, would already be addressed in proposed §§ 117.80(b)(2), 

117.80(c)(2), 117.80(c)(4) and 117.80(c)(10), respectively. As discussed regarding our proposed revisions 

to current § 110.80(b)(10) earlier in this section, FDA 

tentatively concludes that establishing requirements 

for time and temperature controls is not appropriate 

in light of the diversity of food operations. The remaining recommendations regarding cooling batters 

to an adequate temperature and disposing of batters 

at appropriate intervals are better addressed in guidance. Therefore, FDA is proposing to provide flexibility to industry by retaining the performance standard in current § 110.80(b)(12) (i.e., protection against 

contamination) but deleting the examples of mechanisms to achieve compliance rather than proposing to 

establish these recommendations as requirements. 

§ 110.80(b)(13) (Manufacturing operations).Compliance with the requirement for filling, assembling, 

packaging, and other operations to be performed in 

such a way that the food is protected against contamination may be accomplished by any effective 

means, including (i) use of a quality control operation 

in which the critical control points are identified and 

controlled during manufacturing; (ii) adequate cleaning and sanitizing of all food-contact surfaces and 

food containers; (iii) using materials for food containers and food- packaging materials that are safe 

and suitable, as defined in § 130.3(d); (iv) providing 

physical protection from contamination, particularly 

airborne contamination; and (v) using sanitary handling procedures.

FDA is proposing to provide flexibility to industry by retaining the performance standard in current 

§ 110.80(b)(12) (i.e., protection against contamination) but deleting the examples of mechanisms to 

achieve compliance. FDA tentatively concludes that 

such examples would be more appropriate in a guidance document. 

§ 110.80(b)(14) (Manufacturing operations).Mechanisms for compliance with the requirement for 

food (such as dry mixes, nuts, intermediate moisture 

food, and dehydrated food) that relies on the control 

of water activity for preventing the growth of undesirable microorganisms to be processed to and maintained at a safe moisture level.

We considered that the listed mechanisms are not the 

only possible mechanisms for achieving compliance. 

FDA tentatively concludes that it would not be appropriate to establish these recommendations as requirements and that such recommendations would be 

more appropriate in a guidance document. 

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TABLE 8—PROPOSED DELETION OF GUIDANCE CURRENTLY ESTABLISHED IN PART 110—Continued 

Current designation of provision that includes guidance Guidance that FDA is proposing to delete Explanation 

§ 110.80(b)(15) (Manufacturing operations).Compliance with the requirement for food (such as acid 

and acidified food) that relies principally on the control of pH for preventing the growth of undesirable 

microorganisms to be monitored and maintained at a 

pH of 4.6 or below may be accomplished by any effective means, including employment of one or more 

of the following practices: (i) monitoring the pH of raw 

materials, food in process, and finished food and (ii) 

controlling the amount of acid or acidified food added 

to low-acid food.

We considered that the listed mechanisms are not the 

only possible mechanisms for achieving compliance. 

FDA tentatively concludes that it would not be appropriate to establish these recommendations as requirements and that such recommendations would be 

more appropriate in a guidance document. 

§ 110.80(b)(17) (Processes 

and controls—manufacturing operations).

Food-manufacturing areas and equipment used for 

manufacturing human food should not be used to 

manufacture nonhuman food-grade animal feed or inedible products, unless there is no reasonable possibility for the contamination of the human food.

FDA tentatively concludes that this recommendation 

would be more appropriate in a guidance document, 

which could include examples of situations where 

there is no reasonable possibility for the contamination of the human food. 

§ 110.110(e) ......................... Information that a compilation of the current defect action levels for natural or unavoidable defects in food 

for human use that present no health hazard may be 

obtained upon request from the Center for Food 

Safety and Applied Nutrition (HFS–565), Food and 

Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740.

The organizational entity identified in current 

§ 110.110(e) (i.e., HFS–565) no longer exists and 

FDA no longer has printed copies of the compilation 

of defect action levels. An electronic compilation of 

such current defect action levels is available on the 

internet (Ref. 141). 

B. Other Potential Revisions to Current 

Guidance 

As discussed in sections IX.F and 

XI.A of this document, FDA is 

proposing a number of revisions to 

delete some guidance currently 

established in part 110 (e.g., provisions 

using ‘‘should’’ or ‘‘compliance may be 

achieved by’’). In section XI.M of this 

document, FDA requests comment on 

whether to revise other non-binding 

provisions to establish new 

requirements in proposed part 117 or 

retain them as useful recommended 

provisions of a comprehensive CGMP 

provision. 

C. Proposed Revisions for Consistency of 

Terms 

As discussed in section IX.C of this 

document, FDA is proposing revisions 

to use terms consistently throughout 

proposed part 117. Table 9 identifies 

and explains each of these proposed 

revisions. Because other revisions also 

may be proposed for certain sections 

included in Table 9 (e.g., if FDA also is 

proposing a revision to address crosscontact), Table 9 does not state the 

proposed requirement and instead refers 

to the section of this document 

containing the complete proposed 

requirement, including all proposed 

revisions 

TABLE 9—PROPOSED REVISIONS FOR CONSISTENCY OF TERMS

Current designation Proposed revision and explanation 

§ 110.20(b) (Plant Construction and Design).(1) Replace the phrase ‘‘food-manufacturing purposes’’ with the phrase ‘‘food-production purposes 

(i.e., manufacturing, processing, packing, and holding) to consistently use the same group of 

terms in proposed part 117. 

(2) Replace the phrase ‘‘plant and facilities’’ with the single term ‘‘plant’’ as would be defined in proposed § 117.3. The requirement would be clear using the single term ‘‘plant’’ and, thus, the term 

‘‘facilities’’ is unnecessary. In addition, under proposed § 117.3 (Definitions) the term ‘‘facilities’’ 

would be based on the definition in section 418(o)(2) of the FD&C Act, which is not how the term 

is used in current § 110.20(b). 

See section XI.F for the proposed requirement. 

§ 110.20(b)(4) (Plant Construction and Design).(3) Add ‘‘food-packaging materials’’ to the requirement that aisles or working spaces be provided 

between equipment and walls and be adequately unobstructed and of adequate width to permit 

employees to perform their duties and to protect against contaminating food or food-contact surfaces with clothing or personal contact. Contamination of food-packaging materials could lead to 

contamination of the food. See section XI.F for the proposed requirement. 

§ 110.35(c) (Pest control) .......................... Replace the phrase ‘‘processing area’’ with the phrase ‘‘manufacturing, processing, packing and 

holding areas’’ to consistently use the same group of terms in proposed part 117 and to provide 

for internal consistency between the requirements in current § 110.35(c) to not allow pests in ‘‘any 

area of a food plant’’ and to take effective measures to exclude pests from the plant. Pests do not 

belong in any areas where manufacturing, processing, packing or holding of food occurs. See 

section XI.G.3 for the proposed requirement. 

§ 110.35(d)(1) (Food-contact surfaces) ..... Replace the term ‘‘manufacturing’’ with ‘‘manufacturing/processing’’ in light of our proposed definition of manufacturing/processing (see discussion of the definition of manufacturing/processing in 

section X.B of this document). See section XI.G.4 for the proposed requirement. 

§ 110.35(d)(3) (Non-food-contact surfaces) Add ‘‘food-packaging materials’’ to the recommendation that non-food-contact surfaces of equipment 

used in the operation of food plants be cleaned as frequently as necessary to protect against contamination of food. Contamination of food-packaging materials could lead to contamination of the 

food. See section XI.G.5 for the proposed provision. 

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TABLE 9—PROPOSED REVISIONS FOR CONSISTENCY OF TERMS—Continued 

Current designation Proposed revision and explanation 

§ 110.35(d)(4) (Food-contact surfaces) ..... Add ‘‘food-packaging materials’’ to the requirement that single-service articles be handled, dispensed, used, and disposed of in a manner that protects against contamination of food or foodcontact surfaces. Contamination of food-packaging materials could lead to contamination of the 

food. See section XI.G.4 for the proposed requirement. 

§ 110.37(a) (Water supply) ........................ Add ‘‘food-packaging materials’’ to the requirement that any water that contacts food, food-contact 

surfaces, or food-packaging materials be safe and of adequate sanitary quality. Contamination of 

food-packaging materials could lead to contamination of the food. See section XI.H.1 for the proposed requirement. 

§ 110.37(f) (Rubbish and offal disposal) .... Add ‘‘food-packaging materials’’ to the requirement that rubbish and any offal be so conveyed, 

stored, and disposed of as to protect against contamination of food, food-contact surfaces, water 

supplies, and ground surfaces. Contamination of food-packaging materials could lead to contamination of the food. See section XI.H.4 for the proposed requirement. 

§ 110.80(b)(7) (Manufacturing operations) (1) Replace the term ‘‘storage’’ with the term ‘‘holding’’ for consistency with use of the term ‘‘holding’’ throughout proposed part 117. 

(2) Add ‘‘processing’’ and ‘‘packing’’ as activities where protection is needed against contamination 

(and against cross-contact) because contamination and cross-contact can occur during any activities subject to proposed part 117. 

(3) Inserting an ‘‘and,’’ rather than an ‘‘or,’’ between the cited activities to make clear that the requirements for protection against cross-contact and contamination apply to all activities at a plant. 

See section XI.J.3 for the proposed requirement. 

§ 110.110(c) (Defect action levels) ............ Change the designated persons who must ‘‘observe good manufacturing practices’’ and ‘‘at all times 

utilize quality control operations that reduce natural or unavoidable defects to the lowest level currently feasible’’ from the currently identified persons, (i.e., manufacturers, distributors and holders 

of food) to manufacturers, processors, packers and holders of food for consistency with terminology used throughout proposed part 117. 

See section XI.L for the proposed requirement. 

D. Proposed Revisions to Address CrossContact 

As discussed in section IX.D of this 

document, FDA is proposing a number 

of revisions to address cross-contact. 

Some of these proposed revisions would 

clarify that an existing provision that 

requires protection against 

contamination also requires protection 

against cross-contact. Table 10 identifies 

and explains each of these proposed 

revisions addressing cross-contact. 

Table 10 does not state the proposed 

requirement and instead refers to the 

section of this document containing the 

complete proposed requirement, 

including all proposed revisions. 

TABLE 10—PROPOSED REVISIONS REGARDING CROSS-CONTACT

Current designation Nature of proposed change and explanation 

§ 110.10(b) (Cleanliness) ........................... Clarification. Poor hygiene may result in the transfer of food allergens from persons working in direct 

contact with food, food-contact surfaces, and food-packaging materials to food. See section XI.E.1 

for the proposed requirement. 

§ 110.10(b)(1) (Cleanliness) ...................... Clarification. Appropriate use of outer garments protects against the transfer of food allergens from 

food to person to food. See section XI.E.1 for the proposed requirement. 

§ 110.10(b)(9) (Cleanliness) ...................... Clarification. Poor hygiene may result in the transfer of food allergens from persons working in direct 

contact with food, food-contact surfaces, and food-packaging materials to food. See section XI.E.1 

for the proposed requirement. 

§ 110.20(b)(2) (Plant construction and design).Clarification. Inadequate construction and design of a plant can result in the transfer of food allergens to food. Separation of operations is a key means of preventing cross-contact. See section 

XI.F for the proposed requirement. 

§ 110.20(b)(6) (Plant construction and design).Clarification. Inadequate construction and design of a plant can result in the transfer of food allergens to food. Proper ventilation, e.g., over powder dumping operations, and proper operation of 

fans and other air-blowing equipment are essential to prevent the transfer of allergens via dust in 

air currents. See section XI.F for the proposed requirement. 

§ 110.35(a) (General maintenance) ........... Clarification. Improper cleaning and sanitizing that leaves food residues on utensils or equipment 

may result in the transfer of food allergens from utensils or equipment to food, food-contact surfaces, or food packaging materials that come in contact with the improperly cleaned and sanitized 

surfaces. See section XI.G.1 for the proposed requirement. 

§ 110.35(d) (Sanitation of food-contact 

surfaces).

Clarification. Inadequate sanitation of food-contact surfaces may leave residues of food containing 

allergens on the surfaces and result in the transfer of food allergens from food-contact surfaces to 

food. See section XI.G.4 for the proposed requirement. 

§ 110.35(d)(2) (Sanitation of food-contact 

surfaces).

Clarification. Inadequate sanitation of food-contact surfaces may leave residues of food containing 

allergens on the surfaces and result in the transfer of food allergens from food-contact surfaces to 

food. See section XI.G.4 for the proposed requirement. 

§ 110.35(d)(3) (Sanitation of non-food-contact surfaces).Clarification. Inadequate sanitation of non-food contact surfaces may leave residues of food containing allergens on the surfaces and result in the transfer of food allergens from such surfaces to 

food-contact surfaces or food. See section XI.G.5 for the proposed requirement. 

§ 110.35(d)(4) (Sanitation of food-contact 

surfaces).

Clarification. Failure to properly store single-service articles (such as utensils intended for one-time 

use, paper cups, and paper towels) could lead to cross-contact. See section XI.G.4 for the proposed requirement. 

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TABLE 10—PROPOSED REVISIONS REGARDING CROSS-CONTACT—Continued 

Current designation Nature of proposed change and explanation 

§ 110.35(e) (Storage and handling of 

cleaned portable equipment and utensils).

Clarification. Failure to properly store and handle cleaned portable equipment and utensils could 

lead to cross-contact of the equipment and utensils and then to cross-contact of food if the equipment and utensils come in contact with food. See section XI.G.6 for the proposed requirement. 

§ 110.40(a) (Equipment and utensils) ........ Clarification. Equipment and utensils that are improperly designed, cleaned and maintained may result in the transfer of food allergens from equipment and utensils to food. See section XI.I for the 

proposed requirement. 

§ 110.40(b) (Equipment and utensils) ........ Clarification. Equipment and utensils that are improperly designed, cleaned and maintained may result in the transfer of food allergens from equipment and utensils to food. See section XI.I for the 

proposed requirement. 

§ 110.80 (Processes and controls) ............ Clarification. Inadequate processes and controls practices may result in the transfer of food allergens to food. See section XI.J.1 for the proposed requirement. 

§ 110.80 (Processes and controls—General).Clarification. Inadequate processes and controls practices may result in the transfer of food allergens to food. See section XI.J.1 for the proposed requirement. 

§ 110.80(a)(1) (Processes and controls— 

raw materials and ingredients.).

Clarification. Raw materials and ingredients subject to cross-contact due to improper segregation 

prior to receipt or during storage may result in undeclared allergens in food. See section XI.J.2 for 

the proposed requirement. 

§ 110.80(a)(5) (Processes and controls— 

raw materials and ingredients.).

Clarification. Improper handling of raw materials and ingredients may result in the transfer of food 

allergens to food. See section XI.J.2 for the proposed requirement. 

§ 110.80(a)(7) (Processes and controls— 

raw materials and ingredients.).

Clarification. Improper handling of raw materials and ingredients may result in the transfer of food 

allergens to food. See section XI.J.2 for the proposed requirement. 

N/A ............................................................. Cross-contact may be associated with improper identification and holding of raw materials and ingredients that are food allergens, and rework that contains food allergens. Improper identification 

of an allergen-containing raw material, such as a seasoning mix that is not identified as containing 

soy protein, can result in the unintended incorporation of an allergen into a food (i.e., cross-contact). Improper holding, e.g., storing open-containers of raw materials or ingredients, including 

those containing allergens, in the same location can result in cross-contact. See section XI.J.2 for 

the proposed requirement. 

§ 110.80(b)(5) (Processes and controls— 

manufacturing operations).

Clarification. Manufacturing operations may result in the transfer of food allergens to food. See section XI.J.3 for the proposed requirement. 

§ 110.80(b)(6) (Processes and controls— 

manufacturing operations).

Clarification. Manufacturing operations may result in the transfer of food allergens to food. Allergens 

may be transferred from one food to another when raw materials or ingredients are unprotected 

and allergens in unprotected refuse could contaminate food. Cross-contact can occur when food 

is conveyed unprotected. See section XI.J.3 for the proposed requirement. 

§ 110.80(b)(7) (Processes and controls— 

manufacturing operations).

Clarification. Manufacturing operations may result in the transfer of food allergens to food. See section XI.J.3 for the proposed requirement. 

§ 110.80(b)(10) (Processes and controls— 

manufacturing operations).

Clarification. Manufacturing operations may result in the transfer of food allergens to food. See section XI.J.3 for the proposed requirement. 

§ 110.80(b)(12) (Processes and controls— 

manufacturing operations).

Clarification. Manufacturing operations may result in the transfer of food allergens to food. See section XI.J.3 for the proposed requirement. 

§ 110.80(b)(13) (Processes and controls— 

manufacturing operations).

Clarification. Manufacturing operations may result in the transfer of food allergens to food. See section XI.J.3 for the proposed requirement. 

§ 110.93 (Warehousing and distribution) ... Clarification. Inadequate storage and transportation conditions may result in the transfer of food allergens to food. See section XI.K for the proposed requirement. 

We seek comment on these proposed 

changes. 

E. Proposed and Potential Revisions to 

Current § 110.10—Personnel (Proposed 

§ 117.10) 

1. Proposed Revisions to Current 

§ 110.10(b)—Cleanliness 

As discussed in section XI.D of this 

document, FDA is proposing to revise 

current § 110.10(b) (Cleanliness), (b)(1) 

and (b)(9) to make clear that certain 

provisions involving hygienic practices 

protect against cross-contact. Proposed 

§ 117.10(b) would require that all 

persons working in direct contact with 

food, food-contact surfaces, and foodpackaging materials conform to hygienic 

practices while on duty to the extent 

necessary to protect against crosscontact and contamination of food 

(emphasis added). Proposed 

§ 117.10(b)(1) would require that the 

methods for maintaining cleanliness 

include wearing outer garments suitable 

to the operation in a manner that 

protects against the contamination of 

food, food-contact surfaces, or foodpackaging materials, and to protect 

against the cross-contact of food 

(emphasis added). Proposed 

§ 117.10(b)(9) would require taking any 

other necessary precautions to protect 

against the contamination of food, foodcontact surfaces, or food-packaging 

materials with microorganisms or 

foreign substances (including 

perspiration, hair, cosmetics, tobacco, 

chemicals, and medicines applied to the 

skin) and to protect against the crosscontact of food (emphasis added). 

As discussed in section XI.A of this 

document, FDA is proposing to revise 

current § 110.10(b)(5) to remove the 

recommendation that gloves be of an 

impermeable material. Proposed 

§ 117.10(b)(5) would require that the 

methods for maintaining cleanliness 

include maintaining gloves, if they are 

used in food handling, in an intact, 

clean, and sanitary condition. 

2. Potential Revisions to Current 

§ 110.10(c)—Education and Training 

Current § 110.10(c) provides guidance 

that personnel responsible for 

identifying sanitation failures or food 

contamination should have a 

background of education or experience, 

or a combination thereof, to provide a 

level of competency necessary for 

production of clean and safe food. 

Current § 110.10(c) further recommends 

that food handlers and supervisors 

receive appropriate training in proper 

food handling techniques and foodprotection principles and should be 

informed of the danger of poor personal 

hygiene and insanitary practices. 

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3720 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

As discussed in section II.A.1 of this 

document, the CGMP Working Group 

Report identified specific areas that 

presented an opportunity to modernize 

the regulation. One recommendation 

was to ‘‘require appropriate training for 

supervisors and workers to ensure that 

they have the necessary knowledge and 

expertise in food hygiene, food 

protection, employee health and 

personal hygiene to produce safe food 

products. This training must be 

delivered in a manner that can be easily 

understood by the worker. Food 

processors must maintain a record of 

this training for each worker’’ (Ref. 1). 

Our analysis of recalls also indicates 

that ineffective employee training was a 

root cause of 32 percent of CGMPrelated recalls in the 1999–2003 analysis 

(Ref. 58); deficiencies in training were 

identified as a contributing factor in 24 

percent of CGMP-related primary recalls 

in the 2008–2009 analysis (Ref. 59). In 

addition, as discussed with respect to 

the proposed definition of preventive 

controls (see section X.C.4 of this 

document), section 418(o)(3) of the 

FD&C Act recognizes the importance of 

both training and CGMPs in preventing 

hazards from occurring in foods in its 

definition of preventive controls, which 

identifies supervisor, manager, and 

employee hygiene training 

(§ 418(o)(3)(B)) and CGMPs under part 

110 (§ 418(o)(3)(F)) as some of the 

procedures, practices, and processes 

that may be included as preventive 

controls. 

FDA is proposing to re-establish 

current § 110.10(c) as proposed 

§ 117.10(c). In addition, as discussed in 

section XI.M of this document, FDA is 

requesting comment on how best to 

revise current § 110.10(c) to implement 

section 418(o)(3) of the FD&C Act and 

the recommendations of the CGMP 

Working Group with respect to training. 

3. Proposed Revisions to Current 

§ 110.10(d)—Supervision 

Current § 110.10(d) requires that 

responsibility for ‘‘assuring’’ 

compliance by all personnel with all 

requirements of part 110 be clearly 

assigned to competent supervisory 

personnel. FDA is proposing to revise 

current § 110.10(d) to replace the term 

‘‘assuring’’ with ‘‘ensuring’’ to clarify 

FDA’s expectation that supervisory 

personnel make certain that all 

personnel comply with the CGMP 

requirements of proposed subpart B. As 

a grammatical matter, the word 

‘‘ensure’’ more accurately 

communicates this expectation than the 

word ‘‘assure.’’ FDA also is proposing to 

narrow the requirement for supervisory 

personnel to ensure compliance with 

proposed part 117, subpart B rather than 

with all of proposed part 117. Current 

§ 110.10(d) is directed at the 

requirements already established in part 

110 and does not apply to the proposed 

requirements that would be established 

in proposed part 117, subpart C. 

Proposed § 117.10(d) would now state 

that responsibility for ensuring 

compliance by all personnel with all 

requirements of this subpart must be 

clearly assigned to competent 

supervisory personnel (emphasis 

added). 

F. Proposed Revisions to Current 

§ 110.20—Plant and Grounds (Proposed 

§ 117.20) 

As discussed in section XI.C of this 

document, FDA is proposing to revise 

current § 110.20(b) (Plant Construction 

and Design) to make two changes for 

consistency with terms used throughout 

proposed part 117. Proposed § 117.20(b) 

would require that the plant buildings 

and structures be suitable in size, 

construction, and design to facilitate 

maintenance and sanitary operations for 

food-production purposes (i.e., 

manufacturing, processing packing, and 

holding) and would require that specific 

construction and design requirements 

apply to the ‘‘plant’’ rather than the 

‘‘plant and facilities’’ (emphasis added). 

As discussed in section XI.D of this 

document, FDA also is proposing to 

revise current § 110.20(b)(2) and (b)(6) 

to clarify that plants must be 

constructed and designed to protect 

against cross-contact in addition to 

protecting against the contamination of 

food. Proposed § 117.20(b)(2) would 

require that the plant take proper 

precautions to reduce the potential for 

contamination of food, food-contact 

surfaces, or food-packaging materials 

with microorganisms, chemicals, filth, 

and other extraneous material, and to 

reduce the potential for cross-contact 

(emphasis added). The potential for 

cross-contact and contamination must 

be reduced by adequate food safety 

controls and operating practices or 

effective design, including the 

separation of operations in which crosscontact and contamination are likely to 

occur, by one or more of the following 

means: location, time, partition, air 

flow, enclosed systems, or other 

effective means (emphasis added). 

Separation of operations is a key means 

of preventing cross-contact. Proposed 

§ 117.20(b)(6) would require that a plant 

provide adequate ventilation or control 

equipment to minimize odors and 

vapors (including steam and noxious 

fumes) in areas where they may 

contaminate food; and locate and 

operate fans and other air-blowing 

equipment in a manner that minimizes 

the potential for contaminating food, 

food-packaging materials, and foodcontact surfaces and for cross-contact 

(emphasis added). Proper ventilation, 

e.g., over powder dumping operations, 

and proper operation of fans and other 

air-blowing equipment are essential to 

prevent the transfer of allergens via dust 

in air currents. 

In addition, FDA is proposing to 

broaden current § 110.20(b)(3) by 

removing the term ‘‘fermentation’’ so 

that the construction and design 

requirements to permit the taking of 

proper precautions to protect food 

would apply to all outdoor bulk vessels 

(e.g., fermentation vessels, silos, vessels, 

and bins) rather than be limited to 

outdoor bulk fermentation vessels. 

Outdoor bulk vessels containing food 

lack the basic protection from 

environmental factors provided by a 

building, irrespective of whether the 

purpose of the outdoor bulk vessel is 

fermentation or storage. Proposed 

§ 117.20(b)(3) would require that the 

construction and design of a plant 

permit the taking of proper precautions 

to protect food in outdoor bulk vessels 

by any effective means. A conforming 

editorial change to current 

§ 110.20(b)(3)(iv) would revise 

‘‘skimming the fermentation vessels’’ 

(emphasis added) to ‘‘skimming 

fermentation vessels’’ to make clear that 

fermentation vessels would now be only 

one kind of vessel subject to proposed 

§ 117.20(b)(3). 

In addition, as discussed in section 

XI.C of this document, FDA is proposing 

to revise current § 110.20(b)(4) so that it 

is directed to preventing contamination 

of food-packaging materials as well as 

food and food-contact substances. 

Proposed § 117.20(b)(4) would require 

that the plant be constructed in such a 

manner that floors, walls, and ceilings 

may be adequately cleaned and kept 

clean and kept in good repair; that drip 

or condensate from fixtures, ducts and 

pipes does not contaminate food, foodcontact surfaces, or food-packaging 

materials; and that aisles or working 

spaces are provided between equipment 

and walls and are adequately 

unobstructed and of adequate width to 

permit employees to perform their 

duties and to protect against 

contaminating food, food-contact 

surfaces, or food-packaging materials 

with clothing or personal contact 

(emphasis added). 

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G. Proposed Revisions to Current 

§ 110.35—Sanitary Operations 

(Proposed § 117.35) 

1. Proposed Revisions to Current 

§ 110.35(a)—General Maintenance 

As discussed in section XI.D of this 

document, FDA is proposing to revise 

current § 110.35(a) (General 

maintenance) to clarify that cleaning 

and sanitizing of utensils and 

equipment must be conducted in a 

manner that protects against crosscontact of food, food-contact surfaces, or 

food packaging materials in addition to 

protecting these items against 

contamination. Proposed § 117.35(a) 

would require that cleaning and 

sanitizing of utensils and equipment be 

conducted in a manner that protects 

against cross-contact and contamination 

of food, food-contact surfaces, or foodpackaging materials (emphasis added). 

2. Proposed Revisions to Current 

§ 110.35(b)—Substances Used in 

Cleaning and Sanitizing; Storage of 

Toxic Materials 

FDA is proposing to revise current 

§ 110.35(b)(1) to emphasize that 

mechanisms to comply with provisions 

related to cleaning compounds and 

sanitizing agents must be safe and 

effective rather than to emphasize that 

there are multiple ways to achieve such 

compliance. With this shift in emphasis, 

proposed § 117.35(b)(1) would require 

that cleaning compounds and sanitizing 

agents used in cleaning and sanitizing 

procedures must be free from 

undesirable microorganisms and must 

be safe and adequate under the 

conditions of use. Compliance with this 

requirement must be verified by any 

effective means, including purchase of 

these substances under a supplier’s 

guarantee or certification or 

examination of these substances for 

contamination (emphasis added). FDA 

considered whether to delete the 

examples of mechanisms to achieve 

compliance as nonbinding 

recommendations, but tentatively 

concludes that the examples provide 

useful information that is suitable in the 

context in which it remains in the 

provision. 

As discussed in section XI.A of this 

document, FDA is proposing to revise 

current § 110.35(b)(2) to remove the 

recommendation for following all 

relevant regulations promulgated by 

other Federal, State, and local 

government agencies for the application, 

use, or holding of toxic cleaning 

compounds, sanitizing agents, and 

pesticide chemicals. FDA tentatively 

concludes that although such a 

recommendation may be helpful and 

could be included in future guidance, it 

is more properly addressed by the 

applicable Federal, State, and local 

government agencies and is outside the 

scope of proposed part 117. 

3. Proposed Revisions to Current 

§ 110.35(c)—Pest Control 

FDA is proposing to revise current 

§ 110.35(c) (Pest control) to make a 

change for internal consistency and 

clarity as well as to harmonize with 

terminology used in section 418 of the 

FD&C Act. Proposed § 117.35(c) would 

require ‘‘Pests must not be allowed in 

any area of a food plant. Guard or guide 

dogs may be allowed in some areas of 

a plant if the presence of the dogs is 

unlikely to result in contamination of 

food, food-contact surfaces, or foodpackaging materials. Effective measures 

must be taken to exclude pests from the 

manufacturing, processing, packing and 

holding areas and to protect against the 

contamination of food on the premises 

by pests. The use of insecticides or 

rodenticides is permitted only under 

precautions and restrictions that will 

protect against the contamination of 

food, food-contact surfaces, and foodpackaging materials’’ (emphasis added). 

4. Proposed Revisions to Current 

§ 110.35(d)—Sanitation of Food-Contact 

Surfaces 

FDA is proposing several revisions to 

current § 110.35(d) (Sanitation of foodcontact surfaces). First, FDA is 

proposing to redesignate current 

§ 110.35(d)(3) as proposed § 117.35(e) 

(Sanitation of non-food-contact 

surfaces). Current § 110.35(d)(3) 

addresses sanitation of non-food-contact 

surfaces and, thus, does not belong in 

current § 110.35(d), which addresses 

sanitation of food-contact surfaces. As a 

conforming editorial change, current 

§ 110.35(e) would become proposed 

§ 117.35(f). 

Second, FDA is proposing to revise 

current § 110.35(d)(1) to be more 

explicit that food-contact surfaces used 

for manufacturing/processing or holding 

low-moisture food must be in a clean 

condition at the time of use. Current 

§ 110.35(d)(1) requires that food-contact 

surfaces used for manufacturing or 

holding low-moisture food be in a dry, 

sanitary condition at the time of use; to 

be sanitary, a food-contact surface must 

be clean. As discussed in section XI.C 

of this document, the proposed revision 

would apply to ‘‘manufacturing/ 

processing’’ rather than only to 

‘‘manufacturing.’’ Proposed 

§ 117.35(d)(1) would require that foodcontact surfaces used for 

manufacturing/processing or holding 

low-moisture food be in a clean, dry, 

sanitary condition at the time of use 

(emphasis added). 

Third, as discussed in section XI.D of 

this document, FDA is proposing to 

revise current § 110.35(d) and (d)(2) to 

address cross-contact and clarify that 

sanitation of food-contact surfaces must 

protect against cross-contact of food. 

Proposed § 117.35(d) would require that 

all food-contact surfaces, including 

utensils and food-contact surfaces of 

equipment, be cleaned as frequently as 

necessary to protect against crosscontact and contamination of food 

(emphasis added). Proposed 

§ 117.35(d)(2) would require in wet 

processing, when cleaning is necessary 

to protect against cross-contact and the 

introduction of microorganisms into 

food, all food-contact surfaces be 

cleaned and sanitized before use and 

after any interruption during which the 

food-contact surfaces may have become 

contaminated (emphasis added). 

Fourth, as discussed in section XI.C of 

this document, FDA also is proposing to 

revise current § 110.35(d)(4) (proposed 

§ 117.35(d)(3)) so that it is directed to 

preventing contamination of foodpackaging materials as well as food and 

food-contact substances. As discussed 

in section XI.D of this document, FDA 

also is proposing to revise current 

§ 110.35(d)(4) (proposed § 117.35(d)(3)) 

to address cross-contact and clarify that 

single-service articles (such as utensils 

intended for one-time use, paper cups, 

and paper towels) must be handled, 

dispensed, used, and disposed of in a 

manner that protects against crosscontact of food. In addition, in section 

XI.M of this document, we are 

requesting comment on whether to 

require, rather than recommend, that 

single-service articles (such as utensils 

intended for one-time use, paper cups, 

and paper towels) be stored in 

appropriate containers to prevent 

contamination of food, food-contact 

surfaces, or food-packaging materials. 

Proposed § 117.35(d)(3) would provide 

that single-service articles (such as 

utensils intended for one-time use, 

paper cups, and paper towels) should be 

stored in appropriate containers and 

must be handled, dispensed, used, and 

disposed of in a manner that protects 

against cross-contact and contamination 

of food, food-contact surfaces, or foodpackaging materials (emphasis added). 

Fifth, FDA is proposing to delete 

current § 110.35(d)(5), which requires 

that sanitizing agents be adequate and 

safe under conditions of use and 

recommends that cleaning agents be 

adequate and safe under conditions of 

use. Current § 110.35(d)(5) is redundant 

with proposed § 117.35(b)(1), which 

requires that both cleaning compounds 

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and sanitizing agents be safe and 

adequate under the conditions of use. 

5. Proposed Revisions to Current 

§ 110.35(d)(3)—Sanitation of Non-FoodContact Surfaces 

As discussed in sections XI.C and 

XI.D of this document, FDA is 

proposing to revise current 

§ 110.35(d)(3) (proposed § 117.35(e); 

sanitation of non-food-contact surfaces) 

to recommend that such cleaning of 

non-food contact surfaces protect 

against cross-contact as well as against 

contamination and to recommend that 

such cleaning protect against 

contamination of food-packaging 

materials as well as protect against 

contamination of food and food-contact 

surfaces. Proposed § 117.35(e) would 

recommend that non-food-contact 

surfaces of equipment used in the 

operation of a food plant be cleaned in 

a manner and as frequently as necessary 

to protect against cross-contact and 

contamination of food, food-contact 

surfaces, and food-packaging materials 

(emphasis added). In addition, as 

discussed in section XI.M of this 

document, FDA also is requesting 

comment on whether to revise current 

§ 110.35(d)(3) (proposed § 117.35(e)) to 

require, rather than recommend, that 

non-food-contact surfaces of equipment 

used in the operation of a food plant be 

cleaned in a manner and as frequently 

as necessary to protect against crosscontact and contamination of food, 

food-contact surfaces, and foodpackaging materials. 

6. Proposed Revisions to Current 

§ 110.35(e)—Storage and Handling of 

Cleaned Portable Equipment and 

Utensils 

As discussed in section XI.D of this 

document, FDA is proposing to revise 

current § 110.35(e) (proposed 

§ 117.35(f); storage and handling of 

cleaned portable equipment and 

utensils) to address cross-contact and to 

recommend storing cleaned and 

sanitized portable equipment with foodcontact surfaces and utensils in a 

location and manner that protects foodcontact surfaces from cross-contact as 

well as from contamination. Proposed 

§ 117.35(f) would recommend that 

cleaned and sanitized portable 

equipment with food-contact surfaces 

and utensils be stored in a location and 

manner that protects food-contact 

surfaces from cross-contact and 

contamination (emphasis added). In 

addition, as discussed in section XI.M of 

this document, FDA also is requesting 

comment on whether to revise current 

§ 110.35(e) (proposed § 117.35(f)) to 

require, rather than recommend, that 

cleaned and sanitized portable 

equipment with food-contact surfaces 

and utensils be stored in a location and 

manner that protects food-contact 

surfaces from cross-contact and 

contamination. 

H. Proposed Revisions to Current 

§ 110.37—Sanitary Facilities and 

Controls (Proposed § 117.37) 

1. Proposed Revisions to Current 

§ 110.37(a)—Water Supply 

As discussed in section XI.C of this 

document, FDA is proposing to revise 

current § 110.37(a) so that it is directed 

to preventing contamination of foodpackaging materials as well as food and 

food-contact substances. Proposed 

§ 117.37(a) would require that the water 

supply be sufficient for the operations 

intended and be derived from an 

adequate source. Any water that 

contacts food, food-contact surfaces, or 

food-packaging materials must be safe 

and of adequate sanitary quality 

(emphasis added). Running water at a 

suitable temperature, and under 

pressure as needed, must be provided in 

all areas where required for the 

processing of food, for the cleaning of 

equipment, utensils, and food-packaging 

materials, or for employee sanitary 

facilities. 

2. Proposed Revisions to Current 

§ 110.37(d)—Toilet Facilities 

Current § 110.37(d) requires that each 

plant provide its employees with 

adequate, readily accessible toilet 

facilities and provides 

recommendations for how compliance 

with the requirements may be 

accomplished. These recommendations 

address issues such as the sanitary and 

overall physical condition of the toilet 

facilities, as well as the type and 

location of toilet facilities’ doors. 

We considered whether to revise 

current § 110.37(d) to require, rather 

than recommend, specific provisions for 

achieving compliance with the 

requirements for toilet facilities. In 

doing so, we considered comments 

received in response to proposed 

bathroom requirements contained in the 

proposed rule to establish CGMP 

requirements for dietary supplements 

(the dietary supplement proposed rule; 

68 FR 12158 at 12254). The dietary 

supplement proposed rule would have 

established—as requirements— 

provisions similar to the 

recommendations in current § 110.37(d). 

Comments on these proposed bathroom 

requirements stated that firms should be 

given flexibility in designing their 

bathrooms (72 FR 34752 at 34817). FDA 

agreed that it is unnecessary to require 

specific bathroom features because firms 

may be able to achieve compliance 

through means better suited to their 

operations. The final rule replaced 

requirements for specific bathroom 

features with more general requirements 

for providing employees with adequate, 

readily accessible bathrooms, and for 

bathrooms to be kept clean and not be 

a potential source of contamination to 

components, dietary supplements, or 

contact surfaces (§ 111.15(h)). 

We tentatively conclude that revising 

current § 110.37(d) to establish a 

performance standard for toilet facilities 

similar to the one found in § 111.15(h) 

is a better approach than mandating the 

recommendations in current § 110.37(d). 

Consistent with the discussion in 

section XI.C of this document, the 

proposed performance standard would 

be directed to preventing contamination 

of food-packaging materials as well as 

food and food-contact substances. 

Proposed § 117.37(d) would maintain 

the current requirement that each plant 

provide its employees with adequate, 

readily accessible toilet facilities. In 

addition, proposed § 117.37(d) would 

require that toilet facilities be kept clean 

and not be a potential source of 

contamination of food, food-contact 

surfaces, or food-packaging materials. 

3. Proposed Revisions to Current 

§ 110.37(e)—Hand-washing Facilities 

Current § 110.37(e) requires that 

hand-washing facilities be adequate and 

convenient and be furnished with 

running water at a suitable temperature 

and provides recommendations for how 

compliance with the requirements may 

be accomplished. These 

recommendations address issues such 

as providing hand-washing and handsanitizing facilities, hand-cleaning and 

sanitizing preparations, towel service or 

suitable drying devices, water control 

valves, appropriate signs and refuse 

receptacles that are properly 

constructed and maintained. 

We considered whether to revise 

current § 110.37(e) to require, rather 

than recommend, mechanisms for 

achieving compliance with the 

requirements for hand-washing 

facilities. In doing so, we considered 

comments received in response to 

proposed hand-washing facility 

requirements contained in the dietary 

supplement proposed rule (68 FR 12158 

at 12254). The dietary supplement 

proposed rule would have established— 

as requirements—provisions similar to 

the recommendations in current 

§ 110.37(e). Comments on these 

proposed hand-washing facility 

requirements stated that firms should be 

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Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 3723 

washing facilities and that an overall 

sanitation requirement should be 

sufficient (72 FR 34752 at 34818). FDA 

agreed that it is unnecessary to require 

specific hand-washing mechanisms 

because firms may be able to achieve 

compliance through other means better 

suited for their operations; however, we 

disagreed that an overall sanitation 

requirement would be sufficient because 

such a requirement would not clearly 

state the purpose of the requirement, 

which is to ensure that an employee’s 

hands are not a source of contamination. 

The final rule replaced requirements for 

specific hand-washing facility features 

with more general requirements for 

providing hand-washing facilities 

designed to ensure that an employee’s 

hands are not a source of contamination 

of components, dietary supplements, or 

any contact surface, by providing 

facilities that are adequate, convenient, 

and furnish running water at a suitable 

temperature (§ 111.15(i)). 

We tentatively conclude that 

establishing a performance standard for 

hand-washing facilities similar to the 

one found in § 111.15(i) is a better 

approach than mandating the current 

recommendations in § 110.37(e). 

Consistent with the discussion in 

section XI.C of this document, the 

proposed performance standard would 

be directed to preventing contamination 

of food-packaging materials as well as 

food and food-contact substances. 

Proposed § 117.37(e) would require that 

each plant provide hand-washing 

facilities designed to ensure that an 

employee’s hands are not a source of 

contamination of food, food-contact 

surfaces, or food-packaging materials by 

providing facilities that are adequate, 

convenient, and furnish running water 

at a suitable temperature. 

4. Proposed Revisions to Current 

§ 110.37(f)— Rubbish and Offal Disposal 

As discussed in section XI.C of this 

document, FDA is proposing to revise 

current § 110.37(f) so that it is directed 

to preventing contamination of foodpackaging materials as well as food and 

food-contact substances. Proposed 

§ 117.37(f) would require that rubbish 

and any offal be so conveyed, stored, 

and disposed of as to minimize the 

development of odor, minimize the 

potential for the waste becoming an 

attractant and harborage or breeding 

place for pests, and protect against 

contamination of food, food-contact 

surfaces, food-packaging materials, 

water supplies, and ground surfaces 

(emphasis added). 

I. Proposed Revisions to Current 

§ 110.40—Equipment and Utensils 

(Proposed § 117.40) 

FDA is proposing to reorganize the 

provisions found in current § 110.40(a) 

by creating paragraph designations (1) 

through (6) with associated editorial 

changes. This is a non-substantive 

revision to make it easier to see the 

distinct requirements. As discussed in 

section XI.M of this document, FDA also 

is requesting comment on whether to 

revise current § 110.40(a) to require, 

rather than recommend, that all 

equipment be so installed and 

maintained as to facilitate the cleaning 

of the equipment and of all adjacent 

spaces (proposed § 117.40(a)(3)). 

As discussed in section XI.D of this 

document, FDA is proposing to (1) 

revise current § 110.40(a) (in proposed 

§ 117.40(a)(5)) to clarify that all plant 

equipment and utensils must protect 

against cross-contact in addition to the 

contamination of food and (2) revise 

current § 110.40(b) to clarify that seams 

on food-contact surfaces must be 

smoothly bonded or maintained so as to 

minimize the opportunity for crosscontact. Proposed § 117.40(a)(5) would 

require that food-contact surfaces be 

maintained to protect food from crosscontact and from being contaminated by 

any source, including unlawful indirect 

food additives (emphasis added). 

Proposed § 117.40(b) would require that 

seams on food-contact surfaces be 

smoothly bonded or maintained so as to 

minimize accumulation of food 

particles, dirt, and organic matter and 

thus minimize the opportunity for 

growth of microorganisms and crosscontact (emphasis added). 

As discussed in section XI.A of this 

document, FDA is proposing to delete 

the recommendation in current 

§ 110.40(e) that each freezer and cold 

storage compartment used to store and 

hold food capable of supporting growth 

of microorganisms be fitted with an 

automatic control for regulating 

temperature or with an automatic alarm 

system to indicate a significant 

temperature change in a manual 

operation. Proposed § 117.40(e) would 

require that each freezer and cold 

storage compartment used to store and 

hold food capable of supporting growth 

of microorganisms be fitted with an 

indicating thermometer, temperaturemeasuring device, or temperaturerecording device so installed as to show 

the temperature accurately within the 

compartment. 

FDA is proposing to revise current 

§ 110.40(f) to require that instruments 

and controls used for measuring, 

regulating, or recording temperatures, 

pH, acidity, water activity, or other 

conditions that control or prevent the 

growth of undesirable microorganisms 

in food be precise as well as accurate. 

By using the word ‘‘precise’’ we mean 

that individual measurements must be 

close to each other when made under 

the same conditions so that the variation 

in measurements is not statistically 

significant. An instrument that gives 

widely varying readings from one use to 

the next cannot be consistently accurate 

and therefore cannot ensure product 

safety over time. The proposed 

requirement for such instruments and 

controls to be precise as well as accurate 

would be consistent with the 

requirements in the dietary supplement 

GMPs (§ 111.27(a)(6)(i)), which were 

established after the requirements in 

current § 110.40(f). Proposed § 117.40(f) 

would require that instruments and 

controls used for measuring, regulating, 

or recording temperatures, pH, acidity, 

water activity, or other conditions that 

control or prevent the growth of 

undesirable microorganisms in food be 

accurate and precise and adequately 

maintained, and adequate in number for 

their designated uses (emphasis added). 

J. Proposed Revisions to Current 

§ 110.80—Processes and Controls 

(Proposed § 117.80) 

1. Proposed Revisions to Current 

§ 110.80 

FDA is proposing to reorganize the 

provisions found in six sentences that 

precede current § 110.80(a) by creating 

paragraph designations (a)(1) through 

(6) with associated editorial changes, 

including the title ‘‘General’’ for new 

paragraph (a) of proposed § 117.80. This 

is a non-substantive revision to make it 

easier to see the distinct requirements 

and to clearly identify each requirement 

with a paragraph citation. As 

corresponding changes, current 

§ 110.80(a) would become proposed 

§ 117.80(b) and current § 110.80(b) 

would become proposed § 117.80(c). 

As discussed in section XI.D of this 

document, FDA is proposing to revise 

two provisions to current § 110.80 to 

clarify that certain practices involving 

processes and controls must protect 

against cross-contact. Proposed 

§ 117.80(a)(4), in relevant part, would 

require that reasonable precautions be 

taken to ensure that production 

procedures do not contribute to crosscontact and contamination from any 

source (emphasis added). Proposed 

§ 117.80(a)(5) would require that 

chemical, microbial, or extraneousmaterial testing procedures be used 

where necessary to identify sanitation 

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3724 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

failures or possible cross-contact and 

food contamination (emphasis added). 

2. Proposed Revisions to Current 

§ 110.80(a)—Raw Materials and Other 

Ingredients 

As discussed in section XI.D of this 

document, FDA is proposing a number 

of revisions to current § 110.80(a) (i.e., 

to current § 110.80(a)(1), (a)(5), and 

(a)(7)) to clarify that certain practices 

involving raw materials and ingredients 

must protect against cross-contact. As 

discussed in section XI.D of this 

document, FDA also is proposing to 

clarify that three of the five separate 

statements within current § 110.80(a)(1) 

address cross-contact as well as 

contamination. Proposed § 117.80(b)(1) 

would require, in relevant part, that raw 

materials and ingredients must be 

inspected and segregated or otherwise 

handled as necessary to ascertain that 

they are clean and suitable for 

processing into food and be stored 

under conditions that will protect 

against cross-contact and 

contamination, and minimize 

deterioration (emphasis added). Water 

may be reused for washing, rinsing, or 

conveying food if it does not increase 

the level of contamination of the food or 

cause cross-contact (emphasis added). 

Proposed § 117.80(b)(1) would continue 

to recommend that containers and 

carriers of raw materials should be 

inspected on receipt to ensure that their 

condition has not contributed to crosscontact, contamination, or deterioration 

of food (emphasis added). As discussed 

in section XI.M of this document, FDA 

also is requesting comment on whether 

to revise current § 110.80(a)(1) to 

require, rather than recommend, that 

containers and carriers of raw materials 

be inspected on receipt to ensure that 

their condition has not contributed to 

the cross-contact, contamination or 

deterioration of food. 

Current § 110.80(a)(2) requires that 

raw materials and other ingredients 

either not contain levels of 

microorganisms that may produce food 

poisoning or other disease in humans, 

or they be pasteurized or otherwise 

treated during manufacturing operations 

so that they no longer contain levels that 

would cause the product to be 

adulterated within the meaning of the 

act. FDA is proposing to revise current 

§ 110.80(a)(2) by replacing the phrase 

‘‘may produce food poisoning or other 

disease in humans’’ with ‘‘may render 

the food injurious to the health of 

humans.’’ The proposed revision would 

align the provision with the adulteration 

provision in section 402(a)(4) of the 

FD&C Act. As discussed in section XI.A 

of this document, FDA also is proposing 

to delete guidance regarding how to 

comply with the requirements of current 

§ 110.80(a)(2). Proposed § 117.80(b)(2) 

would require that raw materials and 

ingredients either not contain levels of 

microorganisms that may render the 

food injurious to the health of humans, 

or they be pasteurized or otherwise 

treated during manufacturing operations 

so that they no longer contain levels that 

would cause the product to be 

adulterated (emphasis added). 

Current § 110.80(a)(3) requires that 

raw materials and other ingredients 

susceptible to contamination with 

aflatoxin or other natural toxins comply 

with current FDA regulations and action 

levels for poisonous or deleterious 

substances before these materials or 

ingredients are incorporated into 

finished food. An action level for an 

added poisonous or deleterious 

substance may be established to define 

a level of contamination at which a food 

may be regarded as adulterated (§ 109.4) 

(21 CFR 109.4). In 1990, we issued a 

final rule to revise part 109 to clarify 

that action levels constitute 

prosecutorial guidance rather than 

substantive rules (55 FR 20782, May 21, 

1990). Because action levels themselves 

constitute guidance, revising current 

§ 110.80(a)(3) to reflect that action levels 

are nonbinding would be duplicative 

and unnecessary and FDA is proposing 

to delete the current requirement for 

compliance with action levels from 

current § 110.80(a)(3). Importantly, the 

proposed deletion merely reflects an 

administrative practice to limit the 

number of recommendations we include 

in our regulations; we continue to 

regard action levels as an important 

approach to food safety. As discussed in 

section XI.A of this document, FDA also 

is proposing to delete guidance 

regarding how to comply with the 

requirements of current § 110.80(a)(3). 

Proposed § 117.80(b)(3) would require 

that raw materials and ingredients 

susceptible to contamination with 

aflatoxin or other natural toxins comply 

with current Food and Drug 

Administration regulations for 

poisonous or deleterious substances 

before these materials or ingredients are 

incorporated into finished food 

(emphasis added). 

Current § 110.80(a)(4) requires that 

raw materials, other ingredients, and 

rework susceptible to contamination 

with pests, undesirable microorganisms, 

or extraneous material comply with 

applicable FDA regulations and defect 

action levels for natural or unavoidable 

defects if a manufacturer wishes to use 

the materials in manufacturing food. 

Defect action levels are guidance for 

natural or unavoidable defects in food 

for human use that present no health 

hazard (Ref. 141). FDA establishes 

maximum levels for these defects in 

foods produced under current good 

manufacturing practice and uses these 

levels in deciding whether to 

recommend regulatory action (Ref. 141). 

As discussed above in this section, in 

1990, we issued a final rule to revise 

part 109 to clarify that action levels are 

prosecutorial guidance rather than 

substantive rules (55 FR 20782). 

Because defect action levels themselves 

constitute guidance, revising current 

§ 110.80(a)(4) to reflect that action levels 

are nonbinding would be duplicative 

and unnecessary. Therefore, FDA is 

proposing to delete the current 

requirement for compliance with defect 

action levels in current § 110.80(a)(4). 

As discussed in section XI.A of this 

document, FDA also is proposing to 

delete guidance regarding how to 

comply with the requirements of current 

§ 110.80(a)(4). Proposed § 117.80(b)(4) 

would require raw materials, 

ingredients, and rework susceptible to 

contamination with pests, undesirable 

microorganisms, or extraneous material 

comply with applicable Food and Drug 

Administration regulations for natural 

or unavoidable defects if a manufacturer 

wishes to use the materials in 

manufacturing food. 

As discussed in section XI.D of this 

document, FDA is proposing to revise 

current § 110.80(a)(5) to clarify that raw 

materials, ingredients, and rework be 

held in bulk, or in containers designed 

and constructed so as to protect against 

cross-contact as well as against 

contamination. Proposed § 117.80(b)(5) 

would require that raw materials, 

ingredients, and rework be held in bulk, 

or in containers designed and 

constructed so as to protect against 

cross-contact and contamination and 

must be held at such temperature and 

relative humidity and in such a manner 

as to prevent the food from becoming 

adulterated. Material scheduled for 

rework must be identified as such. 

(Emphasis added.) 

As discussed in section XI.D of this 

document, FDA is proposing to revise 

current § 110.80(a)(7) to clarify that 

liquid or dry raw materials and 

ingredients received and stored in bulk 

form must be held in a manner that 

protects against cross-contact as well as 

contamination. Proposed § 117.80(b)(7) 

would require that liquid or dry raw 

materials and ingredients received and 

stored in bulk form be held in a manner 

that protects against cross-contact and 

contamination (emphasis added). 

As discussed in section XI.D of this 

document, FDA is proposing to 

establish a new requirement in current 

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§ 110.80(a) regarding cross-contact. 

Proposed § 117.80(b)(8) would require 

that raw materials and ingredients that 

are food allergens, and rework that 

contains food allergens, be identified 

and held in a manner that prevents 

cross-contact. We seek comment on this 

proposal. 

3. Proposed Revisions to Current 

§ 110.80(b)—Manufacturing Operations 

As discussed in section XI.C of this 

document, FDA is proposing to revise 

current § 110.80(b)(2) by replacing the 

phrase ‘‘manufacturing, including 

packaging and storage’’ with 

‘‘manufacturing, processing, packing 

and holding.’’ As discussed in section 

XI.A of this document, FDA also is 

proposing to delete guidance regarding 

how to comply with the requirements of 

current § 110.80(b)(2). Proposed 

§ 117.80(c)(2) would require that all 

food manufacturing, processing, 

packing and holding, be conducted 

under such conditions and controls as 

are necessary to minimize the potential 

for the growth of microorganisms or for 

the contamination of food (emphasis 

added). 

Current § 110.80(b)(3) requires that 

food that can support the rapid growth 

of undesirable microorganisms, 

particularly those of public health 

significance, be held in a manner that 

prevents the food from becoming 

adulterated within the meaning of the 

FD&C Act and provides 

recommendations for complying with 

this requirement. FDA is proposing a 

series of revisions to current 

§ 110.80(b)(3). Specifically, FDA is 

proposing to: 

• Replace the phrase ‘‘in a manner’’ 

with ‘‘at temperatures’’ to identify a 

specific manner in which food that 

supports the rapid growth of 

microorganisms must be held—i.e., 

through temperature control. 

Temperature control is generally 

recognized as essential to food safety for 

foods that can support the rapid growth 

of microorganisms (Ref. 137) (Ref. 138) 

(Ref. 139) (Ref. 140). 

• Include the phrase ‘‘during 

manufacturing, processing, packing and 

holding’’ to emphasize that temperature 

controls do not end with the 

manufacturing/processing phase, but 

extend through packing and holding. 

• Delete the recommendations in 

current § 110.80(b)(3)(i) through (iv). 

(See the discussion of the proposed 

deletion in section XI.A of this 

document.) 

With these changes, proposed 

§ 117.80(c)(3) would require that food 

that can support the rapid growth of 

undesirable microorganisms be held at 

temperatures that will prevent the food 

from becoming adulterated, during 

manufacturing, processing, packing and 

holding (emphasis added). 

Current § 110.80(b)(4) requires that 

measures such as sterilizing, irradiating, 

pasteurizing, freezing, refrigerating, 

controlling pH or controlling aw that are 

taken to destroy or prevent the growth 

of undesirable microorganisms, 

particularly those of public health 

significance, shall be adequate under 

the conditions of manufacture, 

handling, and distribution to prevent 

food from being adulterated within the 

meaning of the act. FDA is proposing to 

include ‘‘cooking’’ as an additional such 

measure. Cooking, if done adequately, is 

well accepted as a mechanism of 

destroying microorganisms (Ref. 142). 

FDA also is proposing to delete the 

phrase ‘‘particularly those of public 

health significance’’ because it is 

redundant with the proposed definition 

for the term ‘‘microorganisms’’ 

(proposed § 117.3), which identifies 

microorganisms of public health 

significance as a type of undesirable 

microorganism, and therefore is 

unnecessary. Proposed § 117.80(c)(4) 

would require measures such as 

sterilizing, irradiating, pasteurizing, 

cooking, freezing, refrigerating, 

controlling pH or controlling aw that are 

taken to destroy or prevent the growth 

of undesirable microorganisms be 

adequate under the conditions of 

manufacture, handling, and distribution 

to prevent food from being adulterated 

(emphasis added). 

Current § 110.80(b)(5) requires that 

work-in-process be handled in a manner 

that protects against contamination. 

FDA is proposing to revise current 

§ 110.80(b)(5) to require handling in a 

manner to protect against the growth of 

undesirable microorganisms. The 

growth of any undesirable 

microorganisms already present in a 

food, such as pathogenic sporeformers, 

must be controlled, as well as protecting 

the food against the introduction of 

contaminants. As discussed in section 

XI.D of this document, FDA also is 

proposing to clarify that work-inprocess must be handled in a manner to 

protect against cross-contact. In addition 

we are proposing to revise current 

§ 110.80(b)(5) to broaden the provision 

to include ‘‘rework.’’ The term ‘‘rework’’ 

would be defined in proposed § 117.3 to 

mean clean, unadulterated food that has 

been removed from processing for 

reasons other than insanitary conditions 

or that has been successfully 

reconditioned by reprocessing and that 

is suitable for use as food. As with 

work-in-process, improper handling of 

rework could result in cross-contact, 

contamination, or growth of undesirable 

microorganisms. Proposed § 117.80(c)(5) 

would require that work-in-process and 

rework be handled in a manner that 

protects against cross-contact, 

contamination, and growth of 

undesirable microorganisms (emphasis 

added). 

As discussed in section XI.D of this 

document, FDA is proposing to clarify 

that three provisions in current 

§ 110.80(b)(6) require that effective 

measures be taken to protect finished 

food from cross-contact as well as from 

contamination. Proposed § 117.80(c)(6) 

would require that effective measures be 

taken to protect finished food from 

cross-contact and contamination by raw 

materials, ingredients, or refuse 

(emphasis added). When raw materials, 

ingredients, or refuse are unprotected, 

they must not be handled 

simultaneously in a receiving, loading, 

or shipping area if that handling could 

result in cross-contact or contaminated 

food (emphasis added). Food 

transported by conveyor must be 

protected against cross-contact and 

contamination as necessary (emphasis 

added). 

As discussed in section XI.D of this 

document, FDA is proposing to clarify 

that current § 110.80(b)(7) requires that 

equipment, containers, and utensils 

used to convey, hold, or store raw 

materials, work-in-process, rework, or 

food be constructed, handled, and 

maintained during manufacturing or 

storage in a manner that protects against 

cross-contact as well as against 

contamination. As discussed in section 

XI.C of this document, FDA also is 

proposing to replace the term ‘‘storage’’ 

with the term ‘‘holding’’ for consistency 

with use of the term ‘‘holding’’ 

throughout proposed part 117 and to 

add processing and packing as activities 

where protection is needed against 

contamination and cross-contact. 

Proposed § 117.80(c)(7) would require 

that equipment, containers, and utensils 

used to convey, hold, or store raw 

materials, work-in-process, rework, or 

food be constructed, handled, and 

maintained during manufacturing, 

processing, packing and holding in a 

manner that protects against crosscontact and contamination (emphasis 

added). 

As discussed in section XI.A of this 

document, FDA is proposing to delete 

guidance regarding how to comply with 

the requirements of current 

§ 110.80(b)(8). Proposed § 117.80(c)(8) 

would require that effective measures be 

taken to protect against the inclusion of 

metal or other extraneous material in 

food. 

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Current § 110.80(b)(9) requires that 

food, raw materials, and other 

ingredients that are adulterated must be 

disposed of in a manner that protects 

against the contamination of other food. 

It further requires that if the adulterated 

food is capable of being reconditioned, 

it be reconditioned using a method that 

has been proven to be effective or it be 

reexamined and found not to be 

adulterated within the meaning of the 

act before being incorporated into other 

food. FDA is proposing to delete the 

option for reexamination so that 

adulterated food can only be disposed of 

or reconditioned if the food is capable 

of being reconditioned. FDA is 

proposing this deletion because a food 

may test positive for a contaminant in 

one test and negative in one or more 

additional tests although the food 

continues to be contaminated. For 

example, the distribution of a pathogen 

in a food may not be homogeneous. 

Therefore, a food found to be 

adulterated must be reconditioned 

before it is reexamined. FDA also is 

proposing to combine the two sentences 

in current § 110.80(b)(9) with an ‘‘or’’ to 

make clear that reconditioning, rather 

than disposal, is an option. Proposed 

§ 117.80(c)(9) would require food, raw 

materials, and ingredients that are 

adulterated be disposed of in a manner 

that protects against the contamination 

of other food or, if the adulterated food 

is capable of being reconditioned, it be 

reconditioned using a method that has 

been proven to be effective (emphasis 

added). 

Current § 110.80(b)(10) requires that 

mechanical manufacturing steps such as 

washing, peeling, trimming, cutting, 

sorting and inspecting, mashing, 

dewatering, cooling, shredding, 

extruding, drying, whipping, defatting, 

and forming shall be performed so as to 

protect food against contamination. FDA 

is proposing to revise current 

§ 110.80(b)(10) to replace the phrase 

‘‘mechanical manufacturing steps’’ with 

the single term ‘‘steps’’ because 

‘‘mechanical manufacturing’’ does not 

accurately describe all steps listed in the 

current provision. Current 

§ 110.80(b)(10) also includes three 

recommendations. As discussed in 

section XI.A of this document, FDA is 

proposing to delete two of these 

recommendations (regarding adequate 

cleaning and sanitizing of all foodcontact surfaces and regarding the use of 

time and temperature controls). As 

discussed in section XI.D of this 

document, FDA also is proposing to 

clarify that steps identified in current 

§ 110.80(b)(10) require protection 

against cross-contact. Proposed 

§ 117.80(c)(10) would require that steps 

such as washing, peeling, trimming, 

cutting, sorting and inspecting, 

mashing, dewatering, cooling, 

shredding, extruding, drying, whipping, 

defatting, and forming be performed so 

as to protect food against cross-contact 

and contamination and would continue 

to recommend that food should be 

protected from contaminants that may 

drip, drain, or be drawn into the food 

(emphasis added). As discussed in 

section XI.M of this document, FDA is 

requesting comment on whether to 

establish the third recommendation 

(regarding physical protection of food 

from contaminants that may drip, drain, 

or be drawn into the food) as a 

requirement. 

Current § 110.80(b)(11) requires, in 

relevant part, that where a blanched 

food is washed prior to filling, water 

used be safe and of adequate sanitary 

quality. FDA is proposing to delete this 

requirement because water quality 

would already be addressed in proposed 

§ 117.37(a) and would be redundant in 

proposed § 117.80(c)(11). Current 

§ 110.80(b)(11) also recommends that 

heat blanching, when required in the 

preparation of food, be effected by 

heating the food to the required 

temperature, holding it at this 

temperature for the required time, and 

then either rapidly cooling the food or 

passing it to subsequent manufacturing 

without delay. As discussed in section 

XI.M, of this document, FDA is 

requesting comment on whether to 

establish this recommendation as a 

requirement. Current § 110.80(b)(11) 

also recommends that thermophilic 

growth and contamination in blanchers 

be minimized by the use of adequate 

operating temperatures and by periodic 

cleaning. As discussed in section XI.M 

of this document, FDA is requesting 

comment on whether to establish this 

recommendation as a requirement. 

Proposed § 117.80(c)(11) would 

continue to recommend that heat 

blanching, when required in the 

preparation of food, should be effected 

by heating the food to the required 

temperature, holding it at this 

temperature for the required time, and 

then either rapidly cooling the food or 

passing it to subsequent manufacturing 

without delay (emphasis added). 

Proposed § 117.80(c)(11) also would 

continue to recommend that 

thermophilic growth and contamination 

in blanchers should be minimized by 

use of adequate operating temperatures 

and by periodic cleaning (emphasis 

added). 

Current § 110.80(b)(12) requires that 

batters, breading, sauces, gravies, 

dressings, and other similar 

preparations be treated or maintained in 

such a manner that they are protected 

against contamination and provides 

several recommendations for how to 

comply with this requirement. As 

discussed in section XI.A of this 

document, FDA is proposing to delete 

these recommendations. As discussed in 

section XI.D of this document, FDA also 

is proposing to clarify that steps 

identified in current § 110.80(b)(12) 

require protection against cross-contact. 

Proposed § 117.80(c)(12) would require 

that batters, breading, sauces, gravies, 

dressings, and other similar 

preparations be treated or maintained in 

such a manner that they are protected 

against cross-contact and contamination 

(emphasis added). 

Current § 110.80(b)(13) requires that 

filling, assembling, packaging, and other 

operations be performed in such a way 

that the food is protected against 

contamination. FDA is proposing to 

revise current § 110.80(b)(13) to require 

that filling, assembling, packaging, and 

other operations be performed in such a 

way that the food is protected against 

the growth of undesirable 

microorganisms as well as against 

contamination. The growth of any 

undesirable microorganisms already 

present in a food must be controlled, in 

addition to the introduction of 

contaminants. Current § 110.80(b)(13) 

also includes several recommendations 

for achieving compliance. As discussed 

in section XI.A of this document, FDA 

is proposing to delete these 

recommendations. As discussed in 

section XI.D of this document, FDA also 

is proposing to require protection 

against cross-contact. Proposed 

§ 117.80(c)(13) would require that 

filling, assembling, packaging, and other 

operations be performed in such a way 

that the food is protected against crosscontact, contamination, and growth of 

undesirable microorganisms (emphasis 

added). 

Current § 110.80(b)(14) requires that 

food, such as, but not limited to, dry 

mixes, nuts, intermediate moisture food, 

and dehydrated food, that relies on the 

control of aw for preventing the growth 

of undesirable microorganisms be 

processed to and maintained at a safe 

moisture level. Current § 110.80(b)(14) 

also provides recommendations for 

accomplishing compliance with this 

requirement. As discussed in section 

XI.A of this document, FDA is 

proposing to delete these 

recommendations. Proposed 

§ 117.80(c)(14) would require that food, 

including dry mixes, nuts, intermediate 

moisture food, and dehydrated food, 

that relies on the control of aw for 

preventing the growth of undesirable 

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microorganisms be processed to and 

maintained at a safe moisture level 

(emphasis added). 

Current § 110.80(b)(15) requires that 

food such as, but not limited to, acid 

and acidified food, that relies 

principally on the control of pH for 

preventing the growth of undesirable 

microorganisms be monitored and 

maintained at a pH of 4.6 or below and 

includes two recommendations for how 

to comply with the requirement. As 

discussed in section XI.A of this 

document, FDA is proposing to delete 

these recommendations. Proposed 

§ 117.80(c)(15) would require food, 

including acid and acidified food, that 

relies principally on the control of pH 

for preventing the growth of undesirable 

microorganisms be monitored and 

maintained at a pH of 4.6 or below. 

K. Proposed Revisions to Current 

§ 110.93—Warehousing and Distribution 

(Proposed § 117.93) 

Current § 110.93 requires that storage 

and transportation of finished food be 

under conditions that will protect food 

against physical, chemical, and 

microbial contamination as well as 

against deterioration of the food and the 

container. FDA is proposing a series of 

revisions to current § 110.93. 

FDA is proposing to delete the term 

‘‘finished’’ before ‘‘food’’ because the 

requirements in this provision must 

apply to all food being held for 

distribution regardless of whether it is a 

raw material or ingredient or in its 

finished state. To ensure food safety 

throughout the food chain, food, 

whether a raw material or finished 

product, must be protected against 

contamination. 

As discussed in section XI.D of this 

document, FDA also is proposing to 

revise § 110.93 to clarify that storage 

and transportation of food must be 

under conditions that will protect 

against cross-contact of food in addition 

to protecting against contamination of 

food. 

FDA also is proposing to add 

radiological hazards as an additional 

category of contaminants to the list of 

contaminants which may be 

encountered in warehousing and 

distribution because food may be 

subject to contamination with 

radiological hazards. As discussed in 

section XII.B, FDA now recognizes four 

types of hazards: biological, chemical, 

physical and radiological. Our CGMP 

regulation for bottled water in part 129 

requires plants to analyze product 

samples for bacteriological, chemical, 

physical and radiological purposes 

(§ 129.80(g)). Therefore, the proposed 

addition of radiological contaminants to 

the list of contaminants would be 

consistent with part 129. FDA 

tentatively concludes that there is no 

basis for requiring a facility to protect 

against some types of hazards but not 

others, and thus is proposing to include 

radiological hazards among those from 

which food must be protected. 

FDA also is proposing to require 

protection against ‘‘biological,’’ rather 

than ‘‘microbial’’ contamination of food 

so that, when a provision specifies all 

four types of hazards that must be 

addressed, the list is presented 

consistently throughout proposed part 

117. In section XII.B.3 of this document, 

we discuss a requirement, which would 

be established in proposed § 117.130(b), 

for a hazard analysis to address 

biological, chemical, radiological, and 

physical hazards. FDA also is proposing 

to present the list of types of hazards in 

the same order as the list would be 

presented in proposed § 117.130(b). 

Proposed § 117.93 would require that 

storage and transportation of food be 

under conditions that will protect 

against cross-contact and biological, 

chemical, physical, and radiological 

contamination of food as well as against 

deterioration of the food and the 

container (emphasis added). 

L. Proposed Revisions to Current 

§ 110.110—Natural or Unavoidable 

Defects in Food for Human Use That 

Present No Health Hazard (Proposed 

§ 117.110) 

As discussed in section XI.C of this 

document, FDA is proposing to revise 

current § 110.110(c) to change the 

designated persons who must ‘‘observe 

good manufacturing practices’’ and ‘‘at 

all times utilize quality control 

operations that reduce natural or 

unavoidable defects to the lowest level 

currently feasible’’ from the currently 

identified persons (i.e., manufacturers, 

distributors and holders of food) to 

manufacturers, processors, packers and 

holders of food. FDA also is proposing 

to update the reference in current 

§ 110.110(c) to section 402(a)(4) of the 

FD&C Act to make it more complete by 

specifying that the insanitary conditions 

are those whereby food may have 

become contaminated with filth, or 

whereby food may have been rendered 

injurious to health. Proposed 

§ 117.110(c) would specify that 

compliance with defect action levels 

does not excuse violation of the 

requirement in section 402(a)(4) of the 

Federal Food, Drug, and Cosmetic Act 

that food not be prepared, packed, or 

held under unsanitary conditions 

whereby it may have become 

contaminated with filth, or whereby it 

may have been rendered injurious to 

health, or the requirements in part 117 

that food manufacturers, processors, 

packers, and holders must observe 

current good manufacturing practice 

(emphasis added). Evidence indicating 

that such a violation exists causes the 

food to be adulterated, even though the 

amounts of natural or unavoidable 

defects are lower than the currently 

established defect action levels. The 

manufacturer, processor, packer and 

holder of food must at all times utilize 

quality control operations that reduce 

natural or unavoidable defects to the 

lowest level currently feasible. 

FDA is proposing to revise current 

§ 110.110(d) to replace the clause ‘‘The 

mixing of a food containing defects 

above the current defect action level 

* * *’’ with ‘‘The mixing of a food 

containing defects at levels that render 

the food adulterated * * *’’ We are 

proposing this change to clarify that 

food containing defects above the 

current defect action level is not 

automatically adulterated under the 

FD&C Act. A defect action level is 

nonbinding and is directed to a natural 

or unavoidable defect in food that 

presents no health hazards for humans 

(Ref. 141). Whether food containing 

defects above the current defect action 

levels adulterate the food is a case-bycase determination that depends on the 

circumstances. Proposed § 117.110(d) 

would specify that the mixing of a food 

containing defects at levels that render 

that food adulterated with another lot of 

food is not permitted and renders the 

final food adulterated, regardless of the 

defect level of the final food (emphasis 

added). 

As discussed in section XI.A of this 

document, FDA is proposing to delete 

current § 110.110(e), which provides 

that a compilation of the current defect 

action levels for natural or unavoidable 

defects in food for human use that 

present no health hazard may be 

obtained upon request. 

M. Potential Revisions To Establish 

Requirements in Place of Current 

Guidance 

1. Overview 

In sections IX.F and XI.A of this 

document, we discuss our intent to 

delete some non-binding provisions of 

current part 110 (e.g., provisions using 

‘‘should’’ or ‘‘compliance may be 

achieved by’’). In this section of this 

document, we request comment on 

whether to revise other non-binding 

provisions to establish new 

requirements in proposed part 117 or 

retain them as useful recommendations 

of a comprehensive CGMP provision. 

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3728 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

We discuss each of these immediately 

below. 

We believe that these CGMP 

provisions are science-based and an 

important part of a modern food safety 

system. Because these non-binding 

provisions have been in place for 

decades, they are widely used and 

commonly accepted in many sectors of 

the food industry. In addition, under 

section 418(o)(3) of the FD&C Act, the 

procedures, practices, and processes 

described in the definition of preventive 

controls may include sanitation 

procedures for food contact surfaces of 

utensils and equipment; supervisor, 

manager, and employee hygiene 

training; and CGMPs under part 110 of 

title 21 (or any successor regulations). 

The vast majority of the costs related 

to a revised mandatory sanitary 

operations, process and controls 

program would be for the time that 

workers are in training for the 

alternative requirements rather than in 

production. We estimate that this 

alternative, when implemented as part 

of a preventive approach, could impose 

an incremental annual cost of $560– 

$28,000 per facility based on size 

(number of employees) to facilities that 

do not already comply with this 

alternative. This would result in an 

estimated aggregate cost of $16 million 

for domestic facilities and an estimated 

aggregate cost of $17,400,000 for foreign 

facilities. This estimate assumes that 

about half of the qualified facilities 

would need to review their operations 

and perform the training. Most nonqualified facilities would have met the 

requirements by following the 

requirements for sanitation controls in 

subpart C but for those that do not have 

hazards that are reasonably likely to 

occur or for those with sanitation 

controls that do not fully address the 

requirements of the sanitary operations, 

they would need to review their 

operations and perform the training. 

Further details are provided in the 

‘‘Consideration of Other Provisions’’ 

section of the RIA. 

2. Summary of Potential Revisions To 

Establish Requirements in Place of 

Current Guidance 

Table 11 identifies each of the 

potential revisions to establish new 

requirements and either explains the 

reason for establishing the requirement 

or, for such revisions with longer 

explanations, refers to the section of this 

document where the potential 

requirement is explained. 

TABLE 11—POTENTIAL REVISIONS TO ESTABLISH REQUIREMENTS IN PLACE OF CURRENT GUIDANCE

Designation of proposed 

provision 

Potential additional revision to establish a requirement 

in place of a recommendation (emphasis added) Basis for potential revision 

§ 117.10(c) ........................... Personnel responsible for identifying sanitation failures 

or food contamination must have a background of 

education or experience, or a combination thereof, to 

provide a level of competency necessary for production of clean and safe food. Food handlers and supervisors must receive appropriate training in proper 

food handling techniques and food-protection principles and should be informed of the danger of poor 

personal hygiene and insanitary practices.

See explanation and questions about whether more detail would be appropriate in section XI.M.3 of this 

document. 

§ 117.35(d)(3) (Sanitation of 

food-contact substances).

Single-service articles (such as utensils intended for 

one-time use, paper cups, and paper towels) must be 

stored in appropriate containers and must be handled, dispensed, used, and disposed of in a manner 

that protects against cross-contact and contamination 

of food, food-contact surfaces, or food-packaging materials.

Failure to properly store such articles could lead to contamination of the articles and then to contamination 

of food if the articles come in contact with food. 

§ 117.35(e) (Sanitation of 

non-food-contact substances).

Non-food-contact surfaces of equipment used in the operation of a food plant must be cleaned in a manner 

and as frequently as necessary to protect against 

cross-contact and contamination of food and foodcontact surfaces.

Failure to clean non-food-contact surfaces could lead to 

contamination of food-contact surfaces of the equipment and utensils and then to contamination of food 

if the contaminated equipment and utensils come in 

contact with food. For example, cleaning non-foodcontact surfaces is essential to prevent contamination 

of food from environmental pathogens such as L. 

monocytogenes and Salmonella spp. 

§ 117.35(f) (Storage and 

handling of cleaned portable equipment and utensils).

Cleaned and sanitized portable equipment with foodcontact surfaces and utensils must be stored in a location and manner that protects food-contact surfaces from contamination.Failure to properly store and handle such equipment 

and utensils could lead to contamination of the equipment and utensils and then to contamination of food 

if the equipment and utensils come in contact with 

food. 

§ 117.40(a)(1) (Equipment 

and utensils).

All equipment must be so installed and maintained as 

to facilitate the cleaning of the equipment and of all 

adjacent spaces.

Failure to properly clean equipment and adjacent 

spaces due to improper installation and maintenance 

could lead to contamination of the equipment and 

then contamination of food if the equipment comes in 

contact with the food. 

§ 117.80(b)(1) (Processes 

and controls—raw materials and ingredients).

Containers and carriers of raw materials must be inspected on receipt to ensure that their condition has 

not contributed to the contamination or deterioration 

of food.

Containers and carriers of raw materials not properly 

maintained can lead to contamination or deterioration 

of food. 

§ 117.80(c)(10) (Manufacturing operations).Food must be protected from contaminants that may 

drip, drain, or be drawn into the food during manufacturing steps such as washing, peeling, trimming, cutting, sorting and inspecting, mashing, dewatering, 

cooling, shredding, extruding, drying, whipping, 

defatting, and forming.

There are no circumstances where it would not be necessary to provide adequate physical protection of 

food from contaminants that may drip, drain, or be 

drawn into food. 

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TABLE 11—POTENTIAL REVISIONS TO ESTABLISH REQUIREMENTS IN PLACE OF CURRENT GUIDANCE—Continued 

Designation of proposed 

provision 

Potential additional revision to establish a requirement 

in place of a recommendation (emphasis added) Basis for potential revision 

§ 117.80(c)(11) (Manufacturing operations).Heat blanching, when required in the preparation of 

food, must be effected by heating the food to the required temperature, holding it at this temperature for 

the required time, and then either rapidly cooling the 

food or passing it to subsequent manufacturing without delay.

Properly heating and cooling food during blanching is 

necessary to protect food from contamination and 

would apply in all cases for food when heat blanching is required in the preparation. 

§ 117.80(c)(11) (Manufacturing operations).Thermophilic growth and contamination in blanchers 

must be minimized by the use of adequate operating 

temperatures and by periodic cleaning.

Adequate operating temperatures and proper cleaning 

are necessary for controlling growth of thermophilic 

bacteria and contamination and would apply in all 

cases for food when heat blanching is required in the 

preparation. 

3. Potential Revisions To Establish 

Requirements in Place of Current 

Guidance for Education and Training 

Current § 110.10(c) provides guidance 

that personnel responsible for 

identifying sanitation failures or food 

contamination should have a 

background of education or experience, 

or a combination thereof, to provide a 

level of competency necessary for 

production of clean and safe food. 

Current § 110.10(c) further recommends 

that food handlers and supervisors 

receive appropriate training in proper 

food handling techniques and foodprotection principles and should be 

informed of the danger of poor personal 

hygiene and insanitary practices. 

As discussed in section II.A.1 of this 

document, the CGMP Working Group 

Report identified specific areas that 

presented an opportunity to modernize 

the regulation. One recommendation 

was to ‘‘require appropriate training for 

supervisors and workers to ensure that 

they have the necessary knowledge and 

expertise in food hygiene, food 

protection, employee health and 

personal hygiene to produce safe food 

products. This training must be 

delivered in a manner that can be easily 

understood by the worker. Food 

processors must maintain a record of 

this training for each worker’’ (Ref. 1). 

Our analysis of recalls also indicates 

that ineffective employee training was a 

root cause of 32 percent of CGMPrelated recalls in the 1999–2003 analysis 

(Ref. 58); deficiencies in training were 

identified as a contributing factor in 24 

percent of CGMP-related primary recalls 

in the 2008–2009 analysis (Ref. 59). In 

addition, as discussed with respect to 

the proposed definition of preventive 

controls (see section X.C.4 of this 

document), section 418(o)(3) of the 

FD&C Act recognizes the importance of 

both training and CGMPs in preventing 

hazards from occurring in foods in its 

definition of preventive controls, which 

identifies supervisor, manager, and 

employee hygiene training 

(§ 418(o)(3)(B)) and CGMPs under part 

110 (§ 418(o)(3)(F)) as some of the 

procedures, practices, and processes 

that may be included as preventive 

controls. 

The vast majority of costs related to a 

mandatory education and training 

program would be for the time that 

workers would be training rather than in 

production. We estimate that a 

requirement for education and training, 

when implemented as part of a 

preventive approach, could impose an 

incremental annual cost of $1,000– 

$25,000 per facility based on size 

(number of employees) to facilities that 

do not already conduct training. This 

would result in an estimated aggregate 

cost of $93 million for domestic 

facilities and an estimated aggregate cost 

of $101,300,000 for foreign facilities. 

This estimate assumes that both 

qualified and nonqualified facilities 

would be required to perform the 

training. Further details are provided in 

the ‘‘Consideration of Other Provisions’’ 

section of the RIA. 

We request comment on how best to 

revise current § 110.10(c) in light of 

section 418(o)(3) of the FD&C Act and 

the recommendations of the CGMP 

Working Group with respect to training. 

Should we replace the current 

recommendations for personnel 

education and experience with 

requirements? Doing so would be 

consistent with the emphasis in section 

418(o)(3) of the FD&C Act on the 

importance of both training and CGMPs 

in preventing hazards from occurring in 

foods in its definition of preventive 

controls and with the recommendation 

in the CGMP Working Group Report. If 

so, what is the appropriate level of 

specificity? For example, should we 

simply replace the ‘‘shoulds’’ in current 

§ 110.10(c) with ‘‘musts’’? This would 

provide flexibility for each 

establishment to determine the type and 

frequency of education and training 

appropriate for its personnel. 

FDA also requests comment on 

whether more detail would be 

appropriate, by, for example: 

• Specifying that each person 

engaged in food manufacturing, 

processing, packing, or holding 

(including temporary and seasonal 

personnel and supervisors) receive 

training as appropriate to the person’s 

duties; 

• Specifying the frequency of training 

(e.g., upon hiring and periodically 

thereafter); 

• Specifying that training include the 

principles of food hygiene and food 

safety, including the importance of 

employee health and personal hygiene, 

as applied at the facility; and 

• Specifying that records document 

required training of personnel and, if so, 

specifying minimum requirements for 

the documentation (e.g., the date of the 

training, the type of training, and the 

person(s) trained). 

We also request comment on whether 

to establish some or all of the potential 

requirements for education and training 

in subpart B, subpart C, or both. If we 

establish a requirement for education 

and training in subpart B, that 

requirement would apply to all persons 

who manufacture, process, pack or hold 

food, with the exceptions of persons 

who would be exempt from subpart B 

(i.e., under proposed § 117.5(k), a 

requirement in subpart B would not 

apply to ‘‘farms’’, activities of ‘‘farm 

mixed-type facilities’’ that fall within 

the definition of ‘‘farm,’’ or the holding 

or transportation of one or more RACs). 

On the other hand, if we establish a 

requirement for education and training 

in subpart C, that requirement would 

not apply to persons who would be 

exempt from the requirements of 

proposed subpart C (e.g., qualified 

facilities and persons conducting 

activities subject to HACCP regulations 

for juice or seafood). 

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3730 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

N. Request for Comment on Additional 

CGMP Requirements 

We request comment on any 

additional proposed revisions or 

clarifications to our CGMP regulations 

that should be included in subpart B, 

including whether to further implement 

the ‘‘opportunities’’ for CGMP 

modernization identified by the CGMP 

Working Group or to enhance the CGMP 

regulations in some other way. For 

example, we request comment on 

whether a final rule based on this 

proposed rule should include CGMP 

requirements for environmental 

monitoring for L. monocytogenes, and 

whether such requirements should 

include other environmental pathogens 

such as Salmonella spp. If so, we also 

request comment on what such 

requirements should be. For additional 

information on environmental 

monitoring for L. monocytogenes and 

Salmonella spp., see sections I.D and I.E 

of the Appendix to this document. 

XII. Proposed New Requirements for 

Hazard Analysis and Risk-Based 

Preventive Controls (Proposed Part 117, 

Subpart C) 

A. Proposed § 117.126—Requirement for 

a Food Safety Plan 

1. Requirements of Section 418 of the 

FD&C Act 

Section 418(h) of the FD&C Act 

requires that the owner, operator, or 

agent in charge of a facility shall prepare 

a written plan that documents and 

describes the procedures used by the 

facility to comply with the requirements 

of section 418 of the FD&C Act, 

including analyzing the hazards under 

section 418(b) of the FD&C Act and 

identifying the preventive controls 

adopted under section 418(c) of the 

FD&C Act to address those hazards. 

Section 418(h) of the FD&C Act also 

requires that such written plan, together 

with the documentation described in 

section 418(g) of the FD&C Act, shall be 

made promptly available to a duly 

authorized representative of the 

Secretary upon oral or written request. 

2. Proposed § 117.126(a)—Requirement 

for a Food Safety Plan 

Proposed § 117.126(a) would require 

that the owner, operator, or agent in 

charge of a facility prepare, or have 

prepared, and implement a written food 

safety plan. We use the term ‘‘written 

food safety plan’’ in proposed 

§ 117.126(a) to mean the ‘‘written plan’’ 

referred to in section 418(h) of the FD&C 

Act. To make clear that the written plan 

is related to food safety rather than to 

other plans a facility may have (such as 

quality control plans or food defense 

plans), we have designated the ‘‘written 

plan’’ to be a ‘‘food safety plan.’’ 

Proposed § 117.126(a) would require 

that the plan be written as is expressly 

required by section 418(h). A written 

food safety plan is essential for the 

facility to implement the plan 

consistently, train its employees, and 

periodically reanalyze and update the 

plan. It is also essential to a facility’s 

food safety team, to auditors, and to 

inspectors. Proposed § 117.126(a) would 

implement section 418(h) of the FD&C 

Act and is consistent with the NACMCF 

HACCP guidelines, the Codex HACCP 

Annex, and Federal HACCP regulations 

for seafood, juice, and meat and poultry. 

The recordkeeping provisions of the 

NACMCF HACCP guidelines 

recommend that the HACCP plan 

include a list of the HACCP team and 

assigned responsibilities; a description 

of the food, its distribution, intended 

use, and consumer; a verified flow 

diagram; a HACCP Plan Summary Table 

that includes information for steps in 

the process that are CCPs, the hazard(s) 

of concern, critical limits, monitoring, 

corrective actions, verification 

procedures and schedule, and recordkeeping procedures (Ref. 34). The Codex 

HACCP Annex recommends that 

HACCP procedures be documented, 

including the hazard analysis, and 

determinations of CCPs and critical 

limits (Ref. 35). Federal HACCP 

regulations for seafood, juice, and meat 

and poultry require a written plan 

(§§ 123.6(b)) and 120.8(a) and 9 CFR 

417.2(b), respectively). 

Proposed § 117.126(a) would provide 

flexibility for the owner, operator, or 

agent in charge of the facility to either 

prepare the written food safety plan or 

have that plan prepared, in whole or in 

part, on its behalf. This flexibility is 

consistent with the NACMCF HACCP 

guidelines (Ref. 34), which advise that 

a HACCP team may need assistance 

from outside experts who are 

knowledgeable in the hazards associated 

with the product and the process. This 

flexibility also is consistent with the 

Codex HACCP Annex, which 

acknowledges that small and/or less 

developed businesses do not always 

have the resources and the necessary 

expertise on site for the development 

and implementation of an effective 

HACCP plan and recommends that 

expert advice be obtained when 

necessary from other sources, such as 

trade and industry associations, 

independent experts and regulatory 

authorities. In addition, proposed 

§ 117.126 would provide flexibility for 

facilities in the development of their 

food safety plans by allowing facilities 

to group food types or production 

method types if the hazards, control 

measures, parameters, and required 

procedures such as monitoring are 

essentially identical. 

Proposed § 117.126(a) would require 

that the owner, operator, or agent in 

charge of a facility implement the 

written food safety plan. Although 

section 418(h) of the FD&C Act is silent 

with respect to implementation of the 

required written plan, other provisions 

of section 418 address implementation. 

For example, section 418(c) of the FD&C 

Act requires, in relevant part, that the 

owner, operator, or agent in charge of a 

facility both establish and implement 

preventive controls (emphasis added). 

In addition, other provisions of section 

418 (e.g., section 418(d) regarding 

monitoring, section 418(e) regarding 

corrective actions, and section 418(f) 

regarding verification) all establish 

requirements related to the preventive 

controls required under section 418(c). 

As discussed immediately below, the 

written food safety plan would include 

the hazard analysis required under 

section 418(b) of the FD&C Act, the 

preventive controls required under 

section 418(c) of the FD&C Act, the 

monitoring procedures required under 

section 418(d) of the FD&C Act, the 

corrective action procedures required 

under section 418(e) of the FD&C Act, 

the verification procedures required 

under section 418(f) of the FD&C Act, 

and the recall plan as authorized by 

section 418(o)(3)(E) of the FD&C Act. 

Specific provisions for implementing 

these sections of the statute would be 

established throughout proposed 

subpart C. 

3. Proposed § 117.126(b)—Contents of a 

Food Safety Plan 

Proposed § 117.126(b)(1) through (6) 

would require that the contents of a 

food safety plan include: 

• The written hazard analysis as 

required by proposed § 117.130(a)(2); 

• The written preventive controls as 

required by proposed § 117.135(b); 

• The written procedures, and the 

frequency with which they are to be 

performed, for monitoring the 

implementation of the preventive 

controls as required by proposed 

§ 117.140(a); 

• The written corrective action 

procedures as required by proposed 

§ 117.145(a)(1); 

• The written verification procedures 

as required by proposed § 117.150(e); 

and 

• The written recall plan as required 

by § 117.137(a). 

Section 418(h) requires that the 

written plan document and describe the 

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procedures used by the facility to 

comply with the requirements of section 

418, ‘‘including analyzing the hazards 

under [section 418(b) of the FD&C Act] 

and identifying the preventive controls 

adopted under [section 418(c) of the 

FD&C Act] to address those hazards’’ 

(emphasis added). Although section 

418(h) of the FD&C Act explicitly 

references sections 418(b) and (c), the 

term ‘‘including,’’ indicates that the 

contents of a food safety plan need not 

be limited to the provisions of sections 

418(b) and (c) of the FD&C Act. 

FDA interprets the requirement in 

section 418(h) of the FD&C Act that the 

written plan document and describe the 

procedures used by the facility to 

comply with the requirements of section 

418 of the FD&C Act to mean that the 

written food safety plan would include 

all procedures required under section 

418 of the FD&C Act. As discussed in 

sections XII.E.6.a, XII.F.2, XII.G.6, and 

XII.D.2 of this document, the proposed 

rule would require written procedures 

for monitoring the implementation of 

the preventive controls (proposed 

§ 117.140(a)); written corrective action 

procedures (proposed § 117.145(a)(1)); 

written procedures for some verification 

activities (proposed § 117.150(e)); and a 

written recall plan (proposed 

§ 117.137(a)). 

FDA interprets the requirement in 

section 418(h) that the written plan 

describe the procedures used by the 

facility to comply with the requirements 

of section 418, including analyzing the 

hazards and identifying the preventive 

controls adopted to address those 

hazards, to mean that the contents of the 

food safety plan must include the 

hazard analysis conducted by the 

facility and the preventive controls that 

a facility must establish for hazards that 

its hazard analysis identifies as 

reasonably likely to occur, rather than 

procedures for analyzing the hazards 

and procedures for identifying the 

preventive controls. The general 

requirement in section 418(a) of the act 

is directed, in relevant part, to 

evaluating the hazards that could affect 

food manufactured, processed, packed, 

or held by a facility, and identifying and 

implementing preventive controls to 

significantly minimize or prevent the 

occurrence of such hazards and provide 

assurances that such food is not 

adulterated under section 402 of the 

FD&C Act or misbranded under section 

403(w) of the FD&C Act. Review of the 

evaluation of hazards in the hazard 

analysis is sufficient to determine the 

adequacy of the hazard analysis. Written 

procedures for conducting the hazard 

analysis are not necessary. Similarly, 

the preventive controls identified by the 

facility can be reviewed fully for 

adequacy without having a separate 

procedures document. 

Under our interpretation of section 

418(h) of the FD&C Act, proposed 

§ 117.126(b)(1) and (2) are consistent 

with the NACMCF HACCP guidelines, 

the Codex HACCP Annex, and Federal 

HACCP regulations for seafood, juice, 

and meat and poultry. The NACMCF 

HACCP guidelines recommend that a 

HACCP plan include the hazards of 

concern (which are the end product of 

the hazard analysis), the CCPs (which 

are the steps at which control can be 

applied and which are essential to 

prevent or eliminate a food safety 

hazard or reduce it to an acceptable 

level), and critical limits (which are the 

maximum or minimum values 

established at a CCP to control a hazard) 

(Ref. 34). The Codex HACCP Annex 

(Ref. 35) recommends that the HACCP 

plan include documentation of the 

hazard analysis and determinations of 

CCPs and critical limits. Federal HACCP 

regulations for seafood, juice, and meat 

and poultry all require that the HACCP 

plan list the food [safety] hazards that 

are reasonably likely to occur 

(§§ 123.6(c)(1) and 120.8(b)(1) and 9 

CFR 417.2(c)(1), respectively), the CCPs 

(§§ 123.6(c)(2) and 120.8(b)(2) and 9 

CFR 417.2(c)(2), respectively), and 

critical limits (§§ 123.6(c)(3) and 

120.8(b)(3) and 9 CFR 417.2(c)(3), 

respectively). The FSIS HACCP 

regulation for meat and poultry further 

requires that the written hazard analysis 

be maintained as part of the 

documentation for the establishment’s 

HACCP plan (9 CFR 417.5(a)(1)). None 

of these documents recommends or 

requires that the HACCP plan include 

the procedures for analyzing the hazards 

or procedures for identifying the CCPs 

and critical limits. Rather, these 

documents are clear that it is the 

outcomes rather than the procedures for 

conducting the hazard analysis and 

identifying the preventive controls that 

are part of the plan. 

4. Proposed § 117.126(c)—Preparation of 

the Food Safety Plan by a Qualified 

Individual 

Proposed § 117.126(c) would require 

that the food safety plan be prepared by 

(or its preparation overseen by) a 

qualified individual. (See the discussion 

in section XII.H of this document 

regarding the qualifications of a 

qualified individual as would be 

established in proposed § 117.155(b)). 

Section 418 of the FD&C Act requires 

that firms identify and implement 

preventive controls and that facilities 

monitor and verify the effectiveness of 

the preventive controls. A qualified 

individual must develop the food safety 

plan in order to ensure the preventive 

controls are effective. The plan must be 

designed to identify and to significantly 

minimize or prevent hazards in order to 

prevent illness or injury. Designing a 

plan requires an individual who is 

knowledgeable in the concepts of 

preventive controls, the hazards 

associated with a product and process, 

the appropriate preventive controls, 

with associated monitoring and 

corrective actions for those hazards, and 

appropriate verification activities for the 

applicable preventive controls. Such 

knowledge requires scientific and 

technical expertise developed through 

training, experience, or both. 

Section 418 of the FD&C Act does not 

address the qualifications of the 

individual who would prepare the food 

safety plan. However, proposed 

§ 117.126(c) is consistent with the 

NACMCF HACCP guidelines, the Codex 

HACCP Annex, and Federal regulations 

for seafood, juice, and meat and poultry. 

The NACMCF HACCP guidelines 

recommend that, because of the 

technical nature required for the hazard 

analysis, experts who are 

knowledgeable in the food process 

either participate in or verify the hazard 

analysis and the HACCP plan (Ref. 34). 

Our HACCP regulations for seafood and 

juice require that the individual 

developing the HACCP plan complete 

training in the application of HACCP 

principles to juice or seafood processing 

under a standardized curriculum or be 

qualified through job experience that 

provides knowledge at least equivalent 

to that provided through the 

standardized curriculum (§§ 123.10 and 

120.13, respectively). The FSIS HACCP 

regulation for meat and poultry requires 

that the individual developing the 

HACCP plan complete training in the 

application of HACCP principles to 

meat or poultry product processing (9 

CFR 417.7). 

One way to comply with proposed 

§ 117.126(c) could be for a team of 

individuals (for example, a ‘‘HACCP 

team’’ or a ‘‘food safety team’’) to 

develop the food safety plan under the 

oversight of a qualified individual. Each 

member of a HACCP or food safety team 

generally brings specific expertise 

important in developing the plan. For 

example, a microbiologist could provide 

knowledge of microbial hazards, an 

engineer could establish the critical 

parameters for delivery of heat 

treatments, and a maintenance 

supervisor could identify sources of 

metal contamination. Proposed 

§ 117.126 would not require that all 

such members of a food safety team 

satisfy the requirements in proposed 

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3732 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

§ 117.126(c) for a qualified individual. 

However, under proposed § 117.126(c), 

a qualified individual must be 

responsible for ensuring that all 

components the food safety plan have 

been developed, including reviewing all 

information contained in the food safety 

plan, thereby verifying the hazard 

analysis and food safety plan developed 

by the food safety team. 

5. Facility-Based Nature of the Written 

Food Safety Plan 

The overall framework of section 418 

of the FD&C Act is directed to a facility 

rather than, for example, a corporate 

entity that may have multiple facilities. 

For example, under section 418(b) of the 

FD&C Act the owner, operator, or agent 

in charge of a facility must identify and 

evaluate known or reasonably 

foreseeable hazards that may be 

associated with the facility (emphasis 

added). Thus, proposed § 117.126 

establishes a requirement for every 

facility to have its own written food 

safety plan. The facility-based nature of 

the written food safety plan that would 

be required by proposed § 117.126 is 

consistent with the NACMCF HACCP 

guidelines, the Codex HACCP Annex, 

and Federal HACCP regulations for 

seafood, juice, and meat and poultry. 

The NACMCF HACCP guidelines 

emphasize that it is essential that the 

unique conditions within each facility 

be considered during the development 

of all components of the HACCP plan 

(Ref. 34). The Codex HACCP Annex 

states that HACCP should be applied to 

each specific operation separately (Ref. 

35). Federal HACCP regulations for 

seafood, juice, and meat and poultry 

require that HACCP plans be specific to 

each location where the product is 

processed (§§ 123.6(b)(1) and 120.8(a)(1) 

for seafood and juice, respectively) or to 

‘‘every official establishment’’ (9 CFR 

417.2(a)) for meat and poultry). 

Federal HACCP regulations for 

seafood, juice, and meat and poultry 

allow the HACCP plan to group food 

types or production method types if the 

hazards, critical control points, critical 

limits and required procedures such as 

monitoring are essentially identical, 

provided that any required features of 

the plan that are unique to a specific 

product or production method are 

clearly delineated in the plan and are 

observed in practice (§§ 123.6(b)(2) and 

120.8(a)(2) and 9 CFR 417.2(b)(2) for 

seafood, juice, and meat and poultry, 

respectively). This type of grouping 

would be allowed under proposed 

§ 117.126 and, thus, would provide 

flexibility for facilities in the 

development of their HACCP plans. 

B. Proposed § 117.130—Hazard 

Analysis 

1. Requirements of Section 418 of the 

FD&C Act 

Section 418(b)(1) of the FD&C Act 

specifies, in relevant part, that the 

owner, operator, or agent in charge of a 

facility shall identify and evaluate 

known or reasonably foreseeable 

hazards that may be associated with the 

facility, including (A) biological, 

chemical, physical, and radiological 

hazards, natural toxins, pesticides, drug 

residues, decomposition, parasites, 

allergens, and unapproved food and 

color additives; and (B) hazards that 

occur naturally, or may be 

unintentionally introduced. Section 

418(b)(3) of the FD&C Act specifies, in 

relevant part, that the owner, operator, 

or agent in charge of a facility shall 

develop a written analysis of the 

hazards. 

As discussed in section II.B.2.f of this 

document, this rulemaking is not 

intended to address ‘‘hazards that may 

be intentionally introduced, including 

by acts of terrorism.’’ Therefore, we are 

not implementing section 418(b)(2) of 

the FD&C Act in this proposed rule. 

Section 418(c)(1) of the FD&C Act 

specifies that the owner, operator, or 

agent in charge of a facility shall 

identify and implement preventive 

controls, including at critical control 

points, if any, to provide assurances that 

hazards identified in the hazard analysis 

conducted under section 418(b)(1) of the 

FD&C Act will be significantly 

minimized or prevented. Section 

418(c)(3) of the FD&C Act specifies that 

the food manufactured, processed, 

packed, or held by such facility will not 

be adulterated under section 402 of the 

FD&C Act or misbranded under section 

403(w) of the FD&C Act. 

Sections 418(c)(1) and (c)(3) of the 

FD&C Act, which we will address more 

fully in section XII.C.1 of this 

document, are relevant to our 

discussion of proposed § 117.130(a) 

regarding the purpose of the hazard 

analysis required by section 418(b) of 

the FD&C Act. 

2. Proposed § 117.130(a)—Hazard 

Analysis 

a. Proposed § 117.130(a)(1)— 

Requirement to identify and evaluate 

hazards. Proposed § 117.130(a)(1) 

would require that the owner, operator, 

or agent in charge of a facility identify 

and evaluate known or reasonably 

foreseeable hazards, for each type of 

food manufactured, processed, packed, 

or held at the facility to determine 

whether there are hazards that are 

reasonably likely to occur. As discussed 

more fully in the remainder of this 

section, proposed § 117.130(a)(1) would 

implement section 418(b)(1) of the 

FD&C Act. 

Proposed § 117.130(a)(1) is consistent 

with the NACMCF HACCP guidelines, 

the Codex HACCP Annex, and Federal 

HACCP regulations for seafood, juice, 

and meat and poultry. The NACMCF 

HACCP guidelines describe a two-stage 

process for conducting a hazard analysis 

(Ref. 34), i.e., hazard identification and 

hazard evaluation. Hazard identification 

has been described as a brainstorming 

session designed to facilitate the 

development of a list of potential 

hazards, including those known to be 

associated with a type of food or process 

and those known to have occurred in a 

particular facility, for consideration 

during the hazard evaluation step (Ref. 

143). Hazard evaluation is conducted 

after development of the list of potential 

hazards associated with each step in the 

product’s process. The Codex HACCP 

Annex recommends that the HACCP 

team list all of the hazards that may be 

reasonably expected to occur at each 

step from primary production, 

processing, manufacture, and 

distribution until the point of 

consumption and then conduct a hazard 

analysis to identify which hazards are of 

such a nature that their elimination or 

reduction to acceptable levels is 

essential to the production of a safe food 

(Ref. 35). Our HACCP regulation for 

juice requires that a hazard analysis 

both identify hazards and evaluate 

whether they are reasonably likely to 

occur (§ 120.7(a)(1) and (2)). Federal 

HACCP regulations for seafood and 

meat and poultry require that a 

processor or establishment conduct, or 

have conducted for it, a hazard analysis 

to determine whether there are food 

safety hazards that are reasonably likely 

to occur (§ 123.6(a) and 9 CFR 417.2(a)). 

In considering the proposed 

requirement for a hazard analysis, we 

considered the language of section 

418(b)(1) of the FD&C Act describing the 

hazards that a facility would identify 

and evaluate—i.e., ‘‘known or 

reasonably foreseeable hazards that may 

be associated with the facility.’’ We 

consider that the ‘‘known or reasonably 

foreseeable hazards’’ in section 418(b) of 

the FD&C Act are analogous to the 

‘‘potential hazards’’ discussed in the 

NACMCF HACCP guidelines, and the 

hazards that are required to be 

identified to determine if they are 

‘‘hazards that may be reasonably 

expected to occur at each step’’ in the 

Codex HACCP Annex, or ‘‘reasonably 

likely to occur’’ in Federal HACCP 

regulations for seafood, juice, and meat 

and poultry. 

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Proposed § 117.130(a)(1) would 

establish the requirement to identify 

and evaluate hazards by conducting a 

hazard analysis; we propose specific 

requirements for the hazard 

identification in proposed § 117.130(b) 

(see section XII.B.3 of this document) 

and specific requirements for the hazard 

evaluation in proposed § 117.130(c) (see 

section XII.B.4 of this document). 

Proposed § 117.130(a)(1) would 

require that the identification and 

evaluation of hazards be done ‘‘for each 

type of food manufactured, processed, 

packed, or held at the facility.’’ In 

considering the proposed requirement 

for a hazard analysis, we considered the 

language of section 418(b)(1) of the 

FD&C Act. The purpose of sections 

418(b)(1) appears clear—i.e., that the 

owner, operator, or agent in charge of a 

facility identify and evaluate known or 

reasonably foreseeable hazards that may 

be associated with the food produced by 

the facility. The known or reasonably 

foreseeable hazards associated with the 

facility’s food may differ based on the 

type of food and, thus, the NACMCF 

HACCP guidelines, the Codex HACCP 

Annex, and Federal HACCP regulations 

for seafood, juice, and meat and poultry 

all apply a hazard analysis to each type 

of food manufactured, processed, 

packed, or held at the facility. Proposed 

§ 117.130(a) would do likewise. 

The NACMCF HACCP guidelines 

(Ref. 34) and Codex HACCP Annex (Ref. 

35) describe several preliminary tasks 

that need to be accomplished before 

application of the HACCP principles to 

a specific product and process, 

including describing the food and its 

distribution, describing the intended 

use and consumers of the food, and 

developing a flow diagram for the 

process. Our HACCP regulations for 

seafood and juice require that the 

hazard analysis be conducted for each 

kind of fish or fishery product (or for 

each type of juice product) processed by 

the processor (§§ 123.6(a) and 120.7(a)) 

but do not mandate any particular 

process for the hazard analysis. The 

FSIS HACCP regulation for meat and 

poultry requires that a flow chart be 

prepared describing the steps for each 

process and product flow in the 

establishment (9 CFR 417.2(a)(2)) and 

also requires a HACCP plan for each 

product produced by the establishment 

whenever the hazard analysis reveals 

one or more hazards that are reasonably 

likely to occur (9 CFR 417.2(b)(1)). 

The process of identifying and 

evaluating the hazards that may occur 

for specific types of food handled in a 

facility provides an efficient means for 

keeping track of multiple hazards that 

may occur in a facility that handles 

several types of foods. Such a process 

also provides an efficient means for 

ensuring that preventive controls are 

applied to specific foods when required. 

Thus, a facility may need to conduct 

multiple hazard analyses. For example, 

a facility that produces tea-based 

beverages may package its products in 

both glass and plastic bottles at the same 

facility. Although these two products 

might contain similar ingredients, we 

would consider them to be different 

types of food under proposed 

§ 117.130(a)(1) because the two types of 

packaging entail significant differences 

in the handling of these products during 

processing. The hazard of glass particles 

resulting from glass container breakage 

during plant operations is a known 

hazard associated with glass-packaged 

products and, thus, should be identified 

and evaluated for the product packaged 

in glass but not for the product 

packaged in plastic. 

Proposed § 117.130(a)(1) would 

identify the purpose of the hazard 

analysis—i.e., to determine whether 

there are hazards that are reasonably 

likely to occur. Although section 

418(b)(1) of the FD&C Act does not 

explicitly identify the purpose of the 

hazard analysis, we interpret the 

combined requirements of sections 

418(b), (c)(1) and (c)(3) of the FD&C Act 

to reflect a purpose, i.e., to enable the 

facility to identify and, where necessary, 

implement preventive controls to 

provide assurances that hazards 

identified in the hazard analysis will be 

significantly minimized or prevented 

and that the food manufactured, 

processed, packed or held by the facility 

will not be adulterated under section 

402 of the FD&C Act or misbranded 

under section 403(w) of the FD&C Act. 

If, for example, the facility concludes 

during the hazard analysis that one or 

more (or even all) known or reasonably 

foreseeable hazards are not reasonably 

likely to occur in the facility for a 

certain type of food, the facility could 

conclude that there is no need to 

identify and implement preventive 

controls for those hazards. The purpose 

of the hazard analysis identified in 

proposed § 117.130(a)(1) is consistent 

with the purpose identified in the 

NACMCF HACCP guidelines, the Codex 

HACCP Annex, and Federal HACCP 

regulations for seafood, juice, and meat 

and poultry. The NACMCF HACCP 

guidelines identify the purpose of the 

hazard analysis as the development of a 

list of hazards that are of such 

significance that they are reasonably 

likely to cause illness or injury if not 

effectively controlled (Ref. 34). The 

Codex HACCP Annex recommends that 

the HACCP team identify for the HACCP 

plan hazards that are of such a nature 

that their elimination or reduction to 

acceptable levels is essential to the 

production of a safe food (Ref. 35). The 

stated purpose of the hazard analysis in 

Federal HACCP regulations for seafood, 

juice and meat and poultry is, in 

relevant part, to determine whether 

there are food safety hazards that are 

reasonably likely to occur for each kind 

of product (§§ 123.6(a) and 120.7(a), 

respectively, for seafood and juice) or in 

the production process for meat and 

poultry (9 CFR 417.2(a)). 

b. Proposed § 117.130(a)(2)— 

Requirement for the hazard analysis to 

be written. Proposed § 117.130(a)(2) 

would require that the hazard analysis 

be written, as required by section 

418(b)(3) of the FD&C Act. A written 

hazard analysis can help the facility 

organize the scientific basis for the 

hazard analysis and would be essential 

to the facility’s food safety team, to 

auditors, and to inspectors. The 

facility’s food safety team needs to fully 

understand the nature of the hazards in 

order to produce a safe food. For 

example, although the facility’s food 

safety plan would include corrective 

action procedures that address problems 

that can be anticipated, the food safety 

team will need to make decisions as to 

appropriate corrective actions when 

there is an unanticipated problem (see, 

e.g., the discussion of a proposed 

requirement (proposed § 117.145(b)) for 

corrective actions when there is an 

unanticipated problem in section XII.F.3 

of this document). The written hazard 

analysis would be useful at these times. 

Having a written hazard analysis 

available for auditors and for inspectors 

is essential for them to assess the 

adequacy of the hazard analysis. A 

written hazard analysis also would be 

essential during reanalysis and updates 

of the hazard analysis, as would be 

required by proposed § 117.150(f) so 

that the person doing the reanalysis or 

update has a baseline from which to 

start. A written hazard analysis also 

would be useful for training purposes as 

a tool to make employees aware of food 

safety hazards that are reasonably likely 

to occur. 

The written hazard analysis includes 

the justification for whatever conclusion 

the owner, operator, or agent in charge 

of a facility reaches, including a 

conclusion that no hazards are 

reasonably likely to occur. Thus, 

proposed § 117.130(a)(2) would not 

limit the requirement for a written 

hazard analysis to those circumstances 

where the owner, operator, or agent in 

charge of a facility identifies one or 

more hazards that are reasonably likely 

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3734 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

to occur. Under proposed 

§ 117.130(a)(2), a written hazard 

analysis would be required even if the 

conclusion of the analysis is that there 

are no hazards reasonably likely to 

occur. 

Proposed § 117.130(a)(2) is consistent 

with the NACMCF HACCP guidelines, 

the Codex HACCP Annex, and Federal 

HACCP regulations for juice, seafood, 

and meat and poultry. The NACMCF 

HACCP guidelines and the Codex 

HACCP Annex each specify that the 

hazard analysis be documented in the 

HACCP plan (Ref. 34) (Ref. 35). Our 

HACCP regulation for juice requires a 

written hazard analysis (§ 120.7(a)). Our 

HACCP regulation for seafood requires 

that the list of food safety hazards that 

are reasonably likely to occur, identified 

in the hazard analysis, be included in 

the written HACCP plan (§ 123.6(c)). 

The FSIS HACCP regulation for meat 

and poultry requires a written hazard 

analysis, including all supporting 

documentation (9 CFR 417.5(a)(1)). 

3. Proposed § 117.130(b)—Hazard 

Identification 

Proposed § 117.130(b) would require 

that the hazard analysis consider 

hazards that may occur naturally or may 

be unintentionally introduced, 

including: 

• Biological hazards, including 

microbiological hazards such as 

parasites, environmental pathogens, and 

other microorganisms of public health 

significance (proposed § 117.130(b)(1)); 

• Chemical hazards, including 

substances such as pesticide and drug 

residues, natural toxins, decomposition, 

unapproved food or color additives, and 

food allergens (proposed 

§ 117.130(b)(2)); 

• Physical hazards (proposed 

§ 117.130(b)(3)); and 

• Radiological hazards (proposed 

§ 117.130(b)(4)). 

Proposed § 117.130(b) would 

implement section 418(b)(1) of the 

FD&C Act and would establish four 

groups of hazards (i.e., biological, 

chemical, physical, and radiological). 

Three of the proposed groups of hazards 

(i.e., biological, chemical, and physical) 

are the same as the groups of hazards in 

the NACMCF HACCP guidelines, the 

Codex HACCP Annex, and Federal 

HACCP regulations for juice, seafood, 

and meat and poultry; the proposed 

group ‘‘radiological hazards’’ would be 

in addition to the groups of hazards in 

those HACCP systems. The additional 

group of ‘‘radiological hazards’’ is 

required by section 418(b)(1)(A) of the 

FD&C Act. The NACMCF HACCP 

guidelines and Codex HACCP Annex 

identify biological, chemical, and 

physical hazards as types of hazards in 

the definition of hazard (Ref. 34) (Ref. 

35). Federal HACCP regulations for 

seafood, juice and meat and poultry 

identify biological, chemical, and 

physical hazards as types of hazards in 

the definition of ‘‘food safety hazard’’ 

(§ 123.3(f) and 9 CFR § 417.1 for seafood 

and meat and poultry, respectively) or 

food hazard (§ 120.3(g) for juice). 

Federal HACCP regulations for seafood, 

juice, and meat and poultry identify as 

hazards microbiological contamination, 

parasites, chemical contamination, 

unlawful pesticide residues, 

decomposition, natural toxins, 

unapproved use of food or color 

additives and physical hazards 

(§§ 123.6(c)(1), 120.7(c), and 9 CFR 

417.2(a)(3), respectively). Federal 

HACCP regulations for seafood and 

meat and poultry also identify as 

hazards drug residues (§ 123.6(c)(1)(v) 

and 9 CFR 417.2(a)(3)(v) for seafood and 

meat and poultry, respectively) and 

undeclared ingredients that may be 

allergens (§ 120.7(c)(8) for juice). The 

FSIS HACCP regulation for meat and 

poultry also identifies zoonotic diseases 

as a hazard (9 CFR 417.2(a)(3)). 

Microbiological Hazards 

Proposed § 117.130(b)(1) would 

include microbiological hazards within 

the category of biological hazards. 

Examples of microbiological hazards 

include: 

• Parasites (which are required to be 

considered by section 418(b)(1)(A) of 

the FD&C Act). A parasite is an 

organism that lives on or in an organism 

of another species (often called the host 

organism) and feeds off that other 

species. Cryptosporidium spp., Giardia 

intestinalis, and Toxoplasma gondii are 

examples of parasites. 

• Environmental pathogens (e.g., 

Listeria monocytogenes and Salmonella 

spp.); and 

• Other microorganisms of public 

health significance, including bacteria 

(e.g., Campylobacter spp., Clostridium 

perfringens, Shiga toxin-producing 

Escherichia coli (STEC) O157, STEC 

non-O157, Shigella spp., 

Staphylococcus aureus, Vibrio spp., and 

Yersinia enterocolitica) and viruses 

(e.g., hepatitis A virus and norovirus). 

As discussed in section II.D.1 of this 

document, CDC has estimated that the 

total burden of foodborne illness is 48 

million cases, 128,000 hospitalizations, 

and 3,000 deaths due to illnesses from 

both major pathogens and from 

unspecified agents (Ref. 45) (Ref. 46). 

Focusing only on the foodborne 

illnesses attributable to particular 

pathogens, a recent report estimated that 

31 major pathogens (for which data for 

preparing national estimates are 

available, including those listed above) 

cause 9.4 million episodes of foodborne 

illness, 55,961 hospitalizations and 

1351 deaths in the United States each 

year (Ref. 45). In addition to 

contaminating raw materials, some of 

these pathogens (e.g., Listeria 

monocytogenes and Salmonella spp.) 

are common pathogens of concern with 

respect to contamination from the 

processing environment for specific 

types of facilities (Ref. 144) (Ref. 145). 

(See sections I.D and I.E of the 

Appendix to this document for a 

discussion of testing programs for 

environmental pathogens). 

Contamination of food with some 

pathogens (e.g., Staphylococcus aureus 

and norovius) is often due to poor 

employee hygiene or practices. 

Chemical Hazards 

Proposed § 117.130(b)(2) would 

include substances such as pesticide 

and drug residues, natural toxins, 

decomposition, unapproved food or 

color additives, and food allergens (all 

of which are required to be considered 

by section 418(b)(1)(A) of the FD&C Act) 

within the category of chemical hazards. 

As discussed in section II.D.2.b of this 

document, pesticide residues may be 

present in food in the absence of or in 

excess of a tolerance established by 

EPA. Residues of drugs (e.g., antibiotics 

administered to dairy cows) may be 

present in food derived from the animal 

(such as milk) in the absence of or in 

excess of a tolerance or safe levels 

established and enforced by FDA (Ref. 

146). Natural toxins such as aflatoxin 

and patulin are well recognized as 

hazards in foods such as peanuts and 

apple juice products, respectively (Ref. 

82) (Ref. 85). Decomposition products 

such as histamine, produced from the 

amino acid histidine when certain 

bacteria grow, can pose a risk to health. 

An undeclared food allergen (such as a 

peanut) can cause a life-threatening 

reaction (such as anaphylactic shock) in 

susceptible individuals (Ref. 147). 

Heavy metals (such as lead) can lead to 

impaired cognitive development in 

children (Ref. 88). 

Physical Hazards 

Proposed § 117.130(b)(3) would 

require that the hazard analysis consider 

physical hazards, which are required to 

be considered by section 418(b)(1)(A) of 

the FD&C Act. Examples of physical 

hazards include stones, glass, or metal 

fragments that could inadvertently be 

introduced into food. Physical hazards 

may be associated with raw materials, 

especially RACs. The facility and 

equipment can also be a source of 

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physical hazards, e.g., container glass 

and metal fragments such as nuts and 

bolts. 

Radiological Hazards 

Proposed § 117.130(b)(4) would 

require that the hazard analysis consider 

radiological hazards. As discussed in 

section II.D.2.e of this document, 

examples of radiological hazards 

include radionuclides such as radium226, radium-228, uranium-235, 

uranium-238, strontium-90, iodine-131, 

and cesium-137. The NACMCF HACCP 

guidelines, the Codex HACCP Annex, 

and Federal HACCP regulations for 

seafood, juice, and meat and poultry do 

not identify radiological hazards as a 

type of hazard to be considered in the 

hazard analysis. However, section 

418(b)(1)(A) of the FD&C Act requires 

that radiological hazards be considered, 

and food may be subject to 

contamination with radiological 

hazards—e.g., if water used to 

manufacture a food contains a 

radionuclide. For additional 

information on how radiological 

hazards may contaminate food, see 

section III.D.2.e of this document and 

references discussed therein (Ref. 107) 

(Ref. 108) (Ref. 109). 

4. Proposed § 117.130(c)—Hazard 

Evaluation 

a. Proposed § 117.130(c)(1)— 

Evaluation of whether a hazard is 

reasonably likely to occur, including an 

assessment of the severity of the illness 

or injury if the hazard were to occur. 

Proposed § 117.130(c)(1) would require 

that the hazard analysis include an 

evaluation of the hazards identified in 

§ 117.130(b) to determine whether the 

hazards are reasonably likely to occur, 

including an assessment of the severity 

of the illness or injury if the hazard 

were to occur. As discussed in more 

detail later in this section, proposed 

§ 117.130(c)(1) would implement 

sections 418(b)(1) and (c)(3) of the FD&C 

Act. Proposed § 117.130(c)(1) is 

consistent with the NACMCF HACCP 

guidelines, the Codex HACCP Annex, 

and Federal HACCP regulations for 

seafood, juice, and meat and poultry. 

The NACMCF HACCP guidelines define 

severity as the seriousness of the effects 

of a hazard. The severity of the illness 

or injury includes the magnitude and 

duration of the illness and impact of any 

sequelae (chronic conditions resulting 

from an illness, such as reactive arthritis 

following a Salmonella infection). The 

NACMCF HACCP guidelines also 

recommend considering the likelihood 

of an illness or injury (usually based 

upon a combination of experience, 

epidemiological data, and information 

in the technical literature) and the 

potential effects associated with both 

short-term and long-term exposure (Ref. 

34). Likewise, the Codex HACCP Annex 

recommends that the hazard analysis 

consider the severity of the adverse 

health effects associated with the 

hazards (Ref. 35). Our juice HACCP 

regulation requires that the hazard 

evaluation include an assessment of the 

severity of the illness or injury if the 

hazard occurs (§ 120.7(a)(2)). The 

requirement for a hazard analysis in our 

seafood HACCP regulation does not 

specifically require an assessment of 

severity but addresses the potential for 

illness or injury in its definition of a 

food safety hazard, which refers to 

biological, chemical or physical 

properties that may cause a food to be 

unsafe for human consumption 

(§ 123.3(f)) and in the description of a 

food safety hazard that is reasonably 

likely to occur, which includes illness 

data as a basis for establishing controls 

(§ 123.6(a)). Similarly, the FSIS HACCP 

regulation for meat and poultry does not 

specifically require an assessment of 

severity in the hazard analysis (9 CFR 

417.2(a)), but its definition of a food 

safety hazard refers to biological, 

chemical or physical properties that 

may cause a food to be unsafe for 

human consumption (9 CFR 417.1(c)). 

In the final rule to establish our juice 

HACCP regulation, we agreed with the 

NACMCF approach to conducting the 

hazard analysis—i.e., that the process of 

evaluating food hazards to determine 

which potential hazards need to be 

addressed in the HACCP plan (i.e., those 

that are reasonably likely to occur) takes 

into account both the consequences of 

exposure (i.e., severity) and the 

probability of occurrence (i.e., 

frequency) of the health impact of the 

potential hazards in question (66 FR 

6138 at 6155). 

As discussed in section II.D.2.a of this 

document, contamination of food with 

biological hazards often leads to 

immediate or near-term onset of illness 

or injury (e.g., gastrointestinal illness). 

Exposure to some biological hazards 

may have long-term consequences as 

well (e.g., infections with Salmonella 

spp. may result in reactive arthritis). 

The effects of exposure to some 

biological hazards are severe (e.g., 

Hemolytic Uremic Syndrome (HUS) in 

individuals exposed to E. coli O157:H7 

(63 FR 20450 at 20450) or invasive 

listeriosis in susceptible individuals 

exposed to L. monocytogenes in readyto-eat foods (Ref. 55). Proposed 

§ 117.130(c)(1) would require that such 

biological hazards be considered to 

determine whether they are reasonably 

likely to occur even if the biological 

hazard occurs infrequently. 

As discussed in sections II.D.2.b and 

II.D.2.c of this document, contamination 

of food with chemical hazards may lead 

to immediate or near-term onset of 

illness—e.g., an allergic reaction to an 

undeclared peanut or to a residue in a 

milk product of penicillin used to treat 

the cow. In other instances the focus of 

the evaluation for chemical hazards is 

directed to their long term effects, such 

as impaired cognitive development in 

children exposed to lead in 

contaminated candy (Ref. 88) and liver 

cancer as the result of chronic exposure 

to the mycotoxin aflatoxin (Ref. 89) (Ref. 

90). Proposed § 117.130(c)(1) would 

require that such chemical hazards be 

considered to determine whether they 

are reasonably likely to occur even if the 

chemical hazard occurs infrequently. 

We discuss the regulatory framework 

under the FD&C Act (including 

premarket approval or registration by 

FDA or EPA) of food additives, color 

additives, new animal drugs, and 

pesticides in section II.D.2.b of this 

document. An additive, drug, or 

pesticide that has been approved for use 

in some foods, but not other foods, is 

deemed by the FD&C Act to be unsafe 

for use with those other foods. Proposed 

§ 117.130(c)(1) would require that 

chemical hazards such as unapproved 

food additives, unapproved color 

additives, new animal drugs, and 

pesticides be considered to determine 

whether they are reasonably likely to 

occur. 

We provide information about natural 

toxins (such as aflatoxin and patulin), 

decomposition products (such as 

histamine and other biogenic amines), 

and heavy metals (such as lead) in 

section II.D.2.b of this document and 

references contained therein (Ref. 82) 

(Ref. 83) (Ref. 84) (Ref. 85) (Ref. 86) (Ref. 

87) (Ref. 88) (Ref. 90). Proposed 

§ 117.130(c)(1) would require that such 

chemical hazards be considered to 

determine whether they are reasonably 

likely to occur even if the chemical 

hazard occurs infrequently. 

Physical hazards such as hard and 

sharp foreign objects that may be 

present in food can pose a health risk 

(Ref. 148). Hard or sharp foreign objects 

in food may cause traumatic injury, 

including laceration and perforation of 

tissues of the mouth, tongue, throat, 

stomach and intestine as well as damage 

to the teeth and gums (Ref. 148) (Ref. 

149). Thus, even if physical hazards 

occur infrequently, under proposed 

§ 117.130(c)(1) the potential for severe 

consequences would require 

consideration of these physical hazards 

to determine whether they are 

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reasonably likely to occur. Factors 

relevant to an evaluation of the severity 

of a physical hazard include the 

potential size of the object, the nature of 

the food (e.g., RTE or required to 

undergo further processing), and 

whether intended consumers of the food 

include special risk groups (Ref. 148). 

Contamination of food with 

radiological hazards generally is 

evaluated for long-term effects such as 

the potential for cancer (Ref. 150). A 

significant radiation dose could be 

received as a result of consumption of 

food contaminated as a result of an 

accident at a nuclear power plant or 

other types of accidents (Ref. 150; see 

also (63 FR 43402, August 13, 1998)). 

Foods may contain unsafe levels of 

radionuclides (Ref. 151). Thus, although 

radiological hazards occur infrequently, 

under proposed § 117.130(c)(1) the 

potential for severe consequences would 

require consideration of radiological 

hazards to determine whether they are 

reasonably likely to occur for a 

particular food or facility, especially 

when circumstances arise that could 

lead to contamination of food with 

radiological hazards. 

The purpose of sections 418(b)(1) and 

418(c)(3) of the FD&C Act seems clear— 

i.e., that the owner, operator, or agent in 

charge of a facility identify and evaluate 

known or reasonably foreseeable 

hazards for the purpose of identifying 

and implementing preventive controls 

to provide assurances that identified 

hazards will be significantly minimized 

or prevented and that the food 

manufactured, processed, packed or 

held by the facility will not be 

adulterated under section 402 of the 

FD&C Act or misbranded under section 

403(w) of the FD&C Act. The process of 

evaluating food hazards to determine 

which potential hazards require 

preventive controls must take into 

account the consequences of exposure 

(i.e., severity) as well as the probability 

of occurrence (i.e., frequency) to provide 

assurances that the food manufactured, 

processed, packed or held by the facility 

will not be adulterated under section 

402 of the FD&C Act or misbranded 

under section 403(w) of the FD&C Act. 

Proposed § 117.130(c)(1) would 

implement this statutory direction. 

b. Proposed § 117.130(c)(2)— 

Requirement to evaluate environmental 

pathogens. Proposed § 117.130(c)(2) 

would require that the hazard analysis 

include an evaluation of whether 

environmental pathogens are reasonably 

likely to occur whenever an RTE food is 

exposed to the environment prior to 

packaging. As noted in section II.D.2.a 

of this document, environmental 

pathogens can be a source of 

contamination of food. Examples of 

environmental pathogens that have 

contaminated foods (and, in particular, 

RTE foods) include Salmonella spp. and 

L. monocytogenes. Proposed 

§ 117.130(b)(1) would include 

environmental pathogens as one of the 

biological hazards that must be 

considered in identifying hazards for 

evaluation. Under proposed 

§ 117.130(c)(2), a facility that produces 

an RTE food that is exposed to the 

environment would be required to 

identify environmental pathogens as a 

known or reasonably foreseeable hazard 

under proposed § 117.130(b) and 

evaluate whether contamination of RTE 

food with the environmental pathogen 

is reasonably likely to occur in the 

facility. 

c. Proposed § 117.130(c)(3)— 

Consideration of specific factors 

relevant to the hazard evaluation. 

Proposed § 117.130(c)(3) would require 

that, in conducting the hazard 

evaluation, consideration be given to the 

effect of several specific factors on the 

safety of the finished food for the 

intended consumer. We tentatively 

conclude that these are factors that a 

prudent person who manufactures, 

processes, packs, or holds foods would 

consider when evaluating identified 

hazards to determine whether they are 

reasonably likely to occur. As we 

indicated in proposing our HACCP 

regulation for juice, a prudent processor 

should consider factors such as these in 

doing a hazard analysis (63 FR 20450 at 

20468). 

Proposed § 117.130(c)(3)(i) would 

require that the hazard evaluation 

consider the formulation of the food. 

The addition of certain ingredients such 

as acids and preservatives may be 

critical to the safety of the food, since 

they may inhibit growth of, or even kill, 

microorganisms of public health 

significance. This could impact the 

evaluation at steps during production 

and storage with respect to the hazard 

of ‘‘pathogen growth.’’ A multicomponent food may have individual 

ingredients that do not support growth 

of undesirable microorganisms (e.g., 

because of pH or aw), but when put 

together there may be an interface where 

the pH and aw changes (e.g., pies, 

layered breads). Under proposed 

§ 117.130(c)(3)(i), the interaction of the 

individual ingredients must be 

evaluated as part of the formulation of 

the food. Proposed § 117.130(c)(3)(i) 

also would require that the hazard 

evaluation consider whether or not the 

formulation contains an ingredient 

(such as a flavoring, coloring, or 

incidental additive) that may contain an 

allergen. 

Proposed § 117.130(c)(3)(ii) would 

require that the hazard evaluation 

consider the condition, function, and 

design of the facility and equipment. 

The condition, function, or design of a 

facility or its equipment could 

potentially result in the introduction of 

hazards into foods. For example, older 

equipment (e.g., older slicing, rolling 

and conveying equipment) may be more 

difficult to clean (e.g., with close fitting 

components or hollow parts) and, thus, 

provide more opportunities for 

pathogens to become established in a 

niche environment than modern 

equipment designed to address the 

problem of pathogen harborage in niche 

environments. Proposed 

§ 117.130(c)(3)(ii) would require that 

facilities with such equipment consider 

the impact of the equipment on the 

potential for pathogens to be a hazard 

that is reasonably likely to occur; if so, 

a preventive control such as enhanced 

sanitation controls may be appropriate, 

particularly if the equipment is used in 

production of RTE food. Equipment 

designed such that there is metal-tometal contact may generate metal 

fragments. Proposed § 117.130(c)(3)(ii) 

would require that facilities with such 

equipment consider the impact of the 

equipment on the potential for 

generation of such metal fragments to be 

a hazard that is reasonably likely to 

occur; if so, a preventive control such as 

metal detectors may be appropriate. A 

facility that manufactures, processes, or 

packs soft, fresh cheese (such as queso 

fresco, which is consumed without 

cooking to adequately reduce 

pathogens) may have cold, moist 

conditions that are conducive to the 

development of a niche where the 

pathogen L. monocytogenes can become 

established and contaminate foodcontact surfaces and, eventually, foods. 

Proposed § 117.130(c)(3)(ii) would 

require that facilities with such 

conditions consider the impact of the 

conditions on the potential for whether 

development of a niche where the 

pathogen L. monocytogenes can become 

established is a hazard that is 

reasonably likely to occur; if so, 

enhanced sanitation controls may be 

appropriate. A facility design that has 

closely spaced equipment would 

provide more opportunities for crosscontact (such as from allergens in 

powdered milk or soy) from one line to 

another (e.g., through dust) than a 

facility that has more spacing between 

equipment. Proposed § 117.130(c)(3)(ii) 

would require that facilities with such 

closely spaced equipment consider the 

impact of the close spacing on the 

potential for cross-contact to be a hazard 

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that is reasonably likely to occur; if so, 

targeted food allergen controls may be 

appropriate. 

Proposed § 117.130(c)(3)(iii) would 

require that the hazard evaluation 

consider raw materials and ingredients. 

Current § 110.3 defines ‘‘food’’ to mean 

food as defined in section 201(f) of the 

FD&C Act and includes raw materials 

and ingredients, and that definition 

would be retained (with no proposed 

revisions) in this proposed rule. As 

discussed in section IX.E of this 

document, there is an overlap between 

raw materials and ingredients; not all 

raw materials are ingredients. A food 

can become contaminated through the 

use of contaminated food ingredients. 

For example, in the past several years 

thousands of foods have been recalled 

as a result of contamination of food 

ingredients with pathogens such as 

Salmonella spp. and E. coli O157:H7. 

The ingredients included peanutderived ingredients (Ref. 19) (Ref. 20), 

pistachio-derived ingredients (Ref. 152), 

hydrolyzed vegetable protein (Ref. 23) 

(Ref. 24) (Ref. 153)), instant nonfat dried 

milk, whey protein, and fruit stabilizers 

(Ref. 21) (Ref. 22), and bagged spinach 

(Ref. 154). In some cases, the 

contamination was discovered only after 

the ingredient was associated with an 

outbreak of foodborne illness (Ref. 19). 

In other cases, the contamination was 

discovered in a food and associated 

with a particular ingredient without any 

known incidence of foodborne illness 

(Ref. 152) (Ref. 155) (Ref. 22) (Ref. 154). 

Following some of these recalls, we 

issued guidance recommending that 

manufacturers of foods containing a 

particular type of ingredient either 

obtain the ingredients from suppliers 

with validated processes in place to 

adequately reduce the presence of the 

applicable pathogen, or ensure that their 

own manufacturing process would 

adequately reduce the presence of that 

pathogen (Ref. 6) (Ref. 156). Specific 

pathogens would be considered to be a 

hazard that is reasonably likely to occur 

for raw materials and ingredients that 

have been documented to be 

contaminated with such pathogens, as 

well as for ingredients with similar 

characteristics (because such 

contamination might be expected in 

ingredients that are produced in a 

similar manner). 

A food also may become 

contaminated through the use of 

contaminated raw materials that are not 

food ingredients. In the example of the 

manufacture of the food additive 

sucrose fatty acid esters (see discussion 

in section IX.E of this document), 

§ 172.859 establishes specifications for 

sucrose fatty acid esters, such as 

specifications that arsenic is not more 

than 3 parts per million, total heavy 

metal content (as lead) is not more than 

50 parts per million, and lead is not 

more than 10 parts per million 

(§ 172.859(b)(6), (7), and (8)). The use of 

raw materials that are contaminated 

with arsenic, lead, or other heavy metals 

that would not be removed as part of the 

manufacturing process for sucrose fatty 

acid esters could lead to sucrose fatty 

acid esters that are contaminated with 

arsenic, lead, or other heavy metals such 

that they do not satisfy the 

specifications of the regulation. 

As noted for formulation in the 

discussion of proposed 

§ 117.130(c)(3)(i), ingredients must be 

evaluated for ‘‘hidden’’ allergens such 

as may be present in flavorings, 

colorings, or incidental additives. 

Production and harvesting practices 

may impact whether raw materials and 

ingredients contain hazards. For 

example, machinery-harvested produce 

is more likely to be contaminated with 

physical hazards than hand-picked 

produce, because the machinery often 

picks up foreign material from the field. 

Proposed § 117.130(c)(3)(iv) would 

require that the hazard evaluation 

consider transportation practices. A 

food may become unsafe as a result of 

poor transportation practices for 

incoming raw materials and ingredients 

or for outgoing finished product. For 

example, failure to adequately control 

temperature during transportation could 

make a food unsafe if the product 

requires time and temperature controls 

to ensure safety. Distributing a food in 

bulk without adequate protective 

packaging makes the product 

susceptible to contamination during 

transportation—e.g., from pathogens or 

chemicals present in an inadequately 

cleaned vehicle or from other 

inadequately protected foods that are 

being co-transported and are potential 

sources of contamination (Ref. 157). (For 

additional examples of food safety 

problems that could occur during 

transportation, see 75 FR 22713, April 

30, 2010). 

The Sanitary Food Transportation Act 

of 2005 (SFTA) gives FDA authority to 

require shippers, carriers by motor 

vehicle or rail vehicle, receivers, and 

other persons engaged in the 

transportation of food to use sanitary 

transportation practices to ensure that 

food is not transported under conditions 

that may render the food adulterated. In 

2010, we published an Advance Notice 

of Proposed Rulemaking to request data 

and information on the food 

transportation industry and its practices 

and we expect to issue a separate 

proposed rule to implement the SFTA 

(75 FR 22713, April 30, 2010). We do 

not expect a future rulemaking 

implementing the SFTA to eliminate the 

need for the owner, operator, or agent in 

charge of a facility to consider 

transportation practices when 

determining whether a hazard is 

reasonably likely to occur. 

Proposed § 117.130(c)(3)(v) would 

require that the hazard evaluation 

consider manufacturing/processing 

procedures. For example, hazards may 

arise from manufacturing/processing 

processes such as cooling or holding of 

certain foods due to the potential for 

germination of pathogenic sporeforming 

bacteria such as Clostridium perfringens 

and Bacillus cereus (which may be 

present in food ingredients) as a cooked 

product is cooled and reaches a 

temperature that will allow germination 

of the spores and outgrowth. Hazards 

also may arise from manufacturing/ 

processing processes such as 

acidification due to the potential for 

germination of spores of C. botulinum, 

with subsequent production of 

botulinum toxin, if the acidification is 

not done correctly. Toxins can be 

produced by the bacteria 

Staphylococcus aureus or Bacillus 

cereus in a product that has been heated 

and held at room temperature during 

the manufacturing process if the 

product formulation supports growth 

and toxin formation by the bacteria and 

S. aureus or B. cereus is present in the 

ingredients of the product or is 

introduced by poor employee hygiene 

(e.g., S. aureus). Physical hazards may 

occur from metal fragments generated 

during the manufacture of food on 

equipment in which metal (e.g., wires, 

saw blades or knives) is used to cut 

products during manufacturing. 

Proposed § 117.130(c)(3)(vi) would 

require that the hazard evaluation 

consider packaging activities and 

labeling activities. For example, as 

discussed earlier in this section XII.4.c 

the hazards that are reasonably likely to 

occur would be different depending on 

whether a product is packaged in glass 

bottles or in plastic bottles. A label on 

a food may direct consumers to cook a 

product to a certain temperature; the 

likelihood of consumers following those 

cooking instructions may vary 

depending on the type of food. For 

example, it is well known that 

consumers will eat raw cookie dough, 

even though the cookie dough is clearly 

intended to be cooked, and an outbreak 

of foodborne illness has been associated 

with the consumption of uncooked 

cookie dough (Ref. 77) (Ref. 76) (Ref. 

78). Thus, although label information is 

a factor to consider, a hazard may be 

reasonably likely to occur even with 

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3738 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

label information such as cooking 

instructions. 

Proposed § 117.130(c)(3)(vii) would 

require that the hazard evaluation 

consider storage and distribution. For 

example, biological hazards are more 

likely to be a hazard that is reasonably 

likely to occur during storage and 

distribution in foods that require 

refrigerated storage to maintain safety 

than in shelf-stable foods. Shelf-stable 

foods are designed such that biological 

hazards are controlled. 

Proposed § 117.130(c)(3)(viii) would 

require that the hazard evaluation 

consider intended or reasonably 

foreseeable use. An example of intended 

or reasonably foreseeable use is whether 

the food would be cooked by the 

consumer. In some cases, the intended 

use of a product may include uses 

where it would be cooked by the 

consumer, as well uses where it would 

not be cooked. For example, soup is 

generally cooked, but a dried soup mix 

is often used in RTE form as a 

component of a dip. For another 

example, see the discussion of 

consumption of raw cookie dough 

earlier in this section. When it is known 

or reasonably foreseeable that a food 

would be consumed in RTE form, 

hazards such as Salmonella spp., L. 

monocytogenes, and E. coli O157:H7 

would need to be considered to 

determine if they are hazards reasonably 

likely to occur. 

Proposed § 117.130(c)(3)(ix) would 

require that the hazard evaluation 

consider sanitation, including employee 

hygiene. Sanitation measures and 

practices can impact the likelihood of a 

hazard being introduced into a food. For 

example, the frequency with which a 

production line is shut down for a 

complete cleaning can impact the 

potential for food residues to transfer 

pathogens from equipment to foods 

(e.g., pathogens present on raw produce 

that could carry over into the next 

production cycle on a line). Practices 

directed at worker health and hygiene 

can reduce the potential for transfer of 

pathogens such as Salmonella spp., 

hepatitis A and norovirus. 

Proposed § 117.130(c)(3)(x) would 

require that the hazard evaluation 

consider any other relevant factors that 

might potentially affect the safety of the 

finished food for the intended 

consumer. For example, an unexpected 

natural disaster could flood some or all 

of a facility, creating insanitary 

conditions and potentially 

contaminating the facility with harmful 

microorganisms or chemical residues. 

Following a natural disaster, 

environmental contaminants that could 

be brought into the facility could be a 

hazard reasonably likely to occur. As 

another example, when local water 

authorities advise the public to boil tap 

water for drinking, a facility should 

consider whether bacterial, viral or 

parasitic (e.g., Cryptosporidium and 

Giardia) contamination presents a 

hazard reasonably likely to occur as a 

result of the events that triggered the 

advisory (Ref. 158). 

Proposed § 117.130(c)(3) is consistent 

with the NACMCF HACCP guidelines, 

the Hazards and Controls Guides we 

have issued regarding our HACCP 

regulations for juice and seafood, and 

the Hazards and Controls Guide FSIS 

has issued regarding the FSIS HACCP 

regulation for meat and poultry. The 

NACMCF HACCP guidelines note that 

hazards identified in one operation or 

facility may not be significant in another 

operation producing the same or a 

similar product—e.g., due to differences 

in equipment and/or maintenance 

programs (Ref. 34). Appendix C of the 

NACMCF HACCP guidelines provides 

examples of questions to be considered 

when conducting a hazard analysis and 

identifies factors to consider such as 

ingredients, formulation, processing 

procedures, design of facility, design 

and use of equipment, packaging, 

sanitation, worker health and hygiene, 

storage, intended use, and intended 

consumer. Our Hazards and Controls 

Guide for juice provides 

recommendations related to factors such 

as shelf life of the product, location of 

the processing, and type of processing, 

e.g., thermal or non-thermal processing 

(Ref. 4). Our Hazards and Controls 

Guide for seafood provides 

recommendations related to factors such 

as storage conditions (time and 

temperature), the role of manufacturing 

conditions in minimizing the potential 

for formation of C. botulinum toxin, 

manufacturing procedures (cooking and 

pasteurization) to control pathogenic 

bacteria, manufacturing procedures 

(such as high hydrostatic pressure 

processing, individual quick freezing 

with extended frozen storage, mild heat 

processing, and irradiation) designed to 

retain raw product characteristics, and 

the introduction of pathogenic bacteria 

after pasteurization and specialized 

cooking processes. The FSIS Hazards 

and Controls Guide for meat and poultry 

provides recommendations related to 

factors such as receiving, thawing, 

formulation, manufacturing procedures, 

packaging, storage and shipping (Ref. 

159). 

C. Proposed § 117.135—Preventive 

Controls for Hazards That Are 

Reasonably Likely To Occur 

1. Requirements of Section 418 of the 

FD&C Act 

Section 418(c)(1) of the FD&C Act, in 

relevant part, specifies that the owner, 

operator, or agent in charge of a facility 

shall identify and implement preventive 

controls, including at critical control 

points, if any, to provide assurances that 

hazards identified in the hazard analysis 

conducted under section 418(b)(1) of the 

FD&C Act will be significantly 

minimized or prevented. Section 

418(c)(1)(3) of the FD&C Act), in 

relevant part, specifies that the food 

manufactured, processed, packed, or 

held by such facility will not be 

adulterated under section 402 of the 

FD&C Act or misbranded under section 

403(w) of the FD&C Act. 

As discussed in section X.B.4 of this 

document, section 418(o)(3) of the FD&C 

Act defines preventive controls and 

proposed § 117.3 would include the 

statutory definition in proposed part 

117. Under section 418(o)(3), the 

procedures, practices, and processes 

described in the definition of preventive 

controls may include the following: 

• Sanitation procedures for foodcontact surfaces and utensils and foodcontact surfaces of equipment (section 

418(o)(3)(A) of the FD&C Act); 

• Supervisor, manager, and employee 

hygiene training (section 418(o)(3)(B) of 

the FD&C Act); 

• An environmental monitoring 

program to verify the effectiveness of 

pathogen controls in processes where a 

food is exposed to a potential 

contaminant in the environment 

(section 418(o)(3)(C) of the FD&C Act); 

• A food allergen control program 

(section 418(o)(3)(D) of the FD&C Act); 

• A recall plan (section 418(o)(3)(E) of 

the FD&C Act); 

• CGMPs under part 110 or any 

successor regulations (section 

418(o)(3)(F) of the FD&C Act); and 

• Supplier verification activities that 

relate to the safety of food (section 

418(o)(3)(G) of the FD&C Act). 

2. Proposed § 117.135(a)— 

Requirement To Identify and Implement 

Preventive Controls for Hazards that Are 

Reasonably Likely To Occur 

Proposed § 117.135(a) would require 

that the owner, operator, or agent in 

charge of a facility identify and 

implement preventive controls, 

including at CCPs, if any, to provide 

assurances that hazards identified in the 

hazard analysis as reasonably likely to 

occur will be significantly minimized or 

prevented and the food manufactured, 

processed, packed or held by such 

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facility will not be adulterated under 

section 402 of the FD&C Act or 

misbranded under section 403(w) of the 

FD&C Act. 

As discussed in section XII.B.2.a of 

this document, proposed § 117.130(a) 

would require that the owner, operator, 

or agent in charge of a facility conduct 

a hazard analysis to identify and 

evaluate known or reasonably 

foreseeable hazards for each type of food 

manufactured, processed, packed, or 

held at the facility to determine whether 

there are hazards that are ‘‘reasonably 

likely to occur.’’ Under proposed 

§ 117.135(a), a facility that determines 

through its hazard analysis that there 

are hazards that are reasonably likely to 

occur would then be required to identify 

and implement preventive controls for 

those hazards. Preventive controls 

would be required when applicable 

hazards are identified as reasonably 

likely to occur. As discussed in sections 

XII.B.2 through XII.C.10 of this 

document, the types of preventive 

controls implemented would depend on 

the facility and the food it produces. 

Most hazards would be addressed 

through process controls, food allergen 

controls, and sanitation controls. For 

any type of preventive control, a facility 

would have the flexibility to identify 

and implement preventive controls from 

among all procedures, practices, and 

processes available to it that would 

provide the assurances that would be 

required by proposed § 117.135(a). 

Proposed § 117.135(a) would 

implement section 418(c) of the FD&C 

Act and is consistent with the NACMCF 

HACCP guidelines, the Codex HACCP 

Annex, and Federal HACCP regulations 

for juice, seafood, and meat and poultry, 

although there are some differences 

between HACCP systems and the 

preventive control system established 

by section 418 of the FD&C Act. The 

NACMCF HACCP guidelines (Ref. 34), 

the Codex HACCP Annex (Ref. 35), and 

Federal HACCP regulations for seafood, 

juice, and meat and poultry (§§ 123.6 

and § 120.7 and 9 CFR 417.2, 

respectively) direct a processor to 

address potential hazards that are 

reasonably likely to cause illness or 

injury in the absence of their control by 

determining CCPs and establishing 

critical limits for those CCPs. As 

discussed in section II.C.2 of this 

document, although this proposed rule 

aligns well with HACCP, it differs in 

part in that preventive controls may be 

required at points other than at critical 

control points and critical limits would 

not be required for all preventive 

controls. Under proposed § 117.135(a), a 

processor could address hazards that are 

reasonably likely to occur through 

preventive controls that would be 

applied at CCPs, but doing so would not 

be the only option available to the 

facility in all circumstances. In some 

cases adequate assurances could be 

achieved via preventive controls 

implemented through other procedures 

and practices of a facility, such as its 

food allergen control program, which 

may not have specific CCPs. (For 

discussion of the food allergen control 

program that would be required by 

proposed § 117.135(d)(2), see section 

XII.C.6 of this document.) 

Whatever types of preventive controls 

a facility chooses to apply in its 

operations, the requirement in proposed 

§ 117.135(a) would be risk based. 

Establishing risk-based preventive 

controls involves consideration of the 

available scientific data and information 

related to food safety risks. Typically, 

the hazard evaluation will enable the 

facility to determine appropriate riskbased preventive controls for the hazard 

based on the severity of the hazard and 

the likelihood of its occurrence. 

For example, as discussed in section 

I.D.6 of the Appendix to this document, 

L. monocytogenes is an environmental 

pathogen that can establish a harborage 

in the environment such as on a 

production line used in wet 

manufacturing. Once established, L. 

monocytogenes can intermittently 

contaminate products on the production 

line. When a hazard analysis identifies 

L. monocytogenes as a hazard that is 

reasonably likely to occur in a food, the 

facility would establish sanitation 

controls to prevent L. monocytogenes 

from establishing itself in a harborage 

site. In addition to such sanitation 

controls, a facility may consider 

applying a listericidal process step (i.e., 

a process control applied to adequately 

reduce levels of L. monocytogenes in 

RTE foods). As discussed in section 

II.D.2.a of this document, some RTE 

foods (like soft cheese) support the 

growth of L. monocytogenes, while 

others (like hard cheese) do not. The 

FAO/WHO Listeria risk assessment 

demonstrated that the risk of serious 

illness from consumption of RTE 

products contaminated with L. 

monocytogenes increases with the 

number of L. monocytogenes in an RTE 

food (Ref. 160). Thus, as a risk-based 

approach to the control of the biological 

hazard L. monocytogenes, the facility 

may elect to apply a listericidal process 

step to those RTE foods that support 

growth of L. monocytogenes in addition 

to its sanitation controls, but not apply 

such a process to those RTE foods that 

do not support growth of L. 

monocytogenes. 

3. Proposed § 117.135(b)—Requirement 

for Written Preventive Controls 

Proposed § 117.135(b) would require 

that preventive controls for hazards 

identified in the hazard analysis as 

reasonably likely to occur be written. 

Proposed § 117.135(b) would implement 

section 418(h) of the FD&C Act which, 

as discussed in section XII.A.2 of this 

document, requires that the owner, 

operator, or agent in charge of a facility 

prepare a written food safety plan that, 

among other things, identifies the 

preventive controls within the plan. 

Written preventive controls are essential 

for the facility to implement the 

preventive controls consistently and 

essential for the facility’s food safety 

team, auditors, and inspectors. Written 

preventive controls also would be 

essential for training purposes and 

during reanalysis and updates of the 

preventive controls. Proposed 

§ 117.135(b) is consistent with our 

HACCP regulation for juice, which 

requires that the written hazard analysis 

identify control measures that the 

processor can apply to control the food 

hazards identified as reasonably likely 

to occur (§ 120.7(a)). 

4. Proposed § 117.135(c)—Requirement 

for Parameters Associated With the 

Control of Hazards That Are Reasonably 

Likely To Occur 

Proposed § 117.135(c)(1) would 

require that preventive controls for 

hazards identified in the hazard analysis 

as reasonably likely to occur include, as 

appropriate to the facility and the food, 

parameters associated with the control 

of the hazard, such as parameters 

associated with heat processing, 

acidifying, irradiating, dehydrating, and 

refrigerating foods. Proposed 

§ 117.135(c)(1) would include examples 

of several measures identified in current 

§ 110.80(b)(4) (Manufacturing 

Operations) (proposed § 117.80(c)(4)) 

that if used as a preventive control must 

be adequate when used to prevent 

adulteration, but would not establish an 

exhaustive list of such processes, just as 

current § 110.80(b)(4) (proposed 

§ 117.80(c)(4)) does not establish an 

exhaustive list of measures that must be 

adequate. Examples of other processes 

that would require the identification of 

parameters if used as a preventive 

control are brining, chilling, high 

pressure processing, treating with 

ultraviolet light, and washing with 

antimicrobial agents. The parameters are 

those factors that must be controlled to 

ensure the hazard will be significantly 

minimized or prevented. The specific 

parameters required, and how they 

would be controlled, would depend on 

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the facility and the food. For example, 

for a heat process, parameters such as 

temperature and time must be 

controlled. Temperature may be 

controlled through controls on product 

temperature (as when treating a fluid 

product in a heat exchanger) or through 

controls on oven temperature (as when 

heating product in an oven). Foods such 

as beverages lend themselves to a heat 

exchanger; foods such as baked goods 

lend themselves to an oven. Heating 

time may be controlled automatically by 

a pump setting that controls flow of the 

fluid through the heat exchanger and 

hold tube or manually by an operator 

recording the time a product is put in 

the oven and the time it is removed. 

Heating time may also be controlled by 

the belt speed for the conveyor on a 

continuous oven. A facility would have 

flexibility to establish controls on 

heating time through these or other 

mechanisms. 

Some preventive controls may not 

have specific parameters associated 

with them. For example, preventive 

controls for metal may include an 

equipment preventive maintenance 

program and a metal detector on the 

packaging line. These programs may not 

have specific factors that must be 

controlled to prevent metal 

contamination. Sanitation procedures 

may include scrubbing certain pieces of 

equipment by hand; this may not 

require the identification of specific 

parameters. Similarly, label controls for 

food allergens do not involve 

identification of specific parameters. 

Proposed § 117.135(c)(2) would 

require that preventive controls for 

hazards identified in the hazard analysis 

as reasonably likely to occur include, as 

appropriate to the facility and the food, 

the maximum or minimum value, or 

combination of values, to which any 

biological, chemical, radiological, or 

physical parameter must be controlled 

to significantly minimize or prevent a 

hazard that is reasonably likely to occur. 

Some of the preventive controls a 

facility may implement may be based 

upon scientific studies or other 

information that demonstrate the 

effectiveness of the control measure at 

specific values of a physical, biological, 

radiological or chemical parameter, e.g., 

the application of heat to food at a 

specific time/temperature combination 

to adequately reduce pathogens. 

Proposed § 117.135(c)(2) would require 

that a facility that establishes such a 

preventive control specify values of the 

essential parameters to be applied in 

implementing the control. Specifying 

these values would enable the facility to 

implement them consistently, would 

facilitate validation of the preventive 

controls as would be required by 

proposed § 117.150(a), and would 

facilitate audits and inspection. 

Proposed § 117.135(c)(1) and (2) 

would implement section 418(c) of the 

FD&C Act and are consistent with the 

NACMCF HACCP guidelines, the Codex 

HACCP Annex, and Federal regulations 

for seafood, juice, and meat and poultry, 

although there are some differences 

related to the differences between 

HACCP systems and the preventive 

control system established by section 

418 of the FD&C Act. The NACMCF 

HACCP guidelines and the Codex 

HACCP Annex (Ref. 34) (Ref. 35) each 

specify that the critical limits be 

documented in the HACCP plan. 

Federal HACCP regulations for seafood, 

juice, and meat and poultry each require 

that HACCP plan list the critical limits 

that must be met at each of the CCPs 

(§§ 123.6(c)(3) and 120.8(b)(3), and 9 

CFR 417.2(c)(3), respectively). The 

NACMCF HACCP guidelines define 

‘‘critical limit’’ to mean a maximum 

and/or minimum value to which a 

biological, chemical, or physical 

parameter must be controlled at a CCP 

to prevent, eliminate, or reduce to an 

acceptable level the occurrence of a food 

safety hazard. The definition of ‘‘critical 

limit’’ in Federal HACCP regulations for 

seafood, juice, and meat and poultry are, 

for practical purposes, identical to the 

definition in the NACMCF HACCP 

guidelines (§§ 123.3(c) and 120.3(e) and 

9 CFR 417.1(b), respectively). The 

Codex HACCP Annex defines ‘‘critical 

limit’’ to mean a criterion which 

separates acceptability from 

unacceptability (Ref. 35). 

FSMA does not use the term ‘‘critical 

limit.’’ As discussed in section II.C.2 of 

this document, although this proposed 

rule aligns well with HACCP, it differs 

in part in that preventive controls may 

be required at points other than at 

critical control points and critical limits 

would not be required for all preventive 

controls. Critical limits may not be 

appropriate for preventive controls that 

are not applied at CCPs. Thus, proposed 

§ 117.135(c)(1) and (2) use a broader 

term—i.e., parameter—to encompass 

preventive controls that may or may not 

apply at CCPs. Consistent with the 

NACMCF HACCP guidelines, the Codex 

HACCP Annex, and Federal HACCP 

regulations for seafood, juice, and meat 

and poultry, proposed § 117.135(c)(2) 

would require the maximum or 

minimum value, or combination of 

values, to which any physical, 

biological, radiological, or chemical 

parameter must be controlled to 

significantly minimize or prevent a 

hazard that is reasonably likely to occur. 

This is similar to requiring critical 

limits at CCPs but would apply to 

values set for parameters that apply to 

preventive controls, whether these 

apply at a CCP or not. 

5. Proposed § 117.135(d)(1)—Process 

Controls 

Proposed § 117.135(d)(1) would 

require that preventive controls for 

hazards identified in the hazard analysis 

as reasonably likely to occur include 

process controls that include those 

procedures, practices, and processes 

performed on a food during 

manufacturing/processing that are 

employed to significantly minimize or 

prevent hazards that are reasonably 

likely to occur. Process controls do not 

include those procedures, practices, and 

processes that are not applied to the 

food itself, e.g., controls of personnel or 

the environment that may be used to 

significantly minimize or prevent 

hazards that are reasonably likely to 

occur but are not applied to the food 

itself. Specifying that process controls 

are employed during manufacturing/ 

processing to significantly minimize or 

prevent hazards that are reasonably 

likely to occur would distinguish those 

controls applied in manufacturing/ 

processing that significantly minimize 

or prevent hazards (e.g., cooking, 

cooling, irradiating, refrigerating, and 

reducing water activity) from other 

types of controls that may be applied in 

manufacturing/processing to provide 

the desired product (e.g., controls for 

product size and shape). Many process 

controls, such as the application of heat 

to a food to adequately reduce 

pathogens, are applied in the same 

manner and for the same purpose as 

control measures established within 

HACCP plans and applied at CCPs as 

recommended by the NACMCF HACCP 

guidelines (Ref. 34) and the Codex 

HACCP Annex (Ref. 35) and as required 

by Federal regulations for seafood, juice, 

and meat and poultry (§§ 123.6(c)(3) and 

120.8(b)(3)) and 9 CFR 417.2(c)(3), 

respectively). 

As discussed in section XII.C.4 of this 

document, proposed § 117.135(c)(2) 

would require that preventive controls 

for hazards identified in the hazard 

analysis as reasonably likely to occur 

include, when applicable, the maximum 

or minimum value, or combination of 

values, to which any physical, 

biological, radiological, or chemical 

parameter must be controlled. For 

process controls in particular, the term 

‘‘parameter’’ used in proposed 

§ 117.135(c)(1), and the value associated 

with the parameter in proposed 

§ 117.135(c)(2), are associated with the 

term ‘‘critical limit’’ used in HACCP 

systems. We described the use of the 

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term ‘‘critical limit’’ in other contexts in 

the previous section of this document. 

Collectively, proposed § 117.135(b), (c) 

and (d)(1) would require that a facility 

include in its written process controls 

information equivalent to that provided 

when listing critical limits that must be 

met at each of the CCPs, such as is 

required in our HACCP regulations for 

seafood and juice (§§ 123.6(c)(3) and 

120.8((b)(3), respectively). However, the 

process controls may or may not apply 

at CCPs. 

For example, a facility that holds inshell pistachios in bulk storage units for 

an extended time period until they are 

shelled and packaged may identify the 

potential for growth of aflatoxinproducing molds on the nuts as a hazard 

reasonably likely to occur. As a process 

control to prevent such molds from 

growing on the nuts during storage, the 

facility may elect to dry (dehydrate) the 

nuts to a specific moisture content (e.g., 

no more than seven percent) prior to 

placing them in storage. The process 

control would be ‘‘drying’’ and the 

associated parameter would be moisture 

level, with its maximum value, or limit, 

being seven percent. 

As another example, a facility that 

manufactures refrigerated deli salads 

may identify the potential for growth of 

L, monocytogenes in the salads as a 

hazard reasonably likely to occur. As a 

process control to prevent such growth, 

the facility may elect to add an 

acidifying agent during its process to 

ensure that the pH of the product does 

not exceed 4.4. The process control 

would be ‘‘acidifying’’ and the 

associated parameter would be pH, with 

its maximum value, or limit, being 4.4. 

A facility that manufactures a deli 

salad product may establish 

refrigeration as a process control to 

prevent growth of pathogenic 

sporeformers such as B. cereus, if it 

determines this organism is a hazard 

reasonably likely to occur in the deli 

salads being produced. (A facility may 

conclude that refrigeration is not 

necessary to prevent the growth of 

pathogenic sporeformers if, for example, 

it controls this potential hazard through 

product formulation, such as pH.) The 

facility may also establish process 

controls addressing the amount of time 

that in-process materials are held above 

4 °C (40 °F) during manufacturing and 

addressing their temperatures during 

this time period. If so, the process 

control would be ‘‘manufacturing time’’ 

and the associated parameters would be 

time and temperature, with the 

maximum time that in-process materials 

are held above 4 °C (40 °F) being 

specified. 

6. Proposed § 117.135(d)(2)—Food 

Allergen Controls 

Proposed § 117.135(d)(2)(i) would 

require that food allergen controls 

include those procedures, processes, 

and practices employed for ensuring 

protection of food from cross-contact, 

including during storage and use. 

Examples of such controls include 

procedures for separating ingredients 

and finished products that contain 

allergens from those that do not contain 

allergens, and procedures for separating 

foods that contain different allergens. 

Such controls are essential to prevent 

the inadvertent incorporation of an 

allergen into a product for which it is 

not an ingredient. Examples of such 

procedures for controlling food 

allergens include procedures that: 

• Provide physical barriers; 

• Eliminate or minimize the 

formation of dust, aerosols, or splashes; 

• Conduct manufacturing/processing 

of foods in different parts of a facility; 

• Emphasize separation in time, such 

as by production sequencing or by 

cleaning equipment between production 

runs; 

• Emphasize storage and handling 

appropriate to reduce the potential for 

cross-contact; and 

• Control the movement of tools and 

personnel that might carry allergens 

when the same production lines are 

used for both foods that contain 

allergens and foods that do not, or when 

the same production lines are used for 

foods that contain different allergens. 

Proposed § 117.135(d)(2)(ii) would 

require that food allergen controls 

include those procedures, practices, and 

processes employed for labeling the 

finished food, including ensuring that 

the finished food is not misbranded 

under section 403(w) of the act. Such 

controls can prevent application of the 

wrong label to a food, use of the wrong 

packaging, and use of packaging with an 

incorrect allergen declaration. Examples 

of such procedures for controlling food 

allergens include procedures that: 

• Ensure that the food label correctly 

declares all of the food allergens present 

(including those contained in flavorings, 

colorings, and incidental additives); 

• Ensure that the correct food label is 

applied to a food; 

• Ensure that the correct food is in 

the correct package (e.g., by checking 

that the correct packaging is used for 

each food); and 

• Review formulations and compare 

them to the labels (especially when new 

batches of labels are received). 

Proposed § 117.135(d)(2) would 

implement sections 418(c)(1) and (3) of 

the FD&C Act and 418(o)(3) of the FD&C 

Act. Proposed § 117.135(d)(2) is 

consistent with our HACCP regulation 

for juice, which requires processors to 

consider whether the presence of 

undeclared ingredients that may be 

allergens is a hazard that is reasonably 

likely to occur (§ 120.7(c)(8)). Proposed 

§ 117.135(d)(2) also is consistent with 

the recommendations in the CGMP 

Working Group Report (Ref. 1) that food 

processing establishments that produce 

foods containing a major food allergen 

be required to have a food allergen 

control plan that addresses segregation 

of food allergens during storage and 

handling, prevention of cross-contact 

during processing, product label review, 

and label usage and control. 

7. Proposed § 117.135(d)(3)—Sanitation 

Controls 

Proposed § 117.135(d)(3)(i)(A) and (B) 

would establish two requirements for 

sanitation controls where necessary to 

significantly minimize or prevent 

hazards that are reasonably likely to 

occur (including any environmental 

pathogen that is reasonably likely to 

occur in a ready-to-eat food that is 

exposed to the environment prior to 

packaging, any microorganism of public 

health significance that is reasonably 

likely to occur in a ready-to-eat food due 

to employee handling, and any food 

allergen hazard). Proposed 

§ 117.135(d)(3)(i)(A) would require that 

sanitation controls include procedures 

for the cleanliness of food-contact 

surfaces, including food-contact 

surfaces of utensils and equipment. 

Such hazards would include any 

environmental pathogen that is 

reasonably likely to occur in a ready-toeat food that is exposed to the 

environment prior to packaging and any 

food allergen hazard. (We would 

generally not expect that 

microorganisms of public health 

significance contaminating an RTE food 

due to employee handling would be a 

hazard relevant to procedures for 

cleaning food-contact surfaces.) 

Examples of sanitation controls related 

to the cleanliness of food-contact 

surfaces include cleaning and sanitizing 

procedures (including appropriate 

frequencies for these procedures, 

concentrations of cleaning and 

sanitizing compounds, method of 

application, and contact time). Such 

controls can prevent contamination of 

food with microorganisms of public 

health significance, including 

environmental pathogens, that result 

from inadequate cleaning of foodcontact surfaces. Such controls also can 

prevent cross-contact that results from 

inadequate cleaning of food-contact 

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surfaces or surfaces that transfer 

material to food-contact surfaces. 

Proposed § 117.135(d)(3)(i)(B) would 

require that sanitation controls include 

procedures for the prevention of crosscontact and cross-contamination from 

insanitary objects and from personnel to 

food, food packaging material, and other 

food-contact surfaces and from raw 

product to processed product. Such 

hazards would include any 

environmental pathogen that is 

reasonably likely to occur in a ready-toeat food that is exposed to the 

environment prior to packaging, any 

microorganism of public health 

significance that is reasonably likely to 

contaminate food if employees are 

handling RTE food, and any food 

allergen hazard. Examples of sanitation 

controls to prevent cross-contact 

include procedures for ensuring that 

production utensils and maintenance 

tools do not transfer an allergen from 

one product to another (e.g., by proper 

cleaning of utensils and maintenance 

tools between uses if it is not practical 

to dedicate utensils and tools to specific 

processing lines); procedures for 

ensuring that personnel practices do not 

result in transfer of allergens from one 

production line to another (e.g., by 

ensuring employees do not handle food 

containing an allergen and one that does 

not without washing hands and 

changing outer garments); and 

procedures for minimizing the transfer 

of dust containing allergens (e.g., by 

cleaning powder spills around dumping 

stations as they occur). 

Examples of sanitation controls to 

prevent cross-contamination include 

procedures for ensuring that personnel 

do not touch insanitary objects (e.g., 

waste, trash cans, the floor, and rest 

room fixtures or surfaces) and then food, 

food-contact surfaces, or food packaging 

material without first washing and 

sanitizing their hands; procedures for 

protecting food packaging material from 

environmental contamination; 

procedures for protecting exposed food 

products from contamination from the 

environment; and procedures for 

controlling traffic (including traffic of 

people and traffic of equipment such as 

forklifts) between the raw and finished 

sides of the operation. 

To make clear that sanitation controls 

are required when an environmental 

pathogen is a hazard that is reasonably 

likely to occur in an RTE food that is 

exposed to the environment prior to 

packaging, proposed § 117.135(d)(3)(i) 

includes this circumstance as an 

example where sanitation controls 

would be required. Recent outbreaks of 

foodborne illness caused by 

environmental pathogens (e.g., 

Salmonella spp. and L. monocytogenes), 

as well as the scientific literature, 

emphasize the critical need for 

sanitation controls to minimize the 

potential for food, particularly RTE 

food, to become contaminated with 

environmental pathogens. (See sections 

I.D and I.E of the Appendix to this 

document for a discussion of the 

importance of controlling 

environmental pathogens.) Any time a 

food is exposed to the environment 

during a manufacturing, processing, 

packing, or holding activity, there is the 

potential for the food to be 

contaminated. Appropriate sanitation 

controls can minimize the presence and 

transfer of contaminants, including 

environmental pathogens, to food. The 

need for sanitation controls related to 

food workers has long been recognized; 

however, appreciation of the importance 

of sanitation controls in preventing 

contamination due to environmental 

pathogens is more recent. We request 

comment on whether proposed 

§ 117.135(d)(3) should be more explicit 

about the two most common 

environmental pathogens (i.e., 

Salmonella spp. and L. 

monocytogenes)—e.g., by including 

these two environmental pathogens as 

examples. 

To make clear that sanitation controls 

are required when a microorganism of 

public health significance is a hazard 

reasonably likely to occur in an RTE 

food due to employee handling, 

proposed § 117.135(d)(3)(i) includes this 

circumstance as an example where 

sanitation controls would be required. 

Sanitation controls have long been used 

to prevent cross-contamination with 

pathogens (such as Staphylococcus 

aureus or enteric pathogens such as 

Salmonella spp.) that may be 

introduced by workers. People are 

common carriers of S. aureus—at any 

time up to 50 percent of humans will be 

carriers of this organism (e.g., in the 

nose and on the skin) (Ref. 161). People 

are also a source of enteric pathogens, 

including both symptomatic and 

asymptomatic infected workers (Ref. 

162). Workers can contaminate RTE 

foods during handling, which can result 

in foodborne illness, in particular if the 

food is then held at temperatures that 

support growth and, in the case of S. 

aureus, production of enterotoxin (Ref. 

161) (Ref. 163). Appropriate sanitation 

controls can minimize the transfer of 

microorganisms of public health 

significance from workers to food. 

To make clear that sanitation controls 

are required when a food allergen 

hazard is reasonably likely to occur, 

proposed § 117.135(d)(3)(i) includes this 

circumstance as an example where 

sanitation controls would be required. 

As discussed in section IX.D of this 

document, cross-contact can occur in a 

facility that manufactures, processes, 

packs or holds a food that contains a 

major food allergen and other food that 

does not contain that allergen. 

Appropriate sanitation controls can 

minimize the transfer of food allergens 

that result in cross-contact. 

Proposed § 117.135(d)(3)(i)(A) and (B) 

would implement section 418(c) of the 

FD&C Act. Proposed 

§ 117.135(d)(3)(i)(A) also is consistent 

with the recommendation of the Food 

CGMP Working Group that food 

processors be required to develop and 

maintain, at a minimum, written 

sanitation procedures for all foodcontact equipment and food-contact 

surfaces (Ref. 1). Under proposed 

§ 117.135(b), the preventive controls for 

sanitation required by proposed 

§ 117.135(d)(3)(i)(A) and (B) would have 

to be written. 

HACCP plans, as described in the 

NACMCF HACCP guidelines (Ref. 34), 

the Codex HACCP Annex (Ref. 35), and 

Federal HACCP regulations for seafood, 

juice, and meat and poultry (§ 123.6, 

§ 120.7, and 9 CFR part 417, 

respectively) require that control 

measures be established at CCPs to 

address hazards that are reasonably 

likely to occur. Because sanitation 

covers the entire processing 

environment, not just at CCPs, and is 

not limited to hazards reasonably likely 

to occur, sanitation controls have been 

difficult to fit into HACCP plans and are 

often addressed using prerequisite 

programs (e.g., SSOPs). The NACMCF 

HACCP guidelines (Ref. 34) and the 

Codex HACCP Annex (Ref. 35) address 

sanitation measures as prerequisite 

programs and are silent on their 

inclusion in HACCP plans to address 

identified hazards. FSIS addresses 

sanitation controls for meat and poultry 

products in a separate sanitation 

regulation (9 CFR part 416), which is 

similar to our CGMPs in current part 

110 except that it includes SSOP 

requirements that, unlike our SSOPs, 

require written sanitation procedures. 

In our HACCP regulations for seafood 

and juice, FDA provides processors with 

an option to include sanitation controls 

in their HACCP plans (§§ 123.6(f) and 

120.8(c), respectively). Our HACCP 

regulations require monitoring for eight 

specified sanitary conditions and 

practices (referred to as SSOPs) 

regardless of whether these conditions 

and practices are related to hazards that 

are reasonably likely to occur 

(§§ 123.11(b) and 120.6(a) and (b), 

respectively). The eight conditions and 

practices are: 

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• Safety of the water that comes into 

contact with food or food-contact 

surfaces or that is used in the 

manufacture of ice; 

• Condition and cleanliness of foodcontact surfaces, including utensils, 

gloves, and outer garments; 

• Prevention of cross contamination 

from insanitary objects to food, food 

packaging material, and other foodcontact surfaces, including utensils, 

gloves, and outer garments, and from 

raw product to processed product; 

• Maintenance of hand washing, 

hand sanitizing, and toilet facilities; 

• Protection of food, food packaging 

material, and food-contact surfaces from 

adulteration with lubricants, fuel, 

pesticides, cleaning compounds, 

sanitizing agents, condensate, and other 

chemical, physical, and biological 

contaminants; 

• Proper labeling, storage, and use of 

toxic compounds; 

• Control of employee health 

conditions that could result in the 

microbiological contamination of food, 

food packaging materials, and foodcontact surfaces; and 

• Exclusion of pests from the food 

plant. 

The PMO HACCP Appendix 

essentially includes the same 

requirements as described in the 

HACCP regulation for juice (part 120) 

with respect to the eight conditions and 

practices. However, in the PMO HACCP 

Appendix these conditions and 

practices are referred to as ‘‘required 

prerequisite programs (PPs)’’ rather than 

SSOPs. 

The eight areas for which sanitation 

monitoring is required in our HACCP 

regulations for seafood and juice are 

those elements of sanitation in current 

part 110 that we identified as the most 

likely to have an impact on the safety of 

food. FDA’s HACCP regulations impose 

mandatory monitoring, corrective action 

and recordkeeping for these activities to 

provide a framework to help ensure that 

the provisions of current part 110 that 

relate to the eight specific elements of 

sanitation are addressed in a systematic 

way, resulting in greater compliance 

with those provisions. 

The HACCP regulation for seafood 

recommends but does not require that 

processors develop written SSOPs for 

the eight areas of sanitation 

(§ 123.11(a)). The HACCP regulation for 

juice requires that an SSOP be 

developed for these areas but does not 

require that it be written (§ 120.6(a)). In 

contrast, proposed § 117.135(d) would 

require written procedures for identified 

areas of sanitation and, in addition to 

monitoring and corrective actions as 

required in seafood and juice HACCP 

for the eight areas of sanitation, 

proposed § 117.135(d) would require 

monitoring procedures and verification 

activities. 

In considering the application of 

preventive controls to the eight 

sanitation controls and practices, we 

considered the different framework for 

sanitation controls under this regulation 

(e.g., the additional requirements) as 

compared to the juice and seafood 

HACCP regulations, the traditional role 

of SSOPs as part of prerequisite 

programs, and the broad diversity of the 

food industry covered by this 

regulation. We tentatively conclude that 

it is necessary to require that the two 

areas included in proposed 

§ 117.135(d)(3) be addressed as 

preventive controls under subpart C and 

therefore be subject to requirements 

such as mandatory written procedures. 

Further, we tentatively conclude that for 

each of the other six areas, the current 

CGMPs are sufficient to address any 

hazards and further requirements in 

subpart C are not necessary. For these 

six areas, the value of mandating written 

procedures and other additional 

requirements (e.g., written monitoring 

procedures and verification) would not 

be significant because the relevant 

CGMP provisions in essence serve as the 

written procedures to which the facility 

must adhere. Some facilities may find 

value in adding more detail to the 

material contained in subpart B, but 

FDA has tentatively concluded that that 

would not be necessary in order to 

ensure that the hazards that are 

reasonably likely to occur are 

significantly minimized or prevented. 

For example, one of the six areas of 

sanitation is the safety of water used in 

food operations. In many facilities, the 

water is supplied by a municipal water 

authority that monitors the water and 

alerts its customers of any safety 

problems. Where facilities use well 

water, monitoring usually consists of an 

annual collection and analysis of the 

water for microbiological (and 

sometimes also chemical and 

radiological) safety. Another of the six 

areas contains provisions that ill 

workers must be excluded from 

operations where their presence could 

lead to contamination of food. A 

requirement in this regulation to 

develop written procedures for ensuring 

that this condition is met does not 

appear to be necessary, given the rather 

straightforward and universal nature of 

the controls (i.e., observe employees for 

signs of illness and redirect their 

activities accordingly). Similarly, 

procedures for ensuring the cleanliness 

of rest rooms or checking for the 

presence of pests appear to be 

unnecessary, given the rather 

straightforward and universal nature of 

the controls. 

On the other hand, equipment 

cleaning procedures, as would be 

required by proposed 

§ 117.135(d)(3)(i)(A) are very specific to 

the construction of the equipment, the 

nature of the food, the physical 

characteristics of the water used, the 

concentration of cleaning and sanitizing 

chemicals, the method of application, 

and the cleaning and sanitizing interval, 

among other things. For this reason, the 

procedures must be clearly stated to 

ensure that they are consistently 

followed. Often these procedures are 

performed by contract staff, often during 

night shifts where management is less 

likely to be present. In these 

circumstances, explicit cleaning 

procedures are essential. 

Procedures to prevent cross-contact 

and cross-contamination, as required by 

proposed § 117.135(d)(3)(i)(B) are 

similarly complex and very situational. 

Identifying product and traffic flow 

within the facility, employee hand 

washing and sanitizing, and employee 

garbing requirements is critical to 

ensure that employees are trained on the 

correct procedures to ensure product 

safety. 

Proposed § 117.135(d)(3)(ii) would 

require that the owner, operator, or 

agent in charge of a facility take action 

to correct, in a timely manner, 

conditions and practices that are not 

consistent with the procedures that 

would be established in proposed 

§ 117.135(d)(3)(i)(A) or (B). Proposed 

§ 117.135(d)(3)(ii) is consistent with our 

HACCP regulations for seafood and 

juice, which each require that the 

processor correct, in a timely manner, 

those sanitation conditions and 

practices that are not met (§§ 123.11(b) 

and 120.6(b), respectively). Proposed 

§ 117.135(d)(3)(ii) also is consistent with 

9 CFR part 416, which requires, in 

general, that each establishment take 

appropriate corrective action(s) when 

the establishment’s SSOPs or the 

implementation or maintenance of the 

SSOPs, may have failed to prevent 

direct contamination or adulteration of 

product(s); corrective actions must 

include procedures to ensure 

appropriate disposition of product(s) 

that may be contaminated, restore 

sanitary conditions, and prevent the 

recurrence of direct contamination or 

adulteration of product(s), including 

appropriate reevaluation and 

modification of the SSOPs or 

appropriate improvements in the 

execution of the SSOPs (9 CFR 416.15). 

Proposed § 117.135(d)(3)(iii) would 

provide that the owner, operator, or 

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agent in charge of a facility is not 

required to follow the corrective actions 

that would be established in proposed 

§ 117.145(a) and (b) when the owner, 

operator, or agent in charge of a facility 

takes action, in accordance with 

proposed § 117.135(d)(3)(ii), to correct 

conditions and practices that are not 

consistent with the procedures in 

proposed § 117.135(d)(3)(i) (A) or (B). 

As discussed in sections XII.F.2 and 

XII.F.3 of this document, proposed 

§ 117.145(a) would require that the 

owner, operator or agent in charge of a 

facility establish and implement written 

corrective action procedures that must 

be taken if preventive controls are not 

properly implemented, and outlines 

specific components that must be 

included. Proposed § 117.145(b) would 

require specific actions in the event of 

an unanticipated problem when a 

preventive control is not properly 

implemented and a specific corrective 

action procedure has not been 

established or a preventive control is 

found to be ineffective. For sanitation 

controls, proposed § 117.135(d)(3)(ii) 

would require that the owner, operator 

or agent in charge of a facility take 

action to correct, in a timely manner, 

conditions and practices that are not 

consistent with the established 

sanitation control practices. 

There are many different ways in 

which conditions and practices for 

sanitation can deviate from the 

established procedures. In many 

instances the actions taken will be the 

same, regardless of the deviation. The 

corrective actions will generally involve 

re-establishing sanitary conditions (e.g., 

re-cleaning a piece of equipment) and/ 

or retraining personnel to carry out the 

procedures correctly. In many instances 

the procedural deviations are not 

reasonably likely to impact product 

(e.g., insanitary food-contact surfaces 

are usually detected by a pre-production 

inspection of the equipment by plant 

personnel; deviations in cleaning 

solution strength rarely result in the 

production of unsafe product if other 

cleaning and sanitizing procedures were 

properly carried out). Thus, there is 

rarely a need to evaluate the impact of 

the sanitation failure on food and to 

prevent food from entering commerce, 

as would be required by proposed 

§ 117.145(a)(2)(ii) and (iii). Because the 

corrective actions that will need to be 

taken for most sanitation controls are so 

general, we see little benefit in requiring 

a facility to develop written corrective 

action procedures for the many 

sanitation deviations that could occur. 

We do expect the facility to take action 

to correct conditions and practices as 

appropriate to the situation as would be 

required by proposed § 117.135(d)(3)(ii). 

The requirement in proposed 

§ 117.135(d)(3)(ii) to take action to 

correct, in a timely manner, sanitation 

conditions and practices that are not in 

accordance with procedures is 

consistent with proposed 

§ 117.145(a)(2)(i), which would require 

that appropriate action be taken to 

identify and correct a problem with 

implementation of a preventive control 

to reduce the likelihood that the 

problem will recur. 

Proposed § 117.135(d)(3)(iv) would 

require that all corrective actions taken 

in accordance with proposed 

§ 117.135(d)(3)(ii) be documented in 

records that would be subject to 

verification in accordance with 

proposed § 117.150(c) and records 

review in accordance with proposed 

§ 117.150(d)(2)(i). The records that 

document corrective actions would be 

used to verify that appropriate decisions 

about corrective actions are being made 

and appropriate corrective actions are 

being taken. 

8. Proposed § 117.135(d)(4)—Recall Plan 

Proposed § 117.135(d)(4) would 

require that preventive controls include, 

as appropriate, a recall plan as would be 

required by proposed § 117.137. 

Proposed § 117.135(d)(4) would 

incorporate the statutory definition of 

‘‘preventive controls’’ from section 

418(o)(3)(E) of the FD&C Act, which 

establishes that preventive controls may 

include a recall plan. We include the 

details of the recall plan in proposed 

§ 117.137 and discuss it in section XII.D 

of this document. 

9. Proposed § 117.135(d)(5)—Other 

Controls 

Proposed § 117.135(d)(5) would 

require that preventive controls for 

hazards identified in the hazard analysis 

as reasonably likely to occur include 

any other controls necessary to satisfy 

the requirements of proposed 

§ 117.135(a)—i.e., to significantly 

minimize or prevent hazards identified 

in the hazard analysis and to provide 

assurance that the food manufactured, 

processed, packed or held by such 

facility will not be adulterated under 

section 402 of the FD&C Act or 

misbranded under section 403(w) of the 

FD&C Act. For example, if a facility 

produces a refrigerated product that 

could support the growth of pathogens 

if proper temperature is not maintained 

during transportation, the facility must 

consider the need to implement 

preventive controls to minimize or 

prevent the potential for pathogen 

growth due to failure to control the 

temperature of the product during 

transportation. Most instances of failing 

to control temperature result primarily 

in quality issues such as product 

degradation or shortened shelf life, 

rendering the product unpalatable and 

thus precluding consumption. However, 

it is not common that products reach 

high enough temperatures for sufficient 

time to become hazardous due to growth 

of pathogens that may be present. For 

products that present a risk that 

pathogens would grow and present a 

health hazard, preventive controls could 

include temperature monitoring during 

transportation or other procedures that 

would ensure that product was not 

exposed to temperature/time intervals 

during transportation that would result 

in increased product temperatures for 

sufficient time to result in a potential 

safety issue. Often such procedures 

involve the shipper ensuring that 

product temperature is controlled 

during loading of the transportation 

vehicle, use of temperature recording 

devices that record the temperature of 

the transportation compartment during 

transportation, and the receiver 

verifying the temperature of product 

during transit as displayed by the 

temperature device. 

FDA notes that some of the controls 

listed in section 418(o) of the FD&C Act 

are not explicitly identified in proposed 

§ 117.135. In section XII.J of this 

document, we request comment on an 

environmental monitoring program 

(which section 418(o)(3)(C) of the FD&C 

Act indicates is one of the procedures, 

practices, and processes that preventive 

controls may include, and which 

section 418(f)(4) of the FD&C Act 

identifies as a verification activity). In 

section XII.J of this document, we also 

request comment on a supplier approval 

and verification program as one of the 

procedures, practices, and processes 

that preventive controls may include 

(section 418(o)(3)(G)). In section XI.M, 

of this document, we request comment 

on supervisor, manager, and employee 

hygiene training. We discuss CGMPs in 

section XI of this document. Further, as 

discussed in section XII.C.7 of this 

document, training and CGMP controls 

are traditionally considered to be part of 

prerequisite programs, essential to 

effective preventive controls but often 

not part of them. FDA expects that 

compliance with those requirements in 

proposed part 117, subpart B will be 

sufficient. However, a facility may 

determine that in some circumstances it 

would be appropriate to include certain 

Current Good Manufacturing Practice 

provisions among their preventive 

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controls (i.e., as ‘‘other controls’’ in 

proposed § 117.135(d)(6)). 

10. Proposed § 117.135(e)— 

Applicability of Monitoring, Corrective 

Actions, and Verification 

Proposed § 117.135(e)(1)(i) through 

(iii) would specify that, except as 

provided by proposed § 117.135(e)(2), 

the preventive controls required under 

this section would be subject to 

monitoring as would be required by 

proposed § 117.140; corrective actions 

as would be required by proposed 

§ 117.145; and verification as would be 

required by proposed § 117.150. 

Proposed § 117.135(e)(1)(i) through (iii) 

would restate the requirements of 

proposed §§ 117.140, 117.145, and 

117.150 to clearly communicate the 

applicability of proposed §§ 117.140, 

117.145, and 117.150 to the preventive 

controls that would be required under 

proposed § 117.135 and would establish 

no new requirements. 

Proposed § 117.135(e)(2) would 

provide that the recall plan that would 

be established in proposed § 117.137 

would not be subject to the 

requirements of proposed 

§ 117.135(e)(1). A recall plan would 

address food that had left the facility, 

whereas the proposed requirements for 

monitoring, corrective actions, and 

verification would all be directed at 

food while it remains at the facility. 

Thus, as proposed, the requirements for 

monitoring, corrective actions, and 

verification have limited applicability to 

a recall plan. However, a ‘‘mock recall’’ 

(i.e., a simulated recall situation) is a 

verification activity that could identify 

problems with a recall plan, enable a 

facility to correct the problems, and 

provide reasonable assurance that the 

recall plan would be effective in 

removing products from commerce. 

FDA requests comments on whether to 

include a requirement for a mock recall 

as verification activity in the final rule. 

D. Proposed § 117.137—Recall Plan for 

Food With a Hazard That Is Reasonably 

Likely To Occur 

1. Requirements of Section 418 of the 

FD&C Act 

Section 418(c) of the FD&C Act 

specifies that the owner, operator, or 

agent in charge of a facility shall 

identify and implement preventive 

controls, including at critical control 

points, if any, to provide assurances 

that: 

• Hazards identified in the hazard 

analysis conducted under section 

418(b)(1) of the FD&C Act will be 

significantly minimized or prevented 

(section 418(c)(1) of the FD&C Act); and 

• The food manufactured, processed, 

packed, or held by such facility will not 

be adulterated under section 402 of the 

FD&C Act or misbranded under section 

403(w) of the FD&C Act (section 

418(c)(3) of the FD&C Act). 

Under section 418(o)(3)(D), the 

procedures, practices, and processes 

described in the definition of preventive 

controls may include, in relevant part, 

a recall plan. 

2. Proposed § 117.137—Recall Plan for 

Food With a Hazard That is Reasonably 

Likely To Occur 

Proposed § 117.137(a) would require 

that the owner, operator, or agent in 

charge of a facility establish a written 

recall plan for food in which there is a 

hazard that is reasonably likely to occur. 

Although a recall is different from other 

preventive controls in that it is carried 

out after a product is distributed, it 

shares the purpose of significantly 

minimizing or preventing hazards, 

which is accomplished by limiting 

consumption of the affected food. Time 

is critical during a recall. A written 

recall plan is essential to minimizing 

the time needed to accomplish a recall; 

additional time during which the food 

is on the market can result in additional 

consumer exposure. Following an 

existing plan that addresses all 

necessary elements of a recall helps 

minimize delay created by uncertainty 

as to the appropriate actions to take and 

helps ensure critical actions are not 

overlooked. 

Proposed § 117.137(a) would 

implement sections 418(c)(1) and (3) of 

the FD&C Act and 418(o)(3)(E) of the 

FD&C Act and is consistent with the 

NACMCF HACCP guidelines and the 

Codex GPFH. The NACMCF HACCP 

guidelines recommend that a recall 

system be in place (Ref. 34). The GPFH 

recommends that managers ensure 

effective procedures are in place to 

enable the complete, rapid recall of any 

implicated lot of the finished food from 

the market (Ref. 44). Our HACCP 

regulations for seafood and juice do not 

include any requirements for a recall 

plan; recommendations for addressing a 

recall for food can be found in our 

general guidance on policy, procedures, 

and industry responsibilities regarding 

recalls in subpart C of part 7 (§§ 7.40 

through 7.59). The guidance advises 

firms to prepare and maintain a current 

written contingency plan for use in 

initiating and effecting a recall (§ 7.59). 

Likewise, the FSIS HACCP regulation 

for meat and poultry does not require a 

recall plan; FSIS addresses recalls 

through guidance to industry. 

Proposed § 117.137(b) would require 

that the recall plan include procedures 

that describe the steps to be taken, and 

assign responsibility for taking those 

steps, to perform the following actions: 

• Directly notify the direct consignees 

of the product being recalled and how 

to return or dispose of the affected food 

(proposed § 117.137(b)(1)); 

• Notify the public about any hazard 

presented by the food when appropriate 

to protect public health (proposed 

§ 117.137(b)(2)); 

• Conduct effectiveness checks to 

verify that the recall is carried out 

(proposed § 117.137(b)(3)); and 

• Appropriately dispose of recalled 

food—e.g., through reprocessing, 

reworking, diverting to a use that does 

not present a safety concern, or 

destroying the food (proposed 

§ 117.137(b)(4)). 

Procedures that describe the steps to 

be taken would enable a facility to act 

promptly by following its plan when the 

facility determines that a recall is 

warranted rather than developing a plan 

of action after the need for a recall is 

identified. Procedures that assign 

responsibility for taking those steps 

would save the time needed to make 

such determinations during a recall and 

enable the owner, operator, or agent in 

charge of a facility to clearly 

communicate such responsibilities to 

applicable managers or staff so that such 

managers or staff can take action as soon 

as the decision to conduct a recall is 

made. 

Directly notifying direct consignees 

about the recall (proposed 

§ 117.137(b)(1)) is the most effective 

mechanism to ensure direct consignees 

know that the product is being recalled 

and is consistent with our general 

guidance on recall communications in 

§ 7.49(a). Further, instructing direct 

consignees how to return or dispose of 

an affected product minimizes the 

chance the affected product will be 

disposed of improperly and allows 

direct consignees to act quickly. 

Further, it is consistent with our 

guidance on the content of recall 

communications in § 7.49(c)(4). We 

have provided guidance to industry on 

model recall letters (Ref. 164) (Ref. 165). 

This guidance may be useful in 

developing procedures for directly 

notifying direct consignees about the 

recall and on how to return or dispose 

of an affected product. 

Notification procedures could identify 

a variety of communication means, 

including email, telephone, fax, text 

messaging, and urgent mail delivery. 

Notification procedures that would 

establish only a general notification to 

the public (e.g., through a press release 

or through information posted on a 

facility’s Web site), without procedures 

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for concurrent contact directly with 

direct consignees about how to access 

the general notification, would not 

satisfy proposed § 117.137(b)(1); a 

general notification to the public would 

rely on the chance that the direct 

consignees would see the information 

and may not be effective. 

Notifying the public about any hazard 

presented by the food when appropriate 

to protect public health is a common 

practice (e.g., see FDA’s Web site that 

provides information gathered from 

press releases and other public notices 

about recalls of food (Ref. 166)). 

Notifying the public in such 

circumstances is consistent with our 

guidance on a recall strategy that the 

purpose of a public warning is to alert 

the public that a product being recalled 

presents a hazard to health (§ 7.42(b)). 

Notifying the public, in addition to 

direct consignees, may not be necessary 

to protect the public if, for example, the 

food being recalled was all distributed 

to food service operations (who were 

notified as a direct consignee) and not 

distributed for retail sale. Procedures in 

the recall plan for notifying the public 

could include model press releases and 

procedures for disseminating 

information to the public though press 

releases or other means, such as by 

information posted on the facility’s Web 

site or provided to consumers using 

social media. We have provided 

guidance to industry with examples of 

model press releases for the presence in 

food of undeclared food allergens and 

several foodborne pathogens, including 

Salmonella spp. and L. monocytogenes 

(Ref. 164) (Ref. 165) (Ref. 167) (Ref. 168) 

(Ref. 169). 

An effectiveness check is a procedure 

designed to verify that all notified 

consignees have received notification 

about the recall and have taken 

appropriate action; procedures to 

conduct effectiveness checks would be 

consistent with our guidance on a recall 

strategy in § 7.42(c)(3). Procedures to 

conduct an effectiveness check could 

expand on the procedures used to 

directly contact consignees about the 

recall—e.g., to include forms for 

consignees to provide information about 

the amount of recalled product on hand, 

to include information on follow up 

contacts via phone or email, or to 

include personal visits to consignees by 

sales representatives. We have provided 

guidance to industry on conducting 

effectiveness checks (Ref. 164); this 

guidance includes a model effectiveness 

check letter (Ref. 170), a model 

effectiveness check response form that 

could be sent to a consignee (Ref. 171), 

and a model questionnaire to be used 

during effectiveness checks conducted 

by telephone or by personal visit (Ref. 

172). 

A facility that receives recalled 

product from their customers must 

appropriately dispose of the product— 

e.g., through reprocessing, reworking, 

diverting to a use that does not present 

a safety concern, or destroying the 

product. These types of disposition 

actions are similar to the disposition 

actions that a facility would consider as 

a corrective action as a result of a 

problem that is discovered before the 

product leaves the facility (see, e.g., the 

discussion of corrective actions in the 

final rule to establish our HACCP 

regulation for seafood; 60 FR 65096 at 

65127). Procedures for disposition of a 

product can help the facility ensure that 

disposition of recalled product will be 

appropriate and will not present a risk 

to consumers. Implementation of such 

procedures is part of determining 

whether a recall can be considered 

terminated. Thus, having procedures in 

place can result in more efficient 

completion of a recall. Under § 7.55, 

appropriate disposition of recalled 

product is a consideration in 

determining whether a recall is 

terminated. 

We request comment on whether the 

procedures to be included in the recall 

plan (i.e., to directly notify consignees, 

to notify the public, to conduct 

effectiveness checks and to 

appropriately dispose of recalled 

product) are appropriate for all types of 

facilities or if they should be modified 

for certain facilities. 

We request comment on whether we 

should require a recall plan to include 

procedures and assignments of 

responsibility for notifying FDA of 

recalls subject to the plan. Notifying 

FDA could enhance the effectiveness of 

a recall by allowing FDA to take 

appropriate steps to minimize the risk of 

illness or injury related to recalled 

products. As discussed in section II.A.6 

of this document, notifying FDA of a 

reportable food is required by section 

417 of the FD&C Act. Reportable food 

reports include information about 

whether a reportable food is being 

recalled. Thus, in some cases, reporting 

a recall to FDA could be accomplished 

by submitting a reportable food report 

required under section 417. In other 

cases, facilities could notify the local 

FDA district office of the recall. 

E. Proposed § 117.140—Monitoring 

1. Requirements of Section 418 of the 

FD&C Act 

Section 418(a) of the FD&C Act 

specifies that the owner, operator, or 

agent in charge of a facility shall 

monitor the performance of the 

preventive controls. Section 418(d) of 

the FD&C Act specifies that the owner, 

operator, or agent in charge of a facility 

shall monitor the effectiveness of the 

preventive controls implemented under 

section 418(c) of the FD&C Act to 

provide assurances that the outcomes 

described in section 418(c)] shall be 

achieved. The outcomes relevant to this 

proposal are those that provide 

assurances that hazards identified in the 

hazard analysis will be significantly 

minimized or prevented and that food 

manufactured, processed, packed or 

held by a facility will not be adulterated 

under section 402 of the FD&C Act or 

misbranded under section 403(w) of the 

FD&C Act. 

Section 418(g) of the FD&C Act 

requires, in relevant part, that the 

owner, operator, or agent in charge of a 

facility maintain records documenting 

the monitoring of the preventive 

controls implemented under section 

418(c) of the FD&C Act. 

Section 418(h) of the FD&C Act 

requires, in relevant part, that the 

owner, operator, or agent in charge of a 

facility prepare a written plan that 

documents and describes the 

procedures used by the facility to 

comply with the requirements of section 

418 of the FD&C Act. 

2. Monitoring in HACCP Systems 

Proposed § 117.3 would define 

‘‘monitor’’ to mean ‘‘to conduct a 

planned sequence of observations or 

measurements to assess whether a 

process, point, or procedure is under 

control and to produce an accurate 

record for use in verification.’’ We 

discussed this definition, and how it is 

used in HACCP systems, including in 

guidelines developed by NACMCF and 

Codex, in section X.B.4 of this 

document. Examples of monitoring 

activities include: visual observation 

and measurement of temperature, time, 

pH, and moisture level (Ref. 34). The 

NACMCF HACCP guidelines identify 

three purposes of monitoring (Ref. 34). 

First, monitoring is essential to 

managing food safety because it 

facilitates tracking of the operation (i.e., 

the ‘‘process, point or procedure’’ that is 

being controlled). This provides ongoing 

information about whether the process, 

point or procedure is under control (i.e., 

operating according to plan), and can 

provide information about shifts away 

from control. If monitoring indicates 

that there is a trend towards loss of 

control, a facility can take action to 

bring the process back into control 

before a deviation from a critical limit 

occurs. For example, if the temperature 

needed to ensure safety of roasted nuts 

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is 290 °F, and the procedure for roasting 

the nuts in an oil roaster calls for an 

operating temperature of 350 °F, 

monitoring would detect that the 

temperature in the oil roaster was 

dropping and enable the facility to 

identify and fix the problem with 

temperature before the temperature 

drops to 290 °F. Second, monitoring is 

used to determine when a deviation 

occurs at a critical control point (i.e., 

exceeding or not meeting a critical 

limit), indicating there is loss of control. 

In the previous example, there would be 

loss of control if the temperature drops 

to 289 °F. When a deviation occurs, an 

appropriate corrective action must be 

taken—e.g., stop the roasting process 

until the temperature in the oil roaster 

can be maintained above 290 °F and 

reprocess nuts that were not roasted at 

the appropriate temperature. Third, 

monitoring provides written 

documentation for use in verification. 

For example, if the facility monitors the 

temperature of the oil roaster 

continuously, using a temperature 

recording device, the output of the 

temperature recording device is 

available during the verification activity 

of review of records. Under this 

approach, monitoring is directed to 

evaluating implementation of the 

preventive controls, and the written 

documentation of the monitoring is then 

used in verification. 

3. Verification in HACCP Systems 

Proposed § 117.3 would define 

‘‘verification’’ to mean ‘‘those activities, 

other than monitoring, that establish the 

validity of the food safety plan and that 

the system is operating according to the 

plan.’’ We discussed this definition, and 

how it is used in HACCP systems, in 

section X.B.4 of this document. The 

NACMCF HACCP guidelines identify 

several aspects of verification (Ref. 34). 

One aspect of verification is the initial 

validation of the HACCP plan to 

determine that the plan is scientifically 

and technically sound, that all hazards 

have been identified and that if the 

HACCP plan is properly implemented 

these hazards will be effectively 

controlled. Another aspect of 

verification is evaluating whether the 

facility’s HACCP system is functioning 

according to the HACCP plan. Both of 

these aspects are directed at the 

effectiveness of a preventive control; 

they establish that the preventive 

control is scientifically valid for 

controlling the hazard and verify that 

the preventive control is accomplishing 

its intended purpose. The Codex 

HACCP Annex addresses verification as 

determining compliance with the 

HACCP plan and confirming that the 

HACCP system is working effectively 

(Ref. 35). Examples of verification 

activities include review of monitoring 

records and review of records for 

deviations and corrective actions. We 

discuss verification activities in more 

detail during our discussion of proposed 

§ 117.150 (Verification) in section XII.G 

of this document. 

4. Relationship Between Monitoring and 

Verification 

Monitoring and verification are 

closely related; both address the 

performance of preventive controls, and 

verification relies in part on monitoring 

records to establish that preventive 

controls developed to significantly 

minimize or prevent hazards are being 

implemented according to plan. Three 

provisions of section 418(f) of the FD&C 

Act (Verification) are particularly 

relevant when considering the role of 

monitoring. First, section 418(f)(1) of the 

FD&C Act requires that the owner, 

operator, or agent in charge of a facility 

verify that ‘‘the preventive controls 

implemented * * * are adequate to 

control the hazards identified.* * *’’ 

Second, section 418(f)(2) of the FD&C 

Act requires that the owner, operator, or 

agent in charge of a facility verify that 

‘‘the owner, operator, or agent is 

conducting monitoring.* * *’’ Third, 

section 418(f)(4) of the FD&C Act 

requires that the owner, operator, or 

agent in charge of a facility verify that 

‘‘the preventive controls implemented 

* * * are effectively and significantly 

minimizing or preventing the 

occurrence of identified hazards.* * *’’ 

5. Monitoring the Performance of 

Preventive Controls 

Section 418(a) requires monitoring the 

‘‘performance’’ of preventive controls 

whereas section 418(d) requires 

monitoring their ‘‘effectiveness.’’ We 

tentatively conclude that the language of 

section 418 regarding monitoring is 

ambiguous and that it would be 

appropriate to require monitoring of the 

performance of preventive controls. 

‘‘Performance’’ means ‘‘the execution or 

accomplishment of an action, operation, 

or process undertaken or ordered’’ 

(Shorter Oxford English Dictionary, 

Fifth Ed. (2002), p. 2157) and is 

consistent with use of the term 

‘‘monitoring’’ in traditional HACCP. 

Monitoring the performance of 

preventive controls would be 

undertaken to determine whether a 

facility is implementing its preventive 

controls and would generate records 

that would be used to verify 

implementation of the controls. For 

example, monitoring performance could 

include visual observations and 

measurements of temperature, time pH, 

and moisture level. In contrast, 

‘‘effectiveness’’ refers to the quality of 

‘‘having an effect or result’’ (Shorter 

Oxford English Dictionary, Fifth Ed. 

(2002), p. 794) and is not consistent 

with use of the term ‘‘monitoring’’ in 

traditional HACCP. The term 

‘‘verification,’’ not ‘‘monitoring’’ is used 

to refer to effectiveness in traditional 

HACCP systems. Monitoring the 

effectiveness of preventive controls 

would evaluate whether the preventive 

controls were working. 

Requiring monitoring of the 

effectiveness of the preventive controls 

would be redundant with required 

verification activities. Section 418(f) 

requires verification that the preventive 

controls ‘‘are effectively and 

significantly minimizing the occurrence 

of the identified hazards.* * *’’ The 

activities necessary for such verification 

are the same as would be required for 

monitoring the effectiveness of the 

preventive controls. For example, 

because effectiveness addresses whether 

the hazard is controlled, monitoring the 

effectiveness could include testing for 

the presence of the hazard, such as 

testing for the presence of 

staphylococcal enterotoxin that can 

occur during cheese making if the pH 

does not drop to a low enough level in 

a short enough time. Further, requiring 

monitoring of effectiveness rather than 

performance of the preventive controls 

would create a significant gap in the 

preventive controls system if the factors 

that are critical to control of the hazard, 

e.g., pH of the cheese curd and time, are 

not monitored to ensure the process is 

implemented correctly. In contrast, 

monitoring the performance of 

preventive controls would provide 

evidence that the preventive controls 

established to control the identified 

hazards are implemented appropriately 

(e.g., pH of the cheese curd drops below 

5.6 within 8 hours) and thereby are 

effectively and significantly minimizing 

or preventing the hazards (e.g., 

staphylococcal enterotoxin). 

As discussed more fully in the next 

section of this document, this 

interpretation also is grounded in our 

existing HACCP regulations and 

guidance. Section 418(n)(5) of the FD&C 

Act directs the Secretary, in 

promulgating these regulations, to 

review hazard analysis and preventive 

control programs in existence to ensure 

that this regulation is consistent to the 

extent practicable with applicable 

domestic and internationally-recognized 

standards in existence. Requiring 

monitoring of the performance of 

preventive controls is consistent with 

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applicable domestic and internationally 

recognized standards. 

Therefore, we tentatively conclude 

that this interpretation is reasonable, 

and we propose to adopt it in the 

proposed requirements implementing 

section 418(d) of the FD&C Act. We 

request comment on this interpretation. 

6. Proposed § 117.140—Monitoring 

a. Proposed § 117.140(a)— 

Requirement for written procedures for 

monitoring. Proposed § 117.140(a) 

would require that the owner, operator, 

or agent in charge of a facility establish 

and implement written procedures, 

including the frequency with which 

they are to be performed, for monitoring 

the preventive controls. Proposed 

§ 117.140(a) would implement sections 

418(d) and (h) of the FD&C Act. 

Proposed § 117.140(a) is consistent 

with the NACMCF HACCP guidelines, 

the Codex HACCP Annex, and Federal 

HACCP regulations for seafood, juice, 

and meat and poultry. We discuss the 

purposes that the NACMCF HACCP 

guidelines identify for monitoring under 

a HACCP system in section II.C.4.d of 

this document. Each of these purposes 

applies to preventive controls as well, 

and we tentatively conclude that these 

purposes would be achieved by 

proposed § 117.140(a). Proposed 

§ 117.140(a) would facilitate tracking 

the implementation of the preventive 

controls to provide assurance that they 

are consistently performed; if 

monitoring indicates that there is a 

trend towards loss of control, a facility 

can take action to bring the process back 

into control before a preventive control 

is not properly implemented and 

potentially unsafe product is produced. 

Further, if monitoring is conducted with 

sufficient frequency to ensure 

preventive controls are consistently 

performed, it will detect if a preventive 

control is not properly implemented 

(e.g., if the temperature of an oven falls 

below the temperature needed to ensure 

safety), indicating loss of control and 

signaling the need for an appropriate 

corrective action. Finally, the proposed 

monitoring requirement would result in 

written documentation for use in 

verification. 

The Codex HACCP Annex advises 

that monitoring procedures must be able 

to detect loss of control at the CCP and 

ideally should provide this information 

in time to make adjustments to ensure 

control of the process to prevent 

violating the critical limits. The Codex 

HACCP Annex also recommends that, 

where possible, process adjustments be 

made when monitoring results indicate 

a trend towards loss of control at a CCP, 

before a deviation occurs (Ref. 35). 

Federal HACCP regulations for seafood, 

juice, and meat and poultry require in 

the written HACCP plan monitoring of 

control measures to determine whether 

physical, chemical, or biological 

parameters are being met (i.e., 

monitoring of critical control points to 

ensure compliance with the critical 

limits) (§ 123.6(b) and (c)(4)), § 120.8(a) 

and (b)(4), and 9 CFR 417.2(b)(1) and 

(c)(4), respectively). Like the Federal 

HACCP regulations for seafood, juice, 

and meat and poultry, the requirements 

for monitoring in proposed § 117.140(a) 

focus on evaluating performance of the 

preventive controls. 

Proposed § 117.140(a) would require 

that the monitoring procedures be 

written. Under section 418(d) of the 

FD&C Act, the owner, operator, or agent 

in charge of a facility must monitor the 

effectiveness of the preventive controls 

implemented under section 418(c) of the 

FD&C Act, and under section 418(h) of 

the FD&C Act the procedures used by 

the facility to comply with the 

requirements of section 418 of the FD&C 

Act must be included in the written 

plan. The NACMCF HACCP guidelines 

note under record-keeping and 

documentation procedures that the 

procedures for monitoring should be 

provided (Ref. 34). The Codex HACCP 

Annex includes ‘‘monitoring 

procedures’’ in its example of a HACCP 

worksheet (Ref. 35). Federal HACCP 

regulations for seafood, juice and meat 

and poultry require that the HACCP 

plan be written (§§ 123.6(b), 120.8(a), 

and 9 CFR 417.2(b)(1), respectively) and 

that procedures for monitoring be 

included in the written HACCP plan 

(§§ 123.6(c)(4), 120.8(b)(4), and 9 CFR 

417.2(c)(4), respectively). 

Proposed § 117.140(a) would require 

that the monitoring procedures include 

the frequency with which they are to be 

performed. We discuss the frequency of 

monitoring in the next section of this 

document. Briefly, the frequency of 

monitoring must be sufficient to ensure 

that the preventive control is 

consistently performed in order to help 

ensure that the preventive control is 

effective. The NACMCF HACCP 

guidelines note that the frequency of 

monitoring should be provided in the 

HACCP Plan Summary Table (Ref. 34). 

Federal HACCP regulations for seafood, 

juice and meat and poultry require that 

the written HACCP plan include the 

procedures, and frequency thereof, that 

will be used for monitoring 

(§§ 123.6(c)(4), 120.8(b)(4), and 9 CFR 

417.2(c)(4), respectively). 

b. Proposed § 117.140(b)—Frequency 

of monitoring. Proposed § 117.140(b) 

would require that the owner, operator, 

or agent in charge of a facility monitor 

the preventive controls with sufficient 

frequency to provide assurance that they 

are consistently performed. Proposed 

§ 117.140(b) does not specify a single 

monitoring frequency applicable to all 

facilities and processes. Rather, it 

requires monitoring with ‘‘sufficient 

frequency’’ to assure that the preventive 

controls are consistently performed. 

Proposed § 117.140(b) would implement 

section 418(d) of the FD&C Act and is 

consistent with the NACMCF HACCP 

guidelines and the Codex HACCP 

Annex. 

The NACMCF guidelines recommend 

continuous monitoring where possible 

(Ref. 34). Continuous monitoring is 

possible with many types of physical 

and chemical parameters. For example, 

the temperature and time for many 

thermal processes can be recorded 

continuously on temperature recording 

charts. If the temperature falls below the 

scheduled temperature or the time is 

insufficient, as recorded on the chart, 

the affected product can be retained and 

evaluated to determine the appropriate 

disposition. Examples of other 

parameters that can be monitored 

continuously include pressure, flow rate 

and pH. 

However, the NACMCF guidelines 

acknowledge that continuous 

monitoring may not be possible, or even 

necessary, in all cases. For example, it 

may not be practical to continuously 

monitor the size of particles in a food 

to ensure they do not exceed the 

maximum dimensions that are required 

to ensure a process such as cooking, 

cooling, or acidification can be properly 

implemented. NACMCF states that if 

monitoring is not continuous it may be 

difficult to ensure that the preventive 

controls are consistently implemented 

and a problem has not occurred. Thus, 

according to NACMCF, the frequency of 

non-continuous monitoring must be 

sufficient to ensure that a critical 

control point (or, in the case of this 

proposed rule, a preventive control) is 

under control (Ref. 34). The Codex 

HACCP Annex also notes that, if 

monitoring is not continuous, then the 

amount or frequency of monitoring must 

be sufficient to guarantee the CCP is in 

control (Ref. 35). The frequency of noncontinuous monitoring would depend 

on factors such as the proximity of 

operating conditions to the conditions 

needed to ensure safety and the 

variability of the process. For example, 

if the temperature needed to ensure 

safety of roasted nuts is 290 °F, noncontinuous monitoring would need to 

be more frequent when an oil roaster for 

nuts is operated at 300 °F than when the 

oil roaster is operated at 350 °F. As 

another example, if temperatures vary 

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by 10–15 °F during processing, 

monitoring would need to be more 

frequent than if the variation is only 1– 

2 degrees. 

As discussed in the previous section 

of this document, Federal HACCP 

regulations for seafood, juice, and meat 

and poultry require that the written 

HACCP plan include the procedures, 

and frequency thereof, that will be used 

for monitoring (§§ 123.6(c)(4), 

120.8(b)(4), and 9 CFR 417.2(c)(4), 

respectively). Our Fish and Fishery 

Products Hazards and Controls 

Guidance discusses the frequency of 

monitoring and notes that the frequency 

of monitoring depends upon the 

circumstances, with continuous 

monitoring being desirable; in some 

cases, continuous monitoring may be 

necessary, while in other cases, it may 

not be necessary or practical (Ref. 173). 

Our Juice HACCP Hazards and Controls 

Guidance provides examples of 

‘‘Summary HACCP Plans,’’ which show 

how the frequency of monitoring would 

depend on the circumstances (Ref. 4). 

c. Proposed § 117.140(c)— 

Requirement for records. Proposed 

§ 117.140(c) would require that all 

monitoring of preventive controls in 

accordance with proposed § 117.140 be 

documented in records that are subject 

to verification in accordance with 

§ 117.150(b) and records review in 

accordance with proposed 

§ 117.150(d)(2)(i). Proposed § 117.140(c) 

would implement section 418(g) of the 

FD&C Act and is consistent with the 

NACMCF HACCP guidelines, the Codex 

HACCP Annex, and Federal HACCP 

regulations for seafood, juice, and meat 

and poultry. The NACMCF HACCP 

guidelines recommend that the records 

maintained for the HACCP system 

include records that are generated 

during the operation of the plan (Ref. 

34). The Codex HACCP Annex gives 

records of CCP monitoring activities as 

an example of records (Ref. 35). Our 

HACCP regulations for seafood and 

juice require that the HACCP plan 

provide for a recordkeeping system that 

documents the monitoring of the critical 

control points (§§ 123.6(c)(7) and 

120.8(b)(7), respectively). The FSIS 

HACCP regulation for meat and poultry 

requires records documenting the 

monitoring of CCPs and their critical 

limits, including the recording of actual 

times, temperatures, or other 

quantifiable values. 

The monitoring records would be 

used to verify that the preventive 

controls are adequate, as would be 

required by proposed § 117.150(a), and 

to verify that the preventive controls are 

effectively and significantly minimizing 

or preventing the hazards that are 

reasonably likely to occur, as would be 

required by proposed § 117.150(d). This 

is further discussed in section XII.G.5.b 

of this document. Together, proposed 

§§ 117.140(a), (b), and (c) and 

117.150(a), (b), and (d) would establish 

a system that would provide assurance 

that hazards identified in the hazard 

analysis conducted under section 

418(b)(1) of the FD&C Act will be 

significantly minimized or prevented 

and that food manufactured, processed, 

packed or held by such facility will not 

be adulterated under section 402 of the 

FD&C Act or misbranded under section 

403(w) of the FD&C Act. 

F. Proposed § 117.145—Corrective 

Actions 

1. Requirements of Section 418 of the 

FD&C Act 

Section 418(h) of the FD&C Act, in 

relevant part, specifies that the owner, 

operator, or agent in charge of a facility 

shall prepare a written plan that 

documents and describes the 

procedures used by the facility to 

comply with the requirements of section 

418 of the FD&C Act. Section 418(e) of 

the FD&C Act specifies that the owner, 

operator, or agent in charge of a facility 

shall establish procedures to ensure 

that, if the preventive controls 

implemented under section 418(c) of the 

FD&C Act are not properly implemented 

or are found to be ineffective: 

• Appropriate action is taken to 

reduce the likelihood of recurrence of 

the implementation failure (section 

418(e)(1) of the FD&C Act); 

• All affected food is evaluated for 

safety (section 418(e)(2) of the FD&C 

Act); and 

• All affected food is prevented from 

entering into commerce if the owner, 

operator or agent in charge of such 

facility cannot ensure that the affected 

food is not adulterated under section 

402 of the FD&C Act or misbranded 

under section 403(w) of the FD&C Act 

(section 418(e)(3) of the FD&C Act). 

Section 418(f)(4) of the FD&C Act 

requires, in relevant part, that the 

owner, operator, or agent in charge of a 

facility verify that the preventive 

controls implemented under section 

418(c) of the FD&C Act are effectively 

and significantly minimizing or 

preventing the occurrence of identified 

hazards. 

2. Proposed § 117.145(a)—Corrective 

Action Procedures 

Proposed § 117.145(a)(1) would 

require that the owner, operator, or 

agent in charge of a facility establish 

and implement written corrective action 

procedures that must be taken if 

preventive controls are not properly 

implemented. Having written 

procedures in place would enable 

facilities to act quickly and 

appropriately when preventive controls 

are not properly implemented—e.g., 

when a parameter associated with heat 

processing exceeds a maximum value or 

falls below a minimum value. Proposed 

§ 117.145(a)(1) would implement 

section 418(e) of the FD&C Act and is 

consistent with the NACMCF HACCP 

guidelines, the Codex HACCP Annex, 

and Federal HACCP regulations for 

seafood, juice, and meat and poultry. 

The NACMCF HACCP guidelines 

define a corrective action as procedures 

followed when a deviation occurs at a 

CCP and recommend that specific 

corrective actions be developed in 

advance for each CCP and included in 

the HACCP plan (Ref. 34). The Codex 

HACCP Annex advises that specific 

corrective actions be developed for each 

CCP in the HACCP system (Ref. 35). Our 

HACCP regulations for seafood and 

juice require that processers take 

corrective action whenever a deviation 

from a critical limit occurs, either by 

following specific corrective action 

procedures specified in the regulation, 

or by following procedures in written 

corrective action plans that the 

processor develops (§§ 123.7 and 

120.10, respectively). If the processor of 

a seafood or juice product covered by 

the applicable HACCP regulation 

develops such plans, they must be 

included in the written HACCP plan 

(§§ 123.6(c)(5) and 123.7(b) and 

120.8(b)(5), respectively). The FSIS 

HACCP regulation for meat and poultry 

requires that the written HACCP plan 

identify the corrective action to be 

followed in response to a deviation from 

a critical limit (9 CFR 417.3(a)). 

As discussed in section XII.C.4 of this 

document, the proposed rule would 

establish requirements for preventive 

controls (which may be at critical 

control points), and proposed 

§ 117.135(c)(2) would require that the 

preventive controls include, as 

appropriate to the facility and the food, 

the maximum or minimum value, or 

combination of values, to which any 

physical, biological, radiological, or 

chemical parameter must be controlled 

to significantly minimize or prevent a 

hazard that is reasonably likely to occur 

(which reflects the NACMCF definition 

of a critical limit). As already noted 

earlier in this section, if a parameter 

associated with heat processing falls 

below a minimum value, corrective 

action would be triggered. Thus, the 

concept in the proposed rule of taking 

corrective action when a preventive 

control is not properly implemented is 

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3750 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

similar to the concept in HACCP 

systems of taking corrective action for a 

deviation from a critical limit at a 

critical control point. 

The benefits from identifying 

corrective action procedures in advance 

of the need to actually take corrective 

action largely derive from having the 

procedures in written form. Written 

corrective action procedures would be 

essential to the facility’s food safety 

team, to auditors, and to inspectors. The 

facility’s food safety team will be 

responsible for ensuring that 

appropriate corrective actions are taken 

if preventive controls are not properly 

implemented. Having access to 

appropriate, written corrective action 

procedures determined in advance of 

the need for such action can ensure that 

correct and complete actions are taken 

in a timely fashion without the need for 

the team to meet and decide on the 

appropriate action. Having written 

corrective action procedures available 

for auditors and for inspectors is 

essential for them to assess the 

adequacy of the food safety plan; the 

procedures a facility will use to address 

implementation failures are essential to 

the production of safe food, and without 

them a complete assessment cannot be 

made. Written corrective action 

procedures also would be useful for 

training purposes, so that employees 

who would need to implement the 

corrective action procedures will be 

prepared for what they would need to 

do. 

Proposed § 117.145(a)(2) would 

implement section 418(e) of the FD&C 

Act (i.e., that the owner, operator, or 

agent in charge of a facility must 

establish corrective action procedures) 

and section 418(h) of the FD&C Act (i.e., 

that the owner, operator, or agent in 

charge of a facility must prepare a 

written plan). Proposed § 117.145(a)(2) 

is consistent with the NACMCF HACCP 

guidelines, the Codex HACCP Annex, 

and with Federal HACCP regulations for 

seafood, and juice, and meat and 

poultry. The NACMCF HACCP 

guidelines recommend that specific 

corrective actions be included in the 

HACCP plan (Ref. 34). In its discussion 

of corrective actions, the Codex HACCP 

Annex advises that deviation and 

product disposition procedures be 

documented in the HACCP record 

keeping (Ref. 35). Our HACCP 

regulations for seafood and juice both 

require that the written HACCP plan 

include any corrective action plans that 

have been developed by the processor 

(§§ 123.6(c)(5) and 123.7(b) and 

120.8(b)(5)). The FSIS HACCP 

regulation for meat and poultry requires 

that the written HACCP plan identify 

the corrective action to be followed in 

response to a deviation from a critical 

limit (9 CFR 417.3(a)). 

Proposed § 117.145(a)(2) would 

require that corrective action procedures 

describe the steps to be taken to ensure 

that: 

• Appropriate action is taken to 

identify and correct a problem with 

implementation of a preventive control 

to reduce the likelihood that the 

problem will recur (proposed 

§ 117.145(a)(2)(i)); 

• All affected food is evaluated for 

safety (proposed § 117.145(a)(2)(ii)); and 

• All affected food is prevented from 

entering into commerce, if the owner, 

operator or agent in charge of such 

facility cannot ensure that the affected 

food is not adulterated under section 

402 of the FD&C Act or misbranded 

under section 403(w) of the FD&C Act 

(proposed § 117.145(a)(2)(iii)). 

The hazard analysis and risk-based 

preventive controls in this proposed 

rule are designed to identify hazards 

that are reasonably likely to occur, and 

to significantly minimize or prevent the 

occurrence of such hazards and provide 

assurances that such food is not 

adulterated under section 402 of the 

FD&C Act or misbranded under section 

403(w) of the FD&C Act. However, a 

preventive controls system, similar to a 

HACCP system (Ref. 34), accounts for 

the possibility of implementation and 

effectiveness problems and includes 

procedures for addressing those 

problems and any affected food. 

Proposed § 117.145(a)(2) would 

implement sections 418(e)(1)-(3) of the 

FD&C Act and is consistent with the 

NACMCF HACCP guidelines, the Codex 

HACCP Annex, and Federal HACCP 

regulations for seafood, juice, and meat 

and poultry. The NACMCF HACCP 

guidelines recommend that corrective 

actions include elements to determine 

and correct the cause of non-compliance 

and to determine the disposition of noncompliant product (Ref. 34). The Codex 

HACCP Annex advises that the specific 

corrective actions must ensure that the 

CCP has been brought under control and 

that actions taken must also include 

proper disposition of the affected 

product (Ref. 35). Our HACCP 

regulations for seafood and juice 

establish that a corrective action plan 

that is appropriate for a particular 

deviation is one that describes the steps 

to be taken and assigns responsibility 

for taking those steps, to ensure that no 

product enters commerce that is either 

injurious to health or is otherwise 

adulterated as a result of the deviation, 

and the cause of the deviation is 

corrected (§§ 123.7(b) and 120.10(a), 

respectively). The FSIS HACCP 

regulation for meat and poultry requires 

that the HACCP plan describe the 

corrective action to be taken, and assign 

responsibility for taking corrective 

action, to ensure: (1) The cause of the 

deviation is identified and eliminated; 

(2) the CCP will be under control after 

the corrective action is taken; (3) 

measures to prevent recurrence are 

established; and (4) no product that is 

injurious to health or otherwise 

adulterated as a result of the deviation 

enters commerce (9 CFR 417.3(a)). 

Section 418(e)(1) of the FD&C Act and 

proposed § 117.145(a)(2)(i) explicitly 

require that action be taken to reduce 

the likelihood of recurrence of the 

implementation failure. Although not 

prescribed by proposed 

§ 117.145(a)(2)(i), reducing the 

likelihood of recurrence of an 

implementation failure is best 

accomplished by identifying the root 

cause of failure and then taking action 

to address that root cause. If the root 

cause is not identified and corrected, it 

is more likely that the failure will recur. 

For example, if the temperature of a heat 

process cannot be maintained, a 

corrective action to raise the 

temperature using the controller may 

correct the problem short-term. 

However, if the root cause is a lack of 

boiler capacity to run multiple heating 

units at the same time, corrective action 

should address replacing the boiler to 

increase capacity. Similarly, if a facility 

cannot cool a food rapidly enough in a 

refrigerator to meet the cooling times 

and temperatures in its HACCP plan, 

the initial corrective action may be to 

move product into a freezer for cooling. 

If the root cause is determined to be that 

the product was filled too high in the 

cooling tray, the corrective action may 

be to include procedures to measure the 

depth of product in the tray. If the root 

cause is determined to be insufficient 

cooling capacity to remove heat from 

the amount of product being cooled, the 

corrective action may involve using a 

cooling unit with greater cooling 

capacity or changing the method of 

cooling, e.g., to a blast freezer. 

Proposed § 117.145(a)(2)(ii) and (iii), 

would require that corrective action 

procedures include an evaluation of all 

food affected by a problem and 

procedures for ensuring that affected 

food is prevented from entering into 

commerce if the owner, operator or 

agent in charge of the facility cannot 

ensure that the affected food is not 

adulterated under section 402 of the 

FD&C Act or misbranded under section 

403(w) of the FD&C Act. Such an 

evaluation is implicit in our HACCP 

regulations for seafood and juice 

(§§ 123.7(b) and 120.10(a)) in that these 

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sections do not explicitly require that 

food affected by the problem be 

evaluated, but do require that steps be 

taken to ensure that product that is 

injurious to health or otherwise 

adulterated does not enter commerce. 

Although our HACCP regulations for 

seafood and juice do not specify the 

steps that must be described in a 

corrective action plan, the regulations 

require that specific steps be taken 

when a deviation from a critical limit 

occurs and the processor does not have 

a corrective action plan that is 

appropriate for that deviation 

(§§ 123.7(c) and 120.10(b), respectively). 

Under these regulations, required steps 

include segregating and holding effected 

product, performing or obtaining a 

review to determine the acceptability of 

the affected product for distribution and 

taking corrective action, when 

necessary, to ensure that no product 

enters commerce that is either injurious 

to health or is otherwise adulterated as 

a result of the deviation. FDA notes that 

the corrective action procedures in the 

HACCP regulations do not reference 

misbranding under section 403(w) of the 

FD&C Act. Section 403(w) of the FD&C 

Act was added to the FD&C Act by the 

Food Allergen Labeling and Consumer 

Protection Act of 2004 (Pub. L. 108–282, 

Title II), which was enacted after 

issuance of both the seafood and juice 

HACCP regulations. However, our 

HACCP regulation for juice includes the 

presence of undeclared ingredients that 

may be allergens as a potential hazard 

that must be considered in the hazard 

analysis (§ 120.7(c)(8)), and our Fish and 

Fishery Products Hazards and Controls 

Guidance (Fourth Edition) (Ref. 173) 

and Juice HACCP Hazards and Controls 

Guidance (Ref. 4) both include 

recommendations directed to hazards 

from undeclared food allergens. 

3. Proposed § 117.145(b)—Corrective 

Action in the Event of an Unanticipated 

Problem 

Proposed § 117.145(b)(1) would 

require that if a preventive control is not 

properly implemented and a specific 

corrective action has not been 

established, or a preventive control is 

found to be ineffective, the owner, 

operator, or agent in charge of a facility 

take corrective action to identify and 

correct the problem, evaluate all 

affected food for safety, and, as 

necessary, prevent affected food from 

entering commerce as would be done 

following a corrective action procedure 

under proposed § 117.145(a)(2)(i)–(iii). 

However, a facility might not anticipate 

all of the problems that may occur, and 

a facility may experience an 

implementation failure for which a 

corrective action procedure has not been 

established. Regardless of whether a 

problem was anticipated and a 

corrective action procedure was 

developed in advance, corrective 

actions to accomplish the steps that 

would have been included in a 

corrective action procedure are 

necessary. Likewise, a facility might 

determine (e.g., as a verification activity 

in accordance with proposed 

§ 117.150(d), discussed in section 

XII.G.5 of this document), that a 

preventive control is ineffective. For 

example, detecting a pathogen in an 

RTE food may signal that preventive 

controls for that pathogen are 

ineffective. As in the case of an 

unanticipated implementation failure of 

a preventive control, corrective actions 

would be necessary if a preventive 

control is found to be ineffective. 

Proposed § 117.145(b)(1) is consistent 

with Federal HACCP regulations for 

seafood, juice, and meat and poultry. 

Our HACCP regulations for seafood and 

juice require that, when a deviation 

from a critical limit occurs and the 

processor does not have a corrective 

action plan that is appropriate for that 

deviation, the processor segregate and 

hold the affected product; perform or 

obtain a review to determine the 

acceptability of the affected product for 

distribution; take corrective action, 

when necessary, with respect to the 

affected product to ensure that no 

product enters commerce that is either 

injurious to health or is otherwise 

adulterated as a result of the deviation; 

and take corrective action, when 

necessary, to correct the cause of the 

deviation (§§ 123.7(c)(1)–(4) and 

120.10(b)(1)–(4), respectively). The FSIS 

HACCP regulation for meat and poultry 

(9 CFR 417.3(b)) requires, in relevant 

part, that if a deviation not covered by 

a specified corrective action occurs, or 

if another unforeseen hazard arises, the 

establishment must: (1) Segregate and 

hold the affected product, at least until 

the requirements of 9 CFR 417.3(b)(2) 

and (3) are met; (2) perform a review to 

determine the acceptability of the 

affected product for distribution; and (3) 

take action, when necessary, with 

respect to the affected product to ensure 

that no product that is injurious to 

health or otherwise adulterated, as a 

result of the deviation, enters 

commerce. The NACMCF HACCP 

guidelines and the Codex HACCP 

Annex are silent on the specific issue of 

taking corrective actions when a 

preventive control is not properly 

implemented and a specific corrective 

action has not been established or when 

a preventive control has been found to 

be ineffective. However, proposed 

§ 117.145(b)(1) is consistent with 

HACCP principles, discussed earlier in 

this section, recommended in the 

NACMCF HACCP guidelines and Codex 

HACCP Annex regarding the importance 

of corrective actions whenever there is 

a deviation from a critical limit. In each 

of the situations described (following an 

established corrective action, taking 

corrective action in the absence of a 

plan, or taking corrective action when 

the preventive control is found to be 

ineffective) the intent of taking 

corrective action is to restore control 

and to ensure that hazardous foods do 

not reach the consumer. 

Proposed § 117.145(b)(2) would 

require that the owner, operator, or 

agent in charge of a facility reanalyze 

the food safety plan in accordance with 

proposed § 117.150(f) to determine 

whether modification of the food safety 

plan is required if a preventive control 

is not properly implemented and a 

specific corrective action has not been 

established, or if a preventive control is 

found to be ineffective. (We use the term 

‘‘reanalyze’’ when we refer to a 

reassessment of the validity of a 

preventive control or the food safety 

plan to control a hazard.) Under 

proposed § 117.150(a), the verification 

required by section 418(f) of the FD&C 

Act would include validation of the 

food safety plan, referring to whether it 

is effectively controlling the hazards or 

‘‘working correctly.’’ See section XII.G 

of this document for a discussion of 

proposed requirements for verification 

(including validation and reanalysis) 

under section 418(f) of the FD&C Act. 

Proposed § 117.145(b)(2) would apply to 

unanticipated food safety problems, and 

the unanticipated nature of the 

problems is relevant to the reanalysis of 

the food safety plan. If the owner, 

operator, or agent in charge of a facility 

has assessed its procedures, practices, 

and processes and has not identified a 

specific failure as a foreseeable 

occurrence, the owner, operator, or 

agent in charge must assess whether the 

problem is simply an implementation 

failure that could be expected to occur 

in the normal course of manufacturing, 

processing, packing or holding the food, 

or the result of a system-wide problem 

that is not being properly addressed by 

the plan (e.g., ineffective preventive 

controls). If the problem is simply an 

implementation failure, and such a 

failure is now a foreseeable 

circumstance, reanalysis of the food 

safety plan would be necessary to 

determine whether a corrective action 

procedure should be established for that 

foreseeable failure. Likewise, if the 

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problem is the result of a system-wide 

problem that is not being properly 

addressed by the plan (or is otherwise 

a result of ineffective preventive 

controls), reanalysis of the food safety 

plan would be necessary to identify 

effective preventive controls. Either 

way, reanalyzing the food safety plan 

and modifying it as necessary would be 

necessary to reduce the risk of 

recurrence of the problem. 

Proposed § 117.145(b)(2) is consistent 

with the NACMCF HACCP guidelines, 

the Codex HACCP Annex, and Federal 

HACCP regulations for seafood, juice, 

and meat and poultry. The NACMCF 

HACCP guidelines, in relevant part, 

recommend that validations (i.e., an 

assessment of the validity of the HACCP 

plan) be conducted when there is an 

unexplained system failure (e.g., an 

implementation failure or ineffective 

preventive controls) (Ref. 34). The 

Codex HACCP Annex, in relevant part, 

advises that verification procedures be 

used to determine if the HACCP system 

is working correctly (Ref. 35); such 

verification procedures would also be 

used if an unexpected implementation 

failure of a preventive control suggests 

that the system is not working correctly. 

Our HACCP regulations for seafood and 

juice, in relevant part, require that, 

when a deviation from a critical limit 

occurs and the processor does not have 

a corrective action plan that is 

appropriate for that deviation, the 

processor must perform or obtain timely 

reassessment or verification by a trained 

individual to determine whether 

modification of the HACCP plan is 

required to reduce the risk of recurrence 

of the deviation and to modify the 

HACCP plan as necessary (§§ 123.7(c)(5) 

and 120.10(b)(5), respectively). The 

FSIS regulation for meat and poultry 

requires, in relevant part, that if a 

deviation not covered by a specified 

corrective action occurs, or if another 

unforeseen hazard arises, the 

establishment must perform or obtain 

reassessment to determine whether the 

newly identified deviation or other 

unforeseen hazard should be 

incorporated into the HACCP plan (9 

CFR 417.3(b)(4)). (The FSIS HACCP 

regulation for meat and poultry uses the 

term ‘‘reassessment’’ much as this 

proposed rule would use the term 

‘‘reanalysis.’’) 

4. Proposed § 117.145(c)— 

Documentation 

Proposed § 117.145(c) would require 

that all corrective actions taken in 

accordance with this section be 

documented in records that are subject 

to verification in accordance with 

§ 117.150(c) and records review in 

accordance with § 117.150(d)(2)(i). The 

records that document corrective 

actions would be used to verify that 

appropriate decisions about corrective 

actions are being made and appropriate 

corrective actions are being taken. 

G. Proposed § 117.150—Verification 

1. Requirements of Section 418 of the 

FD&C Act 

Section 418(f) of the FD&C Act 

requires that the owner, operator, or 

agent in charge of a facility verify that: 

• The preventive controls 

implemented under section 418(c) of the 

FD&C Act are adequate to control the 

hazards identified under [section 418(b) 

of the FD&C Act (section 418(f)(1) of the 

FD&C Act); 

• The owner, operator, or agent is 

conducting monitoring in accordance 

with section 418(d) of the FD&C Act 

(section 418(f)(2) of the FD&C Act); 

• The owner, operator, or agent is 

making appropriate decisions about 

corrective actions taken under section 

418(e) of the FD&C Act (section 418(f)(3) 

of the FD&C Act); 

• The preventive controls 

implemented under section 418(c) of the 

FD&C Act are effectively and 

significantly minimizing or preventing 

the occurrence of identified hazards, 

including through the use of 

environmental and product testing 

programs and other appropriate means 

(section 418(f)(4) of the FD&C Act); and 

• There is documented, periodic 

reanalysis of the plan under section 

418(i) of the FD&C Act to ensure that the 

plan is still relevant to the raw 

materials, conditions and processes in 

the facility, and new and emerging 

threats (section 418(f)(5) of the FD&C 

Act). 

In addition, section 418(g) of the 

FD&C Act specifies, in relevant part, 

that the owner, operator, or agent in 

charge of a facility shall maintain, for 

not less than 2 years, records 

documenting the monitoring of the 

preventive controls implemented under 

section 418(c) of the FD&C Act, 

instances of nonconformance material to 

food safety, the results of testing and 

other appropriate means of verification 

under section 418(f)(4) of the FD&C Act, 

instances when corrective actions were 

implemented, and the efficacy of 

preventive controls and corrective 

actions. 

Further, section 418(i) of the FD&C 

Act specifies that the owner, operator, 

or agent in charge of a facility shall 

conduct a reanalysis under section 

418(b) of the FD&C Act (the requirement 

to identify and evaluate known or 

reasonably foreseeable hazards) 

whenever a significant change is made 

in the activities conducted at a facility 

operated by such owner, operator, or 

agent if the change creates a reasonable 

potential for a new hazard or a 

significant increase in a previously 

identified hazard or not less frequently 

than once every 3 years, whichever is 

earlier. Such reanalysis shall be 

completed and additional preventive 

controls needed to address the hazard 

identified, if any, shall be implemented 

before the change in activities at the 

facility is operative. The owner, 

operator, or agent shall revise the 

written plan required under section 

418(h) of the FD&C Act if such a 

significant change is made or document 

the basis for the conclusion that no 

additional or revised preventive 

controls are needed. The Secretary may 

require a reanalysis under section 418(i) 

of the FD&C Act to respond to new 

hazards and developments in scientific 

understanding, including, as 

appropriate, results from the 

Department of Homeland Security 

biological, chemical, radiological, or 

other terrorism risk assessment. 

2. Proposed Requirements for Validation 

a. Proposed § 117.150(a)—Validation 

that preventive controls are adequate to 

control the hazard. Proposed 

§ 117.150(a) (Validation) would require 

that, except as provided by paragraph 

(a)(3), the owner, operator, or agent in 

charge of a facility validate that the 

preventive controls identified and 

implemented in accordance with 

§ 117.135 to control the hazards 

identified in the hazard analysis as 

reasonably likely to occur are adequate 

to do so. Proposed § 117.150(a) would 

implement section 418(f)(1) of the FD&C 

Act and is consistent with the NACMCF 

HACCP guidelines, the Codex HACCP 

guidelines, and Federal HACCP 

regulations for seafood, juice, and meat 

and poultry. The NACMCF HACCP 

guidelines describe verification as 

activities that, in relevant part, 

determine the validity of the HACCP 

plan (Ref. 34). The NACMCF guidelines 

advise that an important aspect of 

verification is the initial validation of 

the HACCP plan to determine that the 

plan is scientifically and technically 

sound, that all hazards have been 

identified and that, if the HACCP plan 

is properly implemented, these hazards 

will be effectively controlled (Ref. 34). 

The Codex HACCP guidelines 

recommend that, where possible, 

validation activities include actions to 

confirm the efficacy of all elements of 

the HACCP system (Ref. 35). Our 

HACCP regulation for seafood does not 

specifically use the term ‘‘validation,’’ 

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but it reflects the concept in requiring 

that every processor verify that the 

HACCP plan is adequate to control the 

hazards (§ 123.8(a)). Our HACCP 

regulation for juice addresses both 

validation of the HACCP plan 

(§ 120.11(b)) and the hazard analysis 

(§ 120.11(c)). The regulation requires 

each processor to validate that the 

HACCP plan is adequate to control food 

hazards that are reasonably likely to 

occur at least once within 12 months 

after implementation and at least 

annually thereafter. (This annual 

validation is the same as reanalysis 

proposed in § 117.150(f) and discussed 

in section XII.G.7 of this document. The 

requirement for validation of the hazard 

analysis in § 120.11(c) aligns more with 

a requirement for reanalysis and is 

discussed in section XII.G.2.a of this 

document). The FSIS HACCP regulation 

for meat and poultry (9 CFR 417.4(a)) 

requires that every establishment 

validate the HACCP plan’s adequacy in 

controlling the food safety hazards 

identified during the hazard analysis. 

The regulations and guidelines 

described above reflect the widespread 

recognition of the importance of 

ensuring that preventive controls, if 

properly implemented, will adequately 

control the hazards. 

b. Proposed § 117.150(a)(1)— 

Validation by a qualified individual 

prior to implementation and on 

reanalysis. Proposed § 117.150(a)(1) 

would require that the validation of the 

preventive controls be performed by (or 

overseen by) a qualified individual. The 

preventive controls must be adequate to 

control the hazards identified in the 

hazard analysis as reasonably likely to 

occur. Determining whether specific 

preventive controls are adequate 

requires an individual who is 

knowledgeable in the hazards associated 

with a product and process and the 

appropriate preventive controls for 

those hazards. Such knowledge requires 

scientific and technical expertise 

developed through training, experience 

or both. 

Proposed § 117.150(a)(1)(i) would 

require that validation occur prior to 

implementation of the food safety plan 

or, when necessary, during the first six 

weeks of production. The validation of 

preventive controls includes collecting 

and evaluating scientific and technical 

information (or, when such information 

is not available or is insufficient, 

conducting studies), as discussed in the 

next section of this document. The 

collected data or information, or the 

studies, would establish a scientific and 

technical basis for the preventive 

controls used, in particular those that 

involve critical control points. This 

scientific and technical basis largely 

must be established prior to producing 

a product to ensure that the food 

produced using those preventive 

controls will be safe. However, as a 

practical matter, the scientific and 

technical basis for some aspects of a 

preventive control may require 

production conditions and, thus, would 

be established by the collection of data 

or information during, rather than 

before, producing a product. For 

example, ensuring that limits for control 

parameters can be met during 

production would be done under 

production conditions. FDA tentatively 

concludes that preventive controls that 

require the collection of data or 

information, or studies, during 

production conditions are part of 

validation, and, thus proposed 

§ 117.150(a)(1)(i) would require that the 

validation of preventive controls be 

performed, when necessary, during the 

first six weeks of production. We 

selected six weeks as a time interval that 

would be adequate to allow facilities to 

methodically collect data and 

information during production, yet 

would be close to implementation of a 

preventive control. 

The NACMCF HACCP guidelines 

recommend that initial validation be 

conducted prior to and during initial 

implementation of the plan (Ref. 34). A 

Codex document entitled ‘‘Guidelines 

for the Validation of Food Safety 

Control Measures’’ (hereinafter the 

Codex validation guidelines) 

recommends that validation of control 

measures be performed, whenever 

possible, before their full 

implementation (Ref. 127). Codex also 

includes as a validation measure the 

collection of data, e.g., product and/or 

environmental sampling and testing, 

during operating conditions in the food 

operation for a specified period (e.g., 3– 

6 weeks) (Ref. 127). The HACCP 

regulation for juice requires that 

validation of HACCP plans be 

conducted once during the year after 

implementation and at least annually 

thereafter (§ 120.11(b)). The FSIS 

HACCP regulation for meat and poultry 

(9 CFR 417.4(a)) requires that initial 

validation be conducted upon 

completion of the hazard analysis and 

development of the HACCP plan to 

determine that the HACCP plan is 

functioning as intended (9 CFR 

417.4(a)(1)). During the HACCP plan 

validation period, the meat or poultry 

establishment must repeatedly test the 

adequacy of the CCPs, critical limits, 

monitoring and recordkeeping 

procedures, and corrective actions set 

forth in the HACCP plan (9 CFR 

417.4(a)(1)). 

FDA requests comment on whether 

the proposed time frame for validation 

should be shorter or longer. Comments 

should provide the basis for an 

alternative time frame. 

Proposed § 117.150(a)(1)(ii) would 

require that the validation of the 

preventive controls be performed 

whenever a reanalysis of the food safety 

plan reveals the need to do so. The 

circumstances under which a reanalysis 

would be required are addressed in 

proposed § 117.150(f). Proposed 

§ 117.150(f)(1)(ii) would require that the 

owner, operator, or agent in charge of a 

facility complete such reanalysis and 

implement any additional preventive 

controls needed to address the hazard 

identified, if any, before the change in 

activities at the facility is operative, or, 

when necessary, during the first six 

weeks of production. All preventive 

controls established to address a hazard 

identified as reasonably likely to occur 

must have a scientific and technical 

basis; establishing that scientific and 

technical basis is a validation activity 

regardless of whether the preventive 

control is established in the facility’s 

initial food safety plan or as a result of 

reanalysis of the food safety plan. 

c. Proposed § 117.150(a)(2)— 

Validation based on scientific and 

technical information. Proposed 

§ 117.150(a)(2) would require that, 

except as provided by paragraph (a)(3) 

of this section, the validation of 

preventive controls include collecting 

and evaluating scientific and technical 

information or, when such information 

is not available or is insufficient, 

conducting studies to determine 

whether the preventive controls, when 

properly implemented, will effectively 

control the hazards that are reasonably 

likely to occur. The NACMCF HACCP 

guidelines note that information needed 

to validate the HACCP plan often 

includes (1) expert advice and scientific 

studies and (2) in-plant observations, 

measurements and evaluations (Ref. 34). 

The Codex validation guidelines 

address several approaches for 

validating control measures, including 

(1) reference to scientific or technical 

literature, previous validation studies or 

historical knowledge, (2) scientifically 

valid experimental data, (3) collection of 

data during operating conditions, (4) 

mathematical modeling, and (5) surveys, 

and note that these may be used 

individually or in combination (Ref. 

127). 

The scientific and technical 

information that would be evaluated to 

determine whether preventive controls 

effectively control the hazards that are 

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3754 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

reasonably likely to occur may include 

scientific publications, government 

documents, predictive mathematical 

models and other risk-based models, 

and technical information from 

equipment manufacturers, trade 

associations, and other sources. If the 

qualified individual conducting the 

validation relies on sources such as 

scientific publications, the qualified 

individual would need to ensure during 

validation that the conditions used by 

the facility are consistent with those 

described in the publication that is 

being used to support the adequacy of 

the preventive control measure to 

control the hazard. For example, if a 

study demonstrates adequate 

inactivation of Salmonella spp. in 

peanuts using a roasting process, 

conditions such as roaster temperature, 

heating time, bed depth and humidity 

that were critical to achieving 

inactivation in the study must be the 

same when the facility roasts peanuts 

(or any change in the critical parameters 

must be such that the same or greater 

lethality is achieved). Documents 

published by FDA, such as the Food 

Code (Ref. 174), the Pasteurized Milk 

Ordinance (Ref. 37), and the Fish and 

Fisheries Products Hazards and Controls 

Guidance (Ref. 173) may provide 

scientific and technical information 

useful in establishing the validity of a 

preventive control measure, such as 

times and temperatures for cooling 

foods in which bacterial pathogen 

growth may occur or minimum water 

activities, minimum pH values, and 

minimum and maximum temperatures 

for growth of a variety of pathogens. 

Predictive mathematical models that 

describe the growth, survival, or 

inactivation of microorganisms in foods 

may provide scientific and technical 

information useful in determining 

whether a process would be adequate to 

reduce microorganisms of public health 

concern (Ref. 34) (Ref. 127). Other riskbased models may examine the impact 

of a control measure on a hazard and 

may be useful if appropriately validated 

for a specific food. If the model is for a 

different food, it may still provide 

useful validation information that could 

be supplemented by additional data. For 

example, there are many mathematical 

models for thermal resistance of 

Salmonella spp. If a model for the 

thermal resistance of Salmonella spp. is 

developed for the same type of food as 

the food being produced, and the food 

being produced has the same critical 

parameters such as pH and aw that were 

used in developing the thermal 

resistance model, then heat processes 

based on the model would generally be 

considered validated. For example, if a 

model for the thermal resistance of 

Salmonella spp. is developed in 

tomatoes with a pH of 4.3, the model 

would be considered valid for tomatoes 

with a pH of 4.3 or below, but not for 

tomatoes with a higher pH. If, however, 

the model is for thermal resistance of 

Salmonella spp. in a type of food that 

is only similar to the food being 

produced, or has different critical 

parameters than were used in 

developing the thermal resistance 

model, it would be necessary to conduct 

additional thermal resistance studies in 

the food being produced to provide the 

data needed to show that a heat process 

adequately reduces Salmonella spp. in 

that food and to establish the critical 

parameters for the process. For example, 

a model for thermal resistance of 

Salmonella spp. on almonds may not 

apply to hazelnuts, even though the 

foods are similar in that both are tree 

nuts. The extent of such studies would, 

however, be less than the extent of such 

studies if there were no data on the heat 

resistance of Salmonella spp. in a 

similar food. For example, if the thermal 

resistance of Salmonella spp. in initial 

studies with hazelnuts is similar to that 

for almonds, then a thermal resistance 

study used to develop data for hazelnuts 

could investigate fewer times and 

temperatures, or use fewer replicates, 

than would be the case in the absence 

of the information about the thermal 

resistance of Salmonella spp. in 

almonds. 

A process validation study would 

establish the relationship between 

parameters such as process times and 

temperatures and other factors and the 

rate at which pathogens are reduced, 

and a prevalence study would 

determine the levels at which pathogens 

may occur in the raw material, 

ingredient, or food product to establish 

the cumulative amount of pathogen 

reduction that would be required to 

adequately reduce the risk of illness 

from that pathogen. Such studies are 

typically published or otherwise 

broadly disseminated within the 

scientific community and, when 

properly designed and carried out, are 

generally regarded by experts as 

scientifically definitive with respect to 

the matters addressed by the study. 

However, if scientific and technical 

information is not available or is 

insufficient to support the adequacy of 

a preventive control measure to control 

the hazard, the owner, operator or agent 

in charge of a facility would need to 

conduct controlled scientific studies to 

establish that a preventive control 

measure is adequate to control the 

hazard. As an example, a facility that 

wants to use propylene oxide (PPO) to 

inactivate enteric pathogens such as E. 

coli O157:H7 on shelled hazelnuts 

would need to conduct studies to 

establish that PPO could significantly 

minimize the hazard because no such 

studies currently exist in the public 

domain. Such studies would also 

establish the critical parameters and 

limits (e.g., critical limits at a CCP) that 

the facility would need to use to 

effectively control the hazard. For the 

hazelnut example, the critical factors 

might include amount of PPO, 

temperature of the nuts to be treated, 

treatment time, chamber temperature, 

PPO vaporizer temperature, chamber 

vacuum, and post-treatment hold time 

and temperature. Studies on 

inactivation of Salmonella spp. on 

almonds could provide information 

about appropriate parameters to 

investigate for the inactivation of E. coli 

O157:H7 on shelled hazelnuts, but 

additional studies would be needed to 

establish the specific values for those 

parameters in the inactivation of E. coli 

O157:H7 on shelled hazelnuts. 

Information is available in the 

literature that can assist in the design of 

studies to support the adequacy of 

preventive control measures. For 

example, NACMCF has published 

information on ‘‘Parameters for 

Determining Inoculated Pack/Challenge 

Study Protocols’’ (Ref. 175) and 

‘‘Requisite Scientific Parameters for 

Establishing the Equivalence of 

Alternative Methods of Pasteurization’’ 

(Ref. 176). Studies to validate preventive 

control measures must be conducted by 

persons with experience and expertise 

relevant to the product, process and 

hazard to be controlled. Under proposed 

§ 117.150(a)(1)), any studies needed to 

provide the scientific and technical 

information to establish the validity of 

the plan would either be conducted by 

a qualified individual (as would be 

defined in proposed § 117.3) or would 

be overseen by a qualified individual. In 

other words, the qualified individual 

need not have the experience and 

expertise to conduct validation studies, 

but must have sufficient expertise in 

risk-based preventive controls to 

understand the studies and how they 

support the validity of the preventive 

controls with respect to the hazard of 

concern. 

d. Proposed § 117.150(a)(3)— 

Preventive controls for which validation 

is not required. Proposed 

§ 117.150(a)(3)(i) through (iii) would 

provide that validation need not 

address: 

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• The food allergen controls that 

would be established in proposed 

§ 117.135(d)(2); 

• The sanitation controls that would 

be established in proposed 

§ 117.135(d)(3); and 

• The recall plan that would be 

established in proposed § 117.137. 

According to NACMCF, verification 

involves activities to determine the 

validity of the HACCP plan and that the 

system is operating according to the 

plan (Ref. 34). Thus, validation is a 

verification activity. The purpose of 

validation is to provide the scientific 

and technical basis for ensuring that the 

preventive controls implemented are 

adequate to control the hazards 

identified as reasonably likely to occur. 

FDA tentatively concludes that 

validation, i.e., the evaluation of 

scientific and technical information, is 

either not an essential activity, is not 

practical or is not relevant, for the 

controls identified in proposed 

§ 117.150(a)(3). 

Food Allergen Controls 

As discussed in section XII.C.6 of this 

document, proposed § 117.135(d)(2)(i) 

would require that food allergen 

controls include those procedures, 

practices, and processes employed for 

ensuring protection of food from crosscontact, including during storage and 

use. Examples of such procedures, 

practices, and processes include 

providing physical barriers between 

sections of a facility, conducting 

manufacturing/processing of foods in 

different parts of a facility, and 

controlling the movement of tools and 

personnel that might carry allergens 

when the same production lines are 

used for both foods that contain 

allergens and foods those that do not, or 

when the same production lines are 

used for foods that contain different 

allergens. These types of controls 

generally are not evaluated through 

scientific studies or by the collection of 

technical information as would be 

required under proposed 

§ 117.150(a)(2). Instead, monitoring 

(e.g., by visual observation) that these 

activities do not result in cross-contact 

provides sufficient assurance that the 

controls are functioning as intended to 

prevent the hazard of undeclared 

allergens in the food due to crosscontact. Examples of such visual 

observations include observations that 

bags of allergenic foods (such as soy 

flour) are stored in sealed containers, 

that spills of allergen powders are 

promptly cleaned, and that equipment 

is cleaned between manufacturing/ 

processing of different foods. Thus, FDA 

tentatively concludes that this proposed 

rule should not propose to require 

validation of the adequacy of the food 

allergen cross-contact controls that 

would be established in proposed 

§ 117.135(d)(2)(i). We request comment 

on this approach. 

As discussed in section XII.C.6 of this 

document, proposed § 117.135(d)(2)(ii) 

would require that food allergen 

controls include those procedures, 

practices, and processes employed for 

labeling the finished food, including, 

including ensuring that foods are not 

misbranded under section 403(w) of the 

FD&C Act. Examples of such 

procedures, processes, and practices 

include ensuring that the food label 

correctly declares all of the food 

allergens present (including those 

contained in flavorings, colorings, and 

incidental additives), ensuring that the 

correct food label is applied to a food, 

and ensuring that the correct food is in 

the correct package (e.g., by checking 

that the correct packaging is used for 

each food). These types of controls 

generally are not evaluated through 

scientific studies or by the collection of 

technical information as would be 

required under proposed 

§ 117.150(a)(2). Instead, verifying that 

labels contain appropriate information 

and monitoring that the correct label is 

being applied to the product provide 

sufficient assurance that the controls are 

functioning as intended to prevent the 

hazard of undeclared allergens in the 

food due to incorrect labels. Thus, FDA 

tentatively concludes that this proposed 

rule should not propose to require 

validation of the adequacy of the food 

allergen labeling controls that would be 

required by proposed § 117.135(d)(2)(ii). 

We request comment on this approach. 

Sanitation Controls 

As discussed in section XII.C.7 of this 

document, proposed 

§ 117.135(d)(3)(i)(A) would require that, 

where relevant to hazards that are 

reasonably likely to occur, sanitation 

controls include procedures for the 

cleanliness of food-contact surfaces, 

including food-contact surfaces of 

utensils and equipment. Traditionally, 

sanitarians employed by the facility or 

experts employed by companies that 

supply cleaning and sanitizing 

compounds will establish critical 

parameters and associated limits for 

cleaning and sanitation, including the 

choice and strength of the cleaning and 

sanitizing chemicals, contact time, and 

temperature requirements, based on 

studies conducted by the manufacturers 

of the products. Antimicrobial solutions 

applied to food processing equipment 

and utensils to sanitize such objects 

after they have been washed are 

included in the definition of ‘‘pesticide 

chemical’’ and therefore, are subject to 

regulation by EPA under section 408 of 

the FD&C Act (Ref. 118). Chapter 4 

(Additional Considerations for 

Antimicrobial Products) of EPA’s 

‘‘Pesticide Registration Manual’’ (Ref. 

177) outlines EPA’s requirements and 

recommendations for registration of 

antimicrobial substances, including 

testing against a validated protocol to be 

granted EPA-registered claims for 

pathogen reduction. Thus, FDA 

tentatively concludes that this proposed 

rule should not propose to require 

validation of the adequacy of the 

sanitation controls that would be 

required by proposed 

§ 117.135(d)(3)(i)(A). Monitoring 

activities to ensure the procedures are 

followed will provide assurance that the 

controls are functioning as intended to 

prevent hazards from insanitary foodcontact surfaces. We request comment 

on this approach. 

As discussed in section XII.C.7 of this 

document, proposed 

§ 117.135(d)(3)(i)(B) would require that, 

where relevant to hazards that are 

reasonably likely to occur, sanitation 

controls include procedures for the 

prevention of cross-contact and crosscontamination from insanitary objects 

and from employees to food, food 

packaging material, and other foodcontact surfaces and from raw product 

to processed product. As already 

discussed with respect to proposed 

§ 117.135(d)(3)(i)(A), sanitation controls 

to prevent cross-contamination can be 

established by sanitarians or by 

companies that supply cleaning and 

sanitizing compounds without the need 

for validation by the facility. Cleaning 

procedures established by sanitation 

experts should also be adequate to 

remove allergens from equipment and 

the environment in facilities where raw 

materials or ingredients containing 

allergens are used. Although it is 

prudent to validate the efficacy of 

cleaning with respect to allergens, 

appropriate allergen test methods may 

not be available at present for this 

purpose in all situations (Ref. 124). For 

example, when the same equipment is 

used to make milk-based and soy-based 

beverages, the availability of analytical 

methods that can detect milk protein 

and soy protein may make it practical to 

clean the equipment and then test a 

water rinse of the system to determine 

whether milk or soy proteins can be 

detected in the rinse water. However, 

this may not be the case when 

equipment used to make breaded 

shrimp is subsequently used to make 

breaded fish. We tentatively conclude 

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3756 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

that validation by the facility to 

demonstrate that sanitation controls 

adequately protect against cross-contact 

is not feasible for all situations at this 

time. 

Regardless of whether this proposed 

rule would require the specific 

verification activity of validation to 

demonstrate that sanitation controls 

adequately protect against cross-contact, 

proposed § 117.135(d)(3)(i)(A) would 

require that the owner, operator, or 

agent in charge of a facility establish 

appropriate allergen sanitation 

procedures to ensure that products do 

not contain undeclared allergens from 

other products. Cleaning procedures 

established to remove food residues and 

verification that food residues have been 

removed (e.g., by visual inspection) 

should significantly minimize or 

prevent the presence of undeclared food 

allergens. When appropriate tests are 

available, we recommend that facilities 

use testing as well as visual inspection 

to verify that procedures have been 

done adequately. We request comment 

on this approach. We also request 

comment on whether we should require 

validation of sanitation controls to 

protect against cross-contact in those 

situations where appropriate analytical 

methods for use in validation studies 

are currently available, even if such 

methods are not available for all major 

food allergens. 

Recall Plan 

As discussed in section XII.C.8 of this 

document, a recall plan can 

significantly minimize or prevent 

hazards by limiting consumption of 

affected food during a recall. Following 

an existing plan that addresses all 

necessary elements of a recall helps 

minimize delay created by uncertainty 

as to the appropriate actions to take and 

helps ensure critical actions are not 

overlooked. The proposed requirement 

to validate a preventive control by 

collecting and evaluating scientific and 

technical information or by conducting 

studies simply does not apply to such 

a plan. Thus, FDA tentatively concludes 

that this proposed rule should not 

propose to require validation of the 

recall plan that would be required by 

proposed § 117.137. 

3. Proposed § 117.150(b)—Verification 

of Monitoring 

Proposed § 117.150(b) would require 

that the owner, operator, or agent in 

charge of a facility verify that 

monitoring is being conducted, as 

would be required by proposed 

§ 117.140. One example of verification 

that monitoring is being conducted is a 

periodic observation of the monitoring 

activity, e.g., by a supervisor. Another 

example of such a verification activity is 

an independent test made by a person 

other than the person doing the 

monitoring. For example, if the line 

operator is verifying the operation of a 

metal detector by running test pieces 

through the metal detector every two 

hours to verify it rejects them, a quality 

assurance technician could periodically 

run a similar test—e.g., once per shift. 

Proposed § 117.150(b) does not address 

the review of monitoring records, which 

would be required under proposed 

§ 117.150(d)(2)(i) (see the discussion in 

section XII.G.5.b of this document). 

Proposed § 117.150(b) would 

implement section 418(f)(2) of the FD&C 

Act and is consistent with the FSIS 

HACCP regulation for meat and poultry, 

which requires direct observations of 

monitoring activities as an ongoing 

verification activity (9 CFR 

417.4(a)(2)(ii)). Proposed § 117.150(b) 

would differ from the NACMCF HACCP 

guidelines (Ref. 34), the Codex HACCP 

guidelines (Ref. 35), and FDA’s HACCP 

regulations for seafood and juice 

(§§ 123.8(a)(3)(i) and 120.11(a)(1)(iv)(A), 

respectively), which address verification 

of monitoring through the review of 

records (which would be required by 

proposed § 117.150(d)(2)(i)) but do not 

otherwise address verification activities 

for monitoring. 

Proposed § 117.150(b) would not 

specify the verification activities that 

must be conducted for monitoring. We 

request comment on whether proposed 

§ 117.150(b) should do so, and if so, 

what verification activities should be 

required. 

4. Proposed § 117.150(c)—Verification 

of Corrective Actions 

Proposed § 117.150(c) would require 

that the owner, operator, or agent in 

charge of a facility verify that 

appropriate decisions about corrective 

actions are being made, as would be 

required by proposed § 117.145 and by 

proposed § 117.135(d)(3)(ii). An 

example of verification that appropriate 

decisions about corrective actions are 

being made is observation of the 

corrective actions being taken, e.g., by a 

supervisor. Proposed § 117.150(c) would 

implement section 418(f)(3) of the FD&C 

Act and is consistent with the FSIS 

HACCP regulation for meat and poultry, 

which includes direct observations of 

corrective actions as an ongoing 

verification activity (9 CFR 417.4(2)(ii)). 

Proposed § 117.150(c) would differ from 

the NACMCF HACCP guidelines (Ref. 

34), the Codex HACCP guidelines (Ref. 

35), and FDA’s HACCP regulations for 

seafood and juice (§§ 123.8(a)(3)(ii) and 

120.11(a)(1)(iv)(B), respectively), which 

address verification of corrective actions 

through the review of records (which 

would be required by proposed 

§ 117.150(d)(2)(i)) but do not otherwise 

address verification activities for 

corrective actions. 

Proposed § 117.150(c) would not 

specify the verification activities that 

must be conducted for corrective 

actions. We request comment on 

whether proposed § 117.150(c) should 

do so, and if so, what verification 

activities should be required. 

5. Proposed § 117.150(d)— 

Implementation and Effectiveness 

Proposed § 117.150(d) would require 

that the owner, operator, or agent in 

charge of a facility verify the preventive 

controls are consistently implemented 

and are effectively and significantly 

minimizing or preventing the hazards 

that are reasonably likely to occur. This 

must include the requirements in 

proposed § 117.150(d)(1) and (2), as 

appropriate to the facility and the food. 

Proposed § 117.150(d) would implement 

section 418(f)(4) of the FD&C Act, which 

requires in relevant part verification by 

‘‘appropriate means’’ that the preventive 

controls ‘‘are effectively and 

significantly minimizing or preventing 

the occurrence of identified hazards.’’ 

a. Proposed § 117.150(d)(1)— 

Calibration. Proposed § 117.150(d)(1) 

would require calibration of process 

monitoring instruments and verification 

instruments. As discussed in section 

II.D.3 of this document, the combination 

of monitoring (proposed § 117.140(a)), 

recordkeeping (proposed § 117.175), and 

verification (proposed § 117.150(a) and 

(d)) would establish a system that would 

provide assurance that hazards 

identified in the hazard analysis 

conducted under section 418(b)(1) of the 

FD&C Act would be significantly 

minimized or prevented and that food 

manufactured, processed, packed or 

held by such facility would not be 

adulterated under section 402 of the 

FD&C Act or misbranded under section 

403(w) of the FD&C Act. In many 

instances, monitoring and verification 

activities rely on instruments (such as a 

pH meter or a thermometer) that must 

be calibrated. Calibration provides 

assurance that an instrument is 

measuring accurately. If these 

instruments are not properly calibrated, 

the values they provide may not provide 

the necessary assurance that hazards 

will be significantly minimized or 

prevented. If an instrument is calibrated 

against a known reference, the reference 

standard may also need periodic 

calibration (e.g., the standard reference 

thermometer used to calibrate a 

thermometer used in processing 

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equipment will itself also need to be 

calibrated periodically). 

Instrument calibration is performed 

on a regular or periodic basis based 

upon the type of instrument being used 

and its sensitivity to factors such as the 

operating environment and the wear 

and tear of ongoing use. The type of 

instruments used in a particular facility 

and the manner of their use will largely 

determine the need for, and the 

frequency of, calibration, and the 

frequency of calibration is often 

prescribed by the instrument 

manufacturer. Therefore, proposed 

§ 117.150(d)(1) would not specify a 

frequency for calibration. 

b. Proposed § 117.150(d)(2)—Records 

review. Proposed § 117.150(d)(2) would 

require a review of specific records 

related to monitoring, corrective actions 

and certain verification activities within 

specified time frames, by (or under the 

oversight of) a qualified individual, to 

ensure that the records are complete, the 

activities reflected in the records 

occurred in accordance with the food 

safety plan, the preventive controls are 

effective, and appropriate decisions 

were made about corrective actions. 

Proposed § 117.150(d)(2)(i) would 

require review of the monitoring and 

corrective action records within a week 

after the records are made. Proposed 

§ 117.150(d)(2)(ii) would require review 

of the records related to calibration 

within a reasonable time after the 

records are made. (As discussed in 

section XII.I.2 of this document, 

proposed § 117.175 would list the 

records that facilities must establish and 

maintain, including records that 

document the monitoring of preventive 

controls as required by § 117.140(c), 

corrective actions as required by 

§ 117.140(d), and verification activities 

as required by § 117.150(g)). 

Proposed § 117.150(d)(2) would 

implement section 418(f) of the FD&C 

Act and is consistent with the NACMCF 

HACCP guidelines, the Codex HACCP 

guidelines, and Federal HACCP 

regulations for seafood, juice, and meat 

and poultry. The NACMCF HACCP 

guidelines provide examples of 

verification activities, including review 

of the HACCP plan for completeness, 

review of monitoring records, and 

review of records for deviations and 

corrective actions (Ref. 34). The 

examples of verification activities in the 

Codex HACCP Annex include a review 

of the HACCP plan and its records (Ref. 

35). Our HACCP regulations for seafood 

(§ 123.8(a)(3)(i) through (iii)) and juice 

(§ 120.11(a)(1)(iv)(A) through (C)) 

require a review of the records that 

document the monitoring of critical 

control points, the taking of corrective 

actions, the calibrating of any process 

control instruments used at critical 

control points, and the performing of 

any periodic end-product or in-process 

testing that is part of the processor’s 

verification activities. The FSIS HACCP 

regulation for meat and poultry requires 

a review of all required records (9 CFR 

417(a)(2)(iii)). 

Proposed § 117.150(d)(2) would 

establish that the purpose of the review 

of records would be to ensure that the 

records are complete, the activities 

reflected in the records occurred in 

accordance with the food safety plan, 

the preventive controls are effective, 

and appropriate decision were made 

about corrective actions. We tentatively 

conclude that review of the records 

required by proposed § 117.150(d)(2)(i) 

and (ii) would accomplish these 

purposes. Reviewing monitoring records 

can reveal whether they contain 

information on all the parameters that 

were to be monitored to determine 

whether a process is delivered in 

accordance with the food safety plan. 

For example, if both the size of food 

particles to be acidified and the pH of 

the food after acidification are critical to 

the safety of the food, review of the 

monitoring records would demonstrate 

whether both particle size and pH were 

monitored and whether the values were 

within specified parameter values. 

Reviewing monitoring records can 

reveal whether a process followed the 

procedures specified in the facility’s 

food safety plan (e.g., if the monitoring 

records show the pH of every other 

batch of an acidified food when the plan 

specified the measurement of every 

batch). Review of monitoring records 

also can reveal whether any information 

is missing—e.g., a designated lot 

number—so that the missing 

information can be quickly identified 

and added to the record if necessary. We 

seek comment on this proposal. 

If the review of the records reveals 

that the records do not contain all 

information specified by the food safety 

plan, or that the procedure in the food 

safety plan was not followed, the facility 

will not be able to conclude that its 

preventive controls were implemented 

in accordance with its food safety plan 

for those activities. Because the food 

safety plan establishes the procedures 

needed to ensure preventive controls are 

effective, if the records review indicates 

that the plan is not being followed, e.g., 

the records are missing critical 

information or the activities were not 

performed as specified in the plan, the 

facility will not be able to conclude its 

preventive controls were effective. For 

example, if the records show that food 

particle size is not being determined or 

that the particles are too large, 

acidification of all parts of the particle 

may not occur rapidly enough to ensure 

control of pathogens such as C. 

botulinum. If the plan requires 

determination of the pH of each batch 

of product but the records do not show 

that the pH was measured on all 

batches, the facility cannot be sure that 

the pH of those batches is correct, again 

posing a potential risk from C. 

botulinum. As a result, the facility 

would not be able to verify that its 

preventive controls are effectively and 

significantly minimizing or preventing 

the occurrence of identified hazards as 

required by Section 418(f) of the FD&C 

Act. 

Review of records can also reveal 

whether appropriate decisions were 

made about corrective actions. The 

review should determine whether all 

the corrective action procedures 

required by proposed § 117.145(a)(3) 

have been followed, e.g., that actions are 

taken to prevent recurrence of the 

problem, that affected food has been 

evaluated for safety, and that affected 

food is prevented from entering 

commerce unless it can be determined 

that the food is not adulterated under 

section 402 of the FD&C Act or 

misbranded under section 403(w) of the 

FD&C Act. For example, a food safety 

plan may require that each package of 

product pass through a properly 

functioning metal detector and that the 

operator determine every two hours 

whether metal test pieces of a specified 

type and size are rejected when passed 

through the metal detector. If one of the 

test pieces was not rejected but 

production continued until a supervisor 

doing a verification check noted the 

problem, then corrective actions should 

have been taken and a corrective action 

record produced. A review of the 

corrective action records should reveal 

that all packages of product that passed 

through the metal detector since the last 

test showing the metal detector was 

functioning appropriately were held and 

passed through a functioning metal 

detector before being released into 

commerce. The records should also 

show that the metal detector was 

adjusted to reject the metal test pieces 

before it was used again to check 

product during production. 

Proposed § 117.150(d)(2) would 

require that the review of records be 

performed by (or under the oversight of) 

a qualified individual (see the 

discussion in section XII.H of this 

document regarding the activities that 

must be performed (or overseen) by a 

qualified individual as would be 

established in proposed § 117.155). The 

review of records is critical to assessing 

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3758 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

the facility’s application of the 

preventive controls system and, thus, is 

fundamental to ensuring its successful 

operation. Our HACCP regulations for 

seafood (§ 123.8(a)(3)) and juice 

(§ 120.11(a)(1)(iv)) require that the 

review of records be conducted by an 

individual who has successfully 

completed training in the application of 

HACCP principles to the processing of 

the applicable food product at least 

equivalent to that received under 

standardized curriculum recognized as 

adequate by FDA, or who is otherwise 

qualified through job experience to 

perform this function. The FSIS HACCP 

regulation for meat and poultry requires 

that records be reviewed, ‘‘preferably’’ 

by an individual trained by successfully 

completing a course of instruction in the 

application of the HACCP principles to 

meat or poultry product processing (9 

CFR 417.5(c) and 417.7(b)). The 

NACMCF HACCP guidelines stress the 

role of qualified experts in the 

development and evaluation of a 

HACCP plan, and recommend periodic 

comprehensive verification of the 

HACCP system by an unbiased, 

independent authority, internal or 

external to the food operation, including 

review of appropriate records from 

operation of the plan (Ref. 34). The 

Codex HACCP Annex does not 

specifically address the need for a 

qualified individual to review the 

records other than to recommend that 

where certain verification activities 

cannot be performed in-house, 

verification be performed on behalf of 

the business by external experts or 

qualified third parties (Ref. 35). 

Proposed § 117.150(d)(2)(i) would 

require review of the monitoring and 

corrective action records within a week 

after the records are made. Although 

proposed § 117.150(d)(2)(i) would 

establish a more frequent review of 

these records than recommended in the 

NACMCF guidelines (which 

recommend monthly verification of 

monitoring records and corrective 

action records), it is consistent with our 

HACCP regulations for seafood 

(§ 123.8(a)(3)(i) and (ii)) and juice 

(§ 120.11(a)(1)(iv)(A) and (B)), which 

require that the review of monitoring 

records and corrective action records 

occur within one week of the day that 

the records are made. Even for shelfstable foods (e.g., low-acid canned foods 

and acidified foods) our experience has 

demonstrated that review of these kinds 

of records is a critical verification tool 

(60 FR 65096 at 65133). We seek 

comment on the proposed one week 

timeline. The FSIS HACCP regulation 

for meat and poultry requires records to 

be reviewed prior to shipping product (9 

CFR 417.5(c). As discussed in the 

seafood HACCP final rule (60 FR 65096 

at 65132), review of records needs to 

occur with sufficient frequency so as to 

ensure that any problems in the design 

and implementation of the HACCP plan 

are uncovered promptly and to facilitate 

prompt modifications. The concept is 

roughly that of a ‘‘feedback loop,’’ with 

information coming out of the record 

review process in such a timely manner 

that it can have impact on the 

production of subsequent lots of the 

product. If a problem with product is 

discovered during a review of records, 

all product since the last review could 

be affected. Although verification prior 

to shipment provides a valuable added 

assurance, FDA explained in the 

preamble to the seafood HACCP final 

rule (60 FR 65096 at 65132) that with 

highly perishable products this is not 

always possible and that a weekly 

review of monitoring and corrective 

action records would provide for timely 

feedback of information and limit the 

amount of product impacted by any 

problems identified during the review of 

the records. 

Proposed § 117.150(d)(2)(ii) would 

require review of the records related to 

calibration within a reasonable time 

after the records are made. The review 

of calibration records will depend in 

part on the frequency with which 

calibrations occur, which will be 

established in the food safety plan. If 

calibrations occur daily, it would be 

reasonable to review these records 

weekly. Where several instruments are 

calibrated each month, a monthly 

review of all the calibrations would be 

reasonable. Consequently, FDA 

tentatively concludes that setting a 

specific frequency for review of these 

records is not warranted. Proposed 

§ 117.150(d)(2)(ii) is, in relevant part, 

consistent with our HACCP regulations 

for seafood (§ 123.8(a)(3)(iii)) and juice 

(§ 120.11(a)(1)(iv)(C)), which require 

that the review of records of calibrating 

of any process control instruments used 

at critical control points occur within a 

reasonable time after the records are 

made. 

As noted previously, proposed 

§ 117.150(d)(2) would require a review 

of records in part to determine whether 

the preventive controls are effective. A 

review should determine whether 

monitoring and corrective actions have 

been done in accordance with the food 

safety plan and whether the instruments 

used in monitoring and verification 

were properly calibrated. If food safety 

activities appropriate to the facility have 

been conducted in accordance with the 

plan and this is reflected in the records, 

the facility thus verifies the preventive 

controls are effective, i.e., that its 

preventive controls are effectively and 

significantly minimizing or preventing 

the occurrence of identified hazards as 

required by Section 418(f) of the FD&C 

Act. 

6. Proposed § 117.150(e)—Written 

Procedures for Verification Activities 

Proposed § 117.150(e) would require 

that the owner, operator, or agent in 

charge of a facility establish and 

implement written procedures for the 

frequency of calibrating process 

monitoring instruments and verification 

instruments. We are proposing to 

require written procedures for the 

frequency of calibration because the 

frequency of calibration will vary 

depending on the instrument and the 

process or verification activity that it 

pertains to. 

We are not proposing to require that 

written procedures be developed for all 

verification procedures. In some 

instances the records of verification 

activities provide the information 

needed to understand how the 

verification activity has been carried out 

and to assess whether the verification 

activity is adequately demonstrating 

that the preventive controls are effective 

in significantly minimizing or 

preventing the hazards reasonably likely 

to occur. For example, we are not 

proposing to require written procedures 

for validation, verification of monitoring 

and corrective actions, or calibration of 

process monitoring instruments and 

verification instruments (other than for 

the frequency of calibration). Validation 

involves a variety of procedures, 

including evaluation of scientific and 

technical information and conducting 

laboratory and in-plant studies that 

generally do not follow a standardized 

protocol or approach. Records of 

monitoring and corrective actions 

provide the information needed to 

understand how the verification activity 

was carried out. In many instances the 

calibration of process monitoring 

instruments and verification 

instruments will be done by contract 

with other entities and the facility 

would not have access to the procedures 

used; having instruments calibrated and 

documenting the calibration provides 

the necessary assurance that such 

instruments will be accurate. However, 

the frequency of calibration must be 

specified to ensure that the instruments 

are calibrated on a schedule appropriate 

to the instrument and the process it 

controls. 

Section 418(f) of the FD&C Act 

establishes certain requirements for 

verification, and section 418(h) of the 

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FD&C Act requires that the procedures 

used by the facility to comply with the 

requirements of section 418 be included 

in the written plan. Our HACCP 

regulations for seafood and juice both 

require that the HACCP plan be written 

(§§ 123.6(b) and 120.8(a), respectively) 

and that procedures for verification be 

included in the written HACCP plan 

(§§ 123.6(c)(6) and 120.8(b)(6), 

respectively). The FSIS HACCP 

regulation for meat and poultry requires 

that the establishment maintain a record 

of the written HACCP plan, including, 

in relevant part, documents supporting 

the verification procedures selected and 

the frequency of those procedures (9 

CFR 417.5(a)(2)). Thus, requiring 

verification procedures to be written 

implements the requirements in section 

418 of the FD&C Act and is consistent 

with the requirements in HACCP 

regulations for seafood, juice, and meat/ 

poultry. 

7. Proposed § 117.150(f)—Reanalysis 

a. Proposed § 117.150(f)(1)— 

Reanalysis on the initiative of the 

owner, operator, or agent in charge of a 

facility. Proposed § 117.150(f)(1)(i) 

would require that the owner, operator, 

or agent in charge of a facility conduct 

a reanalysis of the food safety plan: 

• At least once every 3 years 

(proposed § 117.150(f)(1)(i)(A)); 

• Whenever a significant change is 

made in the activities conducted at a 

facility operated by such owner, 

operator, or agent in charge if the 

change creates a reasonable potential for 

a new hazard or a significant increase in 

a previously identified hazard 

(proposed § 117.150(f)(1)(i)(B)); 

• Whenever such owner, operator or 

agent in charge becomes aware of new 

information about potential hazards 

associated with the food (proposed 

§ 117.150(f)(1)(i)(C)); 

• Whenever a preventive control is 

not properly implemented and a 

specific corrective action procedure has 

not been established (proposed 

§ 117.150(f)(1)(i)(D)); and 

• Whenever a preventive control is 

found to be ineffective (proposed 

§ 117.150(f)(1)(i)(E)). 

For example, if a facility that bottles 

beverages develops a food safety plan 

for its products packaged in plastic 

bottles and subsequently introduces a 

glass bottling line, the facility would be 

required to reanalyze its food safety 

plan because the glass bottling line 

creates a reasonable potential for a new 

hazard, i.e., glass particles. Similarly, if 

a facility that conducts dry roasting 

operations for nuts makes design 

changes to its roasters to increase 

product throughput, the facility would 

be required to reanalyze its food safety 

plan because a design change to 

equipment that is used to control a 

hazard that is reasonably likely to occur 

would be a significant change in the 

activities conducted at the facility. 

The owner, operator or agent in 

charge of a facility may become aware 

of a problem due to the finding of a 

hazard in a food as the result of testing 

by a regulatory agency (Federal, State, 

tribal, or foreign government) that 

would require an analysis of the food 

safety plan to ensure the hazard is 

significantly minimized or prevented by 

appropriate preventive controls. In 

addition, new hazards can emerge—e.g., 

as identified through the investigation 

of outbreaks of foodborne illness by 

CDC or other public health agencies. For 

example, L. monocytogenes was not 

recognized as a food safety hazard until 

a series of outbreaks of foodborne illness 

associated with the consumption of 

foods such as coleslaw and fresh soft 

cheese in the early 1980s (Ref. 178). As 

another example, in 2006–2007 there 

was an outbreak of salmonellosis due to 

contamination of peanut butter with 

Salmonella Tennessee (Ref. 63). This 

was the first outbreak of foodborne 

illness caused by peanut butter 

consumption in the U.S. and it 

demonstrated the need for 

manufacturers to address the hazard of 

Salmonella spp. in this product. 

Information about outbreaks and 

ensuing product recalls is widely 

disseminated, including on FDA’s Web 

site, and modern communication tools 

make it possible for the owner, operator, 

or agent in charge of a facility to receive 

such information automatically. For 

additional discussion related to the 

proposed requirement that the owner, 

operator, or agent in charge of a facility 

conduct a reanalysis whenever such 

owner, operator or agent becomes aware 

of new information about potential 

hazards associated with the food, see 

the discussion in section XII.G.7 of this 

document of proposed § 117.150(f)(3), 

which would provide that FDA may 

require a reanalysis of the food safety 

plan to respond to new hazards and 

developments in scientific 

understanding. 

As noted in section XII.F.3, proposed 

§ 117.145(b)(2) would require that the 

owner, operator, or agent in charge of a 

facility reanalyze the food safety plan in 

accordance with proposed § 117.150(f) 

to determine whether modification of 

the food safety plan is required if a 

preventive control is not properly 

implemented or is found to be 

ineffective, and a specific corrective 

action has not been established. If the 

owner, operator, or agent in charge of a 

facility has not identified a specific 

failure as a foreseeable occurrence, the 

deviation may be the result of a systemwide problem that is not being properly 

addressed by the food safety plan (e.g., 

ineffective preventive controls). Thus, 

an unforeseen failure for which a 

corrective action was not identified may 

indicate an ineffective preventive 

control, and a reanalysis of the food 

safety plan is warranted. Similarly, 

when information arises indicating that 

the preventive control has not been 

effective in significantly minimizing or 

preventing a hazard from occurring, a 

reanalysis must be conducted to 

determine if the food safety plan should 

be modified to ensure that the 

preventive controls implemented are 

adequate to significantly minimize or 

prevent a hazard identified as 

reasonably likely to occur. 

Proposed § 117.150(f)(1)(i) would 

implement sections 418(f)(5) and 418(i) 

of the FD&C Act and is consistent with 

the NACMCF HACCP guidelines, the 

Codex HACCP guidelines, the Codex 

validation guidelines, and Federal 

HACCP regulations for seafood, juice, 

and meat and poultry. FDA notes that 

the terminology used in relation to the 

concept of ‘‘reanalysis’’ varies in the 

regulations and guidelines (e.g., 

‘‘subsequent validation,’’ ‘‘revalidation,’’ ‘‘reassessment of the hazard 

analysis,’’ and ‘‘validation’’ of the 

HACCP plan). The NACMCF HACCP 

guidelines include validation of a 

HACCP plan to ensure that the plan is 

scientifically and technically sound and 

that all hazards have been identified as 

an important verification activity, and 

advise a subsequent validation under 

circumstances such as an unexplained 

system failure; a significant product, 

process or packaging change; or the 

recognition of new hazards (Ref. 34). 

The NACMCF HACCP guidelines also 

discuss the need for a periodic 

comprehensive verification of the 

HACCP system, including a technical 

evaluation of the hazard analysis and 

each element of the HACCP plan, 

independent of other verification 

procedures to ensure that the HACCP 

plan is resulting in control of the 

hazards. If the results of the 

comprehensive verification identify 

deficiencies, the HACCP team modifies 

the HACCP plan as necessary (Ref. 34). 

Likewise, the Codex HACCP Annex 

recommends that the HACCP 

application be reviewed and necessary 

changes made when any modification is 

made in the product, process, or any 

step (Ref. 35). The Codex validation 

guidelines provide examples of 

situations that could lead to the need to 

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re-validate a control measure or 

combination of control measures, e.g., 

system failure, process changes, and 

new scientific or regulatory information 

(Ref. 127). 

Our HACCP regulation for seafood 

requires a reassessment of the adequacy 

of the HACCP plan whenever any 

changes occur that could affect the 

hazard analysis or alter the HACCP plan 

in any way, or at least annually 

(§ 123.8(a)(1)). Our HACCP regulation 

for juice requires an initial validation 

within 12 months after implementation 

and at least annually or whenever any 

changes in the process occur that could 

affect the hazard analysis or alter the 

HACCP plan in any way (§ 120.11(b)). 

The FSIS HACCP regulation for meat 

and poultry requires that every 

establishment reassess the adequacy of 

the HACCP plan at least annually and 

whenever any changes occur that could 

affect the hazard analysis or alter the 

HACCP plan (9 CFR 417.4(a)(3)). 

In addition, Federal HACCP 

regulations for seafood, juice, and meat 

and poultry require a reassessment of 

the hazard analysis when a processor 

does not have a HACCP plan (because 

the hazard analysis revealed no hazards 

reasonably likely to occur) and there are 

changes that could affect whether a food 

safety hazard now exists (§§ 123.8(c) 

and 120.11(c), and 9 CFR 417.4(a)(4) for 

seafood, juice, and meat and poultry, 

respectively). Each of these HACCP 

regulations provides examples of 

changes that may be considered to 

reasonably affect whether a food safety 

hazard now exists and, thus, require 

reassessment of the adequacy of the 

hazard analysis (§§ 123.8(a)(1) and 

120.11(b) and 9 CFR 417.4(a)(4)). Such 

changes include changes in raw 

materials or the source of raw materials; 

product formulation; processing 

methods or systems, including 

computers and their software; 

packaging; finished product distribution 

systems; the intended use or consumers 

of the finished product; and slaughter or 

processing methods or systems for meat 

or poultry. 

The requirement in proposed 

§ 117.150(f)(1)(i)(A) that the periodic 

reanalysis of the food safety plan occur 

at least once every 3 years would be 

different from the current requirement 

in our HACCP regulations for seafood 

and juice and in the FSIS HACCP 

regulation for meat and poultry for 

reassessment (validation) of the 

adequacy of the HACCP plan to be done 

‘‘at least annually’’ (§§ 123.8(a)(1) and 

120.11(b) and 9 CFR 417.4(a)(3), 

respectively). The 3-year minimum 

frequency for the periodic reanalysis of 

the food safety plan is explicitly 

required by section 418(i) of the FD&C 

Act. We tentatively conclude that, as a 

practical matter, the proposed 

requirement for reanalysis whenever a 

significant change is made in the 

activities conducted at a facility if the 

change creates a reasonable potential for 

a new hazard or a significant increase in 

a previously identified hazard makes it 

likely that reanalysis would occur more 

frequently than every 3 years because 

such changes are likely to occur more 

frequently than every 3 years. 

Proposed § 117.150(f)(1)(ii) would 

require that the owner, operator, or 

agent in charge of a facility complete the 

required reanalysis and implement any 

additional preventive controls needed to 

address the hazard identified, if any, 

before the change in activities at the 

facility is operative or, when necessary, 

during the first 6 weeks of production. 

The purpose of the reanalysis is to 

identify the need for, and implement, 

preventive controls in light of a 

reasonable potential for a new hazard, 

or a significant increase in a previously 

identified hazard, that is reasonably 

likely to occur. It follows that the 

preventive controls must be in place 

before making the change that creates 

the potential for a new hazard or a 

significant increase in a previously 

identified hazard. As with initial 

validation in proposed 

§ 117.150(a)(1)(i), we are proposing to 

provide the first six weeks of 

production, when necessary, to 

implement any additional preventive 

controls to allow facilities to 

methodically collect data and 

information during production to ensure 

the needed change can be implemented 

in the facility. We seek comment on this 

timeframe. Proposed § 117.150(f)(1)(ii) 

would implement section 418(i) of the 

FD&C Act. Although proposed 

§ 117.150(f)(1)(ii) has no explicit 

counterpart in the NACMCF HACCP 

guidelines, the Codex HACCP 

guidelines, or Federal HACCP 

regulations for seafood, juice, and meat 

and poultry, it is consistent with the 

importance placed on reanalysis of the 

HACCP plans in those guidelines and 

regulations and with requirements to 

modify the HACCP plan immediately 

whenever validation reveals the need to 

do so, as discussed immediately below. 

Proposed § 117.150(f)(1)(iii) would 

require that the owner, operator, or 

agent in charge of a facility revise the 

written plan if a significant change is 

made or document the basis for the 

conclusion that no additional or revised 

preventive controls are needed. 

Proposed § 117.150(f)(1)(iii) would 

implement section 418(i) of the FD&C 

Act, which requires that the written 

plan be revised ‘‘if * * * a significant 

change is made or document the basis 

for the conclusion that no additional or 

revised preventive controls are needed.’’ 

As discussed in section XII.B.2.b of this 

document, the written hazard analysis is 

required even if the conclusion of the 

analysis is that there are no hazards 

reasonably likely to occur. It is also 

important to document that a reanalysis 

has been conducted even if no change 

has been made, as required by section 

418(i) of the FD&C Act. Such 

documentation demonstrates that a 

facility has considered all relevant 

information on the safety of the 

products being produced, including 

new information that has become 

available since the last analysis, and 

determined that current procedures for 

implementing preventive controls are 

adequate to significantly minimize or 

prevent hazards that are reasonably 

likely to occur. Our HACCP regulations 

for juice and seafood, and the FSIS 

regulation for meat and poultry, require 

that the HACCP plan be modified 

immediately whenever a validation/ 

reassessment reveals that the plan is no 

longer adequate to fully meet the 

requirements of the HACCP regulations 

(§§ 120.11(b) and 123.8(a)(1) and 9 CFR 

417.4(a)(3) for juice, seafood, and meat/ 

poultry, respectively), although they do 

not explicitly require documentation of 

the basis for the conclusion that no 

additional or revised preventive 

controls are needed. Although proposed 

§ 117.150(f)(1)(iii) has no explicit 

counterpart in the NACMCF HACCP 

guidelines or the Codex HACCP 

guidelines, it is consistent with the 

importance placed on reanalysis of the 

HACCP plans in those guidelines and 

regulations, and with the written nature 

of the HACCP plan. The Codex 

validation guidelines indicate that if a 

system failure for which a process 

deviation cause cannot be identified 

occurs, re-validation may be needed 

(i.e., reanalysis is needed whenever a 

preventive control is found to be 

ineffective) (Ref. 127). 

b. Proposed § 117.150(f)(2)— 

Requirement for a qualified individual. 

Proposed § 117.150(f)(2) would require 

that the reanalysis be performed or 

overseen by a qualified individual. 

Proposed § 117.150(f)(2) is consistent 

with proposed §§ 117.126(c) which 

would require that the food safety plan 

be developed or overseen by a qualified 

individual. We tentatively conclude that 

the same qualifications are needed 

whether initially conducting a hazard 

analysis and establishing a food safety 

plan, or reanalyzing a hazard analysis 

and plan. 

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c. Proposed § 117.150(f)(3)— 

Reanalysis on the initiative of FDA. 

Proposed § 117.150(f)(3) establishes that 

FDA may require a reanalysis of the 

food safety plan to respond to new 

hazards and developments in scientific 

understanding. This authority will be 

delegated to the Commissioner of Food 

and Drugs. Proposed § 117.150(f)(2) 

would implement section 418(i) of the 

FD&C Act, which provides in relevant 

part that ‘‘[t]he Secretary may require a 

reanalysis * * * to respond to new 

hazards and developments in scientific 

understanding * * * .’’ As discussed in 

section XII.G.7.a of this document, new 

hazards can emerge—e.g., as identified 

through the investigation of outbreaks of 

foodborne illness by CDC or other 

public health agencies. In addition, new 

developments can occur in the scientific 

understanding of existing or potential 

hazards—e.g., if scientists and food 

safety regulatory agencies develop a 

better understanding of the causes of 

these events. For example, the outbreak 

from Salmonella Tennessee in peanut 

butter resulted in a greater 

understanding of the risks posed by 

environmental contamination and the 

importance of control of water in 

facilities producing low-moisture foods 

(Ref. 145) (Ref. 179). Information 

submitted to the RFR—which is a 

relatively recent addition to the 

regulatory framework for food safety— 

has the potential to identify new 

hazards or routes of contamination even 

before outbreaks occur. For example, the 

January 2011 RFR Annual Report (Ref. 

60) identified a high number of primary 

reports involving Salmonella spp. in 

spices and seasonings, and we have 

requested comments and scientific data 

and information to assist us in our plans 

to conduct a risk profile for pathogens 

and filth in spices (75 FR 20615, April 

20, 2010). The purpose of the risk 

profile is to ascertain the current state 

of knowledge about spices contaminated 

with microbiological pathogens and/or 

filth, and the effectiveness of current 

and potential new interventions to 

reduce or prevent illnesses from 

contaminated spices. 

8. Proposed § 117.150(g)—Requirement 

for Records for Verification 

Proposed § 117.150(g) would require 

that all verification activities taken in 

accordance with this section be 

documented in records. Proposed 

§ 117.150(g) would implement section 

418(g) of the FD&C Act and is consistent 

with the NACMCF HACCP guidelines, 

the Codex HACCP Annex, and Federal 

HACCP regulations for seafood, juice, 

and meat and poultry. The NACMCF 

HACCP guidelines recommend that the 

records maintained for the HACCP 

system include records that are 

generated during the operation of the 

plan and includes verification records 

as an example of HACCP records in an 

appendix (Ref. 34). The Codex HACCP 

Annex gives records of verification 

procedures performed as an example of 

records (Ref. 35). Our HACCP 

regulations for seafood and juice require 

that recordkeeping include the 

calibration of process-monitoring 

instruments (§§ 123.8(d) and 

120.11(a)(2), respectively). The FSIS 

HACCP regulation for meat and poultry 

requires records documenting the 

calibration of process-monitoring 

instruments, as well as verification 

procedures and results. 

H. Proposed § 117.155—Requirements 

Applicable to a Qualified Individual 

Proposed § 117.155(a) would require 

that one or more qualified individuals 

prepare the food safety plan (proposed 

§ 117.126(c)), validate the preventive 

controls (proposed § 117.150(a)(1)), 

review records for implementation and 

effectiveness of preventive controls 

(proposed § 117.150(d)(2)), and perform 

reanalysis of the food safety plan 

(proposed § 117.150(f)(2)). We have 

discussed the basis for requiring that a 

trained individual perform or oversee 

these functions in our discussion of 

each applicable proposed provision. We 

are listing the functions that must be 

performed by a trained individual in 

§ 117.155(a) for simplicity and are not 

imposing any additional requirement 

through this list. A single individual 

with appropriate qualifications could 

perform all of the listed functions, but 

there would be no requirement for the 

same individual to perform all the listed 

functions. 

Proposed § 117.155(b) would establish 

the qualification requirements 

applicable to a qualified individual. To 

be qualified, an individual must have 

successfully completed training in the 

development and application of riskbased preventive controls at least 

equivalent to that received under a 

standardized curriculum recognized as 

adequate by the FDA, or be otherwise 

qualified through job experience to 

develop and apply a food safety system. 

Training or job experience is essential to 

the effective development and 

implementation of a hazard analysis and 

risk-based preventive controls. Only a 

trained individual or individual 

qualified by job experience is capable of 

effectively executing certain activities, 

such as identifying hazards that are 

reasonably likely to occur; identifying 

preventive controls that will address 

those hazards; evaluating scientific and 

technical information to determine 

whether the food safety plan, when 

properly implemented, will effectively 

control the hazards that are reasonably 

likely to occur; determining the 

maximum or minimum value, or 

combination of values, to which any 

biological, chemical, physical, or 

radiological parameter must be 

controlled to significantly minimize or 

prevent a hazard that is reasonably 

likely to occur; determining whether 

monitoring procedures and corrective 

action procedures are appropriate; and 

determining whether specific corrective 

actions have been appropriate and 

effective. In addition, the products 

produced by the food industry are 

diverse, and the hazards that are 

reasonably likely to occur in a particular 

facility depend on a range of factors that 

vary from one facility to the next. We 

seek comment on the scope of the 

qualifications identified. 

Proposed § 117.155 is consistent with 

the NACMCF HACCP guidelines, our 

HACCP regulations for seafood and 

juice, and USDA’s HACCP regulations 

for meat and poultry. The NACMCF 

HACCP guidelines recommend that 

experts who are knowledgeable in the 

food process either participate in or 

verify the completeness of the HACCP 

plan (Ref. 34). Our HACCP regulations 

for seafood and juice both require that 

only a trained individual be responsible 

for developing the hazard analysis (juice 

only), developing the HACCP plan, 

verifying and modifying the HACCP 

plan, and performing the record review 

(§§ 123.10(a)–(c) and 120.13(a)(1)–(4), 

respectively). These regulations also 

provide that job experience will qualify 

an individual to perform these functions 

if it has provided knowledge at least 

equivalent to that provided through the 

standardized curriculum. USDA’s 

HACCP regulations for meat and poultry 

require that only an individual who has 

completed a training course can conduct 

certain activities, such as development 

and modification of the HACCP plan (9 

CFR § 417.7). 

FDA did not conduct HACCP training 

for persons subject to our HACCP 

regulations for seafood or juice. 

However, when implementing those 

regulations, FDA worked with an 

alliance of representatives from Federal 

and State agencies, industry and 

academia, to create a uniform, core 

training program that serves as the 

standardized curriculum against which 

other course materials can be judged. 

FDA will be working with an alliance to 

develop such a standardized curriculum 

for any final rule establishing 

requirements for hazard analysis and 

risk-based preventive controls. Having a 

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standardized curriculum on which 

facilities, as well as private 

organizations and academia that 

conduct training, can base their 

materials and training would provide a 

framework to ensure minimum training 

requirements are met. 

Proposed § 117.155(b) also would 

provide that the qualified individual 

may be, but is not required to be, an 

employee of the facility. FDA expects 

that some facilities may rely on 

assistance from qualified individuals 

that are not employees of the facility, 

such as individuals associated with 

universities, trade associations, and 

consulting companies. Proposed 

§ 117.155(b) is consistent with HACCP 

regulations for seafood and juice, which 

have virtually identical requirements 

(§§ 123.10 and 120.13(b), respectively). 

The option in proposed § 117.155(b) 

would provide flexibility to facilities 

subject to the rule. Such flexibility may 

be particularly important for those 

facilities that have limited technical 

expertise. 

Proposed § 117.155(c) would require 

that all applicable training be 

documented in records, including the 

date of the training, the type of training, 

and the person(s) trained. Such records 

would be a simple mechanism to 

demonstrate that a person has 

successfully completed training in the 

development and application of riskbased preventive controls at least 

equivalent to that received under a 

standardized curriculum recognized as 

adequate by the FDA, as would be 

required under proposed § 117.155(b) 

should the qualified individual not be 

otherwise qualified through job 

experience to develop and apply a food 

safety system. 

I. Proposed § 117.175—Records 

Required for Subpart C 

1. Requirements of Section 418 of the 

FD&C Act 

Section 418(g) of the FD&C Act, in 

relevant part, specifies that the owner, 

operator, or agent in charge of a facility 

shall maintain, for not less than 2 years, 

records documenting the monitoring of 

the preventive controls implemented 

under section 418(c) of the FD&C Act, 

instances of nonconformance material to 

food safety, the results of testing and 

other appropriate means of verification 

under section 418(f)(4) of the FD&C Act, 

instances when corrective actions were 

implemented, and the efficacy of 

preventive controls and corrective 

actions. 

Section 418(h) of the FD&C Act, in 

relevant part, specifies that the owner, 

operator, or agent in charge of a facility 

shall prepare a written plan that 

documents and describes the 

procedures used by the facility to 

comply with the requirements of section 

418 of the FD&C Act, including 

analyzing the hazards under section 

418(b) of the FD&C Act and identifying 

the preventive controls adopted under 

section 418(c) of the FD&C Act to 

address those hazards. Section 418(h) of 

the FD&C Act also specifies that the 

written plan, together with the 

documentation described in Section 

418(g) of the FD&C Act, shall be made 

promptly available to a duly authorized 

representative of the Secretary upon oral 

or written request. 

2. Proposed § 117.175—Records 

Required for Subpart C 

Proposed § 117.175(a)(1) through (5) 

would require that the owner, operator, 

or agent in charge of a facility establish 

and maintain the following records: 

• The written food safety plan, 

including the written hazard analysis, 

preventive controls, monitoring 

procedures, corrective action 

procedures, verification procedures, and 

recall plan; 

• Records that document the 

monitoring of preventive controls; 

• Records that document corrective 

actions; 

• Records that document verification, 

including, as applicable, those related to 

validation; monitoring; corrective 

actions; calibration of process 

monitoring and verification 

instruments; records review; and 

reanalysis; and 

• Records that document applicable 

training for the qualified individual. 

Proposed § 117.175(a) would not 

establish any new requirements but 

merely make it obvious at a glance what 

records are required under proposed 

part 117, subpart C. 

Proposed § 117.175(b) would provide 

that the records that the owner, 

operator, or agent in charge of a facility 

must establish and maintain are subject 

to the requirements of part 117, subpart 

F. As discussed in section XV of this 

document, proposed subpart F would 

provide the general requirements that 

apply to all records required to be 

established and maintained by part 117, 

including provisions for retention of 

records and for making records available 

for official review. 

J. Request for Comment on Additional 

Preventive Controls and Verification 

Procedures Not Being Proposed 

1. Overview 

As discussed in section II.B.2 of this 

document, section 418(n) requires FDA 

to establish science-based minimum 

standards for, among other things, 

implementing preventive controls. In 

addition, section 418(f) requires certain 

verification of those preventive controls. 

In this section of the preamble, we 

discuss several preventive controls (i.e., 

supplier controls) and verification 

measures (i.e., environmental and 

product testing programs) that FDA is 

not including as provisions in proposed 

part 117, subpart C. 

As we have already discussed (see 

section XII.C.1 of this document), 

section 418(c) requires the owner, 

operator, or agent in charge of a facility 

to identify and implement preventive 

controls. Section 418(o)(3) defines 

‘‘preventive controls’’ to mean ‘‘those 

risk-based, reasonably appropriate 

procedures, practices and processes that 

a person knowledgeable about the safe 

manufacturing, processing, packing, or 

holding of food would employ to 

significantly minimize or prevent 

[identified hazards] and that are 

consistent with current scientific 

understanding of safe food 

manufacturing, processing, packing, or 

holding * * * .’’ Section 418(o)(3) 

indicates that those procedures, 

practices and processes may include 

environmental monitoring, supplier 

verification activities, certain sanitation 

controls, and allergen controls. In 

addition, environmental and product 

testing programs are set out in section 

418(f)(4): Section 418(f)(4) requires that 

the owner, operator, or agent in charge 

of a facility ‘‘verify that * * * the 

preventive controls * * * are effectively 

and significantly minimizing or 

preventing the occurrence of identified 

hazards, including through the use of 

environmental and product testing 

programs and other appropriate means.’’ 

We believe that the preventive 

controls and verification measures 

discussed in this section are an 

important part of a modern food safety 

system. We believe that the preventive 

controls discussed in this section (i.e., a 

supplier approval and verification 

program), when implemented 

appropriately in particular facilities, are 

‘‘risk-based, reasonably appropriate 

procedures, practices and processes that 

a person knowledgeable about the safe 

manufacturing, processing, packing, or 

holding of food would employ to 

significantly minimize or prevent 

[identified hazards] and that are 

consistent with current scientific 

understanding of safe food 

manufacturing, processing, packing, or 

holding * * * ’’ The verification 

procedures discussed in this section 

(i.e., environmental and product testing 

programs), when implemented 

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appropriately in particular facilities, 

could be used to verify that the 

preventive controls are effectively and 

significantly minimizing or preventing 

the occurrence of identified hazards. 

The use of and need for these preventive 

controls and verification measures, 

which are science-based, are 

widespread and commonly accepted in 

many sectors of the food industry. We 

request comment on these conclusions. 

As discussed (see section I of this 

document), food safety is best assured if 

each facility understands the hazards 

that are reasonably likely to occur in its 

particular product and operation and 

puts in place scientifically sound 

preventive controls to significantly 

minimize or eliminate those hazards. 

From a regulatory perspective, 

specifying the circumstances and 

manner in which these controls and 

practices are to be applied must take 

into account the wide array of factors, 

including the diversity among food 

products, the wide variety of 

manufacturing and processing methods 

used to produce the food, the variety of 

sources for raw materials and 

ingredients, variations in the nature and 

types of hazards associated with 

manufacturing, processing, packing and 

holding human food, and the possibility 

that different mitigation methods may 

achieve the same end. Further, 

regulatory requirements should make 

clear when one of these preventive 

controls or verification measures is 

necessary yet also be sufficiently 

flexible to account for a vast number of 

food and facility combinations and 

circumstances. 

Although we are not including 

provisions for environmental and 

product testing programs or a supplier 

approval and verification program in 

this proposed rule, we recognize that 

these preventive controls and 

verification measures, when 

implemented appropriately in particular 

facilities, can play important roles in 

effective food safety programs. The role 

and need for these measures varies 

depending on the type of products and 

activities of the facility. To facilitate 

comment and share our current 

thinking, we discuss the topics of 

environmental and product testing 

programs and a supplier approval and 

verification program immediately 

below. See the Appendix to this 

document for additional background 

information relevant to these topics. 

2. Product Testing 

As discussed in section XII.G.1 of this 

document, section 418(f)(4) of the FD&C 

Act states that the owner, operator, or 

agent in charge of a facility shall verify 

that ‘‘the preventive controls 

implemented under [section 418(c) of 

the FD&C Act] are effectively and 

significantly minimizing or preventing 

the occurrence of identified hazards, 

including through the use of 

environmental and product testing 

programs and other appropriate means’’ 

The statute does not indicate the 

specific circumstances where product 

testing would be required or the specific 

manner in which such testing should be 

performed. FDA believes that the role 

and need for these measures varies 

depending on the type of products and 

activities of a facility. FDA further 

believes that the owner, operator, or 

agent in charge of a facility could 

consider a number of factors to establish 

a product testing program. 

Although finished product testing is 

rarely considered a preventive control, 

it plays a very important role as a 

verification measure in ensuring the 

safety of food, when implemented 

appropriately in particular facilities. 

Similarly, testing of raw materials or 

ingredients by a facility that is receiving 

the product often plays an important 

role in verification of hazard control 

that is performed by their supplier. 

Thus, an important purpose of testing is 

to verify that preventive controls, 

including those related to suppliers and 

those related to environmental 

monitoring, are controlling the hazard 

(Ref. 111) (Ref. 112). Testing is used in 

conjunction with other verification 

measures in the food safety system, such 

as audits of suppliers, observations of 

whether activities are being conducted 

according to the food safety plan, and 

reviewing records to determine whether 

process controls are meeting specified 

limits for parameters established in the 

food safety plan. 

Finished product testing is more 

important and useful when there is a 

reasonable probability that exposure to 

an identified hazard will result in 

serious adverse health consequences or 

death to humans or animals. FDA 

believes that there are certain situations 

in which finished product testing is 

particularly useful as a verification 

measure, including the following 

circumstances: 

• The outcome of the hazard analysis 

conducted under proposed § 117.130 is 

that a biological hazard is reasonably 

likely to occur in an ingredient and the 

preventive controls established and 

implemented under proposed § 117.135 

do not include a process control that 

will significantly minimize the hazard. 

Examples include cut raw vegetables 

(such as celery, onions, leafy greens and 

tomatoes) that may contain Salmonella 

spp. or L. monocytogenes and that are 

intended to be used in RTE foods; 

nutrition bars in which dry ingredients 

(such as fruits, nuts, dried milk, soy 

proteins and chocolate) that may 

contain Salmonella spp. are formed into 

a bar without a lethal step; and mixtures 

of shelled nuts in which the nuts may 

be contaminated with Salmonella spp. 

• The outcome of the hazard analysis 

conducted under proposed § 117.130 is 

that a biological hazard is reasonably 

likely to occur in an ingredient that is 

added during manufacturing after the 

stage that applies a process control to 

significantly minimize biological 

hazards. Examples include food (such as 

chips, nuts and cereals) in which 

untreated seasonings that may contain 

Salmonella spp. are applied after a heat 

treatment and food (such as ice cream) 

to which nuts or other ingredients are 

added to an ice cream mix that has been 

pasteurized. 

• The outcome of the hazard analysis 

conducted under proposed § 117.130 is 

that a biological hazard is reasonably 

likely to occur as a result of handling of 

a product or exposure of a product to 

the environment after a process control 

that significantly minimizes a hazard 

such that a hazard could be introduced 

or re-introduced into the product. 

Examples include the manufacture of 

nut butters from roasted nuts (where 

contamination with Salmonella spp. 

from the environment is a concern); the 

mixing of dried, treated spices and 

herbs (where contamination with 

Salmonella spp. from the environment 

is a concern); the addition of herbs or 

vegetables to products such as cream 

cheese or cottage cheese (where 

contamination with L. monocytogenes 

from the environment is a concern); and 

the manual assembly of sandwiches 

(where contamination with S. aureus, L. 

monocytogenes, and enteric pathogens 

such as Salmonella spp. is a concern). 

In addition, the frequency of testing 

and the number of samples tested must 

be determined and needs to take into 

account a variety of hazard/commodity/ 

facility considerations. FDA believes 

that factors to consider include whether 

ingredients that may contain a hazard 

have been tested, the extent of any 

environmental monitoring program, and 

whether other programs established by 

the facility provide added assurance 

that the potential for hazards has been 

minimized. The frequency of testing and 

the number of samples tested should 

have a scientific basis. Sampling plans 

and their performance have been 

described in the literature (Ref. 180) 

(Ref. 181) (Ref. 182) and are included in 

several Codex documents (Ref. 52) (Ref. 

183). We discuss likely considerations 

that could impact finished product 

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3764 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

verification testing in more detail in 

section I.F of the Appendix to this 

document. 

Although we are not including a 

testing provision in this proposed rule, 

we estimate that a requirement for a 

finished product testing program, when 

implemented appropriately in particular 

facilities, could impose an incremental 

annual cost of $14,000–$813,000 per 

facility based on size (number of 

employees) that adopts a testing and 

holding regime. This would result in an 

estimated aggregate cost of $23,500,000 

for domestic facilities based on an 

average of a range of $12,000,000– 

$35,000,000 (assuming between 25 and 

75 percent of relevant facilities 

conducting testing) and an estimated 

aggregate cost of $25,600,000 for foreign 

facilities. (As described in the PRIA, 

foreign costs are estimated by 

multiplying the domestic per facility 

cost by the total number of foreign 

facilities. See section XIX of this 

document for a discussion of the PRIA.) 

These costs assume that facilities will 

take 5 finished product samples per 

product line on a monthly basis. The 

facilities that would adopt a testing and 

holding regime are facilities producing 

products for which finished product 

testing would be particularly useful as 

a verification measure, e.g., the 

production process does not have a step 

that will eliminate or reduce hazards to 

an acceptable level. This estimate 

excludes facilities that would be exempt 

under this proposed rule (using a 

definition of $250,000 for a very small 

business) and facilities that are already 

conducting finished product testing. 

Further details are provided in the 

‘‘Consideration of Other Provisions’’ 

section of the PRIA. 

FDA requests comment on when and 

how product testing programs are an 

appropriate means of implementing the 

statutory directives set out above. 

Although we have not included these 

provisions in the proposed rule, we 

request comment on their inclusion in 

a final rule. Should a product testing 

program be limited to finished product 

testing or include raw material testing? 

What is the appropriate level of 

specificity for a product testing 

program? For example, should we 

simply require that the owner, operator, 

or agent in charge conduct, as 

appropriate to the facility and the food, 

finished product testing, when 

appropriate based on risk, to assess 

whether the preventive controls 

significantly minimize or prevent the 

hazards that are reasonably likely to 

occur? This would provide flexibility to 

account for the wide diversity of food 

and food manufacturing, processing, 

packing and holding systems subject to 

this rule and be consistent with the 

discussions within this proposed rule. 

FDA also requests comment on 

whether more detail would be 

appropriate, by, for example: 

• Specifying particular hazards, 

situations or product types for which 

finished product testing would be 

required; 

• Specifying the frequency of testing 

and, if so, whether this frequency 

should depend on the type of product; 

• Identifying appropriate sampling 

plans for finished product testing; 

• Requiring periodic testing for trend 

analysis and statistical process control; 

and 

• Requiring written procedures for 

conducting finished product testing 

and, if so, also require that procedures 

for finished product testing be 

scientifically valid and include the 

procedures for sampling and the 

sampling frequency. 

FDA also requests comment on the 

impact of product testing requirements 

on small businesses and on whether any 

product testing verification 

requirements should differ based on the 

size of the operation. 

3. Environmental Monitoring 

As discussed in section XII.G.1 of this 

document, section 418(f)(4) of the FD&C 

Act states that the owner, operator, or 

agent in charge of a facility shall verify 

that ‘‘the preventive controls 

implemented under [section 418(c) of 

the FD&C Act] are effectively and 

significantly minimizing or preventing 

the occurrence of identified hazards, 

including through the use of 

environmental and product testing 

programs and other appropriate means’’. 

In addition, section 418(o)(3) indicates 

that preventive controls may include 

environmental monitoring to verify the 

effectiveness of pathogen controls is an 

example of preventive controls. The 

statute does not indicate the specific 

circumstances where environmental 

testing would be required or the specific 

manner in which such testing should be 

performed. Nevertheless, FDA believes 

that this testing can form an important 

component of a modern food safety 

system. FDA believes that the role and 

need for these measures varies 

depending on the type of products and 

activities of a facility. FDA further 

believes that the performance of 

environmental monitoring, for an 

appropriate microorganism of public 

health significance or for an appropriate 

indicator organism, is particularly 

useful as a verification measure for 

preventive controls (i.e., sanitation 

controls) when contamination of food 

with an environmental pathogen is a 

hazard reasonably likely to occur. 

As discussed in sections XII.B.3 and 

XII.B.4.b of this document, proposed 

§ 117.130(b) would require a hazard 

identification that must consider 

hazards that may occur naturally or may 

be unintentionally introduced; proposed 

§ 117.130(c)(2) would require that the 

hazard evaluation include an evaluation 

of whether environmental pathogens are 

reasonably likely to occur whenever a 

RTE food is exposed to the environment 

prior to packaging. The data from recalls 

and the RFR support a conclusion that 

Salmonella spp. is a hazard in lowmoisture RTE food products (such as 

spices and seasonings, nuts and nut 

products, and seed products). When 

RTE foods such as these are exposed to 

the environment, FDA believes that 

most facilities producing such foods 

would identify Salmonella spp. as a 

known or reasonably foreseeable hazard 

under proposed § 117.130(b) and 

evaluate whether Salmonella spp. 

contamination from the environment is 

reasonably likely to occur in the facility 

under proposed § 117.130(c)(2). A 

robust environmental monitoring 

program for Salmonella spp. can verify 

the effectiveness of sanitation controls 

designed to prevent Salmonella spp. 

from contaminating food-contact 

surfaces and food (Ref. 184). 

Likewise, the data from recalls and 

the RFR support a conclusion that L. 

monocytogenes is a hazard in 

refrigerated or frozen RTE food products 

(such as dairy products, fresh-cut 

produce, prepared foods such as 

sandwiches, and frozen foods). When 

RTE foods such as these are exposed to 

the environment, FDA believes that 

most facilities producing such foods 

would identify L. monocytogenes as a 

potential hazard under proposed 

§ 117.130(b) and evaluate whether L. 

monocytogenes is reasonably likely to 

occur in the facility under proposed 

§ 117.130(c)(2). A robust environmental 

monitoring program for L. 

monocytogenes can verify the 

effectiveness of sanitation controls 

designed to prevent L. monocytogenes 

from contaminating food-contact 

surfaces and food (Ref. 52) (Ref. 144) 

(Ref. 185) (Ref. 186). 

As discussed in section A.5.c of the 

Appendix to this document, FDA’s 

current thinking is that Listeria spp. 

may be an appropriate indicator 

organism for L. monocytogenes, because 

tests for Listeria spp. will detect 

multiple species of Listeria, including L. 

monocytogenes. However, FDA’s 

current thinking is that there are no 

currently available indicator organisms 

for Salmonella spp. We request 

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comment on these findings and 

conclusions. 

Although we are not including an 

environmental testing provision in this 

proposed rule, we estimate that an 

environmental monitoring program for 

Salmonella spp., when implemented 

appropriately in particular facilities, 

could impose an incremental annual 

cost of $3,000–$6,000 per facility. These 

costs assume that facilities will take 5– 

15 environmental samples per month, 

based on facility size, and send the 

samples to an outside laboratory for 

testing. This would result in an 

estimated aggregate cost of $4,000,000 

for domestic facilities based on an 

average of a range of $3,000,000– 

$5,000,000 (assuming between 50 and 

75 percent of relevant facilities 

conducting testing) and an estimated 

aggregate cost of $4,400,000 for foreign 

facilities. 

Similarly, we estimate that a 

requirement for an environmental 

monitoring program for Listeria, when 

implemented appropriately in particular 

facilities, could impose an incremental 

annual cost of $3,000–$6,000 per 

facility. These costs assume that 

facilities will take 5–15 environmental 

samples per month, based on facility 

size, and send the samples to an outside 

laboratory for testing. This would result 

in an estimated aggregate cost of 

$5,000,000 for domestic facilities based 

on an average of a range of $4,000,000– 

$6,000,000 (assuming between 50 and 

75 percent of relevant facilities 

conducting testing) and an estimated 

aggregate cost of $5,400,000 for foreign 

facilities. (As described in the PRIA, 

foreign costs are estimated by 

multiplying the domestic per facility 

cost by the total number of foreign 

facilities. See section XIX of this 

document for a discussion of the PRIA.) 

The facilities that could adopt 

environmental monitoring programs are 

facilities producing ready-to-eat 

products exposed to the environment 

whereby they may become 

contaminated and for which such 

testing would be particularly useful as 

a verification measure for sanitation 

controls. These estimates exclude 

facilities that would be exempt under 

this proposed rule (using a definition of 

$250,000 for a very small business) and 

facilities that are already conducting 

finished product testing. Further details 

are provided in the ‘‘Consideration of 

Other Provisions’’ section of the PRIA. 

FDA requests comment on when and 

how environmental testing is an 

appropriate means of implementing the 

statutory directives set out above. 

Although we have not included these 

provisions in the proposed rule, we 

request comment on their inclusion in 

a final rule. If they are included, what 

is the appropriate level of specificity? 

For example, should we simply require 

the performance of environmental 

monitoring, for an appropriate 

microorganism of public health 

significance or for an appropriate 

indicator organism, if contamination of 

food with an environmental pathogen is 

a hazard reasonably likely to occur? 

FDA also requests comment on whether 

more detail would be appropriate, by, 

for example: 

• Specifying the environmental 

pathogen or the indicator organism for 

which the samples must be tested; 

• Specifying the corrective actions 

that should be taken if environmental 

testing identifies the presence of an 

environmental pathogen, such as; 

• Conducting microbial sampling and 

testing of surrounding surfaces and 

areas to determine the extent of the 

contamination and the potential source 

of the contamination; 

• Cleaning and sanitizing the 

contaminated surfaces and surrounding 

areas to eliminate the test organism; 

• Conducting additional microbial 

sampling and testing to determine 

whether the contamination has been 

eliminated; and 

• Conducting finished product 

testing. 

• Specifying the locations within the 

facility at which samples must be 

collected; 

• Specifying the frequency of 

collection of environmental samples 

(e.g., weekly or monthly depending on 

risk). For example, should the frequency 

of collection: 

• Be greatest for foods that are likely 

to be consumed as RTE or consumed 

after a minimal treatment that may not 

adequately reduce the environmental 

pathogen? 

• Be greater for an environmental 

pathogen that is frequently introduced 

into a facility (e.g., L. monocytogenes 

which is ubiquitous in the environment 

and can be continually introduced into 

a facility from many routes, including 

ingredients, people and objects (Ref. 

144) than for an environmental 

pathogen that is less frequently 

introduced? 

• Be greater for refrigerated or frozen 

RTE food products that support growth 

of L. monocytogenes than for those that 

do not? 

• Be greater if there is greater risk of 

a negative impact on public health (e.g., 

the product is specifically intended for 

a sensitive population such as infants) 

than if there is a lesser risk of a negative 

impact on public health? 

• Be greater for products that undergo 

significant handling and exposure to the 

environment than for products that 

undergo limited or no handling or have 

little exposure to the environment? 

• Increase as a result of finding the 

environmental pathogen or an indicator 

of the environmental pathogen or as a 

result of situations that pose an 

increased risk of contamination, e.g., 

construction? (Ref. 52) (Ref. 185) (Ref. 

184) (Ref. 187). 

• Requiring written procedures for 

conducting environmental testing and, 

if so, also requiring that procedures for 

environmental testing be scientifically 

valid and include the procedures for 

sampling and the sampling frequency; 

• Requiring data analysis to detect 

trends. 

In addition, with respect to 

environmental testing for L. 

monocytogenes, FDA requests comment 

on whether it would be appropriate to 

distinguish between environmental 

testing for RTE foods depending on 

whether the food supports the growth of 

L. monocytogenes. We also request 

comment on whether there are 

appropriate indicator organisms for any 

environmental pathogen other than L. 

monocytogenes. We further request 

comment on whether there is benefit in 

conducting routine environmental 

monitoring for other organisms in 

addition to, or instead of, the 

environmental pathogen of concern. 

4. Supplier Approval and Verification 

Program 

Section 418(c) of the FD&C Act 

specifies, in relevant part, that the 

owner, operator, or agent in charge of a 

facility shall identify and implement 

preventive controls, including at critical 

control points, if any, to provide 

assurances that: 

• Hazards identified in the hazard 

analysis conducted under section 

418(b)(1) of the FD&C Act will be 

significantly minimized or prevented; 

and 

• The food manufactured, processed, 

packed, or held by such facility will not 

be adulterated under section 402 of the 

FD&C Act or misbranded under section 

403(w) of the FD&C Act. 

Section 418(o)(3)(G) of the FD&C Act 

indicates that the procedures, practices, 

and processes described in the 

definition of preventive controls may 

include supplier verification activities 

that relate to the safety of food. While 

FSMA refers only to supplier 

verification activities, supplier 

approval, together with supplier 

verification, is widely accepted in the 

domestic and international food safety 

community. The development of a 

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3766 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

supplier approval and verification 

program can be part of a preventive 

approach. The NACMCF HACCP 

guidelines describe supplier controls as 

one of the common prerequisite 

programs for the safe production of food 

products and recommend that each 

facility assure that its suppliers have in 

place effective CGMP and food safety 

programs (Ref. 34). Likewise, Codex 

addresses the safety of ingredients in the 

GPFH and recommends that, where 

appropriate, specifications for raw 

materials be identified and applied and 

laboratory tests be conducted to 

establish fitness for use (Ref. 44). 

Because many facilities acting as 

suppliers procure their raw materials 

and ingredients from other suppliers, 

there is often a chain of suppliers before 

a raw material or other ingredient 

reaches the manufacturer/processor. 

Using a preventive approach, a facility 

receiving raw materials or ingredients 

from a supplier can help ensure that the 

supplier (or a supplier to the supplier) 

has implemented preventive controls to 

significantly minimize or prevent 

hazards that the receiving facility has 

identified as reasonably likely to occur 

in that raw material or other ingredient 

unless the receiving facility will itself 

control the identified hazard. 

A supplier approval and verification 

program can help ensure that raw 

materials and ingredients are procured 

from those suppliers that can meet 

company specifications and have 

appropriate programs in place to 

address the safety of the raw materials 

and ingredients. A supplier approval 

program can ensure a methodical 

approach to identifying such suppliers. 

A supplier verification program can 

help provide initial and ongoing 

assurance that suppliers are complying 

with practices to achieve adequate 

control of hazards in raw materials or 

ingredients. 

The statute does not indicate the 

specific circumstances where supplier 

verification would be required or the 

specific manner in which supplier 

verification should be performed, and 

FDA is not including provisions for 

such verification in this proposed rule. 

FDA believes that the role and need for 

these measures varies depending on the 

type of products and activities of a 

facility. FDA further believes that the 

owner, operator, or agent in charge of a 

facility could consider a number of 

factors to determine the specific 

circumstances and manner where it 

would be appropriate to perform 

supplier verification. FDA believes that 

factors to consider include: 

• The nature of the adverse 

consequences associated with the 

hazard, such as whether consumption of 

food containing the hazard may result in 

serious adverse health consequences or 

death; and 

• The establishment that would be 

controlling the hazard associated with 

the raw material or ingredient (e.g., the 

facility that receives the raw material or 

ingredient, the supplier of that raw 

material or ingredient, or even a 

supplier to the supplier of the raw 

material or ingredient). 

The vast majority of costs related to a 

supplier approval and verification 

program are due to verification activities 

such as audits and testing of raw 

materials and ingredients, which would 

likely be selected based on the hazard 

associated with the raw material or 

ingredient and where the hazard is 

controlled. Although we are not 

including a provision for such a 

program in this proposed rule, we 

estimate that a requirement for a 

supplier approval and verification 

program, if implemented as part of a 

preventive approach, could impose an 

incremental annual cost of $0–$5,000 

per supplier facility based on size 

(number of employees) that undergoes 

an annual audit. This would result in an 

estimated aggregate cost of $11,000,000 

for domestic facilities and an estimated 

aggregate cost of $12,000,000 for foreign 

facilities. (As described in the PRIA, 

foreign costs are estimated by 

multiplying the domestic per facility 

cost by the total number of foreign 

facilities. See section XIX of this 

document for a discussion of the PRIA.). 

We estimate that a requirement for a 

supplier approval and verification 

program could impose an incremental 

annual cost of $7,000–$90,000 per 

facility based on size (number of 

employees) for testing of raw materials 

and ingredients. This would result in an 

estimated aggregate cost of $5,000,000 

for domestic facilities and an estimated 

aggregate cost of $5,400,000 for foreign 

facilities. This estimate excludes 

facilities that would be exempt under 

this proposed rule (using a definition of 

$250,000 for a very small business) and 

facilities that are already doing such 

supplier verification activities. Further 

details are provided in the 

‘‘Consideration of Other Provisions’’ 

section of the PRIA. 

FDA requests comment on when and 

how supplier approval and verification 

is an appropriate means of 

implementing the statutory directives 

set out above. Although we have not 

included these provisions in the 

proposed rule, we request comment on 

their inclusion in a final rule. If they are 

included, what is the appropriate level 

of specificity? Should the requirement 

be very general, for example, requiring 

a supplier approval and verification 

program as appropriate to the facility 

and the food, when appropriate based 

on risk? FDA also requests comment on 

who a supplier approval and 

verification program should apply to— 

e.g., should it apply to all facilities that 

manufacture, process, pack or hold 

food, or be limited (such as to facilities 

that manufacture or process food)? 

FDA also requests comment on 

whether more detail would be 

appropriate, by, for example: 

• Requiring that the supplier 

approval and verification program 

include a written list of approved 

suppliers; 

• Requiring that, in determining 

appropriate verification activities, the 

owner, operator, or agent in charge of a 

facility consider relevant regulatory 

information regarding the supplier, 

including whether the raw material or 

ingredient is the subject of an FDA 

warning letter or import alert relating to 

the safety of the food. 

• Specifying circumstances when a 

supplier approval and verification 

program would not be required—e.g., 

when the preventive controls at the 

receiving facility are adequate to 

significantly minimize or prevent each 

of the hazards the receiving facility has 

identified as reasonably likely to occur; 

or when the receiving facility obtains 

from its customer written assurance that 

the customer has established and is 

following procedures that will 

significantly minimize or prevent the 

hazard. 

• Specifying that the type of 

verification activity be linked to the 

seriousness of the hazard—e.g., whether 

to: 

• Require an onsite audit when there 

is a reasonable probability that exposure 

to the hazard will result in serious 

adverse health consequences or death to 

humans; 

• Provide more flexibility with 

respect to hazards for which there is not 

a reasonable probability that exposure to 

the hazard will result in serious adverse 

health consequences or death to 

humans—e.g., periodic onsite audits, 

periodic or lot-by-lot sampling and 

testing of the raw material or ingredient, 

and periodic review of the supplier’s 

food safety records; 

• Specifying requirements for 

audits—e.g., the qualifications 

(including training, experience, and 

conflict of interest) for persons who 

conduct audits; content of an audit 

(such as compliance with applicable 

food safety regulations and, when 

applicable, compliance with a facility’s 

food safety plan); 

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• Specifying the frequency of 

verification activities (e.g., initially, 

annually, or periodically); 

• Specifying whether, for some 

hazards, it will be necessary to conduct 

more than one verification activity to 

provide adequate assurances that the 

hazard is significantly minimized or 

prevented; 

• Providing for alternative 

requirements if a supplier is a qualified 

facility—e.g., documenting that the 

supplier is a qualified facility and 

obtaining written assurance that the 

supplier is producing the raw material 

or ingredient in compliance with 

sections 402 and 403(w) of the FD&C 

Act; 

• Specifying those records that would 

be appropriate for a supplier approval 

and verification program. 

• Providing for substitution of a 

regulatory inspection (e.g., by FDA or a 

comparable State regulatory agency or 

foreign food safety authority), for an 

onsite audit; and 

• Specifying that a receiving facility 

take appropriate action (e.g., 

discontinuing use of a supplier) if the 

facility determines that the supplier is 

not controlling hazards that the 

receiving facility has identified as 

reasonably likely to occur. 

FDA is aware that many firms that 

could be affected by supplier 

verification may be importing their 

ingredients. We believe that these firms 

are interested in how a supplier 

verification component of preventive 

controls will interface with the 

regulations FDA is required to issue to 

implement foreign supplier verification 

under new section 805 of the FD&C Act. 

Section 805 requires FDA to issue 

regulations to require importers to 

implement foreign supplier verification 

programs (FSVPs) that are adequate to 

provide assurances that the importer’s 

foreign suppliers produce food in 

compliance with processes and 

procedures, including risk-based 

preventive controls, that provide the 

same level of public health protection as 

those required under sections 418 

(concerning hazard analysis and 

preventive controls) and 419 

(concerning produce safety) of the FD&C 

Act, and in compliance with sections 

402 (concerning adulteration) and 

403(w) (concerning misbranding 

regarding allergen labeling) of the FD&C 

Act. 

FDA intends to issue proposed 

regulations implementing section 805 in 

the near future. FDA intends to align 

regulations implementing supplier 

verification under section 418 and 

regulations implementing FSVP under 

section 805 to the fullest extent so we 

do not impose duplicative or unjustified 

requirements under those two 

regulations. For example, if a facility 

imports ingredients, we would not want 

to subject it to duplicative requirements 

under a supplier verification provision 

and an FSVP regulation. 

Likewise, FDA is aware that there is 

great interest from our trading partners 

on, among other things, the potential 

overlap between the supplier 

verification requirements in preventive 

controls and in FSVP. FDA believes that 

the approach to harmonization between 

supplier verification and FSVP 

described above would adequately 

address this and comports with our 

obligations under the World Trade 

Organization (WTO) trade agreements, 

including adherence to the principles of 

the Sanitary and Phytosanitary (SPS) 

Agreement. 

FDA is committed to meeting the 

requirements of the SPS Agreement and 

to complying with our obligations under 

that Agreement as we implement FSMA. 

In enacting FSMA, Congress explicitly 

recognized the importance of 

compliance with international 

agreements by providing in section 404 

of FSMA that ‘‘[n]othing in [FSMA] 

shall be construed in a manner 

inconsistent with the agreement 

establishing the World Trade 

Organization or any other treaty or 

international agreement to which the 

United States is a party.’’ While the 

statutory provisions in FSMA governing 

supplier verification by domestic 

facilities and foreign supplier 

verification by importers differ in some 

respects, they are based on common 

risk-based principles. Implementation of 

these risk-based principles will assure a 

general consistency of approach with 

respect to foreign and domestic facilities 

regarding, for example, when on-site 

audits are required. Implementation of 

FSMA’s risk-based principles will also 

ensure that measures applicable to 

imports are not more trade-restrictive 

than required to achieve the appropriate 

level of sanitary or phytosanitary 

protection of the United States, taking 

into account technical and economic 

feasibility, as required by paragraph 6 of 

Article 5 of the SPS Agreement. 

FDA intends to publish in the very 

near future a proposed rule to 

implement FSMA’s foreign supplier 

verification program requirement. FDA 

will align the comment periods on that 

proposed rule and the preventive 

controls rule addressed in this 

document so that interested parties in 

the United States and other countries 

will be able to assess how they will 

work together in practice. We invite 

comments to assist FDA in issuing final 

rules that protect public health and 

satisfy both FSMA and our international 

obligations. 

K. Request for Comment on Other 

Potential Provisions Not Explicitly 

Included in Section 418 of the FD&C Act 

1. Overview 

This section discusses two measures 

(review of consumer, customer, and 

other complaints, and submission of a 

food safety profile) that FDA is not 

proposing as specific provisions in 

proposed part 117, subpart C. Although 

these measures are not explicitly 

included in section 418, we believe that 

the preventive controls and verification 

measures discussed in this section are 

an important part of a modern food 

safety system. 

2. Complaints 

The role of consumer complaints in 

evaluating the effectiveness of a food 

safety plan is reflected in our HACCP 

regulations for seafood and juice. Our 

HACCP regulation for seafood 

(§ 123.8(a)(2)(i)) requires that 

verification activities include a review 

of any consumer complaints that have 

been received by the processor to 

determine whether they relate to the 

performance of critical control points or 

reveal the existence of unidentified 

critical control points. Our HACCP 

regulation for juice (§ 120.11(a)(1)(i)) 

requires that verification activities 

include a review of any consumer 

complaints that have been received by 

the processor to determine whether the 

complaints relate to the performance of 

the HACCP plan or reveal the existence 

of unidentified critical control points. 

FDA notes that the role of consumer 

complaints is not discussed in the 

NACMCF guidelines or the Codex 

guidelines, and their review is not 

required by the FSIS HACCP regulation 

for meat and poultry. However, as we 

discussed in the seafood HACCP 

proposed rule (59 FR 4142 at 4157), no 

system is foolproof, and consumer 

complaints may be the first alert for a 

processor that deviations are occurring 

and are not being prevented or 

uncovered by the processor’s HACCP 

controls. 

Further, although most consumer 

complaints will be related to quality 

issues, recent experience has 

demonstrated the value that consumer 

and customer complaints can provide in 

bringing attention to possible problems 

within a facility’s preventive controls 

activities. FDA has received a number of 

submissions to the Reportable Food 

Registry (Ref. 60) that have suggested 

that environmental pathogens or food 

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allergen hazards were not adequately 

addressed in a supplier’s food safety 

plan. Some of these were identified 

through customer verification testing 

and others through complaints from 

consumers to a facility. A facility may 

also receive alerts as a result of state 

surveillance and testing programs. (For 

a discussion of such programs, see 

section II.A.6.e of this document). Many 

recall notices identify the results of a 

state surveillance and testing program as 

the trigger for a recall (Ref. 188) (Ref. 

189) (Ref. 190). 

Although this proposed rule does not 

include a provision regarding a review 

of complaints, we estimate that a 

requirement that facility personnel 

review consumer, customer or other 

complaints could impose an 

incremental annual cost of $0– $6,000 

per facility based on size (number of 

employees). This would result in an 

estimated aggregate annual cost of 

$11,500,000 for domestic facilities and 

an estimated aggregate cost of 

$12,500,000 for foreign facilities. 

We request comment on whether and 

how a facility’s review of complaints, 

including complaints from consumers, 

customers, or other parties, should be 

required as a component of its activities 

to verify that its preventive controls are 

effectively minimizing the occurrence of 

hazards. 

3. Submission of a Facility Profile to 

FDA 

Proposed § 117.126 would require 

that the owner, operator, or agent in 

charge of a facility prepare, or have 

prepared, a written food safety plan. 

The food safety plan would include the 

hazard analysis, preventive controls, 

and other records. Currently, 

information of this type is not reviewed 

by FDA investigators until they are 

physically present at a facility and have 

begun an inspection. In light of the large 

number of facilities that would be 

covered by this proposal, FDA 

recognizes several potential benefits to 

having a facility’s food safety plan in 

advance of an inspection, if we were to 

require facilities to do so. Having such 

plans could aid in the efficient oversight 

of preventive controls by allowing FDA 

to better target inspectional activities to 

facilities that produce foods that have 

an increased potential for contamination 

(particularly with biological hazards) 

and to improve on-site inspections by 

focusing attention on hazards and 

preventive controls for which the 

facility appears to have deficiencies. 

Facilities would benefit from our 

advance preparation through interaction 

with better-informed investigators and 

potentially reduced inspection time. We 

could also more quickly identify 

facilities that had not established 

preventive controls for specific hazards 

of concern to the agency and advise 

them to fill such gaps to prevent a 

problem before it occurs. Also, FDA 

could use the plans in evaluating the 

need for guidance on specific hazards or 

controls and prioritizing guidance to 

areas where it is needed most. 

FDA believes that there are significant 

obstacles to realizing these benefits from 

submission of food safety plans, 

however. The agency would expect to 

receive a very large number of plans. 

Further, these plans would be expected 

to vary significantly in content and 

format. Assimilating the underlying 

information in a way that would be 

useful to the agency would be an 

immense challenge. Moreover, not all of 

the information in such plans may be 

essential to realizing the potential 

benefits described above. Therefore, to 

most efficiently realize the potential 

benefits of having certain information 

prior to an inspection, we request 

comment on whether to require 

submission to FDA of a subset of the 

information that would be in a food 

safety plan. This information, which 

could be referred to as a ‘‘facility 

profile,’’ could be submitted through an 

electronic form using a menu selection 

approach. The use of an electronic form 

would enhance our ability to store the 

information in a searchable form. 

Ideally, a searchable electronic system 

could allow FDA to assess information 

when a problem occurs with certain 

types of foods or controls, so that we 

could target inspections to facilities that 

manufacture, process, or pack, foods 

that are at increased risk for a food 

safety problem; to facilities that appear 

to have insufficient controls to prevent 

a problem; or to facilities using a control 

we conclude is ineffective at controlling 

hazards. The data elements for a facility 

profile could include some or all of the 

following: 

• Contact information; 

• Facility type; 

• Products; 

• Hazards identified for each product; 

• Preventive controls established for 

each of the identified hazards; 

• Third-party audit information (have 

you had one and which audit firm(s)); 

• Preventive control employee 

training conducted; 

• Facility size (square footage); 

• Full time operation or seasonal; 

• Operations schedule; 

This information could be submitted 

at the same time as facility registration 

and updated biennially simultaneously 

with the required biennial update of the 

food facility registration. FDA requests 

comment on the utility and necessity of 

such an approach and on the specific 

types of information that would be 

useful in developing a facility profile. 

We also request comment on any 

additional benefits that might be 

obtained from using such an approach 

and any potential concerns with this 

approach. 

We have previously announced an 

opportunity for public comment on the 

proposed collection of additional food 

facility profile information on a 

voluntary basis from firms that complete 

the FDA food facility registration 

process (Federal Register of May 11, 

2012, 77 FR 27779). In that notice, we 

noted that FSMA added section 421 of 

the FD&C Act (21 U.S.C. 350j), which 

directed FDA to allocate resources to 

inspect facilities according to the known 

safety risks of the facilities. We also 

noted that food facility profile 

information voluntarily provided to 

FDA will help us to determine whether 

a firm is high-risk or non-high-risk and 

that we will use the profile information 

to assist us in determining the frequency 

at which we will inspect the firm. In 

contrast to the voluntary submission of 

food facility profile information 

described in that notice, in this 

document we are requesting comment 

on whether the submission of such 

information should be required. 

XIII. Proposed New Provisions for 

Modified Requirements (Proposed Part 

117, Subpart D) 

FSMA provides for the establishment 

of modified requirements for certain 

facilities under certain circumstances. 

In this section of this document, we 

propose such modified requirements. 

A. Proposed § 117.201—Modified 

Requirements That Apply to a Qualified 

Facility 

1. Requirements of Section 418(l) of the 

FD&C Act 

Section 418(l) of the FD&C Act 

establishes modified requirements for 

‘‘qualified facilities.’’ As discussed in 

section II.B.1.b of this document, 

section 418(l)(1) of the FD&C Act 

establishes the conditions for a facility 

to be a ‘‘qualified facility’’ based on 

either business size (section 418(l)(1)(B) 

of the FD&C Act) or a combination of 

the average monetary value of the food 

sold and the value of food sold to 

qualified end users as compared to all 

other purchasers (section 418(l)(1)(C) of 

the FD&C Act), and proposed § 117.3 

would establish a definition for 

‘‘qualified facility’’ based on section 

418(l)(1). 

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Sections 418(l)(2)(A) and (B) of the 

FD&C Act provide that a qualified 

facility is exempt from the requirements 

of sections 418(a) through (i) and (n) of 

the FD&C Act (i.e., the requirements for 

hazard analysis and risk-based 

preventive controls), but must instead 

submit two types of documentation to 

the Secretary of HHS. The first type of 

required documentation relates to food 

safety practices at the facility, and 

section 418(l)(2)(B)(i) provides two 

options for satisfying this 

documentation requirement. Under 

section 418(l)(2)(B)(i)(I), the qualified 

facility may choose to submit 

documentation that demonstrates that 

the owner, operator, or agent in charge 

of the facility has identified potential 

hazards associated with the food being 

produced, is implementing preventive 

controls to address the hazards, and is 

monitoring the preventive controls to 

ensure that such controls are effective. 

Alternatively, under section 

418(l)(2)(B)(i)(II), the qualified facility 

may choose to submit documentation 

(which may include licenses, inspection 

reports, certificates, permits, 

credentials, certification by an 

appropriate agency (such as a State 

department of agriculture), or other 

evidence of oversight), as specified by 

the Secretary of HHS, that the facility is 

in compliance with State, local, county, 

or other applicable non-Federal food 

safety law. 

The second type of required 

documentation relates to whether the 

facility satisfies the definition of a 

qualified facility. Under section 

418(l)(2)(B)(ii) of the FD&C Act, the 

facility must submit documentation, as 

specified by the Secretary of HHS in a 

guidance document, that the facility is 

a qualified facility under section 

418(l)(1)(B) of the FD&C Act or section 

418(l)(1)(C) of the FD&C Act. 

Section 418(l)(7)(A) of the FD&C Act 

requires that a qualified facility that is 

exempt from the requirements under 

sections 418 (a) through (i) and 

subsection (n), and that does not 

prepare documentation under section 

418(l)(2)(B)(i)(I), provide notification to 

consumers by one of two procedures, 

depending on whether a food packaging 

label is required on the food. With 

respect to a food for which a food 

packaging label is required by the 

Secretary of HHS under any other 

provision of the FD&C Act, section 

418(l)(7)(A)(i) of the FD&C Act requires 

that a qualified facility include 

prominently and conspicuously on such 

label the name and business address of 

the facility where the food was 

manufactured or processed. With 

respect to a food for which a food 

packaging label is not required by the 

Secretary of HHS under any other 

provisions of the FD&C Act, section 

418(l)(7)(A)(ii) of the FD&C Act requires 

that a qualified facility prominently and 

conspicuously display, at the point of 

purchase, the name and business 

address of the facility where the food 

was manufactured or processed, on a 

label, poster, sign, placard, or 

documents delivered 

contemporaneously with the food in the 

normal course of business, or, in the 

case of Internet sales, in an electronic 

notice. 

2. Proposed § 117.201(a)— 

Documentation to be Submitted 

a. Proposed § 117.201(a)(1)— 

Documentation that the facility is a 

qualified facility. Proposed 

§ 117.201(a)(1) would require that a 

qualified facility submit to FDA 

documentation that the facility is a 

qualified facility. Consistent with the 

conditions in section 418(l)(1) of the 

FD&C Act for a facility to be a qualified 

facility, and our proposed definition 

(proposed § 117.3) of ‘‘qualified 

facility,’’ the documentation would be 

directed to either the status of the 

facility as a very small business (as 

would be defined in proposed § 117.3) 

or the applicability of conditions for 

average annual monetary value and the 

value of food sold to qualified end users 

as compared to other purchasers (as 

would be included in the definition of 

qualified facility in proposed § 117.3). 

As discussed further in section XIII.A.5, 

FDA tentatively concludes that a 

statement from the owner, operator, or 

agent in charge of a qualified facility 

certifying that the facility is a very small 

business, otherwise meets the definition 

of a qualified facility under proposed 

§ 117.3, or both, would be acceptable for 

the purposes of satisfying the 

requirements that would be established 

in proposed § 117.201(a)(1). We would 

not, for example, require that a facility 

submit financial information to FDA 

demonstrating its total sales or to the 

proportion of sales to qualified end 

users. 

Proposed § 117.201(a)(1) also would 

establish that, for the purpose of 

determining whether a facility satisfies 

the definition of qualified facility, the 

baseline year for calculating the 

adjustment for inflation is 2011. The 

conditions related to average annual 

monetary value established in section 

418(l)(1)(C) of the FD&C Act, and the 

definition of very small business in 

proposed § 117.3, allow adjustment for 

inflation. To establish a level playing 

field for all facilities that may satisfy 

definition of a qualified facility, we are 

proposing to establish the baseline year 

for the calculation in proposed 

§ 117.201(a)(1). We are proposing to 

establish 2011 as the baseline year for 

inflation because 2011 is the year that 

FSMA was enacted into law. We 

tentatively conclude that because 

Congress provided a specific dollar 

amount in section 418(l)(1)(C)(ii)(II)— 

i.e., $500,000—and it provided that the 

dollar amount should be adjusted for 

inflation, it is reasonable to establish the 

baseline year as the year that the law 

was enacted. 

b. Proposed § 117.201(a)(2)— 

Documentation related to food safety 

practices at a facility. Proposed 

§ 117.201(a)(2) would provide two 

options for satisfying the documentation 

requirement in section 418(l)(2)(B)(i) of 

the FD&C Act related to food safety 

practices at the facility. Proposed 

§ 117.201(a)(2)(i) would allow qualified 

facilities to submit documentation to 

demonstrate that the owner, operator, or 

agent in charge of the facility has 

identified the potential hazards 

associated with the food being 

produced, is implementing preventive 

controls to address the hazards, and is 

monitoring the performance of the 

preventive controls to ensure that such 

controls are effective to satisfy this 

requirement. 

Proposed § 117.201(a)(2)(i) would 

implement the provisions of section 

418(l)(2)(B)(i)(I) of the FD&C Act, except 

that proposed § 117.201(a)(2)(i) would 

specify monitoring the performance of 

the preventive controls to ensure that 

such controls are effective (emphasis 

added). As discussed in section II.B.1.a 

of this document, under the overall 

framework of the proposed 

requirements that would be established 

in subpart C, monitoring is directed to 

performance of preventive controls. 

Thus, proposed § 117.201(a)(2)(i) is 

consistent with the statute and the 

overall framework of this proposed rule. 

Proposed § 117.201(a)(2)(ii) would 

provide another option for satisfying the 

documentation requirement in section 

418(l)(2)(B)(i) of the FD&C Act related to 

food safety practices at the facility by 

allowing qualified facilities to submit 

documentation (which may include 

licenses, inspection reports, certificates, 

permits, credentials, certification by an 

appropriate agency (such as a State 

department of agriculture), or other 

evidence of oversight), that the facility 

is in compliance with State, local, 

county, or other applicable non-Federal 

food safety law, including relevant laws 

and regulations of foreign countries. 

Proposed § 117.201(a)(2)(i) would 

implement the provisions of section 

418(l)(2)(B)(i)(II) of the FD&C Act. 

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As discussed further in section 

XIII.A.5 of this document, FDA 

tentatively concludes that a statement 

from the owner, operator, or agent in 

charge of a qualified facility certifying 

that the facility (1) has identified the 

potential hazards associated with the 

food being produced, is implementing 

preventive controls to address the 

hazards, and is monitoring the 

implementation of the preventive 

controls to ensure that such controls are 

effective; or (2) that the facility is in 

compliance with State, local, county, or 

other applicable non-Federal food safety 

law, including relevant laws and 

regulations of foreign countries, would 

be acceptable for the purposes of 

satisfying the requirements that would 

be established in proposed 

§ 117.201(a)(2). We would not, for 

example, require that a facility submit 

documentation to FDA demonstrating 

the content of their hazard 

identification, preventive controls, or 

monitoring of the implementation of 

preventive controls; or copies of their 

non-Federal licenses, inspection reports, 

certificates, permits, credentials, or 

certifications. 

3. Proposed § 117.201(b)—Procedure for 

Submission 

Proposed § 117.201(b) would require 

that qualified facilities submit the 

documentation that would be required 

by proposed § 117.201(a) by one of two 

procedures. Proposed § 117.201(b)(1) 

would provide an option to submit 

documentation electronically at http:// 

www.access.fda.gov by following the 

instructions to be provided on that Web 

page. Proposed § 117.201(b)(1) would 

inform facilities that this Web site is 

available from wherever the Internet is 

accessible, including libraries, copy 

centers, schools, and Internet cafes. 

Although electronic submission is not 

required, proposed § 117.201(b)(1) 

would encourage electronic submission, 

which is efficient for FDA and should 

also be efficient for facilities. Electronic 

submission generally would be available 

24 hours a day, 7 days a week, unless 

the Web site is experiencing technical 

difficulties or is undergoing 

maintenance. 

Proposed § 117.201(b)(1) would 

provide an option to submit 

documentation by mail. A qualified 

facility would have the option to submit 

documents in a paper format or in an 

electronic format on a CD–ROM, by mail 

to the U.S. Food and Drug 

Administration, ATTN: Qualified 

Facility Coordinator, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993. ‘‘Mail’’ would include the U.S. 

mail and businesses that can deliver 

documents to the address provided. We 

would recommend that an owner, 

operator or agent in charge of a qualified 

facility submit by mail only if the 

qualified facility does not have 

reasonable access to the Internet. It is 

not efficient for FDA to receive such 

documents by mail. 

We are not proposing to provide for 

submission by fax. We expect that there 

may be technical difficulties or loss or 

mix-up of some submitted information 

if we were to allow for submission by 

fax. 

In section XIII.A.5 of this document, 

we discuss the information that would 

be submitted. 

4. Proposed § 117.201(c)—Frequency of 

Submission 

Proposed § 117.201(c)(1) would 

require that the documentation that 

would be required by section 

§ 117.201(a) be submitted to FDA 

initially within 90 days of the 

applicable compliance date of the rule. 

As discussed in section VII of this 

document, the compliance date for a 

small business would be 2 years after 

the date of publication of the final rule 

and the compliance date for a very small 

business would be 3 years after the date 

of publication of the final rule. 

Proposed § 117.201(c)(2) would 

require that the documentation that 

would be required by proposed 

§ 117.201(a) also must be resubmitted to 

FDA at least every 2 years, or whenever 

there is a material change to the 

information that would be described in 

proposed § 117.201(a). For the purposes 

of proposed § 117.201, a material change 

would be one that changes whether or 

not a facility is a ‘‘qualified facility.’’ 

The status of a facility as a qualified 

facility has the potential to change 

materially on an annual basis. For 

example, if a facility reports that it is a 

very small business (e.g., under one 

option identified in proposed § 117.3, 

has less than $250,000 in total annual 

sales of food, adjusted for inflation), its 

total annual sales of food likely would 

change on an annual basis, and could 

change so as to exceed $250,000. 

Likewise, if a facility reports that it 

otherwise satisfies the definition of a 

qualified facility, its total annual sales 

of food and value of food sold to 

qualified end users as compared to other 

purchasers likely would change on an 

annual basis, and could change so as to 

no longer satisfy the definition of a 

qualified facility. 

5. Information That Would Be 

Submitted 

Consistent with section 418(l)(2)(B)(ii) 

of the FD&C Act, we intend to issue 

guidance regarding documentation that 

would be submitted under proposed 

§ 117.201(a)(1) to demonstrate that a 

facility is a qualified facility. As 

discussed in sections XIII.A.2.a and 

XIII.A.2.b of this document, we 

tentatively conclude that certified 

statements from the owner, operator, or 

agent in charge of a qualified facility 

would be acceptable for the purposes of 

satisfying the requirements that would 

be established in proposed 

§ 117.201(a)(1) and (2). 

To inform the guidance required 

under section 418(l)(2)(B)(ii) of the 

FD&C Act and any other guidance that 

may be useful in addressing questions 

regarding submission of documentation 

under this subpart, in this document we 

request comment on an option we are 

considering regarding the submission of 

documentation. Specifically, we request 

comment on the efficiency and 

practicality of submitting the required 

documentation using the existing 

mechanism for registration of food 

facilities, with added features to enable 

a facility to identify whether or not the 

facility is a qualified facility. A facility 

that does not identify itself as a 

qualified facility would not be 

prompted to provide additional 

information under proposed 

§ 117.201(a). 

A facility that identifies itself as a 

qualified facility would be prompted to 

provide the following information by 

checking items that apply. Such items 

could include: 

• Whether the facility satisfies the 

conditions for a qualified facility: 

• As a very small business as that 

term would be defined in proposed 

§ 117.3; 

• As a facility that otherwise satisfies 

the definition of qualified facility in 

proposed § 117.3 based on average 

monetary value of sales and value 

of food sold to qualified end users 

as compared to other purchasers; or 

• Both of the above. 

• Whether the facility: 

• Has identified the potential hazards 

associated with the food being 

produced, is implementing 

preventive controls to address the 

hazards, and is monitoring the 

implementation of the preventive 

controls to ensure that such 

controls are effective; 

• Is in compliance with State, local, 

county, or other applicable nonFederal food safety law, including 

relevant laws and regulations of 

foreign countries; or 

• Both of the above. 

In essence, such a system would 

provide for self-certification that the 

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facility has appropriate information 

demonstrating that the facility is a 

qualified facility and either has 

identified the potential hazards 

associated with the food being 

produced, is implementing preventive 

controls to address the hazards, and is 

monitoring the implementation of the 

preventive controls to ensure that such 

controls are effective; or is in 

compliance with State, local, county, or 

other applicable non-Federal food safety 

law, including relevant laws and 

regulations of foreign countries. Such a 

system may include a statement 

reminding submitters that anyone who 

makes a materially false, fictitious, or 

fraudulent statement to the U.S. 

Government is subject to criminal 

penalties under 18 U.S.C. 1001. Using 

such a system, a qualified facility could 

update the documentation required by 

proposed § 117.201(a) during the 

biennial registration required by section 

415(a)(3) of the FD&C Act. 

6. Proposed § 117.201(d)—Notification 

to Consumers 

Proposed § 117.201(d) would require 

that a qualified facility that does not 

submit the type of documentation 

directed to food safety practices 

described in § 117.201(a)(2)(i) provide 

notification to consumers as to the name 

and complete business address of the 

facility where the food was 

manufactured or processed (including 

the street address or P.O. box, city, state, 

and zip code for domestic facilities, and 

comparable full address information for 

foreign facilities) consistent with section 

418(l)(7) of the FD&C Act. If a food 

packaging label is required, proposed 

§ 117.201(d)(1) would require that the 

required notification appear 

prominently and conspicuously on the 

label of the food. If a food packaging 

label is not required, proposed 

§ 117.201(d)(2) would require that the 

required notification appear 

prominently and conspicuously, at the 

point of purchase, on a label, poster, 

sign, placard, or documents delivered 

contemporaneously with the food in the 

normal course of business, or in an 

electronic notice, in the case of Internet 

sales. 

Proposed § 117.201(d) would enable 

consumers to contact the facility where 

a food was manufactured or processed 

(e.g., if the consumer identifies or 

suspects a food safety problem with a 

product) irrespective of whether the 

food product bears a label. The use of 

the term ‘‘business address’’ in section 

418(l)(7) of the FD&C Act contrasts with 

Congress’ use of a different term, ‘‘place 

of business,’’ in section 403(e) of the 

FD&C Act (21 U.S.C. 343(e)). Section 

403(e) provides that foods in package 

form are misbranded unless the product 

label bears the name and place of 

business of the manufacturer, packer, or 

distributor of the food. Our regulations 

interpret ‘‘place of business’’ as 

requiring only the firm’s city, state, and 

zip code to appear on the product label, 

as long as the firm’s street address is 

listed in a current telephone directory or 

other city directory (21 CFR 101.5(d)). 

We tentatively conclude that the use of 

the term ‘‘business address’’ in section 

418(l)(7) demonstrates Congress’ intent 

to require the facility’s full address, 

including the street address or P.O. box, 

to appear on labels or other required 

notifications when the facility has opted 

to not submit documentation directed to 

food safety practices under section 

418(l)(2)(B)(i)(I) of the FD&C Act. If 

Congress had considered the less 

complete address already required 

under section 403(e)(1) of the FD&C Act 

and the ‘‘place of business’’ labeling 

regulation (§ 101.5(d)) to be adequate for 

notification to consumers for foods 

required to bear labels, there would 

have been no need to impose a new, 

more specific requirement in section 

418(l)(7) for the facility’s ‘‘business 

address’’ to appear on the food label. 

Requiring the complete business 

address for this purpose is consistent 

with our guidance to industry on the 

labeling of dietary supplements as 

required by the Dietary Supplement and 

Nonprescription Drug Consumer 

Protection Act (Ref. 130). When 

proposed § 117.201(d) would apply to a 

food for which a food packaging label is 

required under any other provision of 

the FD&C Act, the complete business 

address would substitute for the ‘‘place 

of business’’ required under section 

403(e)(1) of the FD&C Act and 21 C.F.R. 

101.5(d) and would not impose any 

requirement for a label that would be in 

addition to any label required under any 

other provision of the FD&C Act. We 

seek comment on this interpretation. 

7. Records 

Proposed § 117.201(e)(1) would 

require that a qualified facility maintain 

records relied upon to support the 

documentation that would be required 

by § 117.201(a). Proposed § 117.201(a) 

would not require that a qualified 

facility establish any new records, but 

merely retain those that the facility 

relied upon to support the 

documentation that would required by 

proposed § 117.201(a). Proposed 

§ 117.201(e)(2) would establish that the 

records that a qualified facility must 

maintain are subject to the requirements 

of subpart F of part 117. As discussed 

in section XV of this document, 

proposed subpart F would provide the 

general requirements that apply to all 

records required to be established and 

maintained by proposed part 117, 

including provisions for retention of 

records and for making records available 

for official review. Together, proposed 

§ 117.201(a) and (b) would make the 

underlying records qualified facilities 

would rely on to support their selfcertifications available to FDA upon 

request. We tentatively conclude that it 

is appropriate to require that the records 

relied upon to support a self-certified 

statement be retained and made 

available to FDA upon request. 

B. Proposed § 117.206—Modified 

Requirements That Apply to a Facility 

Solely Engaged in the Storage of 

Packaged Food That Is Not Exposed to 

the Environment 

1. Requirements of Section 418 of the 

FD&C Act 

Briefly, as relevant to proposed 

§ 117.206, specific provisions of section 

418 of the FD&C Act require, in relevant 

part, that the owner, operator, or agent 

in charge of a facility: 

• Identify and evaluate known or 

reasonably foreseeable hazards that may 

be associated with the facility and 

develop a written analysis of the 

hazards (section 418(b) of the FD&C 

Act); 

• Identify and implement preventive 

controls to provide assurances that 

hazards identified in the hazard analysis 

will be significantly minimized or 

prevented and the food manufactured, 

processed, packed, or held by such 

facility will not be adulterated under 

section 402 of the FD&C Act (section 

418(c) of the FD&C Act); 

• Monitor the effectiveness of the 

preventive controls implemented under 

section 418(c) of the FD&C Act to 

provide assurances that the outcomes 

described in section 418(c) shall be 

achieved (section 418(d) of the FD&C 

Act); 

• Establish procedures to ensure that, 

if the preventive controls implemented 

under section 418(c) of the FD&C Act 

are not properly implemented or are 

found to be ineffective * * * 

appropriate action is taken to reduce the 

likelihood of recurrence of the 

implementation failure; all affected food 

is evaluated for safety; and all affected 

food is prevented from entering into 

commerce if the owner, operator or 

agent in charge of such facility cannot 

ensure that the affected food is not 

adulterated under section 402 of the 

FD&C Act (section 418(e) of the FD&C 

Act); 

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• Verify that the preventive controls 

are adequate to control the hazards the 

owner, operator, or agent is conducting 

monitoring and is making appropriate 

decisions about corrective actions and 

the preventive controls are effectively 

and significantly minimizing or 

preventing the occurrence of identified 

hazards and there is documented, 

periodic reanalysis of the plan under 

section 418(i) of the FD&C Act to ensure 

that the plan is still relevant to the raw 

materials, conditions and processes in 

the facility, and new and emerging 

threats (section 418(f) of the FD&C Act); 

• Maintain, for not less than 2 years, 

records documenting the monitoring of 

the preventive controls instances of 

nonconformance material to food safety 

and instances when corrective actions 

were implemented (section 418(g) of the 

FD&C Act); 

• Prepare a written plan that 

documents and describes the 

procedures used by the facility to 

comply with the requirements of section 

418 of the FD&C Act, including 

analyzing the hazards and identifying 

the preventive controls adopted to 

address those hazards (section 418(h) of 

the FD&C Act); 

• Conduct a reanalysis under section 

418 (b) of the FD&C Act whenever a 

significant change is made in the 

activities conducted at a facility 

operated by such owner, operator, or 

agent if the change creates a reasonable 

potential for a new hazard or a 

significant increase in a previously 

identified hazard or not less frequently 

than once every 3 years, whichever is 

earlier (section 418(i) of the FD&C Act). 

In addition to these requirements 

directed to the owner, operator, or agent 

in charge of a facility, section 418(m) of 

the FD&C Act provides, in relevant part, 

that the Secretary may, by regulation, 

exempt or modify the requirements for 

compliance under section 418 of the 

FD&C Act with respect to facilities that 

are solely engaged in the storage of 

packaged foods that are not exposed to 

the environment. 

2. Approach to Modified Requirements 

Under Section 418(m) of the FD&C Act 

As discussed in section X.D.4 of this 

document, proposed § 117.7 would both 

provide that subpart C does not apply to 

a facility solely engaged in the storage 

of packaged food that is not exposed to 

the environment (proposed § 117.7(a)) 

and establish that such a facility is 

subject to modified requirements in 

proposed § 117.206 (proposed 

§ 117.7(a)). In the remainder of our 

discussion of these modified 

requirements, we refer to ‘‘packaged 

food that is not exposed to the 

environment’’ as ‘‘unexposed packaged 

food,’’ and we refer to ‘‘unexposed 

refrigerated packaged food that requires 

time/temperature control for safety’’ as 

‘‘unexposed refrigerated packaged TCS 

food.’’ As noted in section X.D.2 of this 

document, we consider ‘‘not exposed to 

the environment’’ and ‘‘unexposed’’ to 

mean that the food is in a form that 

prevents any direct human contact with 

the food. The modified requirements in 

proposed § 117.206 would apply to 

unexposed refrigerated packaged TCS 

food. In essence, proposed § 117.7 

distinguishes between unexposed 

packaged food and unexposed 

refrigerated packaged TCS food. This 

distinction is based on hazards that are 

reasonably likely to occur during the 

storage of unexposed refrigerated 

packaged TCS food, but are not 

reasonably likely to occur during the 

storage of unexposed packaged food that 

does not require time/temperature 

control for safety. 

When an unexposed packaged food is 

a refrigerated TCS food, the principal 

hazard for the unexposed refrigerated 

packaged TCS food is the potential for 

the growth of, or toxin production by, 

microorganisms of public health 

significance. Information about this 

hazard for TCS foods in general (i.e., not 

limited to unexposed packaged food) is 

widely available (Ref. 137) (Ref. 138) 

(Ref. 139) (Ref. 140). In brief, the need 

for time/temperature control is 

primarily determined by (1) the 

potential for contamination with 

microorganisms of public health 

significance and (2) the potential for 

subsequent growth and/or toxin 

production. Refrigeration has long been 

used to retard deterioration of the flavor, 

color, and texture of foods. More 

importantly, refrigeration helps 

maintain the microbiological safety of 

potentially hazardous foods (62 FR 

8248, February 24, 1997). 

Failure to maintain foods at 

appropriate temperatures may result in 

the growth of microorganisms that may 

have contaminated the foods before, or 

at the time of, harvest or during 

processing, handling, or storage. The 

rate of growth of these microorganisms 

is reduced as the storage temperature is 

lowered. Proper refrigeration, therefore, 

prevents or slows the growth of human 

pathogens and spoilage microorganisms 

and reduces the likelihood of foodborne 

illness (62 FR 8248). A review of the 

factors that influence microbial growth 

and an analysis of microbial hazards 

related to time/temperature control of 

foods for safety can be found in a report 

(issued by the Institute of Food 

Technologists (IFT) under contract to 

FDA) on the Evaluation and Definition 

of Potentially Hazardous Foods (Ref. 

140) (the IFT report). The IFT report 

describes properties of common food 

commodities and the microbiological 

hazards that may occur from consuming 

particular food commodities, 

emphasizing microbial concerns that 

would be associated with temperature 

abuse of the products. The IFT report 

discusses foods for which time/ 

temperature control may be necessary 

for safety (Ref. 140). Most foods that are 

stored refrigerated have not been 

processed to eliminate pathogenic 

sporeformers, including Clostridium 

botulinum, Bacillus cereus and C. 

perfringens. If refrigerated foods are 

exposed to high enough temperatures 

for sufficient time, these sporeformers 

may begin to grow and produce toxins. 

Some strains of C. botulinum and B. 

cereus can grow at refrigeration 

temperatures, e.g., some strains of B. 

cereus grow at 39 °F (4 °C) and some 

strains of C. botulinum grow at 38 °F 

(3.3 °C) (Ref. 173). 

Examples of refrigerated foods that are 

capable of supporting the growth of 

pathogenic sporeformers such as B. 

cereus, C. botulinum and C. perfringens 

include many prepared soups, filled 

pastas, and sauces. In addition, some 

foods may be contaminated with L. 

monocytogenes, which, as described in 

section II.D.2.a, can also grow at 

refrigeration temperatures. Examples of 

foods that support the growth of L. 

monocytogenes include milk and soft 

cheese. Producers of refrigerated foods 

minimize the contamination of foods 

with pathogens to the extent possible, 

particularly if the pathogen can grow 

under refrigeration conditions. Growth 

of pathogens is very slow under 

refrigeration, and the lower the 

temperature the longer the time for 

growth (Ref. 140). Conversely, as 

refrigeration temperature increases, the 

growth rate of strains of pathogens that 

grow slowly under refrigeration 

increases and food temperatures may get 

high enough that pathogens that cannot 

grow at normal refrigeration 

temperatures (generally in the range of 

41–45 °F (5 °C–7 °C)) begin to grow (Ref. 

140). For example, the strains of C. 

botulinum that have caused most of the 

outbreaks in the United States do not 

grow and produce toxin until the 

temperature reaches 50 °F (10 °C) (Ref. 

3). Additional information about the 

time/temperature control of food to 

address the potential for 

microorganisms of public health 

significance to grow or produce toxins 

is available in books on food 

microbiology that are available for 

purchase. 

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Such information is sufficiently wellknown and accepted that we tentatively 

conclude that the outcome of each 

individual hazard analysis for an 

unexposed refrigerated packaged TCS 

food, conducted by the owner, operator, 

or agent in charge of each individual 

facility solely engaged in the storage of 

unexposed packaged food, would be the 

same. That outcome would be that the 

potential for the growth of, or toxin 

production by, microorganisms of 

public health significance is a hazard 

reasonably likely to occur in any 

unexposed refrigerated packaged TCS 

food. Likewise, information about 

appropriate preventive controls for this 

hazard is widely available (Ref. 191) 

(Ref. 139). Such information is 

sufficiently well-known and accepted 

that we tentatively conclude that the 

appropriate preventive control selected 

by each individual facility solely 

engaged in the storage of unexposed 

packaged food would be adequate 

controls on the temperature of any 

unexposed refrigerated packaged TCS 

food. 

In light of the general recognition of 

the hazard that is reasonably likely to 

occur in a refrigerated packaged TCS 

food and the appropriate preventive 

control for that hazard, we tentatively 

conclude that it is appropriate to specify 

the hazard and appropriate preventive 

control in the regulation. Under this 

approach, it would not be necessary for 

each individual facility solely engaged 

in the storage of unexposed packaged 

food to conduct its own hazard analysis 

and reach its own conclusion about the 

hazard and the appropriateness of 

temperature control to significantly 

minimize or prevent the growth of, or 

toxin production by, microorganisms of 

public health significance. Instead, what 

would remain for the facility to do to 

comply with section 418 of the FD&C 

Act for the activity of storing an 

unexposed refrigerated packaged TCS 

food would be a subset of the 

requirements for hazard analysis and 

risk-based preventive controls that 

would be established in proposed 

subpart C to implement section 418 of 

the FD&C Act. None of these 

requirements would require a qualified 

individual. This subset of requirements 

would be to: 

• Implement temperature controls 

(section 418(c) of the FD&C Act); 

• Monitor temperature (section 418(d) 

of the FD&C Act); 

• Take appropriate corrective actions 

when there is a problem with 

temperature control (section 418(e) of 

the FD&C Act); 

• Conduct applicable verification 

activities (review of records) (section 

418(f) of the FD&C Act); and 

• Establish and maintain certain 

records (section 418(g) of the FD&C 

Act). We seek comment on the proposed 

list of modified requirements. 

We also tentatively conclude that it 

would not be necessary for each 

individual facility solely engaged in the 

storage of unexposed packaged food to 

conduct the reanalysis specified in 

section 418(i) of the FD&C Act with 

respect to storing an unexposed 

refrigerated packaged TCS food. As 

discussed in section XII.G.6 of this 

document, reanalysis would apply in 

determining whether to apply any 

additional preventive controls and in 

determining whether to update the 

written plan. Under our approach, it is 

FDA who has identified the preventive 

control, and it would be FDA’s 

responsibility, through rulemaking, to 

require any additional preventive 

control. Likewise, under our approach, 

the facility would not be required to 

develop a food safety plan and, 

therefore, would not need to update the 

plan. If, for example, the facility 

changes its procedures for temperature 

control, the specific activities that the 

facility would be required to conduct 

(monitoring temperature; taking 

appropriate corrective actions if there is 

a problem with temperature control; 

conducting applicable verification 

activities; and establishing and 

maintaining appropriate records) would 

be adequate to address the change in 

procedure for temperature control. 

3. Proposed § 117.206—Modified 

Requirements That Apply to a Facility 

Solely Engaged in the Storage of 

Packaged Food that Is Not Exposed to 

the Environment 

Proposed § 117.206(a) would require 

that the owner, operator or agent in 

charge of a facility solely engaged in the 

storage of packaged food that is not 

exposed to the environment conduct 

certain activities for any such 

refrigerated packaged food that requires 

time/temperature control to 

significantly minimize or prevent the 

growth of, or toxin production by, 

microorganisms of public health 

significance. Briefly, those activities 

would encompass: 

• Establishing and implementing 

temperature controls (proposed 

§ 117.206(a)(1)); 

• Monitoring the temperature 

controls (proposed § 117.206(a)(2)); 

• If there is a problem with the 

temperature controls for such 

refrigerated packaged food, taking 

appropriate corrective actions (proposed 

§ 117.206(a)(3)); 

• Verifying that temperature controls 

are consistently implemented (proposed 

§ 117.206(a)(4)); and 

• Establishing and maintaining 

certain records (proposed 

§ 117.206(a)(5)). 

More specifically, proposed 

§ 117.206(a)(1) would require that the 

owner, operator, or agent in charge of a 

facility subject to proposed § 117.206 

establish and implement temperature 

controls adequate to significantly 

minimize or prevent the growth of, or 

toxin production by, microorganisms of 

public health significance in an 

unexposed refrigerated packaged TCS 

food. There are two fundamental 

questions that the owner, operator, or 

agent in charge of a facility subject to 

proposed § 117.206 would need to know 

the answers to in order to comply with 

proposed § 117.206 for any given 

unexposed refrigerated packaged food: 

• Is the food a TCS food? 

• If the food is a TCS food, what is 

the appropriate temperature for storage 

of the food? 

The two primary ways in which the 

owner, operator, or agent in charge of a 

facility subject to proposed § 117.206 

can obtain the answers to these 

questions are: (1) through information 

provided by the manufacturer, 

processor, or packer of the food, either 

in documents exchanged between the 

parties in the course of business or by 

label statements placed on the food by 

the manufacturer, processor, or packer 

of the food; and (2) through applicable 

scientific and technical support 

literature. 

As discussed in section X.D.2 of this 

document, a citizen petition submitted 

to FDA (Docket No. FDA–2011–P–0561) 

asserted that facilities work closely with 

the food manufacturers to understand 

the conditions and controls that need to 

be utilized to ensure the quality of the 

foods they store and distribute and, in 

many cases, those conditions and 

controls are formalized in written 

contracts. If the conditions for storage 

are not formalized in written contracts 

or by other means (e.g., through 

documents of the trade that travel with 

a food product when it moves within 

the supply chain), information relevant 

to safe storage of the food may be 

provided by the manufacturer, 

processor, or packer of the food on the 

food label. For example, in 1997 FDA 

published guidelines for labeling food 

that needs refrigeration by consumers 

due to the potential for the food to be 

rendered unsafe due to the growth of 

infectious or toxigenic microorganisms 

if ‘‘temperature abused’’ (62 FR 8248, 

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February 24, 1997). FDA recommended 

that foods requiring refrigeration by the 

consumer for safety be labeled 

‘‘IMPORTANT Must be Kept 

Refrigerated to Maintain Safety’’ (62 FR 

8248 at 8251) and that foods that are 

intended to be refrigerated but that do 

not pose a safety hazard if temperature 

abused be labeled more simply—e.g.; 

‘‘Keep refrigerated.’’ Such labeling can 

provide facilities with the information 

to identify TCS foods. We tentatively 

conclude that it would be rare for a 

facility solely engaged in the storage of 

unexposed packaged food to not have 

information regarding whether a 

refrigerated packaged food requires 

time/temperature control for safety and, 

if so, what specific temperature controls 

are necessary for safe storage of the 

food. We request comment on this 

tentative conclusion. 

In a situation where the owner, 

operator or agent in charge of a facility 

does not have information from the 

manufacturer, processor, or packer of 

the food about whether an unexposed 

refrigerated packaged food requires 

time/temperature control for safety and, 

if so, what specific temperature controls 

are necessary for safe storage of the 

food, the owner, operator, or agent in 

charge of the facility could either 

consult the scientific and technical 

literature to determine whether a 

particular food is a TCS food or assume 

that any unexposed refrigerated 

packaged food is a TCS food. 

Information about foods that are TCS 

foods, and about the appropriate 

temperatures to address the potential for 

microorganisms of public health 

significance to grow, or produce toxin, 

in food are well-established in the 

scientific literature. Documents 

prepared by or on behalf of FDA 

regarding appropriate time/temperature 

controls for safety (Ref. 173) (Ref. 140) 

provide numerous references to the 

primary scientific literature and serve as 

the basis for time/temperature controls 

for a variety of foods. The two 

temperatures commonly cited in these 

documents as maximum temperatures 

for safe storage of refrigerated food are 

41 °F (5 °C) and 45 °F (7 °C). The cited 

maximum temperature depends on the 

food; in some cases, a maximum storage 

temperature is established through 

rulemaking in a regulation. For 

example: 

• Our regulations for the prevention 

of Salmonella Enteritidis in shell eggs 

during production, storage, and 

transportation (§ 118.4(e)) and for 

refrigeration of shell eggs held for retail 

distribution (§ 115.50(b)(2)) require that 

eggs be held and transported at a 

temperature not to exceed 45°F (7°C). 

• The PMO provides for pasteurized 

Grade ‘‘A’’ milk and milk products to be 

held at 45°F (7°C) (Ref. 37). 

• The FDA Food Code, which has 

been widely adopted in state laws, 

recommends holding most potentially 

hazardous (TCS) food at 41°F (7°C) or 

lower (Ref. 191). 

Storage of refrigerated food at or 

below one of these two temperatures 

(i.e., 41 °F (5 °C) or 45 °F (7 °C)) 

consistent with storage temperatures 

required by regulation or recommended 

in widely adopted documents such as 

the PMO and the FDA Food Code would 

satisfy proposed § 117.206(a). 

We consider frozen food to be a subset 

of refrigerated food. The temperature 

and time required for a frozen food to 

become unsafe would result in 

significant quality issues for such food. 

Although there have been occasional 

problems with frozen food being subject 

to temperatures that allow some 

thawing in storage and distribution, we 

are not aware of situations in which 

frozen foods have been associated with 

the food becoming unsafe. Thus, we 

tentatively conclude that it would be 

rare for an unexposed frozen packaged 

food to be a TCS food. 

Proposed § 117.206(a)(2) would 

require that the owner, operator, or 

agent in charge of a facility solely 

engaged in the storage of unexposed 

packaged food monitor the temperature 

controls established for unexposed 

refrigerated packaged TCS food with 

sufficient frequency to provide 

assurance that they are consistently 

performed. Monitoring can be done by 

use of a continuous temperaturerecording device (e.g., a recording 

thermometer) that indicates and records 

the temperature accurately within the 

refrigeration compartment with a visual 

check of the recorded data at least once 

per day. Monitoring as would be 

required by proposed § 117.206(a)(2) 

would provide the owner, operator, or 

agent in charge of the facility with 

factual information with which to judge 

whether the temperature control is 

operating as intended. Proposed 

§ 117.206(a)(2) is modified relative to 

the analogous monitoring requirement 

that would be established in proposed 

§ 117.140(a) in subpart C in that 

proposed § 117.206(a)(2) would not 

require written procedures for 

monitoring. The records of monitoring 

(which would be required by proposed 

§ 117.206(a)(5)(i)) would demonstrate 

the frequency of monitoring. We request 

comment on whether there would be a 

benefit to requiring a facility to develop 

written procedures for monitoring 

temperature. 

Proposed § 117.206(a)(3) would 

require that, if there is a problem with 

the temperature controls for unexposed 

refrigerated packaged TCS food, the 

owner, operator, or agent in charge of a 

facility solely engaged in the storage of 

unexposed packaged food take 

appropriate corrective actions to correct 

a problem with the control of 

temperature for any refrigerated 

packaged food and reduce the 

likelihood that the problem will recur 

(proposed § 117.206(a)(3)(i)); evaluate 

all affected food for safety (proposed 

§ 117.206(a)(3)(ii)); and prevent the food 

from entering commerce, if the owner, 

operator, or agent in charge of a facility 

cannot ensure the affected food is not 

adulterated under section 402 of the 

FD&C Act (proposed 

§ 117.206(a)(3)(iii)). Such corrective 

actions would be necessary if, for 

example, there was a failure to maintain 

adequate temperature control. Proposed 

§ 117.206(a)(3) is modified relative to 

the analogous proposed requirement for 

corrective actions that would be 

established in proposed § 117.145(a) in 

subpart C in that proposed 

§ 117.206(a)(3) would not require 

written procedures for corrective 

actions. In essence, there is a single 

action to correct the problem (i.e., to 

restore temperature control), followed 

by the need to evaluate the food for 

safety and to prevent food from entering 

commerce when appropriate. The 

corrective actions taken, including 

information to document that product 

was not exposed to temperatures and 

times that would compromise the safety 

of the product, would be documented in 

records subject to agency review. It may 

be necessary for the owner, operator, or 

agent in charge of the facility to consult 

with the applicable manufacturer, 

processor, or packer of the food to 

determine the appropriate disposition of 

the food. 

Proposed § 117.206(a)(4)(i) would 

require that the owner, operator, or 

agent in charge of a facility solely 

engaged in the storage of unexposed 

packaged food verify that temperature 

controls are consistently implemented 

by calibrating temperature monitoring 

and recording devices. As discussed in 

section XII.G.5.a of this document, 

calibration provides assurance that an 

instrument is measuring accurately. If 

these instruments are not properly 

calibrated, the values they provide may 

not provide the necessary assurance 

temperatures are adequate to 

significantly minimize or prevent the 

growth of, or toxin production by, 

microorganisms of public health 

significance in an unexposed 

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refrigerated packaged TCS food. 

Proposed § 117.206(a)(4)(i) is analogous 

to proposed § 117.150(d)(2) in subpart 

C, which would establish a verification 

requirement for calibration of process 

monitoring instruments and verification 

instruments. 

Proposed § 117.206(a)(4)(ii) would 

require that the owner, operator, or 

agent in charge of a facility solely 

engaged in storage of unexposed 

packaged food verify that temperature 

controls are consistently implemented 

by reviewing records of calibration 

within a reasonable time after the 

records are made. As discussed in 

section XII.G.5.b of this document, the 

purpose of the review of records would 

be to ensure that the records are 

complete and that the preventive 

controls are effective. If temperature 

monitoring and recording devices are 

not properly calibrated, the temperature 

controls may not be effective. As 

discussed in section XII.G.5.b of this 

document, the review of calibration 

records will depend in part on the 

frequency with which calibrations 

occur. 

Proposed § 117.206(a)(4)(iii) would 

require that the owner, operator, or 

agent in charge of a facility solely 

engaged in storage of unexposed 

packaged food verify that temperature 

controls are consistently implemented 

by reviewing the records of monitoring 

and actions taken to correct a problem 

with the control of temperature within 

a week after the records are made. As 

discussed in section XII.G.5.b of this 

document, the purpose of the review of 

records would be to ensure that the 

records are complete, that the 

temperatures recorded were adequate to 

significantly minimize or prevent the 

growth of, or toxin production by, 

microorganisms of public health 

significance in an unexposed 

refrigerated packaged TCS food, and 

that appropriate actions were taken to 

correct any problem with the control of 

temperature for any unexposed 

refrigerated packaged TCS food. A 

weekly review of monitoring and 

corrective action records would provide 

for timely feedback of information and 

limit the amount of product impacted 

by any problems identified during the 

review of the records. Proposed 

§ 117.206(a)(4)(iii) is analogous to 

proposed § 117.150(d)(2)(ii) in subpart 

C, which would establish a verification 

requirement for review of records of 

monitoring and corrective action 

records within a week after the records 

are made. 

Proposed § 117.206(a)(4) is modified 

relative to the analogous proposed 

verification requirements in proposed 

§ 117.150 in that proposed 

§ 117.206(a)(4) would not require 

validation or reanalysis. There is a 

single control to verify, which limits the 

need for many of the verification 

procedures that might otherwise apply. 

As noted above, the temperatures to 

control growth of microbial pathogens 

are well documented and do not require 

validation that they are effective in 

controlling the potential for 

microorganisms of public health 

significance to grow, or produce toxin, 

in food. The reasons for not requiring 

reanalysis were discussed in section 

XIII.B.2. Proposed § 117.206(a)(4) also is 

modified relative to the analogous 

proposed verification requirements in 

proposed § 117.150 in that proposed 

§ 117.206(a)(4) would not require that a 

qualified individual perform or oversee 

the review of records of calibration or 

records of monitoring and actions taken 

to correct a problem with the control of 

temperature. The nature of these records 

does not require the qualifications that 

would be required under proposed 

§ 117.155(b). 

Proposed § 117.206(a)(5) would 

require that the owner, operator, or 

agent in charge of a facility solely 

engaged in storage of unexposed 

packaged food establish and maintain 

records documenting the monitoring of 

temperature controls for any unexposed 

refrigerated packaged TCS food 

(proposed § 117.206(a)(5)(i)); records of 

corrective actions taken when there is a 

problem with the control of temperature 

for any unexposed refrigerated packaged 

TCS food (proposed § 117.206(a)(5)(ii)); 

and records documenting verification 

activities (proposed § 117.206(a)(5)(iii)). 

The records that document monitoring 

would be used to verify that the 

temperature controls are effectively and 

significantly minimizing or preventing 

the growth of, or toxin production by, 

microorganisms of public health 

significance. The records that document 

corrective actions would be used to 

verify that appropriate decisions about 

corrective actions are being made and 

appropriate corrective actions are being 

taken. The records that document 

verification activities would be used to 

document that this key element of a 

food safety plan has been implemented. 

These records would be necessary to 

demonstrate compliance with the 

requirements and as such would be 

useful to inspectors and auditors. 

Proposed § 117.206(a)(5) is analogous to 

provisions in proposed §§ 117.140(c), 

117.145(d), and 117.150(f) in subpart C, 

which would require documentation of 

monitoring, corrective actions, and 

verification activities, respectively. 

Proposed § 117.206(b) would establish 

that the records that a facility must 

establish and maintain under proposed 

§ 117.206(a)(5) are subject to the 

requirements of proposed subpart F. 

Proposed subpart F would establish 

requirements that would apply to all 

records that would be required under 

proposed part 117. We describe the 

requirements of proposed subpart F in 

section XV of this document. Proposed 

§ 117.206(b) is analogous to proposed 

§ 117.175(b) in subpart C. 

XIV. Proposed New Provisions for 

Withdrawal of an Exemption 

Applicable to a Qualified Facility 

(Proposed Part 117, Subpart E) 

A. Requirements of Section 418 of the 

FD&C Act 

Section 418(l)(3)(A) of the FD&C Act 

specifies that, in the event of an active 

investigation of a foodborne illness 

outbreak that is directly linked to a 

qualified facility subject to an 

exemption under section 418(l) of the 

FD&C Act, or if the Secretary determines 

that it is necessary to protect the public 

health and prevent or mitigate a 

foodborne illness outbreak based on 

conduct or conditions associated with a 

qualified facility that are material to the 

safety of the food manufactured, 

processed, packed, or held at such 

facility, the Secretary may withdraw the 

exemption provided to such facility 

under section 418(l) of the FD&C Act. 

Section 418 does not expressly prescribe 

the procedures for withdrawing an 

exemption provided to a qualified 

facility under section 418(l). We 

tentatively conclude that it is 

appropriate to be transparent about the 

process we would use to withdraw an 

exemption and that we should include 

the process in the proposed rule. 

B. Proposed § 117.251—Circumstances 

That May Lead FDA To Withdraw an 

Exemption Applicable to a Qualified 

Facility 

1. Proposed § 117.251(a)—Withdrawal 

of an Exemption in the Event of an 

Active Investigation of a Foodborne 

Illness Outbreak 

Proposed § 117.251(a) would provide 

that FDA may withdraw the exemption 

that would be applicable to a qualified 

facility under proposed § 117.5(a) in the 

event of an active investigation of a 

foodborne illness outbreak that is 

directly linked to the qualified facility. 

Proposed § 117.251(a) would implement 

the statutory language of section 

418(l)(3)(A) of the FD&C Act. As 

discussed in section II.A.6.c of this 

document, an outbreak of foodborne 

illness is the occurrence of two or more 

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cases of a similar illness resulting from 

the ingestion of a common food. Food 

can become contaminated at many 

different steps in the farm-to-table 

continuum: on the farm; in packing, 

manufacturing/processing, or 

distribution facilities; during storage or 

transit; at retail establishments; in 

restaurants; and in the home. When 

foodborne illness is associated with 

food, a traceback investigation may 

enable us to directly link the illness to 

the facility or facilities that 

manufactured, processed, packed, and/ 

or held the food. 

For example, in February 2007, CDC 

notified FDA of a multi-state outbreak of 

Salmonella Tennessee infections 

associated with the consumption of 

peanut butter (73 FR 55115 at 55118, 

September 24, 2008). Peanut butter is a 

non-perishable packaged food, sold in 

jars. Consumers who became ill had 

open jars of peanut butter available for 

testing. Investigators were able to test 

samples of peanut butter taken from the 

jars and confirm the presence of 

Salmonella Tennessee in the peanut 

butter. Investigators were able to 

identify the manufacturer through 

information required to be on the label 

of the jars (21 CFR 101.5(a)) and through 

a product code the manufacturer had 

voluntarily placed on the jars. This 

information made it possible for FDA to 

visit the manufacturing facility the day 

after we learned of the outbreak from 

CDC. Investigators were able to use the 

product code to look in the 

manufacturing facility for unopened jars 

of peanut butter manufactured at the 

same time as the jars available from 

consumers. Investigators took samples 

of peanut butter from these unopened 

jars and confirmed the presence of 

Salmonella Tennessee in those samples. 

Because investigators uncovered 

conditions at the manufacturer’s facility 

that were likely to have caused the 

contamination and obtained a positive 

environmental sample, investigators 

saw no need to further trace the peanuts 

back to the farm where the peanuts were 

grown (73 FR 55115 at 55118). In 

circumstances such as the 2007 peanut 

butter outbreak, the available data and 

information from the investigation 

directly linked the outbreak of 

foodborne illness to the manufacturing 

facility. 

2. Proposed § 117.251(b)—Withdrawal 

of an Exemption Based on Conduct or 

Conditions Associated With a Qualified 

Facility 

Proposed § 117.251(b) would provide 

that FDA may withdraw the exemption 

applicable to a qualified facility under 

proposed § 117.5(a) if FDA determines 

that it is necessary to protect the public 

health and prevent or mitigate a 

foodborne illness outbreak based on 

conduct or conditions associated with a 

qualified facility that are material to the 

safety of the food manufactured, 

processed, packed, or held at such 

facility. As an example, we may receive 

reports to the Reportable Food Registry 

under section 417 of the FD&C Act 

about contamination of a food, and the 

reports may lead us to investigate a 

qualified facility that manufactured, 

processed, packed or held the food. If 

our investigation finds conduct or 

conditions associated with the facility 

that are material to the safety of the food 

(for example, conduct or conditions that 

likely led to the contamination of the 

food), we would consider withdrawing 

the exemption applicable to the facility 

under proposed § 117.5(a) if doing so 

would be necessary to protect the public 

health and prevent or mitigate a 

foodborne illness outbreak. Likewise, if 

during a routine inspection of a 

qualified facility, we discover 

conditions and practices that are likely 

to lead to contamination of food with 

microorganisms of public health 

significance, we would consider 

withdrawing the exemption provided to 

the facility under proposed § 117.5(a) if 

doing so would be necessary to protect 

the public health and prevent or 

mitigate a foodborne illness outbreak. 

C. Proposed § 117.254—Issuance of an 

Order To Withdraw an Exemption 

Applicable to a Qualified Facility 

Proposed § 117.254(a) would provide 

that, if FDA determines that an 

exemption applicable to a qualified 

facility under proposed § 117.5(a) 

should be withdrawn, any officer or 

qualified employee of FDA may issue an 

order to withdraw the exemption. We 

intend to create and maintain a written 

record of a determination that the 

withdrawal of an exemption is 

warranted and to include the basis for 

the determination in the written record. 

Proposed § 117.254(b) would require 

that an FDA District Director in whose 

district the qualified facility is located 

(or, in the case of a foreign facility, the 

Director of the Office of Compliance in 

the Center for Food Safety and Applied 

Nutrition), or an FDA official senior to 

such Director, must approve an order to 

withdraw the exemption as part of the 

withdrawal determination procedure 

before the order is issued. A Regional 

Food and Drug Director is an example 

of an FDA official senior to a District 

Director. The Deputy Director and 

Director of the Center for Food Safety 

and Applied Nutrition are examples of 

an FDA official senior to the Director of 

the Office of Compliance. Requiring 

prior approval of a withdrawal order by 

a District Director or an FDA official 

senior to a District Director is consistent 

with the approval requirement for a 

detention order in part 1, subpart K 

(Administrative Detention of Food for 

Human or Animal Consumption). 

Requiring prior approval of a 

withdrawal order by the Director of the 

Office of Compliance in the Center for 

Food Safety and Applied Nutrition is 

consistent with current FDA practices 

when dealing with foreign firms. 

Proposed § 117.254(c) would require 

that FDA issue an order to withdraw the 

exemption to the owner, operator, or 

agent in charge of the qualified facility. 

The requirements of section 418 of the 

FD&C Act are directed to the owner, 

operator, or agent in charge of a facility. 

We tentatively conclude that the 

statutory language of section 418 

enables FDA to issue an exemption 

withdrawal order to any of these 

persons. 

Proposed § 117.254(d) would require 

that FDA issue an order to withdraw the 

exemption in writing, signed and dated 

by the officer or qualified employee of 

FDA who is issuing the order. 

D. Proposed 117.257—Contents of an 

Order To Withdraw an Exemption 

Applicable to a Qualified Facility 

Proposed § 117.257(a) through (i) 

would require that an order to withdraw 

an exemption applicable to a qualified 

facility under § 117.5(a) include the 

following information: 

• (a) The date of the order (proposed 

§ 117.257(a)); 

• (b) The name, address and location 

of the qualified facility (proposed 

§ 117.257(b)); 

• (c) A brief, general statement of the 

reasons for the order, including 

information relevant to: 

• (1) An active investigation of a 

foodborne illness outbreak that is 

directly linked to the facility; or 

• (2) Conduct or conditions 

associated with a qualified facility that 

are material to the safety of the food 

manufactured, processed, packed, or 

held at such facility (proposed 

§ 117.257(c)). 

• (d) A statement that the facility 

must comply with subpart C of this part 

on the date that is 60 calendar days after 

the date of the order (proposed 

§ 117.257(d)); 

• (e) The text of section 418(l) of the 

Federal Food, Drug, and Cosmetic Act 

and of this subpart E (proposed 

§ 117.257(e)); 

• (f) A statement that any informal 

hearing on an appeal of the order must 

be conducted as a regulatory hearing 

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under part 16 of this chapter (21 CFR 

part 16), with certain exceptions 

described in proposed § 117.270 

(proposed § 117.257(f)); 

• (g) The mailing address, telephone 

number, email address, and facsimile 

number of the FDA district office and 

the name of the FDA District Director in 

whose district the facility is located (or, 

in the case of a foreign facility, the same 

information for the Director of the Office 

of Compliance in the Center for Food 

Safety and Applied Nutrition); 

(proposed § 117.257(g)); and 

• (h) The name and the title of the 

FDA representative who approved the 

order (proposed § 117.257(i)). 

FDA tentatively concludes that the 

requirements that we propose in 

§ 117.257 would provide the owner, 

operator, or agent in charge of a 

qualified facility subject to a withdrawal 

with adequate notice of the basis for our 

determination to withdraw the 

exemption and of their opportunity to 

appeal our determination and to request 

an informal hearing. The proposed 

notification procedures are similar to 

and consistent with the notification 

requirements in other regulations 

involving administrative action, such as 

administrative detention of food under 

§ 1.393 orders for diversion or 

destruction of shell eggs under the PHS 

Act under § 118.12(a)(i), and with 

procedures for an informal hearing in 

part 16. 

E. Proposed § 117.260—Compliance 

With, or Appeal of, an Order To 

Withdraw an Exemption Applicable to a 

Qualified Facility 

Proposed § 117.260(a) would require 

that the owner, operator, or agent in 

charge of a qualified facility that 

receives an order under § 117.251 to 

withdraw an exemption applicable to 

that facility under § 117.5(a) either 

comply with applicable requirements of 

this part within 60 calendar days of the 

date of the order; or appeal the order 

within 10 calendar days of the date of 

the order in accordance with the 

requirements of § 117.264. We 

tentatively conclude that either of the 

two circumstances that could result in 

our determination that an exemption 

should be withdrawn (as described in 

proposed § 117.251) warrant prompt 

compliance with the rule in the interest 

of public health. We tentatively 

conclude that ten calendar days for the 

submission of an appeal from the date 

of the receipt of a withdrawal order is 

appropriate for purposes of the efficient 

adjudication of the appeal of a 

withdrawal order and would provide 

reasonable due process that comes to 

closure sufficiently in advance of the 

effective date of the order to provide an 

opportunity for the facility to come into 

compliance if we deny the appeal. 

Proposed § 117.260(b) would establish 

that submission of an appeal, including 

submission of a request for an informal 

hearing, will not delay or stay any 

administrative action, including 

enforcement action by FDA, unless the 

Commissioner of Food and Drugs, as a 

matter of discretion, determines that 

delay or a stay is in the public interest. 

For example, the submission of an 

appeal of a withdrawal order with a 

request for an informal hearing under 

proposed § 117.260(b) would not 

prevent FDA from simultaneously 

detaining food from the facility under 

section 304(h) of the FD&C Act, seizing 

food from the facility under section 

304(a) of the FD&C Act, or seeking or 

enforcing an injunction under section 

302 of the FD&C Act. 

Proposed § 117.260(c) would require 

that, if the owner, operator, or agent in 

charge of the qualified facility appeals 

the order, and FDA confirms the order, 

the owner, operator, or agent in charge 

of the facility must comply with 

applicable requirements of this part 

within 60 calendar days of the date of 

the order. Proposed § 117.260(c) would 

make clear that the 60 calendar day time 

frame for compliance applies regardless 

of whether the owner, operator, or agent 

in charge of a facility requests, and FDA 

grants, a hearing. As already discussed, 

FDA tentatively concludes that the 

circumstances that lead to a 

determination that an exemption should 

be withdrawn warrant prompt 

compliance in the interest of public 

health. 

F. Proposed § 117.264—Procedure for 

Submitting an Appeal 

Proposed § 117.264(a) would require 

that, to appeal an order to withdraw an 

exemption applicable to a qualified 

facility under § 117.5(a), the owner, 

operator, or agent in charge of the 

facility must (1) submit the appeal in 

writing to the FDA District Director in 

whose district the facility is located (or, 

in the case of a foreign facility, the same 

information for the Director of the Office 

of Compliance in the Center for Food 

Safety and Applied Nutrition), at the 

mailing address, email address, or 

facsimile number identified in the order 

within 10 calendar days of the date of 

the order; and (2) respond with 

particularity to the facts and issues 

contained in the order, including any 

supporting documentation upon which 

the owner, operator or agent in charge 

of the facility relies. 

Allowing the owner, operator, or 

agent in charge of the facility to submit 

an appeal in person, by mail, email, or 

fax would provide for flexibility as well 

as speed. For example, submitting in 

person would give the owner, operator, 

or agent in charge direct knowledge that 

the request for appeal had been 

delivered and received. Email and fax 

are instantaneous, and overnight mail 

delivery services are readily available to 

those who choose to use them; however, 

the ten day time frame for appeal of the 

order would not require the use of 

overnight mail delivery. For clarity, 

proposed § 117.264(a) would repeat the 

10 calendar day time frame that would 

be established in proposed 

§ 117.260(a)(2) and would not establish 

any new requirement. Any appeal 

would need to be written in order for 

FDA to evaluate the basis for the appeal. 

We are proposing that a written appeal 

would need to address with 

particularity all of the issues raised in 

the withdrawal order and include all 

supporting documentation so that we 

would be able to issue a final 

determination as to the disposition of 

the appeal solely on the basis of the 

materials submitted as part of the 

written appeal. 

Proposed § 117.264(b) would provide 

that, in a written appeal of the order 

withdrawing an exemption provided 

under § 117.5(a), the owner, operator, or 

agent in charge of the facility may 

include a written request for an informal 

hearing as provided in § 117.267. 

Requesting an informal hearing does not 

mean that a hearing will be held, 

because we may deny the request (see 

discussion of proposed § 117.267(b) in 

the next section of this document). 

However, if the owner, operator, or 

agent in charge of the facility does not 

request an informal hearing at the time 

the written appeal is submitted, the 

owner, operator, or agent in charge of 

the facility will not be entitled to an 

informal hearing. Instead, FDA will 

make a final decision based on the 

written appeal and its supporting 

materials. 

G. Proposed § 117.267—Procedure for 

Requesting an Informal Hearing 

Proposed § 117.267(a)(1) would 

provide that, if the owner, operator, or 

agent in charge of the facility appeals 

the order, the owner, operator, or agent 

in charge of the facility may request an 

informal hearing. Proposed 

§ 117.267(a)(1) would restate an option 

that would be included in proposed 

§ 117.264(b) to highlight the opportunity 

to request an informal hearing. Proposed 

§ 117.267(a)(2) would require that, if the 

owner, operator, or agent in charge of 

the facility appeals the order, the owner, 

operator, or agent in charge of the 

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facility must submit any request for an 

informal hearing together with its 

written appeal submitted in accordance 

with § 117.264 within 10 calendar days 

of the date of the order. We tentatively 

conclude that requiring submission of a 

request for an informal hearing in 

writing at the time that the owner, 

operator, or agent in charge of the 

facility would be required to submit a 

written appeal is appropriate for 

purposes of the efficient adjudication of 

the appeal of a withdrawal order and 

would provide reasonable due process 

that would come to closure sufficiently 

in advance of the effective date of the 

order to provide an opportunity for the 

facility to come into compliance if we 

deny the appeal. 

Proposed § 117.267(b) would establish 

that a request for an informal hearing 

may be denied, in whole or in part, if 

the presiding officer determines that no 

genuine and substantial issue of 

material fact has been raised by the 

material submitted. Proposed 

§ 117.267(b) would also provide that if 

the presiding officer determines that a 

hearing is not justified, written notice of 

the determination will be given to the 

owner, operator, or agent in charge of 

the facility explaining the reason for the 

denial. Under proposed § 117.264(a), a 

written appeal would be required to 

respond with particularity to the facts 

and issues contained in the withdrawal 

order, including any supporting 

documentation upon which the owner, 

operator or agent in charge of the facility 

relies. If the materials submitted do not 

directly address the facts and issues 

contained in the withdrawal order in a 

manner that suggests that there is a 

dispute regarding the material facts 

contained in the order, the presiding 

officer may determine that an informal 

hearing is not warranted. The presiding 

officer may include written notice of the 

determination that a hearing is not 

justified as part of the final decision on 

the appeal. 

H. Proposed § 117.270—Requirements 

Applicable to an Informal Hearing 

Proposed § 117.270(a) would establish 

that, if the owner, operator or agent in 

charge of the facility requests an 

informal hearing, and FDA grants the 

request, the hearing will be held within 

10 calendar days after the date the 

appeal is filed or, if applicable, within 

a time frame agreed upon in writing by 

the owner, operator, or agent in charge 

of the facility and FDA. We tentatively 

conclude that, if we grant a request for 

an informal hearing, holding the hearing 

within 10 calendar days, or within an 

alternative time frame as agreed upon in 

writing, is appropriate for purposes of 

the efficient adjudication of the appeal 

of a withdrawal order and would 

provide reasonable due process that 

would come to closure sufficiently in 

advance of the effective date of the order 

to provide an opportunity for the facility 

to come into compliance if we deny the 

appeal. 

Proposed 117.270(b) would establish 

that the presiding officer may require 

that a hearing conducted under this 

subpart E be completed within 1 

calendar day, if appropriate. We 

tentatively conclude that, if we grant a 

request for an informal hearing, limiting 

the time for the hearing itself to be 

completed within 1 calendar day is 

appropriate for purposes of the efficient 

adjudication of the appeal of a 

withdrawal order and would provide 

reasonable due process that would come 

to closure sufficiently in advance of the 

effective date of the order to provide an 

opportunity for the facility to come into 

compliance if we deny the appeal. 

Proposed § 117.270(c)(1) through (7) 

would establish that, if the owner, 

operator or agent in charge of the facility 

requests an informal hearing, and FDA 

grants the request, FDA must conduct 

the hearing in accordance with part 16, 

except that: 

• (1) The order withdrawing an 

exemption under §§ 117.254 and 

117.257, rather than the notice under 

§ 16.22(a), provides notice of 

opportunity for a hearing under this 

section and is part of the administrative 

record of the regulatory hearing under 

§ 16.80(a) of this chapter. 

• (2) A request for a hearing under 

this subpart E must be addressed to the 

FDA District Director (or, in the case of 

a foreign facility, the Director of the 

Office of Compliance in the Center for 

Food Safety and Applied Nutrition) as 

provided in the order withdrawing an 

exemption. 

• (3) Section 117.274, rather than 

§ 16.42(a), describes the FDA employees 

who preside at hearings under this 

subpart. 

• (4) Section 16.60(e) and (f) of this 

chapter does not apply to a hearing 

under this subpart. The presiding officer 

must prepare a written report of the 

hearing. All written material presented 

at the hearing will be attached to the 

report. The presiding officer must 

include as part of the report of the 

hearing a finding on the credibility of 

witnesses (other than expert witnesses) 

whenever credibility is a material issue, 

and must include a proposed decision, 

with a statement of reasons. The hearing 

participant may review and comment on 

the presiding officer’s report within 2 

calendar days of issuance of the report. 

The presiding officer will then issue the 

final decision. 

• (5) Section 16.80(a)(4) of this 

chapter does not apply to a regulatory 

hearing under this subpart. The 

presiding officer’s report of the hearing 

and any comments on the report by the 

hearing participant under 

§ 117.270(c)(4) are part of the 

administrative record. 

• (6) No party shall have the right, 

under § 16.119 of this chapter to 

petition the Commissioner of Food and 

Drugs for reconsideration or a stay of the 

presiding officer’s final decision. 

• (7) If FDA grants a request for an 

informal hearing on an appeal of an 

order withdrawing an exemption, the 

hearing must be conducted as a 

regulatory hearing under a regulation in 

accordance with part 16, except that 

§ 16.95(b) does not apply to a hearing 

under this subpart. With respect to a 

regulatory hearing under this subpart, 

the administrative record of the hearing 

specified in §§ 16.80(a)(1), (a)(2), (a)(3), 

and (a)(5), and § 117.270(c)(5) 

constitutes the exclusive record for the 

presiding officer’s final decision. For 

purposes of judicial review under 

§ 10.45 of this chapter, the record of the 

administrative proceeding consists of 

the record of the hearing and the 

presiding officer’s final decision. 

Under § 16.1(b), the procedures in 

part 16 apply when a regulation 

provides a person with an opportunity 

for a hearing on a regulatory action 

under part 16. Section 418 of the FD&C 

Act does not expressly provide for a 

hearing if circumstances lead FDA to 

determine that an exemption provided 

to a qualified facility under proposed 

§ 117.5(a) should be withdrawn. 

However, we tentatively conclude as a 

matter of agency discretion that 

providing an opportunity for a hearing 

by regulation in this subpart of the 

proposed rule would provide 

appropriate process to the owner, 

operator, or agent in charge of a 

qualified facility subject to withdrawal 

of the facility’s exemption. We also 

tentatively conclude that the modified 

part 16 procedures contained in this 

proposed rule would provide the owner, 

operator, or agent in charge of a 

qualified facility subject to a withdrawal 

order sufficient fairness and due process 

while enabling FDA to expeditiously 

adjudicate an appeal of a withdrawal 

order for which an informal hearing has 

been granted. 

Section 16.119 provides that, after any 

final administrative action that is the 

subject of a hearing under part 16, any 

party may petition the Commissioner for 

reconsideration of any part or all of the 

decision or action under § 10.33 or may 

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petition for a stay of the decision or 

action under § 10.35. Proposed 

§ 117.270(c)(6) would specify that these 

procedures for reconsideration and stay 

would not apply to the process of 

withdrawing an exemption provided 

under proposed § 117.5(a). The 

circumstances that may lead FDA to 

withdraw an exemption include an 

active investigation of a foodborne 

illness outbreak that is directly linked to 

a qualified facility, or our determination 

that it is necessary to protect the public 

health and prevent or mitigate a 

foodborne illness outbreak based on 

conduct or conditions associated with a 

qualified facility that are material to the 

safety of the food manufactured, 

processed, packed, or held at such 

facility. Such circumstances require 

prompt action. Under § 16.120, a 

qualified facility that disagrees with 

FDA’s decision to withdraw an 

exemption provided under § 117.5(a) 

has an opportunity for judicial review in 

accordance with § 10.45. 

I. Proposed § 117.274—Presiding Officer 

for an Appeal and for an Informal 

Hearing 

Proposed § 117.274 would require 

that the presiding officer for an appeal, 

and for an informal hearing, must be an 

FDA Regional Food and Drug Director 

or another FDA official senior to an FDA 

District Director. Under § 16.42(b), an 

officer presiding over an informal 

hearing is to be free from bias or 

prejudice and may not have participated 

in the investigation or action that is the 

subject of the hearing or be subordinate 

to a person, other than the 

Commissioner, who has participated in 

such investigation or action. An order 

for the withdrawal of an exemption 

applicable to a qualified facility must be 

approved by a District Director or an 

official senior to a District Director. It is 

therefore necessary that appeals of a 

decision to issue a withdrawal order 

should be handled by persons in 

positions senior to the District Directors. 

The Regional Food and Drug Director is 

such a person and could be from the 

same region where the facility is 

located, provided that the Regional 

Food and Drug Director did not 

participate in the determination that an 

exemption should be withdrawn and is 

otherwise free from bias or prejudice. 

Alternatively, the Regional Food and 

Drug Director could be from a different 

region than the region where the facility 

is located, for example in the event the 

Regional Food and Drug Director for the 

region in which the facility is located is 

the FDA official who approved the 

withdrawal order. Any Office Director 

of FDA’s Office of Regulatory Affairs 

could preside at a hearing, provided that 

the Office Director did not participate in 

the determination that an exemption 

should be withdrawn and is otherwise 

free from bias or prejudice. 

J. Proposed § 117.277—Time Frame for 

Issuing a Decision on an Appeal 

Proposed § 117.277(a) would require 

that, if the owner, operator, or agent in 

charge of a facility appeals the order 

without requesting a hearing, the 

presiding officer must issue a written 

report that includes a final decision 

confirming or revoking the withdrawal 

by the tenth calendar day after the 

appeal is filed. Under proposed 

§ 117.251, FDA would issue a 

withdrawal order either in the event of 

an active investigation of a foodborne 

illness outbreak that is directly linked to 

a qualified facility or if we determine 

that an exemption withdrawal is 

necessary to protect the public health 

and prevent or mitigate a foodborne 

illness outbreak based on conduct or 

conditions associated with a qualified 

facility that are material to the safety of 

the food located at the facility. We 

tentatively conclude that we will need 

10 calendar days to review the written 

appeal and the materials submitted with 

the written appeal, and that a final 

decision confirming or revoking a 

withdrawal order should be issued as 

quickly as possible in the interest of the 

public health and to provide reasonable 

due process that would come to closure 

sufficiently in advance of the effective 

date of the order to provide an 

opportunity for the facility to come into 

compliance if we deny the appeal. 

Proposed § 117.277(b)(1) would 

require that, if the owner, operator, or 

agent in charge of a facility appeals the 

order and requests an informal hearing 

and, if FDA grants the request for a 

hearing and the hearing is held, the 

presiding officer must provide a 2 

calendar day opportunity for the hearing 

participants to review and submit 

comments on the report of the hearing 

under § 117.270(c)(4), and must issue a 

final decision within the 10-calendar 

day period after the hearing is held. We 

tentatively conclude that it is 

appropriate to grant the owner, operator, 

or agent in charge of a qualified facility 

subject to a withdrawal order the 

opportunity to review and submit 

comments to the presiding officer’s 

report because the report is part of the 

record of a final agency action (see 

discussion of proposed § 117.284 in 

section XIV.L of this document) that is 

not subject to further reconsideration by 

FDA. The presiding officer would have 

discretion to determine whether to 

revise the report of the hearing in light 

of any comments that might be 

submitted by any of the hearing 

participants. 

Proposed § 117.277(b)(2) would 

require that, if the owner, operator, or 

agent in charge of a facility appeals the 

order and requests an informal hearing 

and if FDA denies the request for a 

hearing, the presiding officer must issue 

a final decision on the appeal 

confirming or revoking the withdrawal 

within 10 calendar days after the date 

the appeal is filed. We tentatively 

conclude that ten calendar days for the 

presiding officer to issue a final decision 

is appropriate for purposes of the 

efficient adjudication of the appeal of a 

withdrawal order, would provide 

reasonable due process that would come 

to closure sufficiently in advance of the 

effective date of the order to provide an 

opportunity for the facility to come into 

compliance if we deny the appeal, and 

is in the interest of public health. 

K. Proposed § 117.280—Revocation of 

an Order To Withdraw an Exemption 

Applicable to a Qualified Facility 

Proposed § 117.280(a) through (c) 

would establish that an order to 

withdraw an exemption applicable to a 

qualified facility under § 117.5(a) is 

revoked if: 

• (a) The owner, operator, or agent in 

charge of the facility appeals the order 

and requests an informal hearing, FDA 

grants the request for an informal 

hearing, and the presiding officer does 

not confirm the order within the 10 

calendar days after the hearing, or issues 

a decision revoking the order within 

that time; or 

• (b) The owner, operator, or agent in 

charge of the facility appeals the order 

and requests an informal hearing, FDA 

denies the request for an informal 

hearing, and FDA does not confirm the 

order within the 10 calendar days after 

the appeal is filed, or issues a decision 

revoking the order within that time; or 

• (c) The owner, operator, or agent in 

charge of the facility appeals the order 

without requesting an informal hearing, 

and FDA does not confirm the order 

within the 10 calendar days after the 

appeal is filed, or issues a decision 

revoking the order within that time. 

We tentatively conclude that an order 

to withdraw an exemption may be 

revoked in one of two manners. First, 

we are proposing that the FDA officer 

responsible for adjudicating the appeal 

and presiding over a hearing, if one is 

granted, may expressly issue a written 

decision revoking the order within the 

specified 10 calendar day time frames. 

Second, we are proposing that the 

failure of the FDA officer responsible for 

adjudicating an appeal to issue a final 

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3780 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

decision expressly confirming the order 

within the specified time frames will 

also serve to revoke the order. We 

tentatively conclude that fairness would 

warrant the revocation of a withdrawal 

order if FDA is unable to meet the 

proposed deadlines for expressly 

confirming an order. 

L. Proposed § 117.284—Final Agency 

Action 

Proposed § 117.284 would establish 

that confirmation of a withdrawal order 

by the presiding officer is considered a 

final agency action for purposes of 

section 702 of title 5 of the United States 

Code (5 U.S.C. 702). A confirmation of 

an order withdrawing an exemption 

therefore would be reviewable by the 

courts under section 702 of title 5 and 

in accordance with § 10.45 (21 CFR 

§ 10.45). 

M. Conforming Amendment to 21 CFR 

Part 16 

We propose to amend § 16.1(b)(2) to 

include part 117, subpart E, relating to 

the withdrawal of an exemption 

applicable to a qualified facility, to the 

list of regulatory provisions under 

which regulatory hearings are available. 

XV. Proposed New Recordkeeping 

Requirements (Proposed Part 117, 

Subpart F) 

A. Relevant Statutory Provisions 

FDA is proposing to create a new 

Subpart F to establish requirements 

applying to records that must be 

established and maintained according to 

the requirements of this proposed rule. 

As discussed in section XII.I of this 

document, section 418 of the FD&C Act 

prescribes several requirements relevant 

to recordkeeping. The statutory 

provisions that are most relevant to 

proposed subpart F are: 

• Section 418(a) of the FD&C Act, 

which requires, in relevant part, that the 

owner, operator, or agent in charge of a 

facility maintain records of monitoring 

the performance of preventive controls 

as a matter of routine practice; 

• Section 418(b)(3) of the FD&C Act, 

which requires, in relevant part, that the 

owner, operator, or agent in charge of a 

facility develop a written analysis of the 

hazards; 

• Section 418(g) of the FD&C Act, 

which requires, in relevant part, that the 

owner, operator, or agent in charge of a 

facility maintain certain records for not 

less than 2 years. The records identified 

in section 418(g) include records 

documenting the monitoring of the 

preventive controls implemented under 

section 418(c) of the FD&C Act, 

instances of nonconformance material to 

food safety, the results of testing and 

other appropriate means of verification 

under section 418(f)(4) of the FD&C Act, 

instances when corrective actions were 

implemented, and the efficacy of 

preventive controls and corrective 

actions; and 

• Section 418(h) of the FD&C Act, 

which requires, in relevant part, that the 

owner, operator, or agent in charge of a 

facility prepare a written plan that 

documents and describes the 

procedures used by the facility to 

comply with the requirements of this 

section and that such written plan, 

together with documentation described 

in section 418(g) of the FD&C Act, shall 

be made promptly available to a duly 

authorized representative of the 

Secretary upon oral or written request; 

• Section 418(n)(1)(A) of the FD&C 

Act, which provides, in relevant part, 

that FDA shall promulgate regulations 

to establish science-based minimum 

standards for documenting hazards and 

documenting the implementation of the 

preventive controls under this section; 

• Section 402(a)(4) of the FD&C Act, 

which provides that food is adulterated 

if it has been prepared, packed, or held 

under insanitary conditions whereby it 

may have become contaminated with 

filth, or whereby it may have been 

rendered injurious to health; 

• Section 701(a) of the FD&C Act [21 

U.S.C. 371(a)], which provides FDA 

with authority to promulgate regulations 

for the efficient enforcement of the 

FD&C Act; and 

• Section 361(a) of the Public Health 

Service Act [42 U.S.C. 264(a)], which 

provides FDA with authority to make 

and enforce such regulations as in 

FDA’s judgment are necessary to 

prevent the introduction, transmission, 

or spread of communicable diseases 

from foreign countries into the States or 

possessions, or from one State or 

possession into any other State or 

possession. 

• Section 418(l)(2)(B) of the FD&C 

Act, which requires a qualified facility 

to submit documentation to the 

Secretary related to its qualified status 

and also submit either documentation of 

the facility’s implementation and 

monitoring of preventive controls or 

documentation of its compliance with 

other appropriate non-Federal food 

safety laws. 

B. Proposed § 117.301—Records Subject 

to the Requirements of This Subpart F 

Proposed § 117.301(a) would establish 

that, except as provided by proposed 

§ 117.301(b) and (c), all records required 

by proposed part 117 would be subject 

to all requirements of proposed subpart 

F. FDA tentatively concludes that the 

requirements in subpart F describing 

how records must be established and 

maintained, including the general 

requirements, record retention 

requirements, and requirements for 

official review and public disclosure, 

are applicable to all records that would 

be required under all subparts, because 

records that would be required under 

each of the subparts aid plants and 

facilities in compliance with the 

requirements of proposed part 117; and 

allow plants and facilities to show, and 

FDA to determine, compliance with the 

requirements of part 110. 

Proposed § 117.301(b) would establish 

that the requirements of proposed 

§ 117.310 apply only to the written food 

safety plan and is discussed in more 

detail in Part D of this section. 

Proposed § 117.301(c) would provide 

that the requirements of § 117.305(b), 

(d), (e), and (f) do not apply to the 

records required by § 117.201(e). As 

discussed in section XIII.A.7 of this 

document, proposed § 117.201(e) would 

require that a qualified facility maintain 

records relied upon to support the selfcertification that would be required by 

§ 117.201(a). Such documentation 

would be directed to the financial basis 

(and, when applicable, percentage of 

sales to qualified end users) as well as 

to food safety practices at the qualified 

facility, and could range from invoices 

to a food safety plan to an operating 

license issued by a state or local 

authority. Such records would not be 

expected to satisfy the provisions of 

proposed § 117.305(b), (d), (e), and (f) 

(which we discuss in the next section of 

this document). To make clear that a 

qualified facility need not comply with 

provisions that do not apply to its 

records, we are proposing to specify that 

those provisions do not apply to such 

records. 

C. Proposed § 117.305—General 

Requirements Applying to Records 

Proposed § 117.305 contains general 

requirements that would apply to 

records that would be required under 

proposed part 117, including the format 

for required records, the recording of 

actual values and observations obtained 

during monitoring, when records must 

be created, and information that must be 

included in each record. 

1. Proposed § 117.305(a) 

Proposed § 117.305(a) would require 

that the records be kept as original 

records, true copies (such as 

photocopies, pictures, scanned copies, 

microfilm, microfiche, or other accurate 

reproductions of the original records), or 

electronic records. True copies of 

records should be of sufficient quality to 

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detect whether the original record was 

changed or corrected in a manner that 

obscured the original entry (e.g., 

through the use of white-out). Proposed 

§ 117.305(a) would provide flexibility 

for mechanisms for keeping records 

while maintaining the integrity of the 

recordkeeping system. The proposed 

requirement allowing true copies is 

consistent with other regulations such 

as our Good Manufacturing Practices 

(GMPs) regulation for dietary 

supplements (§ 111.605(b)) and provides 

options that may be compatible with the 

way records are currently being kept in 

plants and facilities. 

Proposed § 117.305(a) also would 

require that electronic records be kept in 

accordance with part 11 (21 CFR part 

11). Part 11 provides criteria for 

acceptance by FDA, under certain 

circumstances, of electronic records, 

electronic signatures, and handwritten 

signatures executed to electronic 

records as equivalent to paper records 

and handwritten signatures executed on 

paper. The proposed requirement 

clarifies and acknowledges that records 

required by proposed part 117 may be 

retained electronically, provided that 

they comply with part 11. 

FDA tentatively concludes that it is 

appropriate to apply the requirements of 

part 11 to the records that would be 

required to be kept under proposed part 

117. However, we request comment on 

whether there are any circumstances 

that would warrant not applying part 11 

to records that would be kept under 

proposed part 117. For example, would 

a requirement that electronic records be 

kept according to part 11 mean that 

current electronic records and 

recordkeeping systems would have to be 

recreated and redesigned, which we 

determined to be the case in the 

regulation Establishment and 

Maintenance of Records Under the 

Public Health Security and Bioterrorism 

Preparedness and Response Act of 2002 

(69 FR 71562, December 9, 2004 (the BT 

records regulation)) For the purposes of 

the records requirements in the BT 

records regulation, we concluded that it 

was not necessary for new 

recordkeeping systems to be established 

as long as current practices would 

satisfy the requirements of the Act and, 

therefore, we exempted the records from 

the requirements of part 11 (21 CFR 

1.329(b)). We also exempted records 

related to certain cattle materials 

prohibited from use in human food and 

cosmetics from part 11 (21 CFR 

189.5(c)(7) and 700.27(c)(7), 

respectively). We also seek comment on 

whether we should allow additional 

time for electronic records to be kept in 

accordance with part 11. Comments 

should provide the basis for any view 

that the requirements of part 11 are not 

warranted. 

2. Proposed § 117.305(b) 

Proposed § 117.305(b) would require 

that records contain the actual values 

and observations obtained during 

monitoring. It is neither possible to 

derive the full benefits of a preventive 

controls system, nor to verify the 

operation of the system, without 

recording actual values and 

observations to produce an accurate 

record. Notations that monitoring 

measurements, such as heat treatment 

temperatures, are ‘‘satisfactory’’ or 

‘‘unsatisfactory,’’ without recording the 

actual times and temperatures, are 

vague and subject to varying 

interpretations and, thus, will not 

ensure that controls are working 

properly. In addition, it is not possible 

to discern a trend toward loss of control 

without actual measurement values. 

Proposed § 117.305(b) is consistent with 

our HACCP regulations for seafood and 

juice, specifically § 123.6(c)(7) and 

§ 120.12(b)(4), respectively. In addition, 

our HACCP regulation for juice also 

requires that records documenting the 

monitoring of critical control points and 

their critical limits include recording of 

actual times, temperatures, or other 

measurements (§ 120.12(a)(4)(i)). We 

seek comment on this proposal. 

3. Proposed § 117.305(c), (d) and (e) 

Proposed § 117.305(c), (d) and (e) 

would require that records be accurate, 

indelible, and legible (proposed 

§ 117.305(c)); be created concurrently 

with performance of the activity 

documented (proposed § 117.305(d)); 

and be as detailed as necessary to 

provide a history of work performed 

(proposed § 117.305(e)). Proposed 

§ 117.305(c) and (d) would ensure that 

the records are useful to the owner, 

operator, or agent in charge of a plant 

or facility in complying with the 

requirements of proposed part 117, for 

example, in documenting compliance 

with monitoring requirements and 

verifying compliance with the food 

safety plan. These proposed 

requirements would also ensure that the 

records would be useful to FDA in 

determining compliance with the 

requirements of proposed part 117. 

Proposed § 117.305(e) would provide 

flexibility to plants and facilities to 

tailor the amount of detail to the nature 

of the record. These proposed 

requirements are consistent with the 

NACMCF HACCP guidelines, the Codex 

HACCP guidelines, and our HACCP 

regulations for seafood and juice. 

Consistent with the definition of 

‘‘monitor’’ in proposed § 117.3, the 

NACMCF guidelines assert that 

monitoring is a planned sequence of 

observations or measurements to not 

only assess whether a CCP is under 

control but to also produce an accurate 

record for future use in verification (Ref. 

34). The Codex guidelines advise that 

efficient and accurate record keeping is 

essential to the application of a HACCP 

system (Ref. 35). Our HACCP 

regulations for seafood and juice require 

that processing and other information be 

entered on records at the time that it is 

observed (§§ 123.9(a)(4) and 120.12 

(b)(4), respectively). 

4. Proposed § 117.305(f) 

Proposed § 117.305(f) would require 

that the records include (1) the name 

and location of the plant or facility; (2) 

the date and time of the activity 

documented; (3) the signature or initials 

of the person performing the activity; 

and (4) where appropriate, the identity 

of the product and the production code, 

if any. The name and location of the 

plant or facility and the date and time 

would allow the owner, operator, or 

agent in charge of a plant or facility 

(and, during inspection, an FDA 

investigator) to assess whether the 

record is current, to identify when and 

where any deviation occurred, and to 

track corrective actions. The signature of 

the individual who made the 

observation would ensure responsibility 

and accountability. In addition, if there 

is a question about the record, a 

signature would ensure that the source 

of the record will be known. Linking a 

record to a specific product (and, when 

applicable, the production code) would 

enable the owner, operator, or agent in 

charge of a facility to isolate product 

that has not been processed properly 

when there has been a problem, thereby 

limiting the impact of the problem (such 

as the need to reprocess product or to 

recall product) to only those lots with 

the problem. 

Proposed § 117.305(f) is consistent 

with the NACMCF HACCP guidelines 

and our HACCP regulations for seafood 

and juice. The NACMCF HACCP 

guidelines recommend that all records 

and documents associated with CCP 

monitoring be dated and signed or 

initialed by the person doing the 

monitoring (Ref. 34). Our HACCP 

regulations for seafood and juice require 

that all records include the name and 

location of the processor; the date and 

time of the activity that the record 

reflects; the signature or initials of the 

person performing the operation; and 

where appropriate, the identity of the 

product and the production code, if any 

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(§§ 123.9(a) and 120.12 (b), 

respectively). 

D. Proposed § 117.310—Additional 

Requirements Applying to the Food 

Safety Plan 

Proposed § 117.310 would require 

that the owner, operator, or agent in 

charge of a facility sign and date the 

food safety plan upon initial completion 

(proposed § 117.310 (a)) and upon any 

modification (proposed § 117.310(b)). 

Such a signature would provide direct 

evidence of the owner, operator, or 

agent’s acceptance of the plan and 

commitment to implementation of the 

plan. Additionally, the signature, along 

with the date of signing, would serve to 

minimize potential confusion over the 

authenticity of any differing versions or 

editions of the document that might 

exist. The proposed requirement for 

signing and dating is consistent with 

our HACCP regulations for seafood and 

juice, which require that the HACCP 

plan be signed and dated, either by the 

most responsible individual onsite at 

the processing facility or by a higher 

level official of the processor and be 

dated and signed upon initial 

acceptance; upon any modification; and 

upon verification of the plan (for 

seafood) or upon verification and 

validation (for juice) (§§ 123.6(d) and 

120.12 (c) for seafood and juice, 

respectively). 

E. Proposed § 117.315—Requirements 

for Record Retention 

Proposed § 117.315 contains 

requirements on the length of time 

records that would be required under 

proposed part 117 must be retained and 

allowances for offsite storage of records 

under certain circumstances. 

1. Proposed § 117.315(a) and (b) 

Proposed § 117.315(a) would require 

that all records that would be required 

by proposed part 117 be retained at the 

plant or facility for at least 2 years after 

the date they were prepared. Proposed 

§ 117.315(b) would require that records 

that relate to the general adequacy of the 

equipment or processes being used by a 

facility, including the results of 

scientific studies and evaluations, must 

be retained at the facility for at least 2 

years after their use is discontinued 

(e.g., because the facility has updated 

the written food safety plan (§ 117.126) 

or records that document validation of 

the written food safety plan 

(§ 117.150(a)). Proposed § 117.315(a) 

and (b) implement subsection 418(g) of 

the FD&C Act, which requires certain 

records to be maintained for not less 

than 2 years. The 2-year timeframe for 

all records required by proposed part 

117 is consistent with the length of time 

that nonperishable food products, on 

average, can be expected to be in 

commercial distribution plus a 

reasonable time thereafter to ensure that 

the records are available for verification 

activities. As we noted in the proposed 

BT records regulation (68 FR 25188 at 

25198, May 9, 2003), according to 

information provided to FDA by the 

food industry, the minimum time for 

processed food products to clear the 

food production and distribution/retail 

system is 3 years. In addition, the 

average distribution time between 

harvesting and final retail sale of frozen 

fruits and vegetables is approximately 3 

to 24 months (68 FR 25188 at 25198). In 

the final BT records regulation, we 

concluded that 2 years was the 

minimum time records related to 

nonperishable foods for the purpose of 

identifying immediate previous sources 

and immediate subsequent recipients 

should be kept (69 FR 71562 at 71602– 

3). The 2-year record retention 

requirement is also consistent with our 

HACCP regulations for seafood and 

juice, which both require that records be 

retained for at least 2 years after the date 

they were prepared in the case of frozen, 

preserved, or shelf-stable products 

(§§ 123.9(b)(1) and 120.12(d)(1), 

respectively); and with the requirement 

in the seafood HACCP regulation that 

records relating to the general adequacy 

of equipment or processes, including 

scientific studies and evaluations, be 

retained for at least 2 years after their 

applicability to the product being 

produced at the facility (§ 123.9(b)(2)). 

While FDA established shorter records 

retention requirements for records 

related to perishable foods in the BT 

records, seafood HACCP, and juice 

HACCP regulations, in this case 

Congress determined and specified in 

section 418(g) of the FD&C Act that the 

minimum retention period for the 

majority of the records required under 

proposed part 117 for all foods, 

regardless of perishability, is 2 years. 

Therefore, FDA tentatively concludes 

that the same requirement should apply 

to all records required under this 

section, regardless of the perishability of 

the food to which the record relates. 

This would simplify plants’ or facilities’ 

duties in compliance because there 

would only be one 2-year retention 

period to apply to any record required 

under proposed part 117. This 2-year 

retention period would run either from 

the date the record was prepared, for 

day-to-day operational records; or from 

the date at which use of the record is 

discontinued, for records relating to the 

general adequacy or equipment or 

processes (e.g., the written food safety 

plan and records that document 

validation of the written food safety 

plan). We seek comment on this 

proposal. 

2. Proposed § 117.315(c) 

Proposed § 117.315(c) would provide 

that, except for the food safety plan, use 

of offsite storage for records is permitted 

after 6 months following the date that 

the record was made if such records can 

be retrieved and provided onsite within 

24 hours of request for official review. 

The food safety plan would be required 

to remain onsite. FDA realizes that the 

proposed requirements for 

recordkeeping could require some 

plants or facilities to store a significant 

quantity of records, and that there may 

not be adequate storage space in the 

plant or facility for all of these records. 

Providing for offsite storage of most 

records after 6 months would enable a 

facility to comply with the proposed 

requirements for record retention while 

reducing the amount of space needed 

for onsite storage of the records without 

interfering with the purpose of record 

retention, because the records will be 

readily available. 

Proposed § 117.315(c) also would 

provide that electronic records are 

considered to be onsite if they are 

accessible from an onsite location. 

Computerized systems within 

corporations can be networked, 

allowing for the sending and receiving 

of information in a secure fashion to all 

of the different food processing facilities 

of that corporation worldwide. This 

type of system can be used to provide 

access at multiple locations to records 

from multiple plants or facilities. 

Proposed § 117.315(c) is consistent 

with our HACCP regulations for seafood 

and juice. Our HACCP regulation for 

seafood provides for transfer of records 

if record storage capacity is limited on 

a processing vessel or at a remote 

processing site, if the records could be 

immediately returned for official review 

upon request (§ 123.9(b)(3)). Our 

HACCP regulation for juice permits 

offsite storage of processing records after 

6 months following the date that the 

monitoring occurred, if such records can 

be retrieved and provided onsite within 

24 hours of request for official review 

and considers electronic records to be 

onsite if they are accessible from an 

onsite location (§ 120.12(d)(2)). 

3. Proposed § 117.315(d) 

Proposed § 117.315(d) would provide 

that if the plant or facility is closed for 

a prolonged period, the records may be 

transferred to some other reasonably 

accessible location but must be returned 

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to the plant or facility within 24 hours 

for official review upon request. 

Allowing for transfer of records will 

give practical storage relief to seasonal 

operations or those closed for other 

reasons for prolonged periods. Proposed 

§ 117.315(d) is consistent with our 

HACCP regulations for seafood and 

juice, which provide for transfer of 

records for facilities closed for 

prolonged periods (between seasonal 

packs, in the case of juice) if the records 

could be immediately returned for 

official review upon request 

(§ 123.9(b)(3) and 120.12(d)(3) for 

seafood and juice, respectively). 

F. Proposed § 117.320—Requirements 

for Official Review 

Proposed § 117.320 would require 

that all records required by proposed 

part 117 be made promptly available to 

a duly authorized representative of the 

Secretary of Health and Human Services 

upon oral or written request. Proposed 

§ 117.320 implements subsection 418(h) 

of the FD&C Act and is necessary in 

order for FDA to determine compliance 

with the requirements of proposed part 

117. Proposed § 117.320 is consistent 

with our HACCP regulations for seafood 

and juice, which require that all records 

required under those rulemakings be 

available for review and copying at 

reasonable times (§§ 123.9(c) and 

120.12(e), respectively). 

Proposed § 117.320 does not 

explicitly require a facility to send 

records to the agency rather than 

making the records available for review 

at a facility’s place of business. FDA 

requests comment on whether proposed 

§ 117.320 should be modified to 

explicitly address this circumstance, 

and if so, whether FDA should require 

that the records be submitted 

electronically. Obtaining a facility’s 

food safety plan without going to a 

facility could be useful to FDA in a 

number of different circumstances, such 

as to determine whether a recently 

identified hazard is being addressed by 

affected facilities. 

G. Proposed § 117.325—Public 

Disclosure 

Proposed § 117.325 would establish 

that all records required by proposed 

part 117 are subject to the disclosure 

requirements under part 20 of this 

chapter. FDA’s regulations in 21 CFR 

part 20, the Freedom of Information Act 

(FOIA) [5 U.S.C. 552], the Trade Secrets 

Act [18 U.S.C. 1905], and the FD&C Act 

govern FDA’s disclosures of 

information, including treatment of 

commercial confidential information 

(CCI) and trade secret information. Our 

general policies, procedures, and 

practices relating to the protection of 

confidential information received from 

third parties would apply to information 

received under this rule. 

Proposed § 117.325 is consistent with, 

but framed differently than, the 

disclosure provisions of the HACCP 

regulations for seafood and juice 

(§§ 123.9(d) and 120.12(f), respectively). 

Proposed § 117.325 is framed similarly 

to the disclosure provisions for records 

that must be kept under part 118 

(Prevention of Salmonella Enteritidis in 

Shell Eggs During Production) (the shell 

egg production rule). Under § 118.10(f), 

records required by part 118 are subject 

to the disclosure requirements under 

part 20. 

XVI. FSMA’s Rulemaking Provisions 

A. Requirements in Section 418(n)(3) of 

the FD&C Act Regarding Content 

1. Requirements of Section 418 of the 

FD&C Act 

Section 418(n)(3) of the FD&C Act 

specifies that the regulations 

promulgated under section 418(n)(1)(A) 

shall: 

• ‘‘(A) provide sufficient flexibility to 

be practicable for all sizes and types of 

facilities, including small businesses 

such as a small food processing facility 

co-located on a farm;’’ 

• ‘‘(B) comply with chapter 35 of title 

44, United States Code (commonly 

known as the ‘Paperwork Reduction 

Act’), with special attention to 

minimizing the burden (as defined in 

section 3502(2) of such Act) on the 

facility, and collection of information 

(as defined in section 3502(3) of such 

Act), associated with such regulations;’’ 

• ‘‘(C) acknowledge differences in 

risk and minimize, as appropriate, the 

number of separate standards that apply 

to separate foods; and’’ 

• ‘‘(D) not require a facility to hire a 

consultant or other third party to 

identify, implement, certify, or audit 

prevent[ive] controls, except in the case 

of negotiated enforcement resolutions 

that may require such a consultant or 

third party.’’ 

2. Section 418(n)(3)(A) 

Implementing section 418 through 

this proposed rule would provide 

sufficient flexibility to be practicable for 

all sizes and types of facilities. As 

discussed in sections II.C and XII of this 

document, subpart C of the proposed 

rule (and related requirements) are 

consistent with HACCP principles. Like 

HACCP, the preventive controls system 

proposed in this document would 

provide flexibility for facilities to tailor 

their food safety plans to their specific 

foods and operating conditions. This 

proposal would allow facilities to 

establish only those preventive controls 

that are applicable to their 

circumstances, and to choose among 

multiple options wherever there are 

different ways to significantly minimize 

or prevent a hazard that is reasonably 

likely to occur. 

In addition, the specific provisions of 

proposed subpart C (and related 

requirements) have been designed to 

maximize their flexibility and 

practicability wherever it is possible to 

do so consistently with the 

requirements of section 418 of the FD&C 

Act. For example: 

• As discussed in section XII.A.2 of 

this document, proposed § 117.126(a) 

would provide flexibility for the owner, 

operator, or agent in charge of the 

facility to either prepare the written 

food safety plan or have that plan 

prepared, in whole or in part, on its 

behalf. 

• As discussed in section XII.A.3 of 

this document, proposed § 117.126 

would allow facilities to group food 

types or production method types if the 

hazards, control measures, parameters, 

and required procedures such as 

monitoring are essentially identical and, 

thus, would provide flexibility for 

facilities in the development of their 

food safety plans. 

• As discussed in section XII.C of this 

document, proposed § 117.135 would 

provide flexibility with regard to 

preventive controls by allowing 

flexibility to establish the parameters 

and the maximum/minimum values for 

the selected control. 

• As discussed in section XII.C.2 of 

this document, for process controls, 

food allergen controls, sanitation 

controls, and other controls, a facility 

would have the flexibility to identify 

and implement preventive controls from 

among all procedures, practices, and 

processes available to it that would 

provide the assurances that would be 

required by proposed § 117.135(a). 

• As discussed in section XII.H of this 

document, proposed § 117.155(b) would 

provide flexibility for the qualified 

individual to be either an employee of 

the facility or an individual not 

employed by the facility (such as 

individuals associated with universities, 

trade associations, and consulting 

companies). Proposed § 117.155(b) 

would also provide flexibility for the 

qualified individual to be qualified 

either through training or job 

experience. 

• As discussed in section XV.C.1 of 

this document, proposed § 117.305(a) 

would provide flexibility for 

mechanisms for keeping records while 

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3784 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

maintaining the integrity of the 

recordkeeping system. 

• As discussed in section XV.C.3 of 

this document, proposed § 117.305(e) 

would provide flexibility to facilities to 

tailor the amount of detail in their 

records to the amount necessary to 

provide a history of the work performed. 

Section 418(m) of the FD&C act also 

provides us with the authority to 

exempt certain facilities from the 

requirements of section 418, or to 

modify those requirements. As 

discussed in section X.C.9 of this 

document, we propose to use this 

authority to exempt facilities that solely 

engage in the storage or raw agricultural 

commodities, other than fruits and 

vegetables, intended for further 

distribution or processing (§ 117.5(j)). 

As discussed in sections X.D and XII.B 

of this document, we also propose to 

establish modified requirements for 

facilities solely engaged in the storage of 

packaged food that is not exposed to the 

environment under this authority 

(proposed §§ 117.7 and 117.206). These 

proposed modified requirements are 

specifically designed to be targeted to 

the specific circumstances of such 

facilities and therefore to be practicable 

for such facilities. 

We are also proposing to define the 

terms ‘‘small business’’ and ‘‘very small 

business’’ in proposed § 117.3. As 

discussed in sections VII, X.C.1, and 

X.C.6 of this document, the proposed 

rule provides flexibility for small and 

very small businesses in multiple ways. 

These special provisions based on 

business size enhance the flexibility of 

the proposed rule for businesses of all 

sizes. First, FDA proposes to allow 

small and very small businesses more 

time to come into compliance with 

Section 418 after the effective date of 

the rule (2 years and 3 years after the 

date of publication of the final rule, 

respectively). FDA expects that this 

would assist small and very small 

businesses in making changes that 

would be required for compliance. 

Second, FDA is proposing two 

exemptions from proposed subpart C 

that would be available in part based on 

business size. The proposed exemption 

for qualified facilities in § 117.5(a) 

would be available to very small 

businesses, and to certain other 

businesses based in part on business 

size, as set forth in that proposed 

section. Qualified facilities would be 

subject instead to the modified 

requirements in proposed § 117.201, 

which themselves provide significant 

flexibility. For example, proposed 

§ 117.201(a) would not specify the form 

of documentation required for a 

qualified facility to show that it is in 

fact a qualified facility, or to 

demonstrate its own hazard analysis 

and preventive control system or 

compliance with state, local, county, or 

other applicable non-Federal law. 

Instead, FDA is proposing to accept selfcertification of compliance with these 

requirements, provided that facilities 

retain the documentation on which they 

rely and make such documentation 

available to FDA upon request 

(§ 117.201(e) and related requirements 

in proposed subpart F). 

In addition, under section 103(c) of 

FSMA, we have conducted a qualitative 

risk assessment of certain on-farm 

activities. Based on that qualitative risk 

assessment, as discussed in section 

X.C.6 of this document, we are 

proposing to exempt facilities that are 

small or very small businesses engaged 

only in certain low-risk activity/food 

combinations from the requirements of 

section 418. We have identified a 

significant number of activity/food 

combinations that we would consider to 

be low-risk when conducted on-farm by 

small and very small businesses, set 

forth in the proposed exemption in 

§ 117.5(g) and (h). 

Finally, as discussed in section VII of 

this document, FDA is proposing to 

begin enforcement of section 418 of the 

FD&C Act for all facilities subject to that 

section only after providing a sufficient 

time period following publication of the 

final rule for facilities to come into 

compliance. Specifically, FDA is 

proposing that businesses would be 

required to comply with the final rule 

1 year after its publication in the 

Federal Register. Further, FDA is 

proposing to allow one additional year 

for small businesses and two additional 

years for very small businesses to come 

into compliance with the final rule. 

Providing additional time for businesses 

to comply, with the most time given to 

the smallest businesses, helps to make 

the regulation practicable for all sizes of 

facilities. 

3. Section 418(n)(3)(B) 

In implementing section 418 through 

this proposed rule, FDA has complied 

with chapter 35 of title 44, United States 

code (commonly known as the 

‘Paperwork Reduction Act’ (PRA)), with 

special attention to minimizing the 

burden (as defined in section 3502(2) of 

such Act (44 U.S.C. 3502(2))) on the 

facility, and collection of information 

(as defined in section 3502(3) of such 

Act (44 U.S.C. 3502(3))), associated with 

the proposed rule. Under section 

3502(2) of the PRA, ‘‘burden’’ means 

‘‘time, effort, or financial resources 

expended by persons to generate, 

maintain, or provide information to or 

for a Federal agency.’’ Under section 

3502(3) of the PRA, ‘‘collection of 

information’’ means, in relevant part, 

‘‘the obtaining, causing to be obtained, 

soliciting, or requiring the disclosure to 

third parties or the public, of facts or 

opinions by or for an agency, regardless 

of form or format, calling for * * * 

answers to identical questions posed to, 

or identical reporting or recordkeeping 

requirements imposed on, ten or more 

persons* * *.’’ 

In section XVII of this document, we 

discuss how this proposed rule 

complies with the requirements of the 

PRA. In addition, in implementing 

section 418 of the FD&C Act, we have 

paid special attention to minimizing 

burden and collection of information 

associated with the proposed rule. 

As discussed immediately above in 

section XVI.A.2, we are proposing 

requirements that provide significant 

flexibility for different sizes and types of 

facilities. By making these requirements 

flexible enough to be practicable for 

different sizes and types of facilities, the 

proposed rule also avoids creating 

unnecessary information collection 

burden for facilities, because facilities 

should be able to tailor their 

recordkeeping to their specific 

circumstances while still complying 

with the requirements of the proposed 

rule. 

In addition, the only requirements we 

are proposing that constitute collections 

of information are those that are 

necessary to meet the requirements of 

section 418 of the FD&C Act and to 

efficiently enforce that section. Section 

418 requires facilities to establish and 

maintain certain records, such as the 

written food safety plan (sections 

418(b)(3) and 418(h)), records of 

monitoring of preventive controls 

(section 418(g)), records of instances of 

nonconformance material to food safety 

(section 418(g)), records of the results of 

testing and other appropriate means of 

verification (section 418(g)), records of 

implementation of corrective actions 

(section 418(g)), and records of the 

efficacy of preventive controls and 

corrective actions (section 418(g)). 

Section 418(h) also requires facilities to 

make those records promptly available 

to FDA upon request. In this proposed 

rule, FDA has interpreted these 

requirements in a manner calculated to 

minimize the associated burden and to 

minimize recordkeeping requirements 

beyond those explicitly provided for by 

the statute to those that are essential to 

implementation and enforcement of 

section 418. For example: 

• As discussed in section XII.A.3 of 

this document, FDA is proposing to 

interpret section 418(h) not to require 

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written procedures for conducting a 

hazard analysis or written procedures 

for establishing preventive controls, 

thereby avoiding unnecessary 

recordkeeping burden. 

• As discussed in section XII.A.2 of 

this document, proposed § 117.126 

would allow facilities to group food 

types or production method types if the 

hazards, control measures, parameters, 

and required procedures such as 

monitoring are essentially identical and, 

thus, would minimize the number of 

different documents that need to be 

included in the food safety plan and the 

recordkeeping burden associated with 

that plan. 

• As discussed in section XII.C.7 of 

this document, FDA is proposing that 

written corrective action procedures 

would not be required for sanitation 

deviations when the owner, operator, or 

agent in charge of a facility takes 

corrective action in accordance with 

proposed § 117.135(d)(3)(iii), because 

there would be little benefit in requiring 

written corrective action procedures for 

the many sanitation deviations that 

could occur for which the corrective 

actions that would need to be taken are 

very general. 

• As discussed in section XII.D.2 of 

this document, proposed § 117.137 

would require facilities to establish 

recall plans only for foods in which 

there is a hazard reasonably likely to 

occur, not for all foods, thereby avoiding 

unnecessary recordkeeping burden. 

• As discussed in section XII.G.6 of 

this document, FDA is proposing to 

require written verification procedures 

only for the frequency of calibration. 

4. Section 418(n)(3)(C) 

In implementing section 418 through 

this proposed rule, FDA is proposing to 

acknowledge differences in risk and 

minimize, as appropriate, the number of 

separate standards that apply to separate 

foods. 

As discussed in section XII.B.2.a of 

this document, proposed § 117.130(a)(1) 

would identify the purpose of the 

hazard analysis—i.e., to determine 

whether there are hazards that are 

reasonably likely to occur. As such, 

there is a single standard that applies to 

all covered foods when determining 

whether preventive controls are 

required. Proposed § 117.130(a)(1) 

would require that the owner, operator, 

or agent in charge of a facility identify 

and evaluate known or reasonably 

foreseeable hazards for each type of food 

manufactured, processed, packed, or 

held at the facility to determine whether 

there are hazards that are reasonably 

likely to occur. If a food presents no 

hazard reasonably likely to occur, no 

preventive controls would need to be 

established. For foods that present 

hazards reasonably likely to occur, 

facilities would be required to establish 

preventive controls in keeping with one 

general set of requirements set forth in 

proposed § 117.135. Thus, proposed 

subpart C simultaneously acknowledges 

differences in risk among foods and 

applies a single standard to all foods 

subject to that subpart. 

In addition, the proposed rule 

acknowledges differences in risk by 

establishing exemptions and modified 

requirements in certain cases. We 

discuss these proposed exemptions and 

modified requirements in sections X.C 

and X.D of this document. The proposed 

rule would exempt all of the following 

from proposed subpart C: qualified 

facilities; activities subject to part 123 

(seafood HACCP) and in compliance 

with that part; activities subject to part 

120 (juice HACCP) and in compliance 

with that part; activities subject to part 

113 (LACF) and in compliance with that 

part with respect to microbiological 

hazards addressed in that part; 

manufacturing, processing, packing, or 

holding of dietary supplements in 

compliance with part 111 (dietary 

supplement CGMPs) and section 761 of 

the FD&C Act (serious adverse event 

reporting); activities subject to section 

419 of the FD&C Act (standards for 

produce safety); on-farm low-risk 

activity/food combinations conducted 

by small or very small businesses 

engaging only in such activities; 

alcoholic beverages and limited 

amounts of non-alcohol prepackaged 

food at alcohol-related facilities; and 

facilities solely engaged in the storage of 

raw agricultural commodities (other 

than fruits and vegetables) intended for 

further distribution or processing. In 

addition, the proposed rule includes 

modified requirements for facilities 

solely engaged in the storage of 

packaged food that is not exposed to the 

environment. The proposed exemptions 

and modified requirements implement 

specific statutory authorities allowing 

for those exemptions and modifications, 

indicating that Congress intended that 

there should be some differences in the 

requirements for certain foods, certain 

facilities, and certain activities, 

depending on risk and on other aspects 

of the regulatory environment. This 

proposed rule strikes what FDA 

considers to be an appropriate balance 

between acknowledging differences in 

risk and minimizing the number of 

separate standards applied to separate 

foods. We seek comments on our 

approach. 

5. Section 418(n)(3)(D) 

This proposed rule would not require 

a facility to hire a consultant or other 

third party to identify, implement, 

certify, or audit preventive controls. As 

discussed in section XII.H of this 

document, proposed § 117.155(a) would 

require that a qualified individual 

conduct (or oversee) certain required 

activities, and proposed § 117.155(b) 

would provide that the qualified 

individual may be, but is not required 

to be, an employee of the facility. FDA 

expects that some facilities may rely on 

assistance from qualified individuals 

that are not employees of the facility, 

such as individuals associated with 

universities, trade associations, and 

consulting companies. The option in 

proposed § 117.155(b) would provide 

flexibility to facilities subject to the rule. 

Providing an option to use a consultant 

or other third party as the qualified 

individual to conduct specific functions 

would not require using a consultant or 

other third party. These proposed 

provisions are merely permissive and 

FDA tentatively concludes that they are 

consistent with the requirements of 

section 418(n)(3)(D) of the FD&C Act. 

B. Requirements in Section 418(n)(5) of 

the FD&C Act Regarding Review of 

Hazard Analysis and Preventive 

Controls Programs in Existence on the 

Date of Enactment of FSMA 

1. Requirements of Section 418 of the 

FD&C Act 

Section 418(n)(5) of the FD&C Act 

specifies that, ‘‘[i]n promulgating the 

regulations [required by section 

418(n)(1)(A) of the FD&C Act], the 

Secretary shall review regulatory hazard 

analysis and preventive control 

programs in existence on the date of 

enactment of [FSMA], including the 

Grade ‘A’ Pasteurized Milk Ordinance to 

ensure that such regulations are 

consistent, to the extent practicable, 

with applicable domestic and 

internationally-recognized standards in 

existence on such date.’’ 

2. Overview of FDA’s Review of Hazard 

Analysis and Preventive Controls 

Programs 

FDA has conducted the review of 

regulatory hazard analysis and 

preventive control programs and 

internationally-recognized standards 

required by section 418(n)(5) of the 

FD&C Act. To do so, we reviewed the 

following domestically recognized 

standards: 

• NACMCF’s ‘‘Hazard Analysis and 

Critical Control Point Principles and 

Application Guidelines’’ (Ref. 34); 

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• FDA’s regulation in part 120 

(Hazard Analysis and Critical Control 

Points (HACCP) Systems) for juice; 

• FDA’s regulation in part 123 (Fish 

and Fishery Products); 

• FSIS’ regulation in 9 CFR 417 

(Hazard Analysis and Critical and 

Control Point (HACCP) systems) for 

meat and poultry products; and 

• The Grade ‘‘A’’ Pasteurized Milk 

Ordinance (PMO), specifically the 

National Conference on Interstate Milk 

Shipments HACCP alternative found in 

Appendix K (the PMO HACCP 

Appendix) (Ref. 37) (Ref. 192). 

We also reviewed the following 

internationally recognized standards: 

• The Codex Annex to the 

Recommended International Code of 

Practice—General Principles of Food 

Hygiene on the Hazard Analysis and 

Critical Control Point (HACCP) System 

and Guidelines for its Application (Ref. 

35); 

• The European Parliament and 

Council of the European Union 

Regulation (EC) No 852/2004 on the 

Hygiene of Foodstuffs (the EU 

regulation) (Ref. 38); 

• The requirements for food safety 

programs in the Australia New Zealand 

Food Standards Code (the FSANZ Code) 

(Ref. 39); and 

• The Canadian Food Inspection 

Agency’s Food Safety Enhancement 

Program (the CFIA FSEP) (Ref. 40). 

We compared the key features of our 

proposed requirements to implement 

section 418 of the FD&C Act (i.e., the 

proposed requirements that would be 

established in subpart C of proposed 

part 117) to the listed domestic and 

international food safety standards. The 

key features we compared are: 

• Requirement for a food safety plan; 

• Requirement for a hazard analysis; 

• Requirement for preventive 

controls, including a requirement for 

control parameters and maximum or 

minimum values; 

• Requirement for a recall plan; 

• Requirement for monitoring 

procedures; 

• Requirement for corrective actions; 

• Requirement for verification 

procedures; 

• Requirements applicable to a 

qualified individual; and 

• Requirement for records. 

The two most widely applied 

guidelines are the NACMCF HACCP 

guidelines and the Codex HACCP 

Annex. As discussed in section II.C.1 of 

this document, the NACMCF HACCP 

guidelines and the Codex HACCP 

Annex evolved over time, and revisions 

that NACMCF made to its 

recommendations in 1992 and 1997 

were patterned after changes made in 

Codex HACCP documents. Thus, the 

NACMCF HACCP guidelines and the 

Codex HACCP Annex are similar in 

their recommendations, although the 

specific wording is not always identical. 

In general, domestic standards are 

patterned after the NACMCF HACCP 

guidelines and the international 

standards are patterned after the Codex 

HACCP Annex. 

As noted in section II.C.2 of this 

document, throughout this document 

we identify the sections of FSMA 

applicable to specific proposed 

provisions and describe how the 

proposed provisions relate to HACCP 

principles as established in the 

NACMCF HACCP guidelines, the Codex 

HACCP Annex and Federal HACCP 

regulations for seafood, juice, and meat 

and poultry. We do not elaborate 

throughout the document on how the 

proposed provisions relate to the PMO 

HACCP Appendix or international 

standards other than the Codex HACCP 

Annex (i.e., the EU regulation, the 

FSANZ Code, and the CFIA FSEP). 

However, for the purpose of the review 

required by section 418(n)(5) of the 

FD&C Act, we discuss all of these 

standards. We also developed a table 

showing how the proposed 

requirements of subpart C compare to 

the listed domestic and international 

food safety standards; that table is a 

reference to this document (Ref. 193). 

In other sections of this document, we 

refer to ‘‘Federal HACCP regulations for 

seafood, juice, and meat and poultry.’’ 

For the purpose of the review required 

by section 418(n)(5) of the FD&C Act, 

we refer to ‘‘domestic’’ regulations 

rather than ‘‘Federal’’ regulations. 

3. Comparison of Preventive Control 

Programs 

a. Requirement for a food safety plan. 

Proposed § 117.126 would require that 

the owner, operator or agent in charge 

of a facility prepare (or have prepared) 

and implement a written food safety 

plan. As discussed in section II.C.3 of 

this document, NACMCF describes five 

preliminary tasks in the development of 

a HACCP plan and seven HACCP 

principles that apply in implementing a 

HACCP plan (Ref. 34). The Codex 

HACCP Annex also describes these five 

preliminary tasks and seven HACCP 

principles, although the specific 

descriptions are not always identical to 

those in the NACMCF HACCP 

guidelines (Ref. 35). The domestically 

recognized standards and all 

international standards except the 

FSANZ Code focus on ‘‘HACCP 

systems’’ to control hazards; the FSANZ 

Code uses the term ‘‘food safety 

program.’’ 

Consistent with the NACMCF HACCP 

guidelines and the Codex HACCP 

Annex, all domestic HACCP regulations 

and the PMO HACCP Appendix require 

that food establishments as specified in 

the regulation or standard operate in 

accordance with the seven HACCP 

principles. All domestic regulations and 

the PMO HACCP Appendix require a 

written HACCP plan (which in this 

proposed regulation is a food safety 

plan) whenever the hazard analysis 

identifies hazards that are reasonably 

likely to occur. The international 

standards require, in general, that food 

establishments as specified in the 

regulation or standard operate in 

accordance with the seven HACCP 

principles as described by Codex. 

FSANZ requires the food safety program 

to be written, and CFIA FSEP requires 

the HACCP plan to be written, but the 

EU regulation has no explicit 

requirement that HACCP plans be 

written. 

Proposed § 117.126 would require a 

written ‘‘food safety plan,’’ the term 

used by FSMA in section 418(h), rather 

than require a ‘‘HACCP plan.’’ Proposed 

§ 117.126 would specify the contents of 

the food safety plan, including the (1) 

written hazard analysis; (2) written 

preventive controls; (3) written 

monitoring procedures; (4) written 

corrective action procedures; (5) written 

verification procedures; and (6) written 

recall plan. The contents of a written 

HACCP plan in domestic HACCP 

regulations are similar but not identical, 

and include the (1) list of hazards; (2) 

CCPs; (3) critical limits; (4) monitoring 

procedures; (5) corrective action 

procedures; (5) verification procedures; 

and (6) record-keeping procedures. The 

PMO HACCP Appendix requires that 

the HACCP plan include process flow 

diagrams (also a requirement in the FSIS 

HACCP regulation for meat and poultry, 

but not included in the contents of the 

HACCP plan). FSANZ requires that the 

food safety program (1) identify hazards; 

(2) identify where hazards can be 

controlled and the means: (3) provide 

for monitoring; (4) provide for corrective 

actions; (5) provide for regular review 

for adequacy; and (6) provide for 

appropriate records of compliance. The 

CFIA FSEP requires that the HACCP 

plan include all relevant information 

needed to conduct the five preliminary 

steps in addition to the seven HACCP 

principles. The EU regulation has no 

explicit requirement for the contents of 

a HACCP plan other than requiring food 

business operators to put in place 

procedures based on the HACCP 

principles. 

b. Requirement for a hazard analysis. 

Proposed § 117.130 would require that a 

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hazard analysis be conducted to identify 

and evaluate known or reasonably 

foreseeable hazards for each type of food 

manufactured, processed, packed, or 

held at the facility to determine those 

hazards reasonably likely to occur. As 

discussed in section XII.B of this 

document, proposed § 117.130 is 

consistent with the NACMCF HACCP 

guidelines and the Codex HACCP 

Annex. Consistent with the NACMCF 

HACCP guidelines and the Codex 

HACCP Annex, all domestic HACCP 

regulations, the PMO HACCP Appendix, 

and international standards require that 

a hazard analysis be conducted. 

Domestic HACCP regulations specify 

that the outcome is to determine the 

hazards reasonably likely to occur for 

the product being produced, which is 

consistent with the FSANZ requirement 

that a food business identify the 

potential hazards that may be 

reasonably expected to occur in all food 

handling operations. This outcome is 

implied by the EU regulation, which 

requires identifying any hazards that 

must be prevented, eliminated or 

reduced to acceptable levels. 

c. Requirement for preventive 

controls, including a requirement for 

control parameters and maximum or 

minimum values. Proposed § 117.135 

would require that the owner, operator, 

or agent in charge of a facility identify 

and implement preventive controls, 

including at critical control points, if 

any, to provide assurances that hazards 

identified in the hazard analysis as 

reasonably likely to occur will be 

significantly minimized or prevented. 

Proposed § 117.135 also would require 

that preventive controls include, as 

appropriate to the facility and the food, 

parameters associated with the control 

of the hazard and the maximum or 

minimum value, or combination of 

values, to which any physical, 

biological, radiological, or chemical 

parameter must be controlled to 

significantly minimize or prevent a 

hazard that is reasonably likely to occur. 

As discussed in section XII.C of this 

document, proposed § 117.135 is 

consistent with the NACMCF HACCP 

guidelines and the Codex HACCP 

Annex. Consistent with the NACMCF 

HACCP guidelines, all domestic HACCP 

regulations and the PMO HACCP 

Appendix require the inclusion of CCPs 

and critical limits in the HACCP plan to 

control hazards that are identified as 

reasonably likely to occur. Consistent 

with the Codex HACCP Annex, the 

CFIA FSEP and the EU regulation also 

require the inclusion of CCPs and 

critical limits in the HACCP plan. 

FSANZ requires the identification of 

where, in a food handling operation, 

each hazard can be controlled, without 

referring to these as CCPs, and the 

means of control, but does not specify 

the establishment of critical limits. 

d. Requirement for a recall plan. 

Proposed § 117.137 would require that a 

recall plan be established for food in 

which there is a hazard that is 

reasonably likely to occur. The CFIA 

FSEP provides for recall plans as a 

prerequisite program in the HACCP 

system. None of the other domestic or 

international standards include a 

provision for a recall plan as part of 

HACCP requirements. Although not part 

of the Codex HACCP Annex, the Codex 

GPFH specify that managers should 

ensure effective procedures are in place 

to deal with any food safety hazard and 

to enable the complete, rapid recall of 

any implicated lot of the finished food 

from the market (Ref. 44). 

e. Requirement for monitoring 

procedures. Proposed § 117.140 would 

require that the owner, operator, or 

agent in charge of a facility establish 

and implement written procedures, 

including the frequency with which 

they are to be performed, for monitoring 

the preventive controls. As discussed in 

section XII.E of this document, 

proposed § 117.140 is consistent with 

the NACMCF HACCP guidelines and 

the Codex HACCP Annex. Consistent 

with the NACMCF HACCP guidelines, 

all domestic HACCP regulations and the 

PMO HACCP Appendix require 

monitoring procedures (and the 

frequency) for CCPs to ensure 

compliance with critical limits. 

Consistent with the Codex HACCP 

Annex, international standards require 

monitoring, although Codex does not 

specify that the monitoring system 

include the frequency of monitoring. 

The EU regulation requires establishing 

and implementing effective monitoring 

procedures at CCPs. The CFIA FSEP 

requires documented monitoring 

procedures for each CCP and these must 

specify any tests, measurements or 

observations to assess whether the 

control measure is functioning as 

intended and the critical limits are met. 

FSANZ requires that the food safety 

program provide for the systematic 

monitoring of controls. 

f. Requirement for corrective actions. 

Proposed § 117.145 would require that 

the owner, operator, or agent in charge 

of a facility establish and implement 

written corrective action procedures 

that must be taken if preventive controls 

are not properly implemented. As 

discussed in section XII.F of this 

document, proposed § 117.145 is 

consistent with the NACMCF HACCP 

guidelines and the Codex HACCP 

Annex. Consistent with the NACMCF 

HACCP guidelines, all domestic HACCP 

regulations and the PMO HACCP 

Appendix require establishing 

corrective actions (or corrective action 

plans) for deviations from established 

critical limits. Proposed § 117.145 also 

would require that corrective actions be 

taken if a preventive control is not 

properly implemented and a specific 

corrective action procedure has not been 

established, or a preventive control is 

found to be ineffective. This provision 

of proposed § 117.145 is consistent with 

corresponding requirements in domestic 

HACCP regulations for corrective 

actions when there is no corrective 

action plan for a specific deviation. 

Consistent with the Codex HACCP 

Annex, international standards require 

corrective actions. The EU regulation 

and the CFIA FSEP require establishing 

corrective actions when monitoring 

indicates that a critical control point is 

not under control. FSANZ requires that 

the food safety program provide for 

appropriate corrective action when the 

hazard is found not to be under control. 

However, only the CFIA FSEP requires 

that documented deviation procedures 

specify any planned or appropriate 

corrective actions to be taken when 

monitoring results demonstrate that the 

control measure is not functioning as 

intended or; the critical limits are not 

met. 

g. Requirement for verification 

procedures. Proposed § 117.150 would 

require that the owner, operator, or 

agent in charge of a facility establish 

specific verification and validation 

procedures and activities. As discussed 

in section XII.G of this document, 

proposed § 117.150 is consistent with 

the NACMCF HACCP guidelines and 

the Codex HACCP Annex. Consistent 

with the NACMCF HACCP guidelines, 

domestic HACCP regulations and the 

PMO HACCP Appendix require a list of 

the verification procedures (including 

validation in the HACCP regulation for 

juice and the PMO HACCP Appendix), 

and the frequency of performing these 

procedures. Consistent with the Codex 

HACCP Annex, international standards 

(except FSANZ) require the 

establishment of verification 

procedures. The EU regulation requires 

procedures to verify that the HACCP 

system is working effectively and the 

CFIA FSEP requires documentation of 

verification procedures. FSANZ does 

not specifically require verification 

procedures but requires that the food 

safety program provide for the regular 

review of the program by the food 

business to ensure its adequacy. 

In addition to validation, proposed 

§ 117.150 would require specific 

verification activities, i.e., calibration of 

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3788 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

process monitoring instruments and 

verification instruments; records review; 

and reanalysis. Several of these 

requirements are found in domestic 

standards. All domestic HACCP 

regulations and the PMO HACCP Annex 

require calibration of monitoring 

instruments. All domestic HACCP 

regulations and the PMO HACCP 

Appendix require record review as a 

verification activity, and all provide for 

an annual reanalysis; both of these are 

specified by the NACMCF guidelines as 

verification activities. Other than the 

FSANZ requirement that the food safety 

program provide for the regular review 

of the program to ensure its adequacy, 

the only international standard that 

provides specific verification activities 

is the CFIA FSEP, which requires 

observation of monitoring and 

corrective actions (which is also a 

requirement of the FSIS HACCP 

regulation for meat and poultry) and 

records review. 

h. Requirements applicable to a 

qualified individual. Proposed § 117.155 

would establish the requirements 

applicable to a qualified individual. We 

use the term ‘‘qualified individual’’ to 

refer to an individual who is qualified 

by training or job experience to conduct 

certain food safety activities as would be 

specified in proposed subpart C. As 

discussed in section XII.H of this 

document, proposed § 117.155 is 

consistent with the NACMCF HACCP 

guidelines, the Codex HACCP Annex, 

and Federal HACCP regulations for 

seafood, juice, and meat and poultry. 

Proposed § 117.155 is also consistent 

with the PMO HACCP Appendix, in 

which only a person who has met 

certain qualifications (i.e., through 

specific training) can carry out certain 

requirements related to the HACCP 

system. The NACMCF HACCP 

guidelines stress the importance of 

ensuring that individuals have 

appropriate training to develop and 

maintain the HACCP system. Similarly, 

the Codex HACCP Annex emphasizes 

that training is essential for effective 

implementation of HACCP. The EU 

regulation requires ‘‘food business 

operators’’ to ensure that those 

responsible for the development and 

maintenance of procedures based on the 

HACCP principles have received 

adequate training in the application of 

the HACCP principles. The CFIA FSEP 

requires that the individuals responsible 

for monitoring, deviation and 

verification procedures have received 

adequate training. 

i. Requirement for records. Proposed 

§ 117.175 would list the records that 

would required for proposed subpart C, 

including the food safety plan, records 

that document the monitoring of 

preventive controls, records that 

document corrective actions, records 

that document verification activities, 

and records that document applicable 

training for the qualified individual. 

Proposed § 117.175 is consistent with 

the requirements for records in the 

NACMCF HACCP guidelines, all 

domestic HACCP regulations and the 

PMO HACCP Appendix, which require 

records to include the hazard analysis, 

HACCP plan, and records of monitoring, 

corrective actions and verification 

activities. The Codex HACCP Annex 

also specifies documentation, including 

the hazard analysis and CCP and critical 

limit determination, and records for 

monitoring, corrective actions and 

verification procedures. The EU 

regulation requires records to 

demonstrate the effective application of 

the HACCP measures. Similarly, FSANZ 

requires that the food safety program 

provide for appropriate records to be 

made and kept by the food business 

demonstrating action taken in relation 

to, or in compliance with, the food 

safety program. The CFIA FSEP requires 

record keeping to demonstrate the 

effective application of the critical 

control points and to facilitate official 

verifications by the CFIA or other 

competent authority. 

Proposed subpart F would establish 

requirements that apply to the required 

records, including requirements for 

records to be accurate and to include 

specific information and for record 

retention. These record-keeping 

requirements are consistent with the 

requirements for records in all domestic 

HACCP regulations, but such details are 

not found in international standards 

other than the CFIA FSEP. 

XVII. Proposed Removal of 21 CFR Part 

110—Current Good Manufacturing 

Practice in Manufacturing, Packing, or 

Holding Human Food 

Proposed part 117 would replace 

current part 110. Therefore, we are 

proposing to remove current part 110 

after the compliance date for all 

businesses to be in compliance with the 

requirements of new part 117. As 

discussed in section VII of this 

document, we are proposing that 

businesses would be required to comply 

with new part 117 1, 2, or 3 years after 

the date of publication of the final rule 

establishing part 117, depending on the 

size of the business. Thus, we are 

proposing to remove part 110, 3 years 

after the date of publication of the final 

rule. 

XVIII. Proposed Conforming 

Amendments 

Several current regulations refer to the 

requirements of part 110. FDA is 

proposing a series of amendments so 

that these current regulations would 

refer to part 117 as well as part 110. We 

also are proposing that when part 110 is 

removed, all references to part 110 be 

removed from our regulations. The 

affected regulations are: 

• § 106.100(j) and (n) (infant formula 

records); 

• § 114.5 (current good manufacturing 

practice for acidified foods); 

• §§ 120.3, 120.5, and 120.6(b) 

(definitions, current good 

manufacturing practice, and sanitation 

standard operating procedures for juice 

products subject to the HACCP 

regulation for juice); 

• §§ 123.3, 123.5(a), and 123.11(b) 

(definitions, current good 

manufacturing practice, and sanitation 

control procedures for fish and fishery 

products subject to the HACCP 

regulation for seafood); 

• § 129.1 (current good manufacturing 

practice for the processing and bottling 

of bottled drinking water); 

• § 179.25(a) (general provisions for 

food irradiation); and 

• § 211.1(c) (scope of current good 

manufacturing practice for finished 

pharmaceuticals). 

XIX. Preliminary Regulatory Impact 

Analysis 

A. Overview 

FDA has examined the impacts of this 

proposed rule under Executive Order 

12866, Executive Order 13563, the 

Regulatory Flexibility Act (5 U.S.C. 

601–612), and the Unfunded Mandates 

Reform Act of 1995 (Pub. L. 104–4). 

Executive Orders 12866 and 13563 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, when regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety, 

and other advantages; distributive 

impacts; and equity). FDA has 

developed a preliminary regulatory 

impact analysis (PRIA) that presents the 

benefits and costs of this proposed rule 

(Ref. 194). FDA believes that the 

proposed rule will be a significant 

regulatory action as defined by 

Executive Order 12866. FDA requests 

comments on the PRIA. 

The summary analysis of benefits and 

costs included in this document is 

drawn from the detailed PRIA (Ref. 194) 

which is available at http:// 

www.regulations.gov (enter Docket No. 

mstockstill on DSK4VPTVN1PROD with 

Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 3789 

FDA–2011–N–0920), and is also 

available on FDA’s Web site at http:// 

www.fda.gov/AboutFDA/ 

ReportsManualsForms/Reports/ 

EconomicAnalyses/default.htm. 

B. Regulatory Flexibility Act 

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because many small businesses 

will need to implement a number of 

new preventive controls, FDA 

acknowledges that the final rules 

resulting from this proposed rule will 

have a significant economic impact on 

a substantial number of small entities. 

C. Small Business Regulatory 

Enforcement Fairness Act of 1996 

The Small Business Regulatory 

Enforcement Fairness Act of 1996 (Pub. 

L. 104–121) defines a major rule for the 

purpose of congressional review as 

having caused or being likely to cause 

one or more of the following: An annual 

effect on the economy of $100 million 

or more; a major increase in costs or 

prices; significant adverse effects on 

competition, employment, productivity, 

or innovation; or significant adverse 

effects on the ability of United Statesbased enterprises to compete with 

foreign-based enterprises in domestic or 

export markets. In accordance with the 

Small Business Regulatory Enforcement 

Fairness Act, the Office of Management 

and Budget (OMB) has determined that 

this proposed rule is a major rule for the 

purpose of congressional review. 

D. Unfunded Mandates Reform Act of 

1995 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $136 

million, using the most current (2010) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA expects that the 

proposed rule will result in a 1-year 

expenditure that would exceed this 

amount. 

E. Paperwork Reduction Act of 1995 

This proposed rule contains 

information collection provisions that 

are subject to review by OMB under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). The collections of 

information in the proposed rule have 

been submitted to OMB for review 

under Section 3507(d) of the Paperwork 

Reduction Act of 1995. FDA invites 

comments on: (1) Whether the proposed 

collection of information is necessary 

for the proper performance of FDA’s 

functions, including whether the 

information will have practical utility; 

(2) the accuracy of FDA’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) ways to enhance the quality, utility, 

and clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

To ensure that comments on 

information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

title Current Good Manufacturing 

Practice And Hazard Analysis And RiskBased Preventive Controls For Human 

Food. 

In compliance with the Paperwork 

Reduction Act of 1995 (44 U.S.C. 

3407(d)), the Agency has submitted the 

information collection provisions of this 

proposed rule to OMB for review. These 

requirements will not be effective until 

FDA obtains OMB approval. FDA will 

publish a notice concerning OMB 

approval of these requirements in the 

Federal Register. 

F. Public Access to the Analyses 

The analyses that FDA has performed 

in order to examine the impacts of this 

proposed rule under Executive Order 

12866, Executive Order 13563, the 

Regulatory Flexibility Act (5 U.S.C. 

601–612), the Unfunded Mandates 

Reform Act of 1995 (Pub. L. 104–4), and 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520) are available to 

the public in the docket for this 

proposed rule (Ref. 194). 

XX. Analysis of Environmental Impact 

FDA has determined under 21 CFR 

25.30(j) that this action is of a type that 

does not individually or cumulatively 

have a significant effect on the human 

environment. Therefore, neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

XXI. Federalism 

FDA has analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. FDA 

has determined that the proposed rule, 

if finalized, would not contain policies 

that would have substantial direct 

effects on the States, on the relationship 

between the National Government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government. 

Accordingly, the agency tentatively 

concludes that the proposed rule does 

not contain policies that have 

federalism implications as defined in 

the Executive order and, consequently, 

a federalism summary impact statement 

is not required. 

XXII. Comments 

Interested persons may submit either 

written comments regarding this 

document to the Division of Dockets 

Management (see ADDRESSES) or 

electronic comments to http://www/ 

regulations.gov. It is only necessary to 

send one set of comments. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. Received comments may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday, and will be 

posted to the docket at http://www/ 

regulations.gov. 

XXIII. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. (FDA has verified the 

Web site addresses, but FDA is not 

responsible for any subsequent changes 

to the Web sites after this document 

publishes in the Federal Register.) 

1. FDA, ‘‘Food CGMP Modernization — A 

Focus on Food Safety,’’ (http://www.fda.

gov/Food/GuidanceCompliance

RegulatoryInformation/CurrentGood

ManufacturingPracticesCGMPs/

ucm207458.htm), November 2, 2005. 

Accessed and printed on October 14, 

2011. 

2. Shapiro, R. L., C. Hatheway, and D. L. 

Swerdlow, ‘‘Botulism in the United 

States: A Clinical and Epidemiologic 

Review,’’ Annals of Internal Medicine, 

129:221–228, 1998. 

3. FDA, ‘‘Fish and Fishery Products Hazards 

and Controls Guidance, Fourth Edition,’’ 

2011. 

4. FDA, ‘‘Guidance for Industry: Juice 

HACCP Hazards and Controls Guidance 

First Edition; Final Guidance,’’ 2004. 

5. FDA, ‘‘Guidance for Industry: Lead in 

Candy Likely To Be Consumed 

Frequently by Small Children: 

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3790 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

Recommended Maximum Level and 

Enforcement Policy,’’ 2006. 

6. FDA, ‘‘Guidance for Industry: Measures to 

Address the Risk for Contamination by 

Salmonella Species in Food Containing 

a Peanut-Derived Product as an 

Ingredient,’’ 2009. 

7. FDA, ‘‘Compliance Policy Guide Sec. 

527.300 Dairy Products—Microbial 

Contaminants and Alkaline Phosphatase 

Activity,’’ 2010. 

8. FDA, ‘‘Compliance Policy Guide Sec. 

555.300 Foods, Except Dairy Products— 

Adulteration with Salmonella,’’ 1995. 

9. FDA, ‘‘Establishment Inspection Report 

(EIR),’’ (http://www.fda.gov/ICECI/

Inspections/FieldManagementDirectives/

ucm061430.htm), June 7, 2007. Accessed 

and printed on October 17, 2011. 

10. FDA, ‘‘Regulatory Procedures Manual, 

Chapter 4. Advisory Actions,’’ 2010. 

11. FDA, ‘‘Regulatory Procedures Manual, 

Chapter 5. Administrative Actions,’’ 

2011. 

12. FDA, ‘‘Regulatory Procedures Manual, 

Chapter 6. Judicial Actions,’’ 2011. 

13. CDC, ‘‘Foodborne Disease Outbreak 

Surveillance,’’ (http://www.cdc.gov/

outbreaknet/surveillance_data.html), 

September, 2011. Accessed and printed 

on July 19, 2012. 

14. CDC, ‘‘Frequently Asked Questions About 

CDC’s Foodborne Outbreak Online 

Database,’’ (http://www.cdc.gov/ 

outbreaknet/pdf/FAQsonFOOD.pdf), 

December, 2009. Accessed and printed 

on October 14, 2011. 

15. CDC, ‘‘FoodNet—Foodborne Diseases 

Active Surveillance Network,’’ (http:// 

www.cdc.gov/foodnet/), 2012. Accessed 

and printed on July 27, 2012. 

16. CDC, ‘‘Questions and Answers About 

Vital Signs: FoodNet MMWR, 2010,’’ 

(http://www.cdc.gov/foodsafety/vital

signs_questions.html), June 8, 2011. 

Accessed and printed on October 17, 

201. 

17. ‘‘Food Emergency Response Network,’’ 

(http://www.fernlab.org/), 2012. 

Accessed and printed on July 27, 2012. 

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‘‘Welcome to ELEXNET,’’ (https://www.

elexnet.com/portal/server.pt), 2012. 

Accessed and printed on July 27, 2012. 

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www.fda.gov/Safety/Recalls/Major

ProductRecalls/Peanut/default.htm), 

June 18, 2009. Accessed and printed on 

September 9, 2011. 

20. FDA, ‘‘Peanut Butter and Other Peanut 

Containing Products Recall List,’’ 

(http://www.accessdata.fda.gov/scripts/

peanutbutterrecall/index.cfm), October 

28, 2009. Accessed and printed on 

September 9, 2011. 

21. FDA, ‘‘Plainview Milk Cooperative 

Ingredient Recall,’’ (http://www.fda.gov/

Safety/Recalls/MajorProductRecalls/

Milk/default.htm), July 23, 2009. 

Accessed and printed on September 9, 

2011. 

22. FDA, ‘‘Plainview Milk Cooperative 

Ingredient Recall Product List,’’ (http://

www.accessdata.fda.gov/scripts/Milk/), 

July 28, 2009. Accessed and printed on 

September 9, 2011. 

23. FDA, ‘‘Hydrolyzed Vegetable Protein 

Product Recalls,’’ (http://www.fda.gov/

Safety/Recalls/MajorProductRecalls/

HVP/default.htm), December 21, 2011. 

Accessed and printed on July 27, 2012. 

24. FDA, ‘‘Recall: Products Containing 

Hydrolyzed Vegetable Protein,’’ (http://

www.accessdata.fda.gov/scripts/ 

HVPCP/), April 1, 2010. Accessed and 

printed on September 9, 2011. 

25. Council to Improve Foodborne Outbreak 

Response, ‘‘Guidelines for Foodborne 

Disease Outbreak Response,’’ 2009. 

26. FDA, ‘‘State Contracts,’’ (http://www.fda.

gov/ForFederalStateandLocalOfficials/

PartnershipsContracts/StateContracts/

default.htm), 2012. Accessed and printed 

on July 27, 2012. 

27. ‘‘FoodSafety.Gov,’’ (http://www.food

safety.gov/index.html), 2011. Accessed 

and printed on July 27, 2012. 

28. Partnership for Food Safety Education, 

‘‘Fight Bac!’’ (http://www.fightbac.org/), 

2012. Accessed and printed on July 27, 

2012. 

29. FDA, ‘‘Consumers. Food Safety, Nutrition 

Information, and Campaigns,’’ (http://

www.fda.gov/Food/ResourcesForYou/

Consumers/default.htm), 2012. Accessed 

and printed on July 27, 2012. 

30. FDA, ‘‘Health Educators. Food Safety & 

Nutrition Education Campaigns,’’ 

(http://www.fda.gov/Food/ResourcesFor

You/HealthEducators/default.htm), 

2012. Accessed and printed on July 27, 

2012. 

31. FDA Memorandum, ‘‘Consultation with 

USDA on Food Processing Sector 

Study,’’ 2011. 

32. FDA, ‘‘Food Processing Sector Study,’’ 

2011. 

33. FSIS, ‘‘National Advisory Committee on 

Microbiological Criteria for Foods. About 

NACMCF,’’ (http://www.fsis.usda.gov/

About_FSIS/NACMCF_Background/

index.asp), 2010. Accessed and printed 

on December 12, 2011. 

34. National Advisory Committee on 

Microbiological Criteria for Foods, 

‘‘Hazard Analysis and Critical Control 

Point Principles and Application 

Guidelines,’’ Journal of Food Protection, 

61:1246–1259, 1998. 

35. Codex Alimentarius Commission, 

‘‘Hazard Analysis and Critical Control 

Point (HACCP) System and Guidelines 

for Its Application. Annex to CAC/RCP 

1–1969 (Rev. 4—2003),’’ 2003. 

36. National Advisory Committee on 

Microbiological Criteria for Foods, 

‘‘Hazard Analysis and Critical Control 

Point System,’’ International Journal of 

Food Microbiology, 16:1–23, 1992. 

37. FDA, ‘‘Grade ‘‘A’’ Pasteurized Milk 

Ordinance (2011 Revision),’’ 2012. 

38. European Parliament and the Council of 

the European Union, ‘‘Regulation (EC) 

No 852/2004 of the European Parliament 

and of the Council,’’ (http://eur-lex.

europa.eu/LexUriServ/LexUriServ.do?

uri=OJ:L:2004:139:0001:0054:en:PDF), 

April 29, 2004. Accessed and printed on 

December 13, 2011. 

39. Food Standards Australia New Zealand, 

‘‘Standard 3.2.1—Food Safety 

Programs,’’ 2007. 

40. Canadian Food Inspection Agency, ‘‘Food 

Safety Enhancement Program/Hazard 

Analysis Critical Control Points,’’ 

(http://www.inspection.gc.ca/food/fsephaccp/eng/1299855874288/1299859914

238), September 10, 2011. Accessed and 

printed on July 31, 2012. 

41. Global Food Safety Initiative, ‘‘Enhancing 

Food Safety Through Third Party 

Certification,’’ 2011. 

42. World Health Organization, ‘‘Hazard 

Analysis Critical Control Point System 

(HACCP),’’ 2007. 

43. Food and Agriculture Organization, 

‘‘Manual on the Application of the 

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August 13, 1998. Accessed and printed 

on October 17, 2011. 

151. FDA, ‘‘CPG Sec. 560.750 Radionuclides 

in Imported Foods—Levels of Concern,’’ 

2005. 

152. FDA, ‘‘Pistachios and Other Pistachio 

Containing Products Recall List,’’ (http:// 

www.accessdata.fda.gov/scripts/ 

pistachiorecall/index.cfm), June 23, 

2009. Accessed and printed on 

September 9, 2011. 

153. FDA, ‘‘For Consumers: The HVP Recall 

(Updated),’’ (http://www.fda.gov/Food/ 

NewsEvents/WhatsNewinFood/ 

ucm202989.htm), March 24, 2010. 

Accessed and printed on October 14, 

2011. 

154. FDA, ‘‘Pacific Coast Fruit Company 

Voluntarily Recalls Spinach Salad 

Products and Pizza Because of Possible 

Health Risk,’’ (http://www.fda.gov/ 

Safety/Recalls/ArchiveRecalls/2006/ 

ucm112048.htm), September 22, 2006. 

Accessed and printed on October 17, 

2011. 

155. FDA, ‘‘Company Recalls Various 

Products Due to Potential Salmonella 

Contamination. FDA, USDA, CDC 

Investigating; No Link to Human 

Illnesses at This Time,’’ (http:// 

www.fda.gov/NewsEvents/Newsroom/ 

PressAnnouncements/ucm169471.htm), 

June 28, 2009. Accessed and printed on 

September 9, 2011. 

156. FDA, ‘‘Guidance for Industry: Measures 

to Address the Risk for Contamination by 

Salmonella Species in Food Containing 

a Pistachio-Derived Product as an 

Ingredient,’’ 2011. Accessed and printed 

on July 20, 2012. 

157. Wojtala, G., ‘‘Interstate Food 

Transportation Assessment Project,’’ 

(http://www.michigan.gov/documents/ 

mda/truckproj_224450_7.pdf), 2007. 

158. FDA, ‘‘Guidance for Industry: Use of 

Water by Food Manufacturers in Areas 

Subject to a Boil-Water Advisory,’’ 2010. 

Accessed and printed on October 18, 

2011. 

159. FSIS, ‘‘Meat and Poultry Hazards and 

Controls Guide,’’ 2005. 

160. Food and Agriculture Organization and 

World Health Organization, ‘‘Risk 

Assessment of Listeria monocytogenes in 

Ready-to-Eat Foods, Technical Report, 

Part 5. Risk Characterization: Response 

to Codex Questions,’’ 2004. 

161. International Commission on 

Microbiological Specifications for Foods, 

‘‘Staphylococcus aureus,’’ In: 

Microorganisms in Foods 5. 

Characteristics of Microbial Pathogens, 

edited by T. A. Roberts, A. C. BairdParker, and R. B. Tompkin, London, 

Chapter 17, pp. 299–333, Blackie 

Academic & Professional, 1996. 

162. Greig, J. D., E. C. D. Todd, C. A. 

Bartleson, and B. S. Michaels, 

‘‘Outbreaks Where Food Workers Have 

Been Implicated in the Spread of 

Foodborne Disease. Part 1. Description of 

the Problem, Methods and Agents 

Involved,’’ Journal of Food Protection, 

70:1752–1761, 2007. 

163. Todd, E. C. D., J. D. Greig, C. A. 

Bartleson, and B. S. Michaels, 

‘‘Outbreaks Where Food Workers Have 

Been Implicated in the Spread of 

Foodborne Disease. Part 3. Factors 

Contributing to Outbreaks and 

Description of Outbreak Categories,’’ 

Journal of Food Protection, 70:2199– 

2217, 2007. 

164. FDA, ‘‘Industry Guidance. Information 

on Recalls of FDA Regulated Products,’’ 

(http://www.fda.gov/Safety/Recalls/ 

IndustryGuidance/default.htm), 

December 14, 2011. Accessed and 

printed on July 27, 2012. 

165. FDA, ‘‘Model Recall Letter (Generic, All 

Centers),’’ (http://www.fda.gov/ 

downloads/Safety/Recalls/ 

IndustryGuidance/UCM214960.pdf), 

March, 2009. Accessed and printed on 

October 17, 2011. 

166. FDA, ‘‘Recalls, Market Withdrawals, & 

Safety Alerts,’’ (http://www.fda.gov/ 

Safety/Recalls/default.htm), 2012. 

Accessed and printed on July 31, 2012. 

167. FDA, ‘‘Allergens Model Press Release,’’ 

(http://www.fda.gov/Safety/Recalls/ 

mstockstill on DSK4VPTVN1PROD with 

3794 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

IndustryGuidance/ucm129262.htm), May 

31, 2009. Accessed and printed on 

October 17, 2011. 

168. FDA, ‘‘Listeria monocytogenes Model 

Press Release,’’ (http://www.fda.gov/ 

Safety/Recalls/IndustryGuidance/ 

ucm129267.htm), May 31, 2009. 

Accessed and printed on October 17, 

2011. 

169. FDA, ‘‘Salmonella Model Press Release 

(All Serotypes),’’ (http://www.fda.gov/ 

Safety/Recalls/IndustryGuidance/ 

ucm129275.htm), May 31, 2009. 

Accessed and printed on October 17, 

2011. 

170. FDA, ‘‘Model Effectiveness Check Letter 

(Industry),’’ (http://www.fda.gov/ 

downloads/Safety/Recalls/ 

IndustryGuidance/UCM214958.pdf), 

2009. Accessed and printed on October 

17, 2011. 

171. FDA, ‘‘Model Effectiveness Check 

Response Format (Industry),’’ (http:// 

www.fda.gov/downloads/Safety/Recalls/ 

IndustryGuidance/UCM214963.pdf), 

2009. Accessed and printed on October 

17, 2011. 

172. FDA, ‘‘Model Effectiveness Check 

Questionnaire for Telephone or Personal 

Visits (Industry),’’ (http://www.fda.gov/ 

downloads/Safety/Recalls/ 

IndustryGuidance/UCM214971.pdf), 

2009. Accessed and printed on October 

17, 2011. 

173. FDA, ‘‘Fish and Fishery Products 

Hazards and Controls Guidance, Fourth 

Edition. Appendix 4: Bacterial Pathogen 

Growth and Inactivation,’’ 2011. 

174. FDA, ‘‘Food Code 2009,’’ 2009. 

175. National Advisory Committee on 

Microbiological Criteria for Foods, 

‘‘Parameters for Determining Inoculated 

Pack/Challenge Study Protocols,’’ 

Journal of Food Protection, 73:140–202, 

2010. 

176. National Advisory Committee on 

Microbiological Criteria for Foods, 

‘‘Requisite Scientific Parameters for 

Establishing the Equivalence of 

Alternative Methods of Pasteurization,’’ 

Journal of Food Protection, 69:1190– 

1216, 2006. 

177. EPA, ‘‘Pesticide Registration Manual: 

Chapter 4—Additional Considerations 

for Antimicrobial Products,’’ 2011. 

178. FDA and USDA, ‘‘Listeria 

monocytogenes Risk Assessment: I. 

Introduction,’’ (http://www.fda.gov/ 

Food/ScienceResearch/ResearchAreas/ 

RiskAssessmentSafetyAssessment/ 

ucm184052.htm), September, 2003. 

Accessed and printed on October 17, 

2011. 

179. Chen, Y., V. N. Scott, T. A. Freier, J. 

Kuehm, M. Moorman, J. Meyer, T. 

Morille-Hinds, L. Post, L. Smoot, S. 

Hood, J. Shebuski, and J. Banks, ‘‘Control 

of Salmonella in Low-Moisture Foods II: 

Hygiene Practices to Minimize 

Salmonella Contamination and Growth,’’ 

Food Protection Trends, 29:435–445, 

2009. 

180. International Commission on 

Microbiological Specifications for Foods, 

‘‘Sampling Considerations and Statistical 

Aspects of Sampling Plans.,’’ In: 

Microorganisms in Foods 8: Use of Data 

for Assessing Process Control and 

Product Acceptance, edited by K. M. J. 

Swanson, R. L. Buchanan, M. B. Cole, J.- 

L. Cordier, R. S. Flowers, L. G. M. Gorris, 

M. H. Taniwaki, and R. B. Tompkin, 

New York, Appendix A, pp. 355–364, 

Springer, 2011. 

181. International Commission on 

Microbiological Specifications for Foods, 

‘‘Selection of Cases and Attributes 

Plans,’’ In: Microorganisms in Foods 7. 

Microbiological Testing in Food Safety 

Management, edited by R. B. Tompkin, 

L. Gram, T. A. Roberts, R. L. Buchanan, 

M. van Schothorst, S. Dahms, and M. B. 

Cole, New York, Chapter 8, pp. 145–172, 

Kluwer Academic/Plenum Publishers, 

2002. 

182. International Commission on 

Microbiological Specifications for Foods, 

‘‘Sampling Plans,’’ In: Microorganisms in 

Foods 7. Microbiological Testing in Food 

Safety Management, edited by R. B. 

Tompkin, L. Gram, T. A. Roberts, R. L. 

Buchanan, M. van Schothorst, S. Dahms, 

and M. B. Cole, New York, Chapter 7, pp. 

123–143, Kluwer Academic/Plenum 

Publishers, 2002. 

183. Codex Alimentarius Commission, 

‘‘Codex Standard for Natural Mineral 

Waters, CODEX STAN 108–1981,’’ 1981. 

184. Chen, Y., V. N. Scott, T. A. Freier, J. 

Kuehm, M. Moorman, J. Meyer, T. 

Morille-Hinds, L. Post, L. Smoot, S. 

Hood, J. Shebuski, and J. Banks, ‘‘Control 

of Salmonella in Low-Moisture Foods III: 

Process Validation and Environmental 

Monitoring,’’ Food Protection Trends, 

29:493–508, 2009. 

185. Tompkin, R. B., ‘‘Control of Listeria 

monocytogenes in the Food-Processing 

Environment,’’ Journal of Food 

Protection, 65:709–725, 2002. 

186. Scott, V. N., M. Wiedmann, D. Hicks, R. 

Collette, M. L. Jahncke, and K. Gall, 

‘‘Guidelines for Listeria Testing of 

Environmental, Raw Product and 

Finished Product Samples in Smoked 

Seafood Processing Facilities,’’ Food 

Protection Trends, 25:23–34, 2005. 

187. Jarl, D. L. and E. A. Arnold, ‘‘Influence 

of Drying Plant Environment on 

Salmonellae Contamination of Dry Milk 

Products,’’ Journal of Food Protection, 

45:16, 1982. 

188. FDA, ‘‘River Ranch Recalls Products 

Because of Possible Health Risk,’’ 

(http://www.fda.gov/Safety/Recalls/ 

ucm275854.htm), October 13, 2011. 

Accessed and printed on October 26, 

2011. 

189. FDA, ‘‘Taylor Farms Retail Inc. Initiates 

a Precautionary Recall Because of 

Possible Health Risk,’’ (http:// 

www.fda.gov/Safety/Recalls/ 

ucm276459.htm), October 19, 2011. 

Accessed and printed on October 20, 

2011. 

190. FDA, ‘‘Del Bueno Recalls Queso Fresco 

Casero Cheese Because of Possible 

Health Risk,’’ (http://www.fda.gov/ 

Safety/Recalls/ucm272268.htm), 

September 16, 2010. Accessed and 

printed on October 26, 2011. 

191. FDA, ‘‘Food Code 2009: Chapter 3— 

Food,’’ 2009. 

192. FDA, ‘‘Grade ‘‘A’’ Pasteurized Milk 

Ordinance (2011 Revision): Appendix K. 

HACCP Program,’’ 2012. 

193. FDA Memorandum, ‘‘Comparison of 

Proposed Subpart C (Hazard Analysis 

and Risk-Based Preventive Controls) to 

Various Existing Domestic and 

International HACCP Based Standards,’’ 

2012. 

194. FDA, ‘‘Preliminary Regulatory Impact 

Analysis,’’ 2012. 

List of Subjects 

21 CFR Part 1 

Cosmetics, Drugs, Exports, Food 

labeling, Imports, Labeling, Reporting 

and recordkeeping requirements. 

21 CFR Part 16 

Administrative practice and 

procedure. 

21 CFR Part 106 

Food grades and standards, Infants 

and children, Nutrition, Reporting and 

recordkeeping requirements. 

21 CFR Part 110 

Food packaging, Foods. 

21 CFR Part 114 

Food packaging, Foods, Reporting and 

recordkeeping requirements. 

21 CFR Part 117 

Food packaging, Foods. 

21 CFR Part 120 

Foods, Fruit juices, Imports, 

Reporting and recordkeeping 

requirements, Vegetable juices. 

21 CFR Part 123 

Fish, Fishery products, Imports, 

Reporting and recordkeeping 

requirements, Seafood. 

21 CFR Part 129 

Beverages, Bottled water, Food 

packaging, Reporting and recordkeeping 

requirements. 

21 CFR Part 179 

Food additives, Food labeling, Food 

packaging, Radiation protection, 

Reporting and recordkeeping 

requirements, Signs and symbols. 

21 CFR Part 211 

Drugs, Labeling, Laboratories, 

Packaging and containers, Prescription 

drugs, Reporting and recordkeeping 

requirements, Warehouses. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, it is proposed that 

21 CFR chapter 1 be amended as 

follows: 

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Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 3795 

PART 1—GENERAL ENFORCEMENT 

REGULATIONS 

■ 1. The authority citation for 21 CFR 

part 1 continues to read as follows: 

Authority: 15 U.S.C. 1333, 1453, 1454, 

1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 

321, 331, 332, 333, 334, 335a, 343, 350c, 

350d, 352, 355, 360b, 362, 371, 374, 381, 382, 

387, 387a, 387c, 393; 42 U.S.C. 216, 241, 243, 

262, 264. 

■ 2. Section 1.227 is revised to read as 

follows: 

§ 1.227 What definitions apply to this 

subpart? 

The definitions of terms in section 

201 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 321) apply to 

such terms when used in this subpart. 

In addition, for the purposes of this 

subpart: 

Calendar day means every day shown 

on the calendar. 

Facility means any establishment, 

structure, or structures under one 

ownership at one general physical 

location, or, in the case of a mobile 

facility, traveling to multiple locations, 

that manufactures/processes, packs, or 

holds food for consumption in the 

United States. Transport vehicles are 

not facilities if they hold food only in 

the usual course of business as carriers. 

A facility may consist of one or more 

contiguous structures, and a single 

building may house more than one 

distinct facility if the facilities are under 

separate ownership. The private 

residence of an individual is not a 

facility. Nonbottled water drinking 

water collection and distribution 

establishments and their structures are 

not facilities. 

(1) Domestic facility means any 

facility located in any State or Territory 

of the United States, the District of 

Columbia, or the Commonwealth of 

Puerto Rico that manufactures/ 

processes, packs, or holds food for 

consumption in the United States. 

(2) Foreign facility means a facility 

other than a domestic facility that 

manufactures/processes, packs, or holds 

food for consumption in the United 

States. 

Farm means a facility in one general 

physical location devoted to the 

growing and harvesting of crops, the 

raising of animals (including seafood), 

or both. The term ‘‘farm’’ includes: 

(1) Facilities that pack or hold food, 

provided that all food used in such 

activities is grown, raised, or consumed 

on that farm or another farm under the 

same ownership; and 

(2) Facilities that manufacture/process 

food, provided that all food used in 

such activities is consumed on that farm 

or another farm under the same 

ownership. 

Food has the meaning given in section 

201(f) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 321(f)), 

(1) Except for purposes of this 

subpart, it does not include: 

(i) Food contact substances as defined 

in section 409(h)(6) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 

348(h)(6)), or 

(ii) Pesticides as defined in 7 U.S.C. 

136(u). 

(2) Examples of food include: Fruits, 

vegetables, fish, dairy products, eggs, 

raw agricultural commodities for use as 

food or as components of food, animal 

feed (including pet food), food and feed 

ingredients, food and feed additives, 

dietary supplements and dietary 

ingredients, infant formula, beverages 

(including alcoholic beverages and 

bottled water), live food animals, bakery 

goods, snack foods, candy, and canned 

foods. 

Harvesting applies to farms and farm 

mixed-type facilities and means 

activities that are traditionally 

performed by farms for the purpose of 

removing raw agricultural commodities 

from the place they were grown or 

raised and preparing them for use as 

food. Harvesting is limited to activities 

performed on raw agricultural 

commodities on the farm on which they 

were grown or raised, or another farm 

under the same ownership. Harvesting 

does not include activities that 

transform a raw agricultural commodity, 

as defined in section 201(r) of the 

Federal Food, Drug, and Cosmetic Act, 

into a processed food as defined in 

section 201(gg) of the Federal Food, 

Drug, and Cosmetic Act. Gathering, 

washing, trimming of outer leaves of, 

removing stems and husks from, sifting, 

filtering, threshing, shelling, and 

cooling raw agricultural commodities 

grown on a farm or another farm under 

the same ownership are examples of 

harvesting. 

Holding means storage of food. 

Holding facilities include warehouses, 

cold storage facilities, storage silos, 

grain elevators, and liquid storage tanks. 

For farms and farm mixed-type 

facilities, holding also includes 

activities traditionally performed by 

farms for the safe or effective storage of 

raw agricultural commodities grown or 

raised on the same farm or another farm 

under the same ownership, but does not 

include activities that transform a raw 

agricultural commodity, as defined in 

section 201(r) of the Federal Food, Drug, 

and Cosmetic Act, into a processed food 

as defined in section 201(gg) of the 

Federal Food, Drug, and Cosmetic Act. 

Manufacturing/processing means 

making food from one or more 

ingredients, or synthesizing, preparing, 

treating, modifying or manipulating 

food, including food crops or 

ingredients. Examples of 

manufacturing/processing activities are: 

Cutting, peeling, trimming, washing, 

waxing, eviscerating, rendering, 

cooking, baking, freezing, cooling, 

pasteurizing, homogenizing, mixing, 

formulating, bottling, milling, grinding, 

extracting juice, distilling, labeling, or 

packaging. For farms and farm mixedtype facilities, manufacturing/ 

processing does not include activities 

that are part of harvesting, packing, or 

holding. 

Mixed-type facility means an 

establishment that engages in both 

activities that are exempt from 

registration under section 415 of the 

Federal Food, Drug, and Cosmetic Act 

and activities that require the 

establishment to be registered. An 

example of such a facility is a ‘‘farm 

mixed-type facility,’’ which is an 

establishment that grows and harvests 

crops or raises animals and may 

conduct other activities within the farm 

definition, but also conducts activities 

that require the establishment to be 

registered. 

Nonprofit food establishment means a 

charitable entity that prepares or serves 

food directly to the consumer or 

otherwise provides food or meals for 

consumption by humans or animals in 

the United States. The term includes 

central food banks, soup kitchens, and 

nonprofit food delivery services. To be 

considered a nonprofit food 

establishment, the establishment must 

meet the terms of section 501(c)(3) of 

the U.S. Internal Revenue Code (26 

U.S.C. 501(c)(3)). 

Packaging (when used as a verb) 

means placing food into a container that 

directly contacts the food and that the 

consumer receives. 

Packing means placing food into a 

container other than packaging the food. 

For farms and farm mixed-type 

facilities, packing also includes 

activities (which may include 

packaging) traditionally performed by 

farms to prepare raw agricultural 

commodities grown or raised on the 

same farm or another farm under the 

same ownership for storage and 

transport, but does not include activities 

that transform a raw agricultural 

commodity, as defined in section 201(r) 

of the Federal Food, Drug, and Cosmetic 

Act, into a processed food as defined in 

section 201(gg) of the Federal Food, 

Drug, and Cosmetic Act. 

Restaurant means a facility that 

prepares and sells food directly to 

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3796 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

consumers for immediate consumption. 

‘‘Restaurant’’ does not include facilities 

that provide food to interstate 

conveyances, central kitchens, and other 

similar facilities that do not prepare and 

serve food directly to consumers. 

(1) Entities in which food is provided 

to humans, such as cafeterias, 

lunchrooms, cafes, bistros, fast food 

establishments, food stands, saloons, 

taverns, bars, lounges, catering facilities, 

hospital kitchens, day care kitchens, 

and nursing home kitchens are 

restaurants; and 

(2) Pet shelters, kennels, and 

veterinary facilities in which food is 

provided to animals are restaurants. 

Retail food establishment means an 

establishment that sells food products 

directly to consumers as its primary 

function. A retail food establishment 

may manufacture/process, pack, or hold 

food if the establishment’s primary 

function is to sell from that 

establishment food, including food that 

it manufactures/processes, packs, or 

holds, directly to consumers. A retail 

food establishment’s primary function is 

to sell food directly to consumers if the 

annual monetary value of sales of food 

products directly to consumers exceeds 

the annual monetary value of sales of 

food products to all other buyers. The 

term ‘‘consumers’’ does not include 

businesses. A ‘‘retail food 

establishment’’ includes grocery stores, 

convenience stores, and vending 

machine locations. 

Trade name means the name or 

names under which the facility 

conducts business, or additional names 

by which the facility is known. A trade 

name is associated with a facility, and 

a brand name is associated with a 

product. 

U.S. agent means a person (as defined 

in section 201(e) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 

321(e))) residing or maintaining a place 

of business in the United States whom 

a foreign facility designates as its agent 

for purposes of this subpart. A U.S. 

agent cannot be in the form of a 

mailbox, answering machine or service, 

or other place where an individual 

acting as the foreign facility’s agent is 

not physically present. 

(1) The U.S. agent acts as a 

communications link between the Food 

and Drug Administration (FDA) and the 

foreign facility for both emergency and 

routine communications. The U.S. agent 

will be the person FDA contacts when 

an emergency occurs, unless the 

registration specifies under § 1.233(e) 

another emergency contact. 

(2) FDA will treat representations by 

the U.S. agent as those of the foreign 

facility, and will consider information 

or documents provided to the U.S. agent 

the equivalent of providing the 

information or documents to the foreign 

facility. 

(3) Having a single U.S. agent for the 

purposes of this subpart does not 

preclude facilities from having multiple 

agents (such as foreign suppliers) for 

other business purposes. A firm’s 

commercial business in the United 

States need not be conducted through 

the U.S. agent designated for purposes 

of this subpart. 

You or registrant means the owner, 

operator, or agent in charge of a facility 

that manufactures/processes, packs, or 

holds food for consumption in the 

United States. 

■ 3. Section 1.241 is amended by 

revising paragraph (a) to read as follows: 

§ 1.241 What are the consequences of 

failing to register, update, or cancel your 

registration? 

(a) Section 301 of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 331) 

prohibits the doing of certain acts or 

causing such acts to be done. Under 

section 302 of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 332), the 

United States can bring a civil action in 

Federal court to enjoin a person who 

commits a prohibited act. Under section 

303 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 333), the 

United States can bring a criminal 

action in Federal court to prosecute a 

person who is responsible for the 

commission of a prohibited act. Under 

section 306 of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 335a), FDA 

can seek debarment of any person who 

has been convicted of a felony relating 

to importation of food into the United 

States. Failure of an owner, operator, or 

agent in charge of a domestic or foreign 

facility to register its facility, to update 

required elements of its facility’s 

registration, or to cancel its registration 

in accordance with the requirements of 

this subpart is a prohibited act under 

section 301(dd) of the Federal Food, 

Drug, and Cosmetic Act. 

* * * * * 

■ 4. Section 1.276 is amended by 

revising paragraph (b)(9) to read as 

follows: 

§ 1.276 What definitions apply to this 

subpart? 

* * * * * 

(b) * * * 

(9) Manufacturer means the last 

facility, as that word is defined in 

§ 1.227, that manufactured/processed 

the food. A facility is considered the last 

facility even if the food undergoes 

further manufacturing/processing that 

consists of adding labeling or any 

similar activity of a de minimis nature. 

If the food undergoes further 

manufacturing/processing that exceeds 

an activity of a de minimis nature, then 

the subsequent facility that performed 

the additional manufacturing/ 

processing is considered the 

manufacturer. 

* * * * * 

■ 5. Section 1.328 is amended by 

removing the definition for ‘‘Act’’ and 

by alphabetically adding definitions for 

‘‘Harvesting’’, ‘‘Mixed-type facility’’, 

and ‘‘Packing’’, and revising the 

definitions for ‘‘Farm’’, ‘‘Food’’, 

‘‘Holding’’, ‘‘Manufacturing/ 

processing’’, and ‘‘Packaging’’ to read as 

follows: 

§ 1.328 What definitions apply to this 

subpart? 

* * * * * 

Farm means a facility in one general 

physical location devoted to the 

growing and harvesting of crops, the 

raising of animals (including seafood), 

or both. The term ‘‘farm’’ includes: 

(1) Facilities that pack or hold food, 

provided that all food used in such 

activities is grown, raised, or consumed 

on that farm or another farm under the 

same ownership; and 

(2) Facilities that manufacture/process 

food, provided that all food used in 

such activities is consumed on that farm 

or another farm under the same 

ownership. 

Food has the meaning given in section 

201(f) of the Federal Food, Drug, and 

Cosmetic Act. Examples of food include, 

but are not limited to fruits; vegetables; 

fish; dairy products; eggs; raw 

agricultural commodities for use as food 

or as components of food; animal feed, 

including pet food; food and feed 

ingredients and additives, including 

substances that migrate into food from 

the finished container and other articles 

that contact food; dietary supplements 

and dietary ingredients; infant formula; 

beverages, including alcoholic beverages 

and bottled water; live food animals; 

bakery goods; snack foods; candy; and 

canned foods. 

* * * * * 

Harvesting applies to farms and farm 

mixed-type facilities and means 

activities that are traditionally 

performed by farms for the purpose of 

removing raw agricultural commodities 

from the place they were grown or 

raised and preparing them for use as 

food. Harvesting is limited to activities 

performed on raw agricultural 

commodities on the farm on which they 

were grown or raised, or another farm 

under the same ownership. Harvesting 

does not include activities that 

transform a raw agricultural commodity, 

mstockstill on DSK4VPTVN1PROD with 

Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 3797 

as defined in section 201(r) of the 

Federal Food, Drug, and Cosmetic Act, 

into a processed food as defined in 

section 201(gg) of the Federal Food, 

Drug, and Cosmetic Act. Gathering, 

washing, trimming of outer leaves of, 

removing stems and husks from, sifting, 

filtering, threshing, shelling, and 

cooling raw agricultural commodities 

grown on a farm or another farm under 

the same ownership are examples of 

harvesting. 

Holding means storage of food. 

Holding facilities include: Warehouses, 

cold storage facilities, storage silos, 

grain elevators, and liquid storage tanks. 

For farms and farm mixed-type 

facilities, holding also includes 

activities traditionally performed by 

farms for the safe or effective storage of 

raw agricultural commodities grown or 

raised on the same farm or another farm 

under the same ownership, but does not 

include activities that transform a raw 

agricultural commodity, as defined in 

section 201(r) of the Federal Food, Drug, 

and Cosmetic Act, into a processed food 

as defined in section 201(gg) of the 

Federal Food, Drug, and Cosmetic Act. 

Manufacturing/processing means 

making food from one or more 

ingredients, or synthesizing, preparing, 

treating, modifying or manipulating 

food, including food crops or 

ingredients. Examples of 

manufacturing/processing activities are: 

Cutting, peeling, trimming, washing, 

waxing, eviscerating, rendering, 

cooking, baking, freezing, cooling, 

pasteurizing, homogenizing, mixing, 

formulating, bottling, milling, grinding, 

extracting juice, distilling, labeling, or 

packaging. For farms and farm mixedtype facilities, manufacturing/ 

processing does not include activities 

that are part of harvesting, packing, or 

holding. 

Mixed-type facility means an 

establishment that engages in both 

activities that are exempt from 

registration under section 415 of the 

Federal Food, Drug, and Cosmetic Act 

and activities that require the 

establishment to be registered. An 

example of such a facility is a ‘‘farm 

mixed-type facility,’’ which is an 

establishment that grows and harvests 

crops or raises animals and may 

conduct other activities within the farm 

definition, but also conducts activities 

that require the establishment to be 

registered. 

* * * * * 

Packaging (when used as a noun) 

means the outer packaging of food that 

bears the label and does not contact the 

food. Packaging does not include food 

contact substances as they are defined 

in section 409(h)(6) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 

348(h)(6)). 

Packaging (when used as a verb) 

means placing food into a container that 

directly contacts the food and that the 

consumer receives. 

Packing means placing food into a 

container other than packaging the food. 

For farms and farm mixed-type 

facilities, packing also includes 

activities (which may include 

packaging) traditionally performed by 

farms to prepare raw agricultural 

commodities grown or raised on the 

same farm or another farm under the 

same ownership for storage and 

transport, but does not include activities 

that transform a raw agricultural 

commodity, as defined in section 201(r) 

of the Federal Food, Drug, and Cosmetic 

Act, into a processed food as defined in 

section 201(gg) of the Federal Food, 

Drug, and Cosmetic Act. 

* * * * * 

■ 6. Section 1.361 is revised to read as 

follows: 

§ 1.361 What are the record availability 

requirements? 

When FDA has a reasonable belief 

that an article of food is adulterated and 

presents a threat of serious adverse 

health consequences or death to humans 

or animals, any records and other 

information accessible to FDA under 

section 414 or 704(a) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

350c and 374(a)) must be made readily 

available for inspection and 

photocopying or other means of 

reproduction. Such records and other 

information must be made available as 

soon as possible, not to exceed 24 hours 

from the time of receipt of the official 

request, from an officer or employee 

duly designated by the Secretary of 

Health and Human Services who 

presents appropriate credentials and a 

written notice. 

■ 7. Section 1.363 is revised to read as 

follows: 

§ 1.363 What are the consequences of 

failing to establish or maintain records or 

make them available to FDA as required by 

this subpart? 

(a) The failure to establish or maintain 

records as required by section 414(b) of 

the Federal Food, Drug, and Cosmetic 

Act and this regulation or the refusal to 

permit access to or verification or 

copying of any such required record is 

a prohibited act under section 301 of the 

Federal Food, Drug, and Cosmetic Act. 

(b) The failure of a nontransporter 

immediate previous source or a 

nontransporter immediate subsequent 

recipient who enters an agreement 

under § 1.352(e) to establish, maintain, 

or establish and maintain, records 

required under § 1.352(a), (b), (c), or (d), 

or the refusal to permit access to or 

verification or copying of any such 

required record, is a prohibited act 

under section 301 of the Federal Food, 

Drug, and Cosmetic Act. 

(c) The failure of any person to make 

records or other information available to 

FDA as required by section 414 or 

704(a) of the Federal Food, Drug, and 

Cosmetic Act and this regulation is a 

prohibited act under section 301 of the 

Federal Food, Drug, and Cosmetic Act. 

PART 16—REGULATORY HEARING 

BEFORE THE FOOD AND DRUG 

ADMINISTRATION 

■ 8. The authority citation for 21 CFR 

part 16 continues to read as follows: 

Authority: 15 U.S.C. 1451–1461; 21 U.S.C. 

141–149, 321–394, 467f, 679, 821, 1034; 28 

U.S.C. 2112; 42 U.S.C. 201–262, 263b, 364. 

■ 9. Section 16.1 is amended by 

numerically adding the following entry 

in paragraph (b)(2) to read as follows: 

§ 16.1 Scope. 

* * * * * 

(b) * * * 

(2) * * * 

§§ 117.251 through 117.284 (part 117, 

subpart E), relating to withdrawal of an 

exemption applicable to a qualified 

facility. 

* * * * * 

PART 106—INFANT FORMULA 

QUALITY CONTROL PROCEDURES 

■ 10. The authority citation for 21 CFR 

part 106 continues to read as follows: 

Authority: 21 U.S.C. 321,350a, 371. 

■ 11. Section 106.100 is amended by 

revising the fourth sentence of 

paragraph (j) and paragraph (n) to read 

as follows: 

§ 106.100 Records. 

* * * * * 

(j) * * * Records of audits shall 

include the information and data 

necessary for a determination as to 

whether the manufacturer complies 

with the current good manufacturing 

practices and quality procedures 

identified in parts 106, 107, 109, 110, 

113, and 117 of this chapter. * * * 

* * * * * 

(n) Production control, product 

testing, testing results, complaints, and 

distribution records necessary to verify 

compliance with parts 106, 107, 109, 

110, 113, and 117 of this chapter, or 

with other appropriate regulations, shall 

be retained for 1 year after the 

expiration of the shelf life of the infant 

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formula or 3 years from the date of 

manufacture, whichever is greater. 

* * * * * 

PART 110—[REMOVED AND 

RESERVED] 

■ 12. Part 110 is removed and reserved 

[A DATE WILL BE ADDED 3 YEARS 

AFTER DATE OF PUBLICATION OF 

THE FINAL RULE IN THE FEDERAL 

REGISTER]. 

PART 114—ACIDIFIED FOODS 

■ 13. The authority citation for 21 CFR 

part 114 continues to read as follows: 

Authority: 21 U.S.C. 342, 371,374; 42 

U.S.C. 264. 

■ 14. Revise § 114.5 to read as follows: 

§ 114.5 Current good manufacturing 

practice. 

(a)(1) The criteria in §§ 114.10, 

114.80, 114.83, 114.89, and 114.100, as 

well as the criteria in parts 110 and 117 

of this chapter, apply in determining 

whether an article of acidified food is 

adulterated: 

(2) Within the meaning of section 

402(a)(3) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 342(a)(3)) in 

that it has been manufactured under 

such conditions that it is unfit for food, 

or 

(3) Within the meaning of section 

402(a)(4) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 342(a)(4)) in 

that it has been prepared, packed, or 

held under insanitary conditions 

whereby it may have become 

contaminated with filth, or whereby it 

may have been rendered injurious to 

health. 

(b) [Reserved] 

■ 15. Add part 117 to read as follows: 

PART 117—CURRENT GOOD 

MANUFACTURING PRACTICE AND 

HAZARD ANALYSIS AND RISK– 

BASED PREVENTIVE CONTROLS FOR 

HUMAN FOOD 

Subpart A—General Provisions 

Sec. 

117.1 Applicability and status. 

117.3 Definitions. 

117.5 Exemptions. 

117.7 Applicability of subparts C and D to 

a facility solely engaged in the storage of 

packaged food that is not exposed to the 

environment. 

Subpart B—Current Good Manufacturing 

Practice 

117.10 Personnel. 

117.20 Plant and grounds. 

117.35 Sanitary operations. 

117.37 Sanitary facilities and controls. 

117.40 Equipment and utensils. 

117.80 Processes and controls. 

117.93 Warehousing and distribution. 

117.110 Defect Action Levels 

Subpart C—Hazard Analysis and RiskBased Preventive Controls 

117.126 Requirement for a food safety plan. 

117.130 Hazard analysis. 

117.135 Preventive controls for hazards that 

are reasonably likely to occur. 

117.137 Recall plan for food with a hazard 

that is reasonably likely to occur. 

117.140 Monitoring. 

117.145 Corrective actions. 

117.150 Verification. 

117.155 Requirements applicable to a 

qualified individual. 

117.175 Records required for subpart C. 

Subpart D—Modified Requirements 

117.201 Modified requirements that apply 

to a qualified facility. 

117.206 Modified requirements that apply 

to a facility solely engaged in the storage 

of packaged food that is not exposed to 

the environment. 

Subpart E—Withdrawal of an Exemption 

Applicable to a Qualified Facility 

117.251 Circumstances that may lead FDA 

to withdraw an exemption applicable to 

a qualified facility. 

117.254 Issuance of an order to withdraw 

an exemption applicable to a qualified 

facility. 

117.257 Contents of an order to withdraw 

an exemption applicable to a qualified 

facility. 

117.260 Compliance with, or appeal of, an 

order to withdraw an exemption 

applicable to a qualified facility. 

117.264 Procedure for submitting an 

appeal. 

117.267 Procedure for requesting an 

informal hearing. 

117.270 Requirements applicable to an 

informal hearing. 

117.274 Presiding officer for an appeal and 

for an informal hearing. 

117.277 Time frame for issuing a decision 

on an appeal. 

117.280 Revocation of an order to withdraw 

an exemption applicable to a qualified 

facility. 

117.284 Final agency action. 

Subpart F—Requirements Applying to 

Records That Must be Established and 

Maintained 

117.301 Records subject to the requirements 

of this subpart F. 

117.305 General requirements applying to 

records. 

117.310 Additional requirements applying 

to the food safety plan. 

117.315 Requirements for record retention. 

117.320 Requirements for official review. 

117.325 Public disclosure. 

Subpart G—[Reserved] 

Authority: 21 U.S.C. 331, 342, 343, 350d 

note, 350g, 350g note, 371, 374; 42 U.S.C. 

243, 264, 271. 

Subpart A—General Provisions 

§ 117.1 Applicability and status. 

(a) The criteria and definitions in this 

part apply in determining whether a 

food is adulterated: 

(1) Within the meaning of section 

402(a)(3) of the Federal Food, Drug, and 

Cosmetic Act in that the food has been 

manufactured under such conditions 

that it is unfit for food; or 

(2) Within the meaning of section 

402(a)(4) of the Federal Food, Drug, and 

Cosmetic Act in that the food has been 

prepared, packed, or held under 

insanitary conditions whereby it may 

have become contaminated with filth, or 

whereby it may have been rendered 

injurious to health. The criteria and 

definitions in this part also apply in 

determining whether a food is in 

violation of section 361 of the Public 

Health Service Act (42 U.S.C. 264). 

(b) The operation of a facility that 

manufactures, processes, packs, or holds 

food for sale in the United States if the 

owner, operator, or agent in charge of 

such facility is required to comply with, 

and is not in compliance with, section 

418 of the Federal Food, Drug, and 

Cosmetic Act or subparts C, D, E, or F 

of part 117 is a prohibited act under 

section 301(uu) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 

331(uu)). 

(c) Food covered by specific current 

good manufacturing practice regulations 

also is subject to the requirements of 

those regulations. 

§ 117.3 Definitions. 

The definitions and interpretations of 

terms in section 201 of the Federal 

Food, Drug, and Cosmetic Act are 

applicable to such terms when used in 

this part. The following definitions also 

apply: 

Acid foods or acidified foods means 

foods that have an equilibrium pH of 4.6 

or below. 

Adequate means that which is needed 

to accomplish the intended purpose in 

keeping with good public health 

practice. 

Affiliate means any facility that 

controls, is controlled by, or is under 

common control with another facility. 

Batter means a semifluid substance, 

usually composed of flour and other 

ingredients, into which principal 

components of food are dipped or with 

which they are coated, or which may be 

used directly to form bakery foods. 

Blanching, except for tree nuts and 

peanuts, means a prepackaging heat 

treatment of foodstuffs for a sufficient 

time and at a sufficient temperature to 

partially or completely inactivate the 

naturally occurring enzymes and to 

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effect other physical or biochemical 

changes in the food. 

Calendar day means every day shown 

on the calendar. 

Critical control point means a point, 

step, or procedure in a food process at 

which control can be applied and is 

essential to prevent or eliminate a food 

safety hazard or reduce such hazard to 

an acceptable level. 

Cross-contact means the 

unintentional incorporation of a food 

allergen into a food. 

Environmental pathogen means a 

microorganism that is of public health 

significance and is capable of surviving 

and persisting within the 

manufacturing, processing, packing, or 

holding environment. 

Facility means a domestic facility or 

a foreign facility that is required to 

register under section 415 of the Federal 

Food, Drug, and Cosmetic Act, in 

accordance with the requirements of 21 

CFR part 1, subpart H. 

Farm means farm as defined in 

§ 1.227 of this chapter. 

FDA means the Food and Drug 

Administration. 

Food means food as defined in section 

201(f) of the Federal Food, Drug, and 

Cosmetic Act and includes raw 

materials and ingredients. 

Food allergen means a major food 

allergen as defined in section 201(qq) of 

the Federal Food, Drug, and Cosmetic 

Act. 

Food-contact surfaces are those 

surfaces that contact human food and 

those surfaces from which drainage, or 

other transfer, onto the food or onto 

surfaces that contact the food ordinarily 

occurs during the normal course of 

operations. ‘‘Food-contact surfaces’’ 

includes utensils and food-contact 

surfaces of equipment. 

Harvesting applies to farms and farm 

mixed-type facilities and means 

activities that are traditionally 

performed by farms for the purpose of 

removing raw agricultural commodities 

from the place they were grown or 

raised and preparing them for use as 

food. Harvesting is limited to activities 

performed on raw agricultural 

commodities on the farm on which they 

were grown or raised, or another farm 

under the same ownership. Harvesting 

does not include activities that 

transform a raw agricultural commodity, 

as defined in section 201(r) of the 

Federal Food, Drug, and Cosmetic Act, 

into a processed food as defined in 

section 201(gg) of the Federal Food, 

Drug, and Cosmetic Act. Gathering, 

washing, trimming of outer leaves of, 

removing stems and husks from, sifting, 

filtering, threshing, shelling, and 

cooling raw agricultural commodities 

grown on a farm or another farm under 

the same ownership are examples of 

harvesting. 

Hazard means any biological, 

chemical, physical, or radiological agent 

that is reasonably likely to cause illness 

or injury in the absence of its control. 

Hazard reasonably likely to occur 

means a hazard for which a prudent 

person who manufactures, processes, 

packs, or holds food would establish 

controls because experience, illness 

data, scientific reports, or other 

information provides a basis to 

conclude that there is a reasonable 

possibility that the hazard will occur in 

the type of food being manufactured, 

processed, packed, or held in the 

absence of those controls. 

Holding means storage of food. 

Holding facilities include warehouses, 

cold storage facilities, storage silos, 

grain elevators, and liquid storage tanks. 

For farms and farm mixed-type 

facilities, holding also includes 

activities traditionally performed by 

farms for the safe or effective storage of 

raw agricultural commodities grown or 

raised on the same farm or another farm 

under the same ownership, but does not 

include activities that transform a raw 

agricultural commodity, as defined in 

section 201(r) of the Federal Food, Drug, 

and Cosmetic Act, into a processed food 

as defined in section 201(gg) of the 

Federal Food, Drug, and Cosmetic Act. 

Lot means the food produced during 

a period of time indicated by a specific 

code. 

Manufacturing/processing means 

making food from one or more 

ingredients, or synthesizing, preparing, 

treating, modifying or manipulating 

food, including food crops or 

ingredients. Examples of 

manufacturing/processing activities are 

cutting, peeling, trimming, washing, 

waxing, eviscerating, rendering, 

cooking, baking, freezing, cooling, 

pasteurizing, homogenizing, mixing, 

formulating, bottling, milling, grinding, 

extracting juice, distilling, labeling, or 

packaging. For farms and farm mixedtype facilities, manufacturing/ 

processing does not include activities 

that are part of harvesting, packing, or 

holding. 

Microorganisms means yeasts, molds, 

bacteria, viruses, protozoa, and 

microscopic parasites and includes 

species having public health 

significance. The term ‘‘undesirable 

microorganisms’’ includes those 

microorganisms that are of public health 

significance, that subject food to 

decomposition, that indicate that food is 

contaminated with filth, or that 

otherwise may cause food to be 

adulterated. 

Mixed-type facility means an 

establishment that engages in both 

activities that are exempt from 

registration under section 415 of the 

Federal Food, Drug, and Cosmetic Act 

and activities that require the 

establishment to be registered. An 

example of such a facility is a ‘‘farm 

mixed-type facility,’’ which is an 

establishment that grows and harvests 

crops or raises animals and may 

conduct other activities within the farm 

definition, but also conducts activities 

that require the establishment to be 

registered. 

Monitor means to conduct a planned 

sequence of observations or 

measurements to assess whether a 

process, point, or procedure is under 

control and to produce an accurate 

record for use in verification. 

Packaging (when used as a verb) 

means placing food into a container that 

directly contacts the food and that the 

consumer receives. 

Packing means placing food into a 

container other than packaging the food. 

For farms and farm mixed-type 

facilities, packing also includes 

activities traditionally performed by 

farms to prepare raw agricultural 

commodities grown or raised on the 

same farm or another farm under the 

same ownership for storage and 

transport, but does not include activities 

that transform a raw agricultural 

commodity, as defined in section 201(r) 

of the Federal Food, Drug, and Cosmetic 

Act, into a processed food as defined in 

section 201(gg) of the Federal Food, 

Drug, and Cosmetic Act. 

Pest refers to any objectionable 

animals or insects including birds, 

rodents, flies, and larvae. 

Plant means the building or 

establishment or parts thereof, used for 

or in connection with the 

manufacturing, processing, packing, or 

holding of human food. 

Preventive controls means those riskbased, reasonably appropriate 

procedures, practices, and processes 

that a person knowledgeable about the 

safe manufacturing, processing, packing, 

or holding of food would employ to 

significantly minimize or prevent the 

hazards identified under the hazard 

analysis that are consistent with the 

current scientific understanding of safe 

food manufacturing, processing, 

packing, or holding at the time of the 

analysis. 

Qualified end-user, with respect to a 

food, means the consumer of the food 

(where the term consumer does not 

include a business); or a restaurant or 

retail food establishment (as those terms 

are defined in § 1.227 of this chapter) 

that: 

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(1) Is located; 

(i) In the same State as the qualified 

facility that sold the food to such 

restaurant or establishment; or 

(ii) Not more than 275 miles from 

such facility; and 

(2) Is purchasing the food for sale 

directly to consumers at such restaurant 

or retail food establishment. 

Qualified facility means (when 

including the sales by any subsidiary; 

affiliate; or subsidiaries or affiliates, 

collectively, of any entity of which the 

facility is a subsidiary or affiliate) a 

facility that is a very small business as 

defined in this part, or a facility to 

which both of the following apply: 

(1) During the 3-year period preceding 

the applicable calendar year, the average 

annual monetary value of the food 

manufactured, processed, packed or 

held at such facility that is sold directly 

to qualified end-users (as defined in this 

part) during such period exceeded the 

average annual monetary value of the 

food sold by such facility to all other 

purchasers; and 

(2) The average annual monetary 

value of all food sold during the 3-year 

period preceding the applicable 

calendar year was less than $500,000, 

adjusted for inflation. 

Qualified individual means a person 

who has successfully completed 

training in the development and 

application of risk-based preventive 

controls at least equivalent to that 

received under a standardized 

curriculum recognized as adequate by 

FDA or is otherwise qualified through 

job experience to develop and apply a 

food safety system. 

Quality control operation means a 

planned and systematic procedure for 

taking all actions necessary to prevent 

food from being adulterated. 

Ready-to-eat food (RTE food) means 

any food that is normally eaten in its 

raw state or any other food, including 

processed food, for which it is 

reasonably foreseeable that the food 

would be eaten without further 

processing that will significantly 

minimize biological hazards. 

Reasonably foreseeable hazard means 

a potential biological, chemical, 

physical, or radiological hazard that 

may be associated with the facility or 

the food. 

Rework means clean, unadulterated 

food that has been removed from 

processing for reasons other than 

insanitary conditions or that has been 

successfully reconditioned by 

reprocessing and that is suitable for use 

as food. 

Safe-moisture level is a level of 

moisture low enough to prevent the 

growth of undesirable microorganisms 

in the finished product under the 

intended conditions of manufacturing, 

processing, packing, and holding. The 

safe moisture level for a food is related 

to its water activity (aw). An aw will be 

considered safe for a food if adequate 

data are available that demonstrate that 

the food at or below the given aw will 

not support the growth of undesirable 

microorganisms. 

Sanitize means to adequately treat 

cleaned food-contact surfaces by a 

process that is effective in destroying 

vegetative cells of microorganisms of 

public health significance, and in 

substantially reducing numbers of other 

undesirable microorganisms, but 

without adversely affecting the product 

or its safety for the consumer. 

Should is used to state recommended 

or advisory procedures or identify 

recommended equipment. 

Significantly minimize means to 

reduce to an acceptable level, including 

to eliminate. 

Small business means, for purposes of 

this part 117, a business employing 

fewer than 500 persons. 

Subsidiary means any company 

which is owned or controlled directly or 

indirectly by another company. 

Validation means that element of 

verification focused on collecting and 

evaluating scientific and technical 

information to determine whether the 

food safety plan, when properly 

implemented, will effectively control 

the identified hazards. 

Verification means those activities, 

other than monitoring, that establish the 

validity of the food safety plan and that 

the system is operating according to the 

plan. 

Option 1 for Definition of ‘‘Very Small 

Business’’ 

Very small business means, for 

purposes of this part 117, a business 

that has less than $250,000 in total 

annual sales of food, adjusted for 

inflation. 

Option 2 for Definition of ‘‘Very Small 

Business’’ 

Very small business means, for 

purposes of this part 117, a business 

that has less than $500,000 in total 

annual sales of food, adjusted for 

inflation. 

Option 3 for Definition of ‘‘Very Small 

Business’’ 

Very small business means, for 

purposes of this part 117, a business 

that has less than $1,000,000 in total 

annual sales of food, adjusted for 

inflation. 

Water activity (aw) is a measure of the 

free moisture in a food and is the 

quotient of the water vapor pressure of 

the substance divided by the vapor 

pressure of pure water at the same 

temperature. 

§ 117.5 Exemptions. 

(a) Except as provided by subpart E of 

this part, subpart C of this part does not 

apply to a qualified facility. Qualified 

facilities are subject to the modified 

requirements in § 117.201. 

(b) Subpart C of this part does not 

apply with respect to activities that are 

subject to part 123 of this chapter (Fish 

and Fishery Products) at a facility if the 

owner, operator, or agent in charge of 

the facility is required to comply with, 

and is in compliance with, part 123 of 

this chapter with respect to such 

activities. 

(c) Subpart C of this part does not 

apply with respect to activities that are 

subject to part 120 of this chapter 

(Hazard Analysis and Critical Control 

Point (HACCP) Systems) at a facility if 

the owner, operator, or agent in charge 

of the facility is required to comply 

with, and is in compliance with, part 

120 of this chapter with respect to such 

activities. 

(d)(1) Subpart C of this part does not 

apply with respect to activities that are 

subject to part 113 of this chapter 

(Thermally Processed Low-Acid Foods 

Packaged in Hermetically Sealed 

Containers) at a facility if the owner, 

operator, or agent in charge of the 

facility is required to comply with, and 

is in compliance with, part 113 of this 

chapter with respect to such activities. 

(2) The exemption in paragraph (d)(1) 

of this section is applicable only with 

respect to the microbiological hazards 

that are regulated under part 113 of this 

chapter. 

(e) Subpart C does not apply to any 

facility with regard to the 

manufacturing, processing, packing, or 

holding of a dietary supplement that is 

in compliance with the requirements of 

part 111 of this chapter (Current Good 

Manufacturing Practice in 

Manufacturing, Packing, Labeling, or 

Holding Operations for Dietary 

Supplements) and section 761 of the 

Federal Food, Drug, and Cosmetic Act 

(Serious Adverse Event Reporting for 

Dietary Supplements). 

(f) Subpart C of this part does not 

apply to activities of a facility that are 

subject to section 419 of the Federal 

Food, Drug, and Cosmetic Act 

(Standards for Produce Safety). 

(g) Subpart C of this part does not 

apply to on-farm packing or holding of 

food by a small or very small business 

if the only packing and holding 

activities subject to section 418 of the 

Federal Food, Drug, and Cosmetic Act 

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that the business conducts are the 

following low-risk packing or holding 

activity/food combinations on food not 

grown, raised, or consumed on that farm 

mixed-type facility or another farm or 

farm mixed-type facility under the same 

ownership— i.e., packing or re-packing 

(including weighing or conveying 

incidental to packing or re-packing); 

sorting, culling, or grading incidental to 

packing or storing; and storing (ambient, 

cold and controlled atmosphere) of: 

(1) Hard candy, fudge, taffy and toffee; 

(2) Cocoa beans and coffee beans (raw 

and roasted); 

(3) Cocoa products; 

(4) Grains and grain products; 

(5) Honey (raw and pasteurized); 

(6) Intact fruits and vegetables (for 

purposes of paragraph (g) and paragraph 

(h) of this section only, ‘‘intact fruits 

and vegetables’’ refers only to fruits and 

vegetables other than cocoa beans, 

coffee beans, peanuts, sugar beets, 

sugarcane, and tree nuts); 

(7) Jams, jellies and preserves; 

(8) Maple sap for syrup and maple 

syrup; 

(9) Peanuts and tree nuts; 

(10) Soft drinks and carbonated water; 

(11) Sugar beets, sugarcane, and sugar; 

(h) Subpart C of this part does not 

apply to on-farm low-risk 

manufacturing/processing activities 

conducted by a small or very small 

business if the only manufacturing/ 

processing activities subject to section 

418 of the Federal Food, Drug, and 

Cosmetic Act that the business conducts 

are the following: 

(1) When conducted on a farm mixedtype facility’s own raw agricultural 

commodities as defined in section 

201(r) of the Federal Food, Drug, and 

Cosmetic Act (those grown or raised on 

that farm mixed-type facility or another 

farm/farm mixed-type facility under the 

same ownership) for distribution into 

commerce: 

(i) Artificial ripening of intact fruits 

and vegetables; 

(ii) Boiling/evaporation of maple sap 

to make maple syrup; 

(iii) Chopping raw peanuts and raw 

tree nuts; 

(iv) Coating (with coatings other than 

wax, oil, or resin used for the purpose 

of storage or transportation) intact fruits 

and vegetables (e.g., caramel apples) and 

coating raw peanuts and raw tree nuts 

(e.g., adding seasonings); 

(v) Drying/dehydrating intact fruits 

and vegetables (without the addition of 

sulfites) where the drying creates a 

distinct commodity (e.g., drying fruits or 

herbs); 

(vi) Extracting oil from grains (e.g., 

corn, oilseeds, soybeans); 

(vii) Grinding/milling/cracking/ 

crushing grains (e.g., making grain 

products such as corn meal) and raw 

peanuts or raw tree nuts (e.g., making 

ground peanuts); 

(viii) Making jams, jellies and 

preserves from acid foods (e.g., acid 

fruits); 

(ix) Making sugar from sugar beets 

and sugarcane; and 

(x) Salting raw peanuts and raw tree 

nuts. 

(2) When conducted on food other 

than the farm mixed-type facility’s own 

raw agricultural commodities for 

distribution into commerce: 

(i) Artificial ripening of intact fruits 

and vegetables; 

(ii) Chopping peanuts and tree nuts; 

(iii) Coating (with coatings other than 

wax, oil, or resin used for the purpose 

of storage or transportation) intact fruits 

and vegetables (e.g., caramel apples) and 

coating peanuts and tree nuts (e.g., 

adding seasonings); 

(iv) Cooling intact fruits and 

vegetables using cold air; 

(v) Drying/dehydrating (whether for 

storage/transport or for creating a 

distinct commodity) intact fruits and 

vegetables (without sulfiting), cocoa 

beans, coffee beans, grains and grain 

products, and peanuts and tree nuts; 

(vi) Extracting oils from grains (e.g., 

corn, oilseeds, and soybeans); 

(vii) Fermenting cocoa beans and 

coffee beans; 

(viii) Grinding/milling/cracking/ 

crushing cocoa beans, coffee beans, 

grains (e.g., making grain products such 

as corn meal), and peanuts and tree nuts 

(e.g., making ground peanuts); 

(ix) Labeling (including stickering) 

hard candy, cocoa beans, cocoa 

products from roasted cocoa beans 

(other than milk chocolate), coffee 

beans, intact fruits and vegetables, grain 

and grain products (other than those 

containing wheat in a form that would 

not be recognized as containing wheat 

without a label declaration), honey, 

jams/jellies/preserves, maple sap, maple 

syrup, intact single-ingredient peanuts 

or tree nuts (shelled and unshelled), soft 

drinks and carbonated beverages, sugar 

beets, sugarcane, and sugar; 

(x) Making hard candy, fudge, taffy, 

and toffee; 

(xi) Making cocoa products from 

roasted cocoa beans; 

(xii) Making honey; 

(xiii) Making jams, jellies and 

preserves from acid foods (e.g., acid 

fruits); 

(xiv) Making maple syrup; 

(xv) Making soft drinks and 

carbonated water; 

(xvi) Making sugar from sugar beets 

and sugarcane; 

(xvii) Mixing cocoa beans, coffee 

beans, intact fruits and vegetables, grain 

and grain products, honey, maple sap 

and maple syrup, and peanuts and tree 

nuts; 

(xviii) Packaging hard candy, fudge, 

taffy, toffee; cocoa beans; cocoa 

products; coffee beans; intact fruits and 

vegetables (other than modified 

atmosphere or vacuum packaging); grain 

and grain products; honey; jams, jellies 

and preserves; maple syrup; peanuts 

and tree nuts (including modified 

atmosphere or vacuum packaging); soft 

drinks and carbonated water; and sugar 

beets, sugarcane, and sugar; 

(xix) Salting peanuts and tree nuts; 

(xx) Shelling/hulling cocoa beans (i.e., 

winnowing), intact fruits and vegetables 

(e.g., dried beans and peas), and peanuts 

and tree nuts; 

(xxi) Sifting grains and grain 

products; 

(xxii) Sorting, culling, and grading 

(other than when incidental to packing 

or storage) hard candy, fudge, taffy, and 

toffee; cocoa beans; cocoa products; 

coffee beans; intact fruits and 

vegetables; grain and grain products; 

honey; jams, jellies and preserves; 

maple sap; maple syrup; peanuts and 

tree nuts; soft drinks and carbonated 

water; and sugar beets, sugarcane, and 

sugar; 

(xxiii) Treating cocoa beans, coffee 

beans, intact fruits and vegetables, grain 

and grain products, and peanuts and 

tree nuts against pests (other than 

during growing) (e.g., fumigation); 

(xxiv) Waxing (wax, oil, or resin used 

for the purpose of storage or 

transportation) intact fruits and 

vegetables. 

(i)(1) Subpart C of this part does not 

apply with respect to alcoholic 

beverages at a facility that meets the 

following two conditions: 

(i) Under the Federal Alcohol 

Administration Act (27 U.S.C. 201 et 

seq.) or chapter 51 of subtitle E of the 

Internal Revenue Code of 1986 (26 

U.S.C. 5001 et seq.) the facility is 

required to obtain a permit from, 

register with, or obtain approval of a 

notice or application from the Secretary 

of the Treasury as a condition of doing 

business in the United States, or is a 

foreign facility of a type that would 

require such a permit, registration, or 

approval if it were a domestic facility; 

and 

(ii) Under section 415 of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

350d) the facility is required to register 

as a facility because it is engaged in 

manufacturing, processing, packing, or 

holding one or more alcoholic 

beverages. 

(2) Subpart C of this part does not 

apply with respect to food other than 

alcoholic beverages at a facility 

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described in paragraph (i)(1) of this 

section, provided such food: 

(i) Is in prepackaged form that 

prevents any direct human contact with 

such food; and 

(ii) Constitutes not more than 5 

percent of the overall sales of the 

facility, as determined by the Secretary 

of the Treasury. 

(j) Subpart C of this part does not 

apply to facilities that are solely 

engaged in the storage of raw 

agricultural commodities (other than 

fruits and vegetables) intended for 

further distribution or processing. 

(k) Subpart B of this part does not 

apply to ‘‘farms’’ (as defined in § 1.227 

of this chapter), activities of ‘‘farm 

mixed-type facilities’’ (as defined in 

§ 1.227) that fall within the definition of 

‘‘farm,’’ or the holding or transportation 

of one or more ‘‘raw agricultural 

commodities,’’ as defined in section 

201(r) of the Federal Food, Drug, and 

Cosmetic Act. 

§ 117.7 Applicability of subparts C and D 

to a facility solely engaged in the storage 

of packaged food that is not exposed to the 

environment. 

(a) Subpart C of this part does not 

apply to a facility solely engaged in the 

storage of packaged food that is not 

exposed to the environment. 

(b) A facility solely engaged in the 

storage of packaged food that is not 

exposed to the environment is subject to 

the modified requirements in § 117.206 

of subpart D of this part. 

Subpart B—Current Good 

Manufacturing Practice 

§ 117.10 Personnel. 

The plant management must take all 

reasonable measures and precautions to 

ensure the following: 

(a) Disease control. Any person who, 

by medical examination or supervisory 

observation, is shown to have, or 

appears to have, an illness, open lesion, 

including boils, sores, or infected 

wounds, or any other abnormal source 

of microbial contamination by which 

there is a reasonable possibility of food, 

food-contact surfaces, or food-packaging 

materials becoming contaminated, must 

be excluded from any operations which 

may be expected to result in such 

contamination until the condition is 

corrected. Personnel must be instructed 

to report such health conditions to their 

supervisors. 

(b) Cleanliness. All persons working 

in direct contact with food, food-contact 

surfaces, and food-packaging materials 

must conform to hygienic practices 

while on duty to the extent necessary to 

protect against cross-contact and 

contamination of food. The methods for 

maintaining cleanliness include: 

(1) Wearing outer garments suitable to 

the operation in a manner that protects 

against the contamination of food, foodcontact surfaces, or food-packaging 

materials and to protect against the 

cross-contact of food. 

(2) Maintaining adequate personal 

cleanliness. 

(3) Washing hands thoroughly (and 

sanitizing if necessary to protect against 

contamination with undesirable 

microorganisms) in an adequate handwashing facility before starting work, 

after each absence from the work 

station, and at any other time when the 

hands may have become soiled or 

contaminated. 

(4) Removing all unsecured jewelry 

and other objects that might fall into 

food, equipment, or containers, and 

removing hand jewelry that cannot be 

adequately sanitized during periods in 

which food is manipulated by hand. If 

such hand jewelry cannot be removed, 

it may be covered by material which can 

be maintained in an intact, clean, and 

sanitary condition and which effectively 

protects against the contamination by 

these objects of the food, food-contact 

surfaces, or food-packaging materials. 

(5) Maintaining gloves, if they are 

used in food handling, in an intact, 

clean, and sanitary condition. 

(6) Wearing, where appropriate, in an 

effective manner, hair nets, headbands, 

caps, beard covers, or other effective 

hair restraints. 

(7) Storing clothing or other personal 

belongings in areas other than where 

food is exposed or where equipment or 

utensils are washed. 

(8) Confining the following to areas 

other than where food may be exposed 

or where equipment or utensils are 

washed: eating food, drinking beverages, 

or using tobacco. 

(9) Taking any other necessary 

precautions to protect against 

contamination of food, food-contact 

surfaces, or food-packaging materials 

with microorganisms or foreign 

substances (including perspiration, hair, 

cosmetics, tobacco, chemicals, and 

medicines applied to the skin) and to 

protect against cross-contact of food. 

(c) Education and training. Personnel 

responsible for identifying sanitation 

failures or food contamination should 

have a background of education or 

experience, or a combination thereof, to 

provide a level of competency necessary 

for production of clean and safe food. 

Food handlers and supervisors should 

receive appropriate training in proper 

food handling techniques and foodprotection principles and should be 

informed of the danger of poor personal 

hygiene and insanitary practices. 

(d) Supervision. Responsibility for 

ensuring compliance by all personnel 

with all requirements of this subpart 

must be clearly assigned to competent 

supervisory personnel. 

§ 117.20 Plant and grounds. 

(a) Grounds. The grounds about a food 

plant under the control of the operator 

must be kept in a condition that will 

protect against the contamination of 

food. The methods for adequate 

maintenance of grounds must include: 

(1) Properly storing equipment, 

removing litter and waste, and cutting 

weeds or grass within the immediate 

vicinity of the plant buildings or 

structures that may constitute an 

attractant, breeding place, or harborage 

for pests. 

(2) Maintaining roads, yards, and 

parking lots so that they do not 

constitute a source of contamination in 

areas where food is exposed. 

(3) Adequately draining areas that 

may contribute contamination to food 

by seepage, foot-borne filth, or 

providing a breeding place for pests. 

(4) Operating systems for waste 

treatment and disposal in an adequate 

manner so that they do not constitute a 

source of contamination in areas where 

food is exposed. If the plant grounds are 

bordered by grounds not under the 

operator’s control and not maintained in 

the manner described in paragraphs 

(a)(1) through (a)(3) of this section, care 

must be exercised in the plant by 

inspection, extermination, or other 

means to exclude pests, dirt, and filth 

that may be a source of food 

contamination. 

(b) Plant construction and design. 

Plant buildings and structures must be 

suitable in size, construction, and 

design to facilitate maintenance and 

sanitary operations for food-production 

purposes (i.e., manufacturing, 

processing, packing, and holding). The 

plant must: 

(1) Provide sufficient space for such 

placement of equipment and storage of 

materials as is necessary for the 

maintenance of sanitary operations and 

the production of safe food. 

(2) Permit the taking of proper 

precautions to reduce the potential for 

contamination of food, food-contact 

surfaces, or food-packaging materials 

with microorganisms, chemicals, filth, 

and other extraneous material, and to 

reduce the potential for cross-contact. 

The potential for cross-contact and 

contamination may be reduced by 

adequate food safety controls and 

operating practices or effective design, 

including the separation of operations 

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in which cross-contact and 

contamination are likely to occur, by 

one or more of the following means: 

location, time, partition, air flow, 

enclosed systems, or other effective 

means. 

(3) Permit the taking of proper 

precautions to protect food in outdoor 

bulk vessels by any effective means, 

including: 

(i) Using protective coverings. 

(ii) Controlling areas over and around 

the vessels to eliminate harborages for 

pests. 

(iii) Checking on a regular basis for 

pests and pest infestation. 

(iv) Skimming fermentation vessels, 

as necessary. 

(4) Be constructed in such a manner 

that floors, walls, and ceilings may be 

adequately cleaned and kept clean and 

kept in good repair; that drip or 

condensate from fixtures, ducts and 

pipes does not contaminate food, foodcontact surfaces, or food-packaging 

materials; and that aisles or working 

spaces are provided between equipment 

and walls and are adequately 

unobstructed and of adequate width to 

permit employees to perform their 

duties and to protect against 

contaminating food, food-contact 

surfaces, or food-packaging materials 

with clothing or personal contact. 

(5) Provide adequate lighting in handwashing areas, dressing and locker 

rooms, and toilet rooms and in all areas 

where food is examined, processed, or 

stored and where equipment or utensils 

are cleaned; and provide safety-type 

light bulbs, fixtures, skylights, or other 

glass suspended over exposed food in 

any step of preparation or otherwise 

protect against food contamination in 

case of glass breakage. 

(6) Provide adequate ventilation or 

control equipment to minimize odors 

and vapors (including steam and 

noxious fumes) in areas where they may 

contaminate food; and locate and 

operate fans and other air-blowing 

equipment in a manner that minimizes 

the potential for contaminating food, 

food-packaging materials, and foodcontact surfaces and for cross-contact. 

(7) Provide, where necessary, 

adequate screening or other protection 

against pests. 

§ 117.35 Sanitary operations. 

(a) General maintenance. Buildings, 

fixtures, and other physical facilities of 

the plant must be maintained in a 

sanitary condition and must be kept in 

repair sufficient to prevent food from 

becoming adulterated. Cleaning and 

sanitizing of utensils and equipment 

must be conducted in a manner that 

protects against cross-contact and 

contamination of food, food-contact 

surfaces, or food-packaging materials. 

(b) Substances used in cleaning and 

sanitizing; storage of toxic materials. (1) 

Cleaning compounds and sanitizing 

agents used in cleaning and sanitizing 

procedures must be free from 

undesirable microorganisms and must 

be safe and adequate under the 

conditions of use. Compliance with this 

requirement may be verified by any 

effective means, including purchase of 

these substances under a supplier’s 

guarantee or certification or 

examination of these substances for 

contamination. Only the following toxic 

materials may be used or stored in a 

plant where food is processed or 

exposed: 

(i) Those required to maintain clean 

and sanitary conditions; 

(ii) Those necessary for use in 

laboratory testing procedures; 

(iii) Those necessary for plant and 

equipment maintenance and operation; 

and 

(iv) Those necessary for use in the 

plant’s operations. 

(2) Toxic cleaning compounds, 

sanitizing agents, and pesticide 

chemicals must be identified, held, and 

stored in a manner that protects against 

contamination of food, food-contact 

surfaces, or food-packaging materials. 

(c) Pest control. Pests must not be 

allowed in any area of a food plant. 

Guard or guide dogs may be allowed in 

some areas of a plant if the presence of 

the dogs is unlikely to result in 

contamination of food, food-contact 

surfaces, or food-packaging materials. 

Effective measures must be taken to 

exclude pests from the manufacturing, 

processing, packing, and holding areas 

and to protect against the contamination 

of food on the premises by pests. The 

use of insecticides or rodenticides is 

permitted only under precautions and 

restrictions that will protect against the 

contamination of food, food-contact 

surfaces, and food-packaging materials. 

(d) Sanitation of food-contact 

surfaces. All food-contact surfaces, 

including utensils and food-contact 

surfaces of equipment, must be cleaned 

as frequently as necessary to protect 

against cross-contact and contamination 

of food. 

(1) Food-contact surfaces used for 

manufacturing/processing or holding 

low-moisture food must be in a clean, 

dry, sanitary condition at the time of 

use. When the surfaces are wet-cleaned, 

they must, when necessary, be sanitized 

and thoroughly dried before subsequent 

use. 

(2) In wet processing, when cleaning 

is necessary to protect against crosscontact and the introduction of 

microorganisms into food, all foodcontact surfaces must be cleaned and 

sanitized before use and after any 

interruption during which the foodcontact surfaces may have become 

contaminated. Where equipment and 

utensils are used in a continuous 

production operation, the utensils and 

food-contact surfaces of the equipment 

must be cleaned and sanitized as 

necessary. 

(3) Single-service articles (such as 

utensils intended for one-time use, 

paper cups, and paper towels) should be 

stored in appropriate containers and 

must be handled, dispensed, used, and 

disposed of in a manner that protects 

against cross-contact and contamination 

of food, food-contact surfaces, or foodpackaging materials. 

(e) Sanitation of non-food-contact 

surfaces. Non-food-contact surfaces of 

equipment used in the operation of a 

food plant should be cleaned in a 

manner and as frequently as necessary 

to protect against cross-contact and 

contamination of food, food-contact 

surfaces, and food-packaging materials. 

(f) Storage and handling of cleaned 

portable equipment and utensils. 

Cleaned and sanitized portable 

equipment with food-contact surfaces 

and utensils should be stored in a 

location and manner that protects foodcontact surfaces from cross-contact and 

contamination. 

§ 117.37 Sanitary facilities and controls. 

Each plant must be equipped with 

adequate sanitary facilities and 

accommodations including: 

(a) Water supply. The water supply 

must be sufficient for the operations 

intended and must be derived from an 

adequate source. Any water that 

contacts food, food-contact surfaces, or 

food-packaging materials must be safe 

and of adequate sanitary quality. 

Running water at a suitable temperature, 

and under pressure as needed, must be 

provided in all areas where required for 

the processing of food, for the cleaning 

of equipment, utensils, and foodpackaging materials, or for employee 

sanitary facilities. 

(b) Plumbing. Plumbing must be of 

adequate size and design and 

adequately installed and maintained to: 

(1) Carry sufficient quantities of water 

to required locations throughout the 

plant. 

(2) Properly convey sewage and liquid 

disposable waste from the plant. 

(3) Avoid constituting a source of 

contamination to food, water supplies, 

equipment, or utensils or creating an 

unsanitary condition. 

(4) Provide adequate floor drainage in 

all areas where floors are subject to 

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flooding-type cleaning or where normal 

operations release or discharge water or 

other liquid waste on the floor. 

(5) Provide that there is not backflow 

from, or cross-connection between, 

piping systems that discharge waste 

water or sewage and piping systems that 

carry water for food or food 

manufacturing. 

(c) Sewage disposal. Sewage disposal 

must be made into an adequate 

sewerage system or disposed of through 

other adequate means. 

(d) Toilet facilities. Each plant must 

provide its employees with adequate, 

readily accessible toilet facilities. Toilet 

facilities must be kept clean and must 

not be a potential source of 

contamination of food, food-contact 

surfaces, or food-packaging materials. 

(e) Hand-washing facilities. Each 

plant must provide hand-washing 

facilities designed to ensure that an 

employee’s hands are not a source of 

contamination of food, food-contact 

surfaces, or food-packaging materials, by 

providing facilities that are adequate, 

convenient, and furnish running water 

at a suitable temperature. 

(f) Rubbish and offal disposal. 

Rubbish and any offal must be so 

conveyed, stored, and disposed of as to 

minimize the development of odor, 

minimize the potential for the waste 

becoming an attractant and harborage or 

breeding place for pests, and protect 

against contamination of food, foodcontact surfaces, food-packaging 

materials, water supplies, and ground 

surfaces. 

§ 117.40 Equipment and utensils. 

(a)(1) All plant equipment and 

utensils must be so designed and of 

such material and workmanship as to be 

adequately cleanable, and must be 

properly maintained. 

(2) The design, construction, and use 

of equipment and utensils must 

preclude the adulteration of food with 

lubricants, fuel, metal fragments, 

contaminated water, or any other 

contaminants. 

(3) All equipment should be so 

installed and maintained as to facilitate 

the cleaning of the equipment and of all 

adjacent spaces. 

(4) Food-contact surfaces must be 

corrosion-resistant when in contact with 

food. 

(5) Food-contact surfaces must be 

made of nontoxic materials and 

designed to withstand the environment 

of their intended use and the action of 

food, and, if applicable, cleaning 

compounds and sanitizing agents. 

(6) Food-contact surfaces must be 

maintained to protect food from crosscontact and from being contaminated by 

any source, including unlawful indirect 

food additives. 

(b) Seams on food-contact surfaces 

must be smoothly bonded or maintained 

so as to minimize accumulation of food 

particles, dirt, and organic matter and 

thus minimize the opportunity for 

growth of microorganisms and crosscontact. 

(c) Equipment that is in the 

manufacturing or food-handling area 

and that does not come into contact 

with food must be so constructed that it 

can be kept in a clean condition. 

(d) Holding, conveying, and 

manufacturing systems, including 

gravimetric, pneumatic, closed, and 

automated systems, must be of a design 

and construction that enables them to be 

maintained in an appropriate sanitary 

condition. 

(e) Each freezer and cold storage 

compartment used to store and hold 

food capable of supporting growth of 

microorganisms must be fitted with an 

indicating thermometer, temperaturemeasuring device, or temperaturerecording device so installed as to show 

the temperature accurately within the 

compartment. 

(f) Instruments and controls used for 

measuring, regulating, or recording 

temperatures, pH, acidity, water 

activity, or other conditions that control 

or prevent the growth of undesirable 

microorganisms in food must be 

accurate and precise and adequately 

maintained, and adequate in number for 

their designated uses. 

(g) Compressed air or other gases 

mechanically introduced into food or 

used to clean food-contact surfaces or 

equipment must be treated in such a 

way that food is not contaminated with 

unlawful indirect food additives. 

§ 117.80 Processes and controls. 

(a) General. (1) All operations in the 

manufacturing, processing, packing and 

holding of food (including operations 

directed to receiving, inspecting, 

transporting, and segregating) must be 

conducted in accordance with adequate 

sanitation principles. 

(2) Appropriate quality control 

operations must be employed to ensure 

that food is suitable for human 

consumption and that food-packaging 

materials are safe and suitable. 

(3) Overall sanitation of the plant 

must be under the supervision of one or 

more competent individuals assigned 

responsibility for this function. 

(4) All reasonable precautions must be 

taken to ensure that production 

procedures do not contribute to crosscontact and contamination from any 

source. 

(5) Chemical, microbial, or 

extraneous-material testing procedures 

must be used where necessary to 

identify sanitation failures or possible 

cross-contact and food contamination. 

(6) All food that has become 

contaminated to the extent that it is 

adulterated must be rejected, or if 

permissible, treated or processed to 

eliminate the contamination. 

(b) Raw materials and ingredients. (1) 

Raw materials and ingredients must be 

inspected and segregated or otherwise 

handled as necessary to ascertain that 

they are clean and suitable for 

processing into food and must be stored 

under conditions that will protect 

against cross-contact and contamination 

and minimize deterioration. Raw 

materials must be washed or cleaned as 

necessary to remove soil or other 

contamination. Water used for washing, 

rinsing, or conveying food must be safe 

and of adequate sanitary quality. Water 

may be reused for washing, rinsing, or 

conveying food if it does not increase 

the level of contamination of the food or 

cause cross-contact. Containers and 

carriers of raw materials should be 

inspected on receipt to ensure that their 

condition has not contributed to crosscontact, contamination, or deterioration 

of food. 

(2) Raw materials and ingredients 

must either not contain levels of 

microorganisms that may render the 

food injurious to the health of humans, 

or they must be pasteurized or 

otherwise treated during manufacturing 

operations so that they no longer 

contain levels that would cause the 

product to be adulterated. 

(3) Raw materials and ingredients 

susceptible to contamination with 

aflatoxin or other natural toxins must 

comply with current FDA regulations 

for poisonous or deleterious substances 

before these materials or ingredients are 

incorporated into finished food. 

(4) Raw materials, ingredients, and 

rework susceptible to contamination 

with pests, undesirable microorganisms, 

or extraneous material must comply 

with applicable FDA regulations for 

natural or unavoidable defects if a 

manufacturer wishes to use the 

materials in manufacturing food. 

(5) Raw materials, ingredients, and 

rework must be held in bulk, or in 

containers designed and constructed so 

as to protect against cross-contact and 

contamination and must be held at such 

temperature and relative humidity and 

in such a manner as to prevent the food 

from becoming adulterated. Material 

scheduled for rework must be identified 

as such. 

(6) Frozen raw materials and 

ingredients must be kept frozen. If 

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thawing is required prior to use, it must 

be done in a manner that prevents the 

raw materials and ingredients from 

becoming adulterated. 

(7) Liquid or dry raw materials and 

ingredients received and stored in bulk 

form must be held in a manner that 

protects against cross-contact and 

contamination. 

(8) Raw materials and ingredients that 

are food allergens, and rework that 

contains food allergens, must be 

identified and held in a manner that 

prevents cross-contact. 

(c) Manufacturing operations. (1) 

Equipment and utensils and finished 

food containers must be maintained in 

an acceptable condition through 

appropriate cleaning and sanitizing, as 

necessary. Insofar as necessary, 

equipment must be taken apart for 

thorough cleaning. 

(2) All food manufacturing, 

processing, packing, and holding must 

be conducted under such conditions 

and controls as are necessary to 

minimize the potential for the growth of 

microorganisms or for the 

contamination of food. 

(3) Food that can support the rapid 

growth of undesirable microorganisms 

must be held at temperatures that will 

prevent the food from becoming 

adulterated during manufacturing, 

processing, packing and holding. 

(4) Measures such as sterilizing, 

irradiating, pasteurizing, cooking, 

freezing, refrigerating, controlling pH, or 

controlling aw that are taken to destroy 

or prevent the growth of undesirable 

microorganisms must be adequate under 

the conditions of manufacture, 

handling, and distribution to prevent 

food from being adulterated. 

(5) Work-in-process and rework must 

be handled in a manner that protects 

against cross-contact, contamination, 

and growth of undesirable 

microorganisms. 

(6) Effective measures must be taken 

to protect finished food from crosscontact and contamination by raw 

materials, ingredients, or refuse. When 

raw materials, ingredients, or refuse are 

unprotected, they must not be handled 

simultaneously in a receiving, loading, 

or shipping area if that handling could 

result in cross-contact or contaminated 

food. Food transported by conveyor 

must be protected against cross-contact 

and contamination as necessary. 

(7) Equipment, containers, and 

utensils used to convey, hold, or store 

raw materials, work-in-process, rework, 

or food must be constructed, handled, 

and maintained during manufacturing, 

processing, packing and holding in a 

manner that protects against crosscontact and contamination. 

(8) Effective measures must be taken 

to protect against the inclusion of metal 

or other extraneous material in food. 

(9) Food, raw materials, and 

ingredients that are adulterated must be 

disposed of in a manner that protects 

against the contamination of other food 

or, if the adulterated food is capable of 

being reconditioned, it must be 

reconditioned using a method that has 

been proven to be effective. 

(10) Steps such as washing, peeling, 

trimming, cutting, sorting and 

inspecting, mashing, dewatering, 

cooling, shredding, extruding, drying, 

whipping, defatting, and forming must 

be performed so as to protect food 

against cross-contact and 

contamination. Food should be 

protected from contaminants that may 

drip, drain, or be drawn into the food. 

(11) Heat blanching, when required in 

the preparation of food, should be 

effected by heating the food to the 

required temperature, holding it at this 

temperature for the required time, and 

then either rapidly cooling the food or 

passing it to subsequent manufacturing 

without delay. Thermophilic growth 

and contamination in blanchers should 

be minimized by the use of adequate 

operating temperatures and by periodic 

cleaning. 

(12) Batters, breading, sauces, gravies, 

dressings, and other similar 

preparations must be treated or 

maintained in such a manner that they 

are protected against cross-contact and 

contamination. 

(13) Filling, assembling, packaging, 

and other operations must be performed 

in such a way that the food is protected 

against cross-contact, contamination 

and growth of undesirable 

microorganisms. 

(14) Food, including dry mixes, nuts, 

intermediate moisture food, and 

dehydrated food, that relies on the 

control of aw for preventing the growth 

of undesirable microorganisms must be 

processed to and maintained at a safe 

moisture level. 

(15) Food, including acid and 

acidified food, that relies principally on 

the control of pH for preventing the 

growth of undesirable microorganisms 

must be monitored and maintained at a 

pH of 4.6 or below. 

(16) When ice is used in contact with 

food, it must be made from water that 

is safe and of adequate sanitary quality, 

and must be used only if it has been 

manufactured in accordance with 

current good manufacturing practice as 

outlined in this part. 

§ 117.93 Warehousing and distribution. 

Storage and transportation of food 

must be under conditions that will 

protect against cross-contact and 

biological, chemical, physical, and 

radiological contamination of food, as 

well as against deterioration of the food 

and the container. 

§ 117.110 Defect action levels. 

Natural or unavoidable defects in food 

for human use that present no health 

hazard: 

(a) Some foods, even when produced 

under current good manufacturing 

practice, contain natural or unavoidable 

defects that at low levels are not 

hazardous to health. FDA establishes 

maximum levels for these defects in 

foods produced under current good 

manufacturing practice and uses these 

levels in deciding whether to 

recommend regulatory action. 

(b) Defect action levels are established 

for foods when it is necessary and 

feasible to do so. These levels are 

subject to change upon the development 

of new technology or the availability of 

new information. 

(c) Compliance with defect action 

levels does not excuse violation of the 

requirement in section 402(a)(4) of the 

Federal Food, Drug, and Cosmetic Act 

that food not be prepared, packed, or 

held under unsanitary conditions 

whereby it may have become 

contaminated with filth, or whereby it 

may have been rendered injurious to 

health, or the requirements in this part 

that food manufacturers, processors, 

packers, and holders must observe 

current good manufacturing practice. 

Evidence indicating that such a 

violation exists causes the food to be 

adulterated, even though the amounts of 

natural or unavoidable defects are lower 

than the currently established defect 

action levels. The manufacturer, 

processor, packer and holder of food 

must at all times utilize quality control 

operations that reduce natural or 

unavoidable defects to the lowest level 

currently feasible. 

(d) The mixing of a food containing 

defects at levels that render that food 

adulterated with another lot of food is 

not permitted and renders the final food 

adulterated, regardless of the defect 

level of the final food. 

Subpart C—Hazard Analysis and RiskBased Preventive Controls 

§ 117.126 Requirement for a food safety 

plan. 

(a) Food safety plan. The owner, 

operator, or agent in charge of a facility 

must prepare, or have prepared, and 

implement a written food safety plan. 

(b) Contents of a Food Safety Plan. 

The food safety plan must include: 

(1) The written hazard analysis as 

required by § 117.130(a)(2); 

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(2) The written preventive controls as 

required by § 117.135(b); 

(3) The written procedures, and the 

frequency with which they are to be 

performed, for monitoring the 

implementation of the preventive 

controls as required by § 117.140(a); 

(4) The written corrective action 

procedures as required by 

§ 117.145(a)(1); 

(5) The written verification 

procedures as required by § 117.150(e); 

and 

(6) The written recall plan as required 

by § 117.137(a). 

(c) Qualified individual. The food 

safety plan must be prepared by (or its 

preparation overseen by) a qualified 

individual. 

§ 117.130 Hazard analysis. 

(a) Requirement for a hazard analysis. 

(1) The owner, operator, or agent in 

charge of a facility must identify and 

evaluate known or reasonably 

foreseeable hazards for each type of food 

manufactured, processed, packed, or 

held at the facility to determine whether 

there are hazards that are reasonably 

likely to occur. 

(2) The hazard analysis must be 

written. 

(b) Hazard identification. The hazard 

identification must consider hazards 

that may occur naturally or may be 

unintentionally introduced, including: 

(1) Biological hazards, including 

microbiological hazards such as 

parasites, environmental pathogens, and 

other microorganisms of public health 

significance; 

(2) Chemical hazards, including 

substances such as pesticide and drug 

residues, natural toxins, decomposition, 

unapproved food or color additives, and 

food allergens; 

(3) Physical hazards; and 

(4) Radiological hazards. 

(c) Hazard evaluation. (1) The hazard 

analysis must include an evaluation of 

the hazards identified in paragraph (b) 

of this section to determine whether the 

hazards are reasonably likely to occur, 

including an assessment of the severity 

of the illness or injury if the hazard 

were to occur. 

(2) The hazard analysis must include 

an evaluation of whether environmental 

pathogens are reasonably likely to occur 

whenever a ready-to-eat food is exposed 

to the environment prior to packaging. 

(3) The hazard evaluation must 

consider the effect of the following on 

the safety of the finished food for the 

intended consumer: 

(i) The formulation of the food; 

(ii) The condition, function, and 

design of the facility and equipment; 

(iii) Raw materials and ingredients; 

(iv) Transportation practices; 

(v) Manufacturing/processing 

procedures; 

(vi) Packaging activities and labeling 

activities; 

(vii) Storage, and distribution; 

(viii) Intended or reasonably 

foreseeable use; 

(ix) Sanitation, including employee 

hygiene; and 

(x) Any other relevant factors. 

§ 117.135 Preventive controls for hazards 

that are reasonably likely to occur. 

For hazards indentified in the hazard 

analysis as reasonably likely to occur: 

(a) The owner, operator, or agent in 

charge of a facility must identify and 

implement preventive controls, 

including at critical control points, if 

any, to provide assurances that hazards 

identified in the hazard analysis as 

reasonably likely to occur will be 

significantly minimized or prevented 

and the food manufactured, processed, 

packed, or held by such facility will not 

be adulterated under section 402 of the 

Federal Food, Drug, and Cosmetic Act 

or misbranded under section 403(w) of 

the Federal Food, Drug, and Cosmetic 

Act. 

(b) Preventive controls must be 

written. 

(c) Preventive controls must include, 

as appropriate to the facility and the 

food: 

(1) Parameters associated with the 

control of the hazard, such as 

parameters associated with heat 

processing, acidifying, irradiating, and 

refrigerating foods, and 

(2) The maximum or minimum value, 

or combination of values, to which any 

biological, chemical, physical, or 

radiological parameter must be 

controlled to significantly minimize or 

prevent a hazard that is reasonably 

likely to occur. 

(d) Preventive controls must include, 

as appropriate: 

(1) Process controls. Process controls 

must include those procedures, 

practices, and processes performed on a 

food during manufacturing/processing 

that are employed to significantly 

minimize or prevent hazards that are 

reasonably likely to occur. 

(2) Food allergen controls. Food 

allergen controls must include those 

procedures, practices, and processes 

employed for: 

(i) Ensuring protection of food from 

cross-contact, including during storage 

and use; and 

(ii) Labeling the finished food, 

including ensuring that the finished 

food is not misbranded under section 

403(w) of the Federal Food, Drug, and 

Cosmetic Act. 

(3) Sanitation controls. (i) Where 

necessary to significantly minimize or 

prevent hazards that are reasonably 

likely to occur (including any 

environmental pathogen that is 

reasonably likely to occur in a ready-toeat food that is exposed to the 

environment prior to packaging, any 

microorganism of public health 

significance that is reasonably likely to 

occur in a ready-to-eat food due to 

employee handling, and any food 

allergen hazard) sanitation controls 

must include procedures for the: 

(A) Cleanliness of food-contact 

surfaces, including food-contact 

surfaces of utensils and equipment; 

(B) Prevention of cross-contact and 

cross-contamination from insanitary 

objects and from personnel to food, food 

packaging material, and other foodcontact surfaces and from raw product 

to processed product. 

(ii) The owner, operator or agent in 

charge of a facility must take action to 

correct, in a timely manner, conditions 

and practices that are not consistent 

with the procedures in paragraphs 

(d)(3)(i)(A) or (d)(3)(i)(B) of this section. 

(iii) The owner, operator, or agent in 

charge of a facility is not required to 

follow the corrective actions established 

in § 117.145(a) and (b) when the owner, 

operator, or agent in charge of a facility 

takes action, in accordance with 

paragraph (d)(3)(ii) of this section, to 

correct conditions and practices that are 

not consistent with the procedures in 

paragraphs (d)(3)(i)(A) or (d)(3)(i)(B) of 

this section. 

(iv) All corrective actions taken in 

accordance with paragraph (d)(3)(ii) of 

this section must be documented in 

records that are subject to verification in 

accordance with § 117.150(c) and 

records review in accordance with 

§ 117.150(d)(5)(i). 

(4) Recall plan. Recall plan as 

required by § 117.137. 

(5) Other controls. Preventive controls 

must include any other controls 

necessary to satisfy the requirements of 

paragraph (a) of this section. 

(e)(1) Except as provided by 

paragraph (e)(2) of this section, the 

preventive controls required under this 

section are subject to: 

(i) Monitoring as required by 

§ 117.140; 

(ii) Corrective actions as required by 

§ 117.145; and 

(iii) Verification as required by 

§ 117.150. 

(2) The recall plan established in 

§ 117.137 is not subject to the 

requirements of paragraph (e)(1) of this 

section. 

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§ 117.137 Recall plan for food with a 

hazard that is reasonably likely to occur. 

For food with a hazard that is 

reasonably likely to occur: 

(a) The owner, operator, or agent in 

charge of a facility must establish a 

written recall plan for the food. 

(b) The recall plan must include 

procedures that describe the steps to be 

taken, and assign responsibility for 

taking those steps, to perform the 

following actions: 

(1) Directly notify the direct 

consignees of the food being recalled, 

including how to return or dispose of 

the affected food; 

(2) Notify the public about any hazard 

presented by the food when appropriate 

to protect public health; 

(3) Conduct effectiveness checks to 

verify that the recall is carried out; and 

(4) Appropriately dispose of recalled 

food—e.g., through reprocessing, 

reworking, diverting to a use that does 

not present a safety concern, or 

destroying the food. 

§ 117.140 Monitoring. 

(a) The owner, operator, or agent in 

charge of a facility must establish and 

implement written procedures, 

including the frequency with which 

they are to be performed, for monitoring 

the preventive controls. 

(b) The owner, operator, or agent in 

charge of a facility must monitor the 

preventive controls with sufficient 

frequency to provide assurance that they 

are consistently performed. 

(c) All monitoring of preventive 

controls in accordance with this section 

must be documented in records that are 

subject to verification in accordance 

with § 117.150(b) and records review in 

accordance with § 117.150(d)(5)(i). 

§ 117.145 Corrective actions. 

(a) Corrective action procedures. (1) 

The owner, operator, or agent in charge 

of a facility must establish and 

implement written corrective action 

procedures that must be taken if 

preventive controls are not properly 

implemented. 

(2) The corrective action procedures 

must describe the steps to be taken to 

ensure that: 

(i) Appropriate action is taken to 

identify and correct a problem with 

implementation of a preventive control 

to reduce the likelihood that the 

problem will recur; 

(ii) All affected food is evaluated for 

safety; and 

(iii) All affected food is prevented 

from entering into commerce, if the 

owner, operator or agent in charge of 

such facility cannot ensure that the 

affected food is not adulterated under 

section 402 of the Federal Food, Drug, 

and Cosmetic Act or misbranded under 

section 403(w) of the Federal Food, 

Drug, and Cosmetic Act. 

(b) Corrective action in the event of an 

unanticipated problem. If a preventive 

control is not properly implemented 

and a specific corrective action 

procedure has not been established, or 

a preventive control is found to be 

ineffective, the owner, operator, or agent 

in charge of a facility must: 

(1) Take corrective action to identify 

and correct the problem to reduce the 

likelihood that the problem will recur, 

evaluate all affected food for safety, and, 

as necessary, prevent affected food from 

entering commerce as would be done 

following a corrective action procedure 

under paragraphs (a)(2)(i) through 

(a)(2)(iii) of this section; and 

(2) Reanalyze the food safety plan in 

accordance with § 117.150(f) to 

determine whether modification of the 

food safety plan is required. 

(c) Documentation. All corrective 

actions taken in accordance with this 

section must be documented in records 

that are subject to verification in 

accordance with § 117.150(c) and 

records review in accordance with 

§ 117.150(d)(5)(i). 

§ 117.150 Verification. 

(a) Validation. Except as provided by 

paragraph (a)(3) of this section, the 

owner, operator, or agent in charge of a 

facility must validate that the preventive 

controls identified and implemented in 

accordance with § 117.135 to control the 

hazards identified in the hazard analysis 

as reasonably likely to occur are 

adequate to do so. The validation of the 

preventive controls: 

(1) Must be performed by (or overseen 

by) a qualified individual: 

(i) Prior to implementation of the food 

safety plan or, when necessary, during 

the first 6 weeks of production; and 

(ii) Whenever a reanalysis of the food 

safety plan reveals the need to do so; 

(2) Must include collecting and 

evaluating scientific and technical 

information (or, when such information 

is not available or is insufficient, 

conducting studies) to determine 

whether the preventive controls, when 

properly implemented, will effectively 

control the hazards that are reasonably 

likely to occur; and 

(3) Need not address: 

(i) The food allergen controls in 

§ 117.135(d)(2); 

(ii) The sanitation controls in 

§ 117.135(d)(3); and 

(iii) The recall plan in § 117.137. 

(b) Monitoring. The owner, operator, 

or agent in charge of a facility must 

verify that monitoring is being 

conducted, as required by § 117.140. 

(c) Corrective actions. The owner, 

operator, or agent in charge of a facility 

must verify that appropriate decisions 

about corrective actions are being made, 

as required by § 117.145 and 

§ 117.135(d)(3)(ii). 

(d) Implementation and effectiveness. 

The owner, operator, or agent in charge 

must verify that the preventive controls 

are consistently implemented and are 

effectively and significantly minimizing 

or preventing the hazards that are 

reasonably likely to occur. This must 

include the following activities, as 

appropriate to the facility and the food: 

(1) Calibration of process monitoring 

instruments and verification 

instruments; and 

(2) Review of the following records 

within the specified timeframes, by (or 

under the oversight of) a qualified 

individual, to ensure that the records 

are complete, the activities reflected in 

the records occurred in accordance with 

the food safety plan, the preventive 

controls are effective, and appropriate 

decisions were made about corrective 

actions: 

(i) Records of monitoring and 

corrective action records within a week 

after the records are made. 

(ii) Records of calibration within a 

reasonable time after the records are 

made. 

(e) Written procedures for verification 

activities. As appropriate to the facility 

and the food, the owner, operator, or 

agent in charge of a facility must 

establish and implement written 

procedures for the frequency of 

calibrating process monitoring 

instruments and verification 

instruments. 

(f) Reanalysis. (1) The owner, 

operator, or agent in charge of a facility 

must: 

(i) Conduct a reanalysis of the food 

safety plan; 

(A) At least once every 3 years; 

(B) Whenever a significant change is 

made in the activities conducted at a 

facility operated by such owner, 

operator, or agent in charge if the 

change creates a reasonable potential for 

a new hazard or a significant increase in 

a previously identified hazard; 

(C) Whenever such owner, operator or 

agent in charge becomes aware of new 

information about potential hazards 

associated with the food; 

(D) Whenever a preventive control is 

not properly implemented and a 

specific corrective action procedure has 

not been established; and 

(E) Whenever a preventive control is 

found to be ineffective. 

(ii) Complete such reanalysis and 

implement any additional preventive 

controls needed to address the hazard 

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identified, if any, before the change in 

activities at the facility is operative or, 

when necessary, during the first 6 weeks 

of production; and 

(iii) Revise the written plan if a 

significant change is made or document 

the basis for the conclusion that no 

additional or revised preventive 

controls are needed. 

(2) The reanalysis must be performed 

(or overseen) by a qualified individual. 

(3) FDA may require a reanalysis of 

the food safety plan to respond to new 

hazards and developments in scientific 

understanding. 

(g) Documentation. All verification 

activities taken in accordance with this 

section must be documented in records. 

§ 117.155 Requirements applicable to a 

qualified individual. 

(a) One or more qualified individuals 

must do or oversee the following: 

(1) Preparation of the food safety plan 

(§ 117.126(c)); 

(2) Validation of the preventive 

controls (§ 117.150(a)(1)); 

(3) Review of records for 

implementation and effectiveness of 

preventive controls and appropriateness 

of corrective actions (§ 117.150(d)(2)); 

and 

(4) Reanalysis of the food safety plan 

(§ 117.150(f)(2)). 

(b) To be qualified, an individual 

must have successfully completed 

training in the development and 

application of risk-based preventive 

controls at least equivalent to that 

received under a standardized 

curriculum recognized as adequate by 

FDA or be otherwise qualified through 

job experience to develop and apply a 

food safety system. Job experience may 

qualify an individual to perform these 

functions if such experience has 

provided an individual with knowledge 

at least equivalent to that provided 

through the standardized curriculum. 

This individual may be, but is not 

required to be, an employee of the 

facility. 

(c) All applicable training must be 

documented in records, including the 

date of the training, the type of training, 

and the person(s) trained. 

§ 117.175 Records required for subpart C. 

(a) The owner, operator, or agent in 

charge of a facility must establish and 

maintain the following records: 

(1) The written food safety plan, 

including the written hazard analysis, 

preventive controls, monitoring 

procedures, corrective action 

procedures, verification procedures, and 

recall plan. 

(2) Records that document the 

monitoring of preventive controls; 

(3) Records that document corrective 

actions; 

(4) Records that document 

verification, including, as applicable, 

those related to: 

(i) Validation, 

(ii) Monitoring, 

(iii) Corrective actions, 

(iv) Calibration of process monitoring 

and verification instruments, 

(v) Records review, and 

(vi) Reanalysis; and 

(5) Records that document applicable 

training for the qualified individual. 

(b) The records that the owner, 

operator, or agent in charge of a facility 

must establish and maintain are subject 

to the requirements of subpart F of this 

part. 

Subpart D—Modified Requirements 

§ 117.201 Modified requirements that 

apply to a qualified facility. 

(a) Documentation to be submitted. A 

qualified facility must submit the 

following documentation to the FDA: 

(1) Documentation that the facility is 

a qualified facility as defined in § 117.3. 

For the purpose of determining whether 

a facility satisfies the definition of 

qualified facility, the baseline year for 

calculating the adjustment for inflation 

is 2011; and 

(2)(i) Documentation that 

demonstrates that the owner, operator, 

or agent in charge of the facility has 

identified the potential hazards 

associated with the food being 

produced, is implementing preventive 

controls to address the hazards, and is 

monitoring the performance of the 

preventive controls to ensure that such 

controls are effective; or 

(ii) Documentation (which may 

include licenses, inspection reports, 

certificates, permits, credentials, 

certification by an appropriate agency 

(such as a State department of 

agriculture), or other evidence of 

oversight) that the facility is in 

compliance with State, local, county, or 

other applicable non-Federal food safety 

law, including relevant laws and 

regulations of foreign countries. 

(b) Procedure for submission. The 

documentation required by paragraph 

(a) of this section must be submitted to 

FDA by one of the following means: 

(1) Electronic submission. To submit 

electronically, go to http:// 

www.access.fda.gov and follow the 

instructions. This Web site is available 

from wherever the Internet is accessible, 

including libraries, copy centers, 

schools, and Internet cafes. FDA 

encourages electronic submission. 

(2) Submission by mail. To submit 

documents in a paper format or in an 

electronic format on a CD–ROM, by mail 

to the U.S. Food and Drug 

Administration, ATTN: Qualified 

Facility Coordinator, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993. We recommend that an owner, 

operator or agent in charge of a facility 

submit by mail only if the facility does 

not have reasonable access to the 

Internet. 

(c) Frequency of submission. The 

documentation required by paragraph 

(a) of this section must be: 

(1) Submitted to FDA initially within 

90 days of the applicable compliance 

date of this part; and 

(2) Resubmitted at least every 2 years, 

or whenever there is a material change 

to the information described in 

paragraph (a) of this section. For the 

purpose of this section, a material 

change is one that changes whether or 

not a facility is a ‘‘qualified facility.’’ 

(d) Notification to consumers. A 

qualified facility that does not submit 

documentation under paragraph (a)(2)(i) 

of this section must provide notification 

to consumers as to the name and 

complete business address of the facility 

where the food was manufactured or 

processed (including the street address 

or P.O. box, city, state, and zip code for 

domestic facilities, and comparable full 

address information for foreign 

facilities), as follows: 

(1) If a food packaging label is 

required, the notification required by 

paragraph (c)(1) of this section must 

appear prominently and conspicuously 

on the label of the food. 

(2) If a food packaging label is not 

required, the notification required by 

paragraph (c)(1) of this section must 

appear prominently and conspicuously, 

at the point of purchase, on a label, 

poster, sign, placard, or documents 

delivered contemporaneously with the 

food in the normal course of business, 

or in an electronic notice, in the case of 

Internet sales. 

(e) Records. (1) A qualified facility 

must maintain those records relied upon 

to support the documentation required 

by § 117.201(a). 

(2) The records that a qualified facility 

must maintain are subject to the 

requirements of subpart F of this part. 

§ 117.206 Modified requirements that 

apply to a facility solely engaged in the 

storage of packaged food that is not 

exposed to the environment. 

(a) The owner, operator, or agent in 

charge of a facility solely engaged in the 

storage of packaged food that is not 

exposed to the environment must 

conduct the following activities for any 

such refrigerated packaged food that 

requires time/temperature control to 

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significantly minimize or prevent the 

growth of, or toxin production by, 

microorganisms of public health 

significance: 

(1) Establish and implement 

temperature controls adequate to 

significantly minimize or prevent the 

growth of, or toxin production by, 

microorganisms of public health 

significance; 

(2) Monitor the temperature controls 

with sufficient frequency to provide 

assurance they are consistently 

performed; 

(3) If there is a problem with the 

temperature controls for such 

refrigerated packaged food, take 

appropriate corrective actions to: 

(i) Correct the problem and reduce the 

likelihood that the problem will recur; 

(ii) Evaluate all affected food for 

safety; and 

(iii) Prevent the food from entering 

commerce, if the owner, operator, or 

agent in charge of the facility cannot 

ensure the affected food is not 

adulterated under section 402 of the 

Federal Food, Drug, and Cosmetic Act; 

(4) Verify that temperature controls 

are consistently implemented by: 

(i) Calibrating temperature monitoring 

and recording devices; 

(ii) Reviewing records of calibration 

within a reasonable time after the 

records are made; and 

(iii) Reviewing records of monitoring 

and corrective actions taken to correct a 

problem with the control of temperature 

within a week after the records are 

made; 

(5) Establish and maintain the 

following records: 

(i) Records documenting the 

monitoring of temperature controls for 

any such refrigerated packaged food; 

(ii) Records of corrective actions taken 

when there is a problem with the 

control of temperature for any such 

refrigerated packaged food; and 

(iii) Records documenting verification 

activities. 

(b) The records that a facility must 

establish and maintain under paragraph 

(a)(5) of this section are subject to the 

requirements of subpart F of this part. 

Subpart E—Withdrawal of an 

Exemption Applicable to a Qualified 

Facility 

§ 117.251 Circumstances that may lead 

FDA to withdraw an exemption applicable to 

a qualified facility. 

FDA may withdraw the exemption 

applicable to a qualified facility under 

§ 117.5(a): 

(a) In the event of an active 

investigation of a foodborne illness 

outbreak that is directly linked to the 

qualified facility; or 

(b) If FDA determines that it is 

necessary to protect the public health 

and prevent or mitigate a foodborne 

illness outbreak based on conduct or 

conditions associated with the qualified 

facility that are material to the safety of 

the food manufactured, processed, 

packed, or held at such facility. 

§ 117.254 Issuance of an order to withdraw 

an exemption applicable to a qualified 

facility. 

(a) If FDA determines that an 

exemption applicable to a qualified 

facility under § 117.5(a) should be 

withdrawn, any officer or qualified 

employee of FDA may issue an order to 

withdraw the exemption. 

(b) An FDA District Director in whose 

district the qualified facility is located 

(or, in the case of a foreign facility, the 

Director of the Office of Compliance in 

the Center for Food Safety and Applied 

Nutrition), or an FDA official senior to 

such Director, must approve an order to 

withdraw the exemption. 

(c) FDA must issue an order to 

withdraw the exemption to the owner, 

operator, or agent in charge of the 

facility. 

(d) FDA must issue an order to 

withdraw the exemption in writing, 

signed and dated by the officer or 

qualified employee of FDA who is 

issuing the order. 

§ 117.257 Contents of an order to withdraw 

an exemption applicable to a qualified 

facility. 

An order to withdraw an exemption 

applicable to a qualified facility under 

§ 117.5(a) must include the following 

information: 

(a) The date of the order; 

(b) The name, address, and location of 

the qualified facility; 

(c) A brief, general statement of the 

reasons for the order, including 

information relevant to: 

(1) An active investigation of a 

foodborne illness outbreak that is 

directly linked to the facility; or 

(2) Conduct or conditions associated 

with a qualified facility that are material 

to the safety of the food manufactured, 

processed, packed, or held at such 

facility. 

(d) A statement that the facility must 

comply with subpart C of this part on 

the date that is 60 calendar days after 

the date of the order; 

(e) The text of section 418(l) of the 

Federal Food, Drug, and Cosmetic Act 

and of this subpart E; 

(f) A statement that any informal 

hearing on an appeal of the order must 

be conducted as a regulatory hearing 

under part 16 of this chapter, with 

certain exceptions described in 

§ 117.270; 

(g) The mailing address, telephone 

number, email address, and facsimile 

number of the FDA district office and 

the name of the FDA District Director in 

whose district the facility is located (or, 

in the case of a foreign facility, the same 

information for the Director of the Office 

of Compliance in the Center for Food 

Safety and Applied Nutrition); and 

(h) The name and the title of the FDA 

representative who approved the order. 

§ 117.260 Compliance with, or appeal of, 

an order to withdraw an exemption 

applicable to a qualified facility. 

(a) The owner, operator, or agent in 

charge of a qualified facility that 

receives an order under § 117.251 to 

withdraw an exemption applicable to 

that facility under § 117.5(a) must 

either: 

(1) Comply with applicable 

requirements of this part within 60 

calendar days of the date of the order; 

or 

(2) Appeal the order within 10 

calendar days of the date of the order in 

accordance with the requirements of 

§ 117.264. 

(b) Submission of an appeal, 

including submission of a request for an 

informal hearing, will not operate to 

delay or stay any administrative action, 

including enforcement action by FDA, 

unless the Commissioner of Food and 

Drugs, as a matter of discretion, 

determines that delay or a stay is in the 

public interest. 

(c) If the owner, operator, or agent in 

charge of the qualified facility appeals 

the order, and FDA confirms the order, 

the owner, operator, or agent in charge 

of the facility must comply with 

applicable requirements of this part 

within 60 calendar days of the date of 

the order. 

§ 117.264 Procedure for submitting an 

appeal. 

(a) To appeal an order to withdraw an 

exemption applicable to a qualified 

facility under § 117.5(a), the owner, 

operator, or agent in charge of the 

facility must: 

(1) Submit the appeal in writing to the 

FDA District Director in whose district 

the facility is located (or, in the case of 

a foreign facility, the Director of the 

Office of Compliance in the Center for 

Food Safety and Applied Nutrition), at 

the mailing address, email address, or 

facsimile number identified in the order 

within 10 calendar days of the date of 

the order; 

(2) Respond with particularity to the 

facts and issues contained in the order, 

including any supporting 

documentation upon which the owner, 

operator or agent in charge of the facility 

relies. 

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(b) In a written appeal of the order 

withdrawing an exemption provided 

under § 117.5(a), the owner, operator, or 

agent in charge of the facility may 

include a written request for an informal 

hearing as provided in § 117.267. 

§ 117.267 Procedure for requesting an 

informal hearing. 

(a) If the owner, operator, or agent in 

charge of the facility appeals the order, 

the owner, operator, or agent in charge 

of the facility: 

(1) May request an informal hearing; 

and 

(2) Must submit any request for an 

informal hearing together with its 

written appeal submitted in accordance 

with § 117.264 within 10 calendar days 

of the date of the order. 

(b) A request for an informal hearing 

may be denied, in whole or in part, if 

the presiding officer determines that no 

genuine and substantial issue of 

material fact has been raised by the 

material submitted. If the presiding 

officer determines that a hearing is not 

justified, written notice of the 

determination will be given to the 

owner, operator, or agent in charge of 

the facility explaining the reason for the 

denial. 

§ 117.270 Requirements applicable to an 

informal hearing. 

If the owner, operator or agent in 

charge of the facility requests an 

informal hearing, and FDA grants the 

request: 

(a) The hearing will be held within 10 

calendar days after the date the appeal 

is filed or, if applicable, within a time 

frame agreed upon in writing by the 

owner, operator, or agent in charge of 

the facility and FDA. 

(b) The presiding officer may require 

that a hearing conducted under this 

subpart be completed within 1 calendar 

day, as appropriate. 

(c) FDA must conduct the hearing in 

accordance with part 16 of this chapter, 

except that: 

(1) The order withdrawing an 

exemption under §§ 117.254 and 

117.257, rather than the notice under 

§ 16.22(a) of this chapter, provides 

notice of opportunity for a hearing 

under this section and is part of the 

administrative record of the regulatory 

hearing under § 16.80(a) of this chapter. 

(2) A request for a hearing under this 

subpart must be addressed to the FDA 

District Director (or, in the case of a 

foreign facility, the Director of the Office 

of Compliance in the Center for Food 

Safety and Applied Nutrition) as 

provided in the order withdrawing an 

exemption. 

(3) Section 117.274, rather than 

§ 16.42(a) of this chapter, describes the 

FDA employees who preside at hearings 

under this subpart. 

(4) Section 16.60(e) and (f) of this 

chapter does not apply to a hearing 

under this subpart. The presiding officer 

must prepare a written report of the 

hearing. All written material presented 

at the hearing will be attached to the 

report. The presiding officer must 

include as part of the report of the 

hearing a finding on the credibility of 

witnesses (other than expert witnesses) 

whenever credibility is a material issue, 

and must include a proposed decision, 

with a statement of reasons. The hearing 

participant may review and comment on 

the presiding officer’s report within 2 

calendar days of issuance of the report. 

The presiding officer will then issue the 

final decision. 

(5) Section 16.80(a)(4) of this chapter 

does not apply to a regulatory hearing 

under this subpart. The presiding 

officer’s report of the hearing and any 

comments on the report by the hearing 

participant under § 117.270(c)(4) are 

part of the administrative record. 

(6) No party shall have the right, 

under § 16.119 of this chapter to 

petition the Commissioner of Food and 

Drugs for reconsideration or a stay of the 

presiding officer’s final decision. 

(7) If FDA grants a request for an 

informal hearing on an appeal of an 

order withdrawing an exemption, the 

hearing must be conducted as a 

regulatory hearing under a regulation in 

accordance with part 16 of this chapter, 

except that § 16.95(b) does not apply to 

a hearing under this subpart. With 

respect to a regulatory hearing under 

this subpart, the administrative record 

of the hearing specified in 

§§ 16.80(a)(1), (a)(2), (a)(3), and (a)(5), 

and 117.270(c)(5) constitutes the 

exclusive record for the presiding 

officer’s final decision. For purposes of 

judicial review under § 10.45 of this 

chapter, the record of the administrative 

proceeding consists of the record of the 

hearing and the presiding officer’s final 

decision. 

§ 117.274 Presiding officer for an appeal 

and for an informal hearing. 

The presiding officer for an appeal, 

and for an informal hearing, must be an 

FDA Regional Food and Drug Director 

or another FDA official senior to an FDA 

District Director. 

§ 117.277 Time frame for issuing a 

decision on an appeal. 

(a) If the owner, operator, or agent in 

charge of a facility appeals the order 

without requesting a hearing, the 

presiding officer must issue a written 

report that includes a final decision 

confirming or revoking the withdrawal 

by the 10th calendar day after the 

appeal is filed. 

(b) If the owner, operator, or agent in 

charge of a facility appeals the order and 

requests an informal hearing: 

(1) If FDA grants the request for a 

hearing and the hearing is held, the 

presiding officer must provide a 2 

calendar day opportunity for the hearing 

participants to review and submit 

comments on the report of the hearing 

under § 117.270(c)(4), and must issue a 

final decision within 10 calendar days 

after the hearing is held; or 

(2) If FDA denies the request for a 

hearing, the presiding officer must issue 

a final decision on the appeal 

confirming or revoking the withdrawal 

within 10 calendar days after the date 

the appeal is filed. 

§ 117.280 Revocation of an order to 

withdraw an exemption applicable to a 

qualified facility. 

An order to withdraw an exemption 

applicable to a qualified facility under 

§ 117.5(a) is revoked if: 

(a) The owner, operator, or agent in 

charge of the facility appeals the order 

and requests an informal hearing, FDA 

grants the request for an informal 

hearing, and the presiding officer does 

not confirm the order within the 10 

calendar days after the hearing, or issues 

a decision revoking the order within 

that time; or 

(b) The owner, operator, or agent in 

charge of the facility appeals the order 

and requests an informal hearing, FDA 

denies the request for an informal 

hearing, and FDA does not confirm the 

order within the 10 calendar days after 

the appeal is filed, or issues a decision 

revoking the order within that time; or 

(c) The owner, operator, or agent in 

charge of the facility appeals the order 

without requesting an informal hearing, 

and FDA does not confirm the order 

within the 10 calendar days after the 

appeal is filed, or issues a decision 

revoking the order within that time. 

§ 117.284 Final agency action. 

Confirmation of a withdrawal order 

by the presiding officer is considered a 

final agency action for purposes of 5 

U.S.C. 702. 

Subpart F—Requirements Applying to 

Records That Must Be Established and 

Maintained 

§ 117.301 Records subject to the 

requirements of this subpart F. 

(a) Except as provided by paragraphs 

(b) and (c) of this section, all records 

required by this part are subject to all 

requirements of this subpart F. 

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(b) The requirements of § 117.310 

apply only to the written food safety 

plan. 

(c) The requirements of § 117.305(b), 

(d), (e), and (f) do not apply to the 

records required by § 117.201(e). 

§ 117.305 General requirements applying 

to records. 

Records must: 

(a) Be kept as original records, true 

copies (such as photocopies, pictures, 

scanned copies, microfilm, microfiche, 

or other accurate reproductions of the 

original records), or electronic records, 

which must be kept in accordance with 

part 11 of this chapter; 

(b) Contain the actual values and 

observations obtained during 

monitoring; 

(c) Be accurate, indelible, and legible; 

(d) Be created concurrently with 

performance of the activity documented; 

(e) Be as detailed as necessary to 

provide history of work performed; and 

(f) Include: 

(1) The name and location of the plant 

or facility; 

(2) The date and time of the activity 

documented; 

(3) The signature or initials of the 

person performing the activity; and 

(4) Where appropriate, the identity of 

the product and the production code, if 

any. 

§ 117.310 Additional requirements 

applying to the food safety plan. 

The food safety plan must be signed 

and dated by the owner, operator, or 

agent in charge of the facility: 

(a) Upon initial completion; and 

(b) Upon any modification. 

§ 117.315 Requirements for record 

retention. 

(a) All records required by this part 

must be retained at the plant or facility 

for at least 2 years after the date they 

were prepared. 

(b) Records that relate to the general 

adequacy of the equipment or processes 

being used by a facility, including the 

results of scientific studies and 

evaluations, must be retained at the 

facility for at least 2 years after their use 

is discontinued (e.g., because the facility 

has updated the written food safety plan 

(§ 117.126) or records that document 

validation of the written food safety 

plan (§ 117.150(a)); 

(c) Except for the food safety plan, 

offsite storage of records is permitted 

after 6 months following the date that 

the record was made if such records can 

be retrieved and provided onsite within 

24 hours of request for official review. 

The food safety plan must remain 

onsite. Electronic records are considered 

to be onsite if they are accessible from 

an onsite location. 

(d) If the plant or facility is closed for 

a prolonged period, the records may be 

transferred to some other reasonably 

accessible location but must be returned 

to the plant or facility within 24 hours 

for official review upon request. 

§ 117.320 Requirements for official review. 

All records required by this part must 

be made promptly available to a duly 

authorized representative of the 

Secretary of Health and Human Services 

upon oral or written request. 

§ 117.325 Public disclosure. 

Records required by this part are 

subject to the disclosure requirements 

under part 20 of this chapter. 

Subpart G—[Reserved] 

PART 120—HAZARD ANALYSIS AND 

CRITICAL CONTROL POINT (HACCP) 

SYSTEMS 

■ 16. The authority citation for 21 CFR 

part 120 continues to read as follows: 

Authority: 21 U.S.C. 321, 342, 343, 346, 

348, 371, 374, 379e, 381, 393; 42 U.S.C. 241. 

■ 17. Amend § 120.3 by revising the first 

sentence of the introductory text to read 

as follows: 

§ 120.3 Definitions. 

The definitions of terms in section 

201 of the Federal Food, Drug, and 

Cosmetic Act, § 101.9(j)(18)(vi), and 

parts 110 and 117 of this chapter are 

applicable to such terms when used in 

this part, except that the definitions and 

terms in parts 110 and 117 do not 

govern such terms where such terms are 

redefined in this part and except that 

the terms facility, hazard, and 

manufacturing/processing in parts 110 

and 117 do not govern such terms where 

used in this part. * * * 

* * * * * 

■ 18. Revise § 120.5 to read as follows: 

§ 120.5 Current good manufacturing 

practice. 

Except as provided by § 117.5(c), parts 

110 and 117 of this chapter apply in 

determining whether the facilities, 

methods, practices, and controls used to 

process juice are safe, and whether the 

food has been processed under sanitary 

conditions. 

■ 19. Amend § 120.6 by revising the first 

sentence of paragraph (b) to read as 

follows: 

§ 120.6 Sanitation standard operating 

procedures. 

* * * * * 

(b) Monitoring. The processor shall 

monitor the conditions and practices 

during processing with sufficient 

frequency to ensure, at a minimum, 

conformance with those conditions and 

practices specified in part 110 and in 

subpart B of part 117 of this chapter that 

are appropriate both to the plant and to 

the food being processed. * * * 

* * * * * 

PART 123—FISH AND FISHERY 

PRODUCTS 

■ 20. The authority citation for 21 CFR 

part 123 continues to read as follows: 

Authority: 21 U.S.C. 321, 342, 343, 346, 

348, 371, 374, 379e, 381, 393; 42 U.S.C. 241, 

241l, 264. 

■ 21. Revise the first sentence of the 

introductory text in § 123.3 to read as 

follows: 

§ 123.3 Definitions. 

The definitions and interpretations of 

terms in section 201 of the Federal 

Food, Drug, and Cosmetic Act (the act) 

and in parts 110 and 117 of this chapter 

are applicable to such terms when used 

in this part, except that the definitions 

and terms in parts 110 and 117 do not 

govern such terms where such terms are 

redefined in this part and except that 

the terms facility, hazard, and 

manufacturing/processing in parts 110 

and 117 do not govern such terms where 

used in this part. * * * 

* * * * * 

■ 22. Revise paragraph (a) of § 123.5 to 

read as follows: 

§ 123.5 Current good manufacturing 

practice. 

(a) Except as provided by § 117.5(b), 

parts 110 and 117 of this chapter apply 

in determining whether the facilities, 

methods, practices, and controls used to 

process fish and fishery products are 

safe, and whether these products have 

been processed under sanitary 

conditions. 

* * * * * 

■ 23. Amend § 123.11 by revising the 

introductory text of paragraph (b) to 

read as follows: 

§ 123.11 Sanitation control procedures. 

* * * * * 

(b) Sanitation monitoring. Each 

processor shall monitor the conditions 

and practices during processing with 

sufficient frequency to ensure, at a 

minimum, conformance with those 

conditions and practices specified in 

part 110 and in subpart B of part 117 of 

this chapter that are both appropriate to 

the plant and the food being processed 

and relate to the following: 

* * * * * 

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PART 129—PROCESSING AND 

BOTTLING OF BOTTLED DRINKING 

WATER 

■ 24. The authority citation for 21 CFR 

part 129 continues to read as follows: 

Authority: 21 U.S.C. 342, 348, 371, 374; 42 

U.S.C. 264. 

■ 25. Revise § 129.1 to read as follows: 

§ 129.1 Current good manufacturing 

practice. 

The applicable criteria in parts 110 

and 117 of this chapter, as well as the 

criteria in §§ 129.20, 129.35, 129.37, 

129.40, and 129.80 shall apply in 

determining whether the facilities, 

methods, practices, and controls used in 

the processing, bottling, holding, and 

shipping of bottled drinking water are in 

conformance with or are operated or 

administered in conformity with good 

manufacturing practice to assure that 

bottled drinking water is safe and that 

it has been processed, bottled, held, and 

transported under sanitary conditions. 

PART 179—IRRADIATION IN THE 

PRODUCTION, PROCESSING AND 

HANDLING OF FOOD 

■ 26. The authority citation for 21 CFR 

part 179 continues to read as follows: 

Authority: 21 U.S.C. 321, 342, 343, 348, 

373, 374. 

■ 27. Revise paragraph (a) of § 179.25 to 

read as follows: 

§ 179.25 General provisions for food 

irradiation. 

* * * * * 

(a) Any firm that treats foods with 

ionizing radiation shall comply with the 

requirements of parts 110 and 117 of 

this chapter and other applicable 

regulations. 

* * * * * 

PART 211—CURRENT GOOD 

MANUFACTURING PRACTICE FOR 

FINISHED PHARMACEUTICALS 

■ 28. The authority citation for 21 CFR 

part 211 continues to read as follows: 

Authority: 21 U.S.C. 321, 351, 352, 355, 

360b, 371, 374; 42 U.S.C. 216, 262, 263a, 264. 

■ 29. Amend § 211.1 by revising the last 

sentence in paragraph (c) to read as 

follows: 

§ 211.1 Scope. 

* * * * * 

(c) * * * Therefore, until further 

notice, regulations under parts 110 and 

117 of this chapter, and where 

applicable, parts 113 to 129 of this 

chapter, shall be applied in determining 

whether these OTC drug products that 

are also foods are manufactured, 

processed, packed, or held under 

current good manufacturing practice. 

Dated: January 3, 2013. 

Leslie Kux, 

Assistant Commissioner for Policy. 

Note: The following appendix will not 

appear in the Code of Federal Regulations. 

Appendix 

Although the proposed rule that is the 

subject of this document does not include 

provisions for environmental monitoring or 

finished product testing, we believe that 

these regimes can play a critical role in a 

modern food safety system. In sections XII.J.2 

and XII.J.3 of the preamble of this document, 

we request comment on when and how these 

types of testing are an appropriate means of 

implementing the statutory directives set out 

in section 418 of the FD&C Act. In this 

Appendix, we provide background material 

on these testing measures. 

I. The Role of Testing as a Verification 

Measure in a Modern Food Safety System 

A. Verification of Preventive Controls 

The safety of food is principally ensured by 

the effective implementation of scientifically 

valid preventive control measures throughout 

the food chain (Ref. 34) (Ref. 110). Prevention 

of hazards in food is much more effective 

than trying to differentiate safe from unsafe 

food using testing. Although testing is rarely 

considered a control measure, it plays a very 

important role in ensuring the safety of food. 

An important purpose of testing is to verify 

that control measures, including those 

related to suppliers and those verified 

through environmental monitoring, are 

controlling the hazard (Ref. 111) (Ref. 112). 

Testing is used in conjunction with other 

verification measures in the food safety 

system, such as audits of suppliers, 

observations of whether activities are being 

conducted according to the food safety plan, 

and reviewing records to determine whether 

process controls are meeting specified limits 

for parameters established in the food safety 

plan. Although testing may be conducted for 

biological, chemical, physical or radiological 

hazards, the most common testing is for 

microbiological hazards. Thus, much of the 

testing described below focuses on microbial 

testing, but many of the issues discussed 

apply to testing for other hazards as well. We 

focus more of our discussion below on 

verification testing of the environment 

because of the increasing recognition of the 

benefits of such testing in identifying 

conditions that could result in environmental 

pathogens contaminating food; thus such 

verification testing is important in preventing 

contamination in food, whereas verification 

testing of raw materials, ingredients, and 

finished products is used to detect 

contamination that has already occurred. 

As discussed in sections I.C, I.E, and I.F of 

this Appendix, microbial testing may 

include: 

• Testing raw materials and ingredients to 

verify that suppliers have significantly 

minimized or prevented hazards reasonably 

likely to occur in the raw materials and 

ingredients; 

• Testing the environment to verify that 

sanitation controls have significantly 

minimized or prevented the potential for 

environmental pathogens to contaminate RTE 

food; and 

• Testing finished product to verify that 

preventive controls have significantly 

minimized or prevented hazards reasonably 

likely to occur in the food. 

Each type of testing provides information 

applicable to managing hazards in foods, 

depending on the food and process. For 

example, a dry blending operation, e.g., for 

spices and seasonings, often verifies its 

supplier controls by testing incoming 

ingredients before use (as discussed in 

section I.C of this Appendix) and 

periodically sampling and testing finished 

products. If all the ingredients being blended 

had been treated to adequately reduce 

hazards such as Salmonella spp., a dry 

blending operation generally does less testing 

to verify supplier controls than if this were 

not the case. (We use the term ‘‘adequately 

reduce’’ (which is a term used in some of our 

guidance documents) (Ref. 6) (Ref. 156) to 

mean the same as ‘‘significantly minimize or 

prevent’’ as described in section 418 of the 

FD&C Act or ‘‘prevent, eliminate or reduce to 

an acceptable level’’ as used in our seafood 

and juice HACCP regulations. All these terms 

mean to reduce a hazard to an extent that it 

is not reasonably likely to cause illness or 

injury.) A dry blending operation generally 

does not test incoming ingredients if the 

facility treats the blended materials to ensure 

adequate reduction of pathogens but 

sometimes tests finished product to verify 

preventive controls have been effective. A 

dry blending operation also sometimes uses 

environmental monitoring to verify that 

sanitation controls to significantly minimize 

or prevent the potential for environmental 

pathogens to contaminate the blended 

materials have been effective. 

For acidified canned vegetables in which a 

lethal process is delivered in the final 

package, microbial testing of incoming 

ingredients and of finished product provides 

little benefit as a verification activity 

(although it would be used in process 

validation); however, facilities producing 

such products sometimes conduct periodic 

testing of incoming ingredients for pesticides 

as an appropriate supplier verification 

activity. 

B. Scientifically Valid Sampling and Testing 

Consistent with our previous discussion of 

the term ‘‘scientifically valid’’ in the 

proposed rule to establish CGMP 

requirements for dietary ingredients and 

dietary supplements (68 FR 12158 at 12198), 

we use the term ‘‘scientifically valid’’ with 

respect to testing to mean using an approach 

to both sampling and testing that is based on 

scientific information, data, or results 

published in, for example, scientific journals, 

references, text books, or proprietary 

research. A scientifically valid analytical 

method is one that is based on scientific data 

or results published in, for example, 

scientific journals, references, text books, or 

proprietary research (68 FR 12158 at 12198). 

Sampling and testing used for verification in 

a food safety system must be scientifically 

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valid if they are to provide assurance that 

preventive controls are effective. 

C. Verification Testing of Raw Materials and 

Ingredients 

Raw materials and ingredients are often 

tested as part of a supplier approval and 

verification program, as one of the 

verification activities when a preventive 

control that is adequate to significantly 

minimize or prevent the hazard is not 

applied at the receiving facility. The utility 

and frequency of raw material and ingredient 

testing for verification of supplier controls 

depend on many factors, including: 

• The hazard and its association with the 

raw material or ingredient; 

• The likelihood that the consumer would 

become ill if the hazard were present in the 

raw material or ingredient; 

• How that raw material or ingredient will 

be used by the receiving facility (e.g., the 

effect of processing on the hazard); and 

• The potential for contamination of the 

facility’s environment with the hazard in the 

raw material or ingredient. 

Testing a raw material or ingredient occurs 

more frequently when there is a history of the 

hazard in the raw material or ingredient, e.g., 

from a specific supplier or from the country 

of origin. Once a facility has developed a 

relationship with a supplier and there is a 

history of tests negative for the hazard, the 

frequency is often reduced. 

Testing a raw material or ingredient is 

more useful, and a facility generally tests a 

raw material or ingredient more frequently, 

when the raw material or ingredient contains 

a hazard for which there is a reasonable 

probability that exposure to the hazard will 

result in serious adverse health consequences 

or death to humans or animals. However, 

when a hazard that the receiving facility has 

identified as reasonably likely to occur in a 

raw material or ingredient is one for which 

the receiving facility has preventive controls 

that significantly minimize or prevent the 

hazard, testing generally is less frequent. An 

exception to this general paradigm is when 

the process control depends on the amount 

of the hazard present in the raw material or 

ingredient (e.g., when the process control is 

effective at eliminating 100 microorganisms 

per gram of ingredient, but not 1,000 

microorganisms per gram of ingredient) and 

there is a need to verify that the hazard is not 

present in amounts that would render the 

process control ineffective. A receiving 

facility often finds that testing of raw 

materials or ingredients is most useful, and 

generally tests more frequently, when the 

receiving facility does not have a process that 

would significantly minimize the hazard and 

is relying on preventive controls earlier in 

the supply chain to significantly minimize or 

prevent the hazard in the raw material or 

ingredient, as in a bagged salad facility or a 

dry-mix operation producing, for example, 

spice blends or trail mix. In such situations, 

the testing is conducted to verify the 

preventive controls used to ensure that 

hazards in the raw material or ingredient 

have been significantly minimized or 

prevented. 

The frequency of the testing conducted by 

a facility generally depends in part on the 

likelihood and severity of illness to the 

consumer if the hazard were present, the 

ability of supplier controls to significantly 

minimize or prevent the hazard in the raw 

material or ingredient, the practicality of 

testing to detect the hazard, and other factors. 

For example, a facility generally tests a raw 

material or ingredient more frequently from 

a supplier that does not have a kill step for 

Salmonella spp. in shelled nutmeats 

compared to a supplier that steam treats the 

nuts to kill Salmonella spp. As another 

example, if a facility tests a raw material or 

ingredient as part of its food safety program 

for salad greens, the facility is more likely to 

test more frequently for E. coli O157:H7 than 

for other Shiga-toxin producing E. coli 

(pathogenic E. coli that produce the same 

toxin as E. coli O157:H7 but are less likely 

to cause severe illness (Ref. 195)), based on 

both the severity of the illness to the 

consumer and practical problems with 

testing fresh produce for pathogenic strains 

of Shiga-toxin producing E. coli. Where a raw 

material or ingredient could introduce an 

environmental pathogen such as Salmonella 

spp. or L. monocytogenes to the facility (e.g., 

raw nuts or soy powder for Salmonella spp.; 

chopped celery to be used in a salad for L. 

monocytogenes), a facility generally tests the 

raw material or ingredient more frequently to 

verify that supplier controls for the raw 

material or ingredient minimize to the extent 

possible the potential for a contaminated raw 

material or ingredient to introduce the 

environmental pathogen to the facility’s 

environment. 

As discussed in section I.F of this 

Appendix, there are limitations to testing 

food. Thus, as with other testing, raw 

material or ingredient testing is rarely the 

sole basis for making a determination on the 

safety of a raw material or ingredient. 

D. Verification of Sanitation Controls To 

Significantly Minimize or Prevent the 

Potential for an Environmental Pathogen To 

Contaminate Food 

1. Environmental Pathogens in Food 

As discussed in section II.D of the 

preamble of this document, food can become 

contaminated with pathogenic 

microorganisms at many different steps in 

the farm-to-table continuum. Any time a food 

is exposed to the environment during a 

manufacturing, processing, packing, or 

holding activity, there is the potential for the 

food to be contaminated with pathogenic 

microorganisms. As discussed in section X.B 

of the preamble of this document, proposed 

§ 117.3 would define the term 

‘‘environmental pathogen’’ to mean a 

microorganism that is of public health 

significance and is capable of surviving and 

persisting within the manufacturing, 

processing, packing, or holding environment. 

The environmental pathogens most 

frequently involved in the contamination of 

foods leading to foodborne illness are 

Salmonella spp. and L. monocytogenes. 

2. Salmonella spp. as an Environmental 

Pathogen 

We discuss Salmonella spp. in section 

II.D.2.a of the preamble of this document. 

Salmonella has been isolated from a variety 

of foods and it can get into food by a variety 

of mechanisms (see section II.D of the 

preamble of this document). Our focus here 

is on Salmonella contamination from the 

environment (discussed further in section 

I.D.2 of this Appendix), particularly as a 

hazard associated with low-moisture foods 

(Ref. 145) (Ref. 179). Low-moisture foods 

include cereal, peanuts, nuts, nut butters 

(including peanut butter), spices, dried herbs, 

milk powder, chocolate and many other 

foods. Although Salmonella outbreaks from 

low-moisture foods are less common than 

from foods such as eggs and produce, several 

such outbreaks in the last decade have 

involved hundreds of illnesses (Ref. 145). 

The low-moisture foods causing outbreaks 

included cereal, raw almonds, dried snacks, 

spices, and peanut butter (Ref. 145) (Ref. 

196). Chocolate also has been a source of 

outbreaks from Salmonella spp., although 

none in the U.S. in recent years (Ref. 145). 

Dried dairy products, such as milk and whey, 

also present a risk of contamination with 

Salmonella spp. from the environment (Ref. 

197). A review of FDA recall data from 1970 

to 2003 showed there were 21 recalls of 

spices and herbs contaminated with 

Salmonella spp. (Ref. 198). Almost half of the 

86 primary RFR entries reported in the first 

RFR Annual Report due to finding 

Salmonella spp. were from low-moisture 

foods (Ref. 60). 

3. Listeria monocytogenes as an 

Environmental Pathogen 

We discuss L. monocytogenes in section 

II.D.2.a of the preamble of this document. As 

discussed in that section, the FDA/FSIS Lm 

RA shows that the risk of illness from L. 

monocytogenes increases with the number of 

cells ingested and that there is greater risk of 

illness from RTE foods that support growth 

of L. monocytogenes than from those that do 

not (Ref. 56). A key finding of the risk 

assessment released by FAO in 2004 was that 

the models developed predict that nearly all 

cases of listeriosis result from the 

consumption of high numbers of the 

pathogen (Ref. 54). Refrigerated foods present 

a greater risk from L. monocytogenes because 

some refrigerated foods that support growth 

may be held for an extended period of time, 

thus increasing the risk if L. monocytogenes 

is present in a food. Growth of L. 

monocytogenes does not occur if the food is 

frozen, but the organism may survive. If a 

frozen food contaminated with L. 

monocytogenes is thawed and held at 

temperatures that support growth, e.g., under 

refrigeration, the risk of illness from L. 

monocytogenes in that food increases. As 

discussed in section II.D.1 of the preamble of 

this document, contamination of RTE food 

with L. monocytogenes from the environment 

is common and, thus, targeted preventive 

controls to significantly minimize or prevent 

L. monocytogenes contamination of RTE 

foods are warranted. 

4. Environmental Pathogens in the Plant 

Environment 

Environmental pathogens may be 

introduced into a facility through raw 

materials or ingredients, people, or objects 

(Ref. 145) (Ref. 179) (Ref. 199) (Ref. 144) (Ref. 

185). Once in the facility, environmental 

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pathogens can be a source of contamination 

of food. Environmental pathogens may be 

transient strains or resident strains (Ref. 145) 

(Ref. 179) (Ref. 199). Transient strains are 

environmental pathogens that contaminate a 

site in the facility where they can be 

eliminated by normal cleaning and sanitizing 

(Ref. 199). Transient strains tend to vary over 

time within a facility, e.g., they will be found 

in different areas and the specific strain will 

differ. Resident strains are environmental 

pathogens that contaminate a site in the 

facility that is difficult to clean and sanitize 

with normal cleaning and sanitizing 

procedures and, thus, these strains become 

established in what is referred to as a ‘‘niche’’ 

or harborage site (Ref. 145) (Ref. 179) (Ref. 

199) (Ref. 144) (Ref. 185) (Ref. 200). The 

finding of the same specific strain multiple 

times in a facility often indicates a resident 

strain. 

If a harborage site contains nutrients (i.e., 

food) and water and is exposed to a 

temperature that falls within the growth 

range of the environmental pathogen, the 

pathogen can multiply, which increases the 

chance that it will be transferred to other 

sites (including food-contact surfaces) and to 

food. Transfer can occur by people (e.g., if a 

person touches the contaminated site and 

then touches other objects, or tracks the 

pathogen from the contamination site to 

other sites on shoes), by equipment (e.g., if 

the pathogen is picked up by the wheels of 

a cart or forklift and is transferred to other 

locations), by water (e.g., water that contacts 

the harborage site is splashed onto other 

areas, including equipment, or aerosols 

containing the pathogen transfer it to other 

areas) or by air (dissemination of 

contaminated dust particles by air handling 

systems) (Ref. 145) (Ref. 179) (Ref. 200) (Ref. 

144). Such transfer mechanisms from 

harborage sites can result in intermittent 

contamination of food-contact surfaces and 

food over long periods of time, often with the 

same strain of the pathogen (Ref. 145) (Ref. 

199) (Ref. 200) (Ref. 201). 

5. Contamination of Food With Salmonella 

spp. From the Plant Environment 

As discussed immediately below, the 

available data and information associate 

insanitary conditions in food facilities with 

contamination of a number of foods with the 

environmental pathogen Salmonella spp. 

Such contamination has led to recalls and to 

outbreaks of foodborne illness. 

In 1998, a breakfast cereal product was 

implicated in an outbreak, due to Salmonella 

Agona, that caused 409 illnesses and one 

death in 23 states (Ref. 201) (Ref. 202) (Ref. 

203). During the outbreak investigation, 

Salmonella was isolated from various 

locations in the plant, including the floor, 

processing equipment, and the exhaust 

system of the implicated processing line (Ref. 

201). In 2008, the same Salmonella Agona 

strain was again implicated in an outbreak 

linked to a similar cereal product from the 

same manufacturing facility (Ref. 204). In the 

2008 outbreak, the same strain was isolated 

from patients, cereal and the plant 

environment (Ref. 204). 

In 2006–2007, a commercial brand peanut 

butter contaminated with Salmonella 

Tennessee caused 715 illnesses and 129 

hospitalizations (Ref. 62). FDA isolated 

Salmonella Tennessee from 13 unopened jars 

of peanut butter with production dates 

ranging from August 2006 to January 2007 

and from two plant environmental samples 

(Ref. 63). 

During the years 2008 through 2010, there 

were three large recalls of foods containing 

ingredients contaminated with Salmonella 

spp. where FDA’s investigation identified 

insanitary conditions at the facility that 

manufactured the ingredient and detected 

Salmonella spp. in the plant environment 

(Ref. 19) (Ref. 23) (Ref. 66) (Ref. 67) (Ref. 68) 

(Ref. 69) (Ref. 205) (Ref. 155) (Ref. 206). In 

2008–2009, an outbreak was linked to 

Salmonella Typhimurium in peanut butter 

and peanut paste (Ref. 66) (Ref. 67) (Ref. 205). 

This outbreak resulted in an estimated 714 

illnesses, 166 hospitalizations, and 9 deaths 

(Ref. 67). Implicated foods included 

contaminated peanut butter consumed at 

institutional settings and crackers made with 

the contaminated peanut butter as an 

ingredient (Ref. 66) (Ref. 67). Inspections 

conducted by FDA at the two implicated 

ingredient manufacturing facilities (which 

shared ingredients) revealed lack of controls 

to prevent product contamination from pests, 

from an insanitary air-circulation system, 

from insanitary food-contact surfaces, and 

from the processing environment (Ref. 19) 

(Ref. 68) (Ref. 69). Several strains of 

Salmonella spp. were found in multiple 

products and in the plant environment (Ref. 

68). This outbreak led to the recall of more 

than 3900 products containing peanutderived ingredients (Ref. 20). 

In 2009, USDA detected Salmonella spp. in 

a powdered dairy shake and FDA began an 

investigation of the suppliers of ingredients 

used to manufacture the product. The 

inspection of the supplier of one of the 

ingredients uncovered insanitary conditions 

that resulted in the recall of multiple 

ingredients manufactured by that supplier, 

including instant nonfat dried milk and whey 

proteins, produced over a 2-year period (Ref. 

155). During its investigation of the 

supplier’s facility, FDA identified several 

strains of Salmonella spp. on food-contact 

and non-food-contact surfaces and in other 

areas of the plant environment, as well as a 

number of sanitation deficiencies (Ref. 206). 

In 2010, FDA received a report through the 

RFR of Salmonella contamination of 

hydrolyzed vegetable proteins that a 

company purchased as an ingredient. Both 

the company that submitted the report and 

FDA found multiple Salmonella-positive 

samples collected from the plant 

environment, including food-contact 

surfaces. FDA found numerous sanitation 

deficiencies during its inspection of the 

production facility. There were no reports of 

illness associated with the contamination, 

but multiple product recalls resulted (Ref. 

23). 

6. Contamination of Food With L. 

monocytogenes From the Plant Environment 

As discussed immediately below, the 

available data and information associate 

insanitary conditions in food facilities with 

contamination of a number of foods with the 

environmental pathogen L. monocytogenes. 

Such contamination has led to recalls and to 

outbreaks of foodborne illness. 

Between October 2008 and March 2009, 

eight cases of listeriosis from five states were 

linked to Mexican-style cheese that was 

likely contaminated post-pasteurization (Ref. 

72). The outbreak strain was isolated from 

product and from a vat gasket in a postpasteurization section of the processing line. 

In October 2010, the Texas Department of 

State Health Services ordered a fresh-cut 

produce facility to stop processing after 

laboratory tests of chopped celery indicated 

the presence of L. monocytogenes (Ref. 207). 

The testing was done as part of an 

investigation of 10 cases of listeriosis, six of 

which were linked to chopped celery from 

the facility. Texas Department of State Health 

Services and FDA inspectors found 

sanitation deficiencies at the plant (Ref. 207) 

(Ref. 208) and suggested that the L. 

monocytogenes in the chopped celery may 

have contaminated other produce. FDA 

laboratory testing found L. monocytogenes in 

multiple locations in the plant environment, 

including on food-contact surfaces; the DNA 

fingerprint of the L. monocytogenes in the 

FDA samples matched the DNA fingerprint of 

the clinical cases reported by the Texas 

Department of State Health Services (Ref. 

209). 

In 2011, an outbreak of listeriosis from 

cantaloupes was attributed to insanitary 

conditions at a facility that washed, packed, 

cooled, and stored intact cantaloupes (Ref. 

79) (Ref. 80). The outbreak appears to have 

occurred due to a combination of factors, 

including pooled water on the floor of the 

facility (which was also difficult to clean), 

poorly designed equipment (not easily 

cleaned and sanitized) that was previously 

used for a different commodity, no pre-cool 

step, a truck parked near the packing area 

that had visited a cattle operation, and 

possible low level contamination from the 

growing/harvesting operation (Ref. 79). 

There have been several outbreaks in 

which meat or poultry products produced in 

FSIS-inspected establishments were 

contaminated with L. monocytogenes from 

the plant environment (Ref. 210), and much 

of our understanding of sources of L. 

monocytogenes in the plant environment, as 

well as appropriate ways to control this 

organism, has come from the efforts of FSIS 

and the meat and poultry industry to control 

this hazard in FSIS-inspected establishments 

(Ref. 185). For example, harborage sites such 

as hollow rollers, rubber seals, close-fitting 

metal-to-metal spaces in equipment such as 

slicers, and on-off switches of equipment 

were identified in meat and poultry 

establishments. The increased risk of 

contamination resulting from construction, 

and the importance of control of traffic and 

water in the RTE area also became widely 

known as a result of investigations at meat 

and poultry establishments (Ref. 144) (Ref. 

185). 

Outbreaks of listeriosis resulting from 

environmental contamination have also 

occurred in other countries. For example, an 

outbreak of listeriosis in Finland in 1999 was 

associated with butter (Ref. 211). The 

outbreak strain was isolated from the 

manufacturing facility, including from the 

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packaging machine and the floor (Ref. 211). 

An outbreak of listeriosis in 2009 in Austria 

and Germany was associated with acid curd 

cheese; the outbreak strain was found in the 

production facility (Ref. 212). 

Many foods without a known association 

with illnesses have been recalled due to the 

presence of L. monocytogenes (Ref. 188) (Ref. 

189) (Ref. 190) (Ref. 213). There is also an 

extensive body of literature on isolation of L. 

monocytogenes in the food processing 

environment. Information on the 

environment as a source of Listeria has been 

available for many years. For example, in a 

1989 study involving 6 different types of food 

plants (frozen food, fluid dairy, cheese, ice 

cream, potato processing, and dry food), 

drains, floors, standing water, food residues, 

and food-contact surfaces were found to be 

positive (Ref. 214). No finished foods were 

tested, but the authors concluded that food 

production environments could be the source 

of contamination for foods that have received 

listericidal treatments and that measures 

should be taken to prevent survival and 

growth of these organisms in food 

environments (Ref. 214). 

Listeria testing in 62 dairy facilities during 

1987–1988 (including facilities producing 

fluid milk, frozen product, butter, processed 

cheese, natural cheese and dry products) 

found Listeria in a variety of locations, 

including packaging equipment, conveyors, 

coolers, drains and floors (Ref. 215). Listeria 

was detected more frequently in wet 

locations, including drains, conveyors and 

floors (Ref. 215). Pritchard and co-workers 

also examined 21 dairy processing 

environments for Listeria and found 80 of 

378 sites positive for Listeria spp. (Ref. 216). 

Sites positive for L. monocytogenes included 

holding tanks, table tops, conveyor/chain 

systems, a milk filler and a brine pre-filter 

machine (Ref. 216). 

The packaging machine was found to be 

the main problem with L. monocytogenes 

that persisted in an ice cream plant in 

Finland for several years and occasionally 

contaminated finished product (Ref. 217). A 

volumetric doser was found to be the source 

of L. monocytogenes in sauces produced in 

a fresh sauce production plant in Italy (Ref. 

218), and slicers and conveyor belts were 

found to contribute to contamination of 

sandwiches in a Swiss sandwich producing 

plant (Ref. 219). L. monocytogenes also has 

been found on tables, water hoses, air guns, 

floors, gloves, drains and a bread-feeding 

machine (Ref. 219). 

Some of the available data and information 

about the potential presence of the 

environmental pathogen L. monocytogenes 

comes from studies conducted to detect the 

presence of Listeria spp. in lieu of L. 

monocytogenes. Listeria spp. are ‘‘indicators’’ 

of the potential presence of L. 

monocytogenes. (See section I.E of this 

Appendix for a discussion of indicator 

organisms). A study conducted over a 4-year 

time period on the prevalence of L. 

monocytogenes on produce and in the plant 

environment in a large produce processing 

plant in Poland demonstrated that the 

indicator organism Listeria spp., and the 

environmental pathogen L. monocytogenes, 

could be isolated from conveyor belts after 

blanching and from freezing tunnels (Ref. 

220). Studies in a vegetable processing plant 

in Spain found the indicator organism L. 

innocua (commonly found when the species 

of Listeria spp. are determined) in frozen RTE 

vegetables and in the plant environment, e.g., 

washing tunnels, conveyor belts and floors 

(Ref. 221). L. innocua was more prevalent 

than L. monocytogenes in the frozen RTE 

vegetables and in the plant environment. In 

both of these examples, the presence of an 

‘‘indicator organism’’ (either Listeria spp. or 

L. innocua) demonstrated that insanitary 

conditions existed that were conducive to the 

presence and harborage of L. monocytogenes. 

E. Role of Environmental Monitoring in 

Verifying the Implementation and 

Effectiveness of Sanitation Controls in 

Significantly Minimizing or Preventing the 

Potential for an Environmental Pathogen To 

Contaminate Food 

1. Purpose of Environmental Monitoring 

Appropriate sanitation controls can 

minimize the presence of environmental 

pathogens in the plant and the transfer of 

environmental pathogens to food-contact 

surfaces and to food (Ref. 199). The purpose 

of monitoring for environmental pathogens in 

facilities where food is manufactured, 

processed, packed or held is to verify the 

implementation and effectiveness of 

sanitation controls intended to significantly 

minimize or prevent the potential for an 

environmental pathogen to contaminate food. 

In so doing, environmental monitoring can 

find sources of environmental pathogens that 

remain in the facility after routine cleaning 

and sanitizing (particularly strains that may 

have become established in the facility as 

resident strains) so that the environmental 

pathogens can be eliminated by appropriate 

corrective actions (e.g., intensified cleaning 

and sanitizing, sometimes involving 

equipment disassembly). Pritchard et al. 

noted that daily cleaning and sanitizing 

appeared to be effective in eliminating 

transient contaminants from equipment and 

concluded that greater emphasis needs to be 

placed on cleaning and sanitizing the plant 

environment (Ref. 216). A robust 

environmental monitoring program for 

environmental pathogens can detect these 

strains and enables the facility to eliminate 

them from the environment which can 

prevent contamination of food with these 

pathogens and, thus, prevent foodborne 

illnesses (Ref. 52) (Ref. 144) (Ref. 185) (Ref. 

186) (Ref. 184). In the situations described in 

sections I.D.5 and I.D.6 of this Appendix, 

such a program for the environmental 

pathogens Salmonella spp. and L. 

monocytogenes might have allowed the 

facility to detect a problem before product 

contamination occurred, thereby preventing 

an outbreak, recall, or both, or minimizing 

the amount of product affected by a recall. 

Studies of environmental pathogens have 

clearly demonstrated that environmental 

monitoring can identify the presence of 

situations that can lead to contamination of 

food and allow actions to be taken to prevent 

such contamination (Ref. 216) (Ref. 187). 

2. Indicator Organisms 

The term ‘‘indicator organism’’ can have 

different meanings, depending on the 

purpose of using an indicator organism. As 

discussed in the scientific literature, the term 

‘‘indicator organism’’ means a microorganism 

or group of microorganisms that is indicative 

that (1) a food has been exposed to 

conditions that pose an increased risk for 

contamination of the food with a pathogen or 

(2) a food has been exposed to conditions 

under which a pathogen can increase in 

numbers (Ref. 222). This definition in the 

scientific literature is consistent with a 

definition of indicator organism established 

by NACMCF as one that indicates a state or 

condition and an index organism as one for 

which the concentration or frequency 

correlates with the concentration or 

frequency of another microorganism of 

concern (Ref. 223). FDA considers the 

NACMCF definition of an indicator organism 

to be an appropriate working definition for 

the purpose of this document. 

The use of ‘‘indicator organisms’’ as a 

verification of hygiene measures in facilities 

is common practice (Ref. 224). For example, 

it is common practice to use the presence of 

generic (nonpathogenic) E. coli in a food 

processing plant as an indication of whether 

food was prepared, packed, or held under 

insanitary conditions, without considering 

whether the insanitary conditions reflect a 

specific pathogen, such as E. coli O157:H7 or 

Salmonella spp. However, such use of an 

indicator organism is distinct from the use of 

indicator organisms as discussed in the 

remainder of this document—i.e., for the 

specific purpose of monitoring for the 

presence of environmental pathogens. 

Environmental monitoring for 

environmental pathogens can be conducted 

by testing for the specific pathogenic 

microorganism (e.g., Salmonella spp.) or by 

testing for an ‘‘indicator organism.’’ The 

presence of an indicator organism indicates 

conditions in which the environmental 

pathogen may be present. An organism is 

useful as an indicator organism if there is 

sufficient association of conditions that could 

result in the presence of the indicator 

organism and conditions that could result in 

the pathogen such that there can be 

confidence that the pathogen would not be 

present if the indicator is not present. 

Attributes that provide scientific support for 

use of an indicator organism in lieu of a 

specific pathogen include: 

• Similar survival and growth 

characteristics; 

• A shared common source for both 

organisms; and 

• A direct relationship between the state or 

condition that contributes to the presence of 

pathogen and the indicator organism (Ref. 

223). 

The presence of an indicator organism in 

the plant environment, including on a foodcontact surface, does not necessarily mean 

that an environmental pathogen is in the 

plant or in a food produced using that foodcontact surface—the indicator may be present 

but the pathogen may be absent. Pritchard et 

al., in their study on the presence of Listeria 

in dairy plant environments, concluded that, 

because the level of contamination was 

higher in environmental samples than in 

equipment samples, environmental 

contamination with Listeria does not 

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necessarily translate into contamination of 

equipment in the plant (Ref. 216). 

Typically, a facility that finds an indicator 

organism during environmental monitoring 

conducts microbial testing of surrounding 

surfaces and areas to determine the potential 

source of the contamination, cleans and 

sanitizes the contaminated surfaces and 

areas, and conducts additional microbial 

testing to determine whether the 

contamination has been eliminated. If the 

indicator organism is found on retest, the 

facility generally takes more aggressive 

corrective actions (e.g., more intensified 

cleaning and sanitizing, including 

dismantling equipment, scrubbing surfaces, 

and heat-treating equipment parts) (Ref. 144). 

In general, whether a facility takes 

subsequent steps to determine an indicator 

organism detected on a food-contact surface 

is actually the environmental pathogen 

depends, in part, on the risk of foodborne 

illness if the food being produced on a foodcontact surface that has tested positive for an 

indicator organism were to be contaminated. 

For example, the risk of listeriosis is greater 

if the food supports growth of L. 

monocytogenes. In some cases, a facility 

simply assumes that a food produced using 

a food-contact surface that is contaminated 

with an indicator organism is contaminated 

with the environmental pathogen and takes 

corrective action to either reprocess it or 

divert it to a use that would not present a 

food safety concern. 

3. Environmental Monitoring for L. 

monocytogenes and the Use of an Indicator 

Organism 

Tests for the indicator organism Listeria 

spp. detect multiple species of Listeria, 

including the pathogen L. monocytogenes. 

There is Federal precedent for the use of 

Listeria spp. as an appropriate indicator 

organism for L. monocytogenes. FSIS has 

established regulations requiring FSISregulated establishments that produce RTE 

meat or poultry products exposed to the 

processing environment after a lethality 

procedure (e.g., cooking) to prevent product 

adulteration by L. monocytogenes. 

FSIS has issued guidelines (FSIS 

Compliance Guideline for Controlling 

Listeria monocytogenes in Post-lethality 

Exposed Ready-to-Eat Meat and Poultry 

Products) (hereinafter the FSIS Listeria 

Compliance Guideline) to help FSISregulated establishments that produce RTE 

meat or poultry products exposed to the 

processing environment after a lethality 

procedure comply with the requirements of 

9 CFR part 430 (Ref. 225). Under the FSIS 

Listeria Compliance Guideline, FSISregulated establishments may establish an 

environmental monitoring program for 

Listeria spp. rather than for the pathogen, L. 

monocytogenes. 

In general, under the FSIS Listeria 

Compliance Guideline, an FSIS-regulated 

establishment that receives a positive test 

result for an indicator organism on a foodcontact surface: 

• Takes corrective action (i.e., intensify the 

cleaning and sanitizing of the affected foodcontact surface); 

• Retests the affected food-contact surface; 

and 

• Takes additional corrective action 

(intensified each time the test is positive for 

the indicator organism) and conducts 

additional testing until the affected foodcontact surface is negative for the indicator 

organism. 

Some segments of the food industry subject 

to regulation by FDA have adopted the 

principles, described in the FSIS Listeria 

Compliance Guideline, for corrective actions 

after a finding of Listeria spp. on food-contact 

surfaces in the plant. For example, in 

response to a request for comments on a draft 

guidance document directed to control of L. 

monocytogenes in refrigerated or frozen 

ready-to-eat foods, we received letters 

describing programs similar to the program 

in the FSIS Listeria Compliance Guideline, 

using Listeria spp. as an indicator organism 

during environmental monitoring for L. 

monocytogenes (Ref. 226) (Ref. 227) (Ref. 

228) (Ref. 229). In addition, as discussed in 

section II.A.1 of the preamble of this 

document, a key finding of the CGMP 

Working Group Report was the importance of 

updating CGMP requirements to require a 

written environmental pathogen control 

program for food processors that produce 

RTE foods that support the growth of L. 

monocytogenes. Written comments from the 

food industry supported such a control 

program (Ref. 230). Thus, the importance of 

controlling L. monocytogenes in the 

environment of RTE food production 

facilities and using environmental 

monitoring to detect the presence of L. 

monocytogenes or Listeria spp. (as an 

indicator organism for L. monocytogenes) has 

been well-established. 

FDA’s current thinking is that Listeria spp. 

is an appropriate indicator organism for L. 

monocytogenes, because tests for Listeria 

spp. will detect multiple species of Listeria, 

including L. monocytogenes, and because the 

available information supports a conclusion 

that modern sanitation programs, which 

incorporate environmental monitoring for 

Listeria spp., have public health benefits. 

4. Environmental Monitoring for Salmonella 

spp. and the Use of an Indicator Organism 

Salmonella spp. is a member of the family 

Enterobacteriaceae, and thus there is some 

relationship between the presence of 

Salmonella spp. and the presence of 

Enterobacteriaceae. There are few studies 

that have investigated the use of organisms 

such as Enterobacteriaceae or other members 

of the family Enterobacteriaceae, such as E. 

coli, to serve as an indicator organism for 

Salmonella spp. in the environment. The 

European Food Safety Agency (EFSA) 

evaluated whether environmental monitoring 

for Enterobacteriaceae as an indicator 

organism for Salmonella spp. (or for 

Cronobacter spp.) could be useful. Although 

EFSA’s focus was on the utility of 

Enterobacteriaceae as an indicator organism 

in the production of a single product—i.e., 

powdered infant formula—their analysis may 

be relevant to the utility of 

Enterobacteriaceae as an indicator organism 

in other dried foods. EFSA concluded that, 

although there are insufficient data to 

establish a correlation between the presence 

of Enterobacteriaceae and Salmonella spp. in 

powdered infant formula because Salmonella 

spp. is so rarely present, monitoring for 

Enterobacteriaceae in the product 

environment can be used to confirm the 

application of GMPs (Ref. 231). ICMSF also 

considered the utility of environmental 

monitoring for Enterobacteriaceae as an 

indicator organism for Salmonella spp. 

ICMSF indicates that, for powdered infant 

formula manufacturing, low levels of 

Enterobacteriaceae do not guarantee the 

absence of Salmonella spp. (Ref. 232) and 

recommends testing directly for the 

pathogen, as well as for Enterobacteriaceae. 

FDA agrees with EFSA and ICMSF that there 

are insufficient data to establish a correlation 

between the presence of Enterobacteriaceae 

and Salmonella spp. during the production 

of powdered infant formula; FDA is not 

aware of any information supporting the use 

of an indicator organism for the purpose of 

environmental monitoring for Salmonella 

spp. during the production of other foods, 

particularly dried foods. 

ICMSF recommends testing for Salmonella 

spp. in the environment for a number of 

other products, e.g., baked dough products 

(Ref. 233), dry spices receiving a kill step 

(Ref. 234), dried cereal products (Ref. 235), 

nuts (Ref. 236), cocoa powder, chocolate and 

confectionary (Ref. 237), and dried dairy 

products (Ref. 238). For most of these 

products ICMSF also recommends testing the 

environment for Enterobacteriaceae as a 

hygiene indicator, but not in lieu of the 

environmental pathogen Salmonella spp. 

Likewise, food industry guidance for lowmoisture foods recommends testing for 

Salmonella spp. in the environment (Ref. 

184). FDA’s current thinking is that there is 

no currently available indicator organism for 

Salmonella spp. We request data, 

information, and other comment bearing on 

whether there is a currently available 

indicator organism for Salmonella spp. that 

could be used for environmental monitoring. 

5. Environmental Monitoring Procedures 

The procedures associated with an 

environmental monitoring program generally 

include the collection of environmental 

samples at locations within the facility and 

testing the samples for the presence of an 

environmental pathogen or indicator 

organism. One approach to defining sampling 

locations is to divide the facility into zones 

based on the risk with respect to 

contamination of product. A common 

industry practice is to use four zones (Ref. 

199) (Ref. 184): 

• Zone 1 consists of food-contact surfaces; 

• Zone 2 consists of nonfood-contact 

surfaces in close proximity to food and foodcontact surfaces; 

• Zone 3 consists of more remote nonfood-contact surfaces that are in the process 

area and could lead to contamination of 

zones 1 and 2; and 

• Zone 4 consists of non-food-contact 

surfaces, outside of the processing area, from 

which environmental pathogens can be 

introduced into the processing environment. 

Generally the number of samples and 

frequency of testing is higher in zones 1 and 

2 because of the greater risk of food 

contamination if the environmental pathogen 

is detected in these zones. Information on 

appropriate locations for sampling within 

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these zones can be found in the literature 

(Ref. 197) (Ref. 144) (Ref. 215) (Ref. 216) (Ref. 

184). Facilities should become familiar with 

locations in which environmental pathogens 

have been found in other facilities and use 

this information in selecting sites to sample. 

Examples of appropriate food-contact 

surfaces that could be monitored include 

hoppers, bins, conveyors, tables, slicers, 

blenders, knives and scrapers. Testing foodcontact surfaces for Listeria spp. is a 

commonly recommended verification 

measure for facilities producing refrigerated 

RTE foods (Ref. 52) (Ref. 199) (Ref. 144). 

Although some literature suggests that 

routine environmental monitoring for 

Salmonella spp. in low-moisture food 

environments would not normally target 

food-contact surfaces (Ref. 184), the data 

(discussed in the preamble of this document) 

available from investigations of food facilities 

following outbreaks, recalls, or reports to the 

RFR warrant including food-contact surfaces 

in a routine environmental testing program 

for Salmonella spp. However, a routine 

environmental monitoring program for 

Salmonella spp. may not contain the same 

level of food-contact surface testing 

(including the frequency of testing and 

number of samples collected) as a routine 

environmental monitoring program for 

Listeria, because the same benefits may not 

be achieved. For example: 

• L. monocytogenes is usually the 

environmental pathogen of concern for most 

wet RTE food production environments. It is 

important to sample areas where the 

organisms are likely to be present in 

relatively high numbers. L. monocytogenes 

frequently establishes itself in a harborage 

site on equipment and grows (increases in 

number) there, where both food and moisture 

are available. L. monocytogenes organisms 

work their way out of the harborage site 

during production and contaminate food. 

• Salmonella spp. is usually the 

environmental pathogen of concern for most 

dry (e.g., low-moisture) RTE food 

environments. Equipment used in the 

production of dry products is rarely wet and, 

thus, there is no moisture to allow growth of 

Salmonella spp. As a result, Salmonella 

harborage sites are less likely to be found on 

equipment and are more likely to be found 

in the environment in locations where food 

particles lodge and escape a dry cleaning 

process. When these locations get wet, the 

Salmonella spp. grows and contaminates 

other areas of the facility, eventually 

contaminating food-contact surfaces and 

food. Nevertheless, sampling food-contact 

surfaces (e.g., filler hoppers, conveyors, 

valves, sifter cuffs) can be useful, as can 

sampling residues such as sifter tailings and 

product scrapings. 

Examples of appropriate non-food-contact 

surfaces that could be monitored include 

exteriors of equipment, equipment supports, 

control panels, door handles, floors, drains, 

refrigeration units, ducts, overhead 

structures, cleaning tools, motor housings 

and vacuum canisters. Standing water in 

production areas and areas that have become 

wet and then have dried are also appropriate 

places to monitor. Testing non-food-contact 

surfaces for L. monocytogenes or Listeria spp. 

is a commonly recommended verification 

measure for facilities producing refrigerated 

or frozen RTE foods (Ref. 52) (Ref. 199) (Ref. 

144) and can detect L. monocytogenes that is 

brought into the plant by people or objects. 

Corrective actions can prevent transferring 

the organisms to a food-contact surface 

(where they can contaminate food) or from 

establishing a harborage that can serve as a 

source of contamination. Recommendations 

for routine environmental monitoring for 

Salmonella spp. in low moisture food 

environments generally target non-foodcontact surfaces because equipment used in 

the production of low-moisture foods where 

Salmonella spp. is the environmental 

pathogen of concern does not have the 

moisture to allow Salmonella spp. to grow 

and, thus, sampling non-food-contact 

surfaces for Salmonella spp. may be more 

effective in finding the organism than 

sampling food-contact surfaces. Scrapings or 

residues that accumulate under or above 

equipment are more useful samples than 

sponges or swabs of food-contact surfaces 

(Ref. 237). 

As discussed in section I.E.2 of this 

Appendix with respect to indicator 

organisms, a facility that finds an indicator 

organism or an environmental pathogen 

during environmental monitoring typically 

conducts microbial testing of surrounding 

surfaces and areas to determine the potential 

source of the contamination, cleans and 

sanitizes the contaminated surfaces and 

areas, and conducts additional microbial 

testing to determine whether the 

contamination has been eliminated. If the 

organism is found on retest, the facility 

generally takes more aggressive corrective 

actions (e.g., more intensified cleaning and 

sanitizing, including dismantling equipment, 

scrubbing surfaces, and heat-treating 

equipment parts) (Ref. 144). 

The adequacy of a corrective action in 

response to environmental monitoring 

depends in part on the following factors 

related to the risk presented in a particular 

situation: 

• Whether the environmental 

contamination is on a food-contact surface or 

a non-food-contact surface; 

• The proximity of a contaminated nonfood-contact surface to one or more foodcontact surfaces; 

• Whether there have been previous 

positives on the specific food-contact surface 

or non- food-contact surface or in the same 

area; and 

• The environmental monitoring strategy 

for the type of food, and whether the food 

supports growth of the environmental 

pathogen (see the discussion of the relevance 

of whether a food supports the growth of an 

environmental pathogen in section I.D.4 of 

this Appendix). 

If an environmental pathogen or an 

appropriate indicator organism (the test 

organism) is detected in the environment, 

corrective actions are taken to eliminate the 

organism, including finding a harborage site 

if one exists (Ref. 144) (Ref. 185) (Ref. 184). 

Otherwise, the presence of the environmental 

pathogen could result in contamination of 

food-contact surfaces or food. The presence 

of the indicator organism suggests that 

conditions exist in which the environmental 

pathogen may be present and could result in 

contamination of food-contact surfaces or 

food. Corrective actions are taken for every 

finding of an environmental pathogen or 

indicator organism in the environment to 

prevent contamination of food-contact 

surfaces or food. 

Sampling and microbial testing from 

surfaces surrounding the area where the test 

organism was found are necessary to 

determine whether the test organism is more 

widely distributed than on the original 

surface where it was found and to help find 

the source of contamination if other sites are 

involved. Cleaning and sanitizing the 

contaminated surfaces and surrounding areas 

are necessary to eliminate the test organism 

that was found there. Additional sampling 

and microbial testing are necessary to 

determine the efficacy of cleaning and 

sanitizing. For example, detection of the test 

organism after cleaning and sanitizing 

indicates that the initial cleaning was not 

effective, and additional, more intensified 

cleaning and sanitizing, or other actions may 

be needed, including dismantling equipment, 

scrubbing surfaces, and heat-treating 

equipment parts (Ref. 144). Examples of 

additional corrective actions that could be 

taken include reinforcing employee hygiene 

practices and traffic patterns; repairing 

damaged floors; eliminating damp insulation, 

water leaks, and sources of standing water; 

replacing equipment parts that can become 

harborage sites (e.g., hollow conveyor rollers 

and equipment framework), and repairing 

roof leaks (Ref. 144) (Ref. 184). The types of 

corrective actions would depend on the type 

of food, the facility and the environmental 

pathogen. 

The finding of a test organism on a foodcontact surface usually represents transient 

contamination rather than a harborage site 

(Ref. 185). However, finding the test 

organism on multiple surfaces in the same 

area, or continuing to find the test organism 

after cleaning and sanitizing the surfaces 

where it was found, suggests a harborage site 

for the test organism. Mapping the location 

of contamination sites, whether the harborage 

site is on equipment or in the environment, 

can help locate the source of the harborage 

site or identify additional locations to sample 

(Ref. 184). 

The types of facilities that may conduct 

environmental monitoring and that could 

implement corrective actions on finding the 

test organism in the facility are quite diverse, 

and include facilities producing lowmoisture products such as cereals, chocolate 

and dried milk powders and facilities 

producing a variety of RTE refrigerated 

products such as deli salads, cheeses and 

bagged salads. The number of sites 

appropriate for testing and the applicable 

cleaning and sanitizing procedures would 

depend on the facility and the equipment. 

Corrective actions may involve 

investigative procedures when the initial 

corrective actions have not been successful in 

eliminating the environmental pathogen or 

indicator organism. One example of an 

investigative procedure is taking samples 

from food-contact surfaces and/or product 

from the processing line at multiple times 

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during the day while the equipment is 

operating and producing product (Ref. 144). 

Another example of an investigative 

procedure is conducting molecular strain 

typing such as pulsed-field gel 

electrophoresis (PFGE), ribotyping, or 

polymerase chain reaction (PCR) analysis to 

determine if particular strains are persistent 

in the environment (Ref. 200) (Ref. 239) (Ref. 

219) (Ref. 217) (Ref. 218) (Ref. 240). 

Molecular strain typing can indicate that 

strains isolated at different points in time 

have the same molecular ‘‘fingerprint,’’ 

suggesting a common source, and perhaps a 

harborage site, that has not been detected 

based on the results of routine environmental 

monitoring (Ref. 217) (Ref. 218). Molecular 

strain typing can also be used when trying to 

determine if a specific ingredient is the 

source of contamination (Ref. 239). 

If environmental monitoring identifies the 

presence of an environmental pathogen or 

appropriate indicator organism, the facility 

may conduct finished product testing. As 

discussed in section I.F of this Appendix, 

there are shortcomings for microbiological 

testing of food for process control purposes. 

Testing cannot ensure the absence of a 

hazard, particularly when the hazard is 

present at very low levels and is not 

uniformly distributed. If an environmental 

pathogen is detected on a food-contact 

surface, finished product testing would be 

appropriate only to confirm actual 

contamination or assess the extent of 

contamination, because negative findings 

from product testing could not adequately 

assure that the environmental pathogen is not 

present in food exposed to the food-contact 

surface. If a facility detects an environmental 

pathogen on a food-contact surface, the 

facility should presume that the 

environmental pathogen is in the food. 

Finished product testing could be 

appropriate if an environmental pathogen is 

detected on a non-food-contact surface, such 

as on the exterior of equipment, on a floor 

or in a drain. The potential for food to be 

contaminated directly from contamination in 

or on a non-food-contact surface is generally 

low, but transfer from non-food-contact 

surfaces to food-contact surfaces can occur. 

Finished product testing can provide useful 

information on the overall risk of a food 

when pathogens have been detected in the 

environment. In general, finished product 

testing is most appropriate when an indicator 

organism, rather than an environmental 

pathogen, is detected on a food-contact 

surface. 

The results of finished product testing can 

be used in combination with the results of 

environmental monitoring and corrective 

actions to help ensure that the food released 

into commerce is not adulterated. For 

example, if a facility with an aggressive 

environmental monitoring program detects 

an indicator organism on a food-contact 

surface, it may use information such as the 

following in determining whether to release 

product into commerce: 

• The number and location of positive 

sample findings, including from the original 

sampling and from additional/follow-up 

testing of areas surrounding the site of the 

original finding; 

• The root cause analysis of the source of 

the contamination; 

• Information on the efficacy of the 

facility’s corrective actions (including the 

results of additional follow-up sampling); 

• Information obtained from any finished 

product testing, taking into consideration the 

statistical confidence associated with the 

results. 

F. The Role of Finished Product Testing in 

Verifying the Implementation and 

Effectiveness of Preventive Controls 

Although FDA is not including a provision 

for finished product testing in this proposed 

rule, here we set out some considerations 

regarding the appropriate use of such testing. 

The utility of finished product testing for 

verification depends on many factors that 

industry currently considers in determining 

whether finished product testing is an 

appropriate approach to reducing the risk 

that contaminated food would reach the 

consumer and cause foodborne illness. The 

first such consideration is the nature of the 

hazard and whether there is evidence of 

adverse health consequences from that 

hazard in the food being produced or in a 

similar food. If the hazard were to be present 

in the food, how likely is it that illness will 

occur and how serious would the 

consequences be? The more likely and severe 

the illness, the greater the frequency of 

conducting verification testing. For example, 

Salmonella spp. is a hazard that if consumed 

could cause serious illness, particularly in 

children and the elderly. In contrast, in 

situations where unlawful pesticide residues 

are considered reasonably likely to occur, the 

presence of a pesticide residue that is not 

approved for a specific commodity but that 

is within the tolerance approved for other 

commodities, while deemed unsafe as a 

matter of law, may not actually result in 

illness. Thus, a firm is more likely to conduct 

finished product testing to verify Salmonella 

spp. control than to verify control of 

pesticides. 

Another consideration in determining 

whether finished product testing is 

appropriate is the intended consumer of the 

food. The greater the sensitivity of the 

intended consumer (as would be the case, for 

example, for a medical food provided to 

hospitalized adults), the greater the 

likelihood that finished product testing 

would be used as a verification activity. 

Another consideration in determining 

whether finished product testing is 

appropriate is the impact of the food on the 

contaminant. For example, depending on the 

food, pathogens may survive in food, 

increase in number, or die off. Finished 

product testing generally is not conducted if 

pathogens that may be in a food would die 

off in a relatively short period of time (e.g., 

before the food reaches the consumer). For 

example, many salad dressings have 

antimicrobial properties, including low pH, 

high acidity, and preservatives, that are lethal 

for pathogens such as Salmonella spp. or E. 

coli O157:H7. If a facility has validated the 

lethality of the formulation of the salad 

dressing, the facility is unlikely to conduct 

finished product testing for pathogens such 

as Salmonella spp. or E. coli O157:H7, as this 

would not be an effective use of resources, 

particularly if proper formulation of the food 

is verified during production. In contrast, 

verification testing is more likely in food 

where pathogens can survive in a food, 

particularly where pathogens may grow in a 

food. 

Another consideration in determining 

whether finished product testing is 

appropriate is the intended use of the food. 

For example, consumers cook many foods, 

e.g., dried pasta, cake mixes, and most frozen 

vegetables, thereby reducing pathogens. A 

facility should not rely on the consumer to 

eliminate hazards that can be prevented. 

However, there is little benefit in testing a 

food that is normally consumed following a 

step that can be relied on to inactivate the 

hazard. It is important to validate that the 

instructions provided to the consumer 

adequately reduce the pathogen of concern. 

It is also important to understand the 

customary use of the food, which may 

include uses that do not include the hazard 

reduction step. For example, dried soup 

mixes may be mixed with sour cream to 

make a dip, without the pathogen 

inactivation step that occurs when boiling 

the soup mix with water. If Salmonella spp. 

may be present in an ingredient for the soup 

mix, e.g., dried parsley or black pepper, and 

neither the supplier nor the facility treats the 

ingredient or the soup mix in a way that 

significantly reduces Salmonella spp., then 

finished product testing for Salmonella spp. 

would be warranted. Likewise, frozen peas 

and corn may be added to fresh salads, delitype salads, or salsas without a pathogen 

inactivation step; finished product testing for 

L. monocytogenes could be warranted for 

these foods where this is a likely use. 

Another consideration in determining 

whether finished product testing is 

appropriate is the type of controls the 

supplier has implemented to minimize the 

potential for the hazard to be present, e.g., 

whether the supplier uses a kill step for a 

pathogen or has other programs in place that 

will adequately reduce the hazard. A facility 

generally is more likely to conduct finished 

product testing when the supplier does not 

have a program that can ensure the hazard 

has been adequately reduced in the 

ingredient supplied. Another consideration is 

the verification procedures that are in place 

at the supplier and at the receiving facility. 

If the supplier has a well-executed control 

program, including a supplier approval and 

verification program that has been verified 

through audits to adequately reduce the 

hazard, the receiving facility performs 

periodic verification testing of the ingredient 

provided by the supplier, and the supplier 

has a good compliance history, the frequency 

of finished product verification testing by the 

receiving facility is low, particularly if the 

receiving facility has a process that further 

reduces the hazard. However, if the 

ingredient is associated with a hazard and 

the processes used by the supplier and the 

receiving facility will not significantly 

minimize it, or if a facility is using a new 

supplier, the frequency of finished product 

verification testing increases. 

One of the most important considerations 

in determining whether finished product 

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testing is appropriate is the effect of 

processing on the hazard. The frequency of 

finished product testing generally is low 

when a manufacturing process significantly 

minimize the hazard (e.g., a 5-log reduction 

of a pathogen) and procedures are in place 

to prevent recontamination after that process; 

the frequency of finished product testing 

increases when a manufacturing process does 

not significantly minimize the hazard (e.g., 1- 

or 2-log reduction of a pathogen). For 

example, testing is not common for bagged 

spinach that is irradiated to provide a 5-log 

reduction of Salmonella spp. and E. coli 

O157:H7; finished product verification 

testing would be more common if the only 

pathogen reduction step is washing the 

spinach leaves in chlorinated water. 

Likewise, FDA noted in the preamble to the 

juice HACCP regulation that it was not 

requiring end product verification testing for 

juice treated to achieve a 5-log reduction in 

a target pathogen because the post-treatment 

level of microorganisms would be too low to 

be detected using reasonable sampling and 

analytical methods (68 FR 6138 at 6174). 

Another important consideration in 

determining whether finished product testing 

is appropriate is whether a hazard can be 

reintroduced into a food that has been treated 

to significantly minimize the hazard, either 

through exposure to the environment or by 

the addition of an ingredient after a treatment 

to significantly minimize a hazard. For 

example, verification testing is not common 

if a lethal treatment for a pathogen is given 

to food in its final package (such as a 

marinara sauce heated in the jar or hot-filled 

into the jar) but would be more common if 

food exposed to the environment, such as a 

cold gazpacho filled into a container. 

Likewise, verification testing generally is 

more frequent for foods given significant 

handling before packaging, regardless of 

whether they have previously received a 

treatment that would significantly minimize 

a hazard, if they will be consumed without 

a treatment lethal for pathogens that can be 

introduced during handling (e.g., L. 

monocytogenes or Salmonella spp. from the 

environment; pathogens such as 

Staphylococcus aureus or Salmonella spp. 

from food handlers). Verification testing also 

would be more frequent if an ingredient that 

has potential to be contaminated with a 

pathogen is added to a food that was 

previously treated to significantly minimize 

a hazard (e.g., adding seasonings to chips or 

crackers after frying or baking) than if all 

ingredients are added before the treatment. 

In assessing whether to conduct 

verification testing and determine the 

frequency of that testing, a facility generally 

considers the impact of all the preventive 

control measures applied in producing the 

food, because multiple control measures 

provide greater assurance that a hazard is 

being controlled. For example, the frequency 

or finished product verification testing 

generally could be lower for a food that is 

subject to supplier controls that include 

audits and certificates of analysis (COAs); 

that contains ingredients that have been 

subjected to ingredient testing; that is 

produced under well-implemented sanitation 

controls that are verified through a robust 

environmental monitoring program; and that 

is treated using a validated process that 

significantly minimizes the hazard than for a 

food that is not subject to all these controls. 

Finished product testing generally is more 

frequent during initial production cycles 

until there is an accumulation of historical 

data (e.g., finished product test results that 

are negative for the hazard) to confirm the 

adequacy of preventive controls. Once this 

history has been established, the frequency of 

testing generally is reduced to that needed to 

provide ongoing assurance that the 

preventive controls continue to be effective 

and to signal a possible loss of control, as 

discussed further immediately below. 

There are well-known shortcomings of 

product testing, especially microbiological 

testing, for process control purposes, and it 

is generally recognized that testing cannot 

ensure the absence of a hazard, particularly 

when the hazard is present at very low levels 

and is not uniformly distributed (Ref. 222) 

(Ref. 241)). Moreover, the number of samples 

used for routine testing often is statistically 

inadequate to provide confidence in the 

safety of an individual lot in the absence of 

additional information about adherence to 

validated control measures. This is 

illustrated below for Salmonella spp. 

FDA’s Investigations Operations Manual 

(IOM) (Ref. 242) and Bacteriological 

Analytical Manual, BAM, (Ref. 243) provide 

sampling plans to determine the presence of 

Salmonella in processed foods intended for 

human consumption. The stringency of the 

sampling plan is based on the category of the 

food. Category III foods are those that would 

normally be subject to a process lethal to 

Salmonella spp. between the time of 

sampling and consumption (e.g., macaroni 

and noodle products, frozen and dried 

vegetables, frozen dinners, food chemicals). 

Category II foods are those that would not 

normally be subject to a process lethal to 

Salmonella spp. between the time of 

sampling and consumption (e.g., fluid milk 

products, cheeses, nut products, spices, 

chocolate, prepared salads, ready-to-eat 

sandwiches). Category I foods are Category II 

foods intended for consumption by the aged, 

the infirm, and infants (e.g., foods produced 

for a hospital). FDA takes 15 samples for 

Category III foods, 30 for Category II foods, 

and 60 for Category I foods and tests a 25 g 

subsample (analytical unit) from each 

sample. To reduce the analytical workload, 

the analytical units may be composited (Ref. 

244), with the maximum size of a composite 

unit being 375 g (15 analytical units). This 

composite is tested in its entirety for 

Salmonella spp. The probability of detecting 

Salmonella spp. for various contamination 

rates under the three IOM Salmonella 

sampling plans is shown in Table 1. 

(Probability of Detecting Salmonella.) 

TABLE 1—PROBABILITY OF DETECTING SALMONELLA SPP. IN LOTS AT VARIOUS CONTAMINATION RATES UNDER THE

THREE DIFFERENT IOM SALMONELLA SAMPLING PLANS (LEFT) AND THE EXPECTED NUMBER OF POSITIVE COMPOSITE

SAMPLES USING WEEKLY TESTING FOR 1 YEAR UNDER THE IOM SALMONELLA SAMPLING PLANS (RIGHT) 

Contamination 

rate 

CFU/g or CFU/ 

kg 

Probability of detecting Salmonella spp. in a lot 

(percent) 

Expected # of positive composites per year 

(weekly testing) 

N=15* n=30* n=60* n=15* n=30* n=60* 

1 in 10 ............... 1/250g .............. 79 96 >99 40 81 162 

1 in 30 ............... 1/750g .............. 40 64 87 20 41 82 

1 in 100 ............. 1/2.5kg .............. 14 26 45 7 15 29 

1 in 300 ............. 1/7.5kg .............. 4 .9 10 18 2 .5 5 10 

1 in 1000 ........... 1/25kg ............... 1 .5 3 5 .8 0 .8 1 .5 3 

1 in 3000 ........... 1/75kg ............... 0 .5 1 2 0 .3 0 .5 1 

* In the table, ‘‘n’’ is the number of subsamples (which are composited in groups of 15 for analysis). 

The probability of detecting Salmonella 

spp. increases as the defect rate increases. 

For example, when 15 samples are tested, the 

probability of detecting Salmonella spp. is 14 

percent when the contamination rate is 1 in 

100, but 79 percent when the contamination 

rate is 1 in 10. For a given contamination 

rate, the probability of detecting Salmonella 

spp. increases with the number of samples 

tested. For example, at a contamination rate 

of 1 in 30, the probability of detecting 

Salmonella spp. increases from 40 percent if 

15 samples are tested to 87 percent if 60 

samples are tested. 

Table 1 shows that it is clearly not feasible 

to attempt to identify low levels of 

contamination in an individual lot based on 

the IOM Salmonella sampling plan. If the 

contamination levels are high and 1 in 10 

products are contaminated, then Salmonella 

spp. would be detected in the lot greater than 

99 percent, 96 percent, and 79 percent of the 

time using Category I, II, and III testing, 

respectively. If the frequency of 

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contaminated units is reduced to 1 in 300, 

then the contaminated lot would only be 

detected 18 percent, 10 percent, and 4.9 

percent of the time using Category I, II, and 

III testing, respectively. At a very low 

frequency of contamination (e.g., 1 in 1000) 

even with testing 60 samples the 

contaminated lot would be detected only 

about 6 percent of the time. 

Periodic testing for trend analysis and 

statistical process control, however, does 

provide information to assess whether 

processes (or the food safety system) are 

under control over time. Data collected from 

multiple lots of product produced over days, 

months or years are used to establish a 

baseline for the level of control that can be 

attained under a functioning food safety 

system and to verify the system is in control 

or to indicate loss of control. In addition to 

showing the probability of detecting 

contamination in a lot of product for a given 

contamination rate, Table 1 also shows the 

value of periodic testing when contamination 

levels are low. Even though a product with 

1 in 300 contaminated units is unlikely to be 

rejected when sampling a single lot at the 

Category III sampling schedule (i.e., 4.9 

percent of the time), testing of finished 

products with this level of contamination on 

a weekly basis would be expected to find 2.5 

positive composite samples per year. 

Similarly, if the background contamination 

rate is thought to be near 1 in 1000 but 

periodic testing using the Category III 

schedule has found 3 positives in the last 

year, then it seems clear that the actual 

frequency of contaminated units is closer to 

1 in 300. Periodic testing according to the 

Category I Salmonella plan has the potential 

to detect situations where the contamination 

rates are as low as 1 in 1000. If 60 samples 

of a food are collected weekly, then 3,120 

samples would be collected over the course 

of a year. Compositing these 3,120 samples 

into 375g analytical units would reduce the 

number of analytical tests to 208 (4 tests per 

week). If 30 samples are collected weekly, 

and composited, there would be 104 tests 

annually, or two each week. At the 1 in 1000 

contamination rate there would be a greater 

than 95 percent confidence in seeing one or 

more positive tests during the year for testing 

composites from either 60 or 30 samples 

weekly. At higher rates of contamination, 

more positives would be detected. 

There can be significant benefits to a 

facility testing finished products over time 

for process control. First, if a lot of product 

tests positive for a hazard, that lot of product 

can be disposed of such that the consumer 

is not exposed to the hazard (i.e., the product 

can be destroyed, reprocessed, or diverted to 

another use, as appropriate). If the testing 

involves enumeration of an indicator 

organism, it may even be possible to detect 

a trend toward loss of control before 

exceeding the criterion that separates 

acceptable from unacceptable. The process 

can be adjusted before there is a need to 

dispose of product. Second, the detection of 

loss of control, or potential loss of control, 

e.g., an unusual number of positives in a 

given period of time, allows a facility to 

evaluate and modify its processes, 

procedures, and food safety plan as 

appropriate to prevent loss of control in the 

future. In fact, the nature of the trends can 

provide information useful in determining 

the root cause of the problem (Ref. 222). A 

third benefit to ongoing verification testing is 

the accumulation of data that can help 

bracket any problem that occurs. For 

products in which there are large production 

runs without intervening sanitation cycles, 

this may provide data that can be used in 

conjunction with other information to limit 

the scope of a recall. A fourth benefit may be 

in detection of a problem associated with an 

ingredient supplier that results in changes to 

a supplier’s processes, procedures, or food 

safety plan. For example, a positive in 

finished product due to routine verification 

testing was responsible for determining that 

hydrolyzed vegetable protein was 

contaminated with Salmonella spp., resulting 

in over 177 products being recalled (Ref. 24) 

and a recognition of the need for enhanced 

preventive controls for the production of this 

ingredient (Ref. 23). Industry commonly uses 

finished product testing to verify preventive 

controls used by the facility and by the 

facility’s suppliers. Additionally, it is 

common for customers to require suppliers to 

conduct testing of products and ingredients 

being provided. 

G. Metrics for Microbiological Risk 

Management 

Recently there has been much attention 

paid to microbiological risk management 

metrics for verifying that food safety systems 

achieve a specified level of public health 

control, e.g., the Appropriate Level of 

Protection (ALOP), for microbial hazards. 

Microbiological risk management metrics are 

fully discussed in Annex II of the Codex 

‘‘Principles and Guidelines for the Conduct 

of Microbiological Risk Management (MRM)’’ 

(Ref. 245). These metrics include traditional 

metrics such as microbiological criteria, 

process criteria, and product criteria and 

emerging metrics such as food safety 

objectives (FSO), performance objectives and 

performance criteria. Of particular relevance 

are performance objectives and performance 

criteria. A performance objective is the 

maximum frequency and/or concentration of 

a microbiological hazard in a food at a 

specified step in the food chain before the 

time of consumption that provides or 

contributes to an FSO or ALOP, as applicable 

(Ref. 119). A performance criterion is the 

effect in frequency and/or concentration of a 

hazard in a food that must be achieved by the 

application of one or more control measures 

to provide or contribute to a performance 

objective or an FSO (Ref. 119). FDA 

established a performance criterion (or 

performance standard) when we required 

that processors of juice products apply a 

control measure that will consistently 

produce, at a minimum, a 5-log reduction for 

the most resistant microorganism of public 

health significance (§ 120.24). Section 104 of 

FSMA (Performance Standards) requires the 

Secretary to determine the most significant 

foodborne contaminants and issue 

contaminant-specific and science-based 

guidance documents, including guidance 

documents regarding action levels, or 

regulations for products or product classes. 

The proposed rule that is the subject of this 

document would not establish criteria or 

metrics for verifying that preventive controls 

in food safety plans achieve a specified level 

of public health control in this proposed rule. 

However, FDA will give consideration to 

appropriate microbiological risk management 

metrics in the future. 

II. The Role of Supplier Approval and 

Verification Programs in a Food Safety 

System 

A food can become contaminated through 

the use of contaminated raw materials or 

ingredients. In the past several years, 

thousands of food products have been 

recalled as a result of contamination of raw 

materials or ingredients with pathogens such 

as Salmonella spp. and E. coli O157:H7. The 

ingredients included peanut-derived 

ingredients (Ref. 19) (Ref. 20), pistachioderived ingredients (Ref. 152), instant nonfat 

dried milk, whey protein, fruit stabilizers 

(Ref. 21) Ref. 22) (Ref. 155) and hydrolyzed 

vegetable protein (Ref. 153). 

The incident involving Salmonella spp. in 

hydrolyzed vegetable protein illustrates the 

impact one supplier can have on the food 

industry (Ref. 60). A receiving facility 

(manufacturer) detected Salmonella spp. in 

verification testing of finished product. In 

determining the source of the contamination, 

the manufacturer detected Salmonella spp. in 

samples of a hydrolyzed vegetable protein 

ingredient and reported the finding through 

FDA’s RFR. After FDA determined that the 

ingredient was a reportable food, FDA 

requested that the supplier notify the 

immediate subsequent recipients of the 

reported hydrolyzed vegetable protein 

ingredient. Over one thousand reportable 

food reports were submitted to FDA from 

numerous companies concerning the 

potentially contaminated hydrolyzed 

vegetable protein or products made with the 

hydrolyzed vegetable protein. The 

hydrolyzed vegetable protein recall involved 

at least eleven different commodity 

categories and 177 products, showing the 

magnitude of this contamination event 

originating from one supplier (Ref. 60). 

FDA recently reviewed CGMP-related food 

recall information from 2008–2009 to assess 

potential root causes for the contamination 

events. We determined that 36.9 percent of 

the 960 Class I and Class II recalls were 

directly linked to lack of supplier controls 

(Ref. 59). The recent large recalls of foods 

containing contaminated or potentially 

contaminated ingredients have focused 

attention on supplier approval and 

verification programs intended to help a 

manufacturer/processor prevent the 

introduction of a contaminated raw material 

or other ingredient into another product (Ref. 

20) (Ref. 24) (Ref. 22). The application of 

preventive approaches by the entire supply 

chain (including ingredient vendors, brokers 

and other suppliers and, ultimately, the 

manufacturer of a food product) is recognized 

as essential to effective food safety 

management (Ref. 246). 

The development of a supplier approval 

and verification program is part of a 

preventive approach. Because many facilities 

acting as suppliers procure their raw 

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materials and ingredients from other 

suppliers, there is often a chain of suppliers 

before a raw material or other ingredient 

reaches the manufacturer/processor. To 

ensure safe food and minimize the potential 

for contaminated food to reach the consumer, 

each supplier in the chain must implement 

preventive controls appropriate to the food 

and operation for hazards reasonably likely 

to occur in the raw material or other 

ingredient. A facility receiving raw materials 

or ingredients from a supplier must ensure 

that the supplier (or a supplier to the 

supplier) has implemented preventive 

controls to significantly minimize or prevent 

hazards that the receiving facility has 

identified as reasonably likely to occur in 

that raw material or other ingredient unless 

the receiving facility will itself control the 

identified hazard. 

A supplier approval and verification 

program is a means of ensuring that raw 

materials and ingredients are procured from 

those suppliers that can meet company 

specifications and have appropriate programs 

in place, including those related to the safety 

of the raw materials and ingredients. A 

supplier approval program can ensure a 

methodical approach to identifying such 

suppliers. A supplier verification program 

provides initial and ongoing assurance that 

suppliers are complying with practices to 

achieve adequate control of hazards in raw 

materials or ingredients. 

Supplier approval and verification is 

widely accepted in the domestic and 

international food safety community. The 

NACMCF HACCP guidelines describe 

Supplier Control as one of the common 

prerequisite programs for the safe production 

of food products and recommend that each 

facility should ensure that its suppliers have 

in place effective GMP and food safety 

programs (Ref. 34). The American Spice 

Trade Association advocates that spice 

manufacturers establish robust supplier 

prerequisite programs to evaluate and 

approve suppliers (Ref. 247). The Grocery 

Manufacturers Association’s (GMA’s) Food 

Supply Chain Handbook, developed for 

ingredient suppliers to the food industry, 

recommends that all suppliers in the food 

chain consider approval programs for their 

own suppliers; such supplier approval 

programs consist of a collection of 

appropriate programs, specifications, 

policies, and procedures (Ref. 246). GMA 

recommends a number of verification 

activities that suppliers can take in its Food 

Supply Chain Handbook, including selfauditing, third-party auditing and product 

testing. GMA’s handbook also references 

verification activities that a supplier’s 

customers might take, including second-party 

audits (done by an employee of the customer) 

or third-party (independent) audits 

(conducted by persons who do not work for 

either the supplier or the customer). Codex 

specifies that no raw material or ingredient 

should be accepted by an establishment if it 

is known to contain parasites, undesirable 

microorganisms, pesticides, veterinary drugs 

or toxic, decomposed or extraneous 

substances which would not be reduced to an 

acceptable level by normal sorting and/or 

processing (Ref. 44). Codex also specifies 

that, where appropriate, specifications for 

raw materials should be identified and 

applied and that, where necessary, laboratory 

tests should be made to establish fitness for 

use (Ref. 44). 

Supplier verification activities include 

auditing a supplier to ensure the supplier is 

complying with applicable food safety 

requirements, such as CGMP requirements of 

current part 110. Audit activities may 

include a range of activities, such as on-site 

examinations of establishments, review of 

records, review of quality assurance systems, 

and examination or laboratory testing of 

product samples (Ref. 248). Other supplier 

verification activities include conducting 

testing or requiring supplier COAs, review of 

food safety plans and records, or 

combinations of activities such as audits and 

periodic testing. 

An increasing number of establishments 

that sell foods to the public, such as retailers 

and food service providers, are 

independently requiring, as a condition of 

doing business, that their suppliers, both 

foreign and domestic, become certified as 

meeting safety (as well as other) standards. In 

addition, domestic and foreign suppliers 

(such as producers, co-manufacturers, or repackers) are increasingly looking to thirdparty certification programs to assist them in 

meeting U.S. regulatory requirements (Ref. 

248). There are many established third-party 

certification programs designed for various 

reasons that are currently being used by 

industry. Many third party audit schemes 

used to assess the industry’s food safety 

management systems incorporate 

requirements for manufacturers and 

processors to establish supplier approval 

programs. 

The GFSI was established in 2000 to drive 

continuous improvement in food safety 

management systems to ensure confidence in 

the delivery of safe food to consumers 

worldwide. Their objectives include reducing 

risk by delivering equivalence and 

convergence between effective food safety 

management systems and managing cost in 

the global food system by eliminating 

redundancy and improving operational 

efficiency (Ref. 249). GFSI has developed a 

guidance document as a tool that fulfils the 

GFSI objectives of determining equivalency 

between food safety management systems 

(Ref. 249). The document is not a food safety 

standard, but rather specifies a process by 

which food safety schemes may gain 

recognition, the requirements to be put in 

place for a food safety scheme seeking 

recognition by GFSI, and the key elements for 

production of safe food or feed, or for service 

provision (e.g., contract sanitation services or 

food transportation) in relation to food safety 

(Ref. 249). This benchmark document has 

provisions relevant to supplier approval and 

verification programs. For example, it 

specifies that a food safety standard must 

require that the organization control 

purchasing processes to ensure that all 

externally sourced materials and services that 

have an effect on food safety conform to 

requirements. It also specifies that a food 

safety standard must require that the 

organization establish, implement, and 

maintain procedures for the evaluation, 

approval and continued monitoring of 

suppliers that have an effect on food safety. 

Thus, all current GFSI-recognized schemes 

require supplier controls to ensure that the 

raw materials and ingredients that have an 

impact on food safety conform to specified 

requirements. The GFSI guidance document 

also requires audit scheme owners to have a 

clearly defined and documented audit 

frequency program, which must ensure a 

minimum audit frequency of one audit per 

year of an organization’s facility (Ref. 249). 

Because GFSI is a document that outlines 

elements of a food safety management system 

for benchmarking a variety of standards, it 

does not have details about how facilities 

should comply with the elements. This type 

of information is found in the food safety 

schemes that are the basis for certification 

programs. For example, the Safe Quality 

Food (SQF) 2000 Code, a HACCP-based 

supplier assurance code for the food 

industry, specifies that raw materials and 

services that impact on finished product 

safety be supplied by an Approved Supplier. 

SQF 2000 specifies that the responsibility 

and methods for selecting, evaluating, 

approving and monitoring an Approved 

Supplier be documented and implemented, 

and that a register of Approved Suppliers and 

records of inspections and audits of 

Approved Suppliers be maintained. SQF 

2000 requires that the Approved Supplier 

Program contain, among other items, agreed 

specifications; methods for granting 

Approved Supplier status; methods and 

frequency of monitoring Approved Suppliers; 

and details of certificates of analysis if 

required. 

According to SQF, the monitoring of 

Approved Suppliers is to be based on the 

prior good performance of a supplier and the 

risk level of the raw materials supplied. The 

monitoring and assessment of Approved 

Suppliers can include: 

• The inspection of raw materials received; 

• The provision of certificates of analysis; 

• Third party certification of an Approved 

Supplier; or 

• The completion of 2nd party supplier 

audits. 

III. References 

The following references have been placed 

on display in the Division of Dockets 

Management (see ADDRESSES) and may be 

seen by interested persons between 9 a.m. 

and 4 p.m., Monday through Friday. (FDA 

has verified the Web site addresses, but FDA 

is not responsible for any subsequent changes 

to the Web sites after this document 

publishes in the Federal Register.) 

1. National Advisory Committee on 

Microbiological Criteria for Foods, 

‘‘Hazard Analysis and Critical Control 

Point Principles and Application 

Guidelines,’’ Journal of Food Protection, 

61:1246–1259, 1998. 

2. Codex Alimentarius Commission, 

‘‘Principles for the Establishment and 

Application of Microbiological Criteria 

for Foods, CAC/GL 21—1997,’’ 1997. 

3. International Commission on 

Microbiological Specifications for Foods, 

‘‘Microbiological Hazards and Their 

Control,’’ In: Microorganisms in Foods 7. 

mstockstill on DSK4VPTVN1PROD with 

3822 Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 

Microbiological Testing in Food Safety 

Management, edited by R. B. Tompkin, 

L. Gram, T. A. Roberts, R. L. Buchanan, 

M. van Schothorst, S. Dahms, and M. B. 

Cole, New York, Chapter 1, pp. 1–21, 

Kluwer Academic/Plenum Publishers, 

2002. 

4. International Commission on 

Microbiological Specifications for Foods, 

‘‘Selection and Use of Acceptance 

Criteria,’’ In: Microorganisms in Foods 7. 

Microbiological Testing in Food Safety 

Management, edited by R. B. Tompkin, 

L. Gram, T. A. Roberts, R. L. Buchanan, 

M. van Schothorst, S. Dahms, and M. B. 

Cole, New York, Chapter 4, pp. 79–97, 

Kluwer Academic/Plenum Publishers, 

2002. 

5. FDA, ‘‘Guidance for Industry: Measures to 

Address the Risk for Contamination by 

Salmonella Species in Food Containing a 

Peanut-Derived Product as an 

Ingredient,’’ 2009. 

6. FDA, ‘‘Guidance for Industry: Measures to 

Address the Risk for Contamination by 

Salmonella Species in Food Containing 

a Pistachio-Derived Product as an 

Ingredient,’’ 2011. 

7. CDC, ‘‘General Information. Escherichia 

coli (E. coli),’’ (http://www.cdc.gov/ecoli/ 

general/index.html), July 17, 2012. 

Accessed and printed on July 27, 2012. 

8. Scott, V. N., C. Yuhuan, T. A. Freier, J. 

Kuehm, M. Moorman, J. Meyer, T. 

Morille-Hinds, L. Post, L. Smoot, S. 

Hood, J. Shebuski, and J. Banks, ‘‘Control 

of Salmonella in Low-Moisture Foods I: 

Minimizing Entry of Salmonella into a 

Processing Facility,’’ Food Protection 

Trends, 29:342–353, 2009. 

9. Chen, Y., V. N. Scott, T. A. Freier, J. 

Kuehm, M. Moorman, J. Meyer, T. 

Morille-Hinds, L. Post, L. Smoot, S. 

Hood, J. Shebuski, and J. Banks, ‘‘Control 

of Salmonella in Low-Moisture Foods II: 

Hygiene Practices to Minimize 

Salmonella Contamination and Growth,’’ 

Food Protection Trends, 29:435–445, 

2009. 

10. California Department of Public Health, 

‘‘Union International Food Company 

Recall Widened Again,’’ (http:// 

www.cdph.ca.gov/Pages/NR2009– 

23.aspx), April 4, 2009. Accessed and 

printed on September 6, 2011. 

11. Gabis, D. A., R. S. Flowers, D. Evanson, 

and R. E. Faust, ‘‘A Survey of 18 Dry 

Product Processing Plant Environments 

for Salmonella, Listeria and Yersinia,’’ 

Journal of Food Protection, 52:122–124, 

1989. 

12. Vij, V., E. Ailes, C. Wolyniak, F. J. 

Angulo, and K. C. Klontz, ‘‘Recalls of 

Spices Due to Bacterial Contamination 

Monitored by the U.S. Food and Drug 

Administration: The Predominance of 

Salmonellae,’’ Journal of Food 

Protection, 69:233–237, 2006. 

13. FDA, ‘‘FDA Foods Program, The 

Reportable Food Registry: A New 

Approach to Targeting Inspection 

Resources and Identifying Patterns of 

Adulteration. First Annual Report: 

September 8, 2009—September 7, 2010,’’ 

(http://www.fda.gov/downloads/Food/ 

FoodSafety/FoodSafetyPrograms/RFR/ 

UCM240647.pdf), January, 2011. 

Accessed and printed on August 29, 

2011. 

14. FDA and USDA, ‘‘Listeria monocytogenes 

Risk Assessment: VII. Interpretation and 

Conclusions,’’ (http://www.fda.gov/ 

Food/ScienceResearch/ResearchAreas/ 

RiskAssessmentSafetyAssessment/ 

ucm185289.htm), September, 2003. 

Accessed and printed on October 17, 

2011. 

15. Food and Agriculture Organization and 

World Health Organization, ‘‘Risk 

Assessment of Listeria monocytogenes in 

Ready-to-Eat Foods, Technical Report,’’ 

2004. 

16. International Commission on 

Microbiological Specifications for Foods, 

‘‘Sampling to Assess Control of the 

Environment,’’ In: Microorganisms in 

Foods 7. Microbiological Testing in Food 

Safety Management, edited by R. B. 

Tompkin, L. Gram, T. A. Roberts, R. L. 

Buchanan, M. van Schothorst, S. Dahms, 

and M. B. Cole, New York, Chapter 11, 

pp. 199–224, Kluwer Academic/Plenum 

Publishers, 2002. 

17. Tompkin, R. B., V. N. Scott, D. T. 

Bernard, W. H. Sveum, and K. Sullivan 

Gombas, ‘‘Guidelines to Prevent PostProcessing Contamination from Listeria 

monocytogenes,’’ Dairy, Food and 

Environmental Sanitation, 19:551–562, 

1999. 

18. Tompkin, R. B., ‘‘Control of Listeria 

monocytogenes in the Food-Processing 

Environment,’’ Journal of Food 

Protection, 65:709–725, 2002. 

19. Carpentier, B. and O. Cerf, ‘‘Review: 

Persistence of Listeria monocytogenes in 

Food Industry Equipment and 

Premises,’’ International Journal of Food 

Microbiology, 145:1–8, 2011. 

20. Breuer, T., ‘‘CDC Investigations: The May 

1998 Outbreak of Salmonella Agona 

Linked to Cereal,’’ Cereal Foods World, 

44:185–186, 1999. 

21. CDC, ‘‘EPI–AID 98–60 Trip-Report: 

Multistate Outbreak of Salmonella 

Agona Infection Linked to Consumption 

of Oat Cereal, April-June 1997,’’ 1999. 

22. CDC, ‘‘Foodborne Outbreak Online 

Database (FOOD). Search Results 

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Outbreak in Dry Cereal,’’ 2011. Accessed 

and printed on October 21, 2011. 

23. CDC, ‘‘Investigation of Outbreak of 

Infections Caused by Salmonella 

Agona,’’ (http://www.cdc.gov/ 

salmonella/agona/), May 13, 2008. 

Accessed and printed on September 9, 

2011. 

24. CDC, ‘‘Foodborne Outbreak Online 

Database (FOOD). Search Results 

Highlighted for 2006–2007 Salmonella 

Tennessee Outbreak in Peanut Butter.,’’ 

2011. Accessed and printed on October 

18, 2011. 

25. CDC, ‘‘Multistate Outbreak of Salmonella 

Serotype Tennessee Infections 

Associated with Peanut Butter—United 

States, 2006–2007,’’ MMWR, 56:521–524, 

2007. 

26. FDA, ‘‘Peanut Products Recall,’’ (http:// 

www.fda.gov/Safety/Recalls/ 

MajorProductRecalls/Peanut/ 

default.htm), June 18, 2009. Accessed 

and printed on September 9, 2011. 

27. FDA, ‘‘Hydrolyzed Vegetable Protein 

Product Recalls,’’ (http://www.fda.gov/ 

Safety/Recalls/MajorProductRecalls/ 

HVP/default.htm), December 21, 2011. 

Accessed and printed on July 27, 2012. 

28. CDC, ‘‘Multistate Outbreak of Salmonella 

Infections Associated with Peanut Butter 

and Peanut Butter-Containing Products— 

United States, 2008–2009,’’ MMWR, 

58:85–90, 2009. 

29. Cavallaro, E., K. Date, C. Medus, S. 

Meyer, B. Miller, C. Kim, S. Nowicki, S. 

Cosgrove, D. Sweat, P. Quyen, J. Flint, E. 

R. Daly, J. Adams, E. Hyytia-Trees, P. 

Gerner-Smidt, R. M. Hoekstra, C. 

Schwensohn, A. Langer, S. V. Sodha, M. 

C. Rogers, F. J. Angulo, R. V. Tauxe, I. 

T. Williams, and C. Barton Behravesh, 

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610, 2011. 

30. FDA, ‘‘Amended Form 483 (Inspectional 

Observations) for Peanut Corporation of 

America, Blakely, GA, 02/05/2009,’’ 

(http://www.fda.gov/downloads/ 

AboutFDA/CentersOffices/ORA/ 

ORAElectronicReadingRoom/ 

UCM109834.pdf), February 5, 2009. 

Accessed and printed on October 19, 

2011. 

31. FDA, ‘‘Form 483 (Inspectional 

Observations) for Peanut Corporation of 

America, Plainview, TX, 02/26/2009,’’ 

(http://www.fda.gov/downloads/ 

AboutFDA/CentersOffices/ORA/ 

ORAElectronicReadingRoom/ 

UCM114852.pdf), February 26, 2009. 

Accessed and printed on October 17, 

2011. 

32. CDC, ‘‘Foodborne Outbreak Online 

Database (FOOD). Search Results 

Highlighted for 2008 Salmonella 

Typhimurium Outbreak in Peanut Butter 

and Peanut Paste,’’ 2011. Accessed and 

printed on November 23, 2011. 

33. FDA, ‘‘Company Recalls Various Products 

Due to Potential Salmonella 

Contamination. FDA, USDA, CDC 

Investigating; No Link to Human 

Illnesses at This Time,’’ (http:// 

www.fda.gov/NewsEvents/Newsroom/ 

PressAnnouncements/ucm169471.htm), 

June 28, 2009. Accessed and printed on 

September 9, 2011. 

34. FDA, ‘‘FDA Form 483 (Inspectional 

Observations) for Plainview Milk 

Products Cooperative,’’ (http:// 

www.fda.gov/downloads/AboutFDA/ 

CentersOffices/ORA/ 

ORAElectronicReadingRoom/ 

UCM173030.pdf), July 15, 2009. 

Accessed and printed on September 9, 

2011. 

35. FDA, ‘‘Peanut Butter and Other Peanut 

Containing Products Recall List,’’ 

(http://www.accessdata.fda.gov/scripts/ 

peanutbutterrecall/index.cfm), October 

28, 2009. Accessed and printed on 

September 9, 2011. 

36. Jackson, K. A., M. Biggerstaff, M. TobinD’Angelo, D. Sweat, R. Klos, J. Nosari, O. 

Garrison, E. Boothe, L. Saathoff-Huber, L. 

Hainstock, and R. P. Fagan, ‘‘Multistate 

mstockstill on DSK4VPTVN1PROD with 

Federal Register / Vol. 78, No. 11 / Wednesday, January 16, 2013 / Proposed Rules 3823 

Outbreak of Listeria monocytogenes 

Associated with Mexican-Style Cheese 

Made from Pasteurized Milk Among 

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37. Texas Department of State Health 

Services, ‘‘DSHS Orders Sangar Produce 

to Close, Recall Products,’’ (http:// 

www.dshs.state.tx.us/news/releases/ 

20101020.shtm), October 20, 2010. 

Accessed and printed on September 9, 

2011. 

38. FDA, ‘‘FDA Form 483 (Inspectional 

Observations) for Sangar Fresh Cut 

Produce Co., LLC,’’ (http://www.fda.gov/ 

downloads/AboutFDA/CentersOffices/ 

ORA/ORAElectronicReadingRoom/ 

UCM232412.pdf), October 26, 2010. 

Accessed and printed on September 9, 

2011. 

39. FDA, ‘‘FDA Lab Results Positive for 

Listeria at SanGar Fresh Produce,’’ 

(http://www.fda.gov/Food/FoodSafety/ 

Product-SpecificInformation/ 

FruitsVegetablesJuices/ucm232237.htm), 

November 3, 2010. Accessed and printed 

on September 9, 2011. 

40. FDA, ‘‘Information on the Recalled Jensen 

Farms Whole Cantaloupes,’’ (http:// 

www.fda.gov/Food/FoodSafety/ 

CORENetwork/ucm272372.htm), January 

9, 2012. Accessed and printed on July 

19, 2012. 

41. CDC, ‘‘Multistate Outbreak of Listeriosis 

Linked to Whole Cantaloupes from 

Jensen Farms, Colorado,’’ (http:// 

www.cdc.gov/listeria/outbreaks/ 

cantaloupes-jensen-farms/), December 8, 

2011. Accessed and printed on July 27, 

2012. 

42. FDA and USDA, ‘‘Listeria monocytogenes 

Risk Assessment: II. Hazard 

Identification,’’ (http://www.fda.gov/ 

Food/ScienceResearch/ResearchAreas/ 

RiskAssessmentSafetyAssessment/ 

ucm183981.htm), September, 2003. 

Accessed and printed on October 20, 

2011. 

43. Lyytika ̈inen, O., T. Autio, R. Maijala, P. 

Ruutu, T. Honkanen-Buzalski, M. 

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44. Fretz, R., J. Pichler, U. Sagel, P. Much, W. 

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Karpiskova, G. Pfaff, and F. Allerberger, 

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Outbreak Due to ‘‘Quargel’’, a Sour Milk 

Curd Cheese, Caused by Two Different L. 

Monocytogenes Serotype 1/2a Strains, 

2009–2010,’’ Eurosurveillance, 15:2, 

2010. 

45. FDA, ‘‘River Ranch Recalls Products 

Because of Possible Health Risk,’’ 

(http://www.fda.gov/Safety/Recalls/ 

ucm275854.htm), October 13, 2011. 

Accessed and printed on October 26, 

2011. 

46. FDA, ‘‘Taylor Farms Retail Inc. Initiates 

a Precautionary Recall Because of 

Possible Health Risk,’’ (http:// 

www.fda.gov/Safety/Recalls/ 

ucm276459.htm), October 19, 2011. 

Accessed and printed on October 20, 

2011. 

47. FDA, ‘‘Del Bueno Recalls Queso Fresco 

Casero Cheese Because of Possible 

Health Risk,’’ (http://www.fda.gov/ 

Safety/Recalls/ucm272268.htm), 

September 16, 2010. Accessed and 

printed on October 26, 2011. 

48. FDA, ‘‘Fine Mexican Food Products, Inc. 

Recalls 2.2 lb. Frozen Avocado Pulp & 3 

lb. IQF Avocado Halves from Peru 

Because of Possible Health Risk,’’ 

(http://www.fda.gov/Safety/Recalls/ 

ucm271686.htm), September 13, 2011. 

Accessed and printed on November 23, 

2011. 

49. Cox, L. J., T. Kleiss, J. L. Cordier, C. 

Cordellana, P. Konkel, C. Pedrazzini, R. 

Beumer, and A. Siebenga, ‘‘Listeria spp. 

in Food Processing, Non-Food and 

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50. Nelson, J. H., ‘‘Where Are Listeria Likely 

to be Found in Dairy Plants?’’ Dairy, 

Food and Environmental Sanitation, 

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51. Pritchard, T. J., K. J. Flanders, and C. W. 

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of Listeria on Equipment Versus 

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52. Miettinen, M. K., K. J. Bjorkroth, and H. 

J. Korkeala, ‘‘Characterization of Listeria 

monocytogenes from an Ice Cream Plant 

by Serotyping and Pulsed-Field Gel 

Electrophoresis,’’ International Journal 

of Food Microbiology, 46:187–192, 1999. 

53. Pourshaban, M., M. Gianfranceschi, A. 

Gattuso, F. Menconi, and P. Aureli, 

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Contamination Sources in Two Fresh 

Sauce Production Plants by Pulsed-Field 

Gel Electrophoresis,’’ Food Microbiology, 

17:393–400, 2000. 

54. Blatter, S., N. Giezendanner, R. Stephan, 

and C. Zweifel, ‘‘Phenotypic and 

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monocytogenes Isolated from the 

Processing Environment and Products of 

a Sandwich-Producing Plant,’’ Food 

Control, 21:1519–1523, 2010. 

55. Pappelbaum, K., K. Grif, I. Heller, R. 

Wuerzner, I. Hein, L. Ellerbroek, and M. 

Wagner, ‘‘Monitoring Hygiene On- and 

At-Line Is Critical for Controlling Listeria 

monocytogenes During Produce 

Processing,’’ Journal of Food Protection, 

71:735–741, 2008. 

56. Aguado, V., A. I. Vitas, and I. GarciaJalon, ‘‘Characterization of Listeria 

monocytogenes and Listeria innocua 

from a Vegetable Processing Plant by 

RAPD and REA,’’ International Journal 

of Food Microbiology, 90:341–347, 2004. 

57. Codex Alimentarius Commission, 

‘‘Guidelines on the Application of 

General Principles of Food Hygiene to 

the Control of Listeria monocytogenes in 

Ready-to-Eat Foods, CAC/GL 61—2007,’’ 

2007. 

58. Scott, V. N., M. Wiedmann, D. Hicks, R. 

Collette, M. L. Jahncke, and K. Gall, 

‘‘Guidelines for Listeria Testing of 

Environmental, Raw Product and 

Finished Product Samples in Smoked 

Seafood Processing Facilities,’’ Food 

Protection Trends, 25:23–34, 2005. 

59. Chen, Y., V. N. Scott, T. A. Freier, J. 

Kuehm, M. Moorman, J. Meyer, T. 

Morille-Hinds, L. Post, L. Smoot, S. 

Hood, J. Shebuski, and J. Banks, ‘‘Control 

of Salmonella in Low-Moisture Foods III: 

Process Validation and Environmental 

Monitoring,’’ Food Protection Trends, 

29:493–508, 2009. 

60. Jarl, D. L. and E. A. Arnold, ‘‘Influence 

of Drying Plant Environment on 

Salmonellae Contamination of Dry Milk 

Products,’’ Journal of Food Protection, 

45:16, 1982. 

61. Buchanan, R. L., ‘‘Acquisition of 

Microbiological Data to Enhance Food 

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[FR Doc. 2013–00125 Filed 1–4–13; 11:15 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 117 

[Docket No. FDA–2012–N–1258] 

Draft Qualitative Risk Assessment of 

Risk of Activity/Food Combinations for 

Activities (Outside the Farm Definition) 

Conducted in a Facility Co-Located on 

a Farm; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification; request for 

comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of, and requesting comment 

on, a document entitled ‘‘Draft 

Qualitative Risk Assessment of Risk of 

Activity/Food Combinations for 

Activities (Outside the Farm Definition) 

Conducted in a Facility Co-Located on 

a Farm’’ (the draft RA). The purpose of 

the draft RA is to provide a sciencebased risk analysis of those activity/food 

combinations that would be considered 

low risk. FDA conducted this draft RA 

to satisfy requirements of the FDA Food 

Safety Modernization Act (FSMA) to 

conduct a science-based risk analysis 

and to consider the results of that 

analysis in rulemaking that is required 

by FSMA. Elsewhere in this issue of the 

Federal Register, FDA is using the 

results of the draft RA to propose to 

exempt food facilities that are small or 

very small businesses that are engaged 

only in specific types of on-farm 

manufacturing, processing, packing, or 

holding activities identified in the draft 

RA as low-risk activity/food 

combinations from the requirements of 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) for hazard analysis and 

risk-based preventive controls. 

DATES: Submit either electronic or 

written comments on the draft RA by 

February 15, 2013. 

ADDRESSES: Submit electronic 

comments to http:// 

mstockstill on DSK4VPTVN1PROD with