This document is scheduled to be published in the
Federal Register on 01/16/2013 and available online at 
http://federalregister.gov/a/2013-00125
, 
and on 
FDsys.gov
 
 
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 Practi ce 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 (F DA) is proposing to amend its regulation 
for Current Good Manufacturing Practice In Ma nufacturing, Packing, or Holding Human Food 
(CGMPs) to modernize it and to add requirement s for domestic and foreign facilities that are 
required to register under the Federal Food, Drug, a nd Cosmetic Act (the FD&C Act) to establish 
and implement hazard analysis and risk-based pr eventive controls for human food.  FDA also is 
proposing to revise certain definitions in F DA’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 in itiative 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 sy stem for the future that makes 
modern, science-, and risk-based preventive c ontrols the norm across al l sectors of the food 
system.  2 
 
  DATES: Submit either electronic or written comments on the proposed rule by May 16, 2013.  
Submit comments on information collection is sues under the Paperwork Reduction Act of 1995 
by February 15, 2013, (see the “Paperwork Reducti on Act of 1995” section of this document). 
ADDRESSES: You may submit comments, iden tified 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 Ac t 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 Dr ug 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 inform ation provided. For additional 
information on submitting comments, see the “C omments” heading of the SUPPLEMENTARY 
INFORMATION section of this document. 3 
 
  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 fo llow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers La ne, 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 4 
 
  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 Analys is and Critical Control Points (HACCP) 
Systems  
D. Food Safety Problems A ssociated With Ma nufacturing, Processing, Packing, and 
Holding Food for Human Consumption 
E. The Role of Testing as a Verifica tion Measure in a Food Safety System 
F.  The Role of Supplier Approval and Veri fication 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-B ased Preventive Controls 
IV. Public Meeting and Prelim inary 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 5 
 
  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 Re quirements 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 Manuf acturing Practice Requirements of Part 
110 (Proposed Part 117, Subpart B) 
E. Proposed New Requirements for Hazard Anal ysis and Risk-Based Preventive Controls 
(Proposed Part 117, Subpart C) 
F. Proposed New Provisions for Modified Re quirements (Proposed Part 117, Subpart D) 
G. Proposed New Provisions for Withdrawal of  an Exemption Applicable to a Qualified 
Facility (Proposed Pa rt 117, Subpart E) 
H. Proposed New Recordkeeping Require ments (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 6 
 
  B. The Current Legal and Regulatory Fram ework 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 St atus of a Food As a Raw Agricultural 
Commodity or As a Processed Food Affects th e 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 On-F arm Low-Risk Activity/Food Combinations 
Under Section 418 of the FD&C Act 
J. Tentative Conclusions Regarding On-F arm Low-Risk Activity/Food Combinations 
Under Section 421 of the FD&C Act 
IX. Proposed General Revisi ons to Current Part 110 
A. Title  B. Proposed Redesignations  C. Proposed Revisions for Consistency of Terms  D. Proposed Additions Regarding Cross-Contact E. Proposed Revisions for Consistency With the Definition of “Food” F. Proposed Revisions to Addre ss Guidance in Current Part 110 
G. Proposed Editorial Changes 
X. Proposed Revisions to General Provisions of Part 110 (Proposed Part 117, Subpart A) 7 
 
  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 Manuf acturing Practice Requir ements 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 Cross-Contact 
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--San itary 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--W arehousing and Distribution (Proposed § 
117.93) 
L. Proposed Revisions to Current § 110.110--Nat ural or Unavoidable Defects in Food for 
Human Use That Present No Health Hazard (Proposed § 117.110)  
M. Potential Revisions to Establish Requi rements in Place of Current Guidance 8 
 
  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 App licable to a Qualified Individual 
I.  Proposed § 117.175--Records Required for Subpart C 
J. Request for Comment on Additional Preven tive 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 Requirement s That Apply to a Facility Solely 
Engaged in the Storage of Packaged Food That Is Not Exposed to the Environment 9 
 
  XIV. Proposed New Provisions fo r Withdrawal of an Exempti on Applicable to a Qualified 
Facility (Proposed Pa rt 117, Subpart E) 
A. Requirements of Section 418 of the FD&C Act B. Proposed § 117.251--Circumstances That Ma y 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 Ap peal 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 I ssuing 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 Require ments (Proposed Part 117, Subpart F) 
A. Relevant Stat utory Provisions 
B. Proposed § 117.301--Records Subject to th e Requirements of this Subpart F  10 
 
  C. Proposed § 117.305-General Requirements Applying to Records 
D. Proposed § 117.310--Additional Requirement s 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 th e 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 Manufact uring 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    11 
 
  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 Ra w Materials and Ingredients 
D. Verification of Sanitation Controls to Si gnificantly Minimize or Prevent the Potential 
for an Environmental Pathogen to Contaminate Food 
E. Role of Environmental Monitoring in Ve rifying the Implementation and Effectiveness 
of Sanitation Controls in Significantly Mini mizing or Preventing the Potential for an 
Environmental Pathogen to Contaminate Food    F. The Role of Finished Product Testi ng in Verifying the Implementation and 
Effectiveness of Preventive Controls  G. Metrics for Microbiol ogical Risk Management 
II. The Role of Supplier A pproval 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 cu rrent good manufacturing practice (CGMP) 
regulations regarding the manuf acturing, processing, packing, or  holding of human food in two 
fundamental ways.  First, it would add new pr eventive 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 ar e required to register with FDA 
under FDA’s current food facility registration re gulations.  These preven tive controls would 12 
 
  include requirements for covere d facilities to maintain a food safety plan, perform a hazard 
analysis, and institute preventive controls for th e 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 otherwis e 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 regi stration regulations and make co rresponding clarifications to 
FDA’s current regulations for the es tablishment, maintenance, and av ailability of records.  These 
clarifications would affect who would be subjec t to the current regulati ons for registration and 
recordkeeping as well as the new preventive contro ls requirements that would be established by 
this proposed rule.   
To put these changes in context, and to provi de 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, e xplains 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 ha ve resulted from these hazards.  An Appendix 
also describes the role of testing as a verificati on measure in a food safety system, and the role of 
supplier approval and verification progr ams in a food safety system.    13 
 
  Summary of the Major Provisions of the Proposed Rule  
The proposed rule would implement the requi rements 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 pro cedures would be applied to all foods at all 
facilities.   
The proposed rule would also establish a se ries 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 Ac t would be required to comply  with the proposed regulation 
unless they are covered by an exemption.  Th e table immediately below summarizes these 
proposed exemptions in general terms.  Importa ntly, the table in this  Executive Summary does 
not include all the details that you must consider to determine wh ether an exemption applies to 14 
 
  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 Ha zard Analysis and Risk-B ased 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: 
   
• 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 
 
• 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 FDA is proposing three options for defining “very small 
business” and requests comment on which to adopt in a 
final rule. 
 
Modified requirements would apply - i.e., a qualified 
facility would be required to: 
• Notify FDA about its status; and  
• Either: 
o Notify FDA that it is addressing hazards 
through preventive controls and monitoring; 
or 
o 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. 
• Low risk, on farm  activities performed 
by small  business (< 500 employees)  
 
-or- 
 
• Low-risk, on-farm activities performed 
by a very small business  
o Option 1: very small = 
<$250,000  
o Option 2: very small = 
<$500,000 
o Option 3: very small = 
<$1,000,000 
 Small and very small on-farm businesses conducting these 
low risk activities would be exempt from most of the rule’s 
requirements. 
 
We would define the low-risk activities that qualify for the exemption, including the spec ific foods to which they 
relate (such as re-packing intact fruits and vegetables, or 
grinding/milling/cracking/crushing grains) 
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. 15 
 
  Who or What Would Be Exempt From the 
Requirements for Hazard Analysis and Risk-
Based Preventive Controls Notes 
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 requirem ents 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 an alysis 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 qualif ied individual prepare the food safety plan, 
validate preventive controls, review records for implementation and effectiveness of preventive 
controls and the appropriateness of corrective act ions, 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 successf ully complete training with a 
standardized curriculum or be otherwise qualified through job expe rience to develop and apply a 16 
 
  food safety system.   Only a trained individua l or individual qualif ied by job experience is 
capable of effectively ex ecuting these activities. 
FDA is requesting comment on when and how other elements of a preventive controls 
system are an appropriate means of implementi ng the statutory directiv es, including: a product 
testing program, an environmental monitoring program, and a supplier ap proval 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 op tion of the proposed rule.  This 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 17 
 
  Each year, about 48 million Americans (1 in  6) get sick, 128,000 are hospitalized, and 
3,000 die from food-borne diseases, according to r ecent estimates from the Centers for Disease 
Control and Prevention (CDC).  This is a sign ificant public health bu rden that is largely 
preventable.  While many illnesses are the resu lt of improper food handling practices in the home 
and food service settings, which would not be ad dressed by this proposed rule, FDA believes that 
improvements to its current good manufacturing pr actice (CGMP) regulations in part 110 (21 
CFR part 110), including those prescribed by th e 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 safe ty problems rather th an relying primarily on 
reacting to problems after they occur.  The law also provides us with new enforcement 
authorities to help achieve highe r rates of compliance with risk-b ased, 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 part nership with State, local , tribal, and territorial 
authorities. 
This new law continues efforts by the f ood 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 embodi ed 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.  18 
 
  Since passage of the 1906 Act, and the most recent revision of its basic food safety 
provisions in the Federal Food, Drug, and Cosme tic 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.  Thes e efforts include the development and adoption 
by FDA of CGMP standards that have long provided the regulato ry foundation for food safety.  
They also include, in more recent years, the a doption 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 unders tanding that food 
safety is best assured if each producer and pr ocessor understands the hazar ds that are reasonably 
likely to occur in their particular product a nd 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 im plemented such modern preventive control 
systems for other commodities.   
While these efforts have contri buted to progress on food safe ty, and the United States has 
one of the safest food supplies in the world, signi ficant food safety challe nges 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 s eeing commonly known pathogens 
appear in foods where they have not been trad itionally seen.  The popula tion of individuals at 
greater risk for foodborne illness, such as t hose who are immune-compromised, is increasing.  19 
 
  When illness outbreaks occur, they can have devastating impacts on public health and impose 
substantial economic disruption a nd cost on the food industry.  Th e 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 str ong foundation provided by the current food safety system, but it 
also marks an historic turning point for food sa fety.  FSMA directs FDA to build a food safety 
system for the future that makes modern, scienc e- and risk-based prev entive controls the norm 
across all sectors of the food system; meets the f ood safety challenges of the global food system; 
and establishes stronger partnerships for food safety across al l 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-require d regulations that provide the framework 
for industry’s implementation of preventive c ontrols 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 accoun tability of importers to ve rify the safety of food 
produced overseas, and a new program for accr editing 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. 20 
 
  In this document, we propose standards to implement the requireme nt 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, becau se 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 upda ting 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 Manu facturing, 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 manufactur ing, 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)), unde r which food is adulterated if it 
has been prepared, packed, or held under insa nitary 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 pa rt 110 (21 CFR part 110) (42 FR 14301 at 14338, 
March 5, 1977).   21 
 
  In the Federal Register  of June 19, 1986, FDA issued a fi nal rule to revise the CGMP 
regulation in part 110 (her einafter current part 110) (51 FR 22458).  That final rule established 
new, updated, and more detailed CGMP require ments for food industry personnel; plants and 
grounds; sanitary facilities, c ontrols, and operations; equipmen t and utensils; processes and 
controls; warehousing and distribu tion; and natural or avoidable defect levels (51 FR 22458).  
During the rulemaking to establish current part 1 10, we clarified that the CGMP regulations also 
identify the applicable criteria for implemen ting the requirements of section 402(a)(3) of the 
FD&C Act (21 U.S.C. 342(a)(3)),  such that compliance with th e 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 e xplicit, 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 secti on 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 necessa ry 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 he ld,” and that “[d]ue to the nationwide, 22 
 
  interrelated structure of the f ood industry, communicable diseases may, without proper intrastate 
food controls, easily spread in terstate” (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 excepti on that it does not apply to 
establishments engaged solely in the harvesting, storage, or distributi on of raw agricultural 
commodities (RACs) which are ordinarily cleane d, prepared, treated, or otherwise processed 
before being marketed to consumers (§ 110.19(a)).  In 2002, FDA convened a CGMP Moderniza tion Working Group (the CGMP Working 
Group) to determine whether part 110 is in ne ed of further revision.  The CGMP Working Group 
initiated research programs, presented prelimin ary 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 (her einafter 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 presen ted 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 pat hogen control program, including the 
maintenance of appropriate implementation record s, for food processors that produce ready-to-
eat foods that support the growth of the pat hogenic microorganism Listeria  monocytogenes ; 23 
 
  • Requiring food processors to develop and maintain written cleaning and sanitation 
procedures, at a minimum for all food-contact eq uipment and food-contact surfaces, that define 
the scope, cleaning or sanitation objective, mana gement responsibility, monitoring, corrective 
action, and recordkeeping asso ciated with the cleaning or sanitation procedure; 
• Considering whether to remove the current  exemption for facilities solely engaged 
in the harvesting, packing, stor age, and distribution of RACs  by requesting further public 
comment on this issue; 
• Requiring food processors to maintain certa in critical records that document that 
controls and systems that ensure food safety are being properly implemen ted 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 incorporat ed 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 cu rrent 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, pack ing, or holding of certa in specific types of 
food products.  We therefore promulgated additi onal food safety regulations to provide for 
specific process controls for the manufacturi ng, processing, packing, or  holding of certain 
specific foods that are not captured by the mo re 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 re ferred to as LACF) (part 113 (21 CFR 113)) 24 
 
  (Although some hermetically sealed  containers (e.g., pouches and gl ass 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 sh orthand description for “thermally processed 
low-acid foods packaged in hermetically sealed c ontainers,” and we conti nue 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 manufacturin g, processing, packing, and holding of thermally 
processed foods packaged in hermetically seal ed 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 regul ation (38 FR 12716).  In the Federal Register  25 
 
  of January 29, 1974, we issued a final rule to es tablish procedures to implement the emergency 
permit control enforcement mechanism (39 FR 3 748).  The emergency permit control regulation 
is currently codified in 21 CFR part 108. 
In 1979, we issued a final rule to revise th e canned food CGMP regul ation and separate it 
into two distinct regulations.  One of these regula tions, 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 th e 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 ha ve 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 thos e in canned foods (41 FR 30442, July 23, 1976).  
Botulinum toxin can cause botulism, a rare but seri ous paralytic illness that  can be fatal and is 
considered a medical emergency (Ref. 2).  The pr imary 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).   26 
 
  Part 113 establishes requirements for equi pment; control of components, food product 
containers, closures, and in-process material; production and process cont rols; and records and 
reports for LACF.  Part 114 establishes require ments for production and process controls and 
records and reports for acidified foods.  In lig ht of the severity of the hazard presented by 
botulinum toxin, parts 113 and 114 require that supervisory pe rsonnel be trained at schools 
approved by FDA (§§ 113.10 and 114.10, respectively).   
The enforcement regulations in §§ 108.25 a nd 108.35 require manufacturers, processors, 
and packers of acidified foods and LACF, re spectively, to file food canning establishment 
registration information with FDA.  The regi stration 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 acidi fied 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 emerge ncy 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 establis hes the criteria and pr ocedures related to a 
determination of the need for an emergency perm it, revocation of the dete rmination 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 27 
 
  microbiological, physical, chemical , and radiological contaminants  in bottled drinking water (38 
FR 32558).  The quality standard regulation is co dified 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 wa ter (40 FR 11566).  The bottled water CGMP 
regulation is codified in pa rt 129 (21 CFR part 129).   
FDA promulgated part 129 in light of surveys an d 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 so me bottled water failed to meet some of the 
prevailing regulatory criteria  for non-bottled, public dri nking water (38 FR 1019 at 1019, 
January 8, 1973), some of the bottling plants su rveyed did not conduct ad equate 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 bottli ng facility, and quality 
control to ensure the safe ty of the water.  Part 129 also es tablishes certain analytical testing 
requirements for chemical, physical, radiologi cal, 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 infa nt formula products by establishing greater 
regulatory control over the formulation and produc tion of infant formula.  Enactment of the law 
resulted largely from the emergence of a substa ntial number of cases involving a serious medical 
disorder known as hypochloremic metabolic alkalosi s, which is most frequently characterized by 28 
 
  an infant’s inability to thri ve.  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 fina l rules to establish th e 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) regardin g 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 Anti-Drug Abuse 
Act of 1986 (Pub. L. 99-570) (the 1986 infant formula amendments) to address concerns 
regarding the sufficiency of quality contro l 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).   29 
 
  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 re gulations in parts 106 an d 107 to: (1) establish 
CGMPs, including microbiological te sting; (2) revise the quality control procedures in part 106 
to ensure that an infant formula contains the le vel of nutrients necessary to support infant growth 
and development; (3) specify audit procedures to ensure compliance w ith CGMP and quality 
control procedure regulations; (4 ) establish requirements for qual ity factors to ensure that 
required nutrients will be in a bioavailable fo rm; (5) establish batch and CGMP recordkeeping 
requirements; (6) specify submission requireme nts for registration and notification to FDA 
before the introduction of an infant formula in to 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, 200 6).  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 pr ocessors to develop, 
implement, and document sanitation control proc edures and mandates the application of HACCP 
procedures. In the remainder of this documen t, 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 HAC CP regulation in more 
detail in section II.C.5.a of this document. 30 
 
  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” a nd “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 a dded section 402(g) to the FD&C Act (21 
U.S.C. 342(g)).  Section 402(g)(2) in part aut horizes the Secretary of HHS to promulgate 
regulations to prescribe CGMPs fo r dietary supplements.  Section 402(g)(2) also stipulates that 
such regulations must be modeled af ter 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 cap s, and capsules; some 
dietary supplements may contain bioactive ingredients for which specific, contro lled amounts are 
intended to be in each tablet or capsule; v itamins can present a concentrated source of 
biologically active compone nts that have adverse health cons equences at high doses; and herbal 
and botanical dietary supplements are often comp lex mixtures that can vary in composition and 
be contaminated with substances having advers e health consequences depending on factors such 31 
 
  as the part of the plant used, th e location of harvesting and growi ng conditions that can vary from 
year-to-year (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 uten sils.  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 speci fications for incoming ingredients and finished 
product; certain requirements for testing of incoming ingredients and finished product; the 
establishment and implementation of quality cont rol 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 establ ishment and use of certain laboratory control 
processes; the investigation of any product complain t that involves the possi bility 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 suppleme nt 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 th at established in § 115.50 (21 CFR § 115.50) 
refrigeration requirements for shell eggs held fo r 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 th e contamination of shell eggs with Salmonella  
Enteritidis (SE), a specific Salmonella  serotype.  As discussed in th e proposed rule to establish 
the shell egg refrigeration re gulation (64 FR 36492, July 6, 19 99), the disease salmonellosis 32 
 
  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 pr edominant source of SE related 
cases of salmonellosis in the United States where a food vehicle is identifi ed for the illness (64 
FR 36492 at 36493). 
The shell egg refrigeration regula tion requires that shell eggs he ld at retail establishments 
be stored and displayed under re frigeration at a temper ature of 7.2 °C (45 °F) or less to help 
prevent the growth of Salmonella  spp., except for shell eggs th at 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 dest ruction of shell eggs th at have been held in 
violation of the refrigeration requirements. 
h. Production, storage, and tran sportation 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 m easures to prevent SE 
from contaminating eggs on the farm and from further growth during st orage and transportation, 
and maintain records related to their compliance with the requir ements of the regulation.  As 
with the shell egg refrigeration ru le, FDA promulgated part 118 to  reduce SE-associated illnesses 
and deaths by reducing the risk  that shell eggs are contamin ated with SE (74 FR 33030). 33 
 
  3. Food Safety Guidance to Industry  
FDA has issued numerous guidance documents (h ereinafter, “guidance”  or “guidances”) 
to assist the food industry in implementing f ood safety regulatory requirements under FDA’s 
jurisdiction.  We issue guidances, in accord ance 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 establis h legally enforceable rights or re sponsibilities and do not legally 
bind the public or FDA (§ 10.115(d)(1)).  Accord ingly, regulated industr y is not required to 
employ the approaches contained in a guidance and instead may choose to use an alternative 
approach, provided that the alternative appro ach complies with the re levant statutes and 
regulations (§ 10.115(d)(2)).  A lthough guidances do not legally bind FDA, they represent our 
current thinking on a particular in terpretation of or policy regard ing 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 guidanc e in final form, except where prio r public participation is not 
feasible or appropriate, if the guidance (1) sets forth initial in terpretations of statutory or 
regulatory requirements, (2) sets forth changes in interpretation or policy th at are of more than a 
minor nature; (3) includes complex scientific issu es, or (4) covers highly  controversial issues. 
FDA generally issues guidan ce to industry for the purpose of communicating our policy 
decisions and interpretations of our regulatory requirements so that re gulated industry better 
understands how to comply with those require ments.  In some cases, we issue guidance 
specifically targeted to assisting industry in complying with a pa rticular food safety regulation.  
For example, we have issued guidances to assi st industry in complyi ng 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 34 
 
  complying with a particular food safety regulatio n.  For example, we have issued guidance that 
addresses the chemical contamin ation of candy with lead (Ref. 5) and guidance on measures to 
address the risk for contamination by Salmone lla 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 polic y on regulatory issues re lated to the statutes 
and regulations that we are responsible for im plementing.  CPGs advise FDA field inspection 
and compliance personnel as to FDA’s standards a nd procedures to be applied when determining 
industry compliance with our regula tory 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 industr y 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 f ood safety CPGs are relatively focused in scope.  
For example, we have issued a CPG regarding mi crobial contaminants in dairy products (Ref. 7 
Ref. 7), and a CPG that sets fort h 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, proces sed, packed, or held and to in spect all pertin ent equipment, 
finished and unfinished materials, containers, an d labeling located in such establishments (21 
U.S.C. 374).  We inspect food establishments bot h for cause, for example as part of foodborne 35 
 
  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 insp ect facilities according to the 
known safety risks of the facili ties” as determined by several factors, including among other 
things “[t]he known safety risk s of the food manufactured, pro cessed, 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 fr equency of inspection of  all facilities,” and 
includes schedules 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 dire cts FDA to “allocate resources to  inspect any ar ticle of food 
imported into the United States according to the k nown safety risks of the article of food” as 
determined by a number of factors, including among other things “[t]he know n safety risks of the 
countries or regions” from which the food origin ates or through which it is transported, and 
“[t]he compliance history of th e importer” (Section 421(b)).  
FDA inspectors, or inspectors from other Fede ral agencies or the States authorized to 
conduct inspections on our behalf , inspect food establishments to determine whether the 
establishments are in compliance with the requi rements of the FD&C Ac t and other applicable 
laws and regulations, and document their findi ngs in Establishment Inspection Reports.  
Following an inspection, FDA may decide that : (1) no further action is required because no 
objectionable conditions or prac tices were found duri ng 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 36 
 
  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 establishm ent, we may elect to 
take an advisory action, such as issuing a Warn ing 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 vi olations 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 di stribution and give noti ce under section 423(b) of 
the FD&C Act (21 U.S.C. 3501), a seizure of viol ative products, an injunction, or a criminal 
prosecution (Ref. 11) (Ref. 12).  6. Systems for Identifying Food Safety Problems 
a. Contamination of f ood and foodborne illness.
  Food can become contaminated (e.g., 
with biological, chemical, physical, or radiologica l hazards) at many different steps in the farm-
to-table continuum: on the farm; in packing, manu facturing/processing, or distribution facilities; 
during storage or transit; at reta il establishments; in restaurants;  and in the home.  As discussed 
more fully in section II.D of this document, cons umption 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 reca ll to retrieve the contaminat ed product from commerce.   37 
 
  We learn about contaminated food through a variety of mechanisms, including required 
reporting by industry; investig ations of outbreaks of foodborne  illness; recalls; and state 
surveillance and reportin g programs.  We discuss these mechanisms immediately below. 
b. Required reporting by industry.   In some cases, a firm th at manufactures, processes, 
packs, or holds food, or a regulatory official, dete cts contamination of a food in the market.  This 
may occur even when there is no known or suspect ed association between the food and reports of 
foodborne illness. The Food and Drug Admini stration Amendments Act of 2007 (Pub. L.110-
085) established, among other thi ngs, section 417 of the FD&C Act (21 U.S.C. 350f), which 
requires FDA to establish a Reportable Food Registry  (RFR).  A “reportabl e food” is an article 
of food (other than dietary supplements or in fant 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 animal s (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 F DA electronically with certain in formation within 24 hours of 
determining that a food they manufactured, proce ssed, packed, or held is  a reportable food.  On 
September 8, 2009, FDA launched the electronic portal for submissi on of these required reports.  
Information about reportable foods  becomes part of the RFR.   
Infant formula and dietary supplements are ex cluded 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.  Manuf acturers, 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 seriou s adverse event associated with  that dietary supplement when 38 
 
  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 illnes s or injury, quick ac tion 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 ra w agricultural commodities, food ingredients, 
and single- or multi-ingredient processed foods.   
c. Outbreaks of foodborne illness
.  In some cases, contaminated food goes undetected 
until it is associated with an outbreak of foodborne illness. (A n outbreak of foodborne illness is 
the occurrence of two or more cases of a similar illness resulting from th e 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 an d/or tribal health departments 
conduct epidemiologic investigations  to identify the food(s) that may be involved in an outbreak.  
Many outbreaks are reported to th e National Outbreak Reporting System (NORS) by the State, 
local, territorial, or tribal hea lth department that conducted the outbreak investigation. Outbreak 
reporting is voluntary.  Mu lti-state outbreaks are generally re ported to NORS by CDC (Ref. 13).  
The Foodborne Outbreak Online Database (F OOD) allows the public direct access to 
information on foodborne outbreaks  reported to CDC (Ref. 14). 
In July 1995, the Foodborne Diseases Ac tive Surveillance Network (FoodNet) was 
established as a collaborative program among CD C, 10 state health departments, USDA’s Food 
Safety and Inspection Service (FSIS), and FDA.  FoodNet conducts surve illance for infections 
caused by specific pathogenic microorganisms as  diagnosed by laboratory testing of samples 39 
 
  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 th e United States; 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 le ad to improvements in public health practice and 
the development of interventions to reduce th e burden of foodborne illness (Ref. 15).  
Information from FoodNet is used to assess the imp act of food safety initiatives on the burden of 
foodborne illness (Ref. 16). 
FDA works closely with CDC to monitor t hose 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 app ears 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 investiga tion (i.e., an investigation to  determine and document the 
production chain and the source(s) of contamin ated or potentially contaminated food); a 
traceforward operation (i.e., an operation to de termine the distribution of contaminated or 
potentially contaminated food) ; regulatory inspections; and, in some cases, root cause 
investigations (to try and determine the spec ific causes of contamin ation and contributing 
factors).  
PulseNet is another collaborative program for the surveillance and de tection of foodborne 
illness that is coordinated by the CDC, with laboratory participants from state health departments, local health departments, and Fe deral agencies, including FDA and FSIS.  Using 40 
 
  pulsed-field gel electrophoresis (PFGE), PulseNet participants perform standardized molecular 
subtyping (or fingerprinting) of foodborne dise ase 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 identifica tion of common source outb reaks.  PulseNet is 
considered to be a powerful intelligence network that allows for the coll ection and analysis of 
state and local epidemiological surveillance data for the identi fication of outbreaks that may 
otherwise go unnoticed.  In addition, PulseNet helps food regulatory ag encies identify areas 
where the implementation of new measures and enhanced surveilla nce 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 – preventi on, preparedness, response, and recovery – and 
coordinates the testing ac tivities of Federal, st ate, and local laborator ies.  As of April 2011, 
FERN has 172 laboratory members (39 Federal, 116 State, and 17 lo cal), located in all 50 States 
and Puerto Rico.  FERN member laboratories represent the large majo rity of food testing 
laboratories in the U.S., including public he alth, agriculture, vete rinary diagnostic and 
environmental laboratories. At this point, it is estimated that the FERN membership represents about 85% of all eligible food regul atory laboratories in the U.S.   
FERN members use a web-based informati on network (the Electronic Laboratory 
Exchange Network, or eLEXNET) (Ref. 18) as their primary, real-time data exchange and 
communication system.  Many participating labo ratories conduct food surveillance testing 
programs for microbial pathogens (e.g., E. coli
 O157:H7, Salmonella  spp., Listeria 
monocytogenes ,), aflatoxin, antibiotics, undeclared allerg ens, heavy metals, and other threats to 41 
 
  the food supply.  Laboratory results can be uploa ded into eLEXNET for th e early identification 
of threats to the food supply.  For example, overl aying 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 iden tify trends for future surveill ance efforts.  In addition, the 
eLEXNET serves as a method repository for labora tories to rapidly sear ch, access, review, and 
print methods. 
d. Recalls .  In 1978, we established a program re garding recalls, in cluding guidance on 
policy, procedures, and industry responsibilities (43 FR 26202, J une 16, 1978).  Our regulations 
in part 7, subpart C (21 CFR part  7, subpart C) address recall po licy; health hazard evaluation 
and recall classification; recall strategy; FDA -requested recall; firm-i nitiated r ecall; recall 
communications; public notification of  recall; recall status reports;  termination of a recall; and 
general industry guidance.  In  addition, under authority in sec tion 412(f) of the FD&C Act (21 
U.S.C. 350a(f)), we have issued regulations estab lishing specific requirements for infant formula 
recalls (21 CFR part 107, subpart E).  Mo re recently, FSMA amended the FD&C Act by 
establishing section 423 of th e FD&C Act (21 U.S.C. 350l), which provides FDA with 
mandatory recall authority for food (other than in fant 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 pr oduct being recalled by considering whether any 
disease or injuries have already occurred fr om the use of the product; whether any existing 
conditions could contribute to a c linical situation that could expose consumers to a health hazard; 
how the hazard could impact various segmen ts of the population (e .g., children, surgical 
patients), with particular attention paid to the ha zard to those individuals who may be at greatest 42 
 
  risk; the degree of seriousness of the health h azard to which the populations at risk would be 
exposed; the likelihood of occurrence of the hazar d; and the potential consequences (immediate 
or long-range) of occurrence of the hazard. On the ba sis of this evaluation, we classify the recall 
(i.e., Class I, Class II, or Class III) to indicate the re lative degree of health hazard of the product 
being recalled or considered for recall.  A Cla ss I recall is a situation in which there is a 
reasonable probability that the use of, or expos ure to, a violative product will cause serious 
adverse health consequences or death (§ 7.3(m)(1)).  A Class II re call is a situation in which use 
of, or exposure to, a violative product may cause  temporary or medically reversible adverse 
health consequences or where th e 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 he alth consequences (§ 7.3(m)(3)). 
In recent years, recalls of food ingredients have highlighted the potentially large impact 
that contamination (or potential contaminati on) of a single food ingredient can have on 
thousands of food products contai ning that ingredient (Ref. 19)  (Ref. 20 ) (Ref. 21) (Ref. 22) 
(Ref. 23) (Ref. 24), with corre spondingly significant disruptio n and cost for industry and 
consumers.  
e. State surveillance and reporting programs .  State food safety agencies are involved in 
identifying contaminated food by conducting surv eillance 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 al so conduct thousands of inspections and collect 
and analyze food samples at food manufacturers/processors every ye ar under contract to FDA.  
The states perform inspections  of food manufacturers, proces sors, packers and holders to 
determine compliance with the FD&C Act, stat e law, or both.  Such inspections focus on 43 
 
  identifying significant CGMP violations and in sanitary 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.  Stat e inspections also focus on identifying practices 
or other conditions that may have caused f ood to become filthy, putrid, decomposed, or 
contaminated with foreign objects (Ref. 26).  FDA coordinates eLEXNET), which is a web-
based information network that allows state food  safety officials to share laboratory analysis 
findings with FDA and other Federa l, state and local food safety agencies (Ref. 18).  FDA also 
participates in FERN, which is an FDA/FSIS join t initiative to integrate the nation's food-testing 
laboratories at the local, state,  and Federal levels into a netw ork that is able to respond to 
emergencies involving biological, chemical, or radiological contam ination 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 informati on 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.  Fo r example, HHS, USDA, and their constituent 
agencies maintain the Internet site FoodS afety.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 h azards, 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 a nd agencies regarding food safety issues (Ref. 
27).  44 
 
  We also engage in consumer outreach in pa rtnership with non-governmental entities.  
Most prominently, HHS, USDA, and the U.S. De partment of Education work with industry 
associations, academic institutions, consumer a nd public health organizations, and professional 
societies in the food sciences to support the Partnership for Food Safety Education.  This 
partnership, among other things, educates consum ers about the importance of safe food handling 
and health risks posed by specific foodborne i llnesses, prepares and disseminates food safety 
curricula for use by educators, and provides info rmation regarding how consumers can be aware 
of and respond to food recalls (Ref. 28).  
FDA also conducts its own independent in formational 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 Mode rnization Act (FSMA) (Public Law 111–
353) was signed into law.  Section 103 of FSM A, 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 rule making are codified in section 
418 of the FD&C Act. 
a. General requirements .  Section 418 of the FD&C Act c ontains 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, proce ssed, 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) specifie s that the purpose of the preven tive controls is to “prevent 45 
 
  the occurrence of such hazards and provide assu rances that such food is not adulterated under 
section 402 [of the FD&C Act] or misbranded un der section 403(w) [of the FD&C Act] ….” 
In addition to those areas specified in secti on 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 creat es a new section 301(uu) in the FD&C Act (21 
U.S.C. 331(uu)) to prohibit “[t]he operation of a f acility that manufactures , processes, packs, or 
holds food for sale in the United States if the owner,  operator, or agent in ch arge 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 faci lity to be a qualified facility, establishes an 
exemption for qualified facilities, establishes modi fied requirements for qualified facilities, and 
provides that the Secretary may withdraw the exem ption otherwise granted to qualified facilities 
in specified circumstances.  U nder 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 pr eventive 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 it s qualified status and also submit either 46 
 
  documentation of the facility’s implementati on and monitoring of pr eventive controls or 
documentation of its compliance wi th other appropriate non-Federal food safety laws.  Section 
418(l)(3) of the FD&C Act authorizes the Secret ary to withdraw the exemption from a qualified 
facility in specified circumstances.  In secti on 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 th e FD&C Act, there are several othe r 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 faciliti es that are required to comply  and are in compliance with the 
regulations for seafood HACCP, juice HACCP, or th ermally processed low-acid 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 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 secti ons X.C.2 through X.C.4 of this document, we discuss proposed 
exemptions for activities that are subject to pa rt 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 hol ding of dietary supplements (proposed § 
117.5(e)).  47 
 
  As discussed in section II.B.2.e of this docum ent, 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 regard ing 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 facil ities engaged in the manufacturing, 
processing, packing, or holding of alcoholic beverages and other f ood.  In section X.C.7 of this 
document, we discuss proposed exemptions rela ted to such facilities  (proposed § 117.5(i)). 
2. Requirements for Agency Rulemaking 
Section 103 of FSMA contains two separate rulemaking provi sions.  Section 103(a) of 
FSMA requires rulemaking related to the hazard analysis and risk-based preventive controls 
required by section 418 of the FD&C Act.  In  addition, section 103(c) of FSMA requires 
rulemaking in two areas: (1) clarif ication of certain aspects of th e definition of the term “farm” 
under section 415 of the FD&C Act (21 U.S.C. 3 50d) (Registration of F ood Facilities) and (2) 
possible exemption from or modi fication of requirements of sec tion 418 and section 421 of the 
FD&C Act (21 U.S.C. 350j) (Targeting of Inspec tion Resources for Domes tic Facilities, Foreign 
Facilities, and Ports of Entry;  Annual Report) for certain faci lities as the Secretary deems 
appropriate and as further specifie d 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 af ter 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, a nd documenting the implementation of the 
preventive controls ….”   48 
 
  b. Definition of small and very small business .  Section 418(l)(5) of the FD&C Act 
requires the Secretary, in consulta tion with the Secretary of Agricu lture, to conduct a study of the 
food processing sector regulated by the Secretary and to make de terminations 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 co-located on farms, (4) the incide nce 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,” taki ng into considerati on the study of the food 
processing sector required by sect ion 418(l)(5) of the FD&C Act.  These terms are significant 
because section 103 of FSMA contains severa l provisions specific to such entities. 
• Small and very small businesses are subjec t to modifications or exemptions from 
requirements under section 418 or 421 of the FD&C  Act for facilities engaged only in specific 
types of on-farm 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 s ubject 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 “qua lified facility” and would, therefore, 
qualify for the exemptions as discussed in sectio n X.C.1 of this document. (§ 418(l)(1)(B) of the 
FD&C Act).  49 
 
  Consistent with section 418( l)(5) of the FD&C Act, FDA has consulted with USDA 
during its study of the food processing sector (R ef. 31).  The study is av ailable in the docket 
established for this proposed ru le (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 busin ess, 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 fore ign 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 f ood for consumption in the United States to 
register with the Secretary. 
The requirement in section 415 of the FD&C Ac t 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 th e section 415 registrati on regulations) define “farm,” in relevant 
part, as “a facility in one ge neral 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, th e 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)).  50 
 
  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 pr oposed rulemaking in the Federal Register  to issue 
regulations for purposes of section 415 of th e FD&C Act with respec t to “activities that 
constitute on-farm packing or holding of food th at is not grown, raised, or consumed on such 
farm or another farm under the same owners hip” and “activities that constitute on-farm 
manufacturing or processing of f ood 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 with in 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 regul ations to enhance the implem entation of section 415 and to 
clarify the definition of the term “facility.” 
d. Science-based risk analysis and require ments under sections 418 and 421 of the FD&C 
Act.  Section 103(c)(1)(C) of FSM A requires that in issuing th e proposed rule the Secretary 
conduct a science-based risk analysis of: 
• “Specific types of on-farm packing or holdi ng 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 
• 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 consid er the results of the science-
based risk analysis and exempt cer tain facilities from the require ments in sections 418 and 421 of 
the FD&C Act or modify those requirements, as the Secretary determines appropriate, if such 51 
 
  facilities are only engaged in sp ecific types of on-farm manuf acturing, processing, packing, or 
holding activities the Secretary de termines 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 sm all businesses (§ 103( c)(1)(D)(ii) of FSMA). 
In section VIII.G of this document, we discu ss our approach to the requirement in FSMA 
section 103(c) for a science-based risk analys is of the types of on-farm manufacturing, 
processing, packing, or holding opera tions that can involve food th at 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 manufacturin g, processing, packing, and holding of certain “low risk” 
foods from the requirements of section 418 of th e FD&C Act (proposed § 117.5(g) and (h)).  In 
section VIII.J of this document, we discuss our te ntative conclusion that we should not exempt or 
modify the frequency requirements under 421 base d 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 re quirements 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 di scussed in section X.C.8 of this  document, in accordance with 52 
 
  the discretionary language of section 418(m), FDA tentatively concludes th at facilities solely 
engaged in the storage of RACs, other than fruits  and vegetables, intended for further distribution 
or processing should be exempt from the re quirements for hazard analysis and preventive 
controls that we are proposing to es tablish 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 faci lities 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 ar e 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 sing le regulation that cove rs 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, pack s or holds human food.  Section 
103 of FSMA applies to “food,” which is not lim ited 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 tenta tively concludes that the differe nces between human and animal 
food are best addressed through separate regul ations.  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 shoul d consider this proposed  rule as well as the 53 
 
  future proposed rule directed to CGMPs and hazar d 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 th e 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 hazar ds in a separate rulemaking in the future.  
FDA tentatively concludes that intentional haza rds, which are not addressed in traditional 
HACCP or other food safety systems, likely will re quire different kinds of controls and would be 
best addressed in a separate rulemaking. Howe ver, we also recognize that some kinds of 
intentional adulterant s could be viewed as reasonably likely  to occur, e.g., in foods concerning 
which there is a widely recogni zed risk of economically motiv ated adulteration in certain 
circumstances.  An example of this kind of haza rd 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 system atic 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 Adviso ry Committee on Microbiological Criteria for 
Foods (NACMCF) as an effective and rational means of ensuring food safety.  NACMCF is an 54 
 
  advisory committee chartered unde r USDA (Ref. 33).  NACMCF in cludes participants from 
USDA’s FSIS, HHS (FDA and CDC), the Departme nt of Commerce (National Marine Fisheries 
Service), the Department of De fense (Office of the Army Surge on 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 intr oduced 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 adopt ed its current version, “Hazard Analysis 
and Critical Control Point Principles and Applic ation 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 Co mmission (Codex).  (The Codex Alimentarius 
Commission was formed in 1963 by the Food a nd 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 Worl d 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 segmen ts of the food industry from growing, 
harvesting, processing, manufact uring, distributing, and mercha ndising to preparing food for 
consumption (Ref. 34).  Under HACCP, a food oper ation develops a plan that identifies food 
hazards applicable to the food and production pro cess, and the points in the production process 
where a food hazard could be introduced, controlled  or enhanced. A failure at these points would 55 
 
  likely result in a food hazard being created or allowe d to persist.  These points are referred to as 
critical control points (CCPs).  Under HACCP, id entified 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 lo st, including proper dis position of the food 
produced during that period, and th ese actions are documented.  Th e effectiveness of HACCP is 
also systematically verifi ed 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 sec tion 103 of FSMA.  As di scussed in section II.B 
of this document, section 103 of FSMA amende d the FD&C Act by adding section 418.  Section 
418 of the FD&C Act and section 103 of FSMA ar e both titled “Hazard Anal ysis 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 ke y to an effective food safety system.  Further, 
establishment of a system of pr eventive controls for these haza rds 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 c ontrols, “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 56 
 
  all based on HACCP principles.  Further, section 418 uses HACCP terminology throughout, 
including hazard analysis, monitoring, correc tive actions, and verification.  The close 
relationship of section 418 to HAC CP is further illust rated by an exemption created in section 
418(j) for “seafood, juice, and low-acid canne d 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 lite rature.  For example, as discussed in section 
II.C.4.b  of this document, HACCP systems focu s on determining CCPs, whereas section 418(c) 
requires that the owner, operato r, 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 se ction 418(c) of the FD&C Act requires that the 
owner, operator, or agent in charge of a f acility identify and implement preventive controls, 
including at CCPs, if any, without specifying that the preventive cont rols 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 pr oposed rule aligns well with HA CCP, it differs in part in that 
preventive controls may be requi red at points other than  at critical contro l points and critical 
limits would not be required for all preventive controls.  
As another example, as discussed in secti on 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 hazar ds that may be associ ated with the facility, 
including “biological, chemi cal, physical, and radiological  hazards” (emphasis added).  Although 
radiological hazards are not common , the consequences to consumers of exposure to radiological 57 
 
  hazards may be severe (e.g., cancer).  As discu ssed in section II.C.4.a of this document, under 
HACCP systems the hazard analysis includes a wr itten assessment of the likelihood that the 
hazard will occur and its severity  if it does occur (emphasis adde d).  Thus, section 418(b)(1)(A) 
of the FD&C Act is consistent with the framew ork 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 s ections of FSMA applicable to specific 
proposed provisions and describe how the propose d provisions relate to HACCP principles as 
established by NACMCF in the NACMCF HACCP gui delines, 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 recomme nd a process for developing a HACCP 
system, or the implementation of a HACCP plan (Ref. 34).  The “five pr eliminary tasks” of 
HACCP include: (1) Assembling a HACCP team; (2) describing the food and its distribution; (3) 
identifying the intended use and consumers of th e food; (4) developing a flow diagram; and (5) 
verifying the flow diagram.  The NACMCF HA CCP 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 manda te that the owner, 
operator, or agent in charge of a facility conduct these preliminar y tasks, facilities will greatly 
benefit from completing these preliminary tasks in  developing their hazard analysis and risk-
based preventive control systems.   58 
 
  4. The Seven Principles of HACCP 
NACMCF has developed and adopted seven principles that de scribe the HACCP 
concept: (1) Conduct a hazard analysis; (2) Determin e the CCPs; (3) Establish the critical limits; 
(4) Establish monitoring procedures; (5) Establis h corrective actions; (6) Establish verification 
procedures; and (7) Establish recordkeeping and documentation procedures (Ref. 34).  We 
discuss these immediately below. 
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 id entification of control measures fo r each identified hazard, all of 
which should be documented. 
b. Principle 2: Determine the CCPs
.  The second HACCP princi ple 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 manufact uring 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 valu es 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, elimin ate or reduce to an acceptable level the occurrence 59 
 
  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 co ntrol 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 ope rating 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 identif ied as hazards for a food are th e critical limits for that CCP. 
d. Principle 4: Establis h monitoring procedures . The fourth HACCP principle is 
establishing monitoring procedures. The NACMC F HACCP guidelines define monitoring to 
mean conducting a planned sequence of observati ons 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 co ntrolled and a deviation 
occurs.  Because of the potentially serious cons equences of a deviati on from a critical limit, 
monitoring procedures must be effective.  De pending on the circumstances, monitoring may be 
on a continuous or a non-continuous basis.  Con tinuous monitoring of a cr itical 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 mu st be established that  are frequent enough to 
determine whether the measure designed to c ontrol the hazard is consistently being met. 
e. Principle 5: Establish corrective actions .  The fifth HACCP prin ciple is establishing 
corrective actions.  The NACMCF HACCP guidelines  define corrective act ions as procedures 
followed when a deviation occurs (Ref. 34).  Wh ile the HACCP system is intended to prevent 
deviations in a planned process from occurring, to tal prevention can rarely, if ever, be achieved.  60 
 
  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 improvemen t of the process to prevent 
future occurrences. 
f. Principle 6: Establis h verification procedures .  The sixth HACCP principle is 
establishing verification proce dures.  The NACMCF HACCP guideli nes define verification as 
those activities, other than mon itoring, that determine the validit y 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 direct ed to validation, may be very scie ntific and techni cal in nature.  
For additional information about verification activ ities, see the discussion in  section XII.G of this 
document.  For additional information about the sp ecific verification activity  of “validation,” see 
the discussion in section XII.G.2 of this document. 
g. Principle 7: Establish recordk eeping and documentation procedures .  The seventh 
HACCP principle is establishing recordkeepin g 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 pro cessing and importing of fish and 
fishery products (60 FR 65096).  Part 123 requires, among other th ings, that seafood processors 61 
 
  apply HACCP principles to the processing of seaf ood.  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 s eafood HACCP regulation, including microbiological 
hazards, naturally occurring toxins, chemical cont aminants that might be present in the aquatic 
environment, and decomposition of fish and fi shery products that might result from improper 
product handling and produce the toxin, hist amine (59 FR 4142 at 4143 – 4144, January 28, 
1994). 
The HACCP regulation for seafood incorpor ated the seven HACCP principles as 
established in the 1992 revision of  NACMC F’s HACCP Principles for Food Production 
(“Hazard Analysis and Critical Control Point Sy stem”) (Ref. 36).  The HACCP regulation for 
seafood also requires that indivi duals assigned the tasks of deve loping, reassessing, or modifying 
a HACCP plan, and conducting required records re view 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 deve loping their HACCP systems (60 FR 65096 at 65117). 
The HACCP regulation for seaf ood also requires that processors of seafood products 
monitor the conditions and pract ices of a sanitation standard  operating procedure (SSOP); 
correct, in a timely manner, those conditions a nd practices that are no t met; and document the 
monitoring and corrections (§ 123.1 1).  In addition, the HACCP regul ation for seafood is explicit 
that the general, umbrella CGMP requirements fo r human food of part 110 a pply to processors of 62 
 
  fish and fishery products in determining whether the facilities, methods, pr actices, and controls 
used are safe, and whether the products have been processed under sanitary conditions (§ 
123.5(a)). 
In section XII of this docu ment, 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 ot her 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, 1 996).  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 revi sion of NACMCF’s HACCP Principles for Food 
Production (Ref. 36).  Unlike our HACCP regula tions 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 pr ocess and product flow in the establishment be 63 
 
  prepared and that the intended use and consumers of the finish ed product be identified (9 CFR 
417.2(a)(2)). 
The FSIS HACCP regulation for meat and poultr y requires the establishment to develop, 
implement and maintain written SSOPs that de scribe the procedures an establishment will 
conduct daily, before and during operations, to prev ent direct contamination or adulteration of 
products (9 CFR 416.11 and 416.12(a)).  Establishmen ts must monitor the implementation of the 
SSOPs (9 CFR 416.13(c)), take appropriate corr ective actions (9 CFR 416.15), and maintain 
records that document the implementation a nd monitoring of the SSOPs (9 CFR 416.16). 
In section XII of this docu ment, 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 FSI S HACCP regulation for meat and poultry. 
c. HACCP regulation for juice .  In 2001, FDA issued a final ru le 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 requi res, among other things, that processors of 
juice products apply HACCP principles to the pro cessing of juice.  We issued the juice HACCP 
regulation in light of a number of food safety hazards asso ciated 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 regul ation for juice requires that individuals 
assigned the tasks of developing the hazard anal ysis, developing a HACCP plan, and verifying 64 
 
  and modifying the HACCP plan must be adequa tely trained in the application of HACCP 
principles to juice products, evid enced either by the successful co mpletion of the equivalent of a 
standardized curriculum recognized as adequate  by FDA or by suffici ently adequate work 
experience (§ 120.13).  As with the HACCP re gulation 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, th e HACCP regulation for juice requires that 
processors of juice products monitor the condi tions 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 umbre lla 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 pr ocessed under sanitary conditions (§ 120.5). 
Unlike the HACCP regulation for seafood, the HAC CP regulation for juice, with certain 
exceptions, establishes requirements for process controls for pathogen reduction (§ 120.24).  The 
HACCP regulation for juice also establishes re quirements for process verification for juice 
processors, under certain circumst ances, to analyze their finished  juice products for the presence 
of E. coli
 using specified sampling and anal ytical methodologies (§ 120.25).  
In section XII of this docu ment, we describe provisions  of the HACCP regulation for 
juice in more detail when we compare the propo sed 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. 65 
 
  d. Dairy HACCP pilot program .  The Pasteurized Milk Ordi nance (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 re gulation includes prov isions governing the 
processing, packaging and sale of Grade “A” milk  and milk products and provides administrative 
and technical details on how to obt ain satisfactory compliance. It is  published to assist States and 
municipalities in initiating and maintaining eff ective programs for the prevention of milkborne 
disease.  Currently all fifty stat es, the District of Columbia, a nd Puerto Rico have adopted the 
PMO by reference or have codified the PMO in st ate 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 in spection system.  No milk plant, receiving 
station or transfer station ma y 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 se ven HACCP principles established in the 
1998 NACMCF HACCP guidelines and essentially fo llows the same requirements as described 
in the HACCP regulation for juice (part 120).  SS OPs are referred to as “required prerequisite 
programs (PPs).”  In contrast to the HACCP regulations for s eafood 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 documente d.  In this respect, the PMO HACCP Appendix 66 
 
  is broader in scope than HACCP, in that it em phasizes 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 interna tional food safety community .  HACCP is recognized in the 
international food safety community as the stat e-of-the-art means to ensure the safety and 
integrity of food.  In particular, the Committ ee on Food Hygiene of Codex has endorsed the 
HACCP concept as a worldwide guideline incorp orated 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 fo ods 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 Regula tion (EC) No 852/2004 of the European Parliament and Council 
of the European Union Regulation (Ref. 38) (t he 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 whic h are based on the Codex HACCP Annex.   
The HACCP reference documents from NAC MCF and Codex have changed over the 
years as experience has been gained from the application of the con cept 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 ensu ring safety.  In addition to 
these standards serving as the basis for require ments by governments, there has been widespread 
international adoption of HACCP/p reventive controls by industry at the company level, and as 
the foundation for food safety in  third-party auditing schemes and certification efforts for 67 
 
  companies, such as those benchmarked through the Global Food Safety Initiative (GFSI) (Ref. 
41).  (See section II of the A ppendix to this document for more information on GFSI.) 
The proposed rule would require that a f ood safety system similar to HACCP be 
implemented in food facilities and would harmoni ze our requirements with the recommendations 
and requirements of internati onally recognized food safety e xperts/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 Wo rld Health Organization has recognized the 
importance of the HACCP system for prevention of foodborne dis eases for more than 30 years 
and has played an important role in its deve lopment and promotion (Ref. 42).  FAO likewise 
emphasizes the importance of HACCP and promotes  it through internat ional 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 Appli cation of Sanitary and Phytosanitary Measures 
(the "SPS Agreement") and the Agreement on Tec hnical Barriers to Tr ade, had significant 
implications for Codex standards.  Specificall y, the SPS Agreement identifies Codex standards, 
guidelines and other recommendati ons as the baseline for consumer protection.  As a result, the 
work of Codex (including the Codex HACCP An nex (Ref. 35) has become the reference for 
international food safety requirements.  Th e 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 tr ade as well as food safety (Ref. 43).   68 
 
  D. Food Safety Problems Associ ated With Manufact uring, Processing, Packing, and Holding of 
Food for Human Consumption  
1. Contamination of Food  
Food can become contaminated (e.g., with biol ogical, chemical, physi cal, or radiological 
hazards) at many different step s in the farm-to-table continuum: on the farm; in packing, 
manufacturing/processing, or distribution faci lities; 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 estimat es are attributable to food, including those 
illnesses caused by unspecified agents.  These es timates 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 pa thogenic bacteria (such as Campylobacter
 spp., 
Clostridium perfringens , Shiga toxin-producing 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 foodbor ne 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 s ubstances, such as glass (see sections II.D.2.b 
through II.D.2.d of this document for a discussion of these problems).   69 
 
  Early detection of contamination enables f ood establishments to prevent contaminated 
food from leaving their premises.  When contam ination 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 restau rants; or in the home and often 
results in the need for a recall.  Contaminati on 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 ch ain. This cooperative wo rk 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 
outbreaks of foodborne illness. (An outbreak of f oodborne illness is the occurrence of two or 
more cases of a similar illne ss resulting from the ingestion of a common food.)  However, 
changes in consumer preferences, changes in indu stry 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 a ssociated with unknown agents, 
which presents challenges in outbreak investiga tions (Ref. 46).  In a ddition, microorganisms can 
change their characteristics by acquiring genes,  including those for vi rulence, from other 
microorganisms (Ref. 48). 70 
 
  2. Microbiological, Chemical, Phys ical, and Radiological Hazards 
In the following discussion of hazards, we hi ghlight 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 asso ciated with foods than with the others.   
a. Microbiological hazards .  Foodborne illness can have very serious consequences, 
including death. Below, we discuss severa l microorganisms commonly associated with 
foodborne illness. 
Salmonella spp . 
 Salmonella  contamination has been associated w ith 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 foodbor ne illness, CDC reporte d that in 2010 Salmonella  spp. was the most 
common foodborne pathogen and the most common cau se 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  71 
 
  Listeria monocytogenes  is another pathogen often implicated in foodborne illness.  In 
2011, CDC reported that of all the foodborne pa thogens tracked by CDC through FoodNet, L. 
monocytogenes  had the highest case fatality rate (12.8 percent) and the hi ghest hospitalization 
rate (89.6 percent) (Ref. 50).  L. monocytogenes  is a bacterium that occurs widely in both 
agricultural (soil, plan ts and water) and food processing environments.  L. monocytogenes  can 
multiply slowly at refrigeration temperatures, thereby challenging an important defense against foodborne pathogens – i.e., refrig eration (Ref. 52) (Ref. 53).  Ingestion of L. monocytogenes
 can 
cause listeriosis, which can be a life-threateni ng human illness.  Serious illness almost always 
occurs in people considered to be at higher risk, such as th e elderly and those who have a 
preexisting illness that reduces th e 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 h ealthy individuals (Ref. 54) (Ref. 
55).   
The risk of illness from L. monocytogenes  associated with a part icular food is dependent 
on five key factors (Ref. 52) (Ref. 53):  
• Amount and frequency of consumption of a food;  
• Frequency and extent of contaminati on 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. 72 
 
  In 2003, FDA and FSIS, in consultation with CDC, released a quantitative assessment 
(the FDA/FSIS Lm RA) of relative risk associat ed with consumption of 23 categories of ready-
to-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 liste riosis (Ref. 53).  The 
FDA/FSIS Lm RA shows that the risk of illness from L. monocytogenes  increases with the 
number of cells ingested and th at there is greater risk of il lness 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 fi nding 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 froze n, 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 enterohemo rrhagic 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 intest ines of all animals, including humans.  
However, E. coli  O157:H7 is a rare variety of E. coli  that, among other virulence factors, 73 
 
  produces one or more related, potent toxins th at cause severe damage to the lining of the 
intestine. Hemorrhagic colitis is the na me of the acute disease caused by E. coli  O157:H7.  The 
illness is characterized by severe cramping (abdo minal 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 th e 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 pe rmanent loss of kidney 
function and death (Ref. 49). 
Noroviruses  
Noroviruses are a group of re lated, single-stranded RNA, non-enveloped viruses that 
cause acute gastroenteritis in hum ans. Norovirus is the official genus name for the group of 
viruses previously described as “Norwalk-like vi ruses” (NLV) or small round structured viruses 
(SRSVs) because of their morphologic features.  Norovirus infection usually presents as acute-
onset vomiting, watery non-bloody diarrhea 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 complicati on, 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 seri ous long-term sequelae (i.e., chronic conditions 
resulting from the illness) (Ref. 57). Noroviruse s are transmitted primarily through the fecal-oral 
route, either by consumption of fecally contamin ated food or water or by direct person-to-person 
spread. Noroviruses are highly cont agious and as few as 10 viral particles may be sufficient to 
infect an individual. During outbreaks of norovi rus gastroenteritis, more than one mode of 
transmission has been documented – e.g., ini tial foodborne transmission in a restaurant by a 74 
 
  contaminated food, followed by secondary person-t o-person transmission to household contacts. 
CDC recently estimated that there are 5.4 milli on cases of domestically-acquired foodborne 
illness each year due to norovirus infection, and mo re than 58 percent of all foodborne illnesses 
can be attributed to norovirus (Ref. 45).  
As part of the work of the CGMP Worki ng 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 equipmen t sanitation, adequate training of employees, 
review of product labels for accuracy and agreem ent with the product formulation, and adequate 
preventive maintenance of equipment (Ref. 58). The review did not incl ude Class III recalls 
because these recalled products ar e not likely to have caused adverse health consequences.  FDA 
repeated this type of review 5 years later,  for the period 2008-2009 (R ef. 59).  In these two 
reports, the second most common reason for such  recalls was microbiol ogical 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 sec ond annual report on the Reportabl e 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).   75 
 
  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 (usua lly shortened to Salmonella  Tennessee) caused 715 confirmed 
cases of illness, including 129 hos pitalizations (Ref. 62). (Salmonella  spp. are grouped into 
serotypes (also called serovars ) based on cell surface antige ns, 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 sa mples collected at the manufacturer’s facility as 
well as in finished product (R ef. 64) (Ref. 65).  Two years la ter, 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 co nsumed at institutional settings and peanut 
crackers made with the contaminated peanut but ter as an ingredient (Ref. 66).  This single 
outbreak resulted in 714 confirmed cases of il lnesses, including 166 hospitalizations, and 9 
deaths (Ref. 67).  Inspections conducted by FDA at  the manufacturing facilit ies revealed lack of 
controls to prevent product contamination from pe sts, from an insanitary air-circulation system, 
from insanitary food-contact surface s, 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 c onfirmed reports of illnesses, including 8 
hospitalizations.  The likely source of contamin ation 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).   76 
 
  • From October 2008 to March 2009, a multistate L. monocytogenes  outbreak was 
linked to Mexican-style cheese that was contam inated post-pasteuriza tion.  There were 8 
confirmed cases of illness in 5 states (Ref. 71).  An investiga tion at the plant revealed the 
potential for product contamination due to defi ciencies 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 isolat ed the outbreak strain from raw whole white 
pepper, in-process samples, finished products, and environmental samples taken at various 
locations throughout the pro cessing areas (Ref. 75).  
• In 2009, a prepackaged, refrigerated cooki e 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 ou tbreak strain (Ref . 77) (Ref. 78).   
• In 2011, an outbreak of listeriosis from can taloupes was attribut ed to insanitary 
conditions at a facility that wa shed, 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 al so difficult to clean), poorly designed equipment 
(not easily cleaned and sanitized ) that was previously used fo r a different commodity, no pre-
cool step, a truck parked near the packing area that had visite d a cattle operation, and possible 
low level contamination from the grow ing/harvesting operation (Ref. 79).  
b. Chemical hazards othe r than food allergens .  There are a variety of “chemical” hazards 
that may be associated with food, including pe sticide and drug residues, natural toxins, 77 
 
  decomposition resulting in the production of toxi ns such as histamine, unapproved food or color 
additives, and food allergens.  (We discuss food a llergens in more detail in the next section of 
this document).  Under the FD&C Act, certain pr oducts, such as food additives, color additives, 
new animal drugs, and pesticides require premarke t approval before they may be legally used.  
(In the case of pesticides, EPA “registers” (i.e., approves) the use of pest icides and establishes 
tolerances (the maximum amounts of residues that ar e 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 responsib ility of FSIS (Ref. 81).  
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 wh ich 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, depend s on factors such as the amount of 
the food that is consumed and, if the additive, dr ug, 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 residue s, and unapproved food and color additives as 
potential known or reasonably foreseeable hazards that a facility must consider and evaluate in 
its hazard analysis, sec tion 418(b) of the FD&C Act emphasi zes the current provisions of the 
FD&C Act regarding substances th at require premarket review.  
Natural toxins (such as aflatoxin in foods su ch as peanuts and tree nuts and patulin in 
apple juice products) are well recognized as hazards (Ref. 82)  (Ref. 83) (Ref. 84) (Ref. 85).  78 
 
  Decomposition products such as histamine, produced  from the amino acid histidine when certain 
bacteria grow, can pose a risk to health.  Bi ogenic 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 ar e the most common source of illness from histamine and other 
biogenic amines, illness from hi stamine 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 near-term onset of illness (e.g., gastrointestinal illnes s), or may more commonly be associ ated with chronic exposure and long-
term effects.  Industrial chemicals (such as  caustic cleaning compounds ) can cause an acute 
reaction. Examples of long-term effects incl ude impaired cognitive development in children 
exposed over time to relatively low levels of l ead 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 allerg ies 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 St ates (3.9 percent) have food 
allergies (Ref. 94).  This study al so reported that the prevalence of food allergies increased by 18 
percent in this age group be tween 1997 and 2007 (Ref. 94).   
The severity of a food allergic  reaction varies depending on f actors such as the amount of 
allergen ingested, the type of allergen, and th e presence of other underl ying medical conditions.  
Sensitive individuals may experience reactions to allergen doses as low as a few micrograms of 79 
 
  food protein (Ref. 95) (Ref. 96) (Ref. 97).  As high as one-third of sensitive individuals can 
experience severe reactions at the mini mal 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 ye ars of age, CDC estimates that there are 
approximately 9,500 food allergy-re lated hospitalizations per year  (Ref. 101).  The signs and 
symptoms associated with allergic reactions can  range from oral irr itation 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 (FALCP A) (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 contai ns, 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 wa s passed, is labeling problems (i.e ., undeclared allergen).  In 
conjunction with the work of the CGMP Wo rking Group, FDA reviewed CGMP-related 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 dur ing the period 2008-2009, 
with a focus on primary recalls.  (A primary reca ll is a recall initiated by a firm where the food 
safety problem first occurred.  A subsequent re call is triggered by a primary recall.  In a 80 
 
  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 200 4, we continue to see problems with undeclared allergens 
in foods, as evidenced by recalls. 
Some of the problems with undeclared alle rgens come to light only after consumers 
experience allergic reac tions.  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 De cember 2010, a snack product with undeclared 
egg was recalled after a consumer complaint of an allergic reaction. Th e 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, gl ass, 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 me tal fragments such as nuts and bolts from 
equipment used in manufacturing/processing. 
The first RFR Annual Report issued in Janua ry 2011 identified only three primary RFR 
entries for “foreign objects” (which were physical  hazards that could have resulted in serious 
adverse health consequences or de ath), and all of these were in an imal feed or pet food (Ref. 60).  
However, there have been recalls of huma n foods due to contamination or potential 
contamination with physical hazards.  In Octobe r 2010, several types of fr ozen vegetables were 81 
 
  recalled after shards of broken glass were found in some pack ages (Ref. 105) and in May 2011 
several types of English muffins and bread produ cts were recalled due to  possible contamination 
with small pieces of metal (Ref. 106).   
e. Radiological hazards .  Radiological contamination of f oods is a rare event.  Examples 
of radiological hazards include  radionuclides such as radium-226, radium-228, uranium-235, 
uranium-238, plutonium-239, strontium-90, iodi ne-131, and cesium-137.  The most common 
way these radionuclides are incor porated 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, radium-228 and uraniu m 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, follo wing the damage to a nuclear power plant during 
an earthquake and tsunami in Japan, radioac tivity was subsequently  detected in foods, 
particularly milk, vegetables, and seafood produced  in areas neighboring the plant (Ref. 109).   
Consuming food contaminated with radioac tive material will increase the amount of 
radioactivity a person is exposed t o, which could have adverse health  effects.  The health effect 
depends upon the radionuclide and the amount a pers on is exposed to.  For instance, exposure to 
certain levels of radioactive iodine is associated with increased risk of th yroid cancer (Ref. 109).   
f. Summary .  As discussed above, food safety probl ems associated with microbiological, 
chemical, physical, and radiological  hazards continue to cause illn esses and deaths and result in 
significant recalls.  In its re views of CGMP-related food reca lls, FDA summarized key factors 
that contributed to the food safety problems that  initiated the recalls.  For recalls during 1999-
2003, FDA concluded that the contri buting factors (there could be  more than one for a single 82 
 
  recall) included incorrect packaging/labeling ( 68 percent), ineffective employee training (32 
percent), failure to follow processing sta ndard operation proce dures (26 percent), 
excess/mistaken addition of chemicals/ingredients (9 percent), contamination of raw materials (8 
percent), ineffective us e of sanitation principles (8 pe rcent), and unknown (4  percent).  For 
recalls during 2008-2009, FDA us ed a slightly different methodology to categorize the 
contributing factors; the contributin g factors included lack of label controls (57 percent), lack of 
supplier controls (37 percent), de ficiencies in employee training ( 24 percent), lack of sanitation 
controls (17 percent), po or 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 problem s 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 docu ment, HACCP is a preventive food safety 
strategy that is a systematic approach to the id entification and assessment of the risk of hazards 
from a particular food or food production process or practice and the co ntrol of those hazards 
that are reasonably likely to occur.  The HA CCP 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 produc ts meet pre-specified pe rformance criteria (Ref. 
34).  The HACCP system is universally endors ed by international bodie s such as Codex, the 
Food and Agriculture Organization, and the Worl d 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 me at and poultry.  (In the remainder of this 
document, we use the term “Federal HACCP regul ations” to refer to th ese HACCP regulations 83 
 
  for seafood, juice, and meat and poultry.)  C odex 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 in cluding hazard analysis, preventive controls, 
monitoring, corrective actions, verifi cation, and record keeping associ ated with these activities.  
These activities work together to prevent food safety problems; the individual activities, by 
themselves, are not as effective as the combina tion of these activities in the complete HACCP 
system.  For example, a facility may determine that certain pathogens ar e reasonably likely to 
occur in a food product and es tablish and implement a heat treatment, for a specified 
combination of time and temperature, as a contro l to prevent the pathoge ns from contaminating 
finished food products.  Unless the facility moni tors the temperature and time during the heat 
treatment, the facility will not be able to dete rmine 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 m onitoring and the documentation wa s not reviewed so that the 
facility can verify that the pr oper temperature was achieved for sufficient time.  If the proper 
temperature or time is not achieved, corrective acti ons would be necessary to ensure that the food 
is reprocessed, diverted to a us e that does not raise a food safety  concern, or disposed.  For the 
heat treatment to be effective, the level of any pathogens contam inating ingredients or other raw 
materials used to make the food must not exceed th e level of pathogens that  the heat treatment is 
validated to eliminate.   84 
 
  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 Verifi cation Measure in a Food Safety System  
The safety of food is principally ensured by th e effective implementatio n of scientifically 
valid preventive control measures  throughout the food chain (Ref. 34) (Ref. 110).  Prevention of 
hazards in food is much more effective than tryi ng 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 im portant purpose of testing is to verify that control measures, 
including those related to supp liers and those verified through environmental monitoring, are 
controlling the hazard (Ref. 111) (Ref. 112).  Te sting is used in conjunction with other 
verification measures in the food safety system, such as audits of suppliers, observations of 
whether activities are being c onducted 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 discusse d in the Appendix to th is document (see sections I.C, I.E, and 
I.F of the Appendix), microbi al testing may include:  
• Testing raw materials and ingredients to ve rify 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 environm ental pathogens to contaminate RTE food; and  
• Testing finished product to verify that preventive controls have significantly 
minimized or prevented hazards reas onably likely to occur in the food. 85 
 
  Each type of testing provides informati on applicable to managing hazards in foods, 
depending on the food and process.  We discuss the role of testing as a ve rification measure in a 
food safety system in section I of  the Appendix to this document. 
F. The Role of Supplier Approval and Veri fication Programs in a Food Safety System  
The development of a supplier approval a nd verification program can be part of a 
preventive approach. Because ma ny facilities acting as suppliers procure their raw materials and 
ingredients from other suppliers, there is often a ch ain of suppliers before a raw material or other 
ingredient reaches the manufacturer/processor.  Us ing a preventive approach, a facility receiving 
raw materials or ingredients from a supplier can he lp ensure that the suppl ier (or a supplier to the 
supplier) has implemented preventiv e controls to significantly minimize or prevent hazards that 
the receiving facility has identifi ed 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 re lated to the safety of the raw materials and 
ingredients. A supplier approval program can ensu re a methodical approach to identifying such 
suppliers.  A supplier verification program can he lp provide initial and ongoing assurance that 
suppliers are complying with practices to achieve adequate control of hazards in raw materials or 
ingredients.  We discuss supplie r approval and verification program s in more detail in section II 
of the Appendix to this document. 
III. Legal Authority 
FDA is proposing changes to the Curren t Good Manufacturing Regulation under the 
FD&C Act and the Public Health Service Act.  FDA is proposing changes to 21 CFR Part 1, 86 
 
  Subparts H, I, and J under the FDA Food Safety M odernization Act and the FD&C Act.  FDA is 
proposing all other new requirements under the F DA 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 purpos es of section 415 of the FD&C 
Act (Registration of Food Facilities) with respect to “activities that constitute on-farm packing or 
holding of food that is not grown, raised, or co nsumed 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 regi stration regulations (21 
CFR subpart H) to clarify the types of activities th at are included as part of the definition of the 
term “facility” under section 415 of the FD&C Ac t and the scope of the exemption for “farms” 
provided by section 415 of the FD&C Act.  Th e 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 provide s that a food is adultera ted if it consists in 
whole or in part of any filthy, putrid, or decomposed substance,  or if it is otherwise unfit for 87 
 
  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 cond itions whereby it may have become contaminated 
with filth, or whereby it may have been rendered injurious to healt h.  Under section 701(a) of the 
FD&C Act, FDA is authorized to issue regulatio ns for the efficient enforcement of the FD&C 
Act.  The changes to the current CGMP regulati on proposed in this docume nt clarify the existing 
requirements of the regulation and update existi ng requirements to reflect changes in the food 
industry and in scientific understa nding of food safety since issu ance of the current regulation.  
In addition to the FD&C Act, FDA’s legal aut hority for the proposed changes to current CGMP 
requirements derives from the PHS Act to the exte nt such measures are related to communicable 
disease.  Authority under the PHS Act for th e 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 th e Surgeon General to the Secretary.)   
C.  Hazard Analysis and Risk-Based Preventive Controls  
Section 103 of FSMA, Hazard Analysis and Ri sk-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 cont rols ….”  Section 
418(n)(1)(B) of the FD&C Act requ ires that the regulations defi ne the terms “small business” 88 
 
  and “very small business,” taking into considera tion the study of the fo od processing sector 
required by section 418(l)(5) of th e FD&C Act.  Further, secti on 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 f ood for sale in the United States if the owner, 
operator, or agent in charge of such facility is not in complia nce with section 418 [of the FD&C 
Act].”   
In addition to rulemaking requirements, sec tion 418 contains require ments applicable to 
the owner, operator, or agent in charge of a f acility required to regi ster under section 415.  
Section 418(a) is a general provis ion that requires the owner, opera tor, 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 preventiv e controls, monitor the performance of those 
controls, and maintain r ecords of the monitoring.  Section 418(a)  specifies that the purpose of the 
preventive controls is to “pre vent the occurrence of such haza rds and provide assurances that 
such food is not adulterated under section 402 [o f the FD&C Act] or misbranded under section 
403(w) [of the FD&C Act] ….”  In addition to th e 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)), preventiv e controls (§ 418(c)), monitoring (§ 418(d)), 
corrective actions (§ 418(e)), veri fication (§ 418(f)), reco rdkeeping (§ 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 (pr oposed subparts C and F) that would implement 
these provisions of sectio n 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 modi fications to the requirem ents of section 418 of 89 
 
  the FD&C Act.  These include provisions re lated to seafood and juice HACCP, and low-acid 
canned food (§ 418(j)); activities of  facilities subject to sectio n 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 animal s other than man, the storage of raw agricultural commodities 
(other than fruits and vegetables) intended for fu rther distribution or pro cessing, or the storage of 
packaged foods that are not exposed to the envi ronment (§ 418(m)); f acilities engaged only in 
certain low-risk 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 pr oposed provisions (proposed § 117.5(a)-(j), and 
proposed subparts D and E) that would implemen t these provisions of s ection 418 of the FD&C 
Act and section 103 of FSMA. 
FDA tentatively concludes that the provision s in subpart C and re lated requirements in 
subparts A, D, and F should be appli cable to activities that are intras tate in character.  Facilities 
are required to register under se ction 415 of the FD&C Act regard less 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 fac ilities 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 sa le in the United States if the owner, operator, 
or agent in charge of such facili ty is not in compliance with sec tion 418”, or the causing thereof, 
is a prohibited act.   
FDA also is proposing the provisions in subpa rt 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 90 
 
  extent such requirements are necessary to pr event food from being held under insanitary 
conditions whereby it may become contaminated w ith 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 pr ovisions under sections 311, 361, and 368 of the 
PHS Act relating to communicable disease to the ex tent those provisions ar e necessary to prevent 
the interstate spread of communicable disease.  FDA tentatively concl udes 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 analys is 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 cont rolling the hazards, the proposed food safety 
system would establish requirements for m onitoring, corrective acti ons, and verification, 
including validation that the preven tive controls are adequate to control the identified hazards.  
Certain activities would be requi red 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 reasonab ly likely to occur, procedures for monitoring, 
corrective actions, and verificati on, and a recall plan.  The written plan and other documentation 
would be required to be made promptly ava ilable to FDA upon oral or written request.  
FDA tentatively concludes that, taken as a w hole, the food safety system described here 
is necessary to help prevent food safety prob lems associated with microbiological, chemical, 
physical, and radiological hazards in foods.  Ther efore, the proposed system is necessary to 
prevent food from being adulterated because it is  unfit for food or because it has been held under 91 
 
  insanitary conditions whereby it may become contaminated with filth or may be rendered 
injurious to health; to prevent food from b ecoming misbranded under section 403(w) of the 
FD&C Act; and to prevent the spread of communicable disease. 
IV. Public Meeting and Prelim inary 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 pr ovisions in section 418 of the FD&C Act.  
Although the meeting included intr oductory 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 vi ews, including by provi ding opportunities for 
individuals to make presentati ons at the meeting during an op en public and webcast comment 
session, whereby participants could make presen tations in person or via webcast, and during 
another listening session that wa s 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, f ood companies, and state agencies.  The major 
topics discussed in these comments included f ood allergens and the im portance of allergen 
controls, verification and the importance of test ing, submission of food sa fety plans to FDA, 
education and training on preventive  controls, the need for flexibil ity in the regulations, modified 
requirements for certain packaged food items not exposed to the environment, on-farm 
manufacturing, processing, packi ng and holding activities, and st ates partnering with FDA to 
conduct inspections.   92 
 
  Stakeholders were given addi tional 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 manu facturing and small business, preventive controls and the 
relationship to CGMPs, product testing and envi ronmental monitoring, and training and technical 
assistance.  A transcript of FDA’s remarks at the opening session, the open public and webcast 
comment session, and the listening session is av ailable on FDA’s Web site (Ref. 113).  In 
addition, webcast videos were prepared for th e 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, acc redited laboratories, 
environmental monitoring and product testing, flexibility of regulations and guidance, food 
defense, guidance and outreach, preventive contro ls, small businesses and exempted facilities, 
submission of the food safety plans to FDA, a nd 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 provi sions applicable to the comments. 
B. Comments on Allergen Control  
Comments state that FDA should address the ev aluation of allergens as a food hazard and 
the need for preventive controls  for allergens in its implementa tion 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 r ecommend that any required allergen control 
programs be limited to “major food allergens,” as defined in the FD&C Act. 93 
 
  We propose a definition of “food allergen” (p roposed § 117.3) in section X.B.4 of this 
document and discuss proposed requirements for pr eventive controls  directed to food allergens 
(proposed § 117.135(d)(2)) in sectio n 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 no t in the routine course of business (testing 
raw/ingredient, in-process, or fi nished product).  Some  comments state it woul d 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, includ ing use of accredited la boratories in certain 
circumstances.  This document does not pr opose additional requirements for the use of 
accredited laboratories and does not  include a discussion of s ection 422 of the FD&C Act. 
D. Comments on Environmental Monitoring and Product Testing  
Many comments assert that the role and n eed for product testing and environmental 
monitoring varies depending on the type of pr oducts 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 produc t 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 produ ct testing is extremely costly and cannot establish safety.  As 
such, they recommend that industry and FDA shou ld focus on ensuring that  preventive measures 
are properly designated and e ffective instead of relying on finished product testing.  One 
comment mentions that effective testing prog rams use aggressive a nd robust environmental 94 
 
  testing and recognize the limited value of finished product test ing.  A few comments point out 
that finished product testing is particularly important for RTE pr oducts, 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 F DA should require verification testing when any 
food has an identified hazard for which a facil ity has implemented a preventive control, and 
others state that high-risk plants should be re quired to do microbial sampling to a standard and 
frequency set by FDA.  A few comments encour age 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 produ ced in accordance with the plant’s preventive 
control plan. 
Section I in the Appendix to this document di scusses a number of issues associated with 
environmental monitoring and product testing.  Although we are not in cluding provisions for 
environmental monitoring or product testing in this proposed rule, in section XII.J of this 
document, we request co mment 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 risk-based, 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 consul tants either explicitly or in practical terms because of their 
complexity. 
As discussed in section XVI.A of this doc ument, section 418(n)(3) of the FD&C Act 
requires that the content of the regulations promulgated unde r § 418(n)(1) of the FD&C Act 
provide sufficient flexibility to be practicable fo r all sizes and types of facilities; comply with 95 
 
  chapter 35 of title 44, United States code (commo nly 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 requirement s 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 ty pes of expertise within 
companies.  They recommend that FDA allo w manufacturers to develop and maintain two 
distinct sets of documents on these separate i ssues.  One comment suggests that FDA consider 
implementing the food and feed defense-relate d provisions of FSMA th rough guidance, rather 
than regulation. 
FDA discusses its tentative decision not to address “hazards that may be intentionally 
introduced, including by acts of terrori sm” in section II.B.2.f of this document.  As stated there, 
FDA plans to implement section 103 regarding su ch 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 stat e departments of agriculture.  They support guidance that would 
include information on conducting valid hazard an alyses and risk assessments, implementing 
preventive controls, and what constitutes a valid  food safety plan.  Th ey also support guidance 
that would provide access to background resources, such as scientific studies, risk analyses and 96 
 
  risk-based modeling.  They stat e that guidance should include examples of food safety plans, 
both acceptable and unacceptable ones.  One comm ent envisions several different types of 
guidance: how to identify hazards and how to di stinguish preventive cont rols associated with 
HACCP plans from those falling outside HACCP pl ans; preventive controls that should be 
considered for certain categorie s of food (e.g., high risk food); a nd what constitutes a hazard and 
how you determine its likely occurrence. 
Section 103(b) of FSMA requires FDA to i ssue 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 additi on, 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 requirement s 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 h azard analysis and ot her 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 docke t [Docket No. FDA-2011-N-0238] to obtain 
information about preventive controls and other practices used by facili ties to identify and 
address hazards associated with specific type s 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 th e development of guidance on preventive controls 
for food facilities that manufactur e, process, pack, or hold huma n food.  FDA anticipates issuing 
these required guidance documents in a timely ma nner in coordination wi th issuing the final 
regulations to assist our stakeholders in complying with the regulations.   97 
 
  FDA did not conduct HACCP training for pers ons subject to our HA CCP regulations for 
seafood or juice.  However, when implementing those regulations, FDA worked with an alliance 
of representatives from Federal and State agen cies, industry and academia, to create a uniform, 
core training program that serves as the sta ndardized curriculum agai nst which other course 
materials can be judged.  FDA will be working w ith an alliance to develop such a standardized 
curriculum for any final rule es tablishing requirements for ha zard analysis and risk-based 
preventive controls.   
H. Comments on Preventive Controls   
A number of comments point out that not all preventive contro ls 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 fo r that segment or to use existi ng preventive controls programs 
that may already exist for a segment of industr y; those general preven tive controls would be 
tailored to each situation, pl ant design, and product.  One comment asserts that preventive 
controls must consider incoming wa ter as a key risk and states that the risk assessment must be 
informed by current standards and methodologies and take into account re sistance to traditional 
disinfectants. 
FDA is proposing requirements for preventi ve 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 smalle r than those that gr oss $500,000 a year.  One 
comment proposes that FDA define very sma ll business as having fewer than 20 employees, 
stating that the Small Business Administration has done so.  Another suggests that “very small” 98 
 
  business be defined by the volume of product that th ey 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 safe ty law, several comments urge  FDA to require that such 
facilities submit documentation of one option or th e 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 trai ned 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 facili ty” (proposed § 117.5(a)) in s ection 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 w ould govern withdrawal of  an exemption from 
subpart C for a “qualified facili ty” (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 requi re electronic submission of food safety 
plans, pointing out that not only would it be imprac tical, but also that food safety plans are most 
appropriately reviewed by FDA dur ing 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 plan s are of limited utility outside of the plant 
context.  However, a few comments state that F DA should request all initia l food safety plans, as 
this would give us an idea of any misundersta ndings of the preventive control requirements.  99 
 
  These comments also note that submission of pl ans 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 ware houses urge FDA to modify the preventive 
controls requirements for facilities, such as ware houses, that are solely engaged in the storage of 
packaged foods that are not exposed to the en vironment, since no manuf acturing 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 gene ral controls, such as 
sanitation, pest control, storage, segregation, secu rity, and recordkeeping. 
FDA is proposing modified requirements for wa rehouses solely engaged in the storage of 
packaged food that is not exposed to the envi ronment in proposed § 117.7 (discussed in section 
X.D of this document) and proposed § 117.206 (dis cussed in section XIII.B of this document). 
V. Placement of Regulatory Requirements 
We are proposing to establish the revised um brella CGMP requirements, together with 
the new requirements for hazard analysis and ri sk-based preventive controls, in proposed part 
117.  As discussed in section XVII of this docum ent, 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 100 
 
  A.  Overview  
The proposed rule would revise FDA’s curr ent regulations in part 110 regarding the 
manufacturing, processing, packing,  or holding of human food in tw o fundamental ways.  First, 
it would add new provisions to implement section 103 of FSMA.  Second, it would update, revise, or otherwise clarify certa in requirements of our current re gulations 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 A pplicable to a Qualified Facility; and 
• Subpart F--Requirements Applying to R ecords That Must Be Established and 
Maintained.   
• Subpart G would be reserved.   
In the remainder of this section, we highlig ht key provisions of the proposed rule.    
B.  Proposed Revisions to 21 CF R Part 1, Subparts H, I, and J
 
To implement section 103(c) of FSMA, the pr oposed rule would revise certain definitions 
in FDA’s current section 415 regist ration regulations.  These revisi ons would clarify the types of 
activities that are included as part  of the definition of the term “facility” under se ction 415 of the 
FD&C Act and the scope of the exemption fo r “farms” provided by section 415 of the FD&C 
Act.  The proposed rule also would make co rresponding changes in part  1, subpart I (Prior 101 
 
  Notice of Imported Food) and in pa rt 1, subpart J (Establishment, Maintenance, and Availability 
of Records).  . 
C.  Proposed Revisions to General Pr ovisions of 21 CFR Part 110 (Part 110)  
(Proposed Part 117, Subpart A)  
The proposed rule would both re vise current provisions of subpart A of part 110 and add 
new provisions to subpart A as it would be establ ished in proposed part 117.  The new provisions 
would include specified exemptions for certain f acilities, 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 exemp tions 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 microbio logical 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/processi ng activity/food combinations conducted 
on a farm by a small or very small business;  102 
 
  • The receipt, manufacturing, processing, packing, holding, an d distribution of 
alcoholic beverages and other pr epackaged food sold in conjunc tion with alcoholic beverages 
(e.g., gift baskets);  
• Facilities that are solely engaged in the storage of RA Cs (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 Manuf acturing Practice Requir ements of Part 110 
(Proposed Part 117, Subpart B)  
In order to modernize current CGMP requi rements, the proposed rule would make 
revisions including: 
• Modernizing and updating the language th roughout (e.g., by replacing the word 
“shall” with the word “must” and by using certa in terms consistently throughout proposed part 
117); 
• Deleting certain provisions containing recommendati ons, including the specific 
temperatures for maintaining refr igerated, frozen or hot foods;  
• Clarifying that certain CGMP provi sions requiring pr otection against 
contamination require protection ag ainst cross-contact of food as we ll to address allergens; and   
• Proposing that provisions directed to preventing contamination of food and food-
contact substances be directed to preventing cont amination of food-packaging materials as well.   103 
 
  E. Proposed New Requirements for Hazard Anal ysis and Risk-Based Preventive Controls 
(Proposed Part 117, Subpart C)  
1. Written Food Safety Plan 
We propose to require that the ow ner, operator, or agent in ch arge 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 hazar d analysis identify and evaluate known or 
reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at 
the facility to determine whethe r there are hazards that are reas onably likely to occur, including 
biological, chemical, physical, and radiological hazards.  The hazar d analysis would include an 
evaluation of the identified hazards to determin e 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 f acility identify 
and implement preventive controls (including at critical control points, if any) to provide 
assurances that hazards that are reasonably like ly to occur will be significantly minimized or 
prevented and that the food manufac tured, processed, packed or held  by such facility will not be 104 
 
  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 contro l of the hazard and the maximum or 
minimum value, or combination of values, to  which any biological, chemical, physical, or 
radiological parameter must be controlled to sign ificantly 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 monito ring of the preventive controls  to provide assurance that 
they are consistently performed, including requirements to establish and implement written 
monitoring procedures and estab lish and maintain records documenting the implementation of 
the monitoring procedures. 6. Corrective Actions  
We propose to require that facilities esta blish 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.  105 
 
  7. Verification  
We propose to require that f acilities conduct certain verifi cation activities,  including: 
• Validation of a subset of the preventive controls;  
• Verification that monitori ng is being conducted;  
• Verification that appropriate  decisions about correctiv e actions are being made; 
and  
• Verification that the preventive controls  are consistently implemented and are 
effectively and significantly minimizing or prev enting the hazards that are reasonably likely to 
occur.   
We also propose to require reanalysis of th e food safety plan at least once every 3 years 
and more often when circumstances warrant.  8. Qualified Individual  
We propose to establish qualification require ments for a “qualified individual,” who 
would be required to do or overs ee the preparation of the fo od safety plan, validation of 
preventive controls, review of records for im plementation and effectiveness of preventive 
controls and the appropriateness of corrective actions, and reanalys is of a food safety plan.  A 
“qualified individual” would be re quired 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 functi ons if such experience 
has provided an individual with knowledge at least equivalent to th at provided through the 
standardized curriculum.   106 
 
  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 a nd records documenting monitoring of preventive 
controls, corrective actions, veri fication, and applicable traini ng for the qualified individual. 
F.  Proposed New Provisions for Modified Requirements (Proposed Part 117, Subpart D)  
Proposed subpart D would implement certain prov isions in sections 418(l) and (m) of the 
FD&C Act for modified requirements with respect to:  
• Qualified facilities:  Implementing the m odified requirements sp ecified in section 
418(l) of the FD&C Act for facilitie s that satisfy the statutory crit eria for a “qualified facility,” 
we propose to establish re quirements that include: 
• Submission to FDA of documentation that the facility is a qualified 
facility; and 
• Submission to FDA of documentati on demonstrating that the owner, 
operator, or agent in charge of the facility has identified the pote ntial hazards associated with the 
food being produced, is implementing preventive controls to address the hazards, and is 
monitoring the performance of the pr eventive 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 ot her applicable non-Fed eral 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 discre tion 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 107 
 
  storage of packaged food that is  not exposed to the environment conduct certain ac tivities for any 
such refrigerated packag ed food that requires time/temperatur e control to signi ficantly 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 monitori ng of temperature controls;  
• Records of corrective actions; and  
• Records documenting veri fication activities. 
We seek comment on these proposed requirements.  
G.  Proposed New Provisions for Wi thdrawal of an Exemption Appli cable to a Qualified Facility 
(Proposed Part 117, Subpart E)  
Proposed subpart E would implement the provi sions of section 418(l)(3) of the FD&C 
Act and establish the conditions under which an ex emption granted to a “qualified facility” could 
be withdrawn, and the procedures that would be followed to withdraw such an exemption. 
H.  Proposed New Recordkeeping Requi rements (Proposed Part 117, Subpart F)  
Proposed subpart F would establish requirement s that would apply to all records that 
would be required by the various proposed prov isions of proposed part 117, including: 
• General requirements related to th e content and form of records; 108 
 
  • 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, provi des that “[t]he amendments made by this 
section shall take effect 18 months after the da te of enactment” (i.e., by July 4, 2012).  Section 
103(i)(2) of FSMA, Flexibility for Small Businesses,  provides that “[n]ot withstanding paragraph 
(1),” the amendments made by this section “sha ll apply” to a small business and very small 
business beginning on the dates that are 6 mont hs 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 (except as re lates to animal food and inte ntional 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 co mpliance.  The final regulation 
will contain provisions that affect which faci lities are subject to section 418 and which 
provisions apply to particular fa cilities.  Without these provisi ons of the regulation in effect, 
facilities would be uncertain as to the applicabil ity of certain requirements to them.  Further, 
FDA tentatively concludes that compliance with  section 418 will be faci litated 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 recogni zes that it can take time to implement a food 109 
 
  safety system that would require, among othe r 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 af ter publication in the 
Federal Register , with staggered compliance dates.  Howeve r, we recognize that businesses of all 
sizes may need more time to comply with th e new requirements established under FSMA.  FDA 
believes that it is reasonable to allow for 1 year af ter the date of publicatio n of the final rule for 
businesses other than small and very small busin esses to come into compliance with the new 
requirements established under FSMA.  FDA also be lieves 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 da te of publication of 
the final rule for very small businesses to co me 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 a nd training programs needed to 
facilitate implementation of this rule. 
FDA also is proposing to modernize the ex isting CGMP requireme nts, and businesses 
already subject to current part  110 will be subject to the mode rnized CGMPs that would be 
established in proposed part 117.  FDA believes that it is reas onable 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 im plementation 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 110 
 
  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 Includ ed As Part of the Definition of the Term 
“Facility” under Sectio n 415 of the FD&C Act 
Section 103(c)(1)(A) of FSMA requires the Se cretary 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 th at 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 am ended 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 ar e included as part of the defini tion 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 e ngaged in manufacturing, processi ng, packing, or holding food for 
consumption in the United States be registered with the Secretar y.  The registration requirement 
in section 415 of the FD&C Act does not apply to farms.  Our re gulations that implement section 
415 and require food facilities to register with F DA are established in pa rt 1 (21 CFR part 1), 
subpart H (Registration of Food Facilities) (the section 415 regist ration 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 in cluded as part of the definition of the 111 
 
  term “facility” in section 415 of the FD&C Act in order to enhan ce 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 th at are required to regist er 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 regula tory 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 regulati ons.  (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 require ments applicable to a farm under sections 415 and 418 of the 
FD&C Act.  We also articulate a comprehensive se t of organizing principles that form the basis 
for proposed revisions to the section 415 registra tion regulations.  (See section VIII.D.)   
• We describe our proposed revisions to  the definitions in the section 415 
registration regulations, based on the organizing principl es 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 pa rt 1, subpart I (Prior Notice of  Imported Food) (hereinafter the 
prior notice regulations, estab lished under section 307 of the P ublic Health Security and 
Bioterrorism Preparedness and Response Act of 2002 (Pub. L. 107–188) (hereinafter the “BT 
Act”)) and part 1, subpart J (E stablishment, Maintenance, an d Availability of Records) 112 
 
  (hereinafter the section 414 recordkeeping re gulations, established under section 414 of the 
FD&C Act).  (See section VIII.E.)   
• We describe the impact of the proposed re visions to the definitions in the section 
415 registration regulations on farm s and on “farm mixed-type” faci lities.  A “farm mixed-type” 
facility conducts ac tivities that are outside th e scope of the definition of “farm” (e.g., slicing or 
chopping fruits or vegetables) even though it also c onducts activities that ar e within the scope of 
the definition of farm (e.g., growing and harv esting crops or raisi ng animals).  Conducting 
activities outside the definition of  “farm” triggers the requiremen ts in the section 415 registration 
regulations) and, thus, brings the facility within the scope of sect ion 418 of the FD&C Act.  (See 
section VIII.F.)  2. Science-Based Risk Analysis Covering Sp ecific Types of On-Farm Manufacturing, 
Processing, Packing and Holding Activities 
Section 103(c)(1)(C) of FSMA directs the Se cretary 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 packi ng or holding of food that is no t grown, raised, or consumed on 
such farm or another farm under the same owne rship, as such packing and holding relates to 
specific foods; and (ii) specific on-farm manu facturing 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.  113 
 
  3. Exemptions and Modified Require ments 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 th e results of the science-based ri sk analysis… and shall exempt 
certain facilities from the requirements in se ction 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 frequenc y in section 421 of such Act (as added by section 201 [of 
FSMA]), or modify the requirements in such se ctions 418 or 421, as the Secretary determines 
appropriate, if such facilitie s are engaged only in specific types of on-farm manufacturing, 
processing, packing, or holding activ ities that the Secretary determ ines 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 ame nded by [FSMA], if applicable, and shall apply 
only to small businesses and very small businesse s, as defined in the regulation promulgated 
under section 418(n) of the Federal Food, Drug, and Co smetic Act[.]”  In s ection 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 conclu sions regarding combinations of on-farm 
manufacturing, processing, packing, and holding ac tivities and foods determined to be low risk, 
considering the results of the section 103(c)(1)(C) draft RA.  In section V III.J of this document, 
we discuss a proposed approach to using the resu lts of the section 103(c) (1)(C) draft RA for the 
purposes of section 421 of the FD&C Act.  In se ction X.C.6 of this document, we discuss our 
proposal to exempt low-risk 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 114 
 
  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 s ection, section 415 of the FD&C Act directs the Secretary to 
require by regulation that any f acility engaged in manufacturi ng, processing, packing, or holding 
food for consumption in the United States be regist ered with the Secretary.  Section 1.227 in the 
section 415 registration regulations includes definitions that are re levant 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 de termining whether an establishment is a facility 
that must register with FDA and implement a pr ovision (in section 415(b)(1) of the FD&C Act) 
exempting “farms” from the registration requiremen t in section 415.  We ha ve issued guidance to 
assist food facilities in  complying with the section 415 regist ration 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 th e owner, operator, or agent in charge  of a “facility.”  Section 418(o)(2) 
of the FD&C Act defines “facility” for the purpo se 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 115 
 
  definition in § 1.227(b)(3) but do not conduct othe r activities (such as manufacturing/processing 
on food that is not consumed on that farm or anot her farm under the same ownership) that would 
trigger the requirements in the section 415 registra tion regulations.  Because establishments that 
satisfy the definition of “farm” in § 1.227(b)(3 ) are not required to re gister 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 se ction 418 of the FD&C Act. 
The current legal and regulat ory framework provided in sections 415 and 418 of the 
FD&C Act, the section 415 regi stration regulations, and the Food Facility Registration Guidance 
is relevant to the FSMA section 103(c) rulema king 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 s ection 418 of the FD&C Act.  We describe key 
provisions applicable to th e current legal and regulato ry 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. 
§ 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 elev ators, and liquid storage tanks. 116 
 
  Provision of the Section 
415 Registration 
Regulations or the 
FD&C Act Definition or Requirement 
§ 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 manufacturin g/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 cont ainer 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 descri bed in Table 1 establish th at a business qualifies as a 
“farm” that is exempt from the section 415 regist ration regulations if it satisfies the definition of 
“farm” in § 1.227(b)(3), including the activities performed, where th e 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 ha rvesting 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, pr ovided 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,” “pack aging,” and “packing” in the section 414 
recordkeeping regulations (§ 1.328), because farms are excluded from FDA’s authority to establish recordkeeping requirements unde r section 414(b) of the FD&C Act. 117 
 
  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 in spection authority unde r section 704 and the general adulteration 
provisions for food in section 402.  FDA has long recognized that regulati on of farms should be 
sensitive to the agricultural se tting.  As early as 1969, FDA exempted establishments “engaged 
solely in the harvesting, storage, or distributi on” 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 faci lities 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 ma intenance of certain records (c odified 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 fi rst proposed to define “farm” as a facility in 
one general physical location devoted to the growi ng of crops for food, the raising of animals for 
food (including seafood), or both.  Under that pro posed 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 consum ed on that farm; and (ii) facilities that 
manufacture/process food, pr ovided that all food used in such ac tivities is consumed on that farm 
or another farm under the same ownershi p (68 FR 5378 at 5418, February 3, 2003).   
FDA received comments stating that the pr oposed 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 Congre ss to exempt establishments 118 
 
  engaging in activities farms traditionally perform from the section 415 registration regulations, in 
the final rule FDA revised the first part of the fa rm 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 guidances implem enting the section 415 registrati on regulations and the section 
414 regulations, FDA furthe r addressed and interpreted the farm  definition with the goal of doing 
so in a manner recognizing the traditional activit ies of establishments commonly recognized to 
be farms (see the Food Facility Registration Gu idance (Ref. 116) and “Guidance for Industry: 
Questions and Answers Regarding Establishmen t and Maintenance of Records (Edition 4), 
September 2006 (hereinafter “Recordkeeping Guidance” (Ref. 117)). 
Farm mixed-type facilities
 
Consistent with the current legal and regul atory framework under sections 415 and 418 of 
the FD&C Act and the section 415 registration regulations, activitie s 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 trig ger the section 415 regist ration regulations would 
be subject to the requirements of section 418 of  the FD&C Act (and ther efore to the relevant 
parts of this proposed rule), ex cept 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 mixe d-type facility” is an establishment that 
grows and harvests crops or raises animals a nd may conduct other activities within the farm 119 
 
  definition, but that also conducts activities that  trigger the section 415 registration regulations 
(see the discussion of our proposed definition of “f arm mixed-type facility” in section VIII.E of 
this document).  Section 418 of the FD&C Act doe s not explicitly address whether a farm mixed-
type facility is subject to secti on 418 with respect to all of its activ ities or only with respect to its 
activities that tri gger the section 415 registration regulations .  Considering the text of section 103 
of FSMA and the FD&C Act as a whole, FDA te ntatively concludes that a farm mixed-type 
facility should be subject to se ction 418 only with resp ect to its activities th at trigger the section 
415 registration regulations, and not with respect to its activit ies 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 de fines the term “facility” for the purposes 
of section 418 to mean only those facilities re quired to register under section 415 of the FD&C 
Act, FDA tentatively conclude s that Congress intended the ex emptions from the section 415 
registration regulations, includi ng the farm exemption in § 1.226(b), to be meaningful for the 
purposes of defining the applic ability of section 418.  Sec tion 418(a) requires the owner, 
operator, or agent in charge of a facility that is re quired to register under section 415 to “evaluate 
the hazards that could affect f ood manufactured, processed, packed, or held by such facility” and 
to take other steps discussed more fully in se ction XII of this document, including identifying 
and implementing preventive controls, monitoring pr eventive controls, and maintaining records.  
The use of the phrase “food manufactured, processed, packed, or held by th e facility” in section 
418(a) parallels the language in section 415(a)(1) providing th at “[t]he Secretary shall by 
regulation require that any f acility engaged in manufacturi ng, processing, packing, or holding 
food for consumption in the United States be regist ered with the Secretary.”  Considering the text 120 
 
  of FSMA and the FD&C Act as a whole, F DA tentatively concl udes that only those 
manufacturing, processing, packing, or holding activities that trigger registration under the 
section 415 registration regulati ons should be considered to be manufacturing, processing, 
packing, or holding of food by a facility for th e purposes of section 418.  Put another way, FDA 
tentatively concludes that a mixe d-type facility should only be s ubject 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 tr igger the section 415 registration 
regulations.  To conclude othe rwise would mean that, for exam ple, the farm exemption from 
registration would be rendered i rrelevant to the coverage of section 418, except for activities on 
farms that will be subject to requirements unde r section 419 of the FD&C Act (see the discussion 
of the exemption provided by sect ion 418(k) of the FD&C Act to su ch 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 ex ample, 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, wh ich directs FDA to consider exempting or 
modifying the requirements of section 418 for activ ities conducted by a farm mixed-type 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.).     121 
 
  Therefore, unless an exemption from s ection 418 of the FD&C Act applies, FDA 
tentatively concludes that a faci lity that is required to regist er 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 defin ition 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, p acking, or holding -- and in 
doing so to clarify the scope of the farm definiti on 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 facilitie s 
At the time FDA developed the farm definiti on 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 re gulations 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 secti on, activities within the 
farm definition are not subject to section 418 of the FD&C Act, but activ ities 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, proces sing, packing and holding 
activities relevant to that definition, and adju st 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 secti on VIII FDA articulates a comprehensive set of 
organizing principles that  would form the basis for our proposa l for classifying activities to more 
accurately reflect the scope of ac tivities traditionally conducted by farms and to allow for more 122 
 
  certainty among industry with regard  to how their activit ies 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 Agricu ltural Commodities and Processed Food 
To clarify the scope of the farm definition, FDA considered how the activities of farms 
relate to the statutory concep ts of “raw agricultural commodity” and “processed food.”  The 
FD&C Act defines “raw agricultura l commodity” and “processed food”  in relation to each other, 
and identifies certain activities that transfor m 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 marke ting.”  Section 201(gg) of the 
FD&C Act (21 U.S.C. 321(gg)) defines “process ed food” to mean “any food other than a raw 
agricultural commodity and includes any raw agri cultural commodity that has been subject to 
processing, such as canning, cooking, freezing, de hydration, or milling.”  In addition, section 
201(q)(1)(B)(i)(II) of th e FD&C Act (which defines pesticid e chemicals) contains the following 
language regarding activities that do not transf orm a RAC into a processed food: “the treatment 
[with pesticide chemicals] is in a manner that do es not change the status of the food as a raw 
agricultural commodity (including treatment through washi ng, 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 sect ion 403(q)(4) of the FD&C Act (21 U.S.C. 123 
 
  343(q)(4)), FDA has established a voluntary nutriti on labeling program that applies to RACs but 
not to processed foods.  Under 403(w) of th e 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 proces sed food into account, incl uding 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 requ irements 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 di stribution or processing; secti on 419(a)(1)(A) of the FD&C Act 
(21 U.S.C. 350h(a)(1)(A)), which authorizes FDA to establish minimum sc ience-based standards 
applicable to certain fruits a nd vegetables that are RACs; a nd section 204(d)(6)(D) of FSMA (21 
U.S.C. 2223(d)(6)(D)), which contains special pr ovisions for commingled RACs applicable to 
FDA’s authority under section 204 of FSMA to es tablish additional record keeping 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 RA Cs (§ 110.19).  (We discuss this exemption in detail in section 
X.C.9 of this document.) 
The term “raw agricultural commodity” and si milar terms also appear in other Federal 
statutes.  While these statutes are not implem ented or enforced by FDA and do not directly 
impact the interpretation of the definitions in se ctions 201(r) and 201(gg) of the FD&C Act, they 124 
 
  do provide some suggestions about what “raw ag ricultural 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, Effici ent 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 tr ansporting “agricultural commodities” or farm 
supplies within specific areas during planting and harvest peri ods.  In that circumstance, 
“agricultural commodity” is defined as “any ag ricultural commodity, non-processed food, feed, 
fiber, or livestock… and inse cts” (49 U.S.C. 31136 note).  Another example is 19 U.S.C. 
1677(4)(E), which provides for certain circumst ances 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 ag ricultural product” is defined as “any farm or 
fishery product” (19 U.S.C. 1677(4)(E)).  These stat utes are informative in that they suggest that 
the “raw agricultural commodity” concept describe s 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 Rega rding 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 FD A and EPA over antimicrobial s ubstances, FDA and EPA have 
developed guidance regarding whether or not vari ous activities transform RACs into processed 
foods.  FDA and EPA jointly issued a legal and po licy interpretation of th e agencies’ jurisdiction 125 
 
  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: Antim icrobial Food Additives, July 1999 (hereinafter 
“Antimicrobial Guidance”) (Ref. 118)).  As di scussed 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, 
hydro-cooling, refrigeration, shel ling 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 proc essed food: “canning, freezing, 
cooking, pasteurization or homogenization, irra diation, 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 EPA and F DA 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 5453 2 at 54541-2); this conclusion was based on 
EPA’s policy statement on the status of drie d commodities as RACs (61 FR 2386, January 25, 
1996).  FDA and EPA also identified slaughter  of animals for food and activities done to 
carcasses post-slaughter as “processing” for the pu rposes 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 th e 1998 Joint EPA/FDA Policy Interpretation and 
the Antimicrobial Guidance. 126 
 
   
 
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 post-slaughter, including skinning, 
eviscerating, and quartering  
Slicing  
Activities that alter the general state of the commodity  
 
 
The summary in Table 2 demonstrates that th e activities that tr ansform a RAC into a 
processed food (and are sometimes therefore referre d to as “processing” in the context of a 
food’s status as a RAC or processed food) are not coextensive w ith the definition of 
“manufacturing/processing” that FDA establ ished in §§ 1.227(b)(6) and 1.328 for the purposes 
of the section 415 registration regulations a nd the section 414 record keeping regulations, 
respectively.  The definition of “Manufacturing/processing” in t hose regulations includes most 
food-handling activities because it is satisfied by any degree of “making food from one or more 
ingredients, or synthesizing, pr eparing, treating, modifying or ma nipulating 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 tran sform a RAC into a processed fo od are not coextensive with the 127 
 
  definition of “manufacturing/processing” in §§ 1.227(b)(6) and 1.328, a gi ven 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.  Ex amples of such activities include coloring, 
washing, and waxing.  3. The Organizing Principles  
The current section 415 regist ration regulations, section 414 recordkeeping regulations, 
and related guidances demonstrate that some activ ities 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 manufactur ing/processing.  To date, FDA has not articulated organizing 
principles explaining thes e 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 on-farm and of f-farm in the section 415 registration regulations 
and in the section 414 reco rdkeeping regulations, and that we in terpret in guidances.  In section 
VIII.E of this document, we propose to incor porate 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 th at doing so would more 
accurately reflect which activities of these establ ishments 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 c oncepts of RACs and processed food as set forth 
in the 1998 Joint EPA/FDA Policy Interpretation a nd the Antimicrobial Guidance, lead FDA to 
tentatively conclude that the ba sic purpose of farms is to produce RACS and that RACs are the 128 
 
  essential products of farms.  Th is tentative conclusion is the fi rst organizing principle that we 
would incorporate into the defini tions that classify ac tivities related to foods on farms and farm 
mixed-type facilities.   
b. Second organizing principle .  In light of the first organi zing principle (i.e., that the 
basic purpose of farms is to produce RACs, and th at 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, removi ng them from the growi ng areas, and preparing 
them for use as a food RAC, and for packing, hol ding 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 se ctions 415(b)(1) and 414(b) of th e FD&C Act) that FDA exempt 
“farms” from the section 415 registration re gulations and the sect ion 414 recordkeeping 
regulations.  This is the case ev en if the same activities off-farm 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 f ood from one or more ingredie nts, or synthesizing, preparing, 
treating, modifying or manipulating food.” This  tentative conclusion regarding a special 
classification for on-farm 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 organizi ng 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 co ncludes that the second or ganizing 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 definiti ons that classify activities related 129 
 
  to foods on farms and farm mixed-t ype 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 tran sform its RACs into 
processed foods should be considered to ha ve chosen to expand its business beyond the 
traditional business of a farm, thereby opting to beco me a farm mixed-type facility subject to the 
section 415 registration regulations, secti on 414 recordkeeping re gulations, and other 
requirements linked to the regi stration requirement of section 415 of the FD&C Act by FSMA 
(such as compliance with secti on 418 of the FD&C Act).   
d. Fourth organizing principle . In light of the first organi zing 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 c oncludes that the second organizi ng principle (i.e., the special 
classification of on-farm activitie s) should only apply to RACs grow n or raised on the farm itself 
or on other farms under the same ownership becaus e the essential purpose of a farm is to produce 
its own RACs, not to handle RACs grown on unrel ated farms for distribution into commerce.  
(For the purposes of this disc ussion, 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 rece ived a comment implicitly rec ognizing this, urging the agency 
to define farms to include typical post-harves ting operations, if all food is grown on the farm  
(emphasis added) (68 FR 5378 at 5379).  Therefor e, activities farms may perform on others’ 
RACs should appropriately be classified as manu facturing/processing, pack ing, or holding in the 
same manner as these activities are classified off-farm when the RA Cs are to be distributed into 
commerce.  In general, when a farm opts to pe rform activities outside the farm definition (and, 130 
 
  thus, becomes a farm mixed-type facility), the es tablishment’s activities that are within the farm 
definition should be classified  as manufacturing/processing, p acking, or holding in the same 
manner as for a farm that is not a mixed-type faci lity, but the activities th at are outside the farm 
definition should be classified in the same manner as for an off-fa rm food establishment. This is 
the fourth organizing principle th at 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 defi nition because otherwise farms could not feed 
people and animals on the farm without being re quired to register under section 415 of the 
FD&C Act.  This is the fifth organizing principl e 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 on-farm and 
off-farm in the section 415 registration regul ations and in the s ection 414 recordkeeping 
regulations, and that we in terpret in guidances.   
 
Table 3. Summary of Organizing Principles Regard ing 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, sh ould 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 ar e 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 sh ould remain within the farm definition. 131 
 
   
 
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 defi nitions are presented in alphabetical order.  
New definitions that FDA is proposing to add to the section 415 registra tion regulations and the 
section 414 recordkeeping re gulations 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 regist ration regulations (§ 
1.227) and in the section 414 recordkeeping regula tions (§1.328), and to add new definitions to 
those regulations, to reflect the organizing prin ciples articulated in section VIII.D of this 
document and to clarify how those definitions apply to specific activities depending on where the 
activities take place, the food us ed 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.  “Mixed-type facility” would mean an establishment that enga ges 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 regi stration (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 exam ple of such a facility, a definition of a “farm 132 
 
  mixed-type facility.” A “farm mi xed-type facility” would be defined as an establishment that 
grows and harvests crops or raises animals a nd may conduct other activities within the farm 
definition, but also conducts activ ities that require the establis hment to be registered.  FDA 
tentatively concludes that it is ne cessary 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 fa rm under the same ownershi p and activities that 
constitute on-farm manufacturing or processing of food not consum ed on that farm or another 
farm under common ownership.  Because the specif ic classes of activities mentioned in FSMA 
section 103(c) are, by definition, on-farm activities that do not fa ll within the farm definition, 
Congress has explicitly directed FDA to engage in rulemaking a ddressing 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 fa rms 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 perf ormed on raw agricultural commodities on the farm 
on which they were grown or raised, or anot her farm under the same ownership.  Harvesting 
would not include activit ies that transform a raw agricultura l 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, 133 
 
  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 oute r leaves, and cooling) and would add other 
examples to help clarify the scope of the defini tion 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 she ll eggs are RACs, and washing such eggs on the 
farm on which the eggs were produced would be pa rt 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, su ch as at a processing f acility that is not on a 
farm, or when performed by a farm on others’ RA Cs.  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 perf ormed on the farm that produced the eggs (or 
another farm under the same ownership).  Inst ead, washing eggs at th e off-farm processing 
facility would be “manufacturing/processing,” be cause it involves prep aring, treating, modifying 
or manipulating food.   
FDA is proposing to revise the definition of “Holding” in cu rrent §§ 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 w ould 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 tr ansform a RAC, as defined in section 201(r) of 134 
 
  the FD&C Act, into a processed food as define d in section 201(gg) of the FD&C Act.  This 
would mean that more activities than just storag e 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 RA Cs against pests for the purpose of safe and 
effective storage would be “holding” under this  proposed definition.  However, fumigating or 
otherwise treating food against pe sts under other circumstances (suc h 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/proces sing” in current §§ 
1.227(b)(6) and 1.328 by adding to the existing defi nition a criterion applicable to farms and 
farm mixed-type facilities.  The proposed revi sion would state that, for farms and farm mixed-
type facilities, manufact uring/processing would not include activ ities that are part of harvesting, 
packing, or holding.  Under this proposed revi sion, expanded definitions of “packing” and 
“holding,” and the extra category “harvesting” would apply to ac tivities performed by farms and 
farm mixed-type facilities on their own RACs.  These expanded  and extra categories would not 
apply off-farm or to foods other than a farm’s own RACs or a farm mixed-type facility’s own 
RACs.  Thus, some activities that would othe rwise 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.  A ccordingly, these activities would not be 
manufacturing/processing because they would alr eady be classified into the expanded definitions 
of packing or holding, or into th e extra category of harvesting. 
FDA is proposing to revise the definition of “Packing” in cu rrent §§ 1.227(b)(9) and 
1.328 by adding to the existing definition an expanded definition applicable to farms and farm 135 
 
  mixed-type facilities.  The proposed revision w ould state that, for farms and farm mixed-type 
facilities, packing would also include activitie s (which may include p ackaging) 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, bu t would not include activ ities 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 placing food into a 
container other than packaging would be classified  as “packing” when a farm or farm mixed-type 
facility performs those activities  on its own RACs.  For example, packaging (placing food into a 
container that directly contacts the food and th at the consumer receives) a farm’s own RACs 
would be “packing” under this definition becaus e farms traditionally do this to provide greater 
protection for fragile RACs than would be possibl e if the RACs were placed in containers other 
than the consumer container, and because th is 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 t ogether (e.g., in a bag containing three different 
colored bell peppers, or a box of mixed produce fo r a community sponsored agriculture program 
farm share); coating RACs with wax, oil, or resi n coatings used for the purposes of storage or 
transport; placing stickers on RACs; labeling pa ckages containing RACs; sorting, grading, or 
culling RACs; and drying RACs for th e purpose of storage or transport.  136 
 
  Table 4 provides examples of how we woul d classify activities conducted off-farm and 
on-farm (including farm mixed-type facilities) us ing these proposed revisions to the definitions 
in the section 415 registration re gulations and in the section 4 14 recordkeeping regulations.  
Table 4. Classification of Activities Conducted Off-Farm and On-Farm (Including  
Farm Mixed-Type Facilities) 
Classification Off-Farm On-Farm (Includi ng 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. 137 
 
  Classification Off-Farm On-Farm (Includi ng Farm Mixed-Type Facilities) 
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.  Th ese 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.  
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 ar e manufacturing/processing 
are outside the farm definition unless done on food for 
consumption on the farm.
 
 138 
 
  Classification Off-Farm On-Farm (Includi ng Farm Mixed-Type Facilities) 
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 post-
slaughter 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 post-
slaughter operations, irradiation, 
cutting/coring/chopping/slicing, canning, artificial ripening, cooking, pasteurizing/homogenizing, 
infusing, distilling, salting, smoking, grinding/milling, 
and freezing-- the sa me 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 re gistration regulations and revise  all remaining definitions in 
current § 1.227 to refer to “the Federal Food, Drug, a nd 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, a nd Cosmetic Act” rather than “the act.”   
Likewise, as a technical amendment for clar ity and for consistency with our current 
approach to citing the FD&C Act in new regulat ions, FDA is proposing to delete the definition 139 
 
  of “Act” in current § 1.328 of th e section 414 recordkeeping regulat ions 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 pr oposing 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 defi nition 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.  W ith the proposed new, separate definition of 
harvesting, it would be redundant to retain the ex amples of harvesting within the definition of 
“Farm.” 
As a conforming change to the proposed rede signation of § 1.227 to eliminate paragraph 
designations, FDA is proposing to revise § 1.276(b )(9) in the prio r notice regulations to cross-
reference § 1.227 (without any paragraph designa tions) 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 rulema kings 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 activit ies are within the farm definiti on or not.  However, because we 140 
 
  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 ra tionale leading to the classifi cation 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 V III.F.5 of this document, we discuss several examples of 
activities that we previously addressed and inte rpreted during the rulemakings to establish the 
section 415 registration regulations  and the section 414 recordkeepi ng 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 conducte d on a farm or a farm 
mixed-type facility would be within the farm de finition 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 V III.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, w ithout 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.   141 
 
  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 “treati ng against pests” on farms and farm  mixed-type facilities in the 
preamble to the interim final rule on food f acility 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 ag ainst pests by applying 
pesticides prior to harvest is an integral part of growing crops and is th erefore “growing” within 
the farm definition.  For other post-harvest pestic ide applications FDA prev iously 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 contai ning chlorine), FDA previously 
concluded both that some uses are washing with in the farm definition and that another use is 
manufacturing/processing outside  the farm definition.  Specifica lly, 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 ap plication 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 th at the application by a farm of wash water 
containing chlorine added by the farm to wash water at levels above 200 ppm is 142 
 
  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 applica tion of a pesticide to 
a farm or farm mixed-type facility’s own RA Cs 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 pest s 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 cl assification of such treatments 
would not be affected by the pr oposed 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 mi xed-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 infe station and damage duri ng 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 farm s and farm mixed-type f acilities 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 mixe d-type facility’s own RACs for the purpose of 
removing the crop from the growing area and prepar ing it for use as food to be harvesting.  An 
example of such activity is washing a crop in wa ter containing an antimicrobial chemical after 143 
 
  removing the crop from the growing area.  Gene rally, 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, unde r the proposed revisions 
to part 1 addition of that antimicrobial chemi cal to reduce the microbial load on a farm’s own 
RACs or a farm mixed-type facility’s own RA Cs would now be classified within the farm 
definition rather than be classifi ed as manufacturing/processing outside the farm definition.  For 
example, the application of wash water containi ng 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 harves ting 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, th ese 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 applicati ons of water containing chlorine  are washing within the farm 
definition, the classification of wa shing a crop in water containing an antimicrobial chemical as 
within the farm definition would represent a change from its previous classification as 
manufacturing/processing out side the farm definition.  
Continuing to use the general term “tr eating” 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 “treati ng” 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 “t reating” (e.g., delivering a heat treatment) has 144 
 
  been, and would continue to be, classified as manufacturing/processing outside the farm 
definition.  Second, for a farm or farm mixed-t ype facility conducting op erations on its own 
RACs, only those activitie s that do not satisfy either the expanded definition of packing or 
holding, or the new definition of harvesting, woul d be classified as manufacturing/processing 
outside the farm definition.  Thus, although applica tion 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 harvesti ng, application of a pesticide tr eatment off-farm has been, and 
would be continue to be, clas sified as manufacturing/processi ng 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 Facil ity’s Own Raw Agricult ural Commodities for 
Storage or Transport (e.g., Wa x, Oil, or Resin Coatings)  
FDA lists “waxing” as an example of a manufacturing/proce ssing 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 additio n, FDA has previously addressed 
“waxing” on farms and farm mixe d-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/processi ng outside the farm 
definition.   
This previous conclusion that on-farm wa xing 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 145 
 
  RACs for the purpose of protecting them during stor age or transport, and not to create a distinct 
commodity, would now be within the expanded definition of pack ing 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 applie d to fresh produce such 
as cucumbers, apples, and avocados.  FDA is aware that such treatm ents 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 treatme nts fit the proposed de finition of “packing” 
applicable to farms and farm mixe d-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 chocolat e or coating apples in caramel), that activity 
would create a processed food and would not fit the expanded defi nition of packing.  Thus, the 
act of applying the coating would continue to be classified as manufactur ing/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 pestic ide treatments, activities that are conducted on a 
farm or farm mixed-type facility and are with in the expanded definitions of packing and holding, 
or the new definition of harvesti ng, would be classified within th e farm definition rather than 
classified as manufactur ing/processing outside the farm de finition.  The current definition of 
manufacturing/processing in §§ 1.227(b)(6) and 1.328 and the exampl es of harvesting within the 
definition of farm in §§ 1.227(b)(3) and 1.328 demons trate that FDA has consistently cited some 
activities as examples of manuf acturing/processing as a genera l matter, but classified them 
differently in specific situations based on re levant circumstances.  Washing, trimming, and 146 
 
  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 act ivity as an example of 
manufacturing/processing in cu rrent §§ 1.227(b)(6) and 1.328, or the proposed revision of that 
definition, does not represent a conclusion th at the activity is al ways 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 Agricu ltural 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 thr ee conclusions relevant to drying: (1) drying 
peppermint naturally during storage in a barn wo uld not be manufacturing/ processing; (2) drying 
hay naturally or artificially is  an essential part of harves ting hay to prevent spontaneous 
combustion and is therefore not manufacturing/pro cessing; 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 regard ing drying (i.e., the previous conclusion 
regarding drying herbs) would ch ange under the proposed revisions to part 1.  As discussed in 
section VIII.D of this document, FDA tentativel y 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 esse ntial products of farms and processed foods are 
not.  Thus, activities that transform foods from RACs into processed foods would not be within 147 
 
  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 RA Cs.  Instead, anything 
that transforms a RAC into a processed food would be classifi ed 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; Stat us 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 transpor tation or storage of the commod ity prior to processing.  As a 
practical matter, this means that some RACs become processed foods when they are dried, 
because the drying creates a dis tinct commodity from the RAC.  An example of this kind of 
drying is drying grapes to crea te raisins; raisins are proces sed 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, le gumes, hays, other grasses, hops, rice, beans, 
and corn), the dried commodity re mains 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 durin g storage, respectively), becaus e these crops are traditionally 
dried by farms for the purpose of preparing for storag e 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 RA C).  Drying hay and alfalfa in the manner FDA 148 
 
  previously discussed would continue to be classi fied within the farm definition.  In contrast, 
drying herbs such as peppermint would now be cl assified as manufactur ing/processing outside 
the farm definition, because drying an herb cr eates a distinct comm odity 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 “packagi ng” (when used as a verb) as placing 
food into a container that direc tly contacts the food and that th e consumer receives, and that 
definition of “packaging” would remain unc hanged 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/proces sing 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 ot her than packaging the 
food.  Under the proposed revisions to the definiti ons in part 1, that definition of “packing” 
would be expanded to include activ ities 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 fa rms and farm mixed-type facilities, and 
off-farm, in the Food Facility Registrati on 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 thos e documents, FDA previously reached four 149 
 
  conclusions relevant to “packag ing” and “packing” activities on farms and farm mixed-type 
facilities: (1) placing RACs into consumer-r eady containers (e.g., plac ing 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” th an packaging (despite m eeting the definition of 
packaging) because it does not a lter 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/pro cessing 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 in stead be based on the organizing principles 
articulated in the proposed revisi ons to the definitions in part 1.  Specifically, bottling wine and 
placing cereal in plastic box liners would continue to be classifi ed as packaging and therefore 
manufacturing/processing, regardless of wher e such activities are pe rformed, because those 
foods are processed foods to which the expande d proposed definition of packing would not be 
applicable.  Placing apples received from elsewher e in bulk into plastic bags would continue to 
be classified as packaging and therefore ma nufacturing/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 thei r RACs for storage or 
transport, and this activity does not transform the RACs into a processed food.  Examples of this 150 
 
  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, ther e 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 expa nded definition of packing would 
not apply, so this activity would be now be  classified as packaging (and, therefore, 
manufacturing/processing).  Off-farm, as a pract ical 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 Ac t, and therefore already are subject to section 418 of the 
FD&C Act, whether this activity is classified as  packing or manufacturi ng/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 manufactur ing/processing, because 
the expanded definition of packing would only appl y to a farm’s own RACs.  This change in 
classification would impact a farm or farm mixed-type facility th at conducts such activities if it 
is not currently required to regist er.  This classification result is  consistent with the organizing 
principles articulated in section VIII.D of th is 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 c onduct such activities are acting as distributors 
for another farm’s products and FDA considers th at the activities they conduct on others’ RACs 
should be classified as manufact uring/processing, packing, or hol ding in the same manner as are 151 
 
  activities performed by off-farm di stributors 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. 
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 152 
 
  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? 
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); 
  Chocolate on nuts 
or caramel on 
apples: Manufacturing/ 
processing  
outside the farm definition (creates 
a distinct 
commodity and 
thus creates a 
processed food) Waxes, oils, 
and resins on 
fresh produce: No 
 
Chocolate on nuts or caramel 
on apples: Yes Yes  
Drying  153 
 
  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 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 
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  154 
 
  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? 
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 155 
 
  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 
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 
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 co-located 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 On-Farm 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 anal ysis 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 156 
 
  manufacturing and processing activi ties 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, th e 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” shoul d 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 component s: risk assessment, risk 
management and risk communication.   
• Risk assessment is a scientifically-based 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 ri sk assessment and other factors 
relevant for the health protection of consumers a nd for the promotion of fair trade practices, and, 
if needed, selecting appropriate prevention and cont rol options.   
• Risk communication is the interactive exchange of information and opinions 
throughout the risk analysis proc ess 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.  157 
 
   Because section 103(c)(1)(C) of FSMA calls fo r a science-based risk analysis, we are 
applying the Codex definitions to th e extent possible.  It is not clear whether the requirement of 
section 103(c)(1)(C) of FSMA to conduct a scie nce-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 secti on 418 of the FD&C Act, including hazard analysis and preventive 
controls, and the mandatory inspection fre quency 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 th e agency’s risk management decisions with 
respect to exempting or modifying requirement s applicable to low-risk on-farm 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 d ecisions required by sect ion 103(c)(1)(D).  The 
risk communication component of the risk an alysis 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 conducte d a qualitative risk assessment (Ref. 115) 
(“Section 103(c)(1)(C) draft RA ”) related to activity/food comb inations for the purpose of 
determining which activity/food combinations w ould be considered low risk.  We focused on 
activity/food combinations that we identified as being conducte d on farms (and, thus, might be 158 
 
  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 th an separately considering the ri sk of specific food categories 
because doing so better enabled us to focu s on whether 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, th e 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 versi on of the RA and will a nnounce the availability 
of the final version of the RA when it is availabl e.  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 th e results of the section 103(c )(1)(C) draft RA, arranged in 
three lists.  References to “farms ” in these lists should be unders tood to include farm mixed-type 
facilities.  The lists are shaped by the proposed definitions for harvesting, manufacturing/processing, pack ing, or holding in the sectio n 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/proces sing, packing, or holding) depe nding on whether the food being 
operated upon is a RAC and whether the RAC was grown or raised on the farm or farm mixed-159 
 
  type facility performing the activity or a farm under the same ownershi p.  We request comment 
on the lists in sections V III.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, ora nge, and almond) such that fruit m eans the harvestable or harvested 
part of a plant developed from a flower.  For th e purposes of this document, a vegetable is the 
edible part of an herbaceous plant (such as ca bbage or potato) or fles hy 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, leav es, or flower parts are used as food and includes mushrooms, 
sprouts, and herbs (such as basil or cilantro).  Examples of fruits a nd vegetables are apples, 
apricots, avocados, bananas, be rries, broccoli, cabbage, cantal oupe, 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 se eds, that are grown and 
processed for use as meal, flour, baked goods, cereal s and oils rather than for fresh consumption 
(including cereal grains, pseudo cer eals, oilseeds and other plants used in the same fashion).  
Examples of food grains include barley, dent- or flint-corn, so rghum, oats, rice, rye, wheat, 
amaranth, quinoa, buckwheat, cotton seed, and soybeans.  
For the purpose of the section 103(c)(1)(C) draf t RA, “intact fruits and vegetables” refers 
only to fruits and vegetables other than coco a beans, coffee beans, peanuts, sugar beets, 
sugarcane, and tree nuts.  Cocoa beans, coffee bean s, peanuts, sugar beets, sugarcane, and tree 160 
 
  nuts can be considered part of “fruits and vegeta bles” 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 combin ations likely to be performed on farm mixed-type facilities on 
those foods as compared to other fruits and vege tables, as well as spec ific hazards associated 
with certain of those foods.  1. List of low-risk on-farm packing and hol ding activity/food combinations when conducted on 
food not grown, raised, or consumed on that fa rm or another farm under the same ownership 
The section 103(c)(1)(C) draft RA identified the following lo w-risk packing and holding 
activity/food combinations when conducted on a fa rm on food not grown, raised, or consumed 
on that farm or another farm under the same ow nership - i.e., packing or re-packing (including 
weighing or conveying incidental  to packing or re-packing); sorting, culling, or grading 
incidental to packing or storin g; and storing (ambient, cold an d 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. 161 
 
  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 owners hip, 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 activ ity/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 activ ity/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 sa p 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 appl es) and raw peanuts and raw tree 
nuts (e.g., adding seasonings);  
• Drying/dehydrating intact fruits and vege tables (without the addition of sulfites) 
where the drying creates a distinct co mmodity (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 tr ee 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. 162 
 
  3. List of low-risk on-farm manufacturing/processing activ ity/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 activ ity/food combinations when conduc ted on a 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 a pples) and peanuts and tree nuts 
(e.g., adding seasonings);  
• Cooling intact fruits and ve getables 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 p eanuts 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 ca ndy, cocoa beans, cocoa products from 
roasted cocoa beans (other than milk chocolate), coffee beans, intact frui ts and vegetables, grain 
and grain products (other than t hose containing wheat in a form th at would not be recognized as 163 
 
  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 fro m acid foods (e.g., acid fruits);  
• Making maple syrup;  
• Making soft drinks a nd 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 to ffee; cocoa beans; cocoa products; 
coffee beans; intact fruits and vegetables (o ther than modified atmosphere or vacuum 
packaging); grain and grain produc ts; honey; jams, jellies and pres erves; maple syrup; peanuts 
and tree nuts (including modified atmosphere or vacuum pa ckaging); 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), a nd peanuts and tree nuts;  
• Sifting grains and grain products;  
• Sorting, culling and grading (o ther than when incidental  to packing or storage) 
hard candy, fudge, taffy, and toffee; cocoa beans; co coa products; coffee beans; intact fruits and 164 
 
  vegetables; grain and grain products ; honey; jams, jellies and preser ves; maple sap; maple syrup; 
peanuts and tree nuts; soft dr inks and carbonated water; and sugar beets and sugarcane;  
• Treating cocoa beans, coffee beans, intact  fruits and vegetabl es, 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 pur pose of storage or transportation) intact 
fruits and vegetables.  
We note that the list in this secti on (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 low-risk 
manufacturing/processing activity/food combinations for a farm’s  own RACs.  This relates to the 
fact that some activities  that would be manufacturing/proces sing when performed on foods other 
than a farm’s own RACs are not manufacturin g/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 activ ities 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 resulti ng in a shorter list of low-risk  activity/food combinations for 
the purpose of the rulemaking requ ired by section 103(c) of FSMA. 
I. Tentative Conclusions Regarding On-F arm 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 bus inesses (as defined in proposed § 117.3) from 165 
 
  requirements under section 418 of the FD&C Act if the only activities subject  to section 418 that 
the business conducts are low-ri sk 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 secti on 415 of the FD&C Act. 
J. Tentative Conclusions Regarding On-F arm Low-Risk Activity/Food Combinations  
Under Section 421 of the FD&C Act  
We tentatively conclude that FDA should c onsider 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 busin esses and allocating in spection resources under 
Section 421 of the FD&C Act, Targeting of Insp ectional Resources for Domestic Facilities.  
However, at this time, FDA tentatively concl udes 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 sm all or very small business.  Current data 
limitations impact our ability to accurately identi fy 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 establis h data submission requirements 
that would allow us to identify these types of facilities in or der 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 cate gory/activity type. We al so request comment on 
these possible data elements and any other criter ia that may be appropriate for the purposes of 
allocating inspection resour ces to these facilities. 166 
 
  IX. Proposed General Revisi ons to Current Part 110 
A. Title  
FDA is proposing to revise the title of  current subpart B from “Current Good 
Manufacturing Practice in Manufact uring, Packing, or Holding Hu man 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 foreign facilities that ar e required to register 
under section 415 of the FD&C Act.  As propose d, 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 with in 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 provisi ons already established in part 110.  The 
proposed redesignation will clear ly 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 redesignati on 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 reorganiza tion and redesignati on of the provisions 
currently in part 110 as they w ould be established in proposed part 117.  The proposed revisions 167 
 
  are intended to enhance the clarity  of proposed part 117 as a whol e.  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 provi sions of part 110 in the order in which they 
would appear in a final rule based on this propo sed rule.  Provisions that we do not propose to 
delete or revise would be re-e stablished 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 clea r that the activities 
that would be subject to proposed part 117 include manufacturing, processing, packing and 
holding.  We describe each of these proposed revi sions elsewhere in this document, in an order 
consistent with the placement of the current or  revised provision.  Sect ion 418 of the FD&C Act 
uses this group of terms to broadly identify act ivities that take place in  food facilities.  In 
addition, we have previously described activit ies that may be considered “manufacturing, 168 
 
  processing, packing, or holding” by establishing de finitions 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 secti on VIII.E of this document) and would incorporate the revised 
definitions of manufacturing/processing, pack ing, and holding in proposed part 117.  We 
tentatively conclude there is no meaningful distinction between “man ufacturing/processing,” 
“packing,” and “holding” as de fined in our proposed revision s to §§ 1.227 and 1.328 and those 
terms as they have been used in current part 110.   We also tentatively co nclude that consistent 
use of these terms throughout proposed part 117, in reference to activi ties taking place in food 
facilities, establishments, or plants, would ma ke 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 “f acility” or “facilities” 
could be confused with the firms that are s ubject to the proposed requirements for hazard 
analysis and risk-based preventive controls re quired by section 418 of th e FD&C Act.  FDA is 
proposing this change to disti nguish between the requirements of  current part 110 (Current Good 
Manufacturing Practices) and requ irements that we are proposing to establish under section 103 
of FSMA.  The term “facility” as used in curr ent part 110 reflects the common meaning of that 
term as something designed, built, or installed to serve a specific func tion.  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, subp art H), we defined the term 
“facility” to have a very speci fic meaning for the purpose of that regulation as follows:   169 
 
  Current section 1.227(b)(2) provides in part that “[f]acility means any establishment, 
structure, or structures under one  ownership at one general physic al location, or, in the case of a 
mobile facility, traveling to multip le 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 re gister 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 fo reign facility that is  required to register  under section 415” of 
the FD&C Act, and proposed § 117.3 would define  “facility” to incor porate this statutory 
definition.  Under proposed § 117.3, the term “fac ility” 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 t hose 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 curr ent part 110 with “establishment” or “plant” in proposed part 
117 is intended to avoid confusion about the ap plicability of proposed part 117 to plants or 
establishments that satisfy th e definition of the term “facili ty” 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 consiste nt with the placement of the current or revised 
provision.  We request comment  on this proposed revision. 
We are not proposing to repla ce the use of the term “facili ties” in current requirements 
directed to specific functional part s 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 170 
 
  contexts would not create confusion.  We reque st comment on whether there is potential for 
confusion such that we should eliminate all use of the term “facility” or “faci lities” as it is used 
in current part 110 irre spective 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 es tablishes 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 requirem ents applicable to “plant management” and 
current § 110.20(a) establishes re quirements for the “operator” of a food plant.  We request 
comment on whether there is any meaningful differe nce 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 wo uld be appropriate to refer to the “owner, 
operator, or agent in charge” of a plant, esta blishment, or facility throughout proposed part 117 
and, if so, whether the requirements would be cl ear if we revise the proposed rule to use 
pronouns (such as “you” and “your”) within pro posed 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 direct ed to preventing cont amination of food and 
food-contact substances also are directed to preventing co ntamination of food-packaging 
materials. Because food-packaging materials co me 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 f ood and food-contact substances 
consistently be directed to pr eventing contamination of food-p ackaging materials as well.  We 171 
 
  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 Cross-Contact  
Proposed § 117.3 would define the term “cro ss-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 th e Federal Food, Drug, and Cosmetic Act.  As 
discussed in section X.B.4 of this  document, it has been estimated that food allergie s 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 prev ent reactions.  To do so they must rely on food 
labels to be complete, clear, and accurate.  Ma nufacturers can provide consumers with the food 
labels they need by using controls to ensure th at labels declare all th e food allergens that are 
intended to be present, controls to ensure that the correct labe l is applied to the product, and 
controls that prevent the unintended presen ce of food allergens through cross-contact. 
Comments submitted to the Food CGMP M odernization 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 develo p and adopt a food allerg en 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 re quire protection against cross-contact, which can 
constitute insanitary conditions that may cause a food to be adulterate d under section 402(a)(4) 
of the FD&C Act if the food may ha ve been rendered injurious to health.  Consistent with this 
interpretation, FDA issued a Notice to Manufact urers titled “Allergy Warning Letter” on June 172 
 
  10, 1996, advising with regard to cr oss-contact that adhering to CG MPs is essential for effective 
reduction of adverse reactions, and urging manufacture rs 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 re ferred to as “contamination” or 
“cross contamination” (Ref. 121), and in many inst ances 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 scientif ic literature 
distinguishing “cross-contact” from  “contamination” and “cross contamination,” FDA tentatively 
concludes that it should begi n 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 th at CGMPs require protection agains t cross-contact, and to ensure 
that CGMPs continue to address he alth concerns related to allerg ens, FDA is proposing to revise 
several provisions of current part  110 to explicitly address cro ss-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 i ngredients.  We are proposing to retain that definition in this 
proposed rule.  There is an overlap between raw ma terials 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, 173 
 
  thus, the manufacture of a food additive is subj ect to current part 110.  An example of a food 
additive is sucrose fatty acid es ters.  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 me thyl ethyl ketone or 
dimethyl sulfoxide and isobutyl alcohol (2-methyl-1 -propanol) may be used in the preparation of 
sucrose fatty acid esters.  The re gulation for sucrose fatty acid es ters identifies a number of raw 
materials used in the production of sucrose fa tty 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 chem ical product.  Likewise, if a 
facility adds the food additive “sucrose fatty ac id 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 este rs as ingredients of its food product. 
The title of current § 110.80(a)  and several provisions with in current § 110.80 refer to 
“raw materials and other ingredient s” rather than to “raw materials and ingredients” as in the 
definition of “food.”  For consistency with the de finition 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 ingred ients” throughout provisions in cu rrent § 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.  174 
 
  F. Proposed Revisions to Addre ss Guidance in Current Part 110  
In 2000, we codified our policies and procedur es 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 en forcement policies.  Under § 10.115(d), guidance 
documents do not establish legally enforceable righ ts or responsibilities and do not legally bind 
the public or FDA. 
Comments submitted to the Food CGMP M odernization Working Group noted that 
several provisions of curren t part 110 use non-binding language such as “should” and 
recommended that we revise part 110 to e xpress all provisions usi ng binding language (e.g., 
“shall” in place of “should”) (Ref. 1).  Consis tent with these comments and with 21 CFR 10.115, 
we are proposing to delete some non-binding prov isions 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 requireme nts 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 th at are editorial in 
nature.  These editorial changes have no substan tive effect on the current requirements of part 175 
 
  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  Cosme tic Act” rather than to “the act” for 
clarity and for consistency with our current appro ach 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” indicat es that the specified list that  follows is not exclusive. The 
phrase “but is not limited to” is unnec essary. (72 FR 34752 at 34765, June 25, 2007) 
• Replace the phrase “adulteration within th e meaning of the act” with the single 
term “adulteration” because “within the meani ng 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 curren t § 110.5(a) as proposed § 117.1(a) with 
associated editorial changes described in secti on IX.G of this document.  Current § 110.5(a) 
establishes that the criteria a nd 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 b een prepared, packed, or  held under insanitary 
conditions whereby it may have become contaminat ed with filth, or whereby it may have been 176 
 
  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 sec tion 361 of the Public 
Health Service Act (42 U.S.C. 264).  FDA is pr oposing 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 provi sions of proposed part 117, in cluding 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 au thorities.  We note that  section 418(a) of the 
FD&C Act provides that faciliti es 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 un der 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 provide s a basis for applying the criter ia and definitions in proposed 
part 117 in determining whether, under partic ular circumstances, a food is adulterated under 
section 402(a)(3) or (a)(4) or in viol ation of section 361 of the PHS Act.  
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 th e list of acts and the causing thereof that are prohibited.  Under 
section 301(uu), the following act, and the causing th ereof, is prohibited: “[t]he operation of a 
facility that manufactures, proces ses, packs, or holds food for sa le in the United States if the 
owner, operator, or agent in charge of such f acility is not in complian ce with section 418 [of the 177 
 
  FD&C Act].”  To clearly communicate that failure  to comply with regu lations established under 
section 418 is a prohibited act, proposed § 117.1(b) would estab lish that the operation of a 
facility that manufactures, proces ses, packs, or holds food for sa le in the United States if the 
owner, operator, or agent in charge of such fac ility 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 th e FD&C Act (21 U.S.C. 331(uu)).   
FDA is proposing to redesignate curren t § 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 requireme nts 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 proce ssed 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; fi nal 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 ar e foods covered by the 178 
 
  current good manufacturing practice requirements that are currently  established in part 110 and 
would be re-established in part 117.  See section II.A of this doc ument 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 re quires that we establish regulations to 
implement requirements for hazard analysis and ri sk-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 h azard analysis and risk-based pr eventive controls within the 
framework of current part 110, as would be re-est ablished in proposed part 117.  As discussed in 
section IX.A of this document, we are proposing that the title of propos ed part 117 reflect the 
addition of these new requirements.  As discusse d more fully in section X.C of this document, 
section 418 of the FD&C Act esta blishes several exemptions from the proposed requirements for 
hazard analysis and risk-based preventive controls .  For example, secti on 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 co mply with, and is in compliance 
with… (A) [t]he Seafood Hazard Analysis Criti cal 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, consiste nt 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 acti vities 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 th e CGMP requirements in proposed subpart B and 
the requirements of part 123.  The same would be true for establishments and facilities that are 179 
 
  subject to other food safety regulations, consistent  with the exemptions th at 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 paragra ph designations (such as (a), (b), and (c)), and add new 
definitions in alphabetical order.  Paragraph de signations are not necessary when the definitions 
are presented in alphabetical order.  Propos ed § 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 us e “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 fina l food or decomposition of the final food.  Current § 110.3(e) was 
established in 1986.  Current § 110.3(e) preceded vari ous 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 417).  Proposed § 117.3 woul d revise the current definition of “critical 
control point” to match the statut ory 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 180 
 
  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 preven t or eliminate a food safety hazard or reduce such 
hazard to an acceptable level.   
A non-substantive difference between the de finition of CCP in proposed § 117.3 and the 
definition of CCP in § 120.3(d) is that pr oposed § 117.3 would incor porate the phrase “food 
safety hazard” into the definition of CCP, wher eas § 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 whet her comparing § 120.3(d) to § 123.3(b) (which 
uses the phrase “food safety hazard” in its defi nition of CCP).  In fact, we see no meaningful 
difference between “food safety hazard” and “ha zard” 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 section X.B.4 of this document).  Section 418 
of the FD&C Act largely refers to “hazards” and the single refere nce to “food safety hazard” is 
in the statutory definition of CCP.  Because th e phrase “food safety hazard” appears in so many 
current definitions of CCP, we tentatively concl ude 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.  Pa rt 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 tent atively conclude that the statut ory definition of CCP in section 181 
 
  418(o)(1) of the FD&C Act is, fo r practical purposes, consistent  with existing definitions and 
that our proposed definition of  CCP would present no conflict w ith existing recommendations.   
The definition of CCP in proposed § 117.3 woul d 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 cons istent 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, whic h may or may not present a food safety hazard, 
depending on the circumstances.  Similarly, th e 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 deco mposition among the hazards to be  identified and evaluated and, 
thus, decomposition is considered within the te rm “hazard” when it affects the safety of the 
product.  
Current § 110.3(g) defines “food-contact surface s” 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 ope rations.  Current § 110.3(g)  also specifies that 
“food-contact surfaces” includes utensils and fo od-contact surfaces of equipment.  FDA is 
proposing to revise the definition for “food-cont act 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 su rfaces that contact the food are 
food-contact surfaces.  Proposed § 117.3 would de fine “food-contact surfaces” to mean those 
surfaces that contact human food an d those surfaces from which dr ainage, or other transfer, onto 
the food or onto surfaces that c ontact the food ordinarily occurs  during the normal course of 182 
 
  operations.  Proposed § 117.3 would also specify th at “food-contact surfa ces” includes utensils 
and food-contact surface s of equipment.  
Current § 110.3(i) defines “microorganisms” to  mean yeasts, molds, bacteria, and viruses 
and includes, but is not limited to, species havi ng public health signifi cance.  Current § 110.3(i) 
also specifies that the term “ undesirable microorganisms” include s those microorganisms that are 
of public health significance, that subject f ood 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) al so states that, occasionally in these regulations, FDA used the 
adjective “microbial” instead of using an adjec tival phrase containing th e word microorganism.  
FDA is proposing to revise the definition for “m icroorganisms” 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 sa nitary production of f oods.  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 woul d also specify that the term “undesirable 
microorganisms” includes those microorganisms th at are of public hea lth 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, pa ckaging, labeling, or holding of human food.  183 
 
  FDA is proposing to revise the definition for “p lant” by adding “processing” and “packing” and 
deleting “labeling” and “packaging” so that activiti es listed in the defini tion are consistent with 
activities covered by proposed part  117.  As discussed in secti on IX.C.2 of this document, FDA 
is proposing to consistently us e the terms “manufacturing, pro cessing, packing and holding” to 
reflect the group of terms used in section 418(a) of the FD&C Act to br oadly identify activities 
that take place in food f acilities.  As discussed later in this  section, “labeling” and “packaging” 
would be  included in the defini tion of manufacturing/processing a nd 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 “f acility” with the term “establishment.”  Proposed § 117.3 would 
define “plant” to mean the building or establishm ent or parts thereof, used for or in connection 
with the manufacturing, processing, p acking, or holding of human food.   
Current § 110.3(n) defines “safe-moisture le vel” as a level of moisture low enough to 
prevent the growth of undesirable microorganism s in the finished prod uct under the intended 
conditions of manufacturi ng, storage, and distribution.  Curren t § 110.3(n) also specifies that the 
maximum safe moisture level for a food is based on its water activity (a w), and that an a w will be 
considered safe for a food if adequate data ar e available that demonstr ate that the food at or 
below the given a w will not support the growth of undesi rable microorganisms.  FDA is 
proposing to revise the definition for “safe-moisture level” to: 
• Delete the hyphen between “safe” and “m oisture.”  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.   184 
 
  • Replace the phrase “based on” with “related  to.”  FDA tentatively concludes that 
the term “related to” is more appropriate beca use 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 discusse d in section IX.C.1 of this 
document, we are proposing to use this group of terms to broadly identif y activities that take 
place in food facilities. 
With these proposed changes, proposed § 117.3 would define “safe 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, pr ocessing, packing, and 
holding.  Proposed § 117.3 would also specify that the safe moisture level for a food is related to 
its water activity (a w), and that an a w will be considered safe for a food if adequate data are 
available that demonstrate that the food at or below the given a w 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 un desirable microorganisms, but 
without adversely affecting the product or its safety for the consumer.  FDA is proposing to 
revise the definition for “sanitize” to include th e term “cleaned” before “food-contact surfaces.”  
It is well established that sanitizers can be inactivated by organic mate rial 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-contac t surfaces by a process that is effective in 
destroying vegetative cells of micr oorganisms of public health si gnificance, and in substantially 185 
 
  reducing numbers of other undesirable microorga nisms, 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 a nother facility.  The pr oposed definition would 
incorporate the definition in se ction 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 “cr oss-contact” to mean the unintentional 
incorporation of a food a llergen into a food.  We discuss cross-contact in more detail in section 
IX.D of this document. 
FDA is proposing to define the term “envir onmental pathogen” to mean a microorganism 
that is of public health signi ficance and is capable of surviv ing 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 s hould 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 sec tion 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.    186 
 
  FDA is proposing to define the term “farm” by reference to the defini tion of that term in 
proposed § 1.227.  See section VIII of this documen t for detailed discussion of farms and mixed-
type 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 regi ster under section 415 of the FD&C Act. We are 
proposing to cross-reference the definition to redu ce the potential confusion that could result if 
we used the term “facility” to have two diffe rent 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 appli cable to part 117 would eliminate the need to 
define the term within each distinct secti on of the regulation and would provide for the 
substitution of “Food and Drug Administrati on” with “FDA” each time “Food and Drug 
Administration appears in current part 110. 
FDA is proposing to define the term “food alle rgen” 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, e gg, fish (e.g., bass, flounder, or cod), Crustacean 
shellfish (e.g., crab, lobster, or shrimp), tr ee 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 ma nufactured, processed, packed, or held by the 187 
 
  facility] is not ... misbranded under section 403(w) [of the FD&C Act].”  Section 403(w) of the 
FD&C Act provides certain labeli ng requirements for foods that bear or contain a major food 
allergen, with certain exceptions.   
FDA is proposing to define the term “harvesti ng” 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 pl ace they were grown or raised and preparing 
them for use as food.  The proposed definition wo uld also specify that harvesting is limited to 
activities performed on raw agricultural commoditie s on the farm on which they were grown or 
raised, or another farm under the same ownership;  and that harvesting doe s not include activities 
that transform a raw agricultural commodity, as de fined 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 out er leaves of, removing stems and husks from, 
sifting, filtering, threshing, shelling, and cooli ng raw agricultural commodities grown on a farm 
or another farm under the same ownership are ex amples 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 m ean 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 biol ogical, chemical, or physical agent that is 
reasonably likely to cause illness or injury in  the absence of its cont rol.  The Codex HACCP 188 
 
  Annex defines “hazard” as a biological, chemical or physical agent in, or condition of, food with 
the potential to cause an advers e 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 property that may cause a food to be 
unsafe for human consumption.  A difference betw een the proposed definition of “hazard” and 
the definitions established in the NACMCF HA CCP 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 wh ereas 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 sectio n 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 manufactur es, 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 manufacture d, processed, packed, or held in the absence of those controls.  
The proposed definition is consistent with Fe deral HACCP regulations for seafood, juice, and 
meat and poultry.  Our HACCP regulation for seaf ood describes a food safety hazard that is 
reasonably likely to occur as one for which a pr udent processor would establish controls because 
experience, illness data, scientific reports, or ot her information provide a basis to conclude that 
there is a reasonable possibility th at it will occur in the particular  type of fish or fishery product 189 
 
  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, illne ss data, scientific reports, or other information 
provide a basis to conclude that there is a re asonable possibility that, in the absence of those 
controls, the food hazard will occur in the par ticular 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 fo r 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 docum ent, we explain how th e term “hazard that is 
reasonably likely to occur” would implement sec tion 418(b)(1) of the FD&C  Act and relate this 
term to the NACMCF HACCP guidelin es and the Codex HACCP Annex. 
FDA is proposing to define the term “hol ding” to mean the st orage of food.  The 
proposed definition would also state that holdi ng facilities include warehouses, cold storage 
facilities, storage silos, grain elevators, and liquid storage tank s; and that, for farms and farm 
mixed-type facilities, holding also includes ac tivities 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 establis hed in proposed § 1.227.  See secti on VIII.E of this document for 
a detailed discussion of “holding.”  190 
 
  FDA is proposing to define the term “man ufacturing/processing” to mean making food 
from one or more ingredients, or synthesizi ng, preparing, treating, modi fying or manipulating 
food, including food crops or ingredients.  The proposed definition w ould also state that 
examples of manufacturing/pr ocessing activities are cut ting, peeling, trimming, washing, 
waxing, eviscerating, rendering, cooking, baki ng, freezing, cooling, pasteurizing, homogenizing, 
mixing, formulating, bottling, milling, grinding, ex tracting juice, dist illing, labeling, or 
packaging.  The proposed definition would also specify that, for farms and farm mixed-type 
facilities, manufacturing/proces sing 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 “manufactur ing/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 u nder section 415 of the FD&C Act 
and activities that require the es tablishment to be registered.  The proposed definition would also 
state that an example of such a f acility is a “farm mixed-type facility,” which is an establishment 
that grows and harvests crops or raises animal s and may conduct other activ ities within the farm 
definition, but also conducts activ ities that require the establishm ent 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 disc ussion 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 veri fication.  The proposed definition is consistent 
with the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP 191 
 
  regulations for seafood, juice, and meat and poultr y.  The proposed definition is the same as the 
definition in our HACCP regula tion 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 “mon itor” to mean the act of conducting a planned 
sequence of observations or measurements of co ntrol parameters to assess whether a CCP is 
under control (Ref. 35).  Our HACCP regulation for seafood, a nd the FSIS HACCP regulation 
for meat and poultry were each established be fore the current NACMCF HACCP guidelines and 
do not define the term “monitor.”  However, as di scussed in section XII.E of this document, both 
of these regulations establish requirements that ar e consistent with the definition of “monitor” in 
proposed § 117.3 and in the NACMCF HACCP guide lines, the Codex HACCP Annex, and our 
HACCP regulation for juice. 
FDA is proposing to define the term “packagin g” to mean (when used as a verb) placing 
food into a container that direc tly contacts the food and that the consumer receives.  FDA is 
proposing to use the same definition of “packag ing” as would be esta blished in proposed § 
1.227.  See section VIII.E of this document for a detailed discussion of “packaging.”    
FDA is proposing to define the term “packi ng” to mean placing food into a container 
other than packaging the food.  The proposed defi nition would also specify that, for farms and 
farm mixed-type facilities, packing also includ es activities traditionally performed by farms to 
prepare raw agricultural commoditie s grown or raised on the same  farm or another farm under 
the same ownership for storage and transport, bu t 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 192 
 
  “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 “preve ntive controls” to m ean 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 id entified under the hazard analysis that are consistent with the 
current scientific understanding of safe food manufacturing, pro cessing, packing, or holding at 
the time of the analysis.  The proposed definiti on would incorporate the definition in section 
418(o)(3) of the FD&C Act.  
FDA is proposing to define the term “qualifie d end-user” to mean, with respect to a food, 
the consumer of the food (where the term consum er does not include a busin ess); or a restaurant 
or retail food establishment (as those terms are de fined in § 1.227) that (1 ) is located (a) in the 
same State as the qualified facility  that sold the food to such rest aurant 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 “qualif ied 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 whic h both of the following apply:  
• During the 3-year period preceding the a pplicable calendar year, the average 
annual monetary value of the food ma nufactured, processed, packed or  held at such facility that 193 
 
  is sold directly to qualified e nd-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 wa s less than $500,000, adjusted for inflation. 
The proposed definition would incorporate th e description of “qualified facility” in 
section 418(l)(1) of the FD &C Act with editorial ch anges to improve clarity. 
FDA is proposing to define the term “qualif ied individual” to mean a person who has 
successfully completed training in the developm ent and application of risk-based preventive 
controls at least equivalent to that received under a standard ized curriculum recognized as 
adequate by the FDA or is ot herwise qualified thr ough job experience to develop and apply a 
food safety system.  FDA is proposing to define th e term “qualified individual” to have a concise 
term to use in proposed provisions that would requi re 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 “read y-to-eat food (RTE food)” to mean any food 
that is normally eaten in its ra w state or any other food, includi ng processed food, for which it is 
reasonably foreseeable that th e 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 Applic ation of General Principles of Food Hygiene to 
the Control of Listeria Monocyt ogenes in Foods (Ref. 52), which defines an RTE food as any 
food which is normally eaten in its raw state or any food handled, pro cessed, mixed, cooked, or 
otherwise prepared into a form which is normally eaten without further list ericidal steps.  By 
referring to “any other food, including processe d food,” our proposed definition for RTE food, in 194 
 
  combination with our proposed definition of “m anufacturing/processing,” would incorporate the 
concepts in the Codex guideli nes for control of Listeria  that RTE food includes foods that have 
been processed, mixed, cooked, or otherwise prepar ed into a form that can be eaten without 
processing in a manner that adequately reduc es 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 wit hout further “processing that will significantly 
minimize biological hazards,” rather than “listericida l 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 cons umed without cooking by the consumer, or that 
reasonably appears to be suitable for consump tion 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 pathoge ns at a facility.  
As discussed in section XII.B.4.b of this doc ument, proposed § 117.130(c)(2) would require that 
a hazard analysis include an evaluation of wh ether environmental pathogens are reasonably 
likely to occur whenever a RTE food is exposed  to the environment pr ior 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 wher e necessary to significan tly minimize or prevent 195 
 
  hazards that are reasonably likely to occur (i ncluding any environmental pathogen that is 
reasonably likely to occur in a ready-to-eat f ood that is exposed to th e environment prior to 
packaging, any microorganism of pub lic health significance that is r easonably likely to occur in a 
ready-to-eat food due to employee handling, and a ny food allergen hazard) sanitation controls 
that include procedures for the (A) Cleanline ss of food-contact surfaces, including food-contact 
surfaces of utensils and equipment; and (B) Prev ention of cross-contact 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. 
Our proposal to include in the proposed defi nition of RTE food the concept that it 
includes food that “is reasonably foreseeable th at the food would be eaten without further 
processing to significantly minimize biological hazar ds” would retain the c oncept, in the draft 
guidance directed to the c ontrol of L. monocytogenes  in refrigerated or frozen RTE foods, that 
an RTE food includes food that “reasonably ap pears 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 al so is well known that consumers use dried soup mix in RTE 
form as a component of a dip; multiple drie d 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 “reasonab ly foreseeable hazard” to mean a potential 
biological, chemical, physical, or ra diological hazard that may be asso ciated 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 196 
 
  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 haza rd evaluation process in HACCP systems.  
FDA is proposing to define the term “signifi cantly minimize” to mean to reduce to an 
acceptable level, including to eliminate.  Th e 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 C odex HACCP Annex, and our HACCP regulation for juice.  
The NACMCF HACCP guidelines define “control meas ure” as any action or activity that can be 
used to prevent, eliminate or reduce a signifi cant 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 le vel (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 es tablished prior to the current NACMCF HACCP 
guidelines, do not define “c ontrol measure.”  However, th ese Federal HACCP regulations 
nonetheless reflect the same concept that would be established in the proposed definition of 
“significantly minimize” in the definition of “cr itical 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 HA CCP regulation for meat and poultry as a point, 
step, or procedure in a food proce ss at which control can be applie d and, as a result, a food safety 
hazard can be prevented, eliminated, or re duced to acceptable levels (9 CFR 417.1).   197 
 
  FDA is proposing to define the term “small bus iness” 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 “subsid iary” to mean any company which is owned 
or controlled directly or indirectly by another company.  The proposed definition would 
incorporate the definition in sec tion 418(l)(4)(D) of  the FD&C Act. 
FDA is proposing to define the term “valida tion” to mean that element of verification 
focused on collecting and evaluating scientific an d 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 scie ntific and technical information to determine whether the 
HACCP plan, when properly implemented, will eff ectively 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).  Anothe r Codex document (i.e., “Guidelines for the 
Validation of Food Safety Control Measures” (Codex validation guidelin es)) defines validation 
more broadly than in the realm of HACCP system s as obtaining evidence that a control measure 
or combination of control measures, if properl y 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 defi ne 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.  198 
 
  FDA is proposing to define the term “verifica tion” to mean those act ivities, other than 
monitoring, that establish the vali dity of the food safety plan and that the system is operating 
according to the plan.  The proposed defin ition is consistent with the NACMCF HACCP 
guidelines, the Codex HACCP Annex and valida tion guidelines, and our HACCP regulation for 
juice.  The NACMCF guidelines (Ref. 34), a nd our HACCP regulation for juice (§ 120.3(q)) 
define verification as those activ ities, other than monitoring, that  determine the validity of the 
HACCP plan and that the system is operating ac cording to the plan.  The Codex HACCP Annex 
defines verification as the appl ication 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 th e application of methods , procedures, tests and 
other evaluations, in ad dition to monitoring to determine wh ether a control measure is or has 
been operating as intended (Ref. 127).  Ou r HACCP regulation for seafood, and the FSIS 
HACCP regulation for meat and poultry, do no t define the term “verification.”  
FDA is proposing to define the term “very sm all business” to mean, for the purposes of 
proposed part 117, a business that has less than $250,000 in total annu al 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 anot her co-proposal, we are proposing to define the 
term “very small business” to mean a busine ss that has less than $1,000,000 in total annual sales 
of foods, adjusted for inflation (Option 3).  S ee section X.B.5 for additional discussion of the 
definition of very small business. 199 
 
  5. Food Processing Sector Study and the Defini tions of “Small Business” and “Very Small 
Business” 
FDA conducted a Food Processi ng Sector Study as required by section 418(l)(5) of the 
FD&C Act (Ref. 32) .  The purpose of that study wa s to make determinations in five areas as 
required by section 418(l)(5 )(A) of the FD&C Act and to use th e results of the study in defining 
the terms “small business” and “very small busin ess.”  These areas include, in part, (1) 
distribution of food prod uction by type and size of operation,  (2) the proportion of food produced 
by each type and size of operation, (3) the numbe r and types of food facilities co-located on 
farms, (4) the incidence of foodborne illness or iginating from each size and type of operation, 
and (5) the effect on foodborne i llness risk associated with cert ain 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 reque st comment on that study.  We will consider 
comments regarding the study, as well as comment s 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 considera tion of harvestable acres, 
income, the number of employees, and the volum e of product in defining the terms “small 
business” and “very small business.”  The F ood Processing Sector St udy (Ref. 32) concluded 
that there was no consistent pattern across food categories in terms of which sizes of 
establishments contribute most to foodborne illn ess 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 200 
 
  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 re levant to the growing 
and harvesting of crops, which are activities not subject to this re gulation.  Harvestable acres and 
volume of food harvested do not provide a meaningf ul measure with respect to the risk from 
food produced by a farm mixed-type f acility (a food facility co-locat ed on a farm subject to this 
regulation); our qualitative ri sk assessment of manufacturi ng, processing, packing and holding 
activities conducted in a facility co-located on a farm s howed that risk was related to 
activity/food combinations; these f oods could be harvested from larg e 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 on-farm facility producing bagged salads (which would not 
be considered a low-risk activity /food combination) could be one th at has very few acres, or the 
bagged salads production could be a small compone nt of a large vegetable growing farm.  FDA 
has previously used both number of employees an d annual sales as criteria for defining small and 
very small businesses, e.g., in 21 CFR 120.1(b)(1) a nd (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 busin ess 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 facil ity.  We are proposing to establish the same 
definition for small business as that which ha s been established by the U.S. Small Business 
Administration under 13 CFR 121 for mo st food manufacturers.  This is also the same definition 201 
 
  for small business as we used to define a sm all business in our juice HACCP regulation (§ 
120.1(b)(1)).  The definition of sma ll business is relevant to two pr ovisions in the proposed rule.  
It would affect which facilities qualify for th e 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 activit ies subject to section 418 of th e FD&C Act are the specific low-
risk activity/food combinati ons listed in those secti ons. 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 fac ility 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 th e definition of a small busine ss and only conducts specific 
manufacturing/processing activity /food combinations would be eligible for an exemption from 
subpart C.  Based on the Food Processing Sect or 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 woul d be co-located on farms.  A subset of those 
facilities would qualify for the exem ption from Subpart C based on their 
manufacturing/processing and p acking and holding activities.  
Other Effects.   
Based on the Food Processing Sector Study we  estimate that businesses employing fewer 
than 500 employees produce approximately 18 per cent (based on sales) of all manufactured food 
produced in the United States.  As discussed in se ction VII of this document, the compliance date 202 
 
  for a small business would be 2 years after the da te 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.”  F DA 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 op tions to include in a final rule.  All three 
proposed definitions are informed  by the findings of the Food Pr ocessing 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 propos ing would be appropriate.  We 
also request comment on how a particular dolla r amount of sales would be in keeping with 
Congressional intent - i. e., in light of the provisions in  section 418(l) re garding qualified 
facilities, including the statutory limitati ons on sales to qualified end-users.  
The definition of very small business is releva nt to 3 provisions of the proposed rule. It 
would affect which facilities qu alify for the exemption in § 11 7.5(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 w ould also affect which facilities 
are automatically “qualified” f acilities subject to the modifi ed 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 th e 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 203 
 
  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 bus iness 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 requiremen ts in proposed § 117.201. The first, limited annual 
monetary value of sales, is based on fixed cr iteria set out in FSMA § 418(l)(1)(C).  The second, 
as provided by § 418(l)(1)(B), is to be a very sm all business as defined by FDA.  Therefore, we 
discuss the affect of the proposed definitions fo r very small business in relation to the existing 
requirements for qualified f acilities in § 418(l)(1)(C). 
Less than $250,000 in Total Annual Sales - E ffect on proposed § 117.5(g) and proposed § 
117.5(h) .   
One possible definition of the term “very sm all business,” for the purposes of proposed 
part 117, would be a business that has less than $250,000 in total annual sale s of foods, adjusted 
for inflation (Option 1 of the co-proposal).  From  the Food Processing Sector Study it is apparent 
that the number of co-loc ated facilities is concentrated at th e smaller end of the size spectrum.  
Using data from Dun & Bradstreet, FDA estim ates that 736 facilitie s 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, p acking 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 qua lified facility to end- users other than those 204 
 
  that would satisfy the definition of “qualified en d-users,” except unlike w ith § 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 fac ilities 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 f acilities 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 - E ffect on proposed § 117.5(g) and proposed § 
117.5(h) .   
One possible definition of the term “very sm all business,” for the purposes of proposed 
part 117, would be a business that has less than $500,000 in total annual sale s of foods, adjusted 
for inflation (Option 2 of the co-proposal).  From  the Food Processing Sector Study it is apparent 
that the number of co-loc ated facilities is concentrated at th e smaller end of the size spectrum.  
Using data from Dun & Bradstreet, FDA estim ates that 903 facilitie s 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, pack ing or holding activities.  
Less than $500,000 in Total Annual Sales - Effect on number of qualified facilities
.  
Defining very small business to mean a bus iness that has less than $500,000 in total 
annual sales of foods would add approximately  45,900 domestic facilitie s to the number of 
qualified facilities beyond the approximately 11,500 domestic f acilities that are qualified 205 
 
  facilities under section 418(l)(1)(C) of th e FD&C Act, leading to a total of 57,400 domestic 
qualified facilities.  These 57,400 domestic qualified facilities w ould have a 3 year compliance 
date. As a group, businesses with less than $500,0 00 in total annual sales of foods produce less 
than one percent of all food pr oduced 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 sm all business,” for the purposes of proposed 
part 117, would be a business that has less th an $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 co-located 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 w ould then qualify for the exempti on from Subpart C based on their 
manufacturing/processing, p acking 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 sma ll 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 qualif ied facilities under sec tion 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, busin esses 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. 206 
 
  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 Applicab le to a Qualified Facility   
Section 418(l) of the FD&C Act establis hes 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 fac ility (proposed § 117.201).  We also define the 
term “qualified facility” in propos ed § 117.3 (see the discussion of de finitions in section X.B.4 of 
this document).  Section 418(l)(2 )(A) of the FD&C Act provides th at 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 provision s of this proposed rule , section 418(l)(2)(A) of 
the FD&C Act provides that a qualified fac ility would be exempt from the proposed 
requirements of subpart C.  Importantly, secti on 418(l)(3) of the FD&C Act provides that the 
Secretary of HHS may withdraw  the exemption provided in s ection 418(l)(2)(A) under certain 
circumstances.  We discuss the withdrawal pr ovisions of section 418( l)(3), and our proposed 
provisions to implement section 418(l )(3) (proposed subpart E), in se ction 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 regulati on the reach of the 
provision.  Proposed § 117.5(a) would provide that  subpart C would not apply to a qualified 
facility, except as provided by subpart E (i.e., except as provided by the proposed provisions for 
withdrawal), and that qualified facilitie s are subject to the modifi ed requirements in § 117.201. 207 
 
  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 Contro l 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 co mply with, and is in compliance 
with, “[t]he Juice Hazard Anal ysis Critical Control Points Program….”  (We interpret “Juice 
Hazard Analysis Critical Contro l Points Program” to mean the requirements of part 120 for 
juice.) 
The purpose of sections 418(j)(1)(A) and (B) appears clear--to ex clude food covered by 
and in compliance with current HACCP requireme nts (parts 120 and 123) from section 418 of 
the FD&C Act.  The exclusion likely reflects a de termination that the similarity of the existing 
HACCP requirements in parts 120 and 123 to the pr eventive control requir ements 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 th e 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 re quired 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,” esta blishments, or plants.  Rather , they apply to the specified 
foods (juice and fish and fishery products, respec tively) and to persons defined as “processors” 
who conduct certain activities i nvolving those foods.  See, e. g., § 120.1 (“The requirements of 208 
 
  this part shall apply to any juice…”), § 120.3(k) (definition of “Processor”), § 123.3(l) 
(definition of “Processor”), and § 123.6(b) (“The pur pose 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) an d (B) under what circumstances a jui ce or seafood processor is required 
to comply with parts 120 or 123 “w ith respect to [a] fac ility,” especially when such a person also 
conducts activities invol ving other foods not subject to part s 120 or 123 at the same facility.  
Because of this ambiguity, FDA consid ered 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 th e facility is required to comply  with and is in compliance with 
part 123 or 120 with respect to any activities in the facility.  Under th is 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, ope rator, or agent in char ge 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 ex ample, if a facility pr ocesses 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 he ld 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 appear s consistent with the purpose of section 418(j)(1)(B) because 
the juice is already subject to the HACCP require ments in part 120.  The resulting exclusion for 
dairy products, however, does not serve the purpose of the exclus ion because the dairy products 
are not subject to the HACCP requirements in pa rts 120 or 123.  Further, the exclusion of food 209 
 
  not subject to part 120 or 123 (e.g., dairy product s) 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 pat hogens 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.  Fi nally, there is no apparent reason to regulate the same type of 
food not subject to part 120 or  123 (e.g., dairy products) differe ntly 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.  Ther efore, we tentatively conclude 
that this interpretation results in an exclusion that is too broad. 
Second, we could interpret secti ons 418(j)(1)(A) and (B) to exem pt an entire facility from 
section 418 only if the owner, operato r, 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, juic e 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 f ood 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 b ecause the facility manufacturers,  processes, packs, or holds 
food not subject to part 120 or 123.  The resu lting application of s ection 418 to the dairy 
products in the example is a logical outcome--t he dairy products are no t subject to any other 
preventive control-type requireme nts.  Further, the coverage ga p created by the first possible 
interpretation is avoided.  The application of section 418 to the ju ice in the example, however, is 
problematic.  The juice is subjec t to part 120, thus application of  section 418 to the juice would 210 
 
  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 tentativ ely conclude that this interpretation results in 
an exclusion that is too narrow. 
Finally, we considered a third interpretati on.  We could interpre t sections 418(j)(1)(A) 
and (B) of the FD&C Act to exempt  those activities of a facility that are subj ect 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 interpreta tion is neither too broa d (because it does not 
exclude food that is not subject to part 120 or 12 3) nor is it too narrow (b ecause 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 th is proposed rule.  We request comment on our 
interpretation of secti ons 418(j)(1)(A) and (B). 
We tentatively conclude that we should in clude the exemptions provided in sections 
418(j)(1)(A) and (B) of the FD&C Ac t in the proposed rule to es tablish 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 (F ish and Fishery Products) 
at a facility if the owner, operato r, or agent in charge of the faci lity is required to comply with, 
and is in compliance with, part 123 with resp ect 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 211 
 
  owner, operator, or agent in charge of the fac ility 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 fac ility as a whole.  For 
example, a facility producing juice and dairy be verages would be exempt only with respect to 
juices subject to, and in compliance, with part 12 0.  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 owne r, operator, or agent in charge of  such facility is required to 
comply with, and is in complia nce 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 regulati ons).  FDA considers the language of section 
418(j)(1)(C) of the FD&C Act to be  ambiguous with regard to app lication of the exemption.  As 
discussed with regard to sections 418(j)( 1)(A) and (B) above, th e 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 be ing required to comply with, an d being in compliance with, part 212 
 
  113 “with respect to such facility[.]”  Howe ver, part 113 does not apply to “facilities,” 
establishments, or plants.  Rath er, it applies to the specified f oods (low-acid canned foods) and to 
persons defined as “commercial processors” who conduct certain activ ities involving those 
foods.  See, e.g., § 113.3(d) (def inition of “Commercial proce ssor”), and section 404 of the 
FD&C Act (21 U.S.C. 344), which provides FDA w ith legal authority to issue part 113 (“[The 
Secretary] shall promulgate regul ations providing for the issuance, to manufacturers, processors, 
or packers of such class of food [presenting specif ic risks defined in the section] in such locality 
of permits to which shall be at tached 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 pr ocessor 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 pa rt 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 se ction 418(j)(1)(C) in the 
same manner as we interpreted sections 418(j)(1)(A ) and (B) – i.e., to exem pt those activities of 
a facility that are subj ect to part 113, and only those activitie s.  Such an interpretation would 
fulfill the apparent goal of the exemption wit hout being too narrow or too broad.  We also 
tentatively conclude that we s hould include the exemption provide d 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 pr ovide that Subpart C would not apply with 
respect to activities that are s ubject to part 113 (Thermally Pro cessed Low-Acid Foods Packaged 
in Hermetically Sealed Containers) at a facility if the owner, opera tor, or agent in charge of the 213 
 
  facility is required to comply with, and is in compliance w ith, part 113 with respect to such 
activities.  For example, a facility produci ng 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.  Consis tent 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 respec t to the microbiological hazards that are 
regulated under part 113.  A facility that is requi red 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) a nd 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 Manuf actures, Processes, 
Packs, or Holds a Dietary Supplement   
Section 103(g) of FSMA provide s that “[n]othing in the amendments made by [section 
103 of FSMA] shall apply to any fa cility with regard to the ma nufacturing, processing, packing, 
or holding of a dietary supplemen t 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 214 
 
  FD&C Act authorizes FDA to issue regulations  to require good manuf acturing practices for 
dietary supplements.  FDA has issued such a re gulation at part 111 (21 CFR 111) (Current Good 
Manufacturing Practice in Manufacturing, Packag ing, 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 se ction 761 (Ref. 130).  
We interpret section 103(g) of FSMA in a manner analogous to our 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 establis h in subpart C of proposed part 
117.  We interpret the referen ce in section 103(g) of FSMA to “compliance with section 
402(g)(2)” to mean compliance w ith part 111 (i.e., the regulation authorized by section 402(g)(2) 
of the FD&C Act).  We tentativ ely conclude that Congressional intent regarding the reach of 
section 103(g) of FSMA is unambiguous in that  section 103(g) of FSM A 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, packi ng, 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 dietar y 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.   215 
 
  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 th at 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 regul ation “science-based 
minimum standards for the safe production a nd harvesting of those types of fruits and 
vegetables, including specific mixes or categor ies of fruits and vegetables, that are raw 
agricultural commodities for which [FDA] has determ ined 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 ar e 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 ac tivities) that 
triggers the section 415 registrati on requirement (“farm mixed-type facilities”), but only with 
respect to their activities that are within the farm definition and ther efore do not trigger the 
registration requirement.  See section VIII.E of this document for a discussion of our proposed 
revisions and additions to the defini tions in current §§ 1.227(b) and 1.328.  
Establishments that are exempt from regi stration under section 415 of the FD&C Act as 
“farms” would not be subject to section 418 of the FD&C Act when  conducting acti vities 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 re garding the reach of sec tion 418(k) of the FD&C 216 
 
  Act is unambiguous in that section 418(k) dire ctly limits the exemption to activities of the 
facility that are subject to sect ion 419 of the FD&C Act.  We al so 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 exem ption.  Proposed § 117.5(f) would provide that 
Subpart C would not apply to activities of a facili ty 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 th e requirements of proposed subpart C for certain 
on-farm, low-risk manufacturing, processing, packi ng or holding activities by a small or very 
small business. 6. Proposed § 117.5(g) and (h)--Exemption App licable to Certain On-farm 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) ac tivities 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 implementa tion of such section 415 [of the FD&C Act] 
and clarify the activities that ar e included as part of the defini tion of the term “facility” under 
such section 415.”  In section VIII of this documen t, we discuss clarifications of certain on-farm 
activities and whether they trigger the section 41 5 registration requirement in order to enhance 217 
 
  the implementation of section 415 by clarifying the treatment of various ac tivities for purposes of 
section 415, including activitie s 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, rais ed, or consumed on such farm or another farm 
under the same ownership, as such packing and holdi ng relates to specific f oods; and (ii) specific 
on-farm manufacturing and processing activities as such activities rela te 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 w ith the requirements of section 103(c)(1)(C) of 
FSMA we have conducted a qualitative risk asse ssment 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 th at, in promulgating th e regulations under 
Section 103(c)(1)(A), “the Secretary shall consider the results of the scienc e-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 insp ection 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 facilitie s are engaged only in specific types of on-farm manufacturing, 
processing, packing, or holding activ ities that the Secretary determ ines 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 218 
 
  Act]… if applicable, and shall apply only to small businesses a nd very small businesses, as 
defined in the regulation promulgated unde r section 418(n) of the [FD&C Act].”  
b. FDA’s interpretation of sec tion 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 requiremen t “if such facilities 
are engaged only in specific types of on-fa rm manufacturing, processing, packing, or holding 
activities that the Secretary dete rmines 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 fa cility from, or modify the requirements of, 
section 418 of the FD&C Act under this authority if th e facility only conduc ts 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 onl y in” the identif ied activities 
involving the identified foods.  This interpreta tion seems both protective of public health and 
consistent with the preventive purpose of sec tion 418 of the FD&C Act.  This interpretation 
would mean that a facility w ould be required to conduct a haza rd analysis and establish and 
implement risk-based preventive controls for a ll activities conducted on a ll foods (including low-
risk activity/food combinati ons) if a facility conducts a singl e activity subject to section 418 of 
the FD&C Act that is not a lo w-risk activity/food combination, unl ess 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 se ction 418 of the FD&C Act that  the business conducts are the 219 
 
  following low-risk packing or holding activity/food combinations on food not grown, raised, or 
consumed on that farm mixed-type facility or an other farm or farm mixed-type facility under the 
same ownership - i.e., packing or re-packing (i ncluding weighing or conv eying incidental to 
packing or re-packing); sorting, cu lling, or grading incidental to packing or stori ng; 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 pur poses 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 holdi ng activity/food combin ations 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 220 
 
  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 s ection 103(c)(1)(C) of FSMA and the proposed §§ 
117.5(g) and (h) exemptions in order to accu rately 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 we ll as differences in risk across  those activity/food combinations. 
d. Proposed § 117.5(h)--Exemptions for on-fa rm 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 ac tivities conducted by a small or very small 
business if the only manufacturing/processing activ ities subject to secti on 418 of the FD&C Act 
that the business conducts are the following: 
(1) When conducted on a farm mixed-type faci lity’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 fa rm/farm mixed-type facility under the same 
ownership) for distribution into commerce: 
(i) Artificial ripening of intact fruits and vegetables;  (ii) Boiling/evaporation of mapl e sap to make maple syrup;  
(iii) Chopping peanuts and tree nuts;  (iv) Coating (with coatin gs other than wax, oil, or resin us ed 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);  221 
 
  (v) Drying/dehydrating intact fruits and vegetables (without  the addition of sulfites) 
where the drying creates a distinct co mmodity (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 preserve s from acid foods (e.g., acid fruits);  
(ix) Making sugar from suga r 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 othe r 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 a nd vegetables using cold air; 
(v) Drying/dehydrating (wheth er for storage/transport or  for creating a distinct 
commodity) intact fruits and vegetables (without sulfiting), cocoa beans, coffee beans, grains and grain products, and p eanuts 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 pea nuts and tree nuts (e.g., making ground peanuts); 222 
 
  (ix) Labeling (including stickering) hard  candy, cocoa beans, cocoa products from 
roasted cocoa beans (other than milk chocolate)co ffee beans, intact fruits and vegetables, grain 
and grain products (other than t hose containing wheat in a form th at 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 beet s, 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 preserve s from acid foods (e.g., acid fruits); 
(xiv) Making maple syrup; (xv) Making soft dri nks and carbonated water; 
(xvi) Making sugar from s ugar beets and sugarcane; 
(xvii) Mixing cocoa beans, coffee beans, in tact fruits and vegetables, grain and grain 
products, honey, maple sap and maple syrup, and peanuts and tree nuts; 
(xviii) Packaging hard candy, fudge, taffy, to ffee; 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 pres erves; and maple syrup; peanuts and tree nuts 
(including modified atmosphere or vacuum packaging); soft dr inks 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;  223 
 
  (xxi) Sifting grains and grain products; 
 (xxii) Sorting, culling and grading (other th an when incidental to packing or storage) 
hard candy, fudge, taffy, and toffee; cocoa beans; co coa products; coffee beans; intact fruits and 
vegetables; grain and grain products;  honey; ja ms, jellies, and preserves; maple sap; maple 
syrup; peanuts and tree nuts; soft drinks and car bonated water; and sugar beets, sugarcane, and 
sugar; 
(xxiii) Treating cocoa beans, coffee beans, in tact fruits and vegeta bles, 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 th e purpose of storage or transportation) intact 
fruits and vegetables. 
The low-risk on-farm manufacturing/proces sing activity/food combin ations 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 Re lated 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) unde r the Federal Alcohol 
Administration Act (27 U.S.C. 201 et  seq.) or chapter 51 of subtit le E of the Internal Revenue 
Code of 1986 (26 U.S.C. 5001 et seq.) is require d 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 regi ster as a facility because such facility is 
engaged in manufacturing, proces sing, packing, or holding 1 or mo re alcoholic beverages, with 224 
 
  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 sec tion 116(a) of FSMA 
“shall not apply to a facility engaged in th e receipt and distributi on of any non-alcohol food, 
except that [section 116(a) of FSMA] shall apply to a facility describe d in [section 116(a) of 
FSMA] that receives and dist ributes non-alcohol food, provided such food is received and 
distributed- (1) in a prepackaged form that prev ents any direct human contact with such food; 
and (2) in amounts that constitute not more than 5 percent of the overall sale s 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 FSM A], [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 alc oholic beverages are requi red to obtain what is 
technically called a “permit” from the Secretar y of the Treasury (“Trea sury”) 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 busine ss.  As examples, distilled spirits plants 
require a Federal Alcohol Administration Act (F AA 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 225 
 
  obtain approval of an applica tion under the IRC (26 U.S.C. 5 351 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 diffe rently for the purposes of section 116 of FSMA, 
FDA tentatively concludes that the phrase “obtain a permit or re gister” is ambiguous and should 
be interpreted broadly, to  include not only faciliti es 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 obta ining approval of a notice or 
application from the Secretary of the Treasur y as a condition of doing business in the United 
States under the relevant statut es 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 facilitie s described in FSMA section 116(a)(1) are 
located in the United States (including Puerto Ri co under the FAA Act).  In  isolation, therefore, 
section 116(a)(1) of FSMA appears to operate to ex empt 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 th e FD&C Act if they me t 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 226 
 
  FD&C Act and FSMA generally; and raises concerns related to U.S. trade obligations, for 
example, those found in the World Trade Orga nization Agreements.  See, e.g., The General 
Agreement on Tariffs and Trade 1994, (GATT 1994) Ar t. III(4) (“The products of the territory of 
any contracting party imported into  the territory of any other cont racting party shall be accorded 
treatment no less favorable than th at accorded to like products of na tional origin in respect of all 
laws, regulations and requirements affecti ng their internal sale….”); Agreement on the 
Application of Sanitary and Phyt osanitary Measures, (SPS Agreemen t), 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 prev ail, including between 
their own territory and that of  other Members.”).  Importantl y, 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 s ection 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 alcohol ic beverages.  There are multiple possible 
interpretations of this provision.  For example,  section 116 of FSMA coul d 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 inappl icable 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 secti on 116(a)(1) to refer not only to 
domestic firms, but also to foreign firms in orde r to be consistent with  the risk-based public 
health principles underlying section 418 of th e FD&C Act and FSMA ge nerally, and to avoid 227 
 
  any inconsistency with treaties or international ag reements 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, registra tion, or approval from Tr easury under the relevant 
statutes, but also to foreign fac ilities of a type that would requir e 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 alc oholic 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 “non-alcohol food” in th e 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 di stribution of any non-alcohol f ood,” except when the non-alcohol 
food is “received and distributed -- (1) in a prepackaged form th at prevents any direct human 
contact with such food; and (2) in amounts that constitute not mo re than 5 percent of the overall 
sales of such facility, as determined  by the Secretary of the Treasury.”   
In order to interpret the applic ation of section 116 to food ot her 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 ph rase refers to food that is completely enclosed in packaging 
during the entire time it is under the facility’s direct control, su ch that direct human contact with 
such food is prevented.  Under this interpretatio n, facilities that conduc t activities using such 
packaged food without opening the packaging afte r receiving the food and before distributing it 
are receiving and distributing food in prepackaged form that prevents any direct human contact 228 
 
  with such food.  For example, a winery that as sembles gift baskets containing bottles of its own 
wine and prepackaged boxes of crackers purch ased from a supplier, without opening the boxes 
of crackers, would be receivi ng and distributing the food othe r than alcoholic beverages 
(crackers) in prepackaged form that prevents  direct human contact with such food.     
Considering this interpretation and the fact that alcohol-relat ed 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 distribut e any food other than alcoholic 
beverages would be entirely ineligible for the ex emption, and therefore who lly 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 distribut es spent grain as animal feed, the entire brewery and all of its 
activities, including the manuf acturing, processing, packing, a nd 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, wh ether the facil ity’s manufactur ing, processing, 
packing, or holding of alcohol w ould be subject to section 418 of the FD&C Act would depend 
on the facility’s activitie s relating to food other th an alcoholic beverages. 
When considering the provision as a whole and in its statutory context, FDA tentatively 
concludes that another interpreta tion is more reasonable.  The ag ency understands section 116 of 
FSMA, in general, to indicate that the ma nufacturing, processing, packing, or holding of 
alcoholic beverages at most alc ohol-related facilities should not be  subject to section 418 of the 229 
 
  FD&C Act.  FDA understands section 116(b) of FSMA to indicate that the receipt and 
distribution of food other than alcoholic beve rages, including any ma nufacturing, processing, 
packing, or holding of such food o ccurring at the facility  between receipt and distribution, should 
be subject to section 418 of th e 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.  Ac tivities related to food other than alcoholic 
beverages (including the receiv ing, manufacturing, processing, p acking, holding, and distributing 
of such foods) would be subject to section 418 of the FD&C Act ev en if those activities occur at 
facilities that are otherwise with in the scope of 116(a) (unless th ey 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 bevera ge distillery also makes non-al coholic beverages, under this 
interpretation the alcoholic beve rage distilling activi ties would be exempt from section 418 of 
the FD&C Act, but the activities related to non-alcoholic beverage s would be subject to section 
418 (assuming the non-alcoholic beverages are not in  prepackaged form and constitute less than 
5 percent of the facil ity’s overall sales) unl ess they 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 FSM A], [section 116 of FSMA] shall 
not be construed to exempt any food, other than alcoholic beverage s, . . . from the requirements 
of this Act.”   
When considering the statute as a whol e, including its underlying purpose, this 
interpretation of section 116 also provides a mo re consistent, risk-based approach supported by 230 
 
  public health principles.  FDA c oncludes 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 fr om a public health perspe ctive than other foods. 
Congress may have made such a conclusion in light  of the potential antimic robial function of the 
alcohol content in such bevera ges and the concurrent regulati on of alcoholic beverage-related 
facilities by both FDA and the Alcohol and To bacco 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 im plementing regulations, related to food.  For 
example, manufacturers of alcoholic  beverages are responsible for adhering to the requirements 
of current part 110.  In addition, alcoholic be verages 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 contro ls of alcoholic beverages, including on-site 
inspections and procedures that require the adva nce 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 holdi ng of alcoholic beverages and their joint 
regulation by both FDA and TTB, the current regu latory scheme was sufficient to control the 
hazards associated with the manufacturing, processing, packing, and holding of alcoholic 
beverages.  At the same time, FDA tentatively c oncludes that Congress did not intend to exempt 
manufacturing, processing, packi ng, or holding of food other th an alcoholic beverages from 231 
 
  section 418 except in the very limited circumstan ces set forth in secti on 116(b)(1) and (2) of 
FSMA.   
At times, the manufacturing, processing, packin g, or holding of alc oholic beverages is 
inseparable from the manufacturing, processing, p acking, or holding of food other than alcoholic 
beverages.  For example, a br ewery that sells its spent grai ns 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 th e FD&C Act does not appl y to such inseparable 
activities.  FDA tentatively conc ludes 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 th e 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 separa ted from the beer, but not before that point.  
Proposed § 117.5(i)(1) would provide that subp art C would not apply with respect to 
alcoholic beverages at faciliti es meeting the criteria in pr oposed § 117.5(i)(1)(i) and (ii).  
Proposed § 117.5(i)(2) would provide that subpart C would not appl y with respect to food other 
than alcoholic beverages at faci lities described in proposed § 117.5(i)(1), provided such food is 
in prepackaged form that prevents direct human  contact with the food a nd constitutes not more 
than 5 percent of the overall sales of the facil ity, as determined by the Secretary of the Treasury. 
We tentatively conclude that we should include a provision impl ementing section 116 of 
FSMA in the proposed rule to establish by regul ation the reach of the provision.  We request 
comment on our interpretation of section 116 of FSMA. 232 
 
  8. Proposed § 117.5(j)--Exemption Applicable to F acilities 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 complia nce 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) intende d for further distribution or processing”. 
Proposed § 117.5(j) would exempt f acilities that are solely en gaged 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 gr ains (such as corn, wheat, barle y, 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, provid ed 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 facilitie s solely engaged in the storage of non-fruit or 
vegetable RACs.  In addition, as discussed in sect ion X.C.9 of this document, facilities that are 
solely engaged in the storage of RACs are ex empt from the current CGMP regulation, and FDA 
proposes to maintain this exemption from the CGMPs.  FDA tentativel y 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 fo r further distribution or processing to the 
requirements of subpart C.  Such facilities w ould remain subject to the requirements of the 
FD&C Act.  For example, if storage is done under insanitary conditions  whereby the food may 233 
 
  become contaminated with filth or rendered inju rious 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 engage d 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 cl eaned, 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 re ferred to as the “RAC exemption.”  Current 
§ 110.19(b) states that we will i ssue special regulations if it is  necessary to cover operations 
excluded under current § 110.19(a).  In section VIII. D of this document, we discuss the meaning 
of the term “raw agricu ltural commodity” (RAC). 
FDA is proposing a series of changes to current § 110.19.  As discussed more fully 
below, FDA is proposing to redesignate curre nt § 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 re quirements in proposed part 117 remains 
limited to the current requirements (which presen tly are established in cu rrent part 110, subparts 
B, C, E, and G and would be re-established in proposed part 117, subpart B under this proposed 
rule); and  
• Adjust and clarify what activities fall w ithin this exemption based on experience 
and changes in related areas of the law since issuance of the CGMP regulation.   234 
 
  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 th e definition of “farm,” or the ho lding 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.  Dele ting current § 110.19(b) would have no substantive 
effect, because current § 110.19(b) establishe s 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 remain s 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 fo r 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 pr oposes 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 activi ties related to holding or 
transporting RACs.  
FDA proposes to explicitly appl y this exemption to “farms” within the meaning of that 
term in proposed § 1.227.  In current § 110.19(a), F DA 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 235 
 
  authorities in sections 414 and 415 of the FD&C Act.  As discu ssed in section VIII.C of this 
document, FDA developed a definition of th e term “farm” through notice and comment 
rulemaking implementing those authorities.  Th rough those rulemakings, FDA learned that the 
terms “growing” and “harvesting” were not e nough to capture the sc ope 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 definiti on of “farm” in proposed § 1.227 grow/raise and 
harvest their own RACs, pack and hold thei r 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 curren t farm definition, but FDA concludes that the 
RAC exemption should apply to a ll 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 statutor y adulteration provision for food, section 402 of 
the FD&C Act) are more appropriate to apply to  farms and their activit ies 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 Inves tigations” (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 110 or r ecommendations 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 th e FD&C Act, so they are not covered by any of proposed part 236 
 
  117.  Activities within the farm definition are addressed by the adulteration provisions of the 
FD&C Act and the requirements in part 118 for eg g producers (as applicable ), and will also be 
addressed (as applicable) in the proposed rule to establish produ ce safety standards under section 
419 of the FD&C Act.   
FDA also proposes to exclude ac tivities of farm mixed-type fa cilities 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 facilit y.”  FDA tentatively concludes 
that the portion of a farm mixed-t ype facility that is within the farm definition should be treated 
the same for the purposes of subpart B as are the same activities on fa rms that only conduct 
activities within the farm definition.  FDA also proposes to exclude activities related to holding 
or transporting RACs, whether or not such act ivities are performed on farms.  The term 
“holding” would have the same meaning here as in the revisions we ar e proposing to current § 
1.227(b)(5).  Current § 110.19(a) uses the term “s torage” to describe these activities.  In 
proposed § 1.227, “holding” is define d as “storage of food” for es tablishments other than farms 
and farm mixed-type facilities.  The term “trans portation” 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 ve hicle 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 w ould be entirely exempted by thes e 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 237 
 
  the establishments that are exempted from subpart  B by this proposed provision are also likely to 
be exempt from subpart C or subject to modi fied requirements under section 418 of the FD&C 
Act, either because they do not have to regi ster 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 propose d § 117.7, exemption for small or very small 
businesses performing only on-farm low-risk  activity/food combinations under 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 re quirements 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 recomme nded that the agency request further comments on the 
appropriate application of CG MP controls to raw agricultu ral product harv esting, packing, 
storage and distribution (Ref. 1) .  These concerns were based on investigations of outbreaks 
linked to fresh produce that had “identified cont amination during production and harvest, initial 
processing and packing, distri bution, 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 sa nitation practices at 
establishments that pack RACs.  Packing of RA Cs has been implicated as a likely source of 238 
 
  contamination in multi-state foodborne illness outb reaks 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 addr essed, 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 a dulteration provisions in the FD &C Act, the requirements of 
part 118 for egg producers (as appl icable), and the proposed rule to establish produce safety 
standards (as applicable) under se ction 419 of the FD&C Act.  F DA 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.  Manuf acturing/processing steps conduc ted 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, incl uding when such activities are performed on 
RACs.  This includes manufacturing/processing step s that may occur at establishments that are 
commonly known as “packinghouses,” such as wash ing and treating fruits  and vegetables.  
“Distribution” is a term that  might include activities such as transportation and packing 
(including re-packing).  For clar ity, we now discuss those two st eps separately.  Transportation 
of non-RACs is subject to the CGMP requireme nts 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) a nd section 416 of the FD&C Act (75 FR 22713, 
April 30, 2010).  Section 416(b) of the FD&C Ac t requires FDA to promulgate regulations to 
“require shippers, carrie rs by motor vehicle or rail vehicle, receivers, and othe r persons engaged 239 
 
  in the transportation of food to use sanitary transportation pr actices prescribed by the Secretary 
to ensure that food is not tran sported under conditions that may re nder 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 no t being sufficiently addressed, either through 
application of the CGMP requirements or in anot her way.  Therefore, FDA tentatively concludes 
that packing of RACs that does not fall within the farm definition shou ld be subject to the 
requirements in proposed subpart B.  We reque st 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 exem pt establishments that conduct any activities 
relating to food for human consumption other than th e specifically identified  activities for RACs.  
FDA tentatively concludes that it would be reasona ble to revise the exemp tion so that it would 
exempt the specifically identified activities when  performed on RACs, regardless of whether the 
establishment that conducts thos e activities also conducts other ac tivities that do not qualify for 
the exemption.  This is because, as in the sec tion 418(j)(1) exemptions discussed in sections 
X.C.2 and X.C.3 of this document (for activitie s covered by parts 120, 123, and 113), it is more 
appropriate to subject these activ ities to controls other than th ose in proposed subpart B, and 
these activities should be regulated in the same way whether or not othe r 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 activi ties should provide the necessary pr otection for food subject to those 240 
 
  activities regardless of whether RACs are also st ored 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 th at it applies to RACs, 
not only some RACs depending on whethe r they receive later manipulation.  
D. Proposed § 117. 7--Applicability of Part 117  to a Facility Solely Enga ged 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 faci lities that are solely engaged in ... th e 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 coal ition of the American Bakers Association, 
the American Frozen Food Institute, the Groc ery Manufacturers Associat ion, the International 
Bottled Water Association, the International Dairy Foods Association, the International 
Warehouse Logistics Association, the Peanut an d Tree Nut Processors Association, and the 
Snack Food Association (the sect ion 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 or modify the requirements for 241 
 
  compliance under section 418 [of the FD&C Act] fo r facilities that are solely engaged in the 
storage of packaged foods that are not exposed to  the environment, by allo wing 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 ar e 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 si gnatories to the petition and ar e supportive of the request to 
exempt such facilities from the provisions of sec tion 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 c ontact 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 facilitie s solely engaged in the 
storage of unexposed packaged foods and that th e foods handled in thes e facilities would have 
already been subjected to hazard analyses and preventive controls (including CGMPs) 
throughout the process of their manufacture and p ackaging for delivery to retailers and end-
users.  They further state that most of the preventive control activiti es carried out in food 
production settings (such as sanita tion of food-contact surfaces a nd utensils) offer no benefit for 
a facility storing unexposed packaged foods and th at 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 242 
 
  governing warehousing and distributi on [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 attrib utable 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, wa rehouse operators work closely with the food 
manufacturers to understand the conditions and contro ls 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 rele vant information that would be necessary for 
them to conduct a hazard analysis, develop prev entive 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 distribut ion parameters and considerations  into the hazard analysis and 
appropriately instructs the warehouses to ensu re unexposed packaged foods are being properly 
stored.  The section 418(m) petitioners thus assert th at 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 F DA use the following language as part of its 
regulations implementing section 41 8 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 require ments of section 418 of the Federal Food, Drug, 
and Cosmetic Act if the facility complies with the requirements set forth at 21 C.F.R. § 110.93.”  243 
 
  FDA notes that petitioners also make argumen ts for their position relevant to “hazards 
that may be intentionally  introduced, including by acts of terrorism,” as de scribed 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 Resp onse 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 appropri ate for facilities solely engaged in the storage 
of unexposed packaged food to be exempt from the requirements that wo uld 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 tentativel y conclude that unexposed packaged food that 
requires time/temperature control for safety coul d be subject to modifi ed 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 preven tive 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 formati on by, microorganisms of public health significance 
when an unexposed refrigerated packaged food requires time/temperature control for safety.  
Information about this hazard and appropriate pr eventive 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/te mperature control for safety to  limit pathogenic microorganism 
growth or toxin formation (Ref. 137).  Earlie r editions (e.g., the 2001 Food Code) included a 244 
 
  similar definition for “potentially hazardous f ood”; since 2005, the defin ition jointly refers to 
“potentially hazardous food” and “time/temperatur e 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-b ased 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 fa cility 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.  Howe ver, we tentatively conclude that proposed § 
117.93, along with other app licable provisions of proposed part  117, subpart B, such as pest 
control in proposed § 117.35, do adequately address mo st 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, s ubpart B justifies the exemption from all 
preventive control requirements sought by the pe titioners in the speci fic case of unexposed 
refrigerated packaged food that requires time /temperature control for safety (hereinafter 
unexposed refrigerated packaged TCS food).  As di scussed more fully in section XIII.B of this 
document, such food requires the implementa tion 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 implemente d, and establishing and 245 
 
  maintaining records documenti ng the monitoring, corrective actio ns, and verification.  FDA 
tentatively concludes that it is appropriate for our response to th e petition to distinguish between 
packaged food that requires such time/temperatur e control and packaged food that does not.   
We also disagree that an exemption provide d under section 418(m)  of the FD&C Act 
should be established in a manner that has the po tential to be interpre ted more broadly than 
section 418(m) provides.  The section 418(m) petit ioners request that we  establish a provision 
that “A facility that is enga ged solely in the storage, holdi ng, warehousing, or distribution of 
packaged foods that are not exposed to the envi ronment 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 faciliti es 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 fac ilities would include, relevant to unexposed packaged food, 
warehouses and cold storage facilitie s.  To the extent that a facil ity that is engaged solely in 
“warehousing” or “distribution” of unexposed packaged food is merely “storing” or “holding” 
the food, an exemption established using the la nguage 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 provi ded 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 requir ements at such faciliti es to require that the 
owner, operator, or agent in charge of such a facility comply with modified requirements for any 246 
 
  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 re quirements would mandate that such a facility 
establish and implement appropriate temperature c ontrols, monitor the temperature controls, take 
corrective actions, verify that the temperatur e controls are consistently implemented, and 
establish and maintain records documenting the monitoring, corrective ac tions, and verification 
activities for unexposed refrigerated packaged TCS food.  These modified requirements would 
be a subset of the proposed requirements that  would be establishe d in subpart C.   
There are limited routes of contamination fo r unexposed packaged food in a facility that 
solely stores unexposed packaged food (e.g., pack aged food in containers in a warehouse).  
Contamination can occur, for example, if rodent s gnaw through packages or if human waste from 
an improperly maintained toilet facility spills and s eeps 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 st orage 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 247 
 
  hazard analysis and risk-based preventive controls that would be established in proposed subpart 
C.  The exception would be for the rare circum stance 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 cont inue to be exempt from CGMPs.  Such an 
establishment is now, and would c ontinue to be, subject to secti on 402(a)(4) of the FD&C Act.  
An establishment that is solely engaged in the st orage of packaged RACs that are not exposed to 
the environment may find the provisions of pro posed subpart B helpful in ensuring compliance 
with section 402(a)(4) of the FD&C Act. 
Many of the requirements that would be es tablished in proposed subpart C would be 
directed to manufacturing, pro cessing, and packing food and would not apply to the storage of 
unexposed packaged food that does not require time/temperature cont rol for safety.  This is the 
case for: 
• Process controls (proposed § 117.135(d)(1)); 
• Food allergen controls (proposed § 117.135(d)(2)); 
• Sanitation controls (p roposed § 117.135(d)(3));  
• Monitoring of process contro ls, food allergen controls , and sanitation controls 
(proposed § 117.140);  
• Corrective actions (proposed § 117.145);  
• Verification (including initi al validation) of proce ss controls (proposed § 
117.150); and 
• A recall plan (proposed § 117.137) (recalls generally are initiated by the 
manufacturer, processor, or  packer of the food).   248 
 
  FDA tentatively concludes that the outcome of  a hazard analysis for storage of unexposed 
packaged food that does not requ ire time/temperature control for safety is that there are no 
hazards reasonably likely to occur.  We also tent atively 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 preven tive controls, with co rresponding monitoring, 
corrective actions, or verification (including va lidation), because there would be no hazards 
reasonably likely to occur to tri gger such 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 anal ysis (proposed § 117.130(a)(3)); 
validating the preventive c ontrols (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 rean alysis of the food safety plan (proposed § 
117.150(e)(1)(iv)), because th e facility would not need to con duct these activities.  Thus, with 
the exception of the unexposed refr igerated packaged TCS food, we tentatively conclude that the 
food safety system that would be established in proposed subpart C is not need ed to significantly 
minimize or prevent the occurrence of hazards th at 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 w ould be established in proposed § 117.206.  These 249 
 
  requirements would apply to the storage of une xposed refrigerated packaged TCS food.  We 
explain the basis for those proposed requireme nts in section XIII.B of this document.  
XI. Proposed Revisions to Current Good Manuf acturing Practice Requir ements of Part 110 
(Proposed Part 117, Subpart B)  
A. Proposed Deletion of Gu idance from Current Part 110  
As discussed in section IX.F of this docum ent, FDA is proposing a number of revisions 
to delete some guidance curren tly established in part 110 (e.g ., provisions using “should” or 
“compliance may be achieved by”).  Table 8 identif ies each of the proposed  deletions and either 
explains the deletion or, for dele tions with longer expl anations, 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, processe d, 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 reco mmendation may be 
helpful and could be included in future 
guidance, FDA tentativel y 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. 250 
 
  Current 
Designation of 
Provision That 
Includes Guidance Guidance that FDA is Proposing to 
Delete  Explanation 
§ 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 au tomatic 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 ing redients. 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. 251 
 
  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 un avoidable 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 th ese 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. 252 
 
  Current 
Designation of 
Provision That 
Includes Guidance Guidance that FDA is Proposing to 
Delete  Explanation 
§ 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, processe d, 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, main taining 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, processe d, 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 no te 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) addresse s 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). 253 
 
  Current 
Designation of 
Provision That 
Includes Guidance Guidance that FDA is Proposing to 
Delete  Explanation 
§ 110.80(b)(8) 
(Manufacturing 
operations) Compliance with the requirement 
for effective measu res 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, processe d, 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. 
§ 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 food-contact 
surfaces.   We considered that the cleaning and 
sanitizing of food-contact surfaces would already be addressed in proposed § 
117.35(d), which would require that all 
food-contact 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, processe d, 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 shelf-stable foods used as 
ingredients in another product.  FDA tentatively concludes that this 
recommendation would be more 
appropriate in a guidance document. 254 
 
  Current 
Designation of 
Provision That 
Includes Guidance Guidance that FDA is Proposing to 
Delete  Explanation 
§ 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 su ch 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 approp riate in light of the 
diversity of food operations.  The 
remaining recommenda tions 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 dele ting 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. 255 
 
  Current 
Designation of 
Provision That 
Includes Guidance Guidance that FDA is Proposing to 
Delete  Explanation 
§ 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. 
§ 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 th e 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) 
 
 256 
 
  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.  Tabl e 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 revisi on to address cross-contact), 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 pu rposes” with the phra se “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” w ith 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 unnecessa ry.  In addition, u nder proposed § 117.3 
(Definitions) the term “facilities” would  be ba sed on the definition in section 418(o)(2) of 
the FD&C Act, which is not how the te rm 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 th at 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 co ntact. Contamination of food-
packaging materials could lead  to contamination of the f ood. See section XI.F for the 
proposed requirement.  257 
 
  Current 
Designation Proposed Revision and Explanation 
§ 110.35(c) 
(Pest control) Replace the phrase “processing ar ea” with the phrase “manufact uring, proce ssing, 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 f ood plant” and to take effective measures to exclude pests 
from the plant.  Pests do not belong in an y areas where manufacturin g, 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 “man ufacturing/processing” in light of our 
proposed definition of manufacturing/processi ng (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 reco mmendation 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 s ection XI.G.5 for the proposed provision. 
§ 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 
food-contact 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 requirem ent 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 gr ound 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 activ ities where protection is needed against 
contamination (and against cross-contact) be cause contamination an d 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 cros s-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 “obs erve 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 Cross-Contact  
As discussed in section IX.D  of this document, FDA is proposing a number of revisions 
to address cross-contact. Some of these propos ed revisions would clar ify that an existing 
provision that requires protecti on against contamination also re quires protection against cross-258 
 
  contact.  Table 10 identifies and explains ea ch of these proposed re visions addressing cross-
contact.  Table 10 does not state th e proposed requirement and instead refers to the section of this 
document containing the complete proposed re quirement, 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 th e transfer of food allergens from persons 
working in direct contact with food, food-c ontact surfaces, and food-packaging materials 
to food.  See section XI.E.1 for the proposed requirement. 
§ 110.10(b)(1) 
(Cleanliness) Clarification.  Appropriate us e of outer garments protects ag ainst the transfer of food 
allergens from food to person to food.  S ee section XI.E.1 for th e proposed requirement. 
§ 110.10(b)(9) 
(Cleanliness) Clarification.  Poor hygiene may result in th e transfer of food allergens from persons 
working in direct contact with food, food-c ontact 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 desi gn of a plant can resu lt 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 desi gn of a plant can resu lt 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 f ood-contact surfaces may leave residues of food 
containing allergens on the surfaces and result in the transfer of fo od 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 sa nitation of food-contact surfaces may leave residues of food 
containing allergens on the surfaces and result in the transfer of fo od 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 sa nitation of non-food contact su rfaces may leave residues of 
food containing allergens on the surfaces and result in the tr ansfer of food allergens from 
such surfaces to food-contact surfaces or food.  See sectio n 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.  259 
 
  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 cont act with food.  See section XI.G.6 for the 
proposed requirement. 
§ 110.40(a) (Equipment and 
utensils) Clarification.  Equipment and utensils th at 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 th at 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 cont rols 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 cont rols 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 ingredient s 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 ma terials 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 ma terials 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 improp er identification and holding of raw materials 
and ingredients that are food allergens, and rewo rk that contains food allergens.  Improper 
identification of an allergen-containing raw ma terial, 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 f ood is conveyed unprotected.  See section XI.J.3 for the 
proposed requirement. 260 
 
  Current 
Designation Nature of Proposed Change and Explanation 
§ 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 stor age 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 Cu rrent § 110.10(b)--Cleanliness 
As discussed in section XI.D of this docum ent, 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) w ould require that all 
persons working in direct contact with food, f ood-contact surfaces, and food-packaging materials 
conform to hygienic practices while on duty to th e extent necessary to protect against cross-
contact  and contamination of food (emphasis a dded).  Proposed § 117.10(b)(1) would require 
that the methods for maintaining cleanliness in clude wearing outer garments suitable to the 
operation in a manner that protects against the contamination of food, food-contact surfaces, or 
food-packaging materials, and to prot ect against the cross-contact of foo d (emphasis added).  
Proposed § 117.10(b)(9) would require taking any ot her necessary precautions to protect against 261 
 
  the contamination of food, food-contact su rfaces, or food-packaging materials with 
microorganisms or foreign substances (includi ng perspiration, hair, cosmetics, tobacco, 
chemicals, and medicines applied to the skin ) and to protect against the cross-contact of food 
(emphasis added).   
As discussed in section XI.A of this docum ent, 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 ha ndling, 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 recommen ds that food handlers and supervisors receive 
appropriate training in proper food handling techniques and food- protection principles and 
should be informed of the danger of poor personal hygiene and in sanitary 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 ap propriate training for supervisor s and workers to ensure that 
they have the necessary knowledge and expert ise in food hygiene, food protection, employee 
health and personal hygiene to produce safe food pr oducts.  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 analys is of recalls also indi cates that ineffective 
employee training was a root cause of 32 per cent of CGMP-related r ecalls in the 1999-2003 262 
 
  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 pr eventive controls (see section X.C.4 of this 
document), section 418(o)(3) of the FD&C Act recognizes the im portance of both training and 
CGMPs in preventing hazards from occurring in f oods in its definition of preventive controls, 
which identifies supervisor, manager, and em ployee 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 curr ent § 110.10(c) as proposed § 117.10(c).  In 
addition, as discussed in secti on 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 Worki ng Group with respect to training.   
3. Proposed Revisions to Curre nt § 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 ma ke certain that all 
personnel comply with the CGMP  requirements of proposed subpart B.  As a grammatical 
matter, the word “ensure” more accurately co mmunicates 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 alread y established in part 110  and does not apply to 
the proposed requirements that would be establishe d in proposed part 117, subpart C.  Proposed 263 
 
  § 117.10(d) would now state that  responsibility for ensurin g 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 docum ent, 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 th e plant buildings and 
structures be suitable in size,  construction, and design to faci litate maintenance and sanitary 
operations for food-production purposes (i.e., manufacturing, processing packing, and holding) 
and would require that specifi c construction and design requir ements apply to the “plant ” rather 
than the “plant and faci lities” (emphasis added). 
As discussed in section XI.D of this documen t, FDA also is proposi ng to revise current 
§§ 110.20(b)(2) and (b)(6) to clarify that plants must be constructed a nd designed to protect 
against cross-contact in additi on to protecting against the cont amination of food.  Proposed § 
117.20(b)(2) would require that the plant take pr oper 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 pot ential 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 cross-contact  and contamination are likely to occur, by one or 
more of the following means: lo cation, 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 provi de adequate ve ntilation or 264 
 
  control equipment to minimize odors and vapors (including steam and noxious fumes) in areas 
where they may contaminate food;  and locate and operate fans a nd other air-blowing equipment 
in a manner that minimizes the potential for co ntaminating food, food-packaging materials, and 
food-contact surfaces and for cross-contact  (emphasis added).  Prope r 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 de sign requirements to permit the taking of proper 
precautions to protect food would apply to a ll outdoor bulk vessels (e.g., fermentation vessels, 
silos, vessels, and bins) rather than be limite d to outdoor bulk fermentation vessels.  Outdoor 
bulk vessels containing food lack the basic protection from envir onmental factors provided by a 
building, irrespective of whethe r 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 prot ect food in outdoor bulk vessels by any effective 
means.  A conforming editorial change to cu rrent § 110.20(b)(3)(iv) would revise “skimming the  
fermentation vessels” (emphasis added) to “skimm ing fermentation vessels” to make clear that 
fermentation vessels would now be only one kind of vessel subject to pr oposed § 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 s ubstances.  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 c ondensate from fixtures, ducts and 
pipes does not contaminate food, food-contact surf aces, or food-packaging materials; and that 265 
 
  aisles or working spaces are provided between equipment and walls and are adequately 
unobstructed and of adequate widt h to permit employees to perfor m their duties and to protect 
against contaminating food, food-contact surfaces, or food-packaging materials  with clothing or 
personal contact (emphasis added). 
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 docum ent, FDA is proposing to revise current § 
110.35(a) (General maintenance) to clarify that cl eaning and sanitizing of utensils and equipment 
must be conducted in a manner that protects ag ainst cross-contact of f ood, food-contact surfaces, 
or food packaging materials in addition to pr otecting these items against contamination.  
Proposed § 117.35(a) would require that cleaning and sanitizing of  utensils and equipment be 
conducted in a manner that pr otects against cross-contact  and contamination of food, food-
contact surfaces, or food-packaging 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 comp ounds 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 cl eaning and sanitizing procedures  must be free from undesirable 
microorganisms and must be safe  and adequate under the conditi ons of use.  Compliance with 
this requirement must
 be verified by any effective means,  including purchase of these substances 
under a supplier's guarantee or certif ication or examination of thes e substances for contamination 266 
 
  (emphasis added).  FDA considered whether to de lete the examples of mechanisms to achieve 
compliance as nonbinding recommendations, but tentat ively 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 docum ent, FDA is proposing to revise current § 
110.35(b)(2) to remove the recommendation for fo llowing all relevant re gulations promulgated 
by other Federal, State, and local government agen cies 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 ap plicable Federal, State, and local government 
agencies and is outside the scope of proposed part 117.    3. Proposed Revisions to Curre nt § 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 “P ests must not be allo wed 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 ta ken 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 permitte d only under precautions 
and restrictions that will prot ect against the contamination of  food, food-contact surfaces, and 
food-packaging materials” (emphasis added).   267 
 
  4. Proposed Revisions to Cu rrent § 110.35(d)--Sanitation of Food-Contact Surfaces 
FDA is proposing several revisions to curre nt § 110.35(d) (Sanitation of food-contact 
surfaces).  First, FDA is proposing to redesi gnate 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 bel ong in current § 110.35(d), which addresses 
sanitation of food-contact surfaces.  As a confor ming 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/processi ng 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 f ood 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 w ould apply to “manufacturing/pro cessing” rather than only to 
“manufacturing.”  Proposed § 117.35(d)(1) would re quire that food-contact 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 addres s cross-contact and clarify th at sanitation of  food-contact 
surfaces must protect against cr oss-contact of food.  Proposed § 117.35(d) would require that all 
food-contact surfaces, including utensils and food-c ontact surfaces of equipment, be cleaned as 
frequently as necessary to protect against cross-contact  and contamination of food (emphasis 
added).  Proposed § 117.35(d)(2) w ould require in wet processing, wh en cleaning is necessary to 
protect against cross-contact  and the introduction of microorga nisms into food, all food-contact 268 
 
  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 secti on 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 food-packaging 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 cro ss-contact and clarify that single-service 
articles (such as utensils intended for one-tim e use, paper cups, and paper towels) must be 
handled, dispensed, used, and disposed of in a ma nner that protects against cross-contact of food.  
In addition, in section XI.M of this document, we are requesting comment on whether to require, 
rather than recommend, that singl e-service articles (such as utensi ls intended for one-time use, 
paper cups, and paper towels) be stored in appr opriate containers to prevent contamination of 
food, food-contact surfaces, or  food-packaging materials.   Proposed § 117.35(d)(3) would 
provide that single-service articl es (such as utensils intended for one-time use, paper cups, and 
paper towels) should be stored in  appropriate containers and mu st 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  (emphasis added).  
Fifth, FDA is proposing to delete current § 110.35(d)(5), which requi res 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 and sani tizing agents be safe and 
adequate under the conditions of use.   269 
 
  5. Proposed Revisions to Current § 110.35(d)(3 )--Sanitation of Non- Food-Contact 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); sa nitation of non-food-c ontact surfaces) to 
recommend that such cleaning of non-food contact surfaces protect against cross-contact as well 
as against contamination and to recommend that su ch cleaning protect ag ainst contamination of 
food-packaging materials as we ll as protect against contamin ation of food and food-contact 
surfaces.  Proposed § 117.35(e) would recommend th at 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 cr oss-contact and contamination of  food, food-contact surfaces, and 
food-packaging materials. 6. Proposed Revisions to Curre nt § 110.35(e)--Storage and Ha ndling of Cleaned Portable 
Equipment and Utensils  
As discussed in section XI.D of this docum ent, FDA is proposing to revise current § 
110.35(e) (proposed § 117.35(f); storage and ha ndling of cleaned portable equipment and 
utensils) to address cross-contact and to r ecommend storing cleaned and sanitized portable 
equipment with food-contact surf aces and utensils in  a location and manner that protects food-
contact surfaces from cross-contact as well as  from contamination.  Proposed § 117.35(f) would 
recommend that cleaned and sanitized portabl e equipment with food- contact surfaces and 270 
 
  utensils be stored in a location and manner that  protects food-contact su rfaces 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 clean ed 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--Sanita ry Facilities and Controls (Proposed § 117.37)  
1. Proposed Revisions to Curre nt § 110.37(a)--Water Supply 
As discussed in section XI.C of this docum ent, FDA is proposing to revise current § 
110.37(a) so that it is directed to  preventing contamination of food-packaging materials as well 
as food and food-contact substances.  Proposed § 117.37(a) would require that the water supply 
be sufficient for the operations inte nded and be derived from an ad equate source.  Any water that 
contacts food, food-contact surfac es, 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 wh ere required for the proc essing of food, for the 
cleaning of equipment, utensils, and food-pack aging materials, or for employee sanitary 
facilities.  2. Proposed Revisions to Current  § 110.37(d)--Toilet Facilities 
Current § 110.37(d) requires th at each plant provide its empl oyees with adequate, readily 
accessible toilet facilities and provides reco mmendations for how compliance with the 
requirements may be accomplished.  These recommenda tions 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.  271 
 
  We considered whether to revise current § 110.37(d) to require, ra ther than recommend, 
specific provisions for achieving compliance with the requirements for toilet facilities.  In doing 
so, we considered comments received in respons e to proposed bathroom requirements contained 
in the proposed rule to establish CGMP requi rements for dietary supplements (the dietary 
supplement proposed rule; 68 FR 12158 at 12254).  The dietary supplement proposed rule would 
have established - as requirements - provision s 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 bathroom s (72 FR 34752 at 34817).  FDA agreed that it is 
unnecessary to require specific bathroom featur es because firms may be able to achieve 
compliance through means better suited to their oper ations.  The final rule replaced requirements 
for specific bathroom features with more gene ral requirements for providing employees with 
adequate, readily accessible bathrooms, and for ba throoms to be kept clean and not be a potential 
source of contamination to components, dietary s upplements, 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 ma terials as well as food and food-contact 
substances.  Proposed § 117.37(d) would maintain the current requirement that each plant 
provide its employees with adequa te, readily accessible toilet fac ilities.  In addition, proposed § 
117.37(d) would require that toilet  facilities be kept clean a nd not be a poten tial source of 
contamination of food, food-contact surf aces, or food-packaging materials.   272 
 
  3. Proposed Revisions to Current § 110.37(e)--Hand-washing Facilities 
Current § 110.37(e) requires th at hand-washing facilities be  adequate and convenient and 
be furnished with running water at a suitabl e temperature and provi des recommendations for 
how compliance with the requirements may be accomplished.  These recommendations address issues such as providing ha nd-washing and hand-sanitizing f acilities, hand-cleaning and 
sanitizing preparations, towel service or suitable drying de vices, water control valves, 
appropriate signs and refuse receptacles th at are properly constructed and maintained. 
We considered whether to revise current § 110.37(e) to require, ra ther 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 supplem ent proposed rule (68 FR 12158 at 12254).  The 
dietary supplement proposed rule would have es tablished - 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  given flexibility to design their hand-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 othe r 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 contaminat ion.  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 273 
 
  of components, dietary supplemen ts, or any contact surface, by  providing facilities that are 
adequate, convenient, and furn ish running water at a suitable temperature (§ 111.15(i)).   
We tentatively conclude that establishi ng a performance standard for hand-washing 
facilities similar to the one f ound in § 111.15(i) is a better appro ach than mandating the current 
recommendations in § 110.37(e).  Consistent wi th the discussion in section XI.C of this 
document, the proposed performance standard woul d be directed to prev enting contamination of 
food-packaging materials as well as food and food-contact substances.  Proposed § 117.37(e) 
would require that each plant provide hand-wash ing facilities designed to ensure that an 
employee’s hands are not a source of contamin ation of food, food-cont act 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 § 1 10.37(f)-- Rubbish and Offal Disposal.  
As discussed in section XI.C of this docum ent, FDA is proposing to revise current § 
110.37(f) so that it is directed to  preventing contamination of food-packaging 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 a nd Utensils (Proposed § 117.40)  
FDA is proposing to reorganize the provisi ons found in current § 110.40(a) by creating 
paragraph designations (1) through (6) with asso ciated editorial cha nges. This is a non-
substantive revision to make it easier to see the di stinct requirements.  As  discussed in section 274 
 
  XI.M of this document, FDA also is request ing comment on whether to revise current § 
110.40(a) to require, rather than re commend, 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 documen t, 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-cont act in addition to the contaminatio n 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 cross-cont act.  Proposed § 117.40(a)(5 ) would require that 
food-contact surfaces be maintained to protect food from cross-contact  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 fo od particles, dirt, and organic matter and thus 
minimize the opportunity for growth of microorganisms and cross-contact  (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 au tomatic alarm system to indicate a significant 
temperature change in a manual operation.  Propos ed § 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, temperature-measuring device, or temperature-recording device so installed as to  show the temperature accurately within the 
compartment.   275 
 
  FDA is proposing to revise current § 110.40(f) to require that instruments and controls 
used for measuring, regulating, or recording temp eratures, pH, acidity, wa ter 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 cond itions so that the variation in measurements 
is not statistically significant.  An instrument th at gives widely varying re adings from one use to 
the next cannot be consistently accurate and ther efore cannot ensure product safety over time.  
The proposed requirement for such instruments and controls to be precis e 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 requiremen ts in current § 110.40(f).  Proposed § 117.40(f) 
would require that instruments and controls used for measuring, regul ating, 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 de signated 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 de signations (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 di stinct 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).  276 
 
  As discussed in section XI.D of this document, FDA is proposing to revise two 
provisions to current § 110.80 to clarify that ce rtain practices involving processes and controls 
must protect against cross-contact.  Proposed § 1 17.80(a)(4), in relevant pa rt, would require that 
reasonable precautions be taken to ensure that production procedures do not contribute to cross-
contact  and contamination from any source (em phasis added).  Proposed § 117.80(a)(5) would 
require that chemical, microbial, or extrane ous-material testing pro cedures be used where 
necessary to identify sanitation failures or possible cross-contact  and food contamination 
(emphasis added).   2. Proposed Revisions to Cu rrent § 110.80(a)--Raw Materi als and Other Ingredients 
As discussed in section XI.D of this docum ent, 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 ingredie nts 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 curr ent § 110.80(a)(1) address cross-cont act as well as contamination.  
Proposed § 117.80(b)(1) would require, in relevant pa rt, 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 st ored under conditions that  will protect against 
cross-contact
 and contamination, and minimize deterior ation (emphasis added).  Water may be 
reused for washing, rinsing, or conveying food if it does not increase the le vel of contamination 
of the food or cause cro ss-contact (emphasis added) .  Proposed § 117.80(b)(1) would continue to 
recommend that containers and ca rriers of raw materials should be inspected on receipt to ensure 
that their condition has not c ontributed to cross-contact , contamination, or deterioration of food 
(emphasis added).  As discussed in section XI .M of this document, FDA also is requesting 277 
 
  comment on whether to revise current § 110.80(a)(1 ) to require, rather than recommend, that 
containers and carriers of raw materials be inspec ted on receipt to ensure that their condition has 
not contributed to the cro ss-contact, contamination or deterioration of food.   
Current § 110.80(a)(2) requires th at raw materials a nd other ingredients either not contain 
levels of microorganisms that may produce food pois oning or other disease in humans, or they be 
pasteurized or otherwise treate d during manufacturing operations so  that they no longer contain 
levels that would cause the produc t to be adulterated within the meaning of the act.  FDA is 
proposing to revise current § 110.80(a)(2) by re placing the phrase “may produce food poisoning 
or other disease in humans” with “may render th e food injurious to the health of humans.”  The 
proposed revision would align th e provision with the adulterati on provision in section 402(a)(4) 
of the FD&C Act.  As discussed in section XI .A of this document, F DA 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 ma terials and ingredient s either not contain 
levels of microorganisms that may rende r the food injurious to the health of humans, or they be 
pasteurized or otherwise treate d 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 th at raw materials and other ingredients susceptible to 
contamination with aflatoxin or other natural toxins comply w ith current FDA regulations and 
action levels  for poisonous or deleterious substances be fore these materials or ingredients are 
incorporated into finished food.  An action level for an added poi sonous or deleterious substance 
may be established to define a level of contamination at wh ich 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 th an substantive rules (55 FR 20782, 278 
 
  May 21, 1990).  Because action levels themselves  constitute guidance, revising current § 
110.80(a)(3) to reflect that action levels ar e nonbinding would be duplicative and unnecessary 
and FDA is proposing to delete the current requ irement 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 r ecommendations we include in our  regulations; we continue to 
regard action levels as an important approach to  food safety.  As discu ssed 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).  Pr oposed § 117.80(b)(3) woul d require that raw 
materials and ingredients susceptible to contamin ation with aflatoxin or  other natural toxins 
comply with current Food and Drug Administra tion regulations for poi sonous 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, undesi rable microorganisms, or extraneous material 
comply with applicable FDA regulations and de fect action levels for natural or unavoidable 
defects if a manufacturer wishes to use the mate rials in manufacturing food.  Defect action levels 
are guidance for natural or unavoi dable defects in food for human use that present no health 
hazard (Ref. 141).  FDA establishes maximum leve ls for these defects in foods produced under 
current good manufacturing practi ce and uses these levels in deciding whether to recommend 
regulatory action (Ref. 141).  As di scussed 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 leve ls themselves constitute guidance, revising 
current § 110.80(a)(4) to reflect  that action levels are nonbind ing would be duplicative and 279 
 
  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 regard ing 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 pest s, undesirable microorganisms, or extraneous 
material comply with appli cable Food and Drug Administrati on regulations for natural or 
unavoidable defects if a manuf acturer wishes to use the materials in manufacturing food.  
As discussed in section XI.D of this docum ent, FDA is proposing to revise current § 
110.80(a)(5) to clarify that raw ma terials, ingredients, and rewo rk 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 requi re that raw material s, 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 su ch temperature and relative humidity and in 
such a manner as to prevent the food from beco ming adulterated.  Material scheduled for rework 
must be identified as such.  (Emphasis added.) 
As discussed in section XI.D of this docum ent, FDA is proposing to revise current § 
110.80(a)(7) to clarify that liquid or dry raw materials and ingred ients 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 materi als 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 doc ument, FDA is proposing to establish a new 
requirement in current § 110.80(a) regarding cr oss-contact.  Proposed  § 117.80(b)(8) would 280 
 
  require that raw materials and i ngredients that are food allergens,  and rework that contains food 
allergens, be identified and he ld in a manner that prevents cr oss-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 docum ent, FDA is proposing to revise current § 
110.80(b)(2) by replacing the phras e “manufacturing, including p ackaging and storage” with 
“manufacturing, processing, packi ng 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 potentia l for the growth of microorganisms or for the 
contamination of food (emphasis added).   
Current § 110.80(b)(3) requires th at food that can support the rapid growth of undesirable 
microorganisms, particularly those of public he alth significance, be held in a manner that 
prevents the food from becoming adulterated with in the meaning of the FD&C Act and provides 
recommendations for complying with this requireme nt.  FDA is proposing a se ries of revisions to 
current § 110.80(b)(3).  Speci fically, 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 grow th 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 grow th of microorganisms (R ef. 137) (Ref. 138) (Ref. 
139) (Ref. 140).     281 
 
  • Include the phrase “during manufacturi ng, 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) w ould require that food that can support the 
rapid growth of undesirable microor ganisms be held at temperatures  that will prevent the food 
from becoming adulterated, during manufact uring, processing, packing and holding  (emphasis 
added). 
Current § 110.80(b)(4) require s that measures such as  sterilizing, irradiating, 
pasteurizing, freezing, refrigerati ng, controlling pH or controlling a w that are taken to destroy or 
prevent the growth of undesirable microorgani sms, particularly those of public health 
significance, shall be adequate under the conditions of manufacture, handling, and distribution to 
prevent food from being adultera ted within the meaning of the act.  FDA is proposing to include 
“cooking” as an additional such measure.  Cooki ng, if done adequately, is well accepted as a 
mechanism of destroying microor ganisms (Ref. 142).  FDA also is  proposing to delete the phrase 
“particularly those of public health significan ce” because it is redundant with the proposed 
definition for the term “microorganisms” (propos ed § 117.3), which identifies microorganisms of 
public health significance as a type of undesirabl e microorganism, and therefore is unnecessary.  
Proposed § 117.80(c)(4) would require measures su ch as sterilizing, ir radiating, pasteurizing, 
cooking,  freezing, refrigerating, contro lling pH or controlling a w that are taken to destroy or 
prevent the growth of undesirable microorga nisms be adequate under the conditions of 282 
 
  manufacture, handling, and distribution to pr event food from being adulterated (emphasis 
added). 
Current § 110.80(b)(5) requires th at work-in-process be handle d in a manner that protects 
against contamination.  FDA is proposing to revi se current § 110.80(b)(5) to  require handling in 
a manner to protect against the growth of unde sirable microorganisms.  The growth of any 
undesirable microorganisms already present in a f ood, 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-in-process must be 
handled in a manner to protect ag ainst cross-contact.  In addi tion 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, un adulterated food that has been removed from 
processing for reasons other th an insanitary conditions or that has been successfully 
reconditioned by reprocessing and th at is suitable for use as f ood.  As with work-in-process, 
improper handling of rework could result in cr oss-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 docum ent, 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 contam ination.  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 (emphasi s added).  When raw materials, ingredients, or 
refuse are unprotected, they must not be handl ed simultaneously in a receiving, loading, or 283 
 
  shipping area if that handling could result in cross-contact  or contaminated food (emphasis 
added).  Food transported by conveyor mu st be protected against cross-contact  and 
contamination as necessary (emphasis added). 
As discussed in section XI.D of this documen t, 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 prot ects 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” fo r 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-contac t.  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, ha ndled, and maintained during manufacturing, 
processing, packing  and holding  in a manner that protects  against cross-contact and  
contamination (emphasis added). 
As discussed in section XI.A of this doc ument, FDA is proposing to delete guidance 
regarding how to comply with the requirem ents of current § 110.80(b)(8).  Proposed § 
117.80(c)(8) would require that effective measures be taken to protect ag ainst the inclusion of 
metal or other extraneous material in food. 
Current § 110.80(b)(9) requires that food, raw ma terials, and other ingredients that are 
adulterated must be disposed of in a manner th at protects against the contamination of other 
food.  It further requires that if the adulterated food is capab le of being reconditioned, it be 
reconditioned using a method that has been proven to be effective or it be reexamined and found 284 
 
  not to be adulterated within the meaning of the act before being incorpor ated into other food.  
FDA is proposing to delete the option for reexam ination so that adulterated food can only be 
disposed of or reconditioned if the food is capab le 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 continue s 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 re examined.  FDA also is proposing to combine the 
two sentences in current § 110.80(b)(9) with an “o r” 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 adultera ted 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 mechani cal manufacturing steps such as washing, 
peeling, trimming, cutting, sorti ng 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 revi se 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 discusse d in section XI.A of this 
document, FDA is proposing to delete two of  these recommendations (regarding adequate 
cleaning and sanitizing of all food-contact 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 ag ainst cross-contact.  285 
 
  Proposed § 117.80(c)(10) woul d require that steps  such as washing, peeling, trimming, cutting, 
sorting and inspecting, mashing, dewatering, c ooling, shredding, extr uding, drying, whipping, 
defatting, and forming be performed so as  to protect food against cross-contact  and 
contamination and would continue to reco mmend that food should be protected from 
contaminants that may drip, drain, or be drawn in to the food (emphasis added).  As discussed in 
section XI.M of this document, FDA is request ing comment on whether to establish the third 
recommendation (regarding physical protection of food from contam inants that may drip, drain, 
or be drawn into the food) as a requirement. 
Current § 110.80(b)(11) requires, in relevant part, that wher e a blanched food is washed 
prior to filling, water used be sa fe and of adequate sanitary quali ty.  FDA is proposing to delete 
this requirement because water quality would al ready 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 prepar ation of food, be effected by heating the food to 
the required temperature, holding it at this te mperature for the required time, and then either 
rapidly cooling the food or passing it to subse quent manufacturing without delay.  As discussed 
in section XI.M, of this document, FDA is re questing comment on whether to establish this 
recommendation as a requirement.  Current § 11 0.80(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 discusse d 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 blan ching, 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 286 
 
  to subsequent manufacturing without delay (e mphasis 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 temp eratures and by period ic cleaning (emphasis 
added).   
Current § 110.80(b)(12) require s that batters, breading, sau ces, gravies, dressings, and 
other similar preparations be treated or mainta ined in such a manner that they are protected 
against contamination and provides several re commendations 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, F DA 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 requir e that batters, breading, sa uces, gravies, dressings, and 
other similar preparations be treated or mainta ined 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 pr otected 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 ag ainst the growth of 
undesirable microorganisms as well as against co ntamination.  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 in cludes 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, F DA also is proposing to 
require protection against cros s-contact.  Proposed § 117.80(c)(13)  would require that filling, 287 
 
  assembling, packaging, and other operations be performed in such a way that the food is 
protected against cross-contact , 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 a w  for preventing 
the growth of undesirable microorganisms be pro cessed to and maintained at a safe moisture 
level.  Current § 110.80(b)(14) also provide s recommendations for accomplishing compliance 
with this requirement.  As discussed in sect ion 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 de hydrated food, that reli es on the control of a w for 
preventing the growth of undesirable microorganism s 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 preven ting 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 requir ement.  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 c ontrol of pH for 
preventing the growth of undesirable microorganism s be monitored and maintained at a pH of 
4.6 or below. 
K. Proposed Revisions to Current § 110.93--W arehousing and Distribution (Proposed § 117.93)  
Current § 110.93 requires that storage and transportation of finished food be under 
conditions that will protect f ood against physical, chemical, and microbial contamination as well 288 
 
  as against deterioration of the food and the container. FDA is pr oposing a series of revisions to 
current § 110.93. 
 FDA is proposing to delete the term “finis hed” 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 en sure food safety throughout the food 
chain, food, whether a raw material or finished pr oduct, must be protected against contamination.  
As discussed in section XI.D of this docum ent, 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 c ontamination with radiological hazards.  As 
discussed in section XII.B, F DA now recognizes four types of hazards: biological, chemical, 
physical and radiological. Our CGMP regulation fo r 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 contamin ants to the list of 
contaminants would be consistent with part 129.  FDA tentatively concludes that there is no basis 
for requiring a facility to prot ect 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 ag ainst “biological,” rather than “microbial” 
contamination of food so that, when a provision speci fies all four types of hazards that must be 
addressed, the list is presented c onsistently throughout proposed part 117.  In  section XII.B.3 of 
this document, we discuss a requirement, wh ich would be established in proposed § 117.130(b), 289 
 
  for a hazard analysis to address biological, chem ical, radiological, and ph ysical hazards.  FDA 
also is proposing to present the lis t 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 storag e and transportation of food be under 
conditions that will prot ect against cross-contact  and biological , chemical, physical, and 
radiological contamination of food as well as against de terioration of the food and the container 
(emphasis added).    
L. Proposed Revisions to Current § 110.110--Natur al or Unavoidable Defects in Food for Human 
Use That Present No Hea lth Hazard (Proposed § 117.110)  
As discussed in section XI.C of this doc ument, 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 contro l operations that reduce natural or unavoidable 
defects to the lowest level currently feasibl e” from the currently id entified persons (i.e., 
manufacturers, distributors a nd holders of food) to manufactur ers, 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 comple te by specifying that th e 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 ex cuse violation of the requirem ent in section 402(a)(4) of the 
Federal Food, Drug, and Cosmetic Act that f ood 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 pa rt 117 that food manufacturers, 
processors, packers, and holders  must observe current good manu facturing practice (emphasis 290 
 
  added).  Evidence indicating that such a violatio n exists causes the food to be adulterated, even 
though the amounts of natural or unavoidable defect s are lower than the currently established 
defect action levels.  The manuf acturer, processor, packer and hol der of food must at all times 
utilize quality control op erations that reduce natu ral or unavoidable defect s 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 adulte rated…”  We are proposing this change to 
clarify that food containing defects above the cu rrent 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 th at presents no health hazards for humans (Ref. 141).  Whether 
food containing defects above the current defect action levels adulterate  the food is a case-by-
case determination that depends on the circumst ances.  Proposed § 117.110(d) would specify that 
the mixing of a food containing defects at le vels 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 docum ent, FDA is proposing to delete current § 
110.110(e), which provides that a compilation of the current defect action le vels for natural or 
unavoidable defects in food for human use that  present no health hazard may be obtained upon 
request.  291 
 
  M. Potential Revisions to Establish Re quirements 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., pr ovisions using “should” or “compliance may be 
achieved by”).  In this section of this document, we request co mment on whether to revise other 
non-binding provisions to establis h new requirements in proposed part 117 or retain them as 
useful recommendations of a comprehensive CG MP provision.  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 accepte d 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 cont rols may include sanitation procedures for food 
contact surfaces of utensils and equipment; supe rvisor, 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 traini ng for the alternative 
requirements rather than in produc tion.  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 (num ber of employees) to facilities that  do not already comply with this 
alternative.  This would resu lt 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 th e qualified facilities w ould need to review their operations and 292 
 
  perform the training.  Most non-qualified f acilities 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 cont rols that do not fully 
address the requirements of the sanitary operations , they would need to review their operations 
and perform the training.  Furthe r details are provided in the “C onsideration of Other Provisions” 
section of the RIA. 2. Summary of Potential Revisions to Establis h Requirements in Place of Current Guidance  
Table 11 identifies each of the potential re visions to establish new requirements and 
either explains the reason for establishing the requirement or, for such revisions with longer 
explanations, refers to th e section of this document where the pot ential requirement is explained.   
Table 11. Potential Revisions to Establis h 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.   293 
 
  Designation of 
Proposed 
Provision  Potential Additional Revision to 
Establish a Requirement in Place of a 
Recommendation (Emphasis Added) Basis for Potential Revision 
§ 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 food-contact 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-
food-contact 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 food-contact 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.  
§ 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.   
 294 
 
  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 recommen ds that food handlers and supervisors receive 
appropriate training in proper food handling techniques and food- protection principles and 
should be informed of the danger of poor personal hygiene and in sanitary 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 ap propriate training for supervisor s and workers to ensure that 
they have the necessary knowledge and expert ise in food hygiene, food protection, employee 
health and personal hygiene to produce safe food pr oducts.  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 analys is of recalls also indi cates that ineffective 
employee training was a root cause of 32 per cent of CGMP-related r ecalls 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 pr eventive controls (see section X.C.4 of this 
document), section 418(o)(3) of the FD&C Act recognizes the im portance of both training and 
CGMPs in preventing hazards from occurring in f oods in its definition of preventive controls, 
which identifies supervisor, manager, and em ployee hygiene training (§  418(o)(3)(B)) and 295 
 
  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 ma ndatory education and training program would 
be for the time that workers would be training rather than in producti on.  We estimate that a 
requirement for education and training, when im plemented 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 faci lities 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.  Furthe r details are provided in the 
“Consideration of Other Provi sions” section of the RIA. 
We request comment on how be st 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 defi nition 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 re place 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:  296 
 
  • 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 traini ng (e.g., upon hiring and periodically 
thereafter); 
• Specifying that training include the prin ciples of food hygiene and food safety, 
including the importance of employ ee health and personal hygiene, as  applied at the facility; and  
•   Specifying that records document re quired training of personnel and, if so, 
specifying minimum requirements for the documenta tion (e.g., the date of the training, the type 
of training, and the pe rson(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 excepti ons 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 educa tion and training in subpart C, that requirement would not apply 
to persons who would be exempt from the re quirements of proposed subpart C (e.g., qualified 
facilities and persons conducting acti vities subject to HACCP regulations for juice or seafood).   
N. Request for Comment on Additional CGMP Requirements  
We request comment on any addi tional proposed revisions or clarifications to our CGMP 
regulations that should be includ ed in subpart B, including wh ether to further implement the 297 
 
  “opportunities” for CGMP modernization identif ied by the CGMP Working Group or to enhance 
the CGMP regulations in some other way.  For example, we request co mment on whether a final 
rule based on this proposed rule should include CGMP requirements for environmental 
monitoring for L. monocytogenes , and whether such require ments should include other 
environmental pathogens such as Salmonella  spp. If so, we also request comment on what such 
requirements should be.  For additional info rmation 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 th e owner, operator, or agent in charge of a 
facility shall prepare a written plan that docum ents and describes the procedures used by the 
facility to comply with the re quirements of section 418 of the FD&C Act, including analyzing 
the hazards under section 418(b) of the FD&C Act and identify ing the preventive controls 
adopted under section 418(c) of the FD&C Act to address those h azards.  Section 418(h) of the 
FD&C Act also requires that such written pla n, together with the doc umentation described in 
section 418(g) of the FD&C Act, shall be made  promptly available to a duly authorized 
representative of th e 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 owne r, operator, or agent in charge of a 
facility prepare, or have prep ared, 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 298 
 
  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 esse ntial 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 sa fety team, to auditors, and to inspectors.  Proposed § 117.126(a) 
would implement section 418(h) of the FD&C Ac t and is consistent with the NACMCF HACCP 
guidelines, the Codex HACCP Annex, and Federa l HACCP regulations for seafood, juice, and 
meat and poultry.  The recordkeeping pr ovisions of the NACMCF HACCP guidelines 
recommend that the HACCP plan include a list of the HACCP team and assigned 
responsibilities; a descri ption of the food, its dist ribution, 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, cr itical limits, monitoring, corrective actions, 
verification procedures and sc hedule, and record-keeping proc edures (Ref. 34).  The Codex 
HACCP Annex recommends that HACCP proce dures be documented, including the hazard 
analysis, and determinations of CCPs and criti cal limits (Ref. 35).  Federal HACCP regulations 
for seafood, juice, and meat a nd poultry require a written pl an (§§ 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 flex ibility is consistent with the NACMCF HACCP 
guidelines (Ref. 34), which advise  that a HACCP team may need assistance from outside experts 299 
 
  who are knowledgeable in the haza rds associated with the pro duct and the process.  This 
flexibility also is consistent with the C odex 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 expe rts and regulatory authorities.   In addition, proposed § 117.126 
would provide flexibility for fac ilities in the development of thei r food safety plans by allowing 
facilities to group food types or production me thod types if the hazards, control measures, 
parameters, and required procedures such as monitoring are essentially identical.  
Proposed § 117.126(a) would require that the owne r, operator, or agent in charge of a 
facility implement the written food safety pla n.  Although section 418(h) of the FD&C Act is 
silent with respect to implemen tation of the required written pl an, 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 char ge of a facility both establish and implemen t preventive 
controls (emphasis added).  In addition, othe r provisions of secti on 418 (e.g., section 418(d) 
regarding monitoring, section 418 (e) regarding correc tive actions, and section 418(f) regarding 
verification) all establish requirements related to the preventive contro ls required under section 
418(c).  As discussed imme diately below, the written food safe ty plan would include the hazard 
analysis required under section 418( b) of the FD&C Act, the prev entive controls required under 
section 418(c) of the FD&C Act, the monitoring procedures require d under section 418(d) of the 
FD&C Act, the corrective action procedures required under secti on 418(e) of the FD&C Act, the 
verification procedures required und er section 418(f) of the FD&C  Act, and the recall plan as 300 
 
  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 requir e 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 prev entive controls as required by proposed 
§ 117.140(a);  
• The written corrective acti on procedures as require d 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 procedures used 
by the facility to comply with the re quirements of section 418, “including  analyzing the hazards 
under [section 418(b) of the FD&C Act] and iden tifying the preventive controls adopted under 
[section 418(c) of the FD&C Act]  to address those hazards” (e mphasis added).  Although section 
418(h) of the FD&C Act explicit ly references sections 418(b) and (c), the term “including,” 
indicates that the contents of a food safety plan need not be limited to th e 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 sa fety plan would include all 301 
 
  procedures required under section 418 of the FD&C Act.  As di scussed 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 implementati on 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 writt en 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 require ments of section 418, including 
analyzing the hazards and identifying the preven tive controls adopted to address those hazards, 
to mean that the contents of th e food safety plan must include the hazard analysis conducted by 
the facility and the preventive cont rols that a facility must esta blish 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 c ontrols.  The general re quirement 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 iden tifying and implementing 
preventive controls to signifi cantly minimize or prevent the o ccurrence of such hazards and 
provide assurances that such food is not a dulterated 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.   302 
 
  Under our interpretation of section 418(h) of the FD&C  Act, proposed § 117.126(b)(1) 
and (2) are consistent with the NACMCF HA CCP 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 includ e 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 maximu m 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 analys is and determinations of CCPs and critical 
limits.  Federal HACCP regulations  for seafood, juice, and meat a nd 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), respectivel y), 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 regul ation for meat and poultry further requires 
that the written hazard analysis be maintain ed 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 incl ude 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 ha zard 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 fo od safety plan be prepared by (or its 
preparation overseen by) a qualifi ed individual.  (See the discu ssion in section XII.H of this 303 
 
  document regarding the qualifica tions 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 faciliti es monitor and verify th e 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 mu st be designed to identify and to significantly 
minimize or prevent hazards in order to prevent il lness 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 prev entive controls, with associated monitoring and 
corrective actions for those haza rds, and appropriate verificati on activities for the applicable 
preventive controls.  Such knowledge requires scientific and technica l expertise developed 
through training, experience, or both.   
Section 418 of the FD&C Act does not addres s 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 w ho are knowledgeable in the food 
process either participate in or  verify the hazard analysis an d 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 qualifie d through job experience th at provides knowledge 
at least equivalent to that provided thr ough the standardized curriculum (§§ 123.10 and 120.13, 
respectively).  The FSIS HACCP regulation for meat and poultry require s that the individual 304 
 
  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) c ould 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 individua l.  Each member of a HACCP or food safety team generally 
brings specific expertise importa nt in developing the plan.  Fo r example, a microbiologist could 
provide knowledge of microbial h azards, an engineer could establ ish the critical parameters for 
delivery of heat treatments, and a maintenan ce supervisor could iden tify sources of metal 
contamination.  Proposed § 117.126 would not require  that all such members of a food safety 
team satisfy the requirements in proposed § 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 de veloped, including revi ewing all information 
contained in the food safety pla n, 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 ma y 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 forese eable hazards that may be associated with the 
facility  (emphasis added).  Thus, proposed § 117.126 esta blishes a requirement for every facility 
to have its own written food safety plan.  The facili ty-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 Federa l HACCP regulations for seafood, juice, and 305 
 
  meat and poultry.  The NACMCF HACCP guidelines emphasize that it is essential that the 
unique conditions within each facility be consid ered during the development of all components 
of the HACCP plan (Ref. 34).  The Codex HACCP  Annex states that HA CCP should be applied 
to each specific operation separa tely (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, re spectively) or to “every 
official establishment” (9 CFR 417.2(a)) for meat and poultry).   
Federal HACCP regulations for seafood, jui ce, and meat and poultry allow the HACCP 
plan to group food types or production method t ypes if the hazards, cri tical control points, 
critical limits and required procedures such as monitoring are essentially identical, provided that 
any required features of the plan that are uni que 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, w ould 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 Ac t 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, in cluding (A) biological, chemical, physical, and 
radiological hazards, natural toxins, pesticid es, drug residues, decomposition, parasites, 
allergens, and unapproved food and color additives; and (B) hazards that o ccur naturally, or may 
be unintentionally introduced.  S ection 418(b)(3) of the FD&C Act specifies, in relevant part, 306 
 
  that the owner, operator, or agent in charge of a facility shall develop a written analys is 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 introd uced, 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 preventiv e controls, including at critical control points, 
if any, to provide assurances that hazards identified in th e 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 a dulterated under section 402 of th e 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 rele vant 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.     307 
 
   Proposed § 117.130(a)(1) is consistent with the NACMCF HACCP guidelines, the 
Codex HACCP Annex, and Federal HACCP regul ations for seafood, juice, and meat and 
poultry.  The NACMCF HACCP guidelines describe a two-stage process fo r conducting a hazard 
analysis (Ref. 34), i.e., hazard identification a nd hazard evaluation.  Haza rd identification has 
been described as a brainstorming session designed  to facilitate the deve lopment 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 considerat ion 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 pr ocess.  The Codex HACCP Annex 
recommends that the HACCP team list all of th e hazards that may be reasonably expected to 
occur at each step from primary production, pr ocessing, manufacture, and distribution until the 
point of consumption and then conduct a hazard an alysis to identify which hazards are of such a 
nature that their elimination or reduction to acceptable levels is  essential to th e 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 h azards that a facility would 
identify and evaluate – i.e., “known or reasonab ly 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 308 
 
  HACCP guidelines, and the hazards that are required  to be identified to determine if they are 
“hazards that may be reasonably expected to occu r at each step” in the Codex HACCP Annex, or 
“reasonably likely to occur” in Federal HACCP  regulations for seafood, juice, and meat and 
poultry.   
Proposed § 117.130(a)(1) would establish the re quirement to identify and evaluate 
hazards by conducting a hazard analysis; we pr opose specific requirements for the hazard 
identification in proposed § 117.130(b) (see secti on XII.B.3 of this document) and specific 
requirements for the hazard evaluation in pr oposed § 117.130(c) (see sec tion 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 ma nufactured, processed, packed, or held at the facility.”  In 
considering the proposed requirement for a haza rd analysis, we consid ered 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 eval uate 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 a nd poultry all apply a hazard analysis to each 
type of food manufactured, pro cessed, 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 specifi c product and process, including describing the food and its 309 
 
  distribution, describing the inte nded use and consumers of th e 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 fi shery 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 regula tion for meat and poultry requires that a flow 
chart be prepared describing the steps for each pr ocess and product flow in the establishment (9 
CFR § 417.2(a)(2)) and also requires a HAC CP plan for each product produced by the 
establishment whenever the hazard analysis reve als 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 ma y 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 ha ndles 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 ha zard analyses.  For example, a facility that 
produces tea-based beverages may package its produc ts in both glass and plastic bottles at the 
same facility.  Although these two products might c ontain similar ingredient s, we would consider 
them to be different types of food under proposed § 117.130(a)(1) because the two types of packaging entail significant diffe rences in the handling of thes e products during processing.  The 
hazard of glass particles resul ting 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 p ackaged in plastic.  
Proposed § 117.130(a)(1) would identify the purpos e of the hazard analysis - i.e., to 
determine whether there are haza rds that are reasonably likely  to occur.  Although section 310 
 
  418(b)(1) of the FD&C Act does not  explicitly identify the purpose of the hazard analysis, we 
interpret the combined requirement s of sections 418(b), (c)(1) a nd (c)(3) of the FD&C Act to 
reflect a purpose, i.e., to enable the facil ity to identify and, wher e necessary, implement 
preventive controls to provide assurances that hazards identified in the hazard analysis will be 
significantly minimized or preven ted and that the food manufactur ed, processed, packed or held 
by the facility will not be adulterated under se ction 402 of the FD&C Act or misbranded under 
section 403(w) of the FD&C Act.  If, for exam ple, 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 cer tain type of food, the f acility 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 guide lines, the Codex HACCP Annex, and Federal 
HACCP regulations for seafood, juice, and m eat and poultry.  The NAC MCF HACCP guidelines 
identify the purpose of the hazard analysis as the de velopment of a list of h azards 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 th at their elimination or reduction to acceptable 
levels is essential to the production of a safe f ood (Ref. 35).  The stated purpose of the hazard 
analysis in Federal HACCP regulations for seaf ood, juice and meat and pou ltry 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), resp ectively, for seafood and juice) or in the 
production process for meat and poultry (9 CFR § 417.2(a)). 311 
 
  b. Proposed § 117.130(a)(2)--Requirement fo r 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 pro cedures that address pr oblems that can be 
anticipated, the food safety team wi ll 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 unan ticipated problem in section 
XII.F.3 of this document).  The written hazard anal ysis 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 h azard analysis also w ould 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 reanalys is or update has a baseline fro m 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 justif ication 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 wher e the owner, operator, or  agent in charge of a 
facility identifies one or more hazards that ar e reasonably likely to occur.  Under proposed § 312 
 
  117.130(a)(2), a written hazard analysis would be re quired 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 fo r juice, seafood, and meat and poultry.  The 
NACMCF HACCP guidelines and the Codex HA CCP Annex each specify that the hazard 
analysis be documented in the HACCP plan (R ef. 34) (Ref. 35).  Our HACCP regulation for 
juice requires a written hazar d analysis (§ 120.7(a)).  Ou r HACCP regulation for seafood 
requires that the list of food safe ty hazards that are r easonably likely to occu r, 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 writ ten hazard analysis, including all supporting 
documentation (9 CFR § 417.5(a)(1)). 3. Proposed § 117.130(b)--Haza rd Identification  
Proposed § 117.130(b) would require that the h azard analysis consider hazards that may 
occur naturally or may be uninten tionally introduced, including: 
• Biological hazards, including microbiol ogical hazards such as parasites, 
environmental pathogens, and other microorgani sms of public health si gnificance (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 (propos ed § 117.130(b)(3)); and   
• Radiological hazards (proposed § 117.130(b)(4)).  313 
 
  Proposed § 117.130(b) would implement sectio n 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 NAC MCF HACCP guidelines, the Code x HACCP Annex, and Federal 
HACCP regulations for juice, seafood, and meat  and poultry; the propos ed group “radiological 
hazards” would be in addition to the groups of h azards 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 de finition 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 de finition of “food safety hazard” (§ 123.3(f) and 9 
CFR § 417.1 for seafood and meat and poultry, re spectively) or food hazard (§ 120.3(g) for 
juice).  Federal HACCP regulations for seafood, ju ice, 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).  Fe deral HACCP regulations for 
seafood and meat and poultry also  identify as hazards drug resi dues (§ 123.6(c)(1 )(v) and 9 CFR 
417.2(a)(3)(v) for seafood and meat and poultry, re spectively) 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 microbiol ogical hazards within the category of 
biological hazards.  Examples of  microbiological hazards include: 314 
 
  • Parasites (which are required to be c onsidered 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 o ff 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 docum ent, 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 unsp ecified agents (Ref. 45) (Ref. 46).  Focusing 
only on the foodborne illnesses attrib utable to particular pathogens,  a recent report estimated that 
31 major pathogens (for which data for prepar ing national estimates ar e 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 contaminat ion 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 te sting 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 . 315 
 
  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 secti on 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).  Natu ral toxins such as aflatoxin and patulin are 
well recognized as hazards in foods such as pean uts and apple juice produc ts, respectively (Ref. 
82) (Ref. 85).  Decomposition products such as  histamine, produced from the amino acid 
histidine when certain ba cteria grow, can pose a risk to he alth.  An undeclared food allergen 
(such as a peanut) can cause a life-threateni ng 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, gla ss, or metal fragments th at 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 physical hazards, e.g., container glass 
and metal fragments such as nuts and bolts. 
Radiological hazards . 316 
 
  Proposed § 117.130(b)(4) would require that th e hazard analysis consider radiological 
hazards.  As discussed in section II.D.2.e of th is document, examples of radiological hazards 
include radionuclides such as radium-226, radium-228, uranium-235, uranium-238, strontium-
90, iodine-131, and cesium-137.  The NACMCF HAC CP guidelines, the Codex HACCP Annex, 
and Federal HACCP regulations for seafood, ju ice, 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 th at 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 do cument 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 wh ether a hazard is reasonably likely to 
occur, including an assessment of the severity of the illness or injury if the hazard were to occu r.  
Proposed § 117.130(c)(1) would require that the h azard 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 th e 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 Fede ral HACCP regulations for 
seafood, juice, and meat and poultry.  The NACMC F HACCP guidelines defi ne severity as the 
seriousness of the effects of a hazard.  The se verity of the illness or injury includes the 
magnitude and duration of the illness and impact  of any sequelae (chroni c conditions resulting 317 
 
  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, epidemiol ogical data, and information in the technical 
literature) and the potential effect s associated with both short-te rm and long-term exposure (Ref. 
34).  Likewise, the Codex HACCP Annex recomme nds that the hazard analysis consider the 
severity of the adverse health effects associat ed 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 requi re an assessment of se verity but addresses 
the potential for illness or injury in its defini tion of a food safety hazard, which refers to 
biological, chemical or physical properties th at may cause a food to be unsafe for human 
consumption (§ 123.3(f)) and in the description of a food safety haza rd that is reasonably likely 
to occur, which includes illness data as a basis fo r establishing controls (§ 123.6(a)).  Similarly, 
the FSIS HACCP regulation for meat and poultry doe s 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 po tential hazards need to  be addressed in the 
HACCP plan (i.e., those that ar e 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 hazard s in question (66 FR 6138 at 6155).    318 
 
  As discussed in section II.D.2.a of this docum ent, 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 Ur emic 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 ready-to-eat foods (Ref. 55).  Proposed § 117.130(c)(1) would 
require that such biological ha zards be considered to determ ine 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 illn ess – 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 evaluati on for chemical hazards is directed to their long 
term effects, such as impaired cognitive de velopment in children exposed to lead in 
contaminated candy (Ref. 88) and liver cancer as  the result of chr onic exposure to the  
mycotoxin aflatoxin (Ref. 89) (Ref. 90).  Pr oposed § 117.130(c)(1) would require that such 
chemical hazards be considered to determine whet her they are reasonably likely to occur even if 
the chemical hazard occurs infrequently.   
We discuss the regulatory framework unde r 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 319 
 
  such as unapproved food additives, unapproved co lor additives, new animal drugs, and pesticides 
be considered to determine whether th ey are reasonably likely to occur.  
We provide information about natural t oxins (such as aflatoxin and patulin), 
decomposition products (such as histamine and ot her biogenic amines), and heavy metals (such 
as lead) in section II.D. 2.b of this document and references contained therein (R ef. 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 fore ign objects that may be present in food can 
pose a health risk (Ref. 148).  Ha rd or sharp foreign objects in food may cause traumatic injury, 
including laceration and perforati on 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) th e potential for severe consequences would 
require consideration of these phys ical hazards to determine whethe r they are 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 sp ecial risk groups (Ref. 148).   
Contamination of food with radiological h azards generally is evaluated for long-term 
effects such as the potential fo r 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 320 
 
  require consideration of radiologi cal 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 th e FD&C Act seems clear – i.e., that 
the owner, operator, or agent in charge of a facility identify and eval uate known or reasonably 
foreseeable hazards for the purpose of identifyi ng and implementing preventive controls to 
provide assurances that identifie d hazards will be significantly mi nimized 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 determ ine 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 no t be adulterated under section 402 of the FD&C 
Act or misbranded under section 403(w) of th e 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 cont amination of food.  Examples of environmental 
pathogens that have contaminated foods (a nd, in particular, RTE foods) include Salmonella  spp. 
and L. monocytogenes .  Proposed § 117.130(b)(1) would incl ude environmental pathogens as 
one of the biological hazards that must be cons idered in identifying hazards for evaluation.  321 
 
  Under proposed § 117.130(c)(2), a fa cility 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 reas onably 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 th at, in conducting the hazard evaluation, 
consideration be given to the eff ect of several specific factors on the safety of the finished food 
for the intended consumer.  We tentatively concl ude 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 proces sor 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 haza rd of “pathogen growth.”  A multi-component 
food may have individual ingredients that do no t support growth of undesirable microorganisms 
(e.g., because of pH or a w), but when put together there may be an interface where the pH and a w 
changes (e.g., pies, layered breads).  Under pr oposed § 117.130(c)(3)(i), th e interaction of the 
individual ingredients must be  evaluated as part of the fo rmulation of the food. Proposed § 
117.130(c)(3)(i) also would require that the hazar d evaluation consider whether or not the 322 
 
  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 th at the hazard evaluation consider the 
condition, function, and design of th e facility and equipment.  The condition, function, or design 
of a facility or its equipment c ould potentially result in the intr oduction of hazards into foods.  
For example, older equipment (e.g., older slic ing, 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 esta blished in a niche envi ronment than modern 
equipment designed to address the problem of pathogen harborage in niche environments.  
Proposed § 117.130(c)(3)(ii) would re quire that facilities with such equipment consider the 
impact of the equipment on the potential for pathoge ns to be a hazard that is reasonably likely to 
occur; if so, a preventive control such as e nhanced sanitation controls may be appropriate, 
particularly if the equipment is used in produc tion of RTE food. Equipmen t designed such that 
there is metal-to-metal cont act may generate metal fragments.  Proposed § 117.130(c)(3)(ii) 
would require that facilities with such equipm ent 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 dete ctors may be appropriate.  A facility that 
manufactures, processes, or packs soft, fresh ch eese (such as queso fresco, which is consumed 
without cooking to adequately reduce pathogens ) may have cold, moist conditions that are 
conducive to the developmen t of a niche where the pathogen L. monocytogenes  can become 
established and contaminate food-contact 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 deve lopment of a niche where the pathogen L. 323 
 
  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 cross-contact (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 that is reasonably likely to occur; if so, targeted f ood 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 define s “food” to mean food as defined in section 
201(f) of the FD&C Act and includes raw material s and ingredients, and th at definition would be 
retained (with no proposed revisions) in this proposed rule.  As disc ussed in section IX.E of this 
document, there is an overlap between raw materi als and ingredients; not  all raw materials are 
ingredients.  A food can become contaminated th rough 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 peanut -derived 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 afte r the ingredient was 
associated with an outbreak of foodborne illness (Ref. 19).  In ot her cases, the contamination was 
discovered in a food and associated with a partic ular ingredient without  any known incidence of 
foodborne illness (Ref. 152) (Ref . 155) (Ref. 22) (Ref. 154).  Following some of these recalls, we 324 
 
  issued guidance recommending that  manufacturers of foods cont aining a particular type of 
ingredient either obtain the i ngredients from suppliers with va lidated processes in place to 
adequately reduce the presence of the appli cable pathogen, or ensu re that their own 
manufacturing process would ade quately 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 simila r characteristics (because such contamination 
might be expected in ingredients that  are produced in a similar manner).  
A food also may become contaminated thr ough 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 le ad) 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 arseni c, lead, or other heavy metals such that they do 
not satisfy the specifications of the regulation.  
As noted for formulation in the discussi on 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, mach inery-harvested produce is more likely to be 325 
 
  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) woul d require that the haza rd 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 te mperature 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 pa ckaging makes the product suscep tible to contamination during 
transportation – e.g., from pathogens  or chemicals present in an in adequately cleaned vehicle or 
from other inadequately protecte d foods that are being co-trans ported 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 vehicl e, receivers, and other persons engaged in the 
transportation of food to  use sanitary transpor tation practices to ensu re that food is not 
transported under conditions that may render th e food adulterated.  In 2010, we published an 
Advance Notice of Proposed Rulemaking to request data and information on the food 
transportation industry and its pr actices and we expect to issu e 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 th e owner, operator, or agent in charge of a 
facility to consider transpor tation practices when determinin g whether a hazard is reasonably 
likely to occur.  326 
 
  Proposed § 117.130(c)(3)(v) would require th at the hazard evaluation consider 
manufacturing/processing procedures.  For example, hazards may arise from 
manufacturing/processing proce sses such as cooling or holding of certain foods due to the 
potential for germination of pathogenic sporef orming bacteria such as Clostridium perfringens  
and Bacillus cereus  (which may be present in  food ingredients) as a c ooked product is cooled and 
reaches a temperature that will allow germinatio n of the spores and outgrowth.  Hazards also 
may arise from manufacturing/proce ssing processes such as acidific ation due to the potential for 
germination of spores of C. botulinum , with subsequent production of botulinum toxin, if the 
acidification is not done correc tly.  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 formula tion 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 equipm ent in which metal (e.g., wires, saw blades 
or knives) is used to cut pr oducts during manufacturing.    
Proposed § 117.130(c)(3)(vi) would require th at the hazard evaluation consider 
packaging activities and labeling ac tivities.  For example, as disc ussed 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 bottl es or in plastic bottles.  A la bel on a food may direct consumers 
to cook a product to a certain temperature; th e likelihood of consumer s 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 foodbor ne illness has been associat ed with the consumption of 327 
 
  uncooked cookie dough (Ref. 77) (Ref . 76) (Ref. 78).  Thus, although label information is a 
factor to consider, a hazard may be reasonably lik ely to occur even with label information such 
as cooking instructions. 
Proposed § 117.130(c)(3)(vii) would require that  the hazard evaluati on consider storage 
and distribution.  For example, biological hazar ds are more likely to be a hazard that is 
reasonably likely to occur duri ng storage and distribution in f oods that require refrigerated 
storage to maintain safety than in shelf-stable foods. Shelf-stab le foods are designed such that 
biological hazards are controlled.    
Proposed § 117.130(c)(3)(viii) would require that  the hazard evaluati on 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 co nsumer, as well uses where it would not be 
cooked.  For example, soup is generally cooked, bu t 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 dete rmine if they are haza rds reasonably likely to 
occur.   
Proposed § 117.130(c)(3)(ix) woul d require that the haza rd evaluation consider 
sanitation, including employee hygiene.  Sanitati on measures and practices can impact the 
likelihood of a hazard being introduced into a f ood.  For example, the frequency with which a 
production line is shut down for a complete clean ing can impact the poten tial for food residues to 
transfer pathogens from equipment to foods (e.g., pathogens present on raw produce that could 328 
 
  carry over into the next producti on cycle on a line).  Practices di rected at worker health and 
hygiene can reduce the potential for transf er 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 poten tially affect the safety of th e finished food for the intended 
consumer.  For example, an unexpected natural di saster 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 th e public to boil tap water for drinking, a facility 
should consider whether bacterial, vi ral 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 w ith 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 HAC CP 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 eq uipment 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 a nd identifies factors to consider such as 
ingredients, formulation, proces sing procedures, design of facilit y, design and use of equipment, 
packaging, sanitation, worker health and hygiene, storage, intended use, and intended consumer.  329 
 
  Our Hazards and Controls Guide for juice provides  recommendations related to factors such as 
shelf life of the product, location of the processi ng, and type of proce ssing, e.g., thermal or non-
thermal processing (Ref. 4).  Our Hazards  and Controls Guide for seafood provides 
recommendations related to factor s such as storage conditions (tim e and temperature), the role of 
manufacturing conditions in minimizing the potential for formation of C. botulinum  toxin, 
manufacturing procedures (cooki ng and pasteurization) to co ntrol pathogenic bacteria, 
manufacturing procedures (such as high hydros tatic pressure proces sing, individual quick 
freezing with extended frozen storage, mild heat processing, and irradiati on) designed to retain 
raw product characteristics, and the introduction of pathogenic bact eria after pasteurization and 
specialized cooking processes.  The FSIS Hazar ds and Controls Guide for meat and poultry 
provides recommendations relate d to factors such as rece iving, thawing, formulation, 
manufacturing procedures, packaging, storage and shipping (Ref. 159).   
C. Proposed § 117.135--Preventive Controls for Hazar ds 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, specif ies that the owner, operator, or 
agent in charge of a facility shall identify and im plement preventive controls , including at critical 
control points, if any, to provide assurances th at 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 Ac t), 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 doc ument, section 418(o)(3 ) of the FD&C Act 
defines preventive controls and proposed § 117.3 would include the statutory definition in 330 
 
  proposed part 117.  Under section 418(o)(3), the procedures, pract ices, and processes described 
in the definition of preventive controls may include the following: 
• Sanitation procedures for food-contact surfaces and utensils  and food-contact 
surfaces of equipment (section 418(o)(3)(A) of the FD&C Act); 
• Supervisor, manager, and employee hygien e 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 contamin ant in the environment 
(section 418(o)(3)(C) of the FD&C Act); 
• A food allergen control program (sec tion 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 re gulations (section 4 18(o)(3)(F) of the 
FD&C Act); and  
• Supplier verification activities that re late to the safety  of food (section 
418(o)(3)(G) of the FD&C Act). 
2. Proposed § 117.135(a)--Requirement to Identif y and Implement Preventive Controls for 
Hazards that are Reasona bly Likely to Occur 
Proposed § 117.135(a) would require that the owne r, operator, or agent in charge of a 
facility identify and implement preventive cont rols, 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 prev ented and the food manufactured, processed, packed or held by 
such facility will not be a dulterated under section 402 of th e FD&C Act or misbranded under 
section 403(w) of the FD&C Act.   331 
 
  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 r easonably likely to occur would then be required 
to identify and implement preventive controls fo r 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 t ypes 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 th e flexibility to identify and implement preventive 
controls from among all procedures, practices, a nd processes available to  it that would provide 
the assurances that would be required by proposed § 117.135(a).   
Proposed § 117.135(a) would implement sec tion 418(c) of the FD&C Act and is 
consistent with the NACMCF HACCP guidelin es, 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 contro l system established by section 418 of the 
FD&C Act.  The NACMCF HACCP guidelines (R ef. 34), the Codex HACCP Annex (Ref. 35), 
and Federal HACCP regulations for seafood, ju ice, and meat and poultry (§§ 123.6 and § 120.7 
and 9 CFR § 417.2, respectively) direct a proces sor to address potential hazards that are 
reasonably likely to cause illness or injury in  the absence of their co ntrol by determining CCPs 
and establishing critical limits for those CCPs.  As discussed in section II.C .2 of this document,  332 
 
  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 a nd critical limits would not be 
required for all preventive c ontrols.  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 th e only option available to the faci lity in all circumstances.  In 
some cases adequate assurances could be achie ved via preventive contro ls 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 th e food allergen control program that would be 
required by proposed § 117.135(d)(2), see se ction XII.C.6 of this document.) 
Whatever types of preventive controls a facil ity 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 scient ific data and inform ation related to food 
safety risks.  Typically, the hazard evaluation wi ll enable the facility to  determine appropriate 
risk-based 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 manu facturing.  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 lik ely to occur in a food, the facility 
would establish sanitation contro ls to prevent L. monocytogenes  from establishing itself in a 
harborage site.  In addition to such sanitati on controls, a facility may consider applying a 
listericidal process step (i.e., a process contro l applied to adequately  reduce levels of L. 333 
 
  monocytogenes  in RTE foods).  As discussed in sec tion 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 c ontaminated 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 f oods 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 whic h, 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, identifi es the preventive contro ls within the plan.  
Written preventive controls are essential for the f acility to implement the preventive controls 
consistently and essential for th e facility’s food safety team, a uditors, and inspectors.  Written 
preventive controls also woul d be essential for training purposes and during reanalysis and 
updates of the preventive cont rols.  Proposed § 117.135(b) is consistent with our HACCP 
regulation for juice, which requires that the writte n hazard analysis identify control measures that 
the processor can apply to control the food hazards identified as reasonably likely to occur (§ 120.7(a)).   334 
 
  4. Proposed § 117.135(c)--Requirement for Parameters  Associated with th e Control of Hazards 
That Are Reasonably Likely to Occur 
Proposed § 117.135(c)(1) would requ ire that preventive controls  for hazards identified in 
the hazard analysis as reasonabl y 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, i rradiating, dehydrating, and refri gerating foods.  Proposed § 
117.135(c)(1) would include examples of several measures identified in  current § 110.80(b)(4) 
(Manufacturing Operations) (propo sed § 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) (p roposed § 117.80(c)(4)) doe s not establish an 
exhaustive list of measures that must be ade quate.  Examples of othe r 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 w ith antimicrobial agents.  The 
parameters are those factors that must be contro lled to ensure the hazard will be significantly 
minimized or prevented. The specific parameters  required, and how they would be controlled, 
would depend on the facility and th e food.  For example, for a heat process, parameters such as 
temperature and time must be controlled.  Te mperature may be controlled through controls on 
product temperature (as when treatin g a fluid product in a heat ex changer) 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 sett ing that controls flow  of the fluid through 
the heat exchanger and hold tube or manually by an operator recording th e time a product is put 
in the oven and the time it is removed.  Heating ti me may also be controlled by the belt speed for 335 
 
  the conveyor on a continuous oven.  A facility woul d 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 controll ed to prevent metal contamina tion.  Sanitation procedures may 
include scrubbing certain pieces of equipment by ha nd; this may not require the identification of 
specific parameters.  Similarly, la bel controls for food allergens do not involve identification of 
specific parameters.   
Proposed § 117.135(c)(2) would requ ire that preventive controls  for hazards identified in 
the hazard analysis as reasonabl y likely to occur include , as appropriate to the facility and the 
food, the maximum or minimum value, or combin ation 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 studie s or other information that demonstrate the 
effectiveness of the control measur e at specific values of a phys ical, 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.  Specifyin g these values would enable the facility to 
implement them consistently, would facilitate va lidation of the preventive controls as would be 
required by proposed § 117.150(a), and would facilitate au dits and inspection.   336 
 
  Proposed § 117.135(c)(1) and (2) would implemen t section 418(c) of  the FD&C Act and 
are consistent with the NAC MCF HACCP guidelines, the Code x HACCP Annex, and Federal 
regulations for seafood, juice, and meat and poul try, 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 NACMC F HACCP guidelines and the Codex HACCP 
Annex (Ref. 34) (Ref. 35) each sp ecify that the critical limits be documented in the HACCP 
plan.  Federal HACCP regulations for seafood, ju ice, 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), respectivel y).  The NACMCF HACCP guidelines define 
“critical limit” to mean a maximum and/or mini mum value to which a bi ological, 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 purp oses, identical to the 
definition in the NACMCF HACCP guideline s (§§ 123.3(c) and 120.3(e) and 9 CFR 417.1(b), 
respectively).  The Codex HACCP Annex defines “critical limit” to m ean 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 we ll with HACCP, it differs in part in that 
preventive controls may be requi red at points other than  at critical contro l points and critical 
limits would not be required for all preventive cont rols.  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 pr eventive controls that may or may not apply at 
CCPs.  Consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and 337 
 
  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 chemi cal parameter must be controlle d to significantly minimize or 
prevent a hazard that is r easonably likely to occur. This is similar to requiring critical limits at 
CCPs but would apply to values set for paramete rs that apply to prev entive controls, whether 
these apply at a CCP or not. 5. Proposed § 117.135(d)(1)--Process Controls 
Proposed § 117.135(d)(1) would requ ire that preventive controls  for hazards identified in 
the hazard analysis as reasonabl y likely to occur include proce ss controls that include those 
procedures, practices, and pro cesses performed on a food duri ng manufacturing/processing that 
are employed to significantly minimize or prevent h azards that are reasonably likely to occur.  
Process controls do not include th ose procedures, practices, and pro cesses 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 ar e employed during manufact uring/processing to 
significantly minimize or prevent hazards that ar e reasonably likely to occur would distinguish 
those controls applied in manuf acturing/processing that significantly minimize or prevent 
hazards (e.g., cooking, cooling, irradiating, refrig erating, and reducing water activity) from other 
types of controls that may be applied in manuf acturing/processing to provide the desired product 
(e.g., controls for product size and shape).  Many pro cess 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 w ithin HACCP plans and applied at CCPs as 
recommended by the NACMCF HACCP guidelines  (Ref. 34) and the Codex HACCP Annex 338 
 
  (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 iden tified 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, radi ological, or chemical parame ter 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 de scribed the use of the te rm “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 incl ude 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 c ontrols may or may not apply at CCPs. 
For example, a facility that holds in-shell pist achios in bulk storage units for an extended 
time period until they are shelled and packaged  may identify the potential for growth of 
aflatoxin-producing molds on the nuts as a hazar d reasonably likely to occur.  As a process 
control to prevent such molds from growing on th e nuts during storage, the facility may elect to 
dry (dehydrate) the nuts to a specif ic moisture content (e .g., no more than seven percent) prior to 
placing them in storage.  The process control w ould 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 manufactur es refrigerated deli salads may identify the 
potential for growth of L, monocytogenes  in the salads as a hazard reasonably likely to occur.  339 
 
  As a process control to prevent such growth, th e facility may elect to add an acidifying agent 
during its process to ensure that the pH of th e product does not exceed 4.4.  The process control 
would be “acidifying” and the associated parame ter 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 pathoge nic 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 th rough product formulation, such as pH.)  The 
facility may also esta blish 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 employe d for ensuring protection of food from cross-
contact, including during storage an d use.  Examples of such c ontrols 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 inadverten t incorporation of an allergen into a product for which it is not 
an ingredient.  Examples of such procedures for controlling food allerg ens include procedures 
that: 340 
 
  • 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 personne l 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 f oods that contain diffe rent allergens.   
Proposed § 117.135(d)(2)(ii) would require that  food allergen controls include those 
procedures, practices, and proce sses employed for labeling the fi nished food, including ensuring 
that the finished food is not misbranded under se ction 403(w) of the act.  Such controls can 
prevent application of the wr ong label to a food, use of th e wrong packaging, and use of 
packaging with an incorrect alle rgen declaration.  Examples of such procedures for controlling 
food allergens include procedures that: 
• Ensure that the food label correctly decl ares all of the food allergens present 
(including those contained in flavorings, co lorings, and incident al 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). 341 
 
  Proposed § 117.135(d)(2) would implement secti ons 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 require s processors to consider whethe r the presence of undeclared 
ingredients that may be allergens is a hazard th at 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 pr ocessing establishments that produce foods containing a major 
food allergen be required to have  a food allergen contro l 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 es tablish two requirements for sanitation 
controls where necessary to significantly minimize or prevent hazards that are reasonably likely 
to occur, (including any environmen tal pathogen that is reasonably likely to occur in a ready-to-
eat food that is exposed to th e 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 pro cedures 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 lik ely to occur in a ready-to-eat  food that is exposed to the 
environment prior to packaging and any food a llergen hazard. (We would generally not expect 
that microorganisms of public health signifi cance contaminating an RTE food due to employee 
handling would be a hazard relevant to pro cedures for cleaning f ood-contact surfaces.)  
Examples of sanitation controls related to th e cleanliness of food-c ontact surfaces include 342 
 
  cleaning and sanitizing procedur es (including appropriate fre quencies for these procedures, 
concentrations of cleaning and sa nitizing compounds, method of a pplication, and contact time).  
Such controls can prevent contamination of  food with microorgani sms of public health 
significance, including environmental pathogens, that result from inade quate cleaning of food-
contact surfaces. Such controls also can prevent cross-contact that results from inadequate 
cleaning of food-contact surfaces or surfaces that transfer material to food-contact surfaces.   
Proposed § 117.135(d)(3)(i)(B) would require that san itation controls include procedures 
for the prevention of cross-contact and cross-c ontamination from insanitary objects and from 
personnel to food, food packaging material, an d other food-contact surfaces and from raw 
product to processed product.  Such hazards woul d include any environmental pathogen that is 
reasonably likely to occur in a ready-to-eat f ood that is exposed to th e environment prior to 
packaging, any microorganism of public health  significance that is r easonably likely to 
contaminate food if employees are handling RTE food, and any food allergen hazard. Examples 
of sanitation controls to prev ent cross-contact include proced ures 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 be tween 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 lin e to another (e.g., by ensuring 
employees do not handle food containing an alle rgen and one that does not without washing 
hands and changing outer garments); and proc edures 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 obj ects (e.g., waste, trash cans, the floor, and rest 343 
 
  room fixtures or surfaces) and then food, food- contact surfaces, or food packaging material 
without first washing and sani tizing 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 controll ing 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 envir onmental pathogen is a 
hazard that is reasonably likely to occur in an RT E 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.  R ecent 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 th e potential for the food to be 
contaminated.  Appropriate sa nitation controls ca n minimize the presen ce and transfer of 
contaminants, including environmental pathogens,  to food.  The need for sanitation controls 
related to food workers has long been recognized; however, apprec iation 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 environm ental pathogens as examples. 344 
 
  To make clear that sanitation controls ar e required when a microorganism of public 
health significance is a hazard reasonably like ly 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 ca rriers of this organism (e.g., in the nose and on 
the skin) (Ref. 161).  People are also a source of  enteric pathogens, incl uding both symptomatic 
and asymptomatic infected workers (Ref. 162) .  Workers can contaminate RTE foods during 
handling, which can result in foodb orne 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 sanita tion controls can minimize the tr ansfer 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 manuf actures, 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 th e transfer of food allergens that  result in cross-contact.   
Proposed § 117.135(d)(3)(i)(A) and (B) would imp lement section 418(c) of the FD&C 
Act.  Proposed § 117.135(d)(3)(i)(A) also is cons istent with the recommendation of the Food 
CGMP Working Group that food processors be requi red to develop and maintain, at a minimum, 
written sanitation procedures for all food-contac t equipment and food-cont act surfaces (Ref. 1).  345 
 
  Under proposed § 117.135(b), the preventive cont rols for sanitation required by proposed § 
117.135(d)(3)(i)(A) and (B) would have to be written.   
HACCP plans, as described in the NACM CF HACCP guidelines (Ref. 34), the Codex 
HACCP Annex (Ref. 35), and Federal HACCP re gulations for seafood, juice, and meat and 
poultry (§ 123.6, § 120.7, and 9 CFR 417, respectivel y) require that control measures be 
established at CCPs to address hazards that are reasonably likely to occu r.  Because sanitation 
covers the entire processing environment, not ju st at CCPs, and is not limited to hazards 
reasonably likely to occur, sanita tion 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 C odex HACCP Annex (Ref. 35) addr ess sanitation measures as 
prerequisite programs and are si lent 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 416), wh ich is similar to our CGMPs in  current part 110 except that 
it includes SSOP requirements that, unlike our SSO Ps, require written sanitation procedures.  
In our HACCP regulations for seafood and ju ice, 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 m onitoring for eight specifi ed sanitary conditions 
and practices (referred to as SSOPs)  regardle ss of whether these conditions and practices are 
related to hazards that are r easonably likely to occur (§ 123.11(b) and 120.6(a) and (b), 
respectively).  The eight c onditions and practices are: 
• Safety of the water that comes into cont act with food or food-contact surfaces or 
that is used in the manufacture of ice; 346 
 
  • Condition and cleanliness of f ood-contact surfaces, includi ng utensils, gloves, and 
outer garments; 
• Prevention of cross contamination from insanitary objects to food, food packaging 
material, and other food-contact surfaces, includi ng 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 p ackaging material, and f ood-contact surfaces from 
adulteration with lubricants, fu el, 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 th at could result in the microbiological 
contamination of food, food packaging mate rials, and food-contact 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 (p art 120) with respect to the ei ght conditions and practices.  
However, in the PMO HACCP Appendix these c onditions and practices are referred to as 
“required prerequisite program s (PPs)” rather than SSOPs. 
The eight areas for which sanitation monitori ng 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 th ese activities to provide a 
framework to help ensure that the provisions of cu rrent part 110 that relate to the eight specific 347 
 
  elements of sanitation are addressed in a syst ematic 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 bu t does not require that it be 
written (§ 120.6(a)).  In cont rast, proposed § 117.135(d) would re quire written procedures for 
identified areas of sanitation a nd, in addition to monitoring and co rrective actions as required in 
seafood and juice HACCP for the eight areas of  sanitation, proposed § 117.135(d) would require 
monitoring procedures and ve rification activities.   
In considering the application of preventive c ontrols to the eight sa nitation controls and 
practices, we considered the different framewor k 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 prerequisi te 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 pr oposed § 117.135(d)(3) be addressed as preventive controls under 
subpart C and therefore be subject to requireme nts 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 s ubpart C are not necessary.  For 
these six areas, the value of mandating written  procedures and other additional requirements 
(e.g., written monitoring procedures and verifica tion) would not be significant because the 
relevant CGMP provisions in essence serve as th e written procedures to which the facility must 
adhere.  Some facilities may find value in adding mo re detail to the material contained in subpart 348 
 
  B, but FDA has tentatively conclude d that that would not be necessary  in order to ensure that the 
hazards that are reasonably likely to occur ar e significantly minimized or prevented.   
For example, one of the six areas of sanita tion is the safety of water used in food 
operations.  In many facilities, th e water is supplied by a municipal water authority that monitors 
the water and alerts its customers of any safe ty 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 require ment 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 cont rols (i.e., observe employees for signs of illness 
and redirect their activities accordingly).  Simila rly, procedures for ensuring the cleanliness of 
rest rooms or checking for the presence of pest s appear to be unnecessa ry, given the rather 
straightforward and universal nature of the controls.   
On the other hand, equipment cleaning proce dures, as would be required by proposed § 
117.135(d)(3)(i)(A) are very specific to the construction of the equi pment, the nature of the food, 
the physical characteristics of the water use d, the concentration of cleaning and sanitizing 
chemicals, the method of application, and th e cleaning and sanitizing interval, among other 
things.  For this reason, the procedures must be clear ly 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 th ese circumstances, explicit  cleaning procedures are 
essential.   349 
 
  Procedures to prevent cross-contact and cr oss-contamination, as  required by proposed § 
117.135(d)(3)(i)(B) are similarly complex and very situational.  Identif ying product and traffic 
flow within the facility, employee hand wa shing 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 re quire 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 416, which requires, in general, that each 
establishment take appropriate corrective acti on(s) when the establishment’s SSOPs or the 
implementation or maintenance of the SSOPs, may ha ve 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 contaminat ed, restore sanitary conditions, and prevent the 
recurrence of direct contamination or adu lteration of product(s) , including appropriate 
reevaluation and modification of the SSOPs or appropriate improve ments in the execution of the 
SSOPs (9 CFR 416.15).  
Proposed § 117.135(d)(3)(iii) would provide that th e owner, operator, or 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 ag ent in charge of a f acility takes action, in 
accordance with proposed § 117.135(d)(3)(ii), to corre ct conditions and practices that are not 350 
 
  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 documen t, 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 prob lem when a preventive control is not properly 
implemented and a specific corrective action proce dure has not been established or a preventive 
control is found to be ineffective.  For sani tation 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 th at are not consistent with the established sanitation control 
practices.   
There are many different ways in which c onditions and practices for sanitation can 
deviate from the established procedures.  In ma ny 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 pie ce of equipment) and/or retrai ning personnel to carry out the 
procedures correctly.  In many instances the proc edural deviations are not  reasonably likely to 
impact product (e.g., insanitary food-contact su rfaces are usually detected by a pre-production 
inspection of the equipment by plant personnel; de viations in cleaning so lution strength rarely 
result in the production of unsafe product if ot her cleaning and saniti zing 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 co mmerce, 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 requiri ng a facility to develop written 351 
 
  corrective action procedures for th e many sanitation deviations that  could occur.  We do expect 
the facility to take action to correct conditions and practices as appropria te 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, sa nitation 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 take n 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) woul d require that all corre ctive actions taken in 
accordance with proposed § 117.135(d)(3)(ii) be documen ted 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 docu ment corrective actions would be used to 
verify that appropriate decisions about corr ective 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 requ ire 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 defin ition of “preventive controls” fro m section 418(o)(3)(E) of the 
FD&C Act, which establishes that preventive contro ls may include a recall plan.  We include the 
details of the recall plan in pr oposed § 117.137 and discuss it in sec tion XII.D of this document.  
9. Proposed § 117.135(d)(5)--Other Controls 
Proposed § 117.135(d)(5) would requ ire that preventive controls  for hazards identified in 
the hazard analysis as reasonabl y likely to occur include any othe r controls necessary to satisfy 
the requirements of proposed § 117.135(a) – i.e., to significantly minimize or prevent hazards 352 
 
  identified in the hazard analysis and to provi de assurance that the f ood 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 th e need to implement preventive 
controls to minimize or prevent the potential fo r pathogen growth due to failure to control the 
temperature of the product during transportati on.  Most instances of failing to control 
temperature result primarily in quality issues su ch as product degradation or shortened shelf life, 
rendering the product unpalatable and thus precl uding consumption.  Howeve r, it is not common 
that products reach high enough temperatures fo r sufficient time to become hazardous due to 
growth of pathogens that may be present.  For pr oducts that present a ri sk that pathogens would 
grow and present a health hazard, preventive co ntrols could include temperature monitoring 
during transportation or other pr ocedures that would ensure th at product was not exposed to 
temperature/time intervals during transporta tion that would result in increased product 
temperatures for sufficient time to result in a pot ential safety issue.  Often such procedures 
involve the shipper ensuring that product temp erature is controlled during loading of the 
transportation vehicle, use of temperature record ing 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 propos ed § 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 pro cedures, practices, and processes that preventive controls may 353 
 
  include, and which section 418(f)(4) of the FD&C Ac t identifies as a verification activity).  In 
section XII.J of this document, we also reque st comment on a supplier approval and verification 
program as one of the procedures, practices, and processes that preventiv e controls may include 
(section 418(o)(3)(G)).  In secti on 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 prerequi site 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 incl ude certain Current Good Manufacturing Practice 
provisions among their preventive  controls (i.e., as “other controls”   in proposed § 
117.135(d)(6)).   10. Proposed § 117.135(e)--Applicability of Monito ring, Corrective Actions, and Verification 
Proposed § 117.135(e)(1)(i) through (iii) woul d specify that, except as provided by 
proposed § 117.135(e)(2), the preventive controls requi red 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 woul d be required by proposed § 117.150.  Proposed 
§ 117.135(e)(1)(i) through (iii) would rest ate the requirements of proposed §§ 117.140, 117.145, 
and 117.150 to clearly communicate the appl icability of proposed §§ 117.140, 117.145, and 
117.150 to the preventive controls  that would be required und er proposed § 117.135 and would 
establish no new requirements. 
Proposed § 117.135(e)(2) would provide that the r ecall plan that would be established in 
proposed § 117.137 would not be subject to the requirements of proposed § 117.135(e)(1).  A 354 
 
  recall plan would address food that had left the facility, wh ereas the proposed requirements for 
monitoring, corrective actions, and ve rification would all be directed  at food while it remains at 
the facility.  Thus, as pro posed, the requirements for monitoring, corrective actions, and 
verification have limited applicability to a re call plan.  However, a “mock recall” (i.e., a 
simulated recall situation) is a verification activ ity that could identify problems with a recall 
plan, enable a facility to corre ct the problems, and provide reas onable 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 crit ical 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 (secti on 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), th e procedures, practices, and processes described in the 
definition of preventive controls may incl ude, in relevant part , a recall plan.   355 
 
  2. Proposed § 117.137--Recall Plan for Food With a H azard That is Reasonably Likely to Occur 
Proposed § 117.137(a) would require that the owne r, operator, or agent in charge of a 
facility establish a written recall plan for food in wh ich there is a hazard that is reasonably likely 
to occur.  Although a recall is different from othe r preventive controls in that it is carried out 
after a product is distributed, it shares the purpose of signifi cantly minimizing or preventing 
hazards, which is accomplished by limiting consump tion of the affected food.  Time is critical 
during a recall. A written recall plan is essentia l to minimizing the time needed to accomplish a 
recall; additional time during whic h the food is on the market can result in additional consumer 
exposure.  Following an existing plan that addres ses 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 consiste nt with the NACMCF HACCP guidelines and the 
Codex GPFH.  The NACMCF HACCP guidelines r ecommend 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 jui ce do not include any requi rements for a recall 
plan; recommendations for addressing a recall fo r food can be found in our general guidance on 
policy, procedures, and industry re sponsibilities regarding recalls in subpart C of part 7 (§§ 7.40 
through 7.59).  The guidance advises firms to prep are and maintain a current written contingency 
plan for use in initiating and effecting a recall (§ 7.59).  Like wise, the FSIS HACCP regulation 
for meat and poultry does not require a recall plan; FSIS addresses recalls through guidance to 
industry.  356 
 
  Proposed § 117.137(b) would require that the recall plan include procedures that describe 
the steps to be taken, and assi gn 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 affect ed food (proposed § 117.137(b)(1));  
• Notify the public about any hazard presented by the food when appropriate to 
protect public health (p roposed § 117.137(b)(2));  
• Conduct effectiveness checks to verify th at the recall is ca rried 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 sa fety concern, or destroying the food (proposed § 
117.137(b)(4)). 
Procedures that describe the st eps to be taken would enable a facility to act promptly by 
following its plan when the facility determines th at a recall is warranted rather than developing a 
plan of action after the need fo r a recall is identified.  Procedur es 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 char ge 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 c onsignees about the recall (p roposed § 117.137(b)(1)) is the 
most effective mechanism to ensure direct cons ignees know that the pr oduct is being recalled 
and is consistent with our ge neral guidance on recall communications in § 7.49(a).  Further, 
instructing direct consignees how  to return or dispose of an affected product minimizes the 357 
 
  chance the affected product will be disposed of improperly and allows direct consignees to act 
quickly.  Further, it is consiste nt with our guidance on the conten t of recall communications in § 
7.49(c)(4).  We have provided guidance to indust ry on model recall letters (Ref. 164) (Ref. 165).  
This guidance may be useful in developing proce dures for directly notif ying direct consignees 
about the recall and on how to return or  dispose of an affected product.   
Notification procedures coul d identify a variety of comm unication means, including 
email, telephone, fax, text messaging, and urgent  mail delivery.  Notification procedures that 
would establish only a general no tification to the public (e.g., th rough a press release or through 
information posted on a facility’s Web site), wit hout procedures for concurrent contact directly 
with direct consignees about how to access the general notifica tion, would not satisfy proposed § 
117.137(b)(1); a general notificati on 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 presente d 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 a bout 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 th e public that a product being recalled presents a hazard to health 
(§ 7.42(b)). Notifying the public, in  addition to direct consign ees, may not be necessary to 
protect the public if, for exam ple, 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 rele ases or other means, 
such as by information posted on the facility’s We b site or provided to consumers using social 358 
 
  media.  We have provided guidan ce to industry with examples of  model press releases for the 
presence in food of undeclared food allerg ens 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 ou r guidance on a recall stra tegy in § 7.42(c)(3).  
Procedures to conduct an effectiveness check co uld expand on the procedures used to directly 
contact consignees about the recall –e.g., to includ e 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 e ffectiveness checks (Ref . 164); this guidance 
includes a model effectiveness check letter (Ref. 170), a mode l 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 tele phone 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, reworki ng, diverting to a use th at does not present a 
safety concern, or destroying the product.  Thes e types of disposition actio ns 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 discussi on of corrective 
actions in the final rule to establish our HA CCP regulation for seafood; 60 FR 65096 at 65127).  
Procedures for disposition of a product can help the facility ensu re 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 reca ll can be considered terminated.  Thus, having 359 
 
  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 wh ether a recall is terminated.  
We request comment on whether th e procedures to be included in the recall plan (i.e., to 
directly notify consignees, to notify the public, to conduct effec tiveness 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 requ ire 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 di scussed in section II.A.6 
of this document, notifying FDA of a reportabl e food is required by se ction 417 of the FD&C 
Act.  Reportable food reports include informa tion about whether a re portable 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 cont rols.  Section 418(d) of the FD&C 
Act specifies that the owner, operator, or agen t in charge of a faci lity shall monitor the 
effectiveness of the preventive controls implemented under secti on 418(c) of the FD&C Act to 
provide assurances that the out comes described in section 418 (c)] shall be achieved.  The 
outcomes relevant to this proposal are those that provide assurances that hazards identified in the 360 
 
  hazard analysis will be significantly minimized  or prevented and that food manufactured, 
processed, packed or held by a facility will not  be adulterated under se ction 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, th at the owner, operator, or 
agent in charge of a facility  maintain records documenting the monitoring of the preventive 
controls implemented under secti on 418(c) of the FD&C Act. 
Section 418(h) of the FD&C Act requires, in relevant part, th at the owner, operator, or 
agent in charge of a facility pr epare a written plan that documen ts and describes the procedures 
used by the facility to comp ly 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 verifi cation.”  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 activiti es include: visual observation 
and measurement of temperature, time, pH, and moisture level (Ref. 34).  The NACMCF 
HACCP guidelines identify three pu rposes of monitoring (Ref. 34).  First, monitoring is essential 
to managing food safety because it facilitates tracking of the operat ion (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., ope rating according to pl an), and can provide 
information about shifts away from control.  If monitoring indicates that there is a trend towards 
loss of control, a facility can ta ke 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 361 
 
  nuts is 290ºF, and the procedure for roasting the nuts in an oil roaster calls for an operating 
temperature of 350ºF, monitoring would detect that the temper ature in the oil roaster was 
dropping and enable the facility to identify and fix the problem with temperature before the 
temperature drops to 290ºF.  Sec ond, monitoring is used to determin e when a deviation occurs at 
a critical control point (i.e., exceeding or not mee ting a critical limit), indicating there is loss of 
control.  In the previous example, there would be loss of control if the temperature drops to 
289ºF.  When a deviation occurs, an appropriate corrective action must be taken – e.g., stop the 
roasting process until the temper ature in the oil roaster can be maintained above 290ºF and 
reprocess nuts that were not roasted at the ap propriate temperature.  Third, monitoring provides 
written documentation for use in verification.  For example, if the f acility 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 act ivity 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 vali dity of the food safety plan and that the system is operating 
according to the plan.”  We discussed this defi nition, 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 a nd technically sound, that all hazards have been 
identified and that if the HACCP plan is prope rly implemented these hazards will be effectively 
controlled.  Another aspect of ve rification is evaluating whether the facility's HACCP system is 362 
 
  functioning according to the HACCP plan.  Both of these aspects are directed at the effectiveness 
of a preventive control; they es tablish that the preventive contro l is scientifically valid for 
controlling the hazard and verify that the prev entive control is accomplishing its intended 
purpose.  The Codex HACCP Anne x addresses verification as de termining compliance with the 
HACCP plan and confirming that the HACCP sy stem is working effectively (Ref. 35).  
Examples of verification activitie s include review of monitoring records and review of records 
for deviations and corrective acti ons.  We discuss verification activ ities in more detail during our 
discussion of proposed § 117.150 (Verification)  in section XII.G of this document. 
4. Relationship Between M onitoring and Verification 
Monitoring and verification ar e closely related; both address the performance of 
preventive controls, and verifi cation relies in part on monito ring records to establish that 
preventive controls developed to signifi cantly minimize or prevent hazards are being 
implemented according to plan.  Three provi sions of section 418(f) of the FD&C Act 
(Verification) are partic ularly relevant when considering the role of monitoring.  First, section 
418(f)(1) of the FD&C Act requires that the owner, operator, or ag ent in charge of a facility 
verify that “the preventive controls implement ed . . . are adequate to control the hazards 
identified. . . .”  Second, section 418(f)(2) of the FD&C Act requires that th e owner, operator, or 
agent in charge of a facility ve rify 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 preventi ve controls implemented . . . are effectively and 
significantly minimizing or prev enting the occurrence of identif ied hazards. . . .”    363 
 
  5. Monitoring the Performan ce of Preventive Controls  
Section 418(a) requires monitoring the “per formance” of preventive controls whereas 
section 418(d) requires monitoring their “effectiveness.”  We te ntatively conclude that the 
language of section 418 regarding monitoring is ambiguous and that  it would be appropriate to 
require monitoring of the performance of prev entive controls.  “Performance” means “the 
execution or accomplishment of an action, operation, or process undertaken or ordered" (Shorter 
Oxford English Dictionary, Fifth Ed. (2002), p. 2 157) and is consistent with use of the term 
“monitoring” in traditional HACCP.  Monitoring the performance of preventive controls would 
be undertaken to determine whethe r 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 obse rvations and measurements of temperature, 
time pH, and moisture level.  In co ntrast, “effectiveness” refers to the quality of "having an effect 
or result" (Shorter Oxford English Dictionary, Fift h 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.  Secti on 418(f) requires verifica tion that the preventive 
controls “are effectively and significantly minimi zing the occurrence of the identified hazards. . . 
.”  The activities necessary for such verifi cation 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, monito ring the effectiveness could include testing for 
the presence of the hazard, such as  testing for the presence of staphylococcal enterotoxin that can 364 
 
  occur during cheese making if the pH does not  drop to a low enough level in a short enough 
time. Further, requiring monitori ng of effectiveness rather than  performance of the preventive 
controls would create a significan t 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 cont rast, monitoring the performance of preventive 
controls would provide evidence that  the preventive controls estab lished to control the identified 
hazards are implemented appropr iately (e.g., pH of the cheese curd drops below 5.6 within 8 
hours) and thereby are effectiv ely 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 re gulations and guidance.  Sec tion 418(n)(5) of the FD&C Act 
directs the Secretary, in promulga ting 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 performa nce of preventive controls is consis tent with applicable domestic and 
internationally recogn ized standards.   
Therefore, we tentatively conc lude that this interpretation is reasonable, and we propose 
to adopt it in the proposed requirements implem enting 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 freque ncy with which they are to be performed, for 365 
 
  monitoring the preventive cont rols.  Proposed § 117.140(a) woul d 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 fo r 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 docum ent.  Each of these purposes applies to 
preventive controls as well, a nd 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 assuranc e 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 pr eventive control is not properly implemented and 
potentially unsafe product is produced.  Further,  if monitoring is c onducted with sufficient 
frequency to ensure preventive cont rols 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), indicati ng loss of control and sign aling the need for an 
appropriate corrective action.  Finally, the pr oposed 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 th is information in time to make adjustments to 
ensure control of the process to prevent violat ing 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 th e written HACCP plan 366 
 
  monitoring of control measures to determin e whether physical, chemical, or biological 
parameters are being met (i.e., monitoring of criti cal 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 Federa l HACCP regulations for seafood, ju ice, 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 m onitoring procedures be written.  Under 
section 418(d) of the FD&C Act, the owner, opera tor, or agent in charge of a facility must 
monitor the effectivenes s of the preventive controls impl emented 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 it s example of a HACCP worksheet (Ref. 35).  
Federal HACCP regulations for seafood, juice a nd 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 th e 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 fre quency of monitoring must be sufficient to ensure 
that the preventive control is consistently perfor med in order to help en sure that the preventive 
control is effective.  The NACMCF HACCP guidelines note that  the frequency of monitoring 367 
 
  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 monito ring (§§ 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 char ge of a facility monito r the preventive controls 
with sufficient frequency to provide assurance th at they are consistently performed.  Proposed § 
117.140(b) does not specify a singl e monitoring frequency appli cable to all facilities and 
processes.  Rather, it requires monitoring with  “sufficient frequency” to assure that the 
preventive controls are consis tently performed.  Proposed § 1 17.140(b) would implement section 
418(d) of the FD&C Act and is consistent wi th 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 type s of physical and chemical parameters.  For 
example, the temperature and time for many ther mal processes can be recorded continuously on 
temperature recording charts.  If the temperatur e falls below the scheduled temperature or the 
time is insufficient, as recorded on the chart, th e affected product can be retained and evaluated 
to determine the appropriate disposition.  Exampl es 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 c ooking, cooling, or acidific ation can be properly 368 
 
  implemented.  NACMCF states that if monitoring is not continuous it may be difficult to ensure 
that the preventive controls are consistently im plemented and a problem has not occurred.  Thus, 
according to NACMCF, the frequency of non-conti nuous 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 non-continuous m onitoring 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 need ed to ensure safety of roasted nuts  is 290ºF, 
non-continuous monitoring would need to be more  frequent when an oil roaster for nuts is 
operated at 300ºF than when the oi l roaster is operated at 350º F.  As another example, if 
temperatures vary by 10-15ºF du ring processing, monitoring woul d 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 monito ring (§§ 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). 369 
 
  c. Proposed § 117.140(c)--Requirement for records .  Proposed § 117.140(c) would 
require that all monitoring of preventive co ntrols 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 th e FD&C Act and is consistent with the NACMCF HACCP 
guidelines, the Codex HACCP Annex, and Federa l 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 genera ted during the operation of  the plan (Ref. 34).  
The Codex HACCP Annex gives reco rds of CCP monitoring activitie s as an example of records 
(Ref. 35).  Our HACCP regulations for seafood a nd juice require that th e HACCP plan provide 
for a recordkeeping system that documents the monitoring of the critic al control points (§§ 
123.6(c)(7) and 120.8(b)(7), respec tively).  The FSIS HACCP re gulation for meat and poultry 
requires records documenting the monitoring of CCPs and their critical limits, including the 
recording of actual times, temperatur es, 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 prev enting 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 provi de 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 manufacture d, processed, packed or held by such facility 370 
 
  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 th e 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 th e owner, operator, or agent in charge of a 
facility shall establish procedures to ensure that, if the preventive co ntrols 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 ente ring into commerce if the owner, operator 
or agent in charge of such facility cannot ensu re that the affected f ood 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 Ac t requires, in relevant part, that the owner, operator, or 
agent in charge of a facility verify that the preventive contro ls implemented under section 418(c) 
of the FD&C Act are effectively and significan tly minimizing or preventing the occurrence of 
identified hazards. 371 
 
  2. Proposed § 117.145(a)--Corrective Action Procedures 
Proposed § 117.145(a)(1) would require that the ow ner, operator, or agent in charge of a 
facility establish and implement written correc tive action procedures th at must be taken if 
preventive controls are not properly implemented .  Having written procedures in place would 
enable facilities to act quickly and appropriate ly 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 th e NACMCF HACCP guidelines, the Codex HACCP 
Annex, and Federal HACCP regulations fo r seafood, juice, and meat and poultry.  
The NACMCF HACCP guidelines define a co rrective action as procedures followed 
when a deviation occurs at a CCP and recommen d 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 deve loped 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 occu rs, either by following specific corrective action 
procedures specified in the regulation, or by fo llowing procedures in written corrective action 
plans that the proce ssor develops (§§ 123.7 a nd 120.10, respectively).  If  the processor of a 
seafood or juice product covered by the applicable HACCP regulati on develops such plans, they 
must be included in the written HACCP pl an (§§ 123.6(c)(5) and 123.7(b) and 120.8(b)(5), 
respectively).  The FSIS HACCP regulation for meat and poultry require s 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)).   372 
 
  As discussed in section XII. C.4  of this document, the proposed rule would establish 
requirements for preventive controls (which may be at critical contro l points), and proposed 
§ 117.135(c)(2) would require that th e 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 chemi cal parameter must be controlled to significantly minimize or 
prevent a hazard that is reasona bly likely to occur (which re flects 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, correc tive action would be triggered.  Thus, the 
concept in the proposed rule of taking correctiv e action when a preventive control is not properly 
implemented is similar to the concept in HA CCP systems of taking corrective action for a 
deviation from a critical limit at  a critical control point.   
The benefits from identifying corrective acti on procedures in advance of the need to 
actually take corrective action la rgely derive from having the pr ocedures in written form.  
Written corrective action procedures would be esse ntial 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 ar e taken if preventive controls are not properly implemented.  
Having access to appropriate, written corrective ac tion 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 appr opriate 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; th e procedures a facility  will use to address 
implementation failures are essential to the produc tion of safe food, and without them a complete 
assessment cannot be made. Written corrective action procedures also would be useful for 373 
 
  training purposes, so that employees who woul d need to implement the corrective action 
procedures will be prepared for what they would need to do.   
Proposed § 117.145(a)(2) would implement secti on 418(e) of the FD&C Act (i.e., that  
the owner, operator, or agent in charge of a f acility must establish co rrective action procedures) 
and section 418(h) of the FD&C Ac t (i.e., that the owner, operato r, or agent in charge of a 
facility must prepare a writte n plan).  Proposed § 117.145(a)(2) is  consistent with the NACMCF 
HACCP guidelines, the Codex HACCP Annex, a nd with Federal HACCP regulations for 
seafood, and juice, and meat and poultry. Th e 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 a dvises that deviation and product disposition 
procedures be documented in the HACCP record keeping (Ref. 35).  Our HACCP regulations for 
seafood and juice both require th at the written HACCP plan incl ude 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 a nd poultry requires that the wr itten 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 co rrective action procedures describe the 
steps to be taken to ensure that: 
• Appropriate action is taken to identify a nd correct a problem with implementation 
of a preventive control to reduce the like lihood that the problem will recur (proposed § 
117.145(a)(2)(i));  
• All affected food is evaluated for sa fety (proposed § 117.145(a)(2)(ii)); and  
• All affected food is prevented from en tering into commerce, if the owner, 
operator or agent in charge of such  facility cannot ensure that th e affected food is not adulterated 374 
 
  under section 402 of the FD&C Act or misbra nded 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 reas onably likely to occur, and to significantly minimize or prevent 
the occurrence of such hazards and provide assu rances 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 sect ions 418(e)(1)-(3) of the FD&C Act and 
is consistent with the NACMCF HACCP gui delines, the Codex HACCP Annex, and Federal 
HACCP regulations for seafood, juice, and m eat and poultry. The NAC MCF HACCP guidelines 
recommend that corrective actions  include elements to determin e and correct the cause of non-
compliance and to determine the disposition of  non-compliant product (Ref. 34).  The Codex 
HACCP Annex advises that the sp ecific 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 se afood 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 taki ng those steps, to ensure that  no product enters commerce that 
is either injurious to h ealth 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 requ ires that the HACCP plan descri be the corrective action to be 
taken, and assign responsibility for taking corrective action, to ensure: (1) the cause of the 375 
 
  deviation is identified and eliminated; (2) th e CCP will be under control after the corrective 
action is taken; (3) measures to  prevent recurrence ar e 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 likeli hood 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 exam ple, if the temperature of a heat process cannot 
be maintained, a corrective action to raise the te mperature 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 re placing the boiler to increase 
capacity.  Similarly, if a facility cannot cool a fo od rapidly enough in a refrigerator to meet the 
cooling times and temperatures in  its HACCP plan, the initial co rrective action may be to move 
product into a freezer for cooling.  If the root cau se 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 determin ed to be insufficient cooling 
capacity to remove heat from the amount of product being cooled, th e 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 co rrective action procedures 
include an evaluation of all food affected by a pr oblem and procedures for ensuring that affected 376 
 
  food is prevented from entering into commerce if the owner, operator or ag ent 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 evalua tion is implicit in our 
HACCP regulations for seafood a nd juice (§§ 123.7(b) and 120.10(a )) in that these sections do 
not explicitly require that food affected by the pr oblem 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 s eafood and juice do not specify the steps that 
must be described in a corrective action plan, the regulati ons require that spec ific steps be taken 
when a deviation from a critical limit occurs a nd the processor does not ha ve a corrective action 
plan that is appropriate for that deviation ( §§ 123.7(c) and 120.10(b), resp ectively).  Under these 
regulations, required steps incl ude segregating and holding eff ected 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 otherw ise 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 Pr otection Act of 2004 (Public Law 108-282, Title 
II), which was enacted after issuance of bot h the seafood and juice HACCP regulations.  
However, our HACCP regulation for juice includes  the presence of undeclar ed 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 H azards and Controls Guidance (Fourth Edition) 
(Ref. 173) and Juice HACCP Hazards and C ontrols Guidance (Ref. 4) both include 
recommendations directed to hazards from undeclared food allergens.    377 
 
  3. Proposed § 117.145(b)--Corrective Action in th e 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 ag ent in charge of a facili ty take corrective action 
to identify and correct the problem, evaluate al l affected food for safe ty, 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 ma y experience an implementation failure for which 
a corrective action procedure has not been esta blished.  Regardless of whether a problem was 
anticipated and a corrective acti on procedure was developed in a dvance, corrective actions to 
accomplish the steps that would have been in cluded in a correctiv e action procedure are 
necessary.  Likewise, a facility  might determine (e.g., as a veri fication activity in accordance 
with proposed § 117.150(d), discussed in section X II.G.5 of this document), that a preventive 
control is ineffective.  For example, detec ting a pathogen in an RTE food may signal that 
preventive controls for that pathogen are ine ffective.  As in the case of an unanticipated 
implementation failure of a preventive control,  corrective actions woul d 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 regulati ons for seafood and juice require that, when a 
deviation from a critical limit occurs and the pro cessor does not have a corre ctive action plan that 
is appropriate for that deviati on, the processor segregate and hol d the affected product; perform 
or obtain a review to determine the acceptability  of the affected product for distribution; take 
corrective action, when necessary, w ith respect to the affected pr oduct to ensure that no product 378 
 
  enters commerce that is either injurious to health or is otherwise adulterated as a result of the 
deviation; and take corr ective action, when necessary, to corr ect 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 devi ation 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 l east 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 adultera ted, as a result of the deviation, 
enters commerce.  The NACMCF HACCP guidelin es 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 ha s not been established or when a preventive 
control has been found to be ineffective.  Ho wever, proposed § 117.145(b)(1) is consistent with 
HACCP principles, discussed earlier in th is section, recommended in the NACMCF HACCP 
guidelines and Codex HACCP Annex regarding th e importance of corrective actions whenever 
there is a deviation from a critic al limit.  In each of the situ ations described (following an 
established corrective action, ta king corrective action in the absence of a plan, or taking 
corrective action when the preven tive 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 ow ner, 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 379 
 
  implemented and a specific corrective action has not  been established, or if a preventive control 
is found to be ineffective.  (We use the term “r eanalyze” 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 require d by section 418(f) of th e FD&C Act would include 
validation of the food safety plan, referring to whet her it is effectively cont rolling the hazards or 
“working correctly.”  See sect ion XII.G of this document for a discussion of proposed 
requirements for verification (including validatio n 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 th e food safety plan.  If 
the owner, operator, or agent in charge of a fac ility 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 preven tive controls).  If the problem is simply an implementation 
failure, and such a failure is now a foreseeable ci rcumstance, reanalysis of the food safety plan 
would be necessary to determine whether a corr ective action procedure s hould be established for 
that foreseeable failure.  Likewise , if the 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 w ould 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.  380 
 
  Proposed § 117.145(b)(2) is consistent with  the NACMCF HACCP guidelines, the Codex 
HACCP Annex, and Federal HACCP regulations fo r seafood, juice, and meat and poultry. The 
NACMCF HACCP guidelines, in rele vant part, recommend that va lidations (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 veri fication procedures would also be used if an 
unexpected implementation failure of a preventiv e control suggests that  the system is not 
working correctly.  Our HACCP regul ations for seafood and juice, in  relevant part, require that, 
when a deviation from a critical limit occurs a nd the processor does not ha ve a corrective action 
plan that is appropriate for that deviation, the processor must perf orm or obtain timely 
reassessment or verification by a trained individual to determin e whether modification of the 
HACCP plan is required to reduc e the risk of recurrence of th e deviation and to modify the 
HACCP plan as necessary (§§ 123.7(c)(5) and 1 20.10(b)(5), respectively).  The FSIS regulation 
for meat and poultry requires, in relevant part, that if a devi ation 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 “r eassessment” much as this proposed rule would 
use the term “reanalysis.”) 4. Proposed § 117.145(c)--Documentation. 
Proposed § 117.145(c) would require that all co rrective actions taken in accordance with 
this section be documented in records that are subject to ve rification in accordance with § 381 
 
  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 abou t corrective actions are 
being made and appropriate correc tive 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 th e owner, operator, or agent in charge of a 
facility verify that: 
• The preventive controls implemented unde r 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 co nducting monitoring in accordance with 
section 418(d) of the FD&C Act (s ection 418(f)(2) of the FD&C Act); 
• The owner, operator, or agent is maki ng 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 unde r section 418(c) of the FD&C Act are 
effectively and significantly minimizing or pr eventing 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, periodi c reanalysis of the plan under section 418(i) of the 
FD&C Act to ensure that the plan  is still relevant to the raw ma terials, conditions and processes 
in the facility, and new and emerging thre ats (section 418(f)(5) of the FD&C Act). 
In addition, section 418(g) of th e FD&C Act specifies, in rele vant part, that the owner, 
operator, or agent in charge of  a facility shall maintain, for not less than 2 years, records 382 
 
  documenting the monitoring of the preventive cont rols 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 verificati on under section 418(f)(4) of th e FD&C Act, instances when 
corrective actions were implemented, and the e fficacy of preventive controls and corrective 
actions. 
Further, section 418(i) of the FD&C Act specifi es 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 c onducted at a facility operated by such owner, 
operator, or agent if the change  creates a reasonable potential fo r 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 id entified, if any, shall be implem ented before the change in 
activities at the facility is opera tive. The owner, operator, or agen t shall revise the written plan 
required under section 418(h) of the FD&C Act if such a signifi cant 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 sec tion 418(i) of the FD&C Act to respond to new 
hazards and developments in scie ntific 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 preventi ve controls are adequate to control the 
hazard .  Proposed § 117.150(a) (Validation) would re quire that, except as provided by paragraph 383 
 
  (a)(3), the owner, operator, or ag ent in charge of a facility vali date 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 o ccur 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 descri be 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 scie ntifically 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 th e efficacy of all elements of the HACCP system 
(Ref. 35).  Our HACCP regulation for seafood does not specifically use th e term “validation,” 
but it reflects the concept in requiring that ev ery processor verify th at 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)) a nd the hazard analysis (§ 120.11(c)).  The 
regulation requires each pr ocessor to validate that the HACCP plan is adequate to control food 
hazards that are reasonably likely to occur at least once within 12 mont hs after implementation 
and at least annually thereafter.  (This annual validation is the sa me as reanalysis proposed in 
§ 117.150(f) and discussed in section XII.G.7 of th is 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 th at every establishment validate the HACCP plan’s adequacy 384 
 
  in controlling the food safety hazards identified  during the hazard analysis. The regulations and 
guidelines described above reflect the widespread recognition of th e importance of ensuring that 
preventive controls, if properly implemente d, will adequately control the hazards.    
b. Proposed § 117.150(a)(1)--Validation by a qualifi ed individual prior to implementation 
and on reanalysis .  Proposed § 117.150(a)(1) would require th at the validation of the preventive 
controls be performed by (or overseen by) a qualif ied individual.  The preventive controls must 
be adequate to control the hazards identified in th e hazard analysis as reasonably likely to occur.  
Determining whether specific preventive controls  are adequate requires an individual who is 
knowledgeable in the hazards as sociated with a product and process and the appropriate 
preventive controls for those haza rds.  Such knowledge requires sc ientific 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 we eks of production.  The 
validation of preventive controls includes coll ecting and evaluating scie ntific and technical 
information (or, when such information is not av ailable or is insufficien t, 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 contro l points.  This scientific and technical basis largely must be 
established prior to producing a product to ensure th at the food produced us ing 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, ra ther than before, producing a 
product.  For example, ensuring that limits for control parameters can be met during production 385 
 
  would be done under production conditions.  FDA te ntatively concludes that preventive controls 
that require the collection of da ta or information, or studies, during production conditions are 
part of validation, and, thus proposed § 117.150(a)(1 )(i) would require th at the validation of 
preventive controls be  performed, when necessa ry, 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 th e plan (Ref. 34).  A Codex document entitled 
“Guidelines for the Validation of Food Safety Control Measur es” (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 im plementation and at least annually thereafter (§ 120.11(b)).  The FSIS 
HACCP regulation for meat and poultry (9 CFR 417.4(a)) requires that in itial 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 poultr y establishment must repeatedly test the 
adequacy of the CCPs, critical limits, monitoring and recordkeep ing procedures, and corrective 
actions set forth in the HACCP plan (9 CFR 417.4(a)(1)).  386 
 
  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 woul d be required are addr essed 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 additi onal preventive controls 
needed to address the ha zard identified, if any, before the change  in activities at the facility is 
operative, or, when necessary, during the first si x weeks of production.  A ll preventive controls 
established to address a hazard identified as reasona bly likely to occur must have a scientific and 
technical basis; establishing that scientific and technical basis is a valid ation activity regardless 
of whether the preventive c ontrol is established in the facility’s initial f ood safety plan or as a 
result of reanalysis of the food safety plan.    
c. Proposed § 117.150(a)(2)--Valid ation based on scientific and technical information .  
Proposed § 117.150(a)(2) would require that, excep t as provided by paragraph (a)(3) of this 
section, the validation of preven tive controls include collecti ng and evaluating scientific and 
technical information or, when such information is not available or is insufficient, conducting 
studies to determine whether the preventiv e controls, when properly implemented, will 
effectively control the hazards  that are reasonably likely to occur.  The NACMCF HACCP 
guidelines note that information needed to vali date 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, prev ious validation studies 387 
 
  or historical knowledge, (2) scient ifically valid experimental data , (3) collection of data during 
operating conditions, (4) mathematical modeling, a nd (5) surveys, and not e 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 effectivel y control the hazards that are reasonably likely to occur may 
include scientific publications , government documents, predictive mathematical models and 
other risk-based models, and technical inform ation from equipment manufacturers, trade 
associations, and other sources.  If the qualif ied individual conducting the validation relies on 
sources such as scientific publications, the qua lified individual would need to ensure during 
validation that the conditions used  by the facility ar e 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 demo nstrates adequate inactivation of Salmonella  spp. 
in peanuts using a roasting proce ss, conditions such as roaster temperature, heating time, bed 
depth and humidity that were critical to achievi ng inactivation in the st udy 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 scientif ic and technical information 
useful in establishing the va lidity of a preventive control measure, such as times and 
temperatures for cooling foods in which bacter ial pathogen growth may occur or minimum water 
activities, minimum pH values, and minimum and maximum temperatur es for growth of a 
variety of pathogens.   388 
 
  Predictive mathematical models that describe  the growth, survival, or inactivation of 
microorganisms in foods may provide scientific a nd technical information useful in determining 
whether a process would be adequate to reduce microorganisms of public health concern (Ref. 
34) (Ref. 127).  Other risk-based models may examine the impact of a control measure on a hazard and may be useful if appropriately valida ted for a specific food.  If the model is for a 
different food, it may still provide useful validat ion information that could be supplemented by 
additional data.  For example, there are many ma thematical 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 a
w that were used in developing th e thermal resistance model, then 
heat processes based on the model would generall y be considered validat ed. 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 tomato es 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 th e 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 pr ocess 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 le ss 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 389 
 
  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 th e relationship between parameters such as 
process times and temperatures and other factor s and the rate at whic h 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 establ ish the cumulative amount of pathogen reduction 
that would be required to adequa tely reduce the risk of illness fr om that pathogen.  Such studies 
are typically published or otherw ise broadly disseminated within  the scientific community and, 
when properly designed and carri ed 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 domai n.  Such studies would also esta blish the critical parameters 
and limits (e.g., critical limits at a CCP) that the f acility would need to us e to effectively control 
the hazard.  For the hazelnut example, the cr itical factors might include amount of PPO, 
temperature of the nuts to be treated, treatm ent time, chamber temperature, PPO vaporizer 
temperature, chamber vacuum, and post-treatme nt hold time and temperature.  Studies on 
inactivation of Salmonella  spp. on almonds could provide information about appropriate 390 
 
  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 meas ures.  For example, NACMCF has published 
information on “Parameters for Determining Inoc ulated Pack/Challenge Study Protocols” (Ref. 
175) and “Requisite Scientific Parameters fo r Establishing the Equiva lence of Alternative 
Methods of Pasteurization” (Ref. 176).  Studies to validate preven tive control measures must be 
conducted by persons with experience and expertis e 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 valid ity 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 qualifie d individual need not have the experience and 
expertise to conduct validation studies, but must have sufficient expertise in risk-based 
preventive controls to understa nd 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 pr ovide that validation need not address: 
• The food allergen controls that would be  established in pr oposed § 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.   391 
 
  According to NACMCF, verification involves act ivities to determine the validity of the 
HACCP plan and that the system is operating accord ing 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 impl emented are adequate to control the hazards 
identified as reasonably likely to occur.  F DA tentatively concludes that validation, i.e., the 
evaluation of scientific and tec hnical information, is either no t an essential activity, is not 
practical or is not relevant, for the co ntrols identified in proposed § 117.150(a)(3). 
Food allergen controls .   
As discussed in section X II.C.6 of this document, proposed § 117.135(d)(2)(i) would 
require that food allergen controls include th ose procedures, practices , and processes employed 
for ensuring protection of food fr om cross-contact, including during storage and use.  Examples 
of such procedures, practices, a nd processes include providing physic al barriers between sections 
of a facility, conducting manufactur ing/processing of foods in di fferent parts of a facility, and 
controlling the movement of t ools and personnel that might carry allergens when the same 
production lines are used for both foods that cont ain allergens and foods those that do not, or 
when the same production lines are used for foods that contain different a llergens.  These types 
of controls generally are not ev aluated through scientific studies or by the collection of technical 
information as would be required under propos ed § 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 ar e functioning as intended to pr event the hazard of undeclared 
allergens in the food due to cross-contact.  Ex amples 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 clea ned, and that equipment is cleaned between 392 
 
  manufacturing/processing of diffe rent foods.  Thus, FDA tentatively concludes that this proposed 
rule should not propose to requir e validation of the adequacy of the food allergen cross-contact 
controls that would be establ ished in proposed § 117.135(d)(2)(i).  We request comment on this 
approach.  
As discussed in section X II.C.6 of this document, proposed § 117.135(d)(2)(ii) would 
require that food allergen controls include th ose 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 su ch procedures, processes,  and practices include 
ensuring that the food label correc tly declares all of the food allergens present (including those 
contained in flavorings, colorings , and incidental additives), ensu ring 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 stud ies or by the collection of tec hnical information as would be 
required under proposed § 117.150(a)(2).  Instead, verifying that labels contain appropriate 
information and monitoring that the correct la bel is being applied to the product provide 
sufficient assurance that the controls are func tioning 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 pr opose 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 X II.C.7 of this document, pr oposed § 117.135(d)(3)(i)(A) would 
require that, where relevant to hazards that are reasonably likely  to occur, sani tation controls 393 
 
  include procedures for the cleanliness of food- contact surfaces, includi ng food-contact surfaces 
of utensils and equipment.  Traditionally, sa nitarians employed by the facility or experts 
employed by companies that supply cleaning an d sanitizing compounds will establish critical 
parameters and associated limits for cleaning and sanitation, including the c hoice and strength of 
the cleaning and sanitizing chem icals, contact time, and temperature requirements, based on 
studies conducted by the manufactur ers of the products.  Antimicrobi al solutions applied to food 
processing equipment and utensils to sanitize su ch objects after they have been washed are 
included in the definition of "p esticide 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” (R ef. 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 th is proposed rule should not propos e to require validation of the 
adequacy of the sanitation c ontrols that would be require d 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 ha zards from insanitary food-contact surfaces.  
We request comment on this approach. 
As discussed in section X II.C.7 of this document, pr oposed § 117.135(d)(3)(i)(B) would 
require that, where relevant to hazards that are reasonably likely  to occur, sani tation controls 
include procedures for the prevention of cross-co ntact and cross-contamination from insanitary 
objects and from employees to food, food packagi ng material, and other food-contact surfaces 
and from raw product to processed product.  As already discussed with respect to proposed § 
117.135(d)(3)(i)(A), sanitation controls to preven t cross-contamination can be established by 394 
 
  sanitarians or by companies that supply cleani ng and sanitizing compounds without the need for 
validation by the facility.  Cleaning procedures established by sanitation ex perts should also be 
adequate to remove allergens from equipmen t and the environment in facilities where raw 
materials or ingredients contai ning allergens are used.  Altho ugh 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 situ ations (Ref. 124).  For ex ample, 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 s oy protein may make it practical to clean the 
equipment and then test a water rinse of the syst em 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 ma ke breaded fish.  We tentatively conclude that 
validation by the facility to demonstrate that sa nitation controls adequate ly protect against cross-
contact is not feasible for all situations at this time.   
Regardless of whether this proposed rule w ould require the specifi c verification activity 
of validation to demonstrate that sanitation cont rols adequately protec t against cross-contact, 
proposed § 117.135(d)(3)(i)(A) would requ ire that the owner, operator,  or agent in charge of a 
facility establish appropriate alle rgen sanitation procedures to ensu re that products do not contain 
undeclared allergens from other products.  Cl eaning procedures establ ished to remove food 
residues and verification that f ood 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 th at 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 395 
 
  against cross-contact in those situations where appropriate an alytical 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 pl an can significantly minimize 
or prevent hazards by limiting consumption of affected food during a recall.  Following an 
existing plan that addresses all necessary elem ents of a recall helps minimize delay created by 
uncertainty as to the appropriate actions to ta ke and helps ensure cr itical actions are not 
overlooked.  The proposed requirement to valid ate a preventive control by collecting and 
evaluating scientific and techni cal information or by conducting st udies simply does not apply to 
such a plan.  Thus, FDA tentativ ely 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 owne r, operator, or agent in charge of a 
facility verify that monitoring is being c onducted, 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 superv isor.  Another example of such a verification activity is an 
independent test made by a person other than th e 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).   396 
 
  Proposed § 117.150(b) would implement sectio n 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 monitori ng activities as an ongoing verificatio n activity (9 CFR 417.4(a)(2)(ii)).  
Proposed § 117.150(b) would differ from the NACM CF HACCP guidelines (Ref. 34), the Codex 
HACCP guidelines (Ref. 35), and FDA’s HACCP  regulations for s eafood and juice (§§ 
123.8(a)(3)(i) and 120.11(a)(1 )(iv)(A), respectively), which a ddress verification of monitoring 
through the review of records (which would be required by proposed § 117.150(d)(2)(i)) but do 
not otherwise address verificati on activities for monitoring.   
Proposed § 117.150(b) would not specify the verification activities that must be 
conducted for monitoring.  We request co mment on whether proposed § 117.150(b) should do 
so, and if so, what verificati on activities should be required. 
4. Proposed § 117.150(c)--Verificatio n of Corrective Actions  
Proposed § 117.150(c) would require that the owne r, operator, or agent in charge of a 
facility verify that appropriate decisions about  corrective actions are be ing made, as would be 
required by proposed § 117.145 and by proposed § 117.135(d )(3)(ii).  An example of verification 
that appropriate decisions a bout corrective actions are bei ng made is observation of the 
corrective actions being taken, e.g., by a supe rvisor.  Proposed § 117.150(c) would implement 
section 418(f)(3) of the FD&C Act and is consis tent with the FSIS HACC P 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 guideline s (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 revi ew of records (which would be required by 397 
 
  proposed § 117.150(d)(2)(i)) but do not otherwise a ddress verification activ ities for corrective 
actions. 
Proposed § 117.150(c) would not specify the verification activities that must be 
conducted for corrective actions.  We reque st comment on whether proposed § 117.150(c) 
should do so, and if so, what verifi cation activities should be required. 
5. Proposed § 117.150(d)--Implemen tation and Effectiveness 
Proposed § 117.150(d) would require that the owne r, operator, or agent in charge of a 
facility verify the preventive controls are c onsistently implemented and are effectively and 
significantly minimizing or preventing the hazards that are reasona bly 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 se ction 418(f)(4) of th e FD&C Act, which 
requires in relevant part veri fication by “appropriate means” th at the preventive controls “are 
effectively and significantly minimizing or prev enting 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 combin ation of monitoring (proposed § 117.140(a)), 
recordkeeping (proposed § 117.175), and verifi cation (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 manufactur ed, 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 ve rification activities rely  on instruments (such 
as a pH meter or a thermometer) that must be calibrated.  Calibration provides assurance that an 398 
 
  instrument is measuring accurately.  If these in struments are not properly calibrated, the values 
they provide may not provide the necessary a ssurance 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., th e standard reference thermometer used to 
calibrate a thermometer used in processing equipment will itself also need to be calibrated periodically). 
Instrument calibration is performed on a regular  or periodic basis ba sed upon the type of 
instrument being used and its sensitivity to fa ctors such as the operating environment and the 
wear and tear of ongoing use.  The type of inst ruments 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 th e 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 rela ted to monitoring, corrective ac tions and certain verification 
activities within specified time frames, by (or und er 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 contro ls are effective, and a ppropriate decisions were 
made about corrective actions.  Proposed § 117.150(d)(2)(i) would requi re 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 reco rds related to calibrati on within a reasonable 
time after the records are made.  (As discussed in section X II.I.2 of this document, proposed § 
117.175 would list the records that facilities must establish a nd maintain, including records that 399 
 
  document the monitoring of preventive controls  as required by § 117.140(c), corrective actions 
as required by § 117.140(d), and verification ac tivities as required by § 117.150(g)). 
Proposed § 117.150(d)(2) would implement sect ion 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 m eat and poultry.  The NAC MCF HACCP guidelines 
provide examples of verificat ion activities, including review of the HACCP plan for 
completeness, review of monitori ng records, and review  of records for devi ations and corrective 
actions (Ref. 34).  The examples of verification activities in the Code x HACCP Annex include a 
review of the HACCP plan and its records (Ref. 35).  Our HA CCP regulations for seafood (§ 
123.8(a)(3)(i) through (iii)) and ju ice (§ 120.11(a)(1)(iv)(A ) through (C)) require a review of the 
records that document the monitoring of critical c ontrol points, the taking of corrective actions, 
the calibrating of any process c ontrol instruments used at cr itical control points, and the 
performing of any periodic end-pr oduct or in-process te sting that is part of the processor's 
verification activities.  The FSI S 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 th e purpose of the review of records would 
be to ensure that the records ar e complete, the activities reflec ted in the records occurred in 
accordance with the food safety plan, the preven tive controls are effective, and appropriate 
decision were made about corrective actions.  We te ntatively 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 contai n 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 partic les to be acidified and the pH of the food after 400 
 
  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 re veal 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 ot her 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 numb er – so that the missing information can be 
quickly identified and added to th e record if necessary.  We seek comment on this proposal.  
If the review of the records reveals that  the records do not co ntain all information 
specified by the food safety plan, or that the pr ocedure 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 re cords are missing critical information or the 
activities were not performed as specified in the pl an, 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 larg e, acidification of all pa rts of the particle may 
not occur rapidly enough to ensure control of pathoge ns such as C. botulinum .  If the plan 
requires determination of the pH of each batch of product but the record s 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 potent ial risk from C. botulinum .  As a result, the f acility would not be 
able to verify that its preventive controls are effectively and signi ficantly minimizing or 
preventing the occurrence of identified hazards as re quired by Section 418(f) of the FD&C Act.   401 
 
  Review of records can also reveal whethe r appropriate decisions were made about 
corrective actions.  The review should determine whether all th e corrective action procedures 
required by proposed § 117.145(a)(3) have been follo wed, 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 a nd size are rejected when passed through the metal 
detector.  If one of the test pieces was not rejected but produc tion 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 act ion records should reveal that 
all packages of product that pa ssed through the metal detector si nce the last test showing the 
metal detector was functioning appropriately we re held and passed thr ough 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 discu ssion in section XII.H of this 
document regarding the activities that must be performed (or ove rseen) by a qualified individual 
as would be established in propos ed § 117.155).  The review of record s is critical to assessing the 
facility’s application of the pr eventive controls system and, thus, is fundamental to ensuring its 
successful operation.  Our HACCP regulati ons for seafood (§ 123.8(a)(3)) and juice (§ 402 
 
  120.11(a)(1)(iv)) require that th e 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 ot herwise qualified through job experience to perform 
this function.  The FSIS HACCP regulation fo r meat and poultry requi res 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 sy stem by an unbiased, i ndependent authority, 
internal or external to the f ood operation, including review of a ppropriate records from operation 
of the plan (Ref. 34).  The Codex HACCP Anne x does not specifically address the need for a 
qualified individual to review the records ot her 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 quali fied third partie s (Ref. 35).   
Proposed § 117.150(d)(2)(i) would re quire review of the mon itoring 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 r ecords than recommended in the NACMCF guidelines 
(which recommend monthly verifica tion of monitoring records and corrective action records), it 
is consistent with our HACCP regulations for seafood (§ 123.8(a)(3)(i) a nd (ii)) and juice (§ 
120.11(a)(1)(iv)(A) and (B)), which require that the review of m onitoring records and corrective 
action records occur within one week of the day th at the records are made.  Even for shelf-stable 
foods (e.g., low-acid canned foods and acidified foods) our experience has demonstrated that 403 
 
  review of these kinds of record s is a critical verification tool  (60 FR 65096 at 65133).  We seek 
comment on the proposed one week timeline. Th e FSIS HACCP regulation for meat and poultry 
requires records to be reviewed prior to shi pping product (9 CFR 417.5(c). As discussed in the 
seafood HACCP final rule (60 FR  65096 at 65132), review of r ecords needs to occur with 
sufficient frequency so as to ensu re that any problems in the design and implementation of the 
HACCP plan are uncovered promptly and to faci litate prompt modifications. The concept is 
roughly that of a “feedback loop,” with informati on 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 disc overed during a review of record s, 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 possi ble and that a weekly review 
of monitoring and corrective ac tion 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 reco rds related to  calibration 
within a reasonable time after the records are made.  The review of calibration records will 
depend in part on the frequency w ith which calibrations occur, which will be established in the 
food safety plan. If calibrations  occur daily, it would be reason able to review these records 
weekly.  Where several instruments are calibra ted each month, a monthly review of all the 
calibrations would be reasonable.  Consequent ly, FDA tentatively concludes that setting a 
specific frequency for review of  these records is not warrante d.  Proposed § 117.150(d)(2)(ii) is, 
in relevant part, consistent w ith our HACCP regulations for s eafood (§ 123.8(a)(3)(iii)) and juice 404 
 
  (§ 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) w ould require a review of records in part 
to determine whether the preventi ve controls are effective. A re view 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 proper ly 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 cont rols are effective, i.e., 
that its preventive controls are effectively and significantly minimizing or preventing the 
occurrence of identified hazards as requi red by Section 418(f) of the FD&C Act. 
6. Proposed § 117.150(e)--Written Procedur es for Verification Activities 
Proposed § 117.150(e) would require that the owne r, operator, or agent in charge of a 
facility establish and implement written proce dures for the frequency of calibrating process 
monitoring instruments and veri fication instruments.  We are proposing to require written 
procedures for the frequency of calibration be cause 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 preven ting the hazards reasonably likely to occur.  For example, we 
are not proposing to require wr itten procedures for validation , verification of monitoring and 405 
 
  corrective actions, or calibration of process monitoring instrument s and verification instruments 
(other than for the frequency of calibration).  Validation involves a va riety of procedures, 
including evaluation of scientific and techni cal information and conducting laboratory and in-
plant studies that generally do not follow a sta ndardized protocol or approach.  Records of 
monitoring and corrective actions provide th e information needed to understand how the 
verification activity was carried out.  In many instances the cal ibration 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; havi ng 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 a ppropriate 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 FD&C Act requ ires 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 wr itten (§§ 123.6(b) and 120.8(a), 
respectively) and that procedures for verificati on be included in the written HACCP plan (§§ 
123.6(c)(6) and 120.8(b)(6), respec tively). The FSIS HACCP regulation for meat and poultry 
requires that the establishment maintain a reco rd of the written HACCP  plan, including, in 
relevant part, documents supporting the verificati on procedures selected and the frequency of 
those procedures (9 CFR 417.5(a)(2)). Thus, requi ring 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 m eat/poultry.    406 
 
  7. Proposed § 117.150(f)--Reanalysis 
a. Proposed § 117.150(f)(1)--Reanalysis on the ini tiative of the owner, operator, or agent 
in charge of a facility .  Proposed § 117.150(f)(1)(i) would requi re 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 char ge 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 ag ent in charge becomes aware of new 
information about potential ha zards associated with the f ood (proposed § 117.150(f)(1)(i)(C)); 
• Whenever a preventive control is not  properly implemented and a specific 
corrective action procedure has not been es tablished (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 th at bottles beverages develops  a food safety plan for its 
products packaged in plastic bottles and subsequen tly introduces a glass bottl ing 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 pa rticles.  Similarly, if a facility that conducts 
dry roasting operations for nuts makes design ch anges 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 re asonably likely to occur would be a 
significant change in the activitie s conducted at the facility.    407 
 
  The owner, operator or agent in  charge of a facility may b ecome 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 analys is 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 thro ugh the investigation of outbreaks of foodborne 
illness by CDC or other public health agen cies.  For example, L. monocytogenes  was not 
recognized as a food safety hazard until a series of outbreaks of foodborne il lness 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 ou tbreak 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 th e U.S. and it demonstrated the need for 
manufacturers to address the hazard of Salmonella  spp. in this product.  Information about 
outbreaks and ensuing produc t recalls is widely disseminated, including on FDA’s Web site, and 
modern communication tools make it possible for th e owner, operator, or agent in charge of a 
facility to receive such information automati cally.  For additional discussion related to the 
proposed requirement that the ow ner, operator, or agent in ch arge 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 th at 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 modificati on of the food safety plan is required if a 408 
 
  preventive control is not properl y implemented or is found to be  ineffective, and a specific 
corrective action has not been established. If the ow ner, operator, or agent in charge of a facility 
has not identified a specific failure as a foreseeab le occurrence, the deviation may be the result of 
a system-wide problem that is not being prope rly addressed by the food safety plan (e.g., 
ineffective preventive controls).  Thus, an unf oreseen failure for which a corrective action was 
not identified may indicate an in effective preventive control, and a reanalysis of the food safety 
plan is warranted. Similarly, when information ar ises 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 sec tions 418(f)(5) and 418 (i) of the FD&C 
Act and is consistent with the NACMCF HACC P 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 re lation to the concept of “reanalysis” varies in 
the regulations and guidelines (e.g., “subsequent validation,” “re-validatio n,” “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 scie ntifically and t echnically sound 
and that all hazards have been identified as an important verification activity, and advise a 
subsequent validation under circ umstances such as an unexplain ed system failure; a significant 
product, process or packaging change; or th e recognition of new hazards (Ref. 34).  The 
NACMCF HACCP guidelines also di scuss the need for a periodic comprehensive verification of 
the HACCP system, including a tech nical evaluation of the hazard an alysis and each element of 409 
 
  the HACCP plan, independent of ot her verification procedures to en sure that the HACCP plan is 
resulting in control of the hazards.  If the re sults 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 th e product, process, or any step (Ref. 35).  The 
Codex validation guidelines provide  examples of situations that could lead to the need to 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 c ould 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 ade quacy of the HACCP plan at least annually and 
whenever any changes occur that could affect th e 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 pr ocessor does not have a HACCP plan (because 
the hazard analysis revealed no hazards reasona bly 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 poul try, respectively).  Each of these HACCP 
regulations provides examples of changes that may be considered to reasonably affect whether a 410 
 
  food safety hazard now exists a nd, 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 material s; 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 sl aughter or processing 
methods or systems for meat or poultry.  
The requirement in proposed § 117.150(f)(1)(i)(A) that the periodic re analysis of the food 
safety plan occur at least once every 3 years woul d be different from the current requirement in 
our HACCP regulations for seafood and juice an d in the FSIS HACCP regulation for meat and 
poultry for reassessment (validati on) of the adequacy of the HAC CP 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 tentativ ely 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 th e change creates a reasonable potential for a new hazard or a 
significant increase in a previously identified ha zard 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 re quire that the owner, operato r, or agent in charge of 
a facility complete the required reanalysis a nd implement any additional preventive controls 
needed to address the ha zard identified, if any, before the change  in activities at the facility is 
operative or, when necessary, during the firs t 6 weeks of production.  The purpose of the 
reanalysis is to identify the need for, and implem ent, preventive controls in light of a reasonable 411 
 
  potential for a new hazard, or a significant incr ease in a previously identified hazard, that is 
reasonably likely to occur. It fo llows that the preventive controls must be in place before making 
the change that creates the potential for a new hazard or a significant in crease 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, wh en necessary, to implement any additional 
preventive controls to allow facilities to me thodically collect data and information during 
production to ensure the needed change can be im plemented 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 exp licit counterpart in  the NACMCF HACCP 
guidelines, the Codex HACCP guidelines, or Fede ral HACCP regulations for seafood, juice, and 
meat and poultry, it is consistent with the importa nce 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 ne ed to do so, as discus sed 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 significa nt change is made or document the basis for the 
conclusion that no additional or revised pr eventive controls are needed.  Proposed 
§ 117.150(f)(1)(iii) would implement section 418(i) of the FD&C Ac t, which requires that the 
written plan be revised “if … a significant ch ange is made or document the basis for the 
conclusion that no additional or revised preventive c ontrols are needed.”  As  discussed in section 
XII.B.2.b of this document, the written hazard analys is is required even if the conclusion of the 
analysis is that there are no hazar ds 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 dem onstrates that a facility has considered all 412 
 
  relevant information on the safety of the pr oducts being produced, including new information 
that has become available since the last analys is, 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 re gulations 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 adequa te 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, respectiv ely), although they do not  explicitly require 
documentation of the basis for th e conclusion that no a dditional or revised pr eventive controls 
are needed.  Although proposed § 117.150(f)(1)(iii) has no explic it 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 gui delines and regulations, and with the written 
nature of the HACCP plan. The Codex validation gui delines indicate that if a system failure for 
which a process deviation cause can not be identified occurs, re-v alidation may be needed (i.e., 
reanalysis is needed whenever a preventive c ontrol is found to be ineffective) (Ref. 127). 
b. Proposed § 117.150(f)(2)--Requireme nt for a qualified individual .  Proposed 
§ 117.150(f)(2) would require that  the reanalysis be perfor med or overseen by a qualified 
individual.  Proposed § 117.150(f )(2) is consistent with pr oposed §§ 117.126(c) which would 
require that the food safety plan be devel oped or overseen by a qualif ied individual.  We 
tentatively conclude that the sa me qualifications are needed whet her initially condu cting a hazard 
analysis and establishing a food safety plan, or  reanalyzing a hazard analysis and plan.   
c. Proposed § 117.150(f)(3)--Reanalys is on the initiative of FDA .  Proposed 
§ 117.150(f)(3) establishes that FDA may require a r eanalysis of the food safety plan to respond 413 
 
  to new hazards and developments in scientific und erstanding.  This authority will be delegated to 
the Commissioner of Food and Drugs.  Propos ed § 117.150(f)(2) would implement section 
418(i) of the FD&C Act, which provides in releva nt part that “[t]he Secretary may require a 
reanalysis . . . to respond to new hazards and de velopments 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 out breaks of foodborne illness by CDC or other public health 
agencies.  In addition, new developments can occu r in the scientific unde rstanding of existing or 
potential hazards – e.g., if scie ntists and food safety regulato ry agencies develop a better 
understanding of the causes of these events .  For example, the outbreak from Salmonella  
Tennessee in peanut butter resulted in a gr eater 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 fo od 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 nu mber 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 pr ofile is to ascertain the current state of 
knowledge about spices contaminated with mi crobiological pathogens and/or filth, and the 
effectiveness of current and potential new inte rventions to reduce or prevent illnesses from 
contaminated spices.   414 
 
  8. Proposed § 117.150(g)--Requirement for Records for Verification  
Proposed § 117.150(g) would require that all veri fication activities ta ken 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 fo r seafood, juice, and meat and poultry.  The 
NACMCF HACCP guidelines recommend that the records maintained for the HACCP system include records that are genera ted during the operati on 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 pr ocedures performed as an exam ple of records (Ref. 35).  Our 
HACCP regulations for seafood and juice require that recordkeep ing include the calibration of 
process-monitoring instrument s (§§123.8(d) and 120.11(a)(2), re spectively).  The FSIS HACCP 
regulation for meat and poultry requires r ecords documenting the ca libration of process-
monitoring instruments, as well as ve rification procedures and results.  
H. Proposed § 117.155--Requirements App licable to a Qualified Individual
 
Proposed § 117.155(a) would require  that one or more qualifi ed individuals prepare the 
food safety plan (proposed § 117.126(c)), vali date the preventive controls (proposed § 
117.150(a)(1)), review records for implementation and effectiveness of preventive controls 
(proposed § 117.150(d)(2)), and perform reanalys is 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 di scussion of each applicable propos ed provision. We are listing 
the functions that must be performed by a trai ned individual in § 117.155(a) for simplicity and 
are not imposing any additional requirement th rough this list.  A single individual with 415 
 
  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 establ ish the qualification requir ements applicable to a 
qualified individual.  To be qualif ied, 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 the FDA, or be otherwise 
qualified through job experi ence to develop and apply a food sa fety system.  Training or job 
experience is essential to the effective developm ent and implementation of a hazard analysis and 
risk-based preventive controls. Only a tr ained individual or individual qualified by job 
experience is capable of effectively executing certa in activities, such as identifying hazards that 
are reasonably likely to occur; identifying preven tive controls that will address those hazards; 
evaluating scientific and technical  information to determine whet her the food safety plan, when 
properly implemented, will effectivel y 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 reasonabl y likely to occur; determining whether monitoring procedures 
and corrective action procedures are appropriate ; and determining whethe r specific corrective 
actions have been appropriate and effective.  In addition, the products  produced by the food 
industry are diverse, and the hazard s 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 th e NACMCF HACCP guidelines, our HACCP 
regulations for seafood and jui ce, and USDA’s HACCP regulati ons for meat and poultry.  The 416 
 
  NACMCF HACCP guidelines reco mmend 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 analys is (juice only), devel oping the HACCP plan, 
verifying and modifying the HA CCP plan, and performing the r ecord review (§§ 123.10(a)-(c) 
and 120.13(a)(1)-(4), respectively). These regula tions also provide that job experience will 
qualify an individual to perform these functions if it has provide d knowledge at least equivalent 
to that provided through the sta ndardized curriculum.  USDA’s HAC CP regulations for meat and 
poultry require that only an i ndividual who has completed a trai ning course can conduct certain 
activities, such as de velopment and modification of the HACCP plan (9 CFR § 417.7).   
FDA did not conduct HACCP training for pers ons subject to our HA CCP regulations for 
seafood or juice.  However, when implementing those regulations, FDA worked with an alliance 
of representatives from Federal and State agen cies, industry and academia, to create a uniform, 
core training program that serves as the sta ndardized curriculum agai nst which other course 
materials can be judged.  FDA will be working w ith an alliance to develop such a standardized 
curriculum for any final rule es tablishing requirements for ha zard analysis and risk-based 
preventive controls.  Having a standardized curr iculum on which faciliti es, as well as private 
organizations and academia that conduct training, can base their materials and training would 
provide a framework to ensure mini mum 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 associati ons, and consulting companies.  Proposed § 417 
 
  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 ru le.  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 pe rson(s) trained.  Such 
records would be a simple mechanism to demonstrate that a person has successfully completed training in the development and app lication of risk-based preventive  controls at least equivalent 
to that received under a standard ized curriculum recognized as adequate by the FDA, as would 
be required under proposed § 117.155(b) should th e qualified individual not be otherwise 
qualified through job experi ence to develop and appl y 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 th e 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 implem ented under section 418(c) of the FD&C Act, 
instances of nonconformance material to food safet y, the results of testin g and other appropriate 
means of verification under sec tion 418(f)(4) of the FD&C Ac t, 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 th e 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 418 
 
  preventive controls adopted unde r section 418(c) of the FD&C Ac t to address those hazards.  
Section 418(h) of the FD&C Act also specifies that the writ ten plan, together with the 
documentation described in Section 418(g) of the FD&C Act, shall be made promptly available 
to a duly authorized repres entative 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, veri fication procedures, and recall 
plan;  
• Records that document the monito ring of preventive controls;  
• Records that document corrective actions;  
• Records that document verification, incl uding, as applicable, those related to 
validation; monitoring; corrective actions; calib ration of process monitoring and verification 
instruments; records review; and reanalysis; and 
• Records that document applicable tr aining for the qualified individual. 
Proposed § 117.175(a) would not establish a ny new requirements but merely make it 
obvious at a glance what record s 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 es tablish 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 re quired to be established and maintained by part 419 
 
  117, including provisions for reten tion of records and for making r ecords 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 certa in verification of those preventi ve controls.  In this section 
of the preamble, we discuss several preventive controls (i.e., supplier c ontrols) and verification 
measures (i.e., environmental and product testin g programs) that FDA is not including as 
provisions in proposed part 117, subpart C.   
As we have already discussed (see secti on 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) defi nes “preventive controls” to m ean “those risk-based, reasonably 
appropriate procedures, practi ces and processes that a pers on knowledgeable about the safe 
manufacturing, processing, packi ng, or holding of food would em ploy to significantly minimize 
or prevent [identified hazards] and that are cons istent with current scientific understanding of 
safe food manufacturing, processing, packing, or  holding….”  Section 418 (o)(3) indicates that 
those procedures, practices and processes ma y include environmental monitoring, supplier 
verification activities, certain  sanitation controls, and alle rgen controls.  In addition, 
environmental and product testing programs are se t out in section 418(f)(4 ):  section 418(f)(4) 
requires that the owner, operator, or agent in charge of a facil ity “verify that ... the preventive 
controls … are effectively a nd significantly minimizing or preventing the occurrence of 420 
 
  identified hazards, including th rough the use of environmental a nd product testing programs and 
other appropriate means.”   
We believe that the preventive controls a nd verification measures discussed in this 
section are an important part of a modern food sa fety system.   We believe that the preventive 
controls discussed in this s ection (i.e., a supplier approval and verification program), when 
implemented appropriately in particular facili ties, are “risk-based, reasonably appropriate 
procedures, practices and proce sses 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 testi ng programs), when implemented 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 m easures, which are science-based, are widespread 
and commonly accepted in many sectors of the f ood industry.  We request comment on these 
conclusions. 
As discussed (see section I of th is document), food safety is best assured if each facility 
understands the hazards that are reasonably likely  to occur in its partic ular 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 f ood products, the wide variety of  manufacturing and processing 
methods used to produce the food, the variety of  sources for raw materi als and ingredients, 421 
 
  variations in the nature and types of hazards associated with manufact uring, processing, packing 
and holding human food, and the pos sibility that different mitig ation methods may achieve the 
same end.  Further, regulatory requirements s hould make clear when one of these preventive 
controls or verification measures is necessary ye t also be sufficiently flexible to account for a 
vast number of food and facility co mbinations and circumstances.   
Although we are not including provisions for environmental and product testing 
programs or a supplier approval and verification pr ogram in this proposed rule, we recognize that 
these preventive controls and verification m easures, when implemented appropriately in 
particular facilities, can play im portant 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 thinkin g, 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 additiona l background information relevant to these 
topics.   
2. Product Testing 
As discussed in section XII. G.1 of this document, secti on 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 th e FD&C Act] are effectively and significantly 
minimizing or preventing the o ccurrence of identifie d hazards, includi ng through the use of 
environmental and product testing programs and ot her appropriate means”  The statute does not 
indicate the specific circumstances where product  testing would be requ ired or the specific 
manner in which such testing s hould be performed.  FDA believes that the role and need for 
these measures varies depending on the type of pr oducts and activities of a facility.  FDA further 422 
 
  believes that the owner, operator, or agent in charge of a facil ity could consider a number of 
factors to establish a pr oduct testing program.   
Although finished product testing is rarely considered a preven tive control, it plays a very 
important role as a verification measure in ensuring the safety of food, when implemented 
appropriately in particular faci lities.  Similarly, testing of ra w materials or ingredients by a 
facility that is receiving the product often play s an important role in verification of hazard 
control that is performed by their supplier.  Thus, an important purpos e of testing is to verify that 
preventive controls, including those related to suppliers and those rela ted to environmental 
monitoring, are controlling the haza rd (Ref. 111) (Ref. 112).  Testing is used in conjunction with 
other verification measures in the food safety syst em, such as audits of suppliers, observations of 
whether activities are being c onducted 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 importan t and useful when there is a reasonable 
probability that exposure to an identified h azard will result in se rious 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 veri fication 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 423 
 
  intended to be used in RTE foods; nutrition bars in which dry ingredients (such as fruits, nuts, 
dried milk, soy proteins and choc olate) that may contain Salmonella  spp. are formed into a bar 
without a lethal step; and mixtur es 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 occu r in an ingredient that is added during 
manufacturing after the stage that  applies a process c ontrol to significantly minimize biological 
hazards.  Examples include food (such as chips, nuts and cereals) in wh ich untreated seasonings 
that may contain Salmonella  spp. are applied after a heat trea tment 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 like ly to occur as a result of ha ndling of a product or exposure of 
a product to the environment after a process cont rol that significantly minimizes a hazard such 
that a hazard could be introduced or re-introdu ced 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 vari ety of hazard/commodity/facility considerations.  424 
 
  FDA believes that factors to consider include whet her ingredients that may contain a hazard have 
been tested, the extent of any environmenta l monitoring program, and whether other programs 
established by the facility provide added assura nce that the potential for hazards has been 
minimized.  The frequency of testing and the numb er of samples tested should have a scientific 
basis.  Sampling plans and their performance have  been described in th e literature (Ref. 180) 
(Ref. 181) (Ref. 182) and are incl uded in several Codex documen ts (Ref. 52) (Ref. 183).  We 
discuss likely considerations that could impact fini shed product verification testing in more detail 
in section I.F of the Appe ndix to this document.  
Although we are not including a test ing provision in this propos ed rule, we estimate that a 
requirement for a finished product testing pr ogram, when implemen ted appropriately in 
particular facilities, could impose an incr emental 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 do mestic facilities base d on an average of a 
range of $12,000,000 - $35,000,000 (assuming between 25 an d 75 percent of relevant facilities 
conducting testing) and an estimated aggregat e cost of $25,600,000 for foreign facilities.  (As 
described in the PRIA, foreign costs are estima ted by multiplying the domestic per facility cost 
by the total number of foreign facilities. See sec tion 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 ad opt a testing and holding regime are facilities 
producing products for which fini shed product testing would be particularly useful as a 
verification measure, e.g., the production process does not have a step th at will eliminate or 
reduce hazards to an acceptable level.  This es timate excludes facilities that would be exempt 
under this proposed rule (using a definition of $250,000 for a very small business) and facilities 425 
 
  that are already conducting fini shed product testing. Further details are provided in the 
“Consideration of Other Provi sions” section of the PRIA. 
FDA requests comment on when and how produc t 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 fini shed product testing or  include raw material 
testing?  What is the appropriate level of specifi city 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, finish ed product testing, when appr opriate based on risk, to assess 
whether the preventive controls significantly minimize or prevent the hazards that are reasonably 
likely to occur?  This would provi de flexibility to account for the wide diversity of food and food 
manufacturing, processing, packing and holding systems subject to th is 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, situatio ns 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 plan s for finished product testing;  
• Requiring periodic testing for trend analys is and statistical process control; and 426 
 
  • Requiring written procedures for conducti ng 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 requirement s should differ based on 
the size of the operation.    3. Environmental Monitoring 
As discussed in section XII. G.1 of this document, secti on 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 th e FD&C Act] are effectively and significantly 
minimizing or preventing the o ccurrence of identifie d hazards, includi ng through the use of 
environmental and product testing programs and ot her appropriate means”.  In addition, section 
418(o)(3) indicates that preventive  controls may include environm ental 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 woul d be required or the specific 
manner in which such testing shou ld be performed.  Nevertheless, FDA believes that this testing 
can form an important component of a modern fo od safety system.  FDA believes that the role 
and need for these measures varies depending on the type of products and activ ities of a facility.  
FDA further believes that the performance of environmental monitoring, for an appropriate 
microorganism of public health significance or for an appropriate i ndicator organism, is 
particularly useful as a verifi cation measure for preventive cont rols (i.e., sanitation controls) 
when contamination of food with an environmen tal pathogen is a hazard reasonably likely to 
occur.   427 
 
  As discussed in sections XII.B.3 and X II.B.4.b of this document, proposed § 117.130(b) 
would require a hazard identification that must c onsider hazards that may occur naturally or may 
be unintentionally introduced; pr oposed § 117.130(c)(2) would requir e that the hazard evaluation 
include an evaluation of whether environmenta l pathogens are reasona bly likely to occur 
whenever a RTE food is exposed to the environmen t prior to packaging.  The data from recalls 
and the RFR support a conclusion that Salmonella  spp. is a hazard in low-moisture RTE food 
products (such as spices and seasonings, nuts an d nut products, and seed products).  When RTE 
foods such as these are exposed to the environm ent, 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 eval uate 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 RF R 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 th at most facilities producing such foods would 
identify L. monocytogenes  as a potential hazard under pr oposed § 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 mon itoring program for L. monocytogenes can verify the 
effectiveness of sanitatio n controls designed to prevent L. monocytogenes  from contaminating 
food-contact surfaces and food (Ref. 52) (Ref. 144) (Ref. 185) (Ref. 186). 428 
 
  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 indica tor 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 ar e no currently available indicator organisms for 
Salmonella  spp.  We request 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 f acilities, could impose an increm ental 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 fo r testing.  This would 
result in an estimated aggregat e cost of $4,000,000 for domestic faci lities based on an average of 
a range of $3,000,000 - $5,000,000 (assuming between 50 and 75 percent of re levant facilities 
conducting testing) and an estimated aggregat e cost of $4,400,000 for foreign facilities.   
Similarly, we estimate that a requirement fo r an environmental monitoring program for 
Listeria , when implemented appropriately in particul ar facilities, could impose an incremental 
annual cost of $3,000 – $6,000 per facility.  These co sts assume that facilities will take 5-15 
environmental samples per month, based on facilit y 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 to tal number of foreign facilities.  See section 
XIX of this document for a discussion of the PRIA.) 429 
 
  The facilities that could a dopt 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 produc t testing. Further details are pr ovided in the “Consideration of 
Other Provisions” section of the PRIA. 
FDA requests comment on when and how enviro nmental testing is an appropriate means 
of implementing the statutory directives set ou t 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 appropria te indicator organism, if c ontamination of food with an 
environmental pathogen is a hazard reasonably li kely 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 s hould be taken if environmental testing 
identifies the presence of an environmental pathogen, such as;   
• Conducting microbial sampling and testi ng 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;  430 
 
  • Conducting additional microbial sampling a nd testing to determine whether the 
contamination has been eliminated; and 
• Conducting finished pr oduct 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 adequa tely reduce the environm ental pathogen?    
• Be greater for an environmental pat hogen 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 ingredie nts, people and objects 
(Ref. 144) than for an environmental pat hogen that is less frequently introduced?  
• Be greater for refrigerated or fr ozen 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 se nsitive population such as infants) than if there 
is a lesser risk of a negati ve impact on public health?  
• Be greater for products that undergo significant handling and exposure to 
the environment than for products that undergo lim ited or no handling or have little exposure to 
the environment?  
• Increase as a result of finding the en vironmental 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).   431 
 
  • Requiring written procedures for conducting environmental testing and, if so, also 
requiring that procedures for environmental test ing be scientifically valid and include the 
procedures for sampling and the sampling frequency; 
• Requiring data analysis to detect trends.  
In addition, with respect to environm ental testing for L. monocytogenes , FDA requests 
comment on whether it would be appropriate to distinguish betw een environmental testing for 
RTE foods depending on whether the food s upports the growth of L. monocytogenes .  We also 
request comment on whether ther e are appropriate indicator or ganisms 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 im plement 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 indi cates that the procedures, practices, and 
processes described in the defi nition of preventive controls ma y include supplier verification 
activities that relate to the safety of food.  While FSMA refers only to supplier verification 432 
 
  activities, supplier approval, t ogether with supplier verification, is widely accepted in the 
domestic and international food safety communit y.  The development of a supplier approval and 
verification program can be part of a preven tive approach.  The NACMCF HACCP guidelines 
describe supplier controls as one of the common prerequisite programs fo r the safe production of 
food products and recommend that each facility assu re that its suppliers ha ve in place effective 
CGMP and food safety programs (Ref. 34).  Likewi se, Codex addresses the safety of ingredients 
in the GPFH and recommends that, where approp riate, specifications for raw materials be 
identified and applied and laborat ory tests be conducted to estab lish fitness for use (Ref. 44).   
Because many facilities acting as  suppliers procure their raw materials and ingredients 
from other suppliers, there is ofte n a chain of suppliers before a ra w 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 preventiv e controls to significantly minimize or prevent hazards that 
the receiving facility has identifi ed 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 safe ty 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 in itial 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 ci rcumstances where supplier verification would 
be required or the specific manner in which s upplier verification should be performed, and FDA 433 
 
  is not including provisions for such  verification in this proposed ru le.  FDA believes that the role 
and need for these measures varies depending on the type of products and activ ities 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 ha zard may result in se rious adverse health 
consequences or death; and 
• The establishment that would be control ling the hazard associated with the raw 
material or ingredient (e.g., the facility that receives the raw ma terial or ingredient, the supplier 
of that raw material or ingred ient, or even a supplier to the supplier of the raw material or 
ingredient). 
The vast majority of costs related to a s upplier approval and verification program are due 
to verification activities such as audits and test ing 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 controlle d.  Although we are not including a prov ision for such a program in this 
proposed rule, we estimate that a requirement fo r a supplier approval and verification program, if 
implemented as part of a preventive approach, c ould 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 co st of $11,000,000 for domestic facilities and an 
estimated aggregate cost of $12,000,000 for forei gn facilities.  (As de scribed 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 docum ent for a discussion of the PRIA.).  We estimate 434 
 
  that a requirement for a supplier approval and ve rification program could impose an incremental 
annual cost of $7,000 – $90,000 per fac ility based on size (number of  employees) for testing of 
raw materials and ingredients. This would result in an estimat ed aggregate cost of $5,000,000 for 
domestic facilities and an estim ated aggregate cost of $5,400,000 fo r 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 faciliti es that are already doing such supplier 
verification activities. Further details are prov ided in the “Considera tion of Other Provisions” 
section of the PRIA. 
FDA requests comment on when and how s upplier approval and ve rification is an 
appropriate means of implementing the statutory directives set out above.    Although we have 
not included these provisions in the proposed ru le, 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, re quiring 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 verifica tion program should apply to - e.g., should it 
apply to all facilities that ma nufacture, process, pack or hold food, or be limited (such as to 
facilities that manufactur e 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 appropriat e verification activities, the owner, 
operator, or agent in charge of a facility consider relevant regulatory information regarding the 435 
 
  supplier, including whether the raw ma terial or ingredient is the s ubject of an FDA warning letter 
or import alert relating to the safety of the food.   
• Specifying circumstances when a supplie r approval and verification program 
would not be required - e.g., when th e preventive controls at  the receiving facility are adequate to 
significantly minimize or preven t each of the hazards the recei ving facility has identified as 
reasonably likely to occur; or when the receiving facility obtai ns 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 ther e 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 haza rd 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 revi ew 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 regula tions and, when applicable, compliance with a 
facility’s food safety plan);  
• Specifying the frequency of verificati on activities (e .g., initially, annually, or 
periodically);   436 
 
  • Specifying whether, for some hazards, it wi ll 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 fac ility and obtaining writ ten assurance that the 
supplier is producing the raw material or ingred ient 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 re gulatory inspection (e.g., by FDA or a 
comparable State regulatory agen cy or foreign food safety aut hority), 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 w ill interface with the regu lations FDA is required 
to issue to implement foreign supplier verification under new s ection 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 assuran ces that the importer’s foreign 
suppliers produce food in compliance with pro cesses and procedures, including risk-based 
preventive controls, that provide  the same level of public health  protection as those required 
under sections 418 (concerning ha zard analysis and preventive  controls) and 419 (concerning 437 
 
  produce safety) of the FD&C Act, and in complia nce with sections 402 (c oncerning adulteration) 
and 403(w) (concerning misbrandi ng regarding allergen labeli ng) of the FD&C Act.   
FDA intends to issue proposed regulations im plementing section 805 in the near future.  
FDA intends to align regulations implementi ng supplier verification under section 418 and 
regulations implementing FSVP und er section 805 to the fullest extent so we do not impose 
duplicative or unjustified require ments under those two regulations.  For example, if a facility 
imports ingredients, we would not want to su bject it to duplicative re quirements under a supplier 
verification provision and an FSVP regulation.   
Likewise, FDA is aware that th ere is great interest from our trading partners on, among 
other things, the potential overlap between the supplier verification requi rements in preventive 
controls and in FSVP.  FDA believes that the approach to  harmonization between supplier 
verification and FSVP described above would ade quately address this and comports with our 
obligations under the World Trad e 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 th at “[n]othing in [FSMA] sh all 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 ar e based on common risk-based principles.  
Implementation of these risk-based principles will  assure a general consis tency of approach with 438 
 
  respect to foreign and domestic facilities rega rding, 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 prot ection of the United States, ta king into account technical and 
economic feasibility, as requi red by paragraph 6 of Article  5 of the SPS Agreement.  
 FDA intends to publish in the very near fu ture 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 ad dressed 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 th at protect public health 
and satisfy both FSMA and our international obligations.      
K. Request for Comment on Other Potential Provis ions Not Explicitly Included in Section 418 of 
the FD&C Act  
1. Overview 
This section discusses two measures (r eview of consumer, customer, and other 
complaints, and submission of a food safety pr ofile) that FDA is not proposing as specific 
provisions in proposed part 117, su bpart C.  Although these measures  are not explicitly included 
in section 418, we believe that th e preventive controls and verificat ion measures discussed in this 
section are an important part of a modern food safety system.   2. Complaints 
The role of consumer complaints in evaluati ng the effectiveness of a food safety plan is 
reflected in our HACCP regula tions for seafood and juice.  Our HACCP regulation for seafood 
(§ 123.8(a)(2)(i)) requires that verification activ ities include a review  of any consumer 439 
 
  complaints that have been received by the processor to determine whether they relate to the 
performance of critical control po ints 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 receiv ed 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 th e 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 occu rring and are not being 
prevented or uncovered by the processor’s HACCP controls. 
Further, although most consumer complaints w ill be related to quality issues, recent 
experience has demonstrated the value that cons umer and customer complaints can provide in 
bringing attention to possible pr oblems within a facility’s preven tive controls activities.  FDA 
has received a number of submissions to the Re portable Food Registry  (Ref. 60) that have 
suggested that environmental pat hogens or food allergen hazards were not adequately addressed 
in a supplier’s food safety plan.  Some of th ese were identified through customer verification 
testing and others through complaints from consum ers to a facility.  A facility may also receive 
alerts as a result of st ate surveillance and testing programs.  (For a discussion of such programs, 
see section II.A.6.e of this document).  Many recall notices identify th e 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 incl ude a provision regarding a review of 
complaints, we estimate that a requirement that f acility personnel review consumer, customer or 440 
 
  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 esti mated 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 pa rties, should be required as a component of its 
activities to verify that its preventive contro ls are effectively minimizing the occurrence of 
hazards.     3. Submission of a Faci lity Profile to FDA 
Proposed § 117.126 would require th at the owner, operator, or  agent in charge of a 
facility prepare, or have prepar ed, a written food safety plan.  Th e food safety plan would include 
the hazard analysis, preventive controls, and other r ecords.  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 bene fits 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 co uld aid in the efficient 
oversight of preventive controls by allowing FD A 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 in spections by focusing attention on hazards and 
preventive controls for which the facility appears to have deficien cies.  Facilities would benefit 
from our advance preparation through interact ion with better-infor med investigators and 
potentially reduced inspection time.  We could al so more quickly identify facilities that had not 
established preventive controls fo r specific hazards of concern to the agency and advise them to 441 
 
  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 cont rols 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 info rmation in such plans may be 
essential to realizing the potenti al benefits described above.  Th erefore, to most efficiently 
realize the potential benefits of  having certain information prio r to an inspection, we request 
comment on whether to require subm ission to FDA of a subset of the information that would be 
in a food safety plan.  This information, which coul d 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 c ontrols, 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;  442 
 
  • 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 sa me time as facility registration and updated 
biennially simultaneously with the required bien nial 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 mi ght be obtained from using such an approach and any potential 
concerns with this approach. 
We have previously announced an oppor tunity for public comment on the proposed 
collection of additional food facility profile in formation on a voluntary basis from firms that 
complete the FDA food facility regi stration process (F ederal Register  of May 11, 2012, 77 FR 
27779).  In that notice, we noted that FSMA a dded section 421 of the FD&C Act (21 U.S.C. 
350j), which directed FDA to allocate resource s 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 voluntar y submission of food facility profile information 443 
 
  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 modi fied 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 establis hes modified requirements for “qualified 
facilities.”  As discussed in se ction II.B.1.b of this document, se ction 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 so ld to qualified end users as co mpared to all other purchasers 
(section 418(l)(1)(C) of the FD&C Act), and pr oposed § 117.3 would establish a definition for 
“qualified facility” based on section 418(l)(1).   
Sections 418(l)(2)(A) a nd (B) of the FD&C Act provide that  a qualified facility is exempt 
from the requirements of sections 418(a) th rough (i) and (n) of th e FD&C Act (i.e., the 
requirements for hazard analysis and risk-based preventive controls), but must instead submit 
two types of documentation to th e Secretary of HHS.  The first type of required documentation 
relates to food safety practices at  the facility, and sect ion 418(l)(2)(B)(i) provides two options for 
satisfying this documentation requirement.  Under s ection 418(l)(2)(B)(i)(I), the qualified facility 
may choose to submit documentation that demonstrat es that the owner, ope rator, or agent in 
charge of the facility has identified potential ha zards associated with the food being produced, is 444 
 
  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 re ports, certificates, permits, cred entials, certification by an 
appropriate agency (such as a Stat e department of agriculture), or other evidence of oversight), as 
specified by the Secretary of HHS, that the facili ty is in compliance with State, local, county, or 
other applicable non-Federal food safety law.   
The second type of required documentation rela tes to whether the f acility 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 S ecretary of HHS in a guidance document, that 
the facility is a qualified facility under se ction 418(l)(1)(B) of th e 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) th rough (i) and subsection (n), and that does not 
prepare documentation under sectio n 418(l)(2)(B)(i)(I), provide not ification to consumers by one 
of two procedures, depending on whether a food packaging label is requi red on the food.  With 
respect to a food for which a food packaging labe l is required by the Secretary of HHS under any 
other provision of the FD&C Ac t, section 418(l)(7)(A )(i) of the FD&C Act requires that a 
qualified facility include prominently and cons picuously on such label the name and business 
address of the facility where th e food was manufactured or processe d.  With respect to a food for 
which a food packaging label is not required by the Secr etary of HHS under any other provisions 
of the FD&C Act, section 418(l)(7 )(A)(ii) of the FD&C Act requi res that a qualified facility 
prominently and conspicuously display, at the po int of purchase, the name and business address 445 
 
  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 qua lified facility submit to FDA documentation 
that the facility is a qualified facility.  Consiste nt with the conditions in  section 418(l)(1) of the 
FD&C Act for a facility to be a qualified facility, and our pro posed definition (proposed § 117.3) 
of “qualified facility,” the documenta tion would be directed to either the status of the facility as a 
very small business (as would be defined in pro posed § 117.3) or the app licability 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 defi nition of a qualified faci lity 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 woul d 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 de finition 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 41 8(l)(1)(C) of the FD&C Act, and the definition of very small business in 446 
 
  proposed § 117.3, allow adjustment for inflation.  To establish a level playing field for all 
facilities that may satisfy definition of a qualif ied facility, we are pr oposing to establish the 
baseline year for the calculation in proposed § 117.201(a)(1).  We are pr oposing 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 Congre ss 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 baseli ne year as the year that the law was enacted.    
b. Proposed § 117.201(a)(2)--Documen tation related to food safety  practices at a facility .  
Proposed § 117.201(a)(2) would provide two op tions 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 faciliti es to submit documentation to 
demonstrate that the owner, operator,  or agent in charge of the fac ility 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 satis fy this requirement.     
Proposed § 117.201(a)(2)(i) would implement the provisions of secti on 418(l)(2)(B)(i)(I) 
of the FD&C Act, except that proposed § 117.201(a)(2)(i) would sp ecify monitoring the 
performance of the  preventive controls to ensure that such controls are effective (emphasis 
added).  As discussed in secti on II.B.1.a of this document, unde r the overall framework of the 
proposed requirements that would be established in subpart C, monitoring is directed to 
performance of preventive contro ls.  Thus, proposed § 117.201(a)(2)( i) is consistent with the 
statute and the overall framewo rk of this proposed rule. 447 
 
  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 qualifie d facilities to submit documentation (which may 
include licenses, inspection re ports, certificates, permits, cred entials, certification by an 
appropriate agency (such as a Stat e department of agriculture), or  other evidence of oversight), 
that the facility is in complia nce with State, local, county, or other applicable non-Federal food 
safety law, including relevant laws and re gulations of foreign countries.  Proposed § 
117.201(a)(2)(i) would implement the provisions of sec tion 418(l)(2)(B)(i)(II) of  the FD&C Act.   
As discussed further in section XIII.A.5 of th is document, FDA tentatively concludes that 
a statement from the owner, operator, or agent in ch arge of a qualified fac ility certifying that the 
facility (1) has identified the potential hazards associated w ith the food being produced, is 
implementing preventive controls to address th e hazards, and is monitoring the implementation 
of the preventive controls to ensure that such contro ls are effective; or (2) that the facility is in 
compliance with State, local, coun ty, or other applicab le non-Federal food safety law, including 
relevant laws and regulations of foreign c ountries, 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 subm it documentation to FDA demonstrating the content 
of their hazard identification, preventive cont rols, 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 § 448 
 
  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 website is available from wherever the 
Internet is accessible, includi ng 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 website is 
experiencing technical difficultie s 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. F ood and Drug Administration, ATTN: Qualified 
Facility Coordinator, 10903 New Hampshire Av e., Silver Spring, MD 20993.  “Mail” would 
include the U.S. mail and businesses that can de liver 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 th e documentation that would be required 
by section § 117.201(a) be submitted to FDA initia lly within 90 days of the applicable 449 
 
  compliance date of the rule.  As discussed in se ction 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 th e 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 describe d in proposed § 117.201(a).  
For the purposes of proposed § 117.201, a material ch ange would be one that changes whether or 
not a facility is a “qualified facility.”  The stat us 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 iden tified in proposed § 117.3, has less than $250,000 
in total annual sales of food, ad justed for inflation), its total annual sales of food likely would 
change on an annual basis, and could change so as to exceed $ 250,000.  Li kewise, if a facility 
reports that it otherwise satisfies the definition of  a qualified facility, its to tal 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 facili ty.  As discussed in sections XIII.A.2.a and 
XIII.A.2.b of this document, we tentatively concl ude that certified statements from the owner, 450 
 
  operator, or agent in charge of a qualified f acility would be acceptab le 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 secti on 418(l)(2)(B)(ii) of the FD&C Act and any 
other guidance that may be useful in a ddressing questions regarding submission of 
documentation under this subpart, in this documen t we request comment on an option we are 
considering regarding the subm ission of documentation.  Specif ically, 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 facilit y.  A facility that does not identify itself as a 
qualified facility would not be prompted to provide additional info rmation 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 th at 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 : 451 
 
  • Has identified the potential hazard s associated with the food being 
produced, is implementing preventive controls to  address the hazards, and is monitoring the 
implementation of the preventive controls to en sure that such controls are effective;  
• Is in compliance with State, local, county, or other applicable non-Federal 
food safety law, including relevant laws and regulations of foreign countries; or 
• Both of the above. 
In essence, such a system would provide fo r self-certification that the facility has 
appropriate information demonstrat ing that the facility is a qua lified facility and either has 
identified the potential hazards associated with the food being produced, is implementing 
preventive controls to addr ess the hazards, and is monito ring the implementation of the 
preventive controls to ensure th at 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 syst em may include a statement reminding submitters 
that anyone who makes a material ly false, fictitious, or fra udulent statement to the U.S. 
Government is subject to cr iminal 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 se ction 415(a)(3) of the FD&C Act.  
6. Proposed § 117.201(d)--Notification to Consumers  
Proposed § 117.201(d) would require that a qua lified 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 comp lete 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 fu ll address information for foreign facilities) 452 
 
  consistent with section 418(l)(7 ) of the FD&C Act.  If a f ood packaging label is required, 
proposed § 117.201(d)(1) would require that the re quired notification appear prominently and 
conspicuously on the label of the food.  If a f ood packaging label is no t required, proposed § 
117.201(d)(2) would require that the require d notification appear prominently and 
conspicuously, at the point of pur chase, 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 fo rm are misbranded unless the product label bears 
the name and place of business of the manufactur er, packer, or distributor of the food.  Our 
regulations interpret “place of bus iness” as requiring only the firm’s  city, state, and zip code to 
appear on the product label, as l ong as the firm’s street address is listed in a current telephone 
directory or other city di rectory (21 C.F.R. 101.5(d)).  We tent atively conclude that the use of the 
term “business address” in se ction 418(l)(7) demonstrates Co ngress’ intent to require the 
facility’s full address, includi ng the street address or P.O. box, to appear on labels or other 
required notifications when the facility has op ted to not submit documentation directed to food 
safety practices under section 418 (l)(2)(B)(i)(I) of the FD&C Act.  If Congr ess had considered 
the less complete address already required unde r 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 453 
 
  for foods required to bear labels , there would have been no need to impose a new, more specific 
requirement in section 418(l)(7) fo r the facility’s “busin ess 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 diet ary 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 labe l is required under any other provision of the 
FD&C Act, the complete business address would s ubstitute 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 additi on 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 qu alified facility main tain records relied 
upon to support the documenta tion that would be require d by § 117.201(a).  Proposed § 
117.201(a) would not require th at a qualified facility establish any new records, but merely retain 
those that the facility  relied upon to support the documenta tion that would required by proposed 
§ 117.201(a).  Proposed § 117.201(e)(2) w ould establish that the record s that a qualified facility 
must maintain are subjec t to the requirements of subpart F of  part 117.  As discussed in section 
XV of this document, proposed subpart F would pr ovide the general requirements that apply to 
all records required to be estab lished and maintained by proposed  part 117, including provisions 
for retention of records and for making records av ailable for official revi ew.  Together, proposed 
§ 117.201(a) and (b) would make the underlying reco rds qualified facilitie s would rely on to 
support their self-certifica tions available to FDA upon request.  We  tentatively conclude that it is 454 
 
  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 A pply 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, sp ecific 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 si gnificantly 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 re duce 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 char ge of such facility cannot ensure that the 455 
 
  affected food is not adulterated under section 40 2 of the FD&C Act (sec tion 418(e) of the FD&C 
Act);  
• Verify that the preventive controls are ad equate to control the hazards the owner, 
operator, or agent is conducting monitoring and is  making appropriate deci sions about corrective 
actions and the preventive controls are effectivel y and significantly mini mizing 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 th e 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, re cords 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 a nd describes the procedures used by the 
facility to comply with the re quirements of section 418 of the FD&C Act, including analyzing 
the hazards and identifying the preventive contro ls adopted to address those hazards (section 
418(h) of the FD&C Act); 
• Conduct a reanalysis under section 41 8 (b) of the FD&C Act whenever a 
significant change is made in the activities c onducted at a facility operated by such owner, 
operator, or agent if the cha nge 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 (secti on 418(i) of the FD&C Act). 
In addition to these requirements directed to th e 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 456 
 
  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 storag e 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 st orage 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 (pr oposed § 117.7(a)).  In the remainder of our 
discussion of these modified requirements, we refe r 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/temperat ure 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 f ood is in a form that prevents any direct human 
contact with the food.  The modified requirements in pr oposed § 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 reasonab ly likely to occur during the st orage 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 refrig erated 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 pu blic health significance.  Info rmation about this hazard for 
TCS foods in general (i.e., not limited to unexpos ed packaged food) is widely available (Ref. 457 
 
  137) (Ref. 138) (Ref. 139) (Ref. 140).  In brief, th e need for time/temperature control is primarily 
determined by (1) the potential for contamin ation 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 f oods before, or at the time of, harvest or during 
processing, handling, or storage. Th e rate of growth of these microorganisms is reduced as the 
storage temperature is lowered. Pr oper refrigeration, therefore, prev ents or slows the growth of 
human pathogens and spoilage microorganisms a nd reduces the likelihood of foodborne illness 
(62 FR 8248). A review of the f actors that influence microbial growth and an analysis of 
microbial hazards related to time/temperature contro l 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 commoditie s, emphasizing microbial concerns that would 
be associated with temperature abuse of the pr oducts.  The IFT report discusses foods for which 
time/temperature control may be necessary for sa fety (Ref. 140).  Most foods that are stored 
refrigerated have not been processed to eliminate pathoge nic sporeformers, including 
Clostridium botulinum,
 Bacillus cereus and C. perfringens .  If refrigerated foods are exposed to 
high enough temperatures for sufficient time, thes e sporeformers may begin to grow and produce 
toxins.  Some strains of C. botulinum and B. cereus can grow at refrigera tion temperatures, e.g., 458 
 
  some strains of B. cereus  grow at 39ºF (4ºC) and so me strains of C. botulinum  grow at 38ºF 
(3.3ºC) (Ref. 173).   
Examples of refrigerated foods that are cap able 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 f oods may be contaminated with L. monocytogenes , 
which, as described in section II. D.2.a, can also grow at refrigera tion temperatures.  Examples of 
foods that support the grow th 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 re frigeration conditions.  Growth of pathogens is 
very slow under refrigeration, a nd 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 increase s and food temperatures may get high enough that 
pathogens that cannot grow at nor mal refrigeration temperatures (generally in the range of 41-
45ºF (5ºC-7ºC)) begin to grow  (Ref. 140).  For example, the strains of C. botulinum  that have 
caused most of the outbreaks in the United St ates do not grow and produce toxin until the 
temperature reaches 50ºF (10ºC)  (Ref. 3).  Additional informa tion about the time/temperature 
control of food to address the pot ential for microorganisms of public  health significance to grow 
or produce toxins is available in  books on food microbiology that are available for purchase.    
Such information is sufficiently well-known and accepted that we tentatively conclude 
that the outcome of each individual hazard analys is 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 f ood, would be the same.  That outcome would be 
that the potential for the growth  of, or toxin production by, microorganisms of public health 459 
 
  significance is a hazard reasonabl y likely to occur in any unexpos ed refrigerated packaged TCS 
food.  Likewise, information about appropriate preventive controls  for this hazard is widely 
available (Ref. 191) (Ref. 139).  Such informati on is sufficiently well-known and accepted that 
we tentatively conclude that the appropriate preventive contro l 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 hazar d that is reasonably likely to occur in a 
refrigerated packaged TCS food and the approp riate preventive control for that hazard, we 
tentatively conclude that it is a ppropriate to specify the hazard a nd appropriate preventive control 
in the regulation.  Under this ap proach, it would not be necessar y for each individual facility 
solely engaged in the storage of unexposed p ackaged 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 preven t the growth of, or toxin pr oduction by, microorganisms of 
public health significance.  Instea d, what would remain for the facility to do to comply with 
section 418 of the FD&C Act for th e activity of storing an unexpos ed refrigerated packaged TCS 
food would be a subset of the requirements fo r hazard analysis and risk-based preventive 
controls that would be establis hed in proposed subpart C to imp lement section 418 of the FD&C 
Act.  None of these requirements would requ ire a qualified individual.  This subset of 
requirements would be to: 
• Implement temperature controls (s ection 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);  460 
 
  • Conduct applicable verificati on activities (review of r ecords) (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 pack aged 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 contro ls and in determining whether to update the 
written plan.  Under our appro ach, it is FDA who has identified the preventive control, and it 
would be FDA’s responsibility, th rough rulemaking, to require any ad ditional preventive control.  
Likewise, under our approach, the facility would not be required to deve lop a food safety plan 
and, therefore, would not need to  update the plan.  If, for exam ple, the facility changes its 
procedures for temperature control, the specific ac tivities that the facility  would be required to 
conduct (monitoring temperature; ta king appropriate corrective actions  if there is a problem with 
temperature control; conducting applicable ve rification activities; and establishing and 
maintaining appropriate records) would be adeq uate to address the change in procedure for 
temperature control. 3. Proposed § 117.206--Modified Require ments 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 461 
 
  control to significantly minimize or preven t the growth of, or toxin production by, 
microorganisms of public health significance.  Briefly, those activities would encompass:  
• Establishing and implementing temperatur e controls (proposed § 117.206(a)(1));    
• Monitoring the temperature cont rols (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 ar e consistently impl emented (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 pr oposed § 117.206 establish and implement temperature 
controls adequate to significantly minimize or prevent th e growth of, or toxin production by, 
microorganisms of public health significance in an unexposed refr igerated 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 a ppropriate temperature for storage of the 
food? 
The two primary ways in which the owner, ope rator, or agent in charge of a facility 
subject to proposed § 117.206 can obtain the answ ers to these questi ons 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 la bel statements placed on the food 462 
 
  by the manufacturer, processor, or packer of th e food; and (2) through app licable scientific and 
technical support literature.    
As discussed in section X.D.2 of this doc ument, a citizen petition submitted to FDA 
(Docket No. FDA-2011-P-0561) asserted  that facilities work closel y 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 c onditions for storage are not forma lized 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), informa tion relevant to safe storage of  the food may be provided by the 
manufacturer, processor, or packer of the f ood on the food label.  For example, in 1997 FDA 
published guidelines for labeling food that needs refrigeration by consumer s due to the potential 
for the food to be rendered unsafe due to the grow th of infectious or toxigenic microorganisms if 
“temperature abused” (62 FR 8248, February 24, 1997).  FDA recommended that foods requiring 
refrigeration by the consumer for safety be labe led “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 a bused be labeled more simply – e.g.; “Keep 
refrigerated.”  Such labeling can provide faciliti es with the information to identify TCS foods.  
We tentatively conclude that it would be rare for a facility so lely engaged in the storage of 
unexposed packaged food to not have informati on regarding whether a re frigerated packaged 
food requires time/temperature control for safety a nd, 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 463 
 
  refrigerated packaged food requires time/temperatur e control for safety and, if so, what specific 
temperature controls are necessary  for safe storage of the food, th e 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 assu me that any unexposed refrigerated packaged 
food is a TCS food.  Information about foods th at are TCS foods, and about the appropriate 
temperatures to address the potential for microor ganisms of public hea lth significance to grow, 
or produce toxin, in food are well-e stablished in the scientific li terature.  Documents prepared by 
or on behalf of FDA regarding a ppropriate time/temperature contro ls for safety (Ref. 173) (Ref. 
140) provide numerous references to the primary sc ientific literature and serve as the basis for 
time/temperature controls for a va riety of foods.  The two temper atures commonly cited in these 
documents as maximum temperatures for safe stor age of refrigerated f ood are 41 ºF (5 ºC) and 
45 ºF (7 ºC).  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 transporta tion (§ 118.4(e)) and for refrigera tion of shell eggs held for 
retail distribution (§ 115.50(b)(2)) re quire that eggs be held and tr ansported at a temperature not 
to exceed 45ºF (7ºC).  
• The PMO provides for pasteurized Grade “A ” milk and milk products to be held 
at 45ºF (7ºC) (Ref. 37).   
• The FDA Food Code, which has been wide ly adopted in state laws, recommends 
holding most potentially hazardous (TCS) food at 41ºF (7ºC) or lower (Ref. 191).   
Storage of refrigerated food at or below one of these two temperatures (i.e., 41 ºF (5 ºC) 
or 45 ºF (7 ºC)) consiste nt with storage temperatures requ ired by regulation or recommended in 464 
 
  widely adopted documents such as the PMO a nd 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 prob lems 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 w ith 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 ow ner, operator, or agent in charge of a 
facility solely engaged in th e 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 temperature-recording device (e.g., a recording thermometer) that indicates and 
records the temperature accurately within the refr igeration 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 ag ent in charge of the facility with factual 
information with which to judge whether the te mperature 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 monito ring.  The records of monitoring (which would 
be required by proposed § 117.206(a )(5)(i)) would demonstrate th e frequency of monitoring.  
We request comment on whether th ere would be a benefit to re quiring a facility to develop 
written procedures for monitoring temperature.    465 
 
  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 te mperature for any refrigerated 
packaged food and reduce the likelihood th at the problem will recur (proposed § 
117.206(a)(3)(i)); evaluate all affected food fo r safety (proposed § 117.206(a)(3)(ii)); and 
prevent the food from entering commerce, if the owne r, operator, or agent in  charge of a facility 
cannot ensure the affected food is not adultera ted under section 402 of th e FD&C Act (proposed 
§ 117.206(a)(3)(iii)).  Such correct ive actions would be necessary if, for example, there was a 
failure to maintain adequate temperature cont rol.  Proposed § 117.206(a)(3) is modified relative 
to the analogous proposed requirement for corr ective actions that woul d be established in 
proposed § 117.145(a) in subpart C in that pr oposed § 117.206(a)(3) would not require written 
procedures for corrective actions.  In essence, there is a single ac tion 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 appropr iate. The corrective acti ons taken, including 
information to document that product was not ex posed to temperatures and times that would 
compromise the safety of the product, would be doc umented in records subject  to agency review.  
It may be necessary for the owner, operator, or agen t in charge of the facility to consult with the 
applicable manufacturer, proces sor, or packer of the food to determine the appropriate 
disposition of the food.     
Proposed § 117.206(a)(4)(i) would requi re 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 ca librating temperature monitoring and recording 466 
 
  devices.  As discussed in secti on XII.G.5.a of this document, ca libration provides assurance that 
an instrument is measuring accurately.  If th ese instruments are not properly calibrated, the 
values they provide may not pr ovide the necessary assurance te mperatures are adequate to 
significantly minimize or preven t the growth of, or toxin pr oduction by, microorganisms of 
public health significance in an unexposed re frigerated packaged TCS food.  Proposed § 
117.206(a)(4)(i) is analogous to proposed § 117.150(d )(2) in subpart C, wh ich would establish a 
verification requirement for calibration of pr ocess monitoring instruments and verification 
instruments. 
Proposed § 117.206(a)(4)(ii) would re quire 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 record s of calibration within a reasonable time after 
the records are made.  As discussed in secti on XII.G.5.b of this document, the purpose of the 
review of records would be to ensure that th e records are complete and that the preventive 
controls are effective.  If temperature m onitoring and recording de vices are not properly 
calibrated, the temperature controls may not be e ffective.  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 re quire that the owner, oper ator, or agent in charge 
of a facility solely engaged in storage of une xposed packaged food verify that temperature 
controls are consistently implemented by review ing the records of monitoring and actions taken 
to correct a problem with the c ontrol of temperature within a w eek after the records are made.  
As discussed in section XII.G.5.b of this documen t, the purpose of the review of records would 
be to ensure that the records are complete, that the temperatur es recorded were adequate to 467 
 
  significantly minimize or preven t the growth of, or toxin pr oduction by, microorganisms of 
public health significance in an unexposed refriger ated 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 revi ew of monitoring and co rrective action records 
would provide for timely feedback of informa tion 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 subpar t C, which would establish a verification 
requirement for review of records of monitori ng 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 pa thogens are well documented and do not require validation that they are 
effective in controlling the potential for microorgani sms of public health si gnificance to grow, or 
produce toxin, in food. The reasons for not requir ing reanalysis were discussed in section 
XIII.B.2.  Proposed § 117.206(a)(4) also is modi fied relative to the analogous proposed 
verification requirements in proposed § 117.150 in that proposed § 117.206(a)(4) would not 
require that a qualified individua l perform or oversee the review of records of calibration or 
records of monitoring and actions taken to correc t a problem with the control of temperature.  
The nature of these records does not require th e qualifications that would be required under 
proposed § 117.155(b). 468 
 
  Proposed § 117.206(a)(5) would require that the ow ner, operator, or agent in charge of a 
facility solely engaged in storage of unexposed  packaged food establis h and maintain records 
documenting the monitoring of temperature contro ls for any unexposed refrigerated packaged 
TCS food (proposed § 117.206(a)(5)( i)); records of co rrective 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 docum enting verification activities (proposed § 
117.206(a)(5)(iii)).  The records that document mon itoring would be used to verify that the 
temperature controls are effectively and significa ntly minimizing or preven ting 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 abou t corrective actions are 
being made and appropriate corre ctive actions are being taken.  The records that document 
verification activities woul d be used to document that this ke y element of a food safety plan has 
been implemented.  These records would be n ecessary 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 ve rification activities, 
respectively. 
Proposed § 117.206(b) would establis h that the records that a f acility 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 th at would apply to all records that would be 
required under proposed part 117.  We describe the requirement s of proposed subpart F in 
section XV of this document.  Proposed § 117.206(b) is analogous to proposed § 117.175(b) in 
subpart C. 469 
 
  XIV. Proposed New Provisions fo r Withdrawal of an Exempti on Applicable to a Qualified 
Facility (Proposed Pa rt 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 qu alified 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 preven t or mitigate a foodborne illness outbreak based 
on conduct or conditions associated w ith a qualified facility that are material to the safety of the 
food manufactured, processed, packe d, or held at such facility, the Secretary may withdraw the 
exemption provided to such facility under sectio n 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 tentativel y conclude that it is appropri ate 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 Exempti on 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 foodbor ne illness outbreak that is directly linked to the qualified facility.  
Proposed § 117.251(a) would implement the statut ory 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 470 
 
  is the occurrence of two or more cases of a si milar 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 distribu tion facilities; during 
storage or transit; at retail establishments; in restaurants; and in the home.  When foodborne 
illness is associated with food, a tr aceback investigation may enable us to directly link the illness 
to the facility or facilities that manufacture d, 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 ta ken from the jars and c onfirm the presence of 
Salmonella
 Tennessee in the peanut butter.  Investigat ors were able to identify the manufacturer 
through information required to be on the la bel of the jars (21 CFR 101.5(a)) and through a 
product code the manufacturer had voluntarily pl aced 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 pea nut 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 we re likely to have caused the contamination and 
obtained a positive environmental sample, investig ators saw no need to further trace the peanuts 
back to the farm where the peanuts were grow n (73 FR 55115 at 55118).  In circumstances such 471 
 
  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 Ex emption Based on Conduct or Conditions 
Associated with a Qu alified 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 illn ess 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 s ection 417 of the FD&C Act about contamination 
of a food, and the reports may l ead us to investigate a qualifie d facility that manufactured, 
processed, packed or held the food.  If our inve stigation finds conduct or  conditions associated 
with the facility that ar e material to the safety of the f ood (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 il lness 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 micr oorganisms of public health si gnificance, we would consider 
withdrawing the exemption provided to the faci lity under proposed § 117.5(a) if doing so would 
be necessary to protect the public health and pr event or mitigate a foodborne illness outbreak.   472 
 
  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 facili ty 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 determina tion that the withdrawal of an exemption is 
warranted and to include the basis for the de termination in the written record.     
Proposed § 117.254(b) would require that an FDA District Direct or in whose district the 
qualified facility is located (or, in the case of a foreign facility, the Di rector of the Office of 
Compliance in the Center for Food Safety and App lied Nutrition), or an F DA official senior to 
such Director, must approve an order to withdr aw the exemption as part of the withdrawal 
determination procedure before the order is issued.  A Regiona l Food and Drug Director is an 
example of an FDA official senior  to a District Director.  The Deputy Director a nd Director of 
the Center for Food Safety and Applied Nutrition ar e examples of an FDA official senior to the 
Director of the Office of Comp liance.  Requiring prior approval  of a withdrawal order by a 
District Director or an FDA official senior to a District Director is cons istent with the approval 
requirement for a detention order in part 1, s ubpart K (Administrative Detention of Food for 
Human or Animal Consumption).  Requiring pr ior approval of a wit hdrawal order by the 
Director of the Office of Compliance in the Ce nter 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 facil ity.  The requirements of section 
418 of the FD&C Act are directed to  the owner, operator, or agent in charge of a facility.  We 473 
 
  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 th at an order to withdraw an exemption 
applicable to a qualified f acility under § 117.5(a) include the following information: 
• (a) The date of the or der (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 r easons for the order, including information 
relevant to: 
• (1) An active investigation of a foodborne illness out break that is directly 
linked to the facility; or  
• (2) Conduct or conditions associated w ith 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 comp ly with subpart C of this part on the 
date that is 60 calendar days after th e 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)); 474 
 
  • (f) A statement that any informal heari ng on an appeal of the order must be 
conducted as a regulatory hearing 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, e-mail address, and facsimile number 
of the FDA district office and the name of the FDA District Director in whos e 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 F DA representative who approved the order 
(proposed § 117.257(i)). 
FDA tentatively concludes that the requi rements that we propose in § 117.257 would 
provide the owner, operator, or agent in charge of a qualified f acility subject to a withdrawal 
with adequate notice of the basi s for our determination to withdr aw the exemption and of their 
opportunity to appeal our determination and to  request an informal hearing.  The proposed 
notification procedures are simila r to and consistent with the no tification requirements in other 
regulations involving administra tive action, such as administra tive detention of food under § 
1.393 orders for diversion or destruction of sh ell eggs under the PHS Act under § 118.12(a)(i), 
and with procedures for an info rmal 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 owne r, 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 60 475 
 
  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 co uld result in our determination that an exemption should be 
withdrawn (as described in proposed § 117.251) warra nt prompt compliance with the rule in the 
interest of public health.  We tentatively conclude that ten cale ndar days for the submission of an 
appeal from the date of the receipt of a wit hdrawal order is appropria te for purposes of the 
efficient adjudication of the appeal of a wit hdrawal order and would provide reasonable due 
process that comes to closure sufficiently in advan ce 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 th e 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 orde r with a request for an informal hearing under 
proposed § 117.260(b) would not prevent FDA fro m simultaneously detaining food from the 
facility under section 304(h) of the FD&C Ac t, seizing food from the facility under section 
304(a) of the FD&C Act, or seeking or enforc ing 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 F DA 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 re gardless of whether the owner, operator, or 476 
 
  agent in charge of a facility requests, and F DA grants, a hearing.  As already discussed, FDA 
tentatively concludes that the ci rcumstances that lead to a determination that an exemption 
should be withdrawn warrant prompt complia nce in the interest  of public health. 
F. Proposed § 117.264--Procedure for Submitting an Appeal  
Proposed § 117.264(a) would require that, to app eal an order to withdraw an exemption 
applicable to a qualified facility  under § 117.5(a), the owner, operato r, 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, e-mail address, or facsimile number id entified in the order with in 10 calendar days of 
the date of the order; and (2) re spond with particularity to the f acts and issues contained in the 
order, including any supporti ng documentation upon which the ow ner, operator or agent in 
charge of the facility relies.  
 Allowing the owner, operator, or  agent in charge of the facil ity to submit an appeal in 
person, by mail, e-mail, or fax would provide for flexibility as well as speed.  For example, 
submitting in person would give the owner, operato r, or agent in charge direct knowledge that 
the request for appeal had been delivered and received.  E-mail and fax are instantaneous, and 
overnight mail delivery services are readily avai lable to those who choose to use them; however, 
the ten day time frame for appeal of the orde r would not require the use of overnight mail 
delivery.  For clarity, proposed § 117.264(a) woul d 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 fo r 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 477 
 
  raised in the withdrawal order and include all suppor ting documentation so that we would be 
able to issue a final determination as to the di sposition of the appeal so lely 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 ch arge 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 fac ility 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 or der, 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 th e owner, operator, or agent in charge of the facility appeals 
the order, the owner, operator, or  agent in charge of the facility  must submit any request for an 
informal hearing together with its written a ppeal 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 owne r, operator, or agent in charge 
of the facility would be required to submit a wr itten appeal is appropriate for purposes of the 478 
 
  efficient adjudication of the appeal of a wit hdrawal 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 establ ish that a  request for an informal hearing may be 
denied, in whole or in part, if the presiding o fficer 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 pr oposed § 117.264(a), a written appeal would be 
required to respond with particular ity to the facts and issues cont ained in the withdrawal order, 
including any supporting documentation upon which th e owner, operator or agent in charge of 
the facility relies.  If the materials submitte d 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 pres iding officer may determine that an informal 
hearing is not warranted.  The pr esiding officer may include writt en notice of the determination 
that a hearing is not jus tified as part of the fi nal decision on the appeal. 
H. Proposed § 117.270--Requirements Applicable to an Informal Hearing
 
Proposed § 117.270(a) would establish that, if th e owner, operator or agent in charge of 
the facility requests an informal hearing, and F DA 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 owne r, operator, or agent in charge of the facility and FDA.  We 
tentatively conclude that, if we  grant a request for an inform al hearing, holding the hearing 
within 10 calendar days, or within  an alternative time frame as  agreed upon in writing, is 479 
 
  appropriate for purposes of the efficient adjudica tion 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 pr ovide an opportunity for the facil ity to come into compliance if 
we deny the appeal.   
Proposed 117.270(b) would establis h 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 wi thin 1 calendar day is appropriat e for purposes of the efficient 
adjudication of the appeal of a withdrawal orde r 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 establis h 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 accordan ce 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 s ubpart E must be addressed to the FDA 
District Director (or, in the cas e of a foreign facility, the Direct or of the Office of Compliance in 
the Center for Food Safety and Applied Nutritio n) as provided in th e order withdrawing an 
exemption.  
• (3) Section 117.274, rather than § 16.42(a) , describes the FDA employees who 
preside at hearings under this subpart.   480 
 
  • (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 wri tten report of the heari ng. All written material 
presented at the hearing will be attached to the re port. The presiding officer must include as part 
of the report of the hearing a findi ng on the credibility of witnesses (other than expert witnesses) 
whenever credibility is a material issue, and must include a proposed d ecision, with a statement 
of reasons. The hearing particip ant 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 th is chapter does not apply to a regulatory hearing 
under this subpart.  The presidi ng officer’s report of the hearin g 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 reconsiderati on or a stay of the presiding officer’s final 
decision.  
• (7) If FDA grants a request for an info rmal hearing on an appeal of an order 
withdrawing an exemption, the hearing must be conducted as a regul atory 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 hearin g under this subpart, the ad ministrative 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 fi nal 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 presid ing officer’s final decision. 481 
 
  Under § 16.1(b), the procedures in part 16 apply when a regulation provides a person 
with an opportunity for a heari ng 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 unde r 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 th e proposed rule would provi de appropriate process 
to the owner, operator, or agent in charge of a qualif ied facility subject to withdrawal of the 
facility’s exemption.  We also tentatively c onclude that the modifi ed part 16 procedures 
contained in this proposed rule would provide the owner, operato r, 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 acti on 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 acti on under § 10.33 or may 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 w ithdrawing an exemption provided under proposed § 
117.5(a).  The circumstances that may lead FDA to withdraw an exemp tion include an active 
investigation of a foodborne  illness outbreak that is  directly linked to a qu alified 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 asso ciated with a qualified facility that are 
material to the safety of the food manufactured, pro cessed, packed, or held at  such facility.  Such 
circumstances require prompt action.  Under § 16.120, a qualified facility that disagrees with 482 
 
  FDA’s decision to withdraw an exemption pr ovided 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 presid ing 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 Dist rict Director.  Under § 16.42(b), an officer presiding over an informal 
hearing is to be free from bias or prejudice and may not have part icipated in the investigation or 
action that is the subject of the hearing or be subordinat e to a person, other than the 
Commissioner, who has participated  in such investigation or acti on.  An order for the withdrawal 
of an exemption applicable to a qualified facility  must be approved by a Di strict Director or an 
official senior to a District Direct or.  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 Direct or did not participate in the 
determination that an exemption should be w ithdrawn and is otherwise free from bias or 
prejudice.  Alternatively, the Re gional Food and Drug Director co uld be from a different region 
than the region where the facili ty is located, for example in the event the Regional Food and 
Drug Director for the region in wh ich the facility is located is the FDA official who approved the 
withdrawal order.  Any Office Di rector of FDA’s Office of Regulat ory Affairs could preside at a 
hearing, provided that the Offi ce Director did not participate in the determination that an 
exemption should be withdrawn and is ot herwise free from bias or prejudice. 483 
 
  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 orde r without requesting a hearing, the pres iding officer must issue a written 
report that includes a final deci sion confirming or revoking the w ithdrawal 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 f oodborne 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 conc lude that we will need 10 cale ndar days to revi ew the written 
appeal and the materials submitted with the writ ten appeal, and that a final decision confirming 
or revoking a withdrawal order shoul d be issued as quickly as po ssible in the in terest of the 
public health and to provide reasonable due proce ss that would come to closure sufficiently in 
advance of the effective date of the order to provi de 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 provi de a 2 calendar day opportunity 
for the hearing participants to review and subm it comments on the report  of the hearing under § 
117.270(c)(4), and must issue a final decision within  the 10-calendar day pe riod 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 s ubject 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 484 
 
  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 w ould 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 inform al hearing and if FDA denies the request for a 
hearing, the presiding officer mu st issue a final decision on th e appeal confirming or revoking 
the withdrawal within 10 calendar days after th e date the appeal is filed.  We tentatively 
conclude that ten calendar days for the presiding officer to issu e 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 co me to closure sufficiently in advance of the effective date of 
the order to provide an opportuni ty for the facility to come into compliance if we deny the 
appeal, and is in the in terest 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 establ ish 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 char ge of the facility appeals the order and 
requests an informal hearing, FDA grants the requ est 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 char ge of the facility appeals the order and 
requests an informal hearing, FDA denies the re quest for an informal hearing, and FDA does not 485 
 
  confirm the order within the 10 ca lendar days after the appeal is filed, or issues a decision 
revoking the order within that time; or 
• (c) The owner, operator, or agent in ch arge 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 revoki ng 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 ar e proposing that the FDA officer responsible for adjudicating the 
appeal and presiding over a hearing, if one is granted, may expressly i ssue a written decision 
revoking the order within the specified 10 calenda r day time frames.  Second, we are proposing 
that the failure of the FDA officer responsible fo r adjudicating an appeal to issue a final decision 
expressly confirming the order within the specif ied 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 d eadlines for expressly confirming an order. 
L. Proposed § 117.284--Final Agency Action  
Proposed § 117.284 would establish that conf irmation of a withdr awal order by the 
presiding officer is considered a final agency action for purposes of sec tion 702 of title 5 of the 
United States Code (5 U.S.C. 702).  A confir mation 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 qual ified facility, to the lis t of regulatory provisions 
under which regulatory hear ings are available. 486 
 
  XV. Proposed New Recordkeeping Require ments (Proposed Part 117, Subpart F) 
A. Relevant St atutory 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 stat utory provisions that are most relevant to 
proposed subpart F are: 
• Section 418(a) of the FD&C Act, which requ ires, in relevant pa rt, that the owner, 
operator, or agent in charge of  a facility maintain records of  monitoring the performance of 
preventive controls as a ma tter 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 fac ility develop a written analysis of the hazards; 
• Section 418(g) of the FD&C Act, which requ ires, in relevant pa rt, 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 secti on 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, instan ces when corrective actions were 
implemented, and the efficacy of preventiv e controls and corrective actions; and 
• Section 418(h) of the FD&C Act, which requ ires, in relevant pa rt, 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 describe d in section 418(g) of th e FD&C Act, shall be 487 
 
  made promptly available to a duly authorized repr esentative of the Secretary upon oral or written 
request; 
• Section 418(n)(1)(A) of the FD&C Act, wh ich provides, in relevant part, that 
FDA shall promulgate regulations to esta blish science-based minimum standards for 
documenting hazards and documenting the implementa tion of the preventive controls under this 
section; 
• Section 402(a)(4) of th e FD&C Act, which provides th at food is adulterated if it 
has been prepared, packed, or held under insa nitary 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 Se rvice Act [42 U.S.C. 264(a)], which 
provides FDA with authority to make and enforc e such regulations as in FDA’s judgment are 
necessary to prevent the introduction, transmissi on, or spread of comm unicable 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 a nd also submit either 
documentation of the facility’s implementati on and monitoring of pr eventive controls or 
documentation of its compliance with other a ppropriate 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, ex cept as provided by proposed § 117.301(b) 
and (c), all records required by proposed part 117 would be subject to all requirements of 488 
 
  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 offici al review and public disclosure, are applicable 
to all records that would be re quired under all subparts,  because records that would be required 
under each of the subparts aid plants and facili ties in compliance with the requirements of 
proposed part 117; and allow plan ts 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 de tail 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 s ection XIII.A.7 of this 
document, proposed § 117.201(e) would require that a qualified facility ma intain records relied 
upon to support the self-certi fication that would be required by § 117.201(a).  Such 
documentation would be directed to the financia l basis (and, when applicable, percentage of 
sales to qualified end users) as well as to food sa fety practices at the qua lified 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 expect ed 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 a pply to its records, we 
are proposing to specify that  those provisions do not a pply 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 requi red records, the recording of 489 
 
  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 reco rds be kept as original records, true 
copies (such as photocopies, pictures, scanned copies, microfilm, microf iche, or other accurate 
reproductions of the original record s), or electronic records.  True  copies of records should be of 
sufficient quality to 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 al lowing true copies is consistent with other 
regulations such as our Good Manufacturing Practices (GMPs) regulation for dietary 
supplements (§ 111.605(b)) and provides options th at 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, electroni c signatures, and handwri tten signatures executed 
to electronic records as equi valent to paper records and ha ndwritten signatures executed on 
paper.  The proposed requirement clarifies a nd acknowledges that record s required by proposed 
part 117 may be retained electronically, pr ovided that they comply with part 11. 
FDA tentatively concludes that it is appropriate to apply th e 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 no t applying part 11 to 
records that would be kept under proposed part  117.  For example, would a requirement that 490 
 
  electronic records be kept according to part 11 mean that current electronic records and 
recordkeeping systems would have to be recrea ted and redesigned, which we determined to be 
the case in the regulation Establishment and Main tenance 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 purpo ses 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 prac tices would satisfy the requiremen ts of the Act and, therefore, 
we exempted the records from the requirement s of part 11 (21 CFR § 1.329(b)).  We also 
exempted records related to cer tain cattle materials prohibited from use in human food and 
cosmetics from part 11 (21 CFR §§ 189.5(c)(7) a nd 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 re cords contain the actual values and 
observations obtained during monitori ng.  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 re cord.  Notations that monitoring measurements, 
such as heat treatment temperat ures, are ‘‘satisfactory’’ or ‘‘uns atisfactory,’’ without recording 
the actual times and temperatures, are vague and subject to varying interpretations and, thus, will 
not ensure that controls are wo rking properly.  In addition, it is not possible to discern a trend 
toward loss of control without actual measurement values.  Propos ed § 117.305(b) is consistent 
with our HACCP regulations for seafood and ju ice, specifically § 123.6( c)(7) and §120.12(b)(4), 491 
 
  respectively.  In addition, our HACCP regul ation for juice also requires that records 
documenting the monitoring of critic al control points and their crit ical 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 conc urrently with perfor mance of the activity 
documented (proposed § 117.305(d)); and be as deta iled as necessary to provide a history of 
work performed (proposed § 117.305(e)).  Propose d § 117.305(c) and (d) would ensure that the 
records are useful to the owner, operator, or agen t 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 us eful 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 guidelin es, the Codex HACCP 
guidelines, and our HACCP regulations for seafood a nd juice.  Consistent with the definition of 
“monitor” in proposed § 117.3, the NACMCF guidelin es 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 us e in verification (Ref. 34).  The Codex guidelines 
advise that efficient and accurate record keepi ng is essential to the application of a HACCP 
system (Ref. 35).  Our HACCP regulations for seafood and juice require that processing and 492 
 
  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 reco rds include (1) the name and location of 
the plant or facility; (2) the date and time of th e 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 acco untability. 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) w ould 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 recal l 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 guide lines recommend that 
all records and documents associ ated with CCP monitoring be da ted 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 loca tion of the processor; th e date and time of the 
activity that the record reflects; the signature or initials of the person performing the operation; 493 
 
  and where appropriate, the identity of the pr oduct and the production code, if any (§§ 123.9(a) 
and 120.12 (b), respectively).    
D. Proposed § 117.310--Additional Requirement s Applying to the Food Safety Plan  
Proposed § 117.310 would require th at 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 provi de 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 pl an be signed and dated, either 
by the most responsible individual on site at the processing facility or by a higher level official of 
the processor and be dated and signed upon in itial acceptance; upon any modification; and upon 
verification of the plan (for seafood) or upon veri fication and validation (f or 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 reco rds 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 th at relate to the general adequacy of the 494 
 
  equipment or processes being used by a facilit y, including the results of scientific studies and 
evaluations, must be retained at the facility for at least 2 year s 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-y ear timeframe for all reco rds required by proposed 
part 117 is consistent with th e length of time that nonperishab le food products, on average, can 
be expected to be in commercial distribution plus  a reasonable time thereaf ter 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 proce ssed food products to cl ear 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 appr oximately 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 reci pients should be kept  (69 FR 71562 at 71602-3).  
The 2-year record retention re quirement is also consistent with our HACCP regulations for 
seafood and juice, which both requir e that records be retained for at least 2 years after the date 
they were prepared in the case of frozen, pres erved, or shelf-stable products (§§ 123.9(b)(1) and 
120.12(d)(1), respectively); and wi th the requirement in the seafood HACCP regulation that 
records relating to the ge neral adequacy of equipment or pro cesses, including scientific studies 
and evaluations, be retained for at least 2 year s after their applicabil ity to the product being 
produced at the facility (§ 123.9(b)(2)).  While  FDA established shorter records retention 495 
 
  requirements for records related to perishable  foods in the BT records, seafood HACCP, and 
juice HACCP regulations, in this case Congress de termined and specified in section 418(g) of 
the FD&C Act that the minimum retention period for the majority of th e records required under 
proposed part 117 for all foods, regardless of pe rishability, is 2 year s.  Therefore, FDA 
tentatively concludes that the same requirement should apply to all reco rds required under this 
section, regardless of the perishab ility of the food to which the record relates.  This would 
simplify plants’ or facilities’ duties in complia nce 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 r ecord was prepared, for day-to-day operational 
records; or from the date at which use of the record is discontinued, fo r 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 pl an).  We seek comment on this proposal.  
2. Proposed § 117.315(c) 
Proposed § 117.315(c) would provide that, except for the food sa fety 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 re main 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 ad equate storage space in the plant or facility for 
all of these records.  Providing for offsite storag e of most records after 6 months would enable a 
facility to comply with the pr oposed 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. 496 
 
  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 wo rldwide. 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 provi des for transfer of records if  record storage capacity is 
limited on a processing vessel or at a remote processing site, if th e 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 followi ng 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 electro nic 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 transf erred to some other reasonably accessible location but must be 
returned to the plant or facility within 24 hour s for official review upon request.  Allowing for 
transfer of records will give pr actical 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 r ecords 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).    497 
 
  F. Proposed § 117.320--Requirements for Official Review  
Proposed § 117.320 would require th at all records required by proposed part 117 be made 
promptly available to a duly authorized represen tative of the Secretar y of Health and Human 
Services upon oral or written request.  Propos ed § 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 consiste nt with our HACCP regulations for seafood 
and juice, which require that a ll records required under those rulema kings 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 reco rds to the agency 
rather than making the records available for revi ew at a facility’s place of business.  FDA 
requests comment on whether proposed § 117.320 should be modified to exp licitly address this 
circumstance, and if so, whether FDA should require  that the records be s ubmitted electronically.  
Obtaining a facility’s food safety plan without go ing 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 r ecords 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 (FOI A) [5 U.S.C. 552], the Trade Secrets Act [18 
U.S.C. 1905], and the FD&C Act govern FDA’s di sclosures of informati on, including treatment 
of commercial confidential information (CCI) and trade secret information. Our general policies, 
procedures, and practices relati ng to the protection of confiden tial information received from 
third parties would apply to inform ation received under this rule.   498 
 
  Proposed § 117.325 is consistent with, but fr amed differently than, the disclosure 
provisions of the HACCP regulations fo r seafood and juice (§§123.9(d) and 120.12(f), 
respectively).  Proposed § 117.325 is framed simila rly 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 producti on rule).  Under § 118.10(f), r ecords 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 re gulations promulgated under 
section 418(n)(1)(A) shall: 
• “(A) provide sufficient flexibility to be  practicable for all sizes and types of 
facilities, including sma ll 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 at tention to minimizing the burden (as defined in 
section 3502(2) of such Act) on th e facility, and collection of info rmation (as defined in section 
3502(3) of such Act), associated with such regulations;” 
• “(C) acknowledge differences in risk and minimize, as a ppropriate, the number of 
separate standards that appl y to separate foods; and” 
• “(D) not require a facility to hire a cons ultant or other thir d party to identify, 
implement, certify, or audit prev ent[ive] controls, except in th e case of negotiated enforcement 
resolutions that may require such a consultant or third party.”  499 
 
  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 facilitie s.  As discussed in sections II.C and XII of this 
document, subpart C of the proposed rule (and re lated requirements) are consistent with HACCP 
principles.  Like HACCP, the preventive contro ls system proposed in this document would 
provide flexibility for facilities to tailor their food safety pl ans to their specific foods and 
operating conditions.  This proposal would allow facilities to establish only those preventive 
controls that are applicable to their circ umstances, and to choose among multiple options 
wherever there are different ways to significantly minimize or prevent a haza rd that is reasonably 
likely to occur.   
In addition, the specific provisi ons of proposed subpart C (and related requirements) have 
been designed to maximize their flexibility and practicability wh erever it is possible to do so 
consistently with the requirements of s ection 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, ope rator, or agent in charge of th e facility to e ither 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 me thod types if the hazards, control measures, 
parameters, and required procedures such as mon itoring are essentially id entical 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 c ontrols by allowing flexibility to establish the 
parameters and the maximum/minimum values for the selected control. 500 
 
  • As discussed in section X II.C.2 of this document, for process controls, food 
allergen controls, sanitation controls, and other c ontrols, a facility would have the flexibility to 
identify and implement preventive controls fr om among all procedures, practices, and processes 
available to it that would pr ovide the assurances that w ould be required by proposed § 
117.135(a).   
• As discussed in section XII.H of th is document, proposed § 117.155(b) would 
provide flexibility for the qualifie d individual to be either an em ployee of the facility or an 
individual not employed by the facility (such as i ndividuals associated wi th universities, trade 
associations, and consulting companies).  Propos ed § 117.155(b) would also provide flexibility 
for the qualified individual to be qualifie d either through traini ng or job experience. 
• As discussed in section XV.C.1 of th is document, proposed § 117.305(a) would 
provide flexibility for mechanisms for keeping records while maintaining the integrity of the 
recordkeeping system.   
• As discussed in section XV.C.3 of th is document, proposed § 117.305(e) would 
provide flexibility to f acilities to tailor the amount of deta il in their records to the amount 
necessary to provide a hist ory 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 th is authority to exempt facilities that solely 
engage in the storage or raw agricultural commod ities, other than fruits and vegetables, intended 
for further distribution or processi ng (§ 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 environmen t under this authority (proposed 501 
 
  §§ 117.7 and 117.206).  These proposed modified require ments are specifically designed to be 
targeted to the specific circumstances of such f acilities and therefore to be practicable for such 
facilities.   
We are also proposing to define the terms “s mall business” and “very small business” in 
proposed § 117.3.  As discussed in sections V II, 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 enhanc e 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, re spectively).  FDA expects that this would assist 
small and very small businesses in making chan ges that would be required for compliance. 
Second, FDA is proposing two exemptions fr om proposed subpart C that would be 
available in part based on business size.  The proposed exemption for qu alified facilities in § 
117.5(a) would be available to very small busines ses, and to certain other businesses based in 
part on business size, as set forth in that proposed section.  Qualif ied 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 f acility to show that it is in fact a qualified facility, or to 
demonstrate its own hazard analysis and preventi ve control system or compliance with state, 
local, county, or other applicable  non-Federal law.  Instead, F DA is proposing to accept self-
certification of compliance with these requireme nts, provided that f acilities retain the 
documentation on which they rely and make su ch documentation available to FDA upon request 
(§ 117.201(e) and related requireme nts in proposed subpart F). 502 
 
  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 proposi ng to exempt facilities that are small or very 
small businesses engaged only in certain lo w-risk activity /food combinations from the 
requirements of section 418.  We have iden tified a significant number of activity/food 
combinations that we would consider to be lo w-risk when conducted on-farm by small and very 
small businesses, set forth in the prop osed 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 a ll facilities subject to that section only after 
providing a sufficient time period fo llowing publication of the final ru le for facilities to come 
into compliance.  Specifically, FDA is proposing that businesses would be required to comply 
with the final rule 1 year after it s 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 fina l rule.  Providing additio nal time for businesses 
to comply, with the most time given to the sma llest businesses, helps to make the regulation 
practicable for all sizes of facilities.   3. Section 418(n)(3)(B) 
 In implementing section 418 through this pr oposed rule, FDA has complied with chapter 
35 of title 44, United States code (commonly kn own as the ‘Paperwork Reduction Act’ (PRA)), 
with special attention to minimizing the burden (a s defined in section 350 2(2) of such Act (44 
U.S.C. 3502(2))) on the facility, a nd collection of information (as defined in section 3502(3) of 
such Act (44 U.S.C. 3502(3))), associated with the proposed rule.  Unde r section 3502(2) of the 
PRA, “burden” means “time, effort, or financ ial resources expended by persons to generate, 503 
 
  maintain, or provide information to or for a Fede ral 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 pu blic, of facts or opinions by or for 
an agency, regardless of form or format, calling fo r … answers to identical questions posed to, or 
identical reporting or recor dkeeping requirements imposed on, ten or more persons….” 
In section XVII of this document, we discu ss how this proposed rule complies with the 
requirements of the PRA.  In addition, in impl ementing 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 secti on XVI.A.2, we are proposing requirements that 
provide significant flexibility for different si zes and types of facilities.  By making these 
requirements flexible enough to be practicable fo r 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 re quirements of the proposed rule. 
In addition, the only requirements we are proposing that constitute collections of 
information are those that are necessary to m eet the requirements of section 418 of the FD&C 
Act and to efficiently enforce that section.  Section 418 requires facilit ies 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)), reco rds 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 504 
 
  (section 418(g)).  Section 418(h) al so requires facilities to make those records promptly available 
to FDA upon request.  In this proposed rule, FD A has interpreted these requirements in a manner 
calculated to minimize the associated burden and to minimize recordkeeping requirements 
beyond those explicitly provided fo r by the statute to those that are essential to implementation 
and enforcement of section 418.  For example: 
• As discussed in section X II.A.3 of this document, FDA is proposing to interpret 
section 418(h) not to require wr itten procedures for conducting a hazard analysis or written 
procedures for establishing preventive contro ls, 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 me thod types if the hazards, control measures, 
parameters, and required procedures such as mon itoring are essentially id entical and, thus, would 
minimize the number of different documents that n eed to be included in the food safety plan and 
the recordkeeping burden associ ated with that plan.   
• As discussed in section X II.C.7 of this document, FDA is proposing that written 
corrective action procedures woul d not be required for sanitati on deviations when the owner, 
operator, or agent in charge of  a facility takes corrective actio n in accordance with proposed § 
117.135(d)(3)(iii), because there w ould be little benefit in re quiring 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 whic h there is a hazard reasonably 
likely to occur, not for all foods, thereby avoiding unnecessary recordkeeping burden. 505 
 
  • As discussed in section X II.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 th at applies to all covered foods 
when determining whether preventive contro ls are required.  Pr oposed § 117.130(a)(1) would 
require that the owner, operator, or agent in ch arge of a facility iden tify 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 reasonabl y 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 reas onably likely to occur, facilities would be 
required to establish preventive c ontrols 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 si ngle standard to all foods subject to that subpart.   
In addition, the proposed rule acknowledge s differences in risk by establishing 
exemptions and modified requirements in certai n 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; activ ities subject to part 
123 (seafood HACCP) and in compliance with that part; activities subject to part 120 (juice 506 
 
  HACCP) and in compliance with that part; ac tivities subject to part 113 (LACF) and in 
compliance with that part with respect to mi crobiological hazards addressed in that part; 
manufacturing, processing, packing,  or holding of dietary supplements in compliance with part 
111 (dietary supplement CGMPs) and section 76 1 of the FD&C Act (serious adverse event 
reporting); activities subject to section 419 of the FD&C Act (s tandards for produce safety); on-
farm low-risk activity/food combinations conducte d by small or very small businesses engaging 
only in such activities; alcoho lic beverages and limited amou nts of non-alcohol prepackaged 
food at alcohol-related faci lities; and facilities solely engaged in the storage of raw agricultural 
commodities (other than fruits and vegetables) in tended for further distribution or processing.  In 
addition, the proposed rule include s modified requirements for faci lities 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 shoul d be some differences in the 
requirements for certain foods, certain facilities,  and certain activities, depending on risk and on 
other aspects of the regu latory 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 requ ire a facility to hire a consul tant or other third party to 
identify, implement, certify, or audit preventive c ontrols.  As discussed in  section XII.H of this 
document, proposed § 117.155(a) would require th at a qualified indivi dual 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 507 
 
  may rely on assistance from qualified individuals that are not employ ees of the facility, such as 
individuals associated with uni versities, trade associations, and consulting companies.  The 
option in proposed § 117.155(b) woul d provide flexibility to fac ilities subject to the rule.  
Providing an option to use a consultant or other th ird party as the qualified  individual to conduct 
specific functions would not require using a cons ultant or other third party.  These proposed 
provisions are merely permissive and FDA tentativel y concludes that they ar e 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 Existe nce 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 S ecretary shall review regulatory 
hazard analysis and preventive control programs in existence on the date of enactment of 
[FSMA], including the Grade ’A’ Pasteurized Milk Or dinance to ensure that  such regulations are 
consistent, to the extent practicable, with a pplicable domestic and in ternationally-recognized 
standards in existence on such date.”     2. Overview of FDA’s Review of Hazard An alysis and Preventive Controls Programs 
FDA has conducted the review of regulatory hazard analysis and preventive control 
programs and internationally-recogn ized standards required by s ection 418(n)(5) of the FD&C 
Act.  To do so, we reviewed the follow ing domestically recognized standards:  
• NACMCF’s “Hazard Analysis and Critic al Control Point Principles and 
Application Guidelines” (Ref. 34); 508 
 
  • FDA’s regulation in part 120 (Hazard An alysis and Critical Control Points 
(HACCP) Systems) for juice ;  
• FDA’s regulation in part 123 (F ish and Fishery Products);  
• FSIS’ regulation in 9 CFR 417 (Hazard Anal ysis and Critical and Control Point 
(HACCP) systems) for meat and poultry products; and   
• The Grade “A” Pasteurized Milk Ordina nce (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 in ternationally recognized standards: 
• The Codex Annex to the Recommended Inte rnational 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 (t he EU regulation) (Ref. 38);    
• The requirements for food safety program s 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 propos ed requirements to implement section 418 of 
the FD&C Act (i.e., the proposed requirements th at 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;  509 
 
  • 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 secti on 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 patte rned 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 word ing is not always identical.  In general, 
domestic standards are patterned after the NACMCF HACCP guidelines and the international 
standards are patterned afte r 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 propos ed provisions and descri be how the proposed 
provisions relate to HACCP principles as es tablished in the NACMC F HACCP guidelines, the 
Codex HACCP Annex and Federal HACCP regulati ons 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 internationa l standards other than the C odex HACCP Annex (i.e., the EU 510 
 
  regulation, the FSANZ Code, and the CFIA FSEP).  However, for the purpose of the review 
required by section 418(n)(5) of th e FD&C Act, we discuss all of  these standards.  We also 
developed a table showing how th e proposed requirements of subpart C compare to the listed 
domestic and international food safe ty standards; that table is a reference to this document (Ref. 
193).   
In other sections of this document, we re fer to “Federal HACCP regulations for seafood, 
juice, and meat and poultry.”  For the purpose of the review re quired by section 418(n)(5) of the 
FD&C Act, we refer to “domestic” regulati ons rather than “Federal” regulations.   
3. Comparison of Preventive Control Programs 
a. Requirement for a food safety plan .  Proposed § 117.126 would re quire that the owner, 
operator or agent in charge of a facility prep are (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 devel opment 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, a lthough the specific descrip tions are not always 
identical to those in the NAC MCF 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 guide lines and the Codex HACCP Annex, all 
domestic HACCP regulations a nd the PMO HACCP Appendix requ ire that food establishments 
as specified in the regulation or standard operate in accordance with the seven HACCP 
principles.  All domestic regulations and th e PMO HACCP Appendix require a written HACCP 
plan (which in this proposed regulation is a f ood safety plan) whenever the hazard analysis 511 
 
  identifies hazards that are reasonably likely to occur.  The internationa l standards require, in 
general, that food establishments as specified in  the regulation or standard operate in accordance 
with the seven HACCP principl es as described by Codex.  FSANZ requires the food safety 
program to be written, and CFIA FSEP require s the HACCP plan to be  written, but the EU 
regulation has no explicit requirem ent 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 “HA CCP plan.”  Proposed § 117.126 would specify the 
contents of the food safety pla n, including the (1) written hazard analysis; (2) written preventive 
controls; (3) written monitoring procedures; (4) written correctiv e action procedures; (5) written 
verification procedures; and (6) wr itten recall plan.  The contents of a written HACCP plan in 
domestic HACCP regulations are similar but not id entical, and include the (1) list of hazards; (2) 
CCPs; (3) critical limits; (4) m onitoring procedures; (5) corr ective action procedures; (5) 
verification procedures; and (6) record-keeping procedures .  The PMO HACCP Appendix 
requires that the HACCP plan include process fl ow diagrams (also a requirement in the FSIS 
HACCP regulation for meat and poultry, but not incl uded in the contents of the HACCP plan).  
FSANZ requires that the food safety program (1 ) identify hazards; (2) id entify where hazards can 
be controlled and the means: (3) provide for mo nitoring; (4) provide fo r corrective actions; (5) 
provide for regular review for adequacy; and (6) provide for appropriate r ecords of compliance.  
The CFIA FSEP requires that the HACCP plan include all relevant information needed to 
conduct the five preliminary st eps in addition to the seven HACCP principles.  The EU 
regulation has no explicit requirement for the co ntents of a HACCP plan other than requiring 
food business operators to put in place pr ocedures based on the HACCP principles.  512 
 
  b. Requirement for a hazard analysis .  Proposed § 117.130 would require that a hazard 
analysis be conducted to identify and evaluate kno wn or reasonably foreseeable hazards for each 
type of food manufactured, proces sed, packed, or held at the fac ility 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 guidelin es and the Codex HACCP Annex.  Consistent 
with the NACMCF HACCP guidelines and th e Codex HACCP Annex, all domestic HACCP 
regulations, the PMO HACCP A ppendix, and international sta ndards require that a hazard 
analysis be conducted.  Domestic HACCP regulati ons specify that the outcome is to determine 
the hazards reasonably likely to occur for the product being produ ced, 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 th at must be prevented, eliminated or reduced 
to acceptable levels. 
c. Requirement for preventive controls, incl uding a requirement fo r 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 significantl y 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, bi ological, radiological, or chemical parameter 
must be controlled to significantly minimize or  prevent a hazard that is reasonably likely to 
occur.  513 
 
  As discussed in section XII.C of this docum ent, proposed § 117.135 is consistent with the 
NACMCF HACCP guidelines and the Codex HACCP Annex.  C onsistent with the NACMCF 
HACCP guidelines, all domestic HACCP regulat ions and the PMO HACCP Appendix require 
the inclusion of CCPs and critical limits in the HACCP plan to control h azards 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 thes e 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 requi re that a recall plan be 
established for food in which there is a hazard th at is reasonably likely to occur.  The CFIA 
FSEP provides for recall plans as  a prerequisite program in th e HACCP system.  None of the 
other domestic or international standards include a provision for a recall pl an as part of HACCP 
requirements.  Although not part of the Code x 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 impli cated lot of the finished  food from the market 
(Ref. 44). 
e. Requirement for monitoring procedures .  Proposed § 117.140 woul d require that the 
owner, operator, or agent in charge of a fac ility establish and implement written procedures, 
including the frequency with wh ich they are to be performed,  for monitoring the preventive 
controls.  As discussed in sect ion XII.E of this document, prop osed § 117.140 is consistent with 
the NACMCF HACCP guidelines and the Code x HACCP Annex.  Consistent with the 
NACMCF HACCP guidelines, al l domestic HACCP regulat ions and the PMO HACCP 514 
 
  Appendix require monitoring proc edures (and the frequency) fo r CCPs to ensure compliance 
with critical limits. Consistent with the Codex HACCP Annex, in ternational standards require 
monitoring, although Codex does not specify that th e monitoring system include the frequency of 
monitoring. The EU regulation re quires establishing and impl ementing 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 asse ss whether the control 
measure is functioning as intended  and the critical limits are me t.  FSANZ requires that the food 
safety program provide for the systematic monitoring of controls.  
f. Requirement for corrective actions .  Proposed § 117.145 would re quire that the owner, 
operator, or agent in charge of a facility establ ish and implement written corrective action 
procedures that must be taken if preventive cont rols 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.  Cons istent with the NACMCF HACCP guidelines, 
all domestic HACCP regulations and the PMO HA CCP Appendix require es tablishing corrective 
actions (or corrective action plans)  for deviations from establishe d critical limits.  Proposed § 
117.145 also would require that corr ective actions be taken if a pr eventive control is not properly 
implemented and a specific corrective action pro cedure has not been esta blished, or a preventive 
control is found to be ineffective.  This pr ovision of proposed § 117.145 is consistent with 
corresponding requirements in domestic HACCP regul ations for corrective ac tions when there is 
no corrective action plan fo r a specific deviation.  
Consistent with the Codex HACCP Annex, in ternational standards require corrective 
actions. The EU regulation and the CFIA FSEP require establishing co rrective actions when 
monitoring indicates that a critical control point is not under control.  FSANZ requires that the 515 
 
  food safety program provide for appropriate correc tive action when the hazard is found not to be 
under control.  However, only the CFIA FSEP re quires that documented deviation procedures 
specify any planned or appropriate corrective actions to be taken when monitoring results 
demonstrate that the control measure is not functi oning as intended or; the cr itical limits are not 
met. 
g. Requirement for verification procedures .  Proposed § 117.150 woul d 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 (inclu ding validation in the HACCP 
regulation for juice and the PMO HACCP Appendi x), and the frequency of performing these 
procedures.  Consistent with the Codex HACCP Annex, internat ional standards (except FSANZ) 
require the establishment of verification procedur es.  The EU regulation requires procedures to 
verify that the HACCP system is worki ng effectively and the CFIA FSEP requires 
documentation of verification procedures.  FS ANZ 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 process monitoring instruments and verification instruments; records 
review; and reanalysis.  Severa l of these requirements are f ound in domestic standards. All 
domestic HACCP regulations and the PMO HA CCP Annex require calib ration of monitoring 
instruments.  All domestic HACCP regulations  and the PMO HACCP Appendix require record 516 
 
  review as a verification activit y, and all provide for an annual reanalysis; both of these are 
specified by the NACMCF guidelines as verifi cation activities.  Other than the FSANZ 
requirement that the food safety program provide fo r the regular review of the program to ensure 
its adequacy, the only internationa l standard that provides specific verification activities is the 
CFIA FSEP, which requires observation of monito ring and corrective actions  (which is also a 
requirement of the FSIS HACCP regulation fo r meat and poultry) and records review.  
h. Requirements applicable to a qualified individual .  Proposed § 117.155 would establish 
the requirements applicable to a qualified indivi dual.  We use the term “qualified individual” to 
refer to an individual who is qualified by trai ning or job experience to conduct certain food 
safety activities as would be specified in proposed  subpart C.  As discu ssed in section XII.H of 
this document, proposed § 117.155 is consistent  with the NACMCF HACCP guidelines, the 
Codex HACCP Annex, and Federal HACCP regul ations 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 ap propriate training to de velop and maintain the 
HACCP system.  Similarly, the Codex HACCP Anne x emphasizes that trai ning is essential for 
effective implementation of HACCP.  The EU re gulation requires “food bus iness operators” to 
ensure that those responsible for the development and maintena nce of procedures based on the 
HACCP principles have received adequate training in the applica tion of the HACCP principles.  
The CFIA FSEP requires that the individuals responsible for monitoring, deviation and 
verification procedures have received adequate training.  517 
 
  i. Requirement for records .  Proposed § 117.175 would list the records that would 
required for proposed subpart C, including the food safety plan, reco rds that document the 
monitoring of preventive contro ls, records that document corrective actions, records that 
document verification activities, and records that  document applicable training for the qualified 
individual.  Proposed § 117.175 is c onsistent with the requiremen ts for records in the NACMCF 
HACCP guidelines, all domestic HACCP regul ations and the PMO HACCP Appendix, which 
require records to include th e hazard analysis, HACCP pla n, and records of monitoring, 
corrective actions and verification activities .  The Codex HACCP A nnex also specifies 
documentation, including the haza rd analysis and CCP and crit ical limit determination, and 
records for monitoring, correctiv e actions and verification pro cedures.  The EU regulation 
requires records to demonstrate the effective ap plication of the HACCP measures.  Similarly, 
FSANZ requires that the food safety program pr ovide for appropriate records to be made and 
kept by the food business demonstrating action take n in relation to, or in compliance with, the 
food safety program. The CFIA FSEP requires re cord keeping to dem onstrate the effective 
application of the critical contro l points and to facilitate offici al verifications by the CFIA or 
other competent authority. 
Proposed subpart F would establish requirement s 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 requireme nts 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.   518 
 
  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 af ter the date of publicati on of the final rule.  
XVIII. Proposed Conforming Amendments 
Several current regulations re fer to the requirements of pa rt 110.  FDA is proposing a 
series of amendments so that these current regu lations 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 pr actice for acidified foods);  
• §§ 120.3, 120.5, and 120.6(b) (definitions, cu rrent good manufacturing practice, 
and sanitation standard operati ng 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 fisher y products subject to the HACCP 
regulation for seafood);  
• § 129.1 (current good manufacturing practice for the processing and bottling of 
bottled drinking water); 519 
 
  •  § 179.25(a) (general provisions  for food irradiation); and  
• § 211.1(c) (scope of current good ma nufacturing 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 Flexibilit y Act (5 U.S.C. 601-612), and the Unfunded 
Mandates Reform Act of 1995 (Public Law 104-4).  Executive Orders 12866 and 13563 direct agencies to assess all costs and be nefits of available re gulatory alternatives  and, when regulation 
is necessary, to select regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safe ty, and other advantages ; distributive impacts; 
and equity).  FDA has developed a preliminary re gulatory impact analysis (PRIA) that presents 
the benefits and costs of this proposed rule (Ref. 194).  FDA belie ves that the proposed rule will 
be a significant regu latory action as defined by Executiv e Order 12866.  FDA requests comments 
on the PRIA. 
The summary analysis of benefits and costs in cluded in this docume nt is drawn from the 
detailed PRIA (Ref. 194) which is available at http://www.regulations.gov  (enter Docket No. 
FDA-2011-N-0920), and is also ava ilable on FDA’s Web site at 
http://www.fda.gov/AboutFDA/Repor tsManualsForms/Reports/Ec onomicAnalyses/default.htm. 
B. Regulatory Flexibility Act
 
The Regulatory Flexibility Act requires agenci es to analyze regulatory options that would 
minimize any significant impact of a rule on sma ll entities.  Because many small businesses will 
need to implement a number of new preventive controls, FDA acknowledges that the final rules 520 
 
  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 (Public Law 104-121) 
defines a major rule for the purpose of congression al review as having caused or being likely to 
cause one or more of the following: An annua l effect on the economy of  $100 million or more; a 
major increase in costs or prices; signifi cant adverse effects on competition, employment, 
productivity, or innovation; or si gnificant adverse eff ects on the ability of United States-based 
enterprises to compete with foreign-based en terprises 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 Refo rm 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 Fede ral mandate that may result in the expenditure 
by State, local, and tribal governments, in th e aggregate, or by th e 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. 521 
 
  E. Paperwork Reduction Act of 1995  
This proposed rule contains information colle ction provisions that ar e 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 s ubmitted to OMB for review under Section 3507(d) 
of the Paperwork Reduction Act of 1995.  FDA i nvites comments on: (1) Whether the proposed 
collection of information is necessary for the pr oper performance of FDA’s functions, including 
whether the information will have practical utilit y; (2) the accuracy of FDA’s estimate of the 
burden of the proposed collection of informati on, including the validity  of the methodology and 
assumptions used; (3) ways to enhance the qualit y, utility, and clarity of the information to be 
collected; and (4) ways to mini mize the burden of the collection of information on respondents, 
including through the use of auto mated 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 In formation and Regulatory Affairs, OMB, Attn: 
FDA Desk Officer, FAX: 202-395-7285, or em ailed to oira_submission@omb.eop.gov.  All 
comments should be identified with the title Current Good Manufacturing Practice And Hazard 
Analysis And Risk-Based Preven tive Controls For Human Food. 
In compliance with the Paperwork Reducti on 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 th ese requirements in the Federal Register
. 522 
 
  F. Public Access to the Analyses  
The analyses that FDA has performed in orde r to examine the impacts of this proposed 
rule under Executive Order 12866, Executive Orde r 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), the Unfunded Mandates Reform Act of 1995 (Public Law 104-4), and the Paperwork Reduction Act of 1995 (44 U.S.C. 3 501–3520) 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 ha ve a significant effect on the hu man environment.  Therefore, 
neither an environmental assessment nor an environmental impact statement is required.  
XXI. Federalism   
FDA has analyzed this proposed rule in acco rdance 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 St ates, or on the distri bution of power and 
responsibilities among the various levels of gove rnment.  Accordingly, the agency tentatively 
concludes that the proposed rule does not contain policies that ha ve federalism implications as 
defined in the Executive order a nd, consequently, a federalism su mmary impact statement is not 
required. 
XXII. Comments 
Interested persons may submit either writte n comments regarding this document to the 
Division of Dockets Management (see ADDR ESSES) or electronic comments to 
http://www/regulations.gov.  It is only necessa ry to send one set of comments.  Identify 523 
 
  comments with the docket number found in brackets in the heading of this document. Received 
comments may be seen in the Division of Dock ets 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 Moderniza tion — A Focus on Food Safety," 
(http://www.fda.gov/Food/GuidanceComplianceRe gulatoryInformation/CurrentGoodManufactur
ingPracticesCGMPs/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 Ha zards and Controls Guidance, Fourth 
Edition," 2011. 
4.  FDA, "Guidance for Industry: Juice HAC CP 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: 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-D erived Product as an Ingredient," 2009. 524 
 
  7.  FDA, "Compliance Policy Guide Sec. 527.300 Dairy Products - Microbial 
Contaminants and Alkaline Phosphatase Activity," 2010. 
8.  FDA, "Compliance Policy Guide S ec. 555.300 Foods, Except Dairy Products - 
Adulteration with Salmonella ," 1995. 
9.  FDA, "Establishment Inspection Report (EIR)," 
(http://www.fda.gov/ICECI/ Inspections/FieldManage mentDirectives/ucm061430.htm ), June 7, 
2007. Accessed and printed on October 17, 2011. 
10.  FDA, "Regulatory Procedures Manu al, Chapter 4. Advisory Actions," 2010. 
11.  FDA, "Regulatory Procedures Manual , Chapter 5. Administrative Actions," 2011. 
12.  FDA, "Regulatory Procedures Manu al, Chapter 6. Judicial Actions," 2011. 
13.  CDC, "Foodborne Disease Outbreak Surveillance," 
(http://www.cdc.gov/outbreakne t/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 Diseas es 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/foodsafet y/vitalsigns_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. 525 
 
  18.  Electronic Laboratory Exchange Network, "Welcome to ELEXNET," 
(https://www.elexnet.com/portal/server.pt ), 2012. Accessed and printed on July 27, 2012. 
19.  FDA, "Peanut Products Recall," 
(http://www.fda.gov/Safety/Recalls/Maj orProductRecalls/Peanut/default.htm ), June 18, 2009. 
Accessed and printed on September 9, 2011. 
20.  FDA, "Peanut Butter and Other Pea nut Containing Products Recall List," 
(http://www.accessdata.fda.gov/scri pts/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/Maj orProductRecalls/Milk/default.htm ), July 23, 2009. 
Accessed and printed on September 9, 2011. 
22.  FDA, "Plainview Milk Cooperati ve 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/Maj orProductRecalls/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. Acce ssed and printed on 
September 9, 2011. 
25.  Council to Improve Foodborne Outbreak  Response, "Guidelines for Foodborne 
Disease Outbreak Response," 2009. 526 
 
  26.  FDA, "State Contracts," 
(http://www.fda.gov/ForFederalStateandLocalOffici als/PartnershipsContra cts/StateContracts/def
ault.htm ), 2012. Accessed and printed on July 27, 2012. 
27.   "FoodSafety.Gov," ( http://www.foodsafety.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/Resources ForYou/Consumers/default.htm ), 2012. Accessed and 
printed on July 27, 2012. 
30.  FDA, "Health Educators. Food Safe ty & Nutrition Education Campaigns," 
(http://www.fda.gov/Food/ResourcesForY ou/HealthEducators/default.htm ), 2012. Accessed and 
printed on July 27, 2012. 
31.  FDA Memorandum, "Consultation w ith USDA on Food Processing Sector 
Study," 2011. 
32.  FDA, "Food Proce ssing Sector Study," 2011. 
33.  FSIS, "National Advisory Committee on Microbiological Criteria for Foods.  
About NACMCF," ( http://www.fsis.usda.gov/About_FSI S/NACMCF_Background/index.asp ), 
2010. Accessed and printed on December 12, 2011. 
34.  National Advisory Committee on Microb iological Criteria for Foods, "Hazard 
Analysis and Critical Control Point Principles and Application Guidelin es," Journal of Food 
Protection , 61:1246-1259, 1998. 527 
 
  35.  Codex Alimentarius Commission, "Hazard Analysis and Critical Control Point 
(HACCP) System and Guidelines for Its A pplication. Annex to CAC/RCP 1-1969 (Rev. 4 - 
2003)," 2003. 
36.  National Advisory Committee on Microb iological Criteria for Foods, "Hazard 
Analysis and Critical Control Point System,"  International Journa l 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 Parl iament and of the Council," ( http://eur-
lex.europa.eu/LexUriServ/LexUriSe rv.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/fsep-
haccp/eng/1299855874288/1299859914238 ), September 10, 2011. Accessed and printed on July 
31, 2012. 
41.  Global Food Safety Initiative, "Enha ncing Food Safety Through Third Party 
Certification," 2011. 
42.  World Health Organization, "Hazard Anal ysis Critical Control Point System 
(HACCP)," 2007. 
43.  Food and Agriculture Organization, "M anual on the Applicat ion of the HACCP 
System in Mycotoxin Prevention and Control," 528 
 
  (http://www.fao.org/doc rep/005/y1390e/y1390e00.htm ), 2001. Accessed and printed on October 
14, 2011. 
44.  Codex Alimentarius Commission, "Gen eral Principles of Food Hygiene, 
CAC/RCP 1-1969 (Rev. 4-2003)," 2003. 
45.  Scallan, E., R. M. Hoekstra, F. J. Angulo, R. V. Tauxe, M. A. Widdowson, S. L. 
Roy, J. L. Jones, and P. M. Griffin, "Foodborne Illness Acquired in th e United States--Major 
Pathogens," Emerging Infectious Diseases , 17:7-15, 2011. 
46.  Scallan, E., P. M. Griffin, F. J. A ngulo, R. V. Tauxe, and R. M. Hoekstra, 
"Foodborne Illness Acquired in the United States--Unspecified Agents," Emerging Infectious 
Diseases , 17:16-22, 2011. 
47.  CDC, "CDC 2011 Estimates: Method," 
(http://www.cdc.gov/foodborneburden/ PDFs/FACTSHEET_E_2011ESTIMATES.pdf ), 2011. 
Accessed and printed on October 14, 2011. 
48.  Scheutz, F., E. Moller Nielsen, J. Frim odt-Moller, N. Boisen, S. Morabito, R. 
Tozzoli, J. P. Nataro, and A. Caprioli, "Characteristics of the Enteroaggregative Shiga Toxin/Verotoxin-Producing Escherichia coli
 O104:H4 Strain Causing the Outbreak of 
Haemolytic Uraemic Syndrome in Germa ny, May to June 2011," Eurosurveillance , 16:6, 2011. 
49.  FDA, "Bad Bug Book: Foodborne Pa thogenic Microorganisms and Natural 
Toxins Handbook. Second Edition," 2012. 
50.  CDC, "Vital Signs: Incidence and Trends  of Infection with Pathogens Transmitted 
Commonly Through Food - Foodborne Diseases Ac tive Surveillance Network, 10 U.S. Sites, 
1996-2010," MMWR , 60:749-755, 2011. 529 
 
  51.  CDC, "What Is Salmonellosis?" ( http://www.cdc.gov/Salmonella/general/ ), April 
5, 2012. Accessed and printed on July 27, 2012. 
52.  Codex Alimentarius Commission, "Guide lines 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. 
53.  FDA and USDA, "Quantitative Assessment of Relative Risk to Public Health 
from Foodborne Listeria monocytogenes  Among Selected Categories of Ready-to-Eat Foods," 
(http://www.fda.gov/Food/Scienc eResearch/ResearchAreas/Ris kAssessmentSafetyAssessment/u
cm183966.htm ), September, 2003. Accessed and printed on July 24, 2012. 
54.  Food and Agriculture Organization and World Health Organization, "Risk 
Assessment of Listeria monocytogenes  in Ready-to-Eat Foods, Technical Report," 2004. 
55.  FDA and USDA, "Listeria monocytogenes  Risk Assessment: Executive 
Summary," 
(http://www.fda.gov/Food/Scienc eResearch/ResearchAreas/Ris kAssessmentSafetyAssessment/u
cm185292.htm ), 2003. Accessed and printed on December 12, 2011. 
56.  FDA and USDA, "Listeria monocytogenes Risk Assessment: VII. Interpretation 
and Conclusions," (http://www.fda.gov/Food/Scienc eResearch/ResearchAreas/Ris kAssessmentSafetyAssessment/u
cm185289.htm ), September, 2003. Accessed and printed on October 17, 2011. 
57.  CDC, "Norovirus: Clinical Overview," 
(http://www.cdc.gov/norovirus/hc p/clinical-overview.html ), April 12, 2012. Accessed and 
printed on July 19, 2012. 530 
 
  58.  FDA Memorandum, "Food GMP Modern ization Working Group: Summary of 
Food Recalls, 1999-2003," 2004. 
59.  FDA Memorandum, "Analysis of Food Recalls Initiated in 2008-2009 by an FDA 
CGMP Working Group," 2012. 
60.  FDA, "FDA Foods Program, The Reportabl e Food Registry: A New Approach to 
Targeting Inspection Resources and Identifying Patterns of A dulteration. First Annual Report: 
September 8, 2009 - September 7, 2010," (http://www.fda.gov/downloads /Food/FoodSafety/FoodSaf etyPrograms/RFR/UCM240647.pdf
), 
January, 2011. Accessed a nd printed on August 29, 2011. 
61.  FDA, "FDA Foods Program, The Reportabl e Food Registry: A New Approach to 
Targeting Inspection Resources and Identifying Patterns of Adu lteration. Second Annual Report: 
September 8, 2010 - September 7, 2011," ( http://www.fda.gov/Food/FoodSafety/FoodS afetyPrograms/RFR/ucm200958.htm), 2012. 
62.  CDC, "Foodborne Outbreak Onlin e Database (FOOD). Search Results 
Highlighted for 2006-2007 Salmonella
 Tennessee Outbreak in P eanut Butter.," 2011. Accessed 
and printed on October 18, 2011. 
63.  CDC, "Multistate Outbreak of Salmonella  Serotype Tennessee Infections 
Associated with Peanut Butter - United States, 2006-2007," MMWR , 56:521-524, 2007. 
64.  FDA, "Establishment Inspection Repor t Conagra Grocery Products 02/14/2007," 
2007. 
65.  FDA, "Establishment Inspection Report Conagra Foods 08/20/2007," 2007. 531 
 
   66.  CDC, "Multistate Outbreak of Salmonella  Infections Associated with 
Peanut Butter and Peanut Butter-Containing Products - United States, 2008-2009," MMWR , 
58:85-90, 2009. 
67.  Cavallaro, E., K. Date, C. Medus, S. Meye r, 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, "Salmonella
 Typhimurium Infections 
Associated with Peanut Products,"  New England Jour nal of Medicine , 365:601-610, 2011. 
68.  FDA, "Amended Form 483 (Inspectional Ob servations) for Peanut Corporation of 
America, Blakely, GA, 02/05/2009," (http://www.fda.gov/downloads/AboutFDA/Cent ersOffices/ORA/ORAEl ectronicReadingRoom/
UCM109834.pdf ), February 5, 2009. Accessed and printed on October 19, 2011. 
69.  FDA, "Form 483 (Inspectional Observations ) for Peanut Corporation of America, 
Plainview, TX, 02/26/2009," 
(http://www.fda.gov/downloads/AboutFDA/Cent ersOffices/ORA/ORAEl ectronicReadingRoom/
UCM114852.pdf ), February 26, 2009. Accessed and printed on October 17, 2011. 
70.  CDC, "Foodborne Outbreak Onlin e Database (FOOD). Search Results 
Highlighted for 2007 Salmonella  Wandsworth and Salmonella  Typhimurium Outbreak in Puffed 
Snacks.," 2011. Accessed and printed on November 18, 2011. 
71.  CDC, "Foodborne Outbreak Onlin e Database (FOOD). Search Results 
Highlighted for 2008-2009 Listeria  Outbreak in Mexican-Style Cheese," 2011. Accessed and 
printed on October 18, 2011. 532 
 
  72.  Jackson, K. A., M. Biggerstaff, M. Tobin- D'Angelo, D. Sweat, R. Klos, J. Nosari, 
O. Garrison, E. Boothe, L. Saathoff-Huber, L. Hainstock, and R. P. Fagan, "Multistate Outbreak 
of Listeria monocytogenes  Associated with Mexican-Style Ch eese Made from Pasteurized Milk 
Among Pregnant, Hispanic Women,"  Journal of Food Protection , 74:949-953, 2011. 
73.  California Department of Public  Health, "Outbreak of Salmonella  Rissen 
Associated with Ground White Pepper," (http://www.cdph.ca.gov/programs/DFDRS/Do cuments/QSS_Presentation_SRissen_and_%20w
hite%20pepper_010611.pdf ), 2011. Accessed and printed on October 17, 2011. 
74.  CDC, "Foodborne Outbreak Onlin e Database (FOOD). Search Results 
Highlighted for 2008 Salmonella  Rissen Outbreak in Ground White Pepper," 2011. Accessed 
and printed on November 23, 2011. 
75.  FDA, "Warning Letter to U.F. Union International Food Company, 11/24/1009," 
(http://www.fda.gov/ICECI/Enforcemen tActions/WarningLetters/ucm192435.htm ), November 
24, 2009. Accessed and printed on October 17, 2011. 
76.  CDC, "Multistate Outbreak of E. coli O157:H7 Infections Linked to Eating Raw 
Refrigerated, Prepackaged Cookie Dough," ( http://www.cdc.gov/ecoli/2009/0630.html ), June 30, 
2009. Accessed and printed on October 17, 2011. 
77.  FDA Public Health Focus Document, "E. coli  in Nestlé Toll House Cookie 
Dough," ( http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm169858.htm ), July 13, 2009. 
Accessed and printed on October 17, 2011. 
78.  FDA, "Nestlé USA's Baking Division Initiates Voluntary Recall," 
(http://www.fda.gov/Safe ty/Recalls/ucm167954.htm ), 2009. Accessed and printed on October 
19, 2011. 533 
 
  79.  FDA, "Information on the Recalled Jensen Farms Whole Cantaloupes," 
(http://www.fda.gov/Food/FoodSaf ety/CORENetwork/ucm272372.htm ), January 9, 2012. 
Accessed and printed on July 19, 2012. 
80.  CDC, "Multistate Outbreak of Listeriosis Linked to Whole Cantaloupes from 
Jensen Farms, Colorado," ( http://www.cdc.gov/listeria/out breaks/cantaloupes-jensen-
farms/120811/index.html ), December 8, 2011. Accessed and printed on July 31, 2012. 
81.  FDA, "Pesticide Monito ring Program - FY 2008," 
(http://www.fda.gov/downloads/Fo od/FoodSafety/FoodContaminants Adulteration/Pe sticides/Res
idueMonitoringReports/UCM230537.pdf ), December 9, 2010. Accessed and printed on October 
14, 2011. 
82.  FDA, "CPG Sec. 570.375 Aflatoxin in Peanuts and Peanut Products," 2005. 
83.  FDA, "CPG Sec. 570.200 Brazil Nuts - Adulteration with Aflatoxin," 2005. 
84.  FDA, "CPG Sec. 570.500 Pistachio Nu ts - Aflatoxin Adulteration," 2005. 
85.  FDA, "CPG Sec.510.150 Apple Juice, Appl e Juice Concentrates, and Apple Juice 
Products - Adulteration with Patulin," 2005. 
86.  Taylor, S. L. and World Health Organization (WHO), "Histamine Poisoning 
Associated with Fish, Cheese, and Other Foods," ( http://whqlibdoc.who.int/hq/1985-
86/VPH_FOS_85.1.pdf ), 1985. Accessed and printed on October 17, 2011. 
87.  Stratton, J. E., R. W. Hutkins, and S. L. Taylor, "Biogenic Amines in Cheese and 
Other Fermented Foods: A Review ," Journal of Food Protection , 54:460-469, 1991. 
88.  FDA, "Supporting Document for Re commended Maximum Level for Lead in 
Candy Likely To Be Consumed Frequently by Small Children," 534 
 
  (http://www.fda.gov/Food/FoodS afety/FoodContaminantsAdu lteration/Metals/Lead/ucm172050.
htm), November, 2006. Accessed and printed on October 14, 2011. 
89.  Williams, J. H., T. D. Phillips, P. E. Jolly, J. K. Stiles, C. M. Jolly, and D. 
Aggarwal, "Human Aflatoxicosis in Developing Countries: a Review of Toxicology, Exposure, 
Potential Health Consequences, and Interventions," American J ournal of Clinical Nutrition , 
80:1106-1122, 2004. 
90.  Shephard, G. S., "Risk Assessment of Aflatoxins in Food in Africa," Food 
Additives and Contaminants: Part A -- Chemis try, Analysis, Control, Exposure and Risk 
Assessment , 25:1246-1256, 2008. 
91.  Sampson, H. A., "Update on Food Aller gy," Journal of Alle rgy and Clinical 
Immunology , 113:805-819, 2004. 
92.  Sampson, H. A., "Food Allergy--Accur ately Identifying Clinical Reactivity," 
Allergy , 60 Suppl 79:19-24, 2005. 
93.  Sicherer, S. H. and H. A. Samps on, "Food Allergy," Jour nal of Allergy and 
Clinical Immunology , 125:S116-S125, 2010. 
94.  Branum, A. M. and S. L. Lukacs, "Food Allergy Among Children in the United 
States," Pediatrics , 124:1549-1555, 2009. 
95.  Bindslev-Jensen, C., D. Briggs, and M. Osterballe, "Can We Determine a 
Threshold Level for Allergenic Foods by Statis tical Analysis of Published Data in the 
Literature?" Allergy , 57:741-746, 2002. 
96.  Taylor, S. L., J. A. Nordlee, L. M. Niemann, and D. M. Lambrecht, "Allergen 
Immunoassays - Considerations for Use of Natu rally Incurred Standa rds," Analytical and 
Bioanalytical Chemistry , 395:83-92, 2009. 535 
 
  97.  Taylor, S. L., D. A. Moneret-Vautrin, R.  W. R. Crevel, D. Sheffield, M. Morisset, 
P. Dumont, B. C. Remington, and J. L. Ba umert, "Threshold Dose for Peanut: Risk 
Characterization Based upon Dia gnostic Oral Challenge of a Se ries of 286 Peanut-Allergic 
Individuals," Food and Chemical Toxicology , 48:814-819, 2010. 
98.  Ross, M. P., M. Ferguson, D. Street, K.  Klontz, T. Schroeder, and S. Luccioli, 
"Analysis of Food-Allergic and Anaphylactic Events in the National Electronic Injury 
Surveillance System," Journal of  Allergy and Clin ical Immunology , 121:166-171, 2008. 
99.  Simon, M. R. and Z. D. Mulla, "A P opulation-Based Epidemiologic Analysis of 
Deaths from Anaphylaxis in Florida," Allergy , 63:1077-1083, 2008. 
100.  Yocum, M. W., J. H. Butterfield, J. S.  Klein, G. W. Volcheck, D. R. Schroeder, 
and M. D. Silverstein, "Epidemiology of Anaphy laxis in Olmsted County: A Population-Based 
Study," Journal of Allerg y and Clinical Immunology , 104:452-456, 1999. 
101.  Branum, A. M. and S. L. Lukacs, "Fo od Allergy Among U.S. Children: Trends in 
Prevalence and Hospitalizations," NCHS Date Brief , 10, 2008. 
102.  Jackson, W. F., Food Allergy , Belgium, ILSI Press, 2003. 
103.  FDA, "Nationwide Milk Allergen Reca ll of Kroger 'Meals Made Simple Shrimp 
Linguini'," (http://www.fda.gov/Safety/Recalls/ucm222663.htm ), August 14, 2010. Accessed and 
printed on October 17, 2011. 
104.  FDA, "Brand Castle, LLC Issues Aller gy Alert on Undeclared Egg in Icing of 
Licensed Rice Krispies Treats Holiday Village K it Distributed Through Michaels Retail Stores 
Only," ( http://www.fda.gov/Safety/Recalls/ucm238089.htm ), December 23, 2010. Accessed and 
printed on October 17, 2011. 536 
 
  105.  FDA, "The Pictsweet Company Announces  a Voluntary Recall of Frozen Green 
Peas Due to Possible Health Risk," ( http://www.fda.gov/Safety/Recalls/ucm229838.htm ), 
October 15, 2010. Accessed and printed on October 17, 2011. 
106.  FDA, "Flowers Foods Issues Voluntary Recall on Certain English Muffins and 
One Bread Item," ( http://www.fda.gov/Safety/Recalls/ucm254434.htm ), May 3, 2011. Accessed 
and printed on October 17, 2011. 
107.  Ayotte, J. D., S. M. Flanagan, and W. S. Morrow, "Occurrence of Uranium and 
222Radon in Glacial and Bedrock Aquifers in the Northern  United States, 1993-2003. U.S. 
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2011. 
108.  Focazio, M. J., Z. Szabo, T. F. Kraemer, A. H. Mullin, T. H. Barringer, and V. T. 
dePaul, "Occurrence of Selected Radionuclides in  Ground Water Used for Drinking Water in the 
United States: A Targeted Reconnaissance Survey, 1998. U.S. Geological Survey Water-
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109.  World Health Organization, "FAQs: Japan Nuclear Concerns," 
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110.  Codex Alimentarius Commission, "Pri nciples for the Establishment and 
Application of Microbiol ogical Criteria for Foods, CAC/GL 21 - 1997," 1997. 537 
 
  111.  International Commission on Microb iological Specifications for Foods, 
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112.  International Commission on Microb iological Specifications for Foods, 
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113.  FDA, "Transcript: Public Meeting on the Food Safety Modernization Act: Focus 
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114.  FDA, "Webcast Videos: Public Meeti ng on the Food Safety Modernization Act: 
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115.  FDA, "Draft Qualitative Risk Assess ment. Risk of Activity/Food Combinations 
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116.  FDA, "Guidance for Industry: Questions  and Answers Regarding Registration of 
Food Facilities (Edition 4); Final Guidance," 2004. 538 
 
  117.  FDA, "Guidance for Industry: Questions and Answers Regarding Establishment 
and Maintenance of Records By Persons Who Manuf acture, Process, Pack, Transport, Distribute, 
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118.  FDA, "Guidance for Industry: Antimicrobial Food Additives," 1999. 119.  Codex Alimentarius Commission, "Code x Alimentarius Commission Procedural 
Manual, Twentieth Edition," 2011. 
120.  FDA, "FDA Allergy Warning Letter. No tice to Manufacturers Label Declaration 
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121.  Deibel, K., T. Trautman, T. DeBoom, W. H. Sveum, G. Dunaif, V. N. Scott, and 
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122.  Taylor, S. L. and J. L. Baumert, "Cro ss-Contamination of Foods and Implications 
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124.  Jackson, L. S., F. M. Al-Taher, M. Moor man, J. W. DeVries, R. Tippett, K. M. J. 
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125.  Troller, J. A., "Sanitizing,"  In: Sanitation in Food Processing , edited by S. Taylor, 
2nd edition, San Diego, Chapter 5, pp. 52-70, Academic Press, Inc., 1993. 539 
 
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127.  Codex Alimentarius Commission, "Guide line for the Validation of Food Safety 
Control Measures, CAC/GL 69-2008," 2008. 
128.  Anderson, J. E., R. R. Beelman, and S.  Doores, "Persistence of Serological and 
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129.  Bennett, M. R. and R. W. Berry, "Serol ogical Reactivity and in Vivo Toxicity of 
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130.  FDA, "Guidance for Industry: Questions and Answers Regarding Adverse Event 
Reporting and Recordkeeping for Dietary Supple ments as Required by the Dietary Supplement 
and Nonprescription Drug Consumer Protection Act," 2009. 
131.  FDA and BATF, "MOU 225-88-2000 Memo randum of Understanding Between 
the Food and Drug Administration and the Bure au of Alcohol, Tobacco and Firearms," 
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DomesticMOUs/ucm116370.htm ), November 20, 1987. Accessed and printed on October 17, 
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132.  FDA, "Guide to Produce Farm Investigations (11/05)," 2005. 133.  FDA, "Guidance for Industry: Guide to  Minimize Microbial Food Safety Hazards 
for Fresh Fruits and Vegetables," 1998. 
134.  Tauxe, R. V., "Emerging Foodborne Di seases: an Evolving Public Health 
Challenge," Emerging Infectious Diseases
, 3:425-434, 1997. 540 
 
  135.  FDA, "Environmental Assessment: Fact ors Potentially C ontributing to the 
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(http://www.fda.gov/Food/FoodSaf ety/FoodborneIllness/ucm276247.htm ), October 19, 2011. 
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136.  CDC, "Multistate Outbreaks of Salmonella  Infections Associated with Raw 
Tomatoes Eaten in Restaurants --- United States, 2005--2006," MMWR , 56:909-911, 2007. 
137.  FDA, "Food Code 2009: Chapter 1 - Purpose and Definitions," 2009. 138.  FDA, "Food Code 2009: Annex 3 - P ublic Health Reasons / Administrative 
Guidelines - Chapter 1, Purpose and Definitions," 2009. 
139.  FDA, "Food Code 2009: Annex 3 - P ublic Health Reasons / Administrative 
Guidelines - Chapter 3, Food," 2009. 
140.  Institute of Food Technologists, "Eva luation and Definition of Potentially 
Hazardous Foods," 
(http://www.fda.gov/Food/ScienceR esearch/ResearchAreas/SafeP racticesforFoodProcesses/ucm
094141 ), December 31, 2001. Accessed and printed on December 14, 2011. 
141.  FDA, "Defect Levels Handbook," 2005. 142.  FDA, "Safe Food Handling. What You Need to Know," 
(http://www.fda.gov/downloads/Food/Re sourcesForYou/Consumers/UCM257049.pdf
), June, 
2011. Accessed and printed on October 17, 2011. 
143.  Bernard, D. T., K. E. Stevenson, and V.  N. Scott, "Hazard Analysis," In: HACCP: 
A Systematic Approach to Food Safety , edited by V. N. Scott and K. E. Stevenson, 4th edition, 
Washington, D.C., Chapter 8, pp. 57-68, The Food Products Association, 2006. 541 
 
  144.  Tompkin, R. B., V. N. Scott, D. T.  Bernard, W. H. Sveum, and K. Sullivan 
Gombas, "Guidelines to Prevent Post-Processi ng Contamination from Listeria monocytogenes ," 
Dairy, Food and Environmental Sanitation , 19:551-562, 1999. 
145.  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: Mi nimizing Entry of Salmonella  into a Processing Facility," Food 
Protection Trends , 29:342-353, 2009. 
146.  National Conference on Interstate Milk Shipments, "M-I-05-5: Tolerance and/or 
Safe Levels of Animal Drug Residues in Milk (Replaces M-I-03-9 (June 30, 2003) and Identifies 
It as "INACTIVE") and also Id entifies M-I-92-1 as "INACTIVE"," 
(http://www.fda.gov/Food/FoodSafety/Product-
SpecificInformation/MilkSafety/CodedMemor anda/MemorandaofInformation/ucm077350.htm ), 
September 27, 2005. Accessed and printed on October 17, 2011. 
147.  FDA, "Approaches to Establish Thre sholds for Major Food Allergens and for 
Gluten in Food," 2006. 
148.  FDA, "CPG Sec. 555.425 Foods, Adultera tion Involving Hard or Sharp Foreign 
Objects," 2005. 
149.  Olsen, A. R., "Regulatory Action Crit eria for Filth and Other Extraneous 
Materials. 1. Review of Hard or Sharp Fore ign Objects as Physical Hazards in Foods," 
Regulatory Toxicology and Pharmacology , 28:181-189, 1998. 
150.  FDA, "Accidental Radioactive Contamin ation of Human Food and Animal Feeds: 
Recommendations for State and Local Agencies," 542 
 
  (http://www.fda.gov/downloads/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocu
ments/UCM094513.pdf ), 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 Pistach io 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/NewsEv ents/WhatsNewinFood/ucm202989.htm ), March 24, 2010. 
Accessed and printed on October 14, 2011. 
154.  FDA, "Pacific Coast Fruit Company Vo luntarily Recalls Sp inach 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 I nvestigating; No Link to Human Illnesses at This Time," 
(http://www.fda.gov/NewsEvents/N ewsroom/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 Tr ansportation Assessment Project," 
(http://www.michigan.gov/doc uments/mda/truckproj_224450_7.pdf ), 2007.  543 
 
  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 Microb iological Specifications for Foods, 
"Staphylococcus aureus ," In: Microorganisms in Foods 5. Characteristics of Microbial 
Pathogens , edited by T. A. Roberts, A. C. Baird- Parker, and R. B. Tompkin, London, Chapter 
17, pp. 299-333, Blackie Academic & Professional, 1996. 
162.  Greig, J. D., E. C. D. Todd, C. A. Ba rtleson, 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 Ag ents Involved," Journa l of Food Protection , 
70:1752-1761, 2007. 
163.  Todd, E. C. D., J. D. Greig, C. A. Ba rtleson, and B. S. Michaels, "Outbreaks 
Where Food Workers Have Been Implicated in th e Spread of Foodborne Disease. Part 3. Factors 
Contributing to Outbreaks and Description of Ou tbreak 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. 544 
 
  165.  FDA, "Model Recall Letter (Generic, All Centers)," 
(http://www.fda.gov/downloads/Safet y/Recalls/IndustryGuidance/UCM214960.pdf ), March, 
2009. Accessed and printed on October 17, 2011. 
166.  FDA, "Recalls, Market Withdrawals, & Safety Alerts," 
(http://www.fda.gov/Safe ty/Recalls/default.htm ), 2012. Accessed and printed on July 31, 2012. 
167.  FDA, "Allergens Model Press Release," 
(http://www.fda.gov/Safety/Reca lls/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/Reca lls/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/Reca lls/IndustryGuidance/ucm129275.htm ), May 31, 2009. 
Accessed and printed on October 17, 2011. 
170.  FDA, "Model Effectiven ess Check Letter (Industry)," 
(http://www.fda.gov/downloads/Safet y/Recalls/IndustryGuidance/UCM214958.pdf ), 2009. 
Accessed and printed on October 17, 2011. 
171.  FDA, "Model Effectiveness Ch eck Response Format (Industry)," 
(http://www.fda.gov/downloads/Safet y/Recalls/IndustryGuidance/UCM214963.pdf ), 2009. 
Accessed and printed on October 17, 2011. 
172.  FDA, "Model Effectiveness Check Questionnaire for Telephone or Personal 
Visits (Industry)," 545 
 
  (http://www.fda.gov/downloads/Safet y/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 Microbio logical Criteria for Foods, "Parameters 
for Determining Inoculated Pack/Challenge St udy Protocols," Journa l of Food Protection
, 
73:140-202, 2010. 
176.  National Advisory Committee on Microbio logical Criteria for Foods, "Requisite 
Scientific Parameters for Establishing th e Equivalence of Alte rnative Methods of 
Pasteurization," Journa l of Food Protection , 69:1190-1216, 2006. 
177.  EPA, "Pesticide Registration Manual: Ch apter 4 - Additional Considerations for 
Antimicrobial Products," 2011. 
178.  FDA and USDA, "Listeria monocytogenes  Risk Assessment: I. Introduction," 
(http://www.fda.gov/Food/Scienc eResearch/ResearchAreas/Ris kAssessmentSafetyAssessment/u
cm184052.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 Pr actices to Minimize Salmonella  Contamination and Growth," 
Food Protection Trends , 29:435-445, 2009. 
180.  International Commission on Microb iological Specifications for Foods, 
"Sampling Considerations and St atistical Aspects of Sampling Pl ans.," In: Microorganisms in 
Foods 8: Use of Data for Assessing Process Control and Product Acceptance , edited by K. M. J. 546 
 
  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 Yo rk, Appendix A, pp. 355-364, Springer, 2011. 
181.  International Commission on Microb iological 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, a nd M. B. Cole, New York, Chapter 8, pp. 145-172, 
Kluwer Academic / Plenum Publishers, 2002. 
182.  International Commission on Microb iological Specifications for Foods, 
"Sampling Plans," In: Microorganisms in Foods 7. Microbiological Te sting 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 Va lidation 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 Testi ng of Environmental, Raw Product and Finished Product Samples 
in Smoked Seafood Processing Faci lities," Food Protection Trends , 25:23-34, 2005. 547 
 
  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/Safe ty/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 Ex isting Domestic and International HACCP Based 
Standards," 2012. 
194.  FDA, "Preliminary Regula tory Impact Analysis," 2012. 
 
List of Subjects
 
21 CFR Part 1 
Cosmetics, Drugs, Exports, Food labe ling, Imports, Labeling, Reporting and 
recordkeeping requirements. 548 
 
  21 CFR Part 16 
Administrative prac tice and procedure. 
21 CFR Part 106 
Food grades and standards, Infants and ch ildren, Nutrition, Reporting and recordkeeping 
requirements. 21 CFR Part 110 
Food packaging, Foods. 
21 CFR Part 114 
Food packaging, Foods, Reporting a nd recordkeeping requirements. 
21 CFR Part 117 
Food packaging, Foods. 
21 CFR Part 120 
Foods, Fruit juices, Imports, Reporting a nd 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, Re porting and recordkeeping requirements. 
21 CFR Part 179 
Food additives, Food labeling, Food packag ing, Radiation protection, Reporting and 
recordkeeping requirements, Signs and symbols. 21 CFR Part 211 549 
 
  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 Dr ugs, it is proposed that 21 CFR chapter 1 be 
amended as follows: 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 th is 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 mob ile facility, traveling to  multiple locations, that 
manufactures/processes, packs, or holds food fo r consumption in the United States. Transport 
vehicles are not faciliti es if they hold food only in the usua l 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 ow nership. The private residence of 550 
 
  an individual is not a facility. Nonbottled wa ter drinking water colle ction and distribution 
establishments and their stru ctures are not facilities. 
(1) Domestic facility  means any facility located in a ny State or Territo ry of the United 
States, the District of Columbia, or th e 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 (i ncluding seafood), or both.  The term "farm" 
includes: 
(1) Facilities that pack or hol d food, provided that all food us ed 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, pr ovided 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, ve getables, fish, dair y products, eggs, raw 
agricultural commodities for use as food or as components of food, animal feed (including pet 
food), food and feed ingredient s, food and feed additives, dietary supplements and dietary 551 
 
  ingredients, infant formula, be verages (including alc oholic beverages and bo ttled 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 commoditie s on the farm on which they were grown or 
raised, or another farm under the same ownershi p.  Harvesting does not include activities that 
transform a raw agricultural commodity, as de fined in section 201(r) of the Federal Food, Drug, 
and Cosmetic Act, into a processed food as de fined 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 facil ities include warehouses, cold storage 
facilities, storage silos, grain el evators, and liquid storage tanks.  For farms and farm mixed-type 
facilities, holding also includes activities trad itionally 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 transf orm 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 manuf acturing/processing activities ar e:  Cutting, peeling, trimming, 
washing, waxing, eviscerating, rendering, cooki ng, baking, freezing, cooling, pasteurizing, 552 
 
  homogenizing, mixing, formulating, bottling, m illing, grinding, extracting juice, distilling, 
labeling, or packaging.  For farm s and farm mixed-type facilitie s, manufacturing/processing does 
not include activities that are part  of harvesting, packing, or holding.  
Mixed-type facility  means an establishment that enga ges in both activities that are 
exempt from registration under section 415 of  the Federal Food, Drug, and Cosmetic Act and 
activities that require the establishm ent 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 co nducts activ ities that 
require the establishment to be registered. 
Nonprofit food establishment  means a charitable entity th at prepares or serves food 
directly to the consumer or otherwise provi des food or meals for consumption by humans or 
animals in the United States. The term in cludes central food banks, soup kitchens, and 
nonprofit food delivery services. To be cons idered a nonprofit food establishment, the 
establishment must meet the terms of section 50 1(c)(3) of the U.S. Inte rnal 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 ot her 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 owne rship for storage and transport, but does not 
include activities that transform a raw agricultural  commodity, as defined in section 201(r) of the 553 
 
  Federal Food, Drug, and Cosmetic Act, into a pro cessed 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 consumers for 
immediate consumption. ``Restaurant'' does not incl ude facilities that prov ide 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 hum ans, such as cafeterias, lunchrooms, cafes, 
bistros, fast food establishments , food stands, saloons, taverns, ba rs, lounges, catering facilities, 
hospital kitchens, day care ki tchens, and nursing home kitc hens are restaurants; and 
(2) Pet shelters, kennels, and veterinary facili ties 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 func tion is to sell from that establishment food, 
including food that it manuf actures/processes, packs,  or holds, directly to  consumers. A retail 
food establishment's primary functi on is to sell food directly to c onsumers if the annual monetary 
value of sales of food products di rectly to consumers exceeds the annual monetary value of sales 
of food products to all other buyers. The term “c onsumers” does not include businesses. A “retail 
food establishment” includes grocery stores, conv enience 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. 554 
 
  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 main taining a place of busine ss in the United States 
whom a foreign facility designate s as its agent for purposes of th is 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 ag ent 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 cont acts 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 ne ed not be conducted through the U.S. agent 
designated for purposes of this subpart. 
You or registrant
 means the owner, operator, or agen t 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 cau sing such acts to be done. Under section 302 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 332), the Unite d States can bring a ci vil action in Federal 555 
 
  court to enjoin a person who commits a prohib ited 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 commissi on of a prohibited act. Under 
section 306 of the Federal Food, Drug, and Cosm etic 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 requireme nts 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 la st 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 "Harvesti ng", "Mixed-type facility", an d “Packing”, and revising the 556 
 
  definitions for “Farm”, “Food”, “Holding”, “Man ufacturing/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 (i ncluding seafood), or both.  The term "farm" 
includes: 
(1) Facilities that pack or hol d food, provided that all food us ed 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, pr ovided 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 limite d to fruits; vegetables; fish; dairy products; 
eggs; raw agricultural commodities for use as fo od or as components of food; animal feed, 
including pet food; food and feed ingredients a nd additives, including s ubstances that migrate 
into food from the finished container and other articles that contact f ood; 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 commoditie s on the farm on which they were grown or 557 
 
  raised, or another farm under the same ownershi p.  Harvesting does not include activities that 
transform a raw agricultural commodity, as de fined in section 201(r) of the Federal Food, Drug, 
and Cosmetic Act, into a processed food as de fined 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. Hold ing facilities include:  Warehouses, cold storage 
facilities, storage silos, grain el evators, and liquid storage tanks.  For farms and farm mixed-type 
facilities, holding also includes activities trad itionally 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 transf orm 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 manuf acturing/processing activities ar e:  Cutting, peeling, trimming, 
washing, waxing, eviscerating, rendering, cooki ng, baking, freezing, cooling, pasteurizing, 
homogenizing, mixing, formulating, bottling, m illing, grinding, extracting juice, distilling, 
labeling, or packaging.  For farm s and farm mixed-type facilitie s, manufacturing/processing does 
not include activities that are part  of harvesting, packing, or holding. 
Mixed-type facility  means an establishment that enga ges in both activities that are 
exempt from registration under section 415 of  the Federal Food, Drug, and Cosmetic Act and 
activities that require the establishm ent to be registered.  An exampl e of such a facility is a “farm 558 
 
  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 co nducts activ ities that 
require the establishment to be registered. *  *  *  *  * 
Packaging
 (when used as a noun) means the outer packaging of food th at bears the label 
and does not contact the food. Pack aging does not include food cont act 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 ot her 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 owne rship 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 pro cessed 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 av ailability requirements?
   
When FDA has a reasonable belief that an ar ticle of food is adulte rated and presents a 
threat of serious adverse health consequences or death to humans or animals, any records and 
other information accessible to FDA under sec tion 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 559 
 
  photocopying or other means of reproduction. Such records and other information must be made 
available as soon as possible, not to exceed 24 ho urs from the time of receipt of the official 
request, from an officer or employee duly desi gnated 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 es tablish or maintain records or make them 
available to FDA as re quired 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 re gulation or the refusal to permit access to or 
verification or copying of any such  required record is a prohibite d act under section 301 of the 
Federal Food, Drug, and Cosmetic Act. 
(b) The failure of a nontransporter immedi ate previous source or a nontransporter 
immediate subsequent recipient who enters an agreement under § 1.352(e) to establish, maintain, 
or establish and maintain, record s 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, a nd Cosmetic Act and this 
regulation is a prohibited act under section 301 of the Federal Food, Drug, and Cosmetic Act. 
PART 16--REGULATORY HEARI NG BEFORE THE FOOD AND DRUG 
ADMINISTRATION 
8. The authority citation for 21 CFR part  16 continues to read as follows: 560 
 
  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), rela ting to withdrawal of an exemption 
applicable to a qualified facility.  * * * * * PART 106--INFANT FORMULA QUAL ITY CONTROL PROCEDURES 
 10.  The authority citation for 21 CFR pa rt 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 cu rrent good manufacturing 
practices and quality proce dures identified in parts 106, 107, 109, 110, 113, and 117 of this 
chapter. * * * * * * * *  561 
 
  (n) Production control, product testing, testing results, co mplaints, and distribution 
records necessary to verify compliance with parts 106, 107, 109, 110, 113, and 117 of this 
chapter, or with other a ppropriate regulations, sha ll be retained for 1 year  after the expiration of 
the shelf life of the infant 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 A DDED 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 pa rt 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, appl y 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 prepar ed, packed, or held under insanitary conditions 
whereby it may have become contaminated with filth, or whereby it may have been rendered 
injurious to health. 562 
 
  (b) [Reserved] 
15. Add part 117 to read as follows: 
PART 117—CURRENT GOOD MANUFACT URING PRACTICE AND HAZARD 
ANALYSIS AND RISK-BASED PREVENTI VE 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 Risk-Based Preventive Controls 117.126 Requirement for a food safety plan. 117.130 Hazard analysis. 563 
 
  117.135 Preventive controls for hazards that  are reasonably li kely to occur. 
117.137 Recall plan for food with a hazard th at 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 facil ity solely engaged in th e 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 withdr aw an exemption applicable to a qualified 
facility. 
117.254 Issuance of an order to withdraw an exem ption applicable to a qualified facility. 
117.257 Contents of an order to withdraw an ex emption 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. 564 
 
  117.280 Revocation of an order to withdraw an ex emption applicable to a qualified facility. 
117.284 Final agency action. Subpart F—Requirements Applying to Records Th at Must be Established and Maintained 
117.301 Records subject to the requi rements 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 pa rt 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).  565 
 
  (b) The operation of a facility that manufactures, processes, p acks, or holds food for sale 
in the United States if the owne r, operator, or agent in charge of such facility is required to 
comply with, and is not in compliance w ith, section 418 of the Federal Food, Drug, and 
Cosmetic Act or subparts C, D, E, or F of pa rt 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 manuf acturing practice regulations also is 
subject to the requirement s of those regulations. 
§ 117.3 Definitions.  
The definitions and interpretations of term s in section 201 of the Federal Food, Drug, and 
Cosmetic Act are applicable to such terms when us ed in this part. The fo llowing definitions also 
apply: 
Acid foods  or acidified foods  means foods that have an e quilibrium 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 compos ed 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 suffici ent temperature to partially or completely 
inactivate the naturally o ccurring enzymes and to effect other physical or biochemical changes in 
the food. 566 
 
  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 incorporati on of a food allergen into a food. 
Environmental pathogen  means a microorganism that is of public health significance and 
is capable of surviving and pe rsisting within the manufacturing, proces sing, packing, or holding 
environment. 
Facility  means a domestic facility or a foreign fa cility that is required to register under 
section 415 of the Federal Food, Drug, and Cosmetic Ac t, 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 defi ned 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 567 
 
  the place they were grown or raised and preparing them for use as food.  Harvesting is limited to 
activities performed on raw agricultural commoditie s on the farm on which they were grown or 
raised, or another farm under the same ownershi p.  Harvesting does not include activities that 
transform a raw agricultural commodity, as de fined in section 201(r) of the Federal Food, Drug, 
and Cosmetic Act, into a processed food as de fined 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 informati on provides a basis to conclude that there is a 
reasonable possibility that the hazard will occu r in the type of food being manufactured, 
processed, packed, or held in the absence of those controls. 
Holding  means storage of food. Holding facil ities include warehouses, cold storage 
facilities, storage silos, grain el evators, and liquid storage tanks.  For farms and farm mixed-type 
facilities, holding also includes activities trad itionally 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 transf orm 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. 568 
 
  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 ma nufacturing/processing activitie s are cutting, peeling, trimming, 
washing, waxing, eviscerating, rendering, cooki ng, baking, freezing, cooling, pasteurizing, 
homogenizing, mixing, formulating, bottling, m illing, grinding, extracting juice, distilling, 
labeling, or packaging.  For farm s and farm mixed-type facilitie s, 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 h ealth significance.  The term “undesirable 
microorganisms” includes those microorganisms th at 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 enga ges in both activities that are 
exempt from registration under section 415 of  the Federal Food, Drug, and Cosmetic Act and 
activities that require the establishm ent 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 co nducts activ ities 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 co ntrol and to produce an a ccurate 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. 569 
 
  Packing  means placing food into a container ot her 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, bu t does not include activities that transform a raw 
agricultural commodity, as defined in secti on 201(r) of the Federal Food, Drug, and Cosmetic 
Act, into a processed food as defined in secti on 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 part s thereof, used for or in connection with 
the manufacturing, processing, pack ing, or holding of human food. 
Preventive controls  means 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 mi nimize or prevent the hazards identified under 
the hazard analysis that are c onsistent with the current scie ntific 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 f ood establishment (as those 
terms are defined in § 1.227 of this chapter) that: 
(1) Is located;  (i) In the same State as the qua lified facility that sold the food to such restaurant or 
establishment; or  
(ii) Not more than 275 miles from such facility; and  570 
 
  (2) Is purchasing the food for sa le directly to consumers at su ch 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 app licable calendar year, the average annual 
monetary value of the f ood 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 wa s less than $500,000, adjusted for inflation. 
Qualified individual  means a person who has successf ully 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 norma lly eaten in its raw state or 
any other food, including processed food, for whic h it is reasonably fore seeable that the food 
would be eaten without further processing that will significantly minimi ze biological hazards. 
Reasonably foreseeable hazard  means a potential biological, chemical, physical, or 
radiological hazard that may be associ ated with the facility or the food. 571 
 
  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.  Th e safe moisture level for a food is related to 
its water activity (a w).  An a w will be considered safe for a food if adequate data are available that 
demonstrate that the food at or below the given a w will not support the growth of undesirable 
microorganisms. 
Sanitize  means to adequately treat cleaned f ood-contact surfaces by a process that is 
effective in destroying vegetative cells of microo rganisms of public health significance, and in 
substantially reducing numbers of other undesirable microorgani sms, but without adversely 
affecting the product or its safety for the consumer. 
Should  is used to state recommended or adviso ry 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 c ontrolled directly or indirectly by 
another company. 
Validation  means that element of verificati on focused on collecting and evaluating 
scientific and technical inform ation to determine whether the food safety plan, when properly 
implemented, will effectively co ntrol the identified hazards. 572 
 
  Verification  means those activities, other than mo nitoring, that establish the validity of 
the food safety plan and that the syst em 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 (a w) 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 s ubject 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 Fish ery Products) at a facility if th e owner, operator, or agent in 
charge of the facility is requi red 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 Analys is and Critical Control Point ( HACCP) Systems) at a facility 573 
 
  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 chap ter with respect to such activities. 
(d)(1) Subpart C of this part does not apply with respect to activiti es that are subject to part 113 
of this chapter (Thermally Processed Low-Ac id Foods Packaged in Hermetically Sealed 
Containers) at a facility if the ow ner, operator, or agent in charge of the facility is required to 
comply with, and is in compliance with, part 113 of  this chapter with resp ect to such activities. 
(2) The exemption in paragraph (d)(1) of this section is a pplicable only with respect to 
the microbiological hazards that are regul ated under part 113 of this chapter. 
(e) Subpart C does not apply to any facility with regard to the ma nufacturing, processing, 
packing, or holding of a dietary s upplement that is in compliance with the requirements of part 
111 of this chapter (Current Good Manufacturin g Practice in Manufactur ing, Packing, Labeling, 
or Holding Operations for Dietary Supplements ) and section 761 of the Federal Food, Drug, and 
Cosmetic Act (Serious Adverse Event Re porting for Dietary Supplements).   
(f) Subpart C of this part doe s not apply to activit ies of a facility th at are subject to 
section 419 of the Federal Food, Drug, and Cosm etic Act (Standards for Produce Safety). 
(g) Subpart C of this part doe s not apply to on-farm packi ng 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 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 anot her farm or farm mixed-type f acility under the same ownership-- 
i.e., packing or re-packing (i ncluding weighing or conveying incidental to packing or re-
packing); sorting, culling, or grading incidental to packing or storing; and stori ng (ambient, cold 
and controlled atmosphere) of: 574 
 
  (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 ve getables” refers only to fruits and vegetables other than cocoa 
beans, coffee beans, peanuts, suga r 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 doe s not apply to on-farm low-ri sk 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 Co smetic Act that the business 
conducts are the following:  
(1) When conducted on a farm mixed-type faci lity’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 fa rm/farm mixed-type facility under the same 
ownership) for distribution into commerce: 
(i) Artificial ripening of intact fruits and vegetables; (ii) Boiling/evaporation of ma ple sap to make maple syrup; 575 
 
  (iii) Chopping raw peanut s and raw tree nuts; 
(iv) Coating (with coatin gs other than wax, oil, or resin us ed 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 (wit hout the addition of sulfites) 
where the drying creates a distinct co mmodity (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 preserve s from acid foods (e.g., acid fruits);  
(ix) Making sugar from suga r 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 othe r 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 a nd vegetables using cold air; 
 (v) Drying/dehydrating (whether for stor age/transport or for creating a distinct 
commodity) intact fruits and vegetables (without sulfiting), cocoa beans, coffee beans, grains and grain products, and p eanuts and tree nuts; 576 
 
  (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 pea nuts 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 frui ts and vegetables, grain 
and grain products (other than t hose containing wheat in a form th at 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 beet s, 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 preserve s from acid foods (e.g., acid fruits); 
(xiv) Making maple syrup;  (xv) Making soft dri nks and carbonated water; 
(xvi) Making sugar from s ugar beets and sugarcane; 
(xvii) Mixing cocoa beans, coffee beans, in tact fruits and vegetables, grain and grain 
products, honey, maple sap and maple syrup, and peanuts and tree nuts; 
(xviii) Packaging hard candy, fudge, taffy, to ffee; 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 pres erves; maple syrup; peanuts and tree nuts 577 
 
  (including modified atmosphere or vacuum packaging); soft dr inks and carbonated water; and 
sugar beets, sugarcane, and sugar; 
(xix) Salting peanuts and tree nuts; (xx) Shelling/hulling cocoa beans (i.e., winnow ing), intact fruits and vegetables (e.g., 
dried beans and peas), a nd 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; co coa products; coffee beans; intact fruits and 
vegetables; grain and grain products ; honey; jams, jellies and preser ves; 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, in tact fruits and vegeta bles, 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 th e purpose of storage or transportation) intact 
fruits and vegetables. 
(i)(1) Subpart C of this part does not appl y with respect to alc oholic beverages at a 
facility that meets the following two conditions: 
(i) Under the Federal Alcohol Admini stration 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 perm it, registration, or approval if it were a domestic 
facility; and  578 
 
  (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 e ngaged in manufacturing, processing, 
packing, or holding one or mo re alcoholic beverages. 
(2) Subpart C of this part does not apply with respect to  food other than alcoholic 
beverages at a facility descri bed in paragraph (i)(1 ) of this section, provided such food: 
(i) Is in prepackaged form that prevents a ny direct human contact with such food; and 
(ii) Constitutes not more than 5 percent of th e overall sales of the f acility, as determined 
by the Secretary of the Treasury. 
(j) Subpart C of this part does not apply to facilitie s 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” (a s defined in § 1.227 of this 
chapter), activities of “farm mi xed-type facilities” (as defined in § 1.227) that fall within the 
definition of “farm,” or the holding or trans portation of one or more “raw agricultural 
commodities,” as defined in se ction 201(r) of the Federal Food, Drug, and Cosmetic Act.  
§ 117.7 Applicability of subparts C and D to a facil ity solely engaged in th e storage of packaged 
food that is not exposed to the environment.  
(a) Subpart C of this part doe s not apply to a facility sole ly engaged in the storage of 
packaged food that is not e xposed 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 require ments in § 117.206 of subpart D of this part. 
Subpart B—Current Good Manufacturing Practice § 117.10 Personnel.
 579 
 
  The plant management must take all reasonable measures and precautions to ensure the 
following: 
(a) Disease control . Any person who, by medical examin ation 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-contac t 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 cont act with food, food- contact surfaces, 
and food-packaging materials must conform to hygi enic practices while on duty to the extent 
necessary to protect against cross-contact and contaminati on of food.  The methods for 
maintaining cleanliness include: 
(1) Wearing outer garments suitable to the ope ration in a manner that protects against the 
contamination of food, food-contac t surfaces, or food-packaging mate rials and to protect against 
the cross-contact of food. 
(2) Maintaining adequate personal cleanliness. (3) Washing hands thoroughly (and saniti zing if necessary to  protect against 
contamination with undesirable microorganisms) in  an adequate hand-was hing 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 ot her objects that mi ght fall into food, 
equipment, or containers, and removing hand jewe lry that cannot be adequately sanitized during 580 
 
  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 contam ination 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 effectiv e manner, hair nets, headbands, caps, beard 
covers, or other effective hair restraints. 
(7) Storing clothing or other personal bel ongings 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 material s 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 id entifying sanitation failures or 
food contamination should have  a background of education or experience, or a combination 
thereof, to provide a level of competency nece ssary for production of clean and safe food. Food 
handlers and supervisors should receive appropriate training in  proper food handling techniques 
and food-protection principles and should be in formed of the danger of poor personal hygiene 
and insanitary practices.   581 
 
  (d) Supervision . Responsibility for ensuring comp liance by all pers onnel with all 
requirements of this subpart must be clearly assigned to competent s upervisory personnel. 
§ 117.20 Plant and grounds.  
(a) Grounds . The grounds about a food plant under th e control of the operator must be 
kept in a condition that will prot ect 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, a nd parking lots so that they do not constitute a source of 
contamination in areas where food is exposed. 
(3) Adequately draining areas that may c ontribute 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 secti on, care must be exercised in 
the plant by inspection, extermination, or other mean s 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 faci litate maintenance and sanitary  operations for food-production 
purposes (i.e., manufacturing, processing, pack ing, and holding).  The plant must: 582 
 
  (1) Provide sufficient space for such placement of equipment and storage of materials as 
is necessary for the maintenan ce 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 f ood-packaging materials with micr oorganisms, chemicals, filth, 
and other extraneous material, a nd to reduce the potential for cr oss-contact.  The potential for 
cross-contact and contamination may be reduced by adequate food safety controls and operating 
practices or effective design, in cluding the separation of operations in which cross-contact and 
contamination are likely to occur, by one or  more of the following means: location, time, 
partition, air flow, enclosed system s, 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 a nd around the vessels to elimin ate 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 fl oors, walls, and ceilings may be adequately 
cleaned and kept clean and kept in good repair; that drip or c ondensate from fixtures, ducts and 
pipes does not contaminate food, food-contact surf aces, or food-packaging materials; and that 
aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate widt h to permit employees to perfor m their duties and to protect 
against contaminating food, food-c ontact surfaces, or food-packagi ng materials with clothing or 
personal contact. 583 
 
  (5) Provide adequate lighting in hand-washi ng areas, dressing and locker rooms, and 
toilet rooms and in all areas where food is exam ined, processed, or stored and where equipment 
or utensils are cleaned; and provi de safety-type light bulbs, fixtur es, 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 cont rol equipment to minimize odors and vapors 
(including steam and noxious fume s) 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, a nd food-contact surfaces a nd for cross-contact. 
(7) Provide, where necessary, adequate scr eening or other protection against pests. 
§ 117.35 Sanitary operations.  
(a) General maintenance . Buildings, fixtures, and other physical facilitie s of the plant 
must be maintained in a sanitary condition and mu st be kept in repair sufficient to prevent food 
from becoming adulterated.  Cleaning and sani tizing of utensils and equipment must be 
conducted in a manner that protects against cr oss-contact and contamination of food, food-
contact surfaces, or food-packaging materials. 
(b) Substances used in cleaning and sa nitizing; 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 an d 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 ex amination of these substances 
for contamination.  Only the following toxic materi als may be used or stored in a plant where 
food is processed or exposed: 584 
 
  (i) Those required to maintain clean and sanitary conditions; 
(ii) Those necessary for use in laboratory testing procedures; (iii) Those necessary for plant and eq uipment maintenance and operation; and 
(iv) Those necessary for us e in the plant's operations. 
(2) Toxic cleaning compounds, sanitizing agen ts, and pesticide chemicals must be 
identified, held, and stored in a manner that pr otects against contaminat ion 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-contac t surfaces, or food-packaging mate rials.  Effective measures 
must be taken to exclude pests from the ma nufacturing, processing, p acking, 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, a nd food-packaging materials. 
(d) Sanitation of food-contact surfaces . All food-contact surfaces , including utensils and 
food-contact surfaces of equipment, must be cleane d as frequently as necessary to protect against 
cross-contact and contamination of food. 
(1) Food-contact surfaces used  for manufacturing/processi ng 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 necessa ry to protect against cross-contact and the 
introduction of microorganisms into food, all food-contact surfaces must be cleaned and 
sanitized before use and after any interruption during which the food-cont act surfaces may have 585 
 
  become contaminated.  Where equipment and utensils are used in a continuous production 
operation, the utensils and food-c ontact 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 mu st be handled, dispensed, used, 
and disposed of in a manner that protects agai nst cross-contact and contamination of food, food-
contact surfaces, or food-packaging 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 cr oss-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 food-contact surfaces from cross-contact and contamination. 
§ 117.37  Sanitary facilities and controls.  
Each plant must be equipped with adequa te sanitary facilities and accommodations 
including: 
(a) Water supply . The water supply must be suffic ient for the operations intended and 
must be derived from an adequate source.  A ny water that contacts f ood, 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 neede d, must be provided in all areas where required 
for the processing of food, for the cleaning of equi pment, utensils, and food-packaging materials, 
or for employee sanitary facilities. 586 
 
  (b) Plumbing . Plumbing must be of adequate size and design and adequately installed and 
maintained to: 
(1) Carry sufficient quantitie s 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 contaminati on to food, water supplies, equipment, or 
utensils or creating an unsanitary condition. 
(4) Provide adequate floor drainage in all areas where floors are s ubject to 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 em ployees 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 su rfaces, 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 s ource of contaminati on 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 br eeding place for pests, and protect against 587 
 
  contamination of food, food-contact surfaces, f ood-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 cleana ble, and must be properly maintained. 
(2) The design, construction, and use of equi pment 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 in stalled and maintained as to facilitate the cleaning of the 
equipment and of all adjacent spaces. 
(4) Food-contact surfaces must  be corrosion-resistant wh en 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 th e action of food, and, if applicable, cleaning 
compounds and sanitizing agents. 
(6) Food-contact surfaces must be maintained to protect food from cross-contact and 
from being contaminated by any source, in cluding 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 micr oorganisms and cross-contact. 
(c) Equipment that is in the manufacturing or  food-handling area a nd that does not come 
into contact with food must be so constructe d that it can be kept in a clean condition. 588 
 
  (d) Holding, conveying, and manufacturing sy stems, including gravimetric, pneumatic, 
closed, and automated systems, must be of a de sign and construction that enables them to be 
maintained in an appropriate sanitary condition. 
(e) Each freezer and cold storage compartm ent used to store and hold food capable of 
supporting growth of microorganisms must be  fitted with an indicating thermometer, 
temperature-measuring device, or temperature-r ecording device so insta lled as to show the 
temperature accurately within the compartment. 
(f) Instruments and controls used for meas uring, regulating, or r ecording temperatures, 
pH, acidity, water activity, or othe r conditions that cont rol or prevent the growth of undesirable 
microorganisms in food must be accurate and preci se and adequately main tained, and adequate 
in number for their designated uses. 
(g) Compressed air or other gases mechanica lly 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 manufactur ing, processing, packing and holding of 
food (including operations directed  to receiving, inspecting, trans porting, 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-pa ckaging materials are safe and suitable.   
(3) Overall sanitation of the plant must be under the supervision of one or more 
competent individuals assigned resp onsibility for this function.   589 
 
  (4) All reasonable precautions must be taken to ensure that production procedures do not 
contribute to cross-contact and co ntamination from any source.   
(5) Chemical, microbial, or extraneous-materia l testing procedures must be used where 
necessary to identify sanitation failures or pos sible cross-contact and food contamination.   
(6) All food that has become c ontaminated 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 ingr edients 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 co nditions that will protect against cross-contact 
and contamination and minimize deterioration.  Ra w materials must be washed or cleaned as 
necessary to remove soil or other contaminati on.  Water used for wash ing, rinsing, or conveying 
food must be safe and of adequate sanitary quali ty.  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 carrier s of raw materials should be insp ected on receipt to ensure that 
their condition has not contribute d to cross-contact, contamina tion, or deterioration of food. 
(2) Raw materials and ingredients must either  not contain levels of microorganisms that 
may render the food injurious to th e health of humans, or they mu st be pasteurized or otherwise 
treated during manufacturing operati ons so that they no longer c ontain 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 re gulations for poisonous or deleterious substances 
before these materials or ingredients are incorporated into finished food. 590 
 
  (4) Raw materials, ingredients, and rework susceptible to contamination with pests, 
undesirable microorganisms, or extraneous ma terial 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 re lative humidity and in such a ma nner as to prevent the food from 
becoming adulterated.  Material scheduled fo r rework must be identified as such. 
(6) Frozen raw materials and ingr edients must be kept frozen.  If thawing is required prior 
to use, it must be done in a manner that pr events the raw material s and ingredients from 
becoming adulterated. 
(7) Liquid or dry raw materials and ingredient s received and stored in bulk form must be 
held in a manner that protects agai nst cross-contact and contamination. 
(8) Raw materials and ingredients that are f ood 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, pr ocessing, 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.  591 
 
  (3) Food that can support the rapid growth of undesirable microorganisms must be held at 
temperatures that will prevent the food fr om becoming adulterated during manufacturing, 
processing, packing and holding. 
(4) Measures such as sterilizing, irradiat ing, pasteurizing, cooking, freezing, refrigerating, 
controlling pH, or controlling a w that are taken to destroy or pr event the growth of undesirable 
microorganisms must be adequate under th e conditions of manufacture, handling, and 
distribution to prevent f ood from being adulterated. 
(5) Work-in-process and rework must be handl ed in a manner that protects against cross-
contact, contamination, and growth of undesirable microorganisms. 
(6) Effective measures must be taken to pr otect finished food from cross-contact and 
contamination by raw materials, ingredients, or refuse.  When raw materials, ingredients, or 
refuse are unprotected, they must not be handl ed 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 agains t cross-contact and contamination as necessary. 
(7) Equipment, containers, and utensils us ed 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 pr otects against cross-contact 
and contamination. 
(8) Effective measures must be taken to prot ect against the inclusi on of metal or other 
extraneous material in food. 
(9) Food, raw materials, and ingr edients that are adulterated must be disposed of in a 
manner that protects against the contamination of other food or, if the adul terated food is capable 592 
 
  of being reconditioned, it must be reconditione d using a method that has been proven to be 
effective. 
(10) Steps such as washing, peeling, trim ming, cutting, sorting and inspecting, mashing, 
dewatering, cooling, shredding, extruding, dryin g, whipping, defatting, and forming must be 
performed so as to protect food against cros s-contact and contamina tion.  Food should be 
protected from contaminants that may dr ip, drain, or be drawn into the food. 
(11) Heat blanching, when required in the preparation of food, s hould be effected by 
heating the food to the required te mperature, holding it at this temp erature for the required time, 
and then either rapidly cooling the food or passi ng it to subsequent manufacturing without delay.  
Thermophilic growth and contamination in bl anchers should be minimized by the use of 
adequate operating temperatures  and by periodic cleaning.   
(12) Batters, breading, sauces, gravies, dressings, and other si milar preparations must be 
treated or maintained in such a manner that  they are protected ag ainst 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-cont act, contamination and growth of undesirable 
microorganisms.  
(14) Food, including dry mixes, nuts, interm ediate moisture food, and dehydrated food, 
that relies on the control of a w for preventing the growth of unde sirable 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 microorga nisms must be monitored and maintained at a 
pH of 4.6 or below. 593 
 
  (16) When ice is used in contact with food, it mu st 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 practi ce 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 de fects that at low levels are not h azardous to health. FDA establishes 
maximum levels for these defects in foods produced under current good manufacturing practice 
and uses these levels in deciding wh ether to recommend regulatory action. 
(b) Defect action levels are es tablished 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 Federa l 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, pro cessors, 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 natura l or unavoidable defects are lower than the 594 
 
  currently established defect acti on levels.  The manufacturer, pro cessor, packer and holder of 
food must at all times utilize qu ality control operations that redu ce natural or unavo idable 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 re nders the final food adulte rated, regardless of the 
defect level of the final food. Subpart C—Hazard Analysis and Risk-Based 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); (2) The written preventive cont rols 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 prev entive controls as required by § 117.140(a);  
(4) The written corrective action pro cedures as required by § 117.145(a)(1);  
(5) The written verification proce dures 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 595 
 
  food manufactured, processed, pack ed, 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 uninten tionally introduced, including: 
(1) Biological hazards, including microbi ological hazards such as parasites, 
environmental pathogens, and other microor ganisms of public h ealth significance; 
(2) Chemical hazards, including substances su ch 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 de termine 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 ev aluation of whether environmental pathogens 
are reasonably likely to occur when ever a ready-to-eat food is exposed to the environment prior 
to packaging. 
(3) The hazard evaluation must consider the e ffect 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 a nd ingredients;    596 
 
  (iv) Transportation practices; 
(v) Manufacturing/pro cessing procedures; 
(vi) Packaging activities and labeling activities;  
(vii) Storage, and distribution; (viii) Intended or reas onably foreseeable use; 
(ix) Sanitation, includin g 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 an alysis as reasonably likely to occur: 
(a) The owner, operator, or agent in charge  of a facility must identify and implement 
preventive controls, including at cr itical 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, p acked, 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 contro ls must be written. 
(c) Preventive controls must include, as appropriate to the f acility and the food: 
(1) Parameters associated with the control of the hazard, such as parameters associated 
with heat processing, acidifying, irra diating, and refrigerating foods, and 
(2) The maximum or minimum value, or combin ation of values, to which any biological, 
chemical, physical, or radiological parameter must  be controlled to significantly minimize or 
prevent a hazard that is r easonably likely to occur. 
(d) Preventive controls must  include, as appropriate: 597 
 
  (1) Process controls . Process controls must include those procedures, practices, and 
processes performed on a f ood during manufacturing/proces sing that are employed to 
significantly minimize or prevent hazards th at are reasonably li kely 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 Fe deral 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 pathoge n that is reasonably 
likely to occur in a ready-to-eat  food that is exposed to the en vironment prior to packaging, any 
microorganism of public health significance that is  reasonably likely to o ccur 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, incl uding food-contact surfaces  of utensils and 
equipment;  
(B) Prevention of cross-contac t and cross-contamination from  insanitary objects and from 
personnel to food, food packaging material, an d other food-contact 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 pro cedures in paragraphs 
(d)(3)(i)(A) or (d)(3)(i )(B) of this section. 598 
 
  (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)(i i) 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 take n in accordance with paragrap h (d)(3)(ii) of this section 
must be documented in records that are subjec t to verification in accordance with § 117.150(c) 
and records review in acco rdance 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 pa ragraph (a) of this section. 
(e)(1) Except as provided by pa ragraph (e)(2) of th is section, the prev entive controls 
required under this sec tion 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.  § 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. 599 
 
  (b) The recall plan must include procedures th at describe the steps to be taken, and assign 
responsibility for taking those steps,  to perform the following actions: 
 (1) Directly notify the dir ect consignees of the food be ing recalled, including how to 
return or dispose of the affected food;  (2) Notify the public about any hazard presen ted by the food when appropriate to protect 
public health;  (3) Conduct effectiveness checks to veri fy that the recall is carried out; and 
 (4) Appropriately dispose of recalle d food--e.g., through reprocessing, reworking, 
diverting to a use that does not presen t 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 m onitor the preventive 
controls with sufficient frequency to provide assurance th at 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 accord ance 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 descri be the steps to be taken to ensure that: 600 
 
  (i) Appropriate action is  taken to identify and correct a problem with implementation of a 
preventive control to reduce the lik elihood that the problem will recur; 
(ii) All affected food is evaluated for safety; and (iii) All affected food is prevented from ente ring into commerce, if the owner, operator or 
agent in charge of such facil ity cannot ensure that the aff ected food is not adulterated under 
section 402 of the Federal Food, Drug, and Cosme tic Act or misbranded under section 403(w) of 
the Federal Food, Drug, and Cosmetic Act. 
(b) Corrective action in the even t of an unanticipated problem
.  If a preventive control is 
not properly implemented and a specific correctiv e action procedure has not been established, or 
a preventive control is found to be  ineffective, the owner, operato r, or agent in charge of a 
facility must: 
(1) Take corrective action to identify and correct the problem to reduc e 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 acco rdance with § 117.150(f) to determine whether 
modification of the food safety plan is required. 
(c) Documentation . All corrective actions taken in accord ance with this section must be 
documented in records that are subject to verification in accordance with § 117.150(c) and 
records review in accord ance 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 601 
 
  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 scie ntific and technical information (or, when 
such information is not availabl e or is insufficient, conducting st udies) to determine whether the 
preventive controls, when prope rly implemented, will effectively control the hazards that are 
reasonably likely to occur; and 
(3) Need not address: (i) The food allergen cont rols in § 117.135(d)(2); 
(ii) The sanitation contro ls in § 117.135(d)(3); and 
(iii) The recall plan in § 117.137.  (b) Monitoring
. The owner, operator, or agent in char ge of a facility must verify that 
monitoring is being conduc ted, 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 cons istently implemented a nd are effectively and 602 
 
  significantly minimizing or preventing the hazards that are reasona bly likely to occur. This must 
include the following activities, as appr opriate to the faci lity and the food: 
(1) Calibration of process monitoring inst ruments and verificati on instruments; and 
(2) Review of the following records within  the specified timeframes, by (or under the 
oversight of) a qualified indivi dual, to ensure that the reco rds 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 a nd corrective action records with in a week after the records 
are made. 
(ii) Records of calibration within a reas onable 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 establis h and implement written 
procedures for the frequency of calibrating pr ocess monitoring instruments and verification 
instruments.  
(f) Reanalysis .  (1) The owner, operator, or ag ent 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 ch ange is made in the activit ies conducted at a facility 
operated by such owner, operator, or agent in char ge if the change creates a reasonable potential 
for a new hazard or a significant increas e 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;  603 
 
  (D) Whenever a preventive control is not prope rly implemented and a specific corrective 
action procedure has not been established; and  
(E) Whenever a preventive contro l is found to be ineffective. 
(ii) Complete such reanalysis and implement any additional preventive controls needed to 
address the hazard identified, if any, before the cha nge 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 revise d 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 preventiv e controls (§ 117.150(a)(1));  
(3) Review of records for implementation a nd 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 indi vidual 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 604 
 
  through job experience to develop and apply a f ood safety system.  Job experience may qualify 
an individual to perform these functions if such experience ha s provided an individual with 
knowledge at least equivalent to  that provided through the sta ndardized curriculum.  This 
individual may be, but is not required to be, an employee of the facility. 
(c) All applicable training must be documen ted in records, incl uding the date of the 
training, the type of traini ng, 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, veri fication procedures, and recall 
plan. 
(2) Records that document the m onitoring of preventive controls; 
(3) Records that document corrective actions; 
(4) Records that document verification, incl uding, as applicable , those related to: 
(i) Validation, (ii) Monitoring, (iii) Corrective actions, (iv) Calibration of process monitori ng and verification instruments, 
(v) Records review, and (vi) Reanalysis; and  (5) Records that document applicable training for the qua lified individual. 605 
 
  (b) The records that the owner, operator, or agent in charge of a facility must establish 
and maintain are subject to the requi rements 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 qualif ied facility as defined in § 117.3.  For the 
purpose of determining whether a fa cility satisfies the definition of qualified facility, the baseline 
year for calculating the adjustme nt for inflation is 2011; and  
(2)(i) Documentation that demons trates 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 th at such controls are effective; or 
(ii) Documentation (which may include license s, inspection reports, certificates, permits, 
credentials, certification by an appr opriate 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 safe ty 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 availa ble from wherever the Internet is accessible, 606 
 
  including libraries, c opy 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. F ood and Drug Administration, ATTN: Qualified 
Facility Coordinator, 10903 New Hampshire Av e., 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 pa ragraph (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 se ction.  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 fo r foreign facilities), as follows:  
(1) If a food packaging label is required, the notification re quired by paragraph (c)(1) of 
this section must appear prominently a nd 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 a ppear prominently and conspicuously, at the point of purchase, on a label, 607 
 
  poster, sign, placard, or documents delivered c ontemporaneously 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 main tain 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 enga ged in the storage of 
packaged food that is not exposed to the envi ronment must conduct the following activities for 
any such refrigerated packaged food that requi res time/temperature cont rol to significantly 
minimize or prevent the growth of, or toxin production by, microorganisms of public health 
significance: 
(1) Establish and implement temperature contro ls adequate to significantly minimize or 
prevent the growth of, or toxin production by, microorganisms of public  health significance;      
(2) Monitor the temperature cont rols with sufficient frequenc y 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 608 
 
  (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 se ction 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 calib ration within a reasonable time  after the records are made; 
and 
(iii) Reviewing records of m onitoring 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 temper ature 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 requireme nts 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 wit hdraw an exemption applicable to a qualified 
facility.  
FDA may withdraw the exemption applicab le to a qualified facility under § 117.5(a): 
(a) In the event of an active investigation of a f oodborne illness outbreak that is directly 
linked to the qualified facility; or 609 
 
  (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 materi al to the safety of the food ma nufactured, processed, packed, or 
held at such facility. § 117.254 Issuance of an order to withdraw an exemption appli cable to a qualif ied facility.
 
(a) If FDA determines that an exemption a pplicable to a qualif ied facility under § 
117.5(a) should be withdrawn, any officer or quali fied employee of FDA may issue an order to 
withdraw the exemption.  
(b) An FDA District Director in  whose district the qualified faci lity is located (or, in the 
case of a foreign facility, the Director of the Of fice of Compliance in the Center for Food Safety 
and Applied Nutrition), or an F DA official senior to such Dir ector, must approve an order to 
withdraw the exemption.  
(c) FDA must issue an order to  withdraw the exemption to th e 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 applic able to a qualified facility under § 117.5(a) 
must include the following information:  
(a) The date of the order; (b) The name, address, and locat ion of the qualified facility; 
(c) A brief, general statement of the reasons for the order, including information relevant 
to: 610 
 
  (1) An active investigation of a foodborne illness outbreak that  is directly linked to the 
facility; or  
(2) Conduct or conditions associated with a qua lified facility that are material to the 
safety of the food manufactured, processe d, 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 th e 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 certa in exceptions described in § 
117.270; 
(g) The mailing address, telephone number, emai l address, and facsimile number of the 
FDA district office and the name of the FDA Distri ct Director in whose di strict the facility is 
located (or, in the case of a forei gn facility, the same information fo r the Director of the Office of 
Compliance in the Center for Food Sa fety 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 th at receives an order 
under § 117.251 to withdraw an exemption applic able to that facility under § 117.5(a) must 
either: 
(1) Comply with applicable requirements of th is part within 60 calendar days of the date 
of the order; or  611 
 
  (2) Appeal the order within 10 calendar days of  the date of the orde r in accordance with 
the requirements of § 117.264.   
(b) Submission of an appeal, including submi ssion of a request for an informal hearing, 
will not operate to delay or stay any administ rative action, including enforcement action by FDA, 
unless the Commissioner of Food a nd 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 exemp tion 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 Distri ct Director in whose district the facility 
is located (or, in the case of a foreign facilit y, the Director of the O ffice 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, ope rator or agent in charge of the facility 
relies. 
(b) In a written appeal of the order wit hdrawing an exemption provided under § 117.5(a), 
the owner, operator, or agent in charge of th e facility may include a written request for an 
informal hearing as provided in § 117.267.   § 117.267 Procedure for requesting an informal hearing.
 612 
 
  (a) If the owner, operator, or agent in charge of th e facility appeals th e 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 cal endar days of the date of the order. 
(b) A request for an informal hearing may be de nied, 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 dete rmines 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 re quests 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 ag reed upon in writing by the owner, operator, or agent in charge 
of the facility and FDA.  
(b) The presiding officer ma y require that a hearing c onducted under this subpart be 
completed within 1 calendar day, as appropriate.  
(c) FDA must conduct the heari ng in accordance with part 16 of  this chapter, except that: 
(1) The order withdrawing an exempti on under §§ 117.254 and 117.257, rather than the 
notice under § 16.22(a) of this chapter, provides notice of opportunity fo r a hearing under this 
section and is part of the administrative record of the regulatory heari ng under § 16.80(a) of this 
chapter.  613 
 
  (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 th is chapter, describes the FDA employees 
who preside at hearings under this subpart.   
(4) Section 16.60(e) and (f) of th is chapter does not apply to a hearing under this subpart. 
The presiding officer must prepar e a written report of the heari ng. All written material presented 
at the hearing will be attached to the report. Th e presiding officer must include as part of the 
report of the hearing a finding on the credibility of witnesses (o ther than expert witnesses) 
whenever credibility is a material issue, and must include a proposed d ecision, with a statement 
of reasons. The hearing particip ant 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 re gulatory hearing under this 
subpart.  The presiding officer’s report of th e hearing and any comment s 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 reconsiderati on 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 614 
 
  this subpart.  With respect to a regulatory hearin g under this subpart, the ad ministrative 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 fi nal 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 presid ing officer’s final decision. 
§ 117.274 Presiding officer for an appeal and for an informal hearing.
 
The presiding officer for an appeal, and fo r 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 issui ng a decision on an appeal.  
(a) If the owner, operator, or  agent in charge of a facil ity appeals the order without 
requesting a hearing, the presidi ng officer must issue a writte n report that includes a final 
decision confirming or revoking the w ithdrawal by the 10th calendar day af ter 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 a nd the hearing is held, the presiding officer 
must provide a 2 calendar day opportunity for th e 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 heari ng, the presiding officer must issue a final 
decision on the appeal confirming or revoking the withdrawal with in 10 calendar days after the 
date the appeal is filed.  § 117.280 Revocation of an order to withdraw an exemption applic able to a qualified facility.
 615 
 
  An order to withdraw an exem ption applicable to a qualifie d facility under § 117.5(a) is 
revoked if: 
(a) The owner, operator, or agent in charge of the facility appeal s 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 appeal s the order and requests 
an informal hearing, FDA denies the request fo r an informal hearing, and FDA does not confirm 
the order within the 10 calendar da ys 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 appe als the order without 
requesting an informal hearing, and FDA does not confirm the orde r within the 10 calendar days 
after the appeal is filed, or issues a deci sion revoking the order within that time.  
 § 117.284 Final agency action.  
Confirmation of a withdrawal order by the pres iding officer is considered a final agency 
action for purposes of 5 U.S.C. 702. Subpart F—Requirements Applying to Records Th at 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, a ll records required by 
this part are subject to all re quirements of this subpart F. 
(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). 616 
 
  § 117.305 General requirements applying to records.  
Records must:   (a) Be kept as original record s, true copies (such as photocop ies, pictures, scanned copies, 
microfilm, microfiche, or other accurate reproductions of the original records), or electronic 
records, which must be kept in acco rdance with part 11 of this chapter; 
(b) Contain the actual values and obs ervations obtained during monitoring; 
(c) Be accurate, indelible, and legible; (d) Be created concurrently with pe rformance of the activity documented; 
(e) Be as detailed as necessary to pr ovide 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 th e person performing the activity; and 
(4) Where appropriate, the identity of th e 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 date d 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 pa rt must be retained at the pl ant or facility for at least 2 
years after the date they were prepared. 617 
 
  (b) Records that relate to the general adequ acy 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 af ter their use is disc ontinued (e.g., because the facility has updated 
the written food safety plan (§ 117.126) or record s that document validat ion of the written food 
safety plan (§ 117.150(a)); 
(c) Except for the food safety plan, offsite st orage of records is permitted after 6 months 
following the date that the record was made if su ch records can be retrie ved 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 acc essible 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 ma de promptly available to a duly authorized 
representative of the Secretary of Health and Human Serv ices 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 pa rt 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. 618 
 
  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 chapte r 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 pro cessed 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 th e conditions and practices during 
processing with sufficient frequency to ensu re, at a minimum, conformance with those 
conditions and practices specified in  part 110 and in subpart B of pa rt 117 of this chapter that are 
appropriate both to the plant and to  the food being processed. * * * 
* * * * * 619 
 
  PART 123--FISH AND FISHERY PRODUCTS 
 20.  The authority citation for 21 CFR pa rt 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 introducto ry text in § 123.3 to read as follows: 
§ 123.3 Definitions.  
The definitions and interpretations of term s in section 201 of the Federal Food, Drug, and 
Cosmetic Act (the act) and in parts 110 and 117 of this chapter are applicab le 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 pa rt and except that the te rms 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), part s 110 and 117 of this chapter apply in 
determining whether the facilities, methods, prac tices, 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 intr oductory text of paragraph (b) to read as follows: 
§ 123.11 Sanitation control procedures.
 
* * * * * 620 
 
  (b) Sanitation monitoring . Each processor shall monito r the conditions and practices 
during processing with sufficient frequency to en sure, at a minimum, conformance with those 
conditions and practices specified in  part 110 and in subpart B of pa rt 117 of this chapter that are 
both appropriate to the plant and the food being processed an d relate to the following: 
* * * * * PART 129--PROCESSING AND BOTTLING OF BOTTLED DR INKING WATER 
 24.  The authority citation for 21 CFR pa rt 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 th is chapter, as well as  the criteria in §§  
129.20, 129.35, 129.37, 129.40, and 129.80 shall apply in dete rmining whether the facilities, 
methods, practices, and controls used in the pr ocessing, bottling, holding, and shipping of bottled 
drinking water are in conformance with or are ope rated 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 tran sported under sanitary conditions. 
PART 179--IRRADIATION IN THE PRODUC TION, PROCESSING AND HANDLING OF 
FOOD  26.  The authority citation for 21 CFR pa rt 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.  
* * * * * 621 
 
  (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 MANUFACTU RING PRACTICE FOR FINISHED 
PHARMACEUTICALS  28.  The authority citation for 21 CFR pa rt 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 manuf actured, processed, packed, or 
held under current good ma nufacturing 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 622 
 
  Although the proposed rule that is the s ubject of this document does not include 
provisions for environmental monitoring or fini shed 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 comme nt on when and how thes e types of testing are 
an appropriate means of implem enting the statutory directives set out in section 418 of the 
FD&C Act. In this Appendix, we provide b ackground 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 th e effective implementatio n of scientifically 
valid preventive control measures  throughout the food chain (Ref. 34) (Ref. 110).  Prevention of 
hazards in food is much more effective than tryi ng 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 supp liers and those verified through environmental monitoring, are 
controlling the hazard (Ref. 111) (Ref. 112).  Te sting is used in conjunction with other 
verification measures in the food safety system, such as audits of suppliers, observations of 
whether activities are being c onducted 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 mo re of our discussion belo w on verification testing 
of the environment because of the increasing r ecognition of the benefits of such testing in 623 
 
  identifying conditions that coul d result in environmental pathoge ns contaminating food; thus 
such verification testing is important in preven ting contamination in food, whereas verification 
testing of raw materials, ingredients, and finished  products is used to de tect 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 ve rify 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 environm ental pathogens to contaminate RTE food; and  
• Testing finished product to verify that preventive controls have significantly 
minimized or prevented hazards reas onably likely to occur in the food. 
Each type of testing provides informati on applicable to managing hazards in foods, 
depending on the food and process.  For exampl e, a dry blending operation, e.g., for spices and 
seasonings, often verifies its s upplier controls by te sting incoming ingredients before use (as 
discussed in section I.C of this Appendix) and periodically sampling and testing finished 
products. If all the ingredients be ing 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 us e 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 re gulations.  All these 
terms mean to reduce a hazard to an  extent that it is not reasonab ly likely to cause illness or 
injury.)  A dry blending operati on generally does not test incomi ng ingredients if the facility 624 
 
  treats the blended materials to  ensure adequate reduction of pathogens but sometimes tests 
finished product to verify preven tive controls have been effectiv e.  A dry blending operation also 
sometimes uses environmental monitoring to verify that sanitation controls to significantly minimize or prevent the potential for environm ental 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 ingredient s and of finished product provides little benefit 
as a verification activity (although it would be used in process va lidation); however, facilities 
producing such products sometimes conduct peri odic testing of incoming ingredients for 
pesticides as an appropriate supplier verifica tion activity.  
B. Scientifically Valid Sampling and Testing 
 
Consistent with our previous discussion of the term “scienti fically valid” in the proposed 
rule to establish CGMP require ments for dietary ingredients a nd 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 tes ting that is based on scientific  information, data, or results 
published in, for example, scientif ic journals, references, text books , or proprietary research.  A 
scientifically valid analytical me thod is one that is based on scie ntific data or results published 
in, for example, scientific journals, references , text books, or proprieta ry research (68 FR 12158 
at 12198).  Sampling and testing used for verifi cation in a food safety system must be 
scientifically valid if they are to provide assu rance that preventive controls are effective.  
C. Verification Testing of Ra w Materials and Ingredients  
Raw materials and ingredients are often test ed as part of a supplier approval and 
verification program, as one of the verification activities when a preventive control that is 625 
 
  adequate to significantly minimize or prevent the h azard is not applied at th e 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 receivi ng facility (e.g., the 
effect of processing on the hazard); and 
• The potential for contamination of the fac ility’s environment with the hazard in 
the raw material or ingredient. 
Testing a raw material or ingred ient occurs more frequently wh en there is a history of the 
hazard in the raw material or ingredient, e.g., fr om a specific supplier or from the country of 
origin.  Once a facility has developed a relationshi p with a supplier and ther e is a history of tests 
negative for the hazard, the fr equency 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 exposur e to the hazard will result in serious adverse 
health consequences or death to humans or animal s.  However, when a hazard that the receiving 
facility has identified as reasonably likely to oc cur in a raw material or  ingredient is one for 
which the receiving facility has preventive contro ls that significantly minimize or prevent the 
hazard, testing generally is less frequent.  An ex ception to this general paradigm is when the 
process control depends on the amount of the haza rd present in the raw material or ingredient 
(e.g., when the process control is effective at  eliminating 100 microor ganisms per gram of 626 
 
  ingredient, but not 1000 microorganisms per gram of i ngredient) and there is a need to verify that 
the hazard is not present in amounts that would render the pro cess control ineffective.  A 
receiving facility often finds th at testing of raw materials or ingredients is most useful, and 
generally tests more frequently, when the receivi ng 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 opera tion 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 ingredie nt have been significantly minimized or prevented.   
The frequency of the testing conducted by a f acility generally depends in part on the 
likelihood and severity of illness to the consumer if the haza rd were present, the ability of 
supplier controls to significantly minimize or prevent the hazard in the raw material or 
ingredient, the practicality of te sting to detect the hazard, and ot her factors.  For example, a 
facility generally tests a raw mate rial 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 f acility 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 illne ss to the consumer and practical problems with 
testing fresh produce for pathogenic stra ins of Shiga-toxin producing E. coli .  Where a raw 
material or ingredient could in troduce 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 627 
 
  to be used in a salad for L. monocytogenes ), a facility generally tests the raw material or 
ingredient more frequently to verify that suppl ier controls for the raw material or ingredient 
minimize to the extent possible the potential for a contaminated raw materi al or ingredient to 
introduce the environmenta l pathogen to the facility’s environment.   
As discussed in section I.F of this Appendi x, there are limitations to testing food. Thus, 
as with other testing, raw materi al or ingredient test ing is rarely the sole basis for making a 
determination on the safety of a raw material or ingredient. 
D. Verification of Sanitation Controls to Signifi cantly 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 pream ble 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 th e environment during a manufacturing, processing, 
packing, or holding activity, th ere is the potential for the food to be contaminated with 
pathogenic microorganisms.  As discussed in se ction 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 capab le of surviving and persisting within the 
manufacturing, processing, packing, or holding environment.  The environmental pathogens 
most frequently involved in the contamina tion 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 f oods and it can get into  food by a variety of 628 
 
  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-mo isture foods (Ref. 145) (Ref. 179) . Low-moisture 
foods include cereal, peanuts, nuts, nut butters (i ncluding peanut butter), sp ices, dried herbs, milk 
powder, chocolate and many other foods.  Although Salmonella  outbreaks from low-moisture 
foods are less common than from foods such as e ggs 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 alm onds, dried snacks, spices, and peanut butter (Ref. 145) (Ref. 
196). Chocolate also has been a s ource of outbreaks from Salmonella  spp., although none in the 
U.S. in recent years (Ref. 145).  Dried dairy produc ts, 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 pr imary 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 pr eamble of this document.  As 
discussed in that section, the FDA/FSIS Lm RA shows that th e risk of illness from L. 
monocytogenes  increases with the number of cells inge sted and that there is greater risk of 
illness from RTE foods that suppor t growth of L. monocytogenes  than from those that do not 
(Ref. 56).  A key finding of the risk assessmen t released by FAO in 2004 was that the models 
developed predict that nearly all cases of listeri osis 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 grow th may be held for an extended period of time, 629 
 
  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 organi sm may survive.  If a frozen food contaminated 
with L. monocytogenes  is thawed and held at temperat ures 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, contamin ation 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 facili ty through raw materials or 
ingredients, people, or object s (Ref. 145) (Ref. 179) (Ref. 199) (Ref. 144) (Ref. 185).  Once in 
the facility, environmental pathogens can be a source of contamination of food.  Environmental 
pathogens may be transient strain s or resident strains (Ref. 145) (Ref. 179) (Ref. 199).  Transient 
strains are environmental pathogens that contamin ate a site in the facil ity 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 differe nt areas and the specific  strain will differ. 
Resident strains are environmenta l pathogens that contaminate a si te in the fac ility that is 
difficult to clean and sanitize with normal clean ing 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).  Th e 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 ot her sites (i ncluding food-630 
 
  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 lo cations), 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 f ood-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 availabl e 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 imp licated 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 th e exhaust system of the implicated processing 
line (Ref. 201).  In 2008, the same Salmonella  Agona strain was again im plicated 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 pati ents, cereal and the plan t environment (Ref. 204). 631 
 
  In 2006-2007, a commercial brand peanut  butter contaminated with Salmonella  
Tennessee caused 715 illnesses and 129 hospitali zations (Ref. 62).  FDA isolated Salmonella  
Tennessee from 13 unopened jars of peanut butte r with production date s ranging from August 
2006 to January 2007 and from two plant environmental samples (Ref. 63).   
During the years 2008 through 2010, there were th ree large recalls of foods containing 
ingredients contaminated with Salmonella  spp. where FDA’s investigat ion identified insanitary 
conditions at the facility that manufactu red 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 ou tbreak was linked to Salmonella  Typhimurium in peanut 
butter and peanut paste (Ref. 66) (Ref. 67) (Ref. 205).  This outb reak 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).  In spections conducted by FDA 
at the two implicated ingredient manufacturing facilities (which shar ed ingredients) revealed lack 
of controls to prevent product contamination fr om pests, from an insanitary air-circulation 
system, from insanitary food-c ontact surfaces, and from the pr ocessing 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 re call of more than 3900 products 
containing peanut-derived ingredients (Ref. 20).  
In 2009, USDA detected Salmonella  spp. in a powdered dairy shake and FDA began an 
investigation of the supp liers of ingredients used to manufactu re the product.  The inspection of 
the supplier of one of the ingredie nts uncovered insanitary conditions that resulted in the recall of 
multiple ingredients manufactured by that supplier , including instant nonfat dried milk and whey 632 
 
  proteins, produced over a 2-year period (Ref. 155).  During its investig ation 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 envir onment, 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 th at 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-contac t surfaces.  FDA found numerous sanitation 
deficiencies during its inspection of the production facility.  There were no reports of illness 
associated with the contamination, but multip le product recalls resulted (Ref. 23).   
6. Contamination of food with L. monocytogenes  from the plant environment.   
As discussed immediately below, the availabl e 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 co ntaminated post-pasteurization (Ref. 72).  The 
outbreak strain was isolated from  product and from a vat gasket in a post-pasteurization section 
of the processing line.   
In October 2010, the Texas Department of St ate 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 investiga tion of 10 cases of 
listeriosis, six of which were linked to chopped ce lery from the facility.  Texas Department of 633 
 
  State Health Services and FDA inspectors found sanitation deficien cies at the plant (Ref. 207) 
(Ref. 208) and suggested th at the L. monocytogenes  in the chopped celery may have 
contaminated other produce.  FDA la boratory testing found L. monocytogenes  in multiple 
locations in the plant envir onment, 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 can taloupes was attribut ed to insanitary 
conditions at a facility that wa shed, 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 al so difficult to clean), poorly designed equipment 
(not easily cleaned and sanitized ) that was previously used fo r a different commodity, no pre-
cool step, a truck parked near the packing area that had visite d a cattle operation, and possible 
low level contamination from the grow ing/harvesting operation (Ref. 79).  
There have been several outbreaks in which meat or poultry products produced in FSIS-
inspected establishments were c ontaminated 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 cont rol 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, harborag e sites such as hollow rollers, rubber seals, close-fitting metal-
to-metal spaces in equipment such as slicers, an d on-off switches of equipment were identified in 
meat and poultry establishments. The increas ed risk of contamination resulting from 
construction, and the importance of control of traffic and water in the RTE area also became 634 
 
  widely known as a result of inve stigations at meat and poultry establishments (Ref. 144) (Ref. 
185).   
Outbreaks of listeriosis resulting from envir onmental contamination have also occurred in 
other countries.  For example, an outbreak of lis teriosis in Finland in 1999 was associated with 
butter (Ref. 211).  The outbreak strain was isolat ed from the manufacturing facility, including 
from the packaging machine and the floor (Ref. 211).  An outbreak of listeriosis in 2009 in 
Austria and Germany was associated with acid cu rd 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 st udy involving 6 different types of food plants (frozen food, fluid 
dairy, cheese, ice cream, potato processing, and dr y 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 concl uded that food production environments could be the source of 
contamination for foods that have received listeri cidal treatments and th at measures should be 
taken to prevent survival and growth of thes e organisms in food environments (Ref. 214).  
Listeria  testing in 62 dairy facilities duri ng 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 packagi ng 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 635 
 
  environments for Listeria  and found 80 of 378 sites positive for Listeria  spp. (Ref. 216).  Sites 
positive for L. monocytogenes  included holding tanks, table t ops, 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 fo r 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 It aly (Ref. 218), and 
slicers and conveyor belts were found to contribu te 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 informa tion 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 Appe ndix 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 be lts after blanching and from freezing 
tunnels (Ref. 220). Studies in a vegetable proces sing 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 ex amples, the presence of an “indicator organism” 636 
 
  (either Listeria  spp. or L. innocua) demonstrated that insanitary conditions existed that were 
conducive to the presence and ha rborage of L. monocytogenes.  
E. Role of Environmental Monitoring in Veri fying the Implementation and Effectiveness of 
Sanitation Controls in Significantl y 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 pat hogens to food-contact su rfaces and to food (Ref. 
199).  The purpose of monitoring for environmen tal pathogens in facilities where food is 
manufactured, processed, packed or held is to verify the impl ementation 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 afte r routine cleaning and 
sanitizing (particularly strains th at may have become established in the facility as resident 
strains) so that the e nvironmental pathogens can be eliminat ed by appropriate corrective actions 
(e.g., intensified cleaning and sanitizing, sometimes involving equipment disassembly).  
Pritchard et al. noted th at daily cleaning and sani tizing appeared to be e ffective in eliminating 
transient contaminants from equipment and concl uded 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 enab les the facility to 
eliminate them from the environment which can  prevent contaminati on 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 637 
 
  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 demonstrat ed 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 contaminat ion (Ref. 216) (Ref. 187). 
2. Indicator Organisms.   
The term “indicator organism” can have diffe rent 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 micr oorganisms that is indi cative that (1) a food 
has been exposed to conditions that pose an incr eased risk for contamination of the food with a 
pathogen or (2) a food has been exposed to c onditions under which a pathogen can increase in 
numbers (Ref. 222).  This definition in the scientif ic literature is consistent with a definition of 
indicator organism established by NACMCF as one  that indicates a stat e or condition and an 
index organism as one for which the concentration or frequency correlates with the concentration 
or frequency of another microorganism of c oncern (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 verifi cation of hygiene measur es in facilities is 
common practice (Ref. 224).  For example, it is co mmon practice to use the presence of generic 
(nonpathogenic) E. coli
 in a food processing plant as an i ndication 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, 638 
 
  such use of an indicator organism is distinct fr om the use of indicator organisms as discussed in 
the remainder of this document – i.e., for the sp ecific purpose of monitoring for the presence of 
environmental pathogens.   
Environmental monitoring for environmental pathogens can be conducted by testing for 
the specific pathogenic mi croorganism (e.g., Salmonella  spp.) or by testing for an “indicator 
organism.”  The presence of an indicator organism indicates c onditions in which the 
environmental pathogen may be present.  An organi sm is useful as an indicator organism if there 
is sufficient association of conditions that could re sult 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 th e indicator is not present.  Attr ibutes 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 in dicator organism (Ref. 223).  
The presence of an indicator organism in  the plant environment, including on a food-
contact surface, does not necessarily mean that an environmental pathogen is in the plant or in a 
food produced using that food-c ontact surface – the indicator ma y be present but the pathogen 
may be absent.  Pritchard et al., in their study on the pres ence 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 
necessarily translate into c ontamination of equipment in the plant (Ref. 216).    639 
 
  Typically, a facility that fi nds 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 de termine whether the c ontamination has been eliminated.  If the 
indicator organism is found on retest, the facili ty 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 genera l, whether a facility 
takes subsequent steps to determine an indicato r 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 food-contact surface that has te sted positive for an indicator organism were 
to be contaminated.  For example, the risk of li steriosis is greater if th e food supports growth of 
L. monocytogenes
. In some cases, a facility simply a ssumes that a food produced using a food-
contact surface that is contamin ated with an indicator organism is contaminated with the 
environmental pathogen and takes co rrective action to either  reprocess it or dive rt 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 indicat or organism for L. monocytogenes .  FSIS has established regulations 
requiring FSIS-regulated establishments that pr oduce RTE meat or poultr y products exposed to 
the processing environment afte r a lethality procedure (e.g., cooking) to prevent product 
adulteration by L. monocytogenes . 640 
 
  FSIS has issued guidelines (FSIS Complian ce Guideline for Controlling Listeria 
monocytogenes  in Post-lethality Exposed Ready-to-Eat  Meat and Poultry Pr oducts) (hereinafter 
the FSIS Listeria  Compliance Guideline) to help FSIS-re gulated establishments that produce 
RTE meat or poultry products exposed to the pr ocessing environment afte r a lethality procedure 
comply with the requirements of 9 CFR part 430 (Ref. 225).  Under the FSIS Listeria  
Compliance Guideline, FSIS-regulated estab lishments 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 re sult for an indicator organism on a food-contact 
surface: 
• Takes corrective action (i.e., intensify the cleaning and sanitizing of the affected 
food-contact surface);   
• Retests the affected food-contact surface; and 
• Takes additional corrective action (intensifi ed each time the test is positive for the 
indicator organism) and conducts additional tes ting until the affected food-contact surface is 
negative for the indicator organism.   
Some segments of the food industry subjec t 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 pl ant.  For example, in response to a 
request for comments on a draft guidance documen t 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. 641 
 
  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 im portance of updating CGMP requirements to 
require a written environmental pathogen control program for food processors that produce RTE 
foods that support the grow th 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 pr esence 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 i ndicator 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 Enter obacteriaceae, and t hus 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 Ente robacteriaceae, such as E. coli,  to serve as an indicator 
organism for Salmonella  spp. in the environment. The Eu ropean Food Safety Agency (EFSA) 
evaluated whether environmental monitoring for En terobacteriaceae 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 or ganism in the production of a single product – i.e., 
powdered infant formula – their analysis may be re levant to the utility of Enterobacteriaceae as 642 
 
  an indicator organism in other dried foods.  E FSA concluded that, althoug h there are insufficient 
data to establish a correlation between the presence of Enterobacter iaceae 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 ut ility of environmental monitoring for 
Enterobacteriaceae as an indicator organism for Salmonella  spp.  ICMSF indicates that, for 
powdered infant formula manufactur ing, low levels of Enterobact eriaceae 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 pres ence 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 sp ices receiving a kill step (Ref. 234), dried 
cereal products (Ref. 235), nuts (R ef. 236), cocoa powder, chocol ate and confectionary (Ref. 
237), and dried dairy products (Ref. 238).  For most of these products ICMSF also recommends 
testing the environment for Ente robacteriaceae as a hygi ene indicator, but not in lieu of the 
environmental pathogen Salmonella  spp. Likewise, food industry guidance for low-moisture 
foods recommends testing for Salmonella  spp. in the environment (Ref. 184). FDA’s current 
thinking is that there is no currently av ailable indicator organism for Salmonella  spp.  We request 
data, information, and other comment bearing on wh ether there is a curren tly available indicator 
organism for Salmonella  spp. that could be used for environmental monitoring. 643 
 
  5. Environmental Monitoring Procedures.   
The procedures associated with an envir onmental monitoring program generally include 
the collection of environmental samples at locatio ns within the facility and testing the samples 
for the presence of an environmental pathogen or indicator organism.  On e approach to defining 
sampling locations is to divide the facility in to zones based on the risk with respect to 
contamination of product.  A common industry pr actice is to use four zones (Ref. 199) (Ref. 
184):  
• Zone 1 consists of food-contact surfaces;  
• Zone 2 consists of non-food-contact surf aces in close proximity to food and food-
contact surfaces;  
• Zone 3 consists of more remote non-food- contact surfaces that are in the process 
area and could lead to contamin ation 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 intr oduced into the processing environment.  
Generally the number of samples and frequenc y 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 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 pa thogens 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 food-contact surfaces for 
Listeria  spp. is a commonly recommended veri fication measure for facilities producing 644 
 
  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 outbreak s, recalls, or reports 
to the RFR warrant including food-contact surfaces  in a routine environmental testing program 
for Salmonella  spp.  However, a routine environm ental monitoring program for Salmonella  spp. 
may not contain the same level of food-contact su rface testing (including th e 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 pa thogen 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 (inc reases 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. Equipm ent 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 like ly 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 645 
 
  food-contact surfaces (e.g., filler hoppers, conveyors , valves, sifter cuffs) can be useful, as can 
sampling residues such as sifter ta ilings and product scrapings.   
Examples of appropriate non- food-contact surfaces that c ould be monitored include 
exteriors of equipment, equipment supports, control panels, door ha ndles, 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 monito r. Testing non-food-contact surfaces for L. 
monocytogenes  or Listeria  spp. is a commonly recommended ve rification 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 peopl e or objects.  Corrective actions can 
prevent transferring the organisms to a food-cont act surface (where they can contaminate food) 
or from establishing a harborage that can serve as a source of contamination.  Recommendations 
for routine environmental mon itoring for Salmonella spp. in low moisture food environments 
generally target non-food-contact surfaces becau se equipment used in the production of low-
moisture foods where Salmonella  spp. is the environmental pa thogen 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 respec t to indicator organisms, a 
facility that finds an indicator organism or  an environmental pathogen during environmental 
monitoring typically conducts mi crobial testing of surrounding su rfaces and areas to determine 
the potential source of the contamination, cleans and sanitizes the contaminated surfaces and 646 
 
  areas, and conducts additional micr obial testing to determine whet her the contamination has been 
eliminated.  If the organism is found on retest, the facility generally takes more aggressive 
corrective actions (e.g., more intensified cl eaning and sanitizing, including dismantling 
equipment, scrubbing surfaces, and heat-tre ating equipment parts) (Ref. 144).   
The adequacy of a corrective action in res ponse to environmental monitoring depends in 
part on the following factors related to the risk  presented in a particular situation:   
• Whether the environmental contaminati on is on a food-contact surface or a non-
food-contact surface;   
• The proximity of a contaminated non- f ood-contact surface to one or more food-
contact 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 (s ee the discussion of the relevance of whether a 
food supports the growth of an environmental pathogen in secti on I.D.4 of this Appendix).  
If an environmental pathogen or an appropriate  indicator organism (t he test organism) is 
detected in the environment, corrective actions  are taken to eliminate the organism, including 
finding a harborage site if one ex ists (Ref. 144) (Ref. 185) (Ref. 184).  Otherwise, the presence 
of the environmental pathogen could result in co ntamination of food-cont act surfaces or food.  
The presence of the indicator organism suggests th at conditions exist in which the environmental 
pathogen may be present and could result in c ontamination of food-cont act surfaces or food.  
Corrective actions are taken for every finding of  an environmental pathogen or indicator 
organism in the environment to prevent cont amination of food-contact surfaces or food.   647 
 
  Sampling and microbial testing from su rfaces 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.  Clean ing and sanitizing the contaminated surfaces and 
surrounding areas are necessary to eliminate the te st 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 afte r cleaning and sanitizing indicates that the initial 
cleaning was not effective, and additional, more  intensified cleaning a nd sanitizing, or other 
actions may be needed, including dismantling equi pment, scrubbing surfaces, and heat-treating 
equipment parts (Ref. 144).  Examples of add itional corrective actions that could be taken 
include reinforcing employee hygiene practices a nd traffic patterns; repa iring damaged floors; 
eliminating damp insulation, water leaks, and so urces of standing water; replacing equipment 
parts that can become harborag e sites (e.g., hollow conveyor roll ers and equipment framework), 
and repairing roof leak s (Ref. 144) (Ref. 184).  The types of  corrective actions would depend on 
the type of food, the facility a nd the environmental pathogen. 
The finding of a test organism on a food-c ontact surface usually represents transient 
contamination rather than a harborage site (R ef. 185).  However, finding the test organism on 
multiple surfaces in the same area, or continui ng to find the test organism after cleaning and 
sanitizing the surfaces where it was found, suggest s a harborage site for the test organism.  
Mapping the location of contamination sites, whethe r the harborage site is on equipment or in the 
environment, can help locate the source of the ha rborage site or identify additional locations to 
sample (Ref. 184).   648 
 
  The types of facilities that  may conduct environmental monitoring and that could 
implement corrective actions on findi ng the test organism in the facility are quite diverse, and 
include facilities producing low-moisture product s 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 testi ng and the applicable 
cleaning and sanitizing procedures would depe nd on the facility and the equipment.   
Corrective actions may involve investigativ e procedures when th e initial corrective 
actions have not been successful  in eliminating the environmental pathogen or indicator 
organism. One example of an investigative pr ocedure is taking samples from food-contact 
surfaces and/or product from the processing line at multiple times 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-fi eld gel electrophoresis (PFGE), 
ribotyping, or polymerase chain re action (PCR) analysis to determ ine 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 is olated at different points in time have the same 
molecular “fingerprint,” sugges ting 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 tr ying 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 shortc omings for microbiologi cal testing of food for 
process control purposes.  Testing cannot ensure the absence of a hazard, particularly when the 649 
 
  hazard is present at very low levels and is not  uniformly distributed.  If an environmental 
pathogen is detected on a food-c ontact 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 f ood-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 environm ental 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 or ganism, rather than an environm ental pathogen, is detected on a 
food-contact surface.   
The results of finished product testing can be used in comb ination 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 determini ng 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;  650 
 
  • The root cause analysis of th e source of the contamination; 
• Information on the efficacy of the fac ility’s corrective actions (including the 
results of additional follow-up sampling); 
• Information obtained from any finished pr oduct testing, taking into consideration 
the statistical confidence a ssociated with the results.  
F. The Role of Finished Product Testing in Ve rifying the Implementation and Effectiveness of 
Preventive Controls  
Although FDA is not including a provision for fi nished product testing in this proposed 
rule, here we set out some cons iderations regarding the appropr iate use of such testing. The 
utility of finished product testi ng 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 comm odity but that is within the tolerance approved 
for other commodities, while deemed unsafe as a matte r of law, may not actually result in illness.  
Thus, a firm is more likely to conduct fi nished product testing to verify Salmonella
 spp. control 
than to verify control of pesticides.   651 
 
  Another consideration in determining whether finished product testi ng is appropriate is 
the intended consumer of the f ood.  The greater the sensitivity of the intended consumer (as 
would be the case, for example, for a medical f ood provided to hospitalize d adults), the greater 
the likelihood that finished product testing w ould be used as a verification activity.   
Another consideration in determining whether finished product testi ng 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, includi ng low pH, high acidity, and preser vatives, that are lethal for 
pathogens such as Salmonella
 spp. or E. coli  O157:H7.  If a facility ha s validated the lethality of 
the formulation of the salad dres sing, 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 pr oper formulation of the food is ve rified during production.  In 
contrast, verification testing is  more likely in food where pa thogens can survive in a food, 
particularly where pathogens may grow in a food.     
Another consideration in determining whether finished product testi ng is appropriate is 
the intended use of the food.  For example, c onsumers cook many foods, e.g., dried pasta, cake 
mixes, and most frozen vegetables, thereby reduci ng pathogens.  A facility  should not rely on the 
consumer to eliminate hazards that can be prevente d.  However, there is little benefit in testing a 
food that is normally consumed following a step that  can be relied on to in activate the hazard.  It 
is important to validate that the instructions provided to the consumer  adequately reduce the 
pathogen of concern.  It is al so important to understand the cu stomary use of the food, which 652 
 
  may include uses that do not include the hazard  reduction step.  For ex ample, dried soup mixes 
may be mixed with sour cream to make a dip, wi thout the pathogen inactiva tion 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, deli-type salads, or sals as without a pathogen inac tivation 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 testi ng is appropriate is 
the type of controls the supplie r has implemented to minimize the potential for the hazard to be 
present, e.g., whether the supplier uses a kill st ep 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 do es not have a program that can  ensure the hazard has been 
adequately reduced in the ingr edient supplied.  Another cons ideration 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, in cluding a supplier approval and ve rification program that has 
been verified through audits to adequately redu ce the hazard, the receiv ing facility performs 
periodic verification testing of the ingredient provided by the supplier, and the supplier has a 
good compliance history, the frequency of finish ed 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 653 
 
  the receiving facility will not significantly minimize it, or if a facility is using a new supplier, the 
frequency of finished product ve rification testing increases.   
One of the most important considerations in  determining whether finished product 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 te sting 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 verifi cation testing would be more 
common if the only pathogen reduction step is washi ng 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 ta rget pathogen 
because the post-treatment level of microorganisms would be t oo low to be detected using 
reasonable sampling and analytical  methods (68 FR 6138 at 6174).   
Another important consideration in determ ining whether finished product testing is 
appropriate is whether a hazard can be reintroduc ed into a food that has been treated to 
significantly minimize the hazard, either through e xposure to the environment or by the addition 
of an ingredient after a treatment to significan tly 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 co ld gazpacho filled into a container.  Likewise, 
verification testing generally is more freque nt for foods given signi ficant handling before 654 
 
  packaging, regardless of whether they have pr eviously 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 woul d be more frequent if an ingr edient that has potential to 
be contaminated with a pathogen is added to a food that was prev iously 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 conduc t verification testing and determine the frequency of that 
testing, a facility generally considers the impact of all the preventive cont rol 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 verifi cation testing generally 
could be lower for a food that is su bject to supplier controls that in clude audits and certificates of 
analysis (COAs); that contains ingr edients that have been subjected to ingredient testing; that is 
produced under well-implemented sanitation co ntrols that are veri fied through a robust 
environmental monitoring program; and that is trea ted 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 init ial production cycles until there is an accumulation 
of historical data (e.g., finished product test results that are ne gative 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.  655 
 
  There are well-known shortcomings of pr oduct 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) (R ef. 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 informa tion about adherence to validated  control measures.  This is 
illustrated below for Salmonella  spp. 
FDA’s Investigations Operations Manua l (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 c onsumption.  The stringency of the sampling 
plan is based on the category of the food.  Catego ry 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, chocol ate, prepared salads, ready-to -eat sandwiches).  Category I 
foods are Category II foods intended for consum ption by the aged, the infirm, and infants (e.g., 
foods produced for a hospital).  FDA takes 15 sa mples for Category III f oods, 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 worklo ad, the analytical units may be  composited (Ref. 244), with the 
maximum size of a composite unit being 375 g (15 anal ytical units).  This composite is tested in 
its entirety for Salmonella  spp. The probability of detecting Salmonella  spp. for various 656 
 
  contamination rates under the three IOM Salm onella 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). 
  Probability of Detecting 
Salmonella  spp. in a Lot 
(Percent) Expected # of Positive Composites per 
year (weekly testing) 
Contamination Rate CFU/g or 
CFU/kg 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 nu mber of subsamples (which ar e composited in groups of 15 for 
analysis).  
The probability of detecting Salmonella
 spp. increases as the def ect 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, th e probability of detecting Salmonella  spp. increases with the 
number of samples tested.  For example, at a c ontamination rate of 1 in  30, the probability of 
detecting Salmonella  spp. increases from 40 percent if 15 sa mples 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 percen t, 96 percent, and 79 pe rcent of the time using 
Category I, II, and III testing, resp ectively.  If the frequency of c ontaminated units is reduced to 657 
 
  1 in 300, then the contaminated lot would only be detected 18 percen t, 10 percent, and 4.9 
percent of the time using Category I, II, and III testing, respectivel y.  At a very low frequency of 
contamination (e.g., 1 in 1000) ev en with testing 60 samples th e contaminated lot would be 
detected only about 6 percent of the time.  
Periodic testing for trend analysis and statis tical 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 pr oduced over days, months or years are used to 
establish a baseline for the level of control th at 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 give n contamination rate, 
Table 1 also shows the value of periodic testi ng 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 fr equency of contaminated units is closer to 1 in 
300.  Periodic testing accordi ng 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 co llected over the course of a year.  Compositing 
these 3,120 samples into 375g analyti cal units would reduce the numbe r 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 contam ination rate there would be a greater than 95 658 
 
  percent confidence in seeing one or more positive tests during th e 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 facili ty testing finished products over time for 
process control.  First, if a lot of product te sts 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 appropriat e).  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 se parates 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 supplie r’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 vege table protein was contaminated with Salmonella
 
spp., resulting in over 177 products being recalle d (Ref. 24) and a recognition of the need for 
enhanced preventive controls for the production of  this ingredient (Ref . 23).  Industry commonly 659 
 
  uses finished product testing to verify preven tive controls used by the facility and by the 
facility’s suppliers. Additionall y, it is common for customers to  require suppliers to conduct 
testing of products and ingr edients being provided.  
G. Metrics for Microbiol ogical Risk Management  
Recently there has been much attention paid to microbiological risk management metrics 
for verifying that food safety systems achieve a sp ecified 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 “Princip les and Guidelines for 
the Conduct of Microbiological Risk Management  (MRM)” (Ref. 245).  These metrics include 
traditional metrics such as microbiological criter ia, process criteria, and product criteria and 
emerging metrics such as food safety objectives  (FSO), performance objectives and performance 
criteria. Of particular releva nce 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 f ood chain before the time of consumption that 
provides or contribut es 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 f ood that must be achieved by the 
application of one or more cont rol measures to provide or cont ribute to a performance objective 
or an FSO (Ref. 119).  FDA established a perfor mance 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 Standa rds) requires the Secretary 
to determine the most significant foodborne cont aminants and issue contaminant-specific and 
science-based guidance documents, including gu idance documents regard ing action levels, or 660 
 
  regulations for products or product classes. The proposed rule that is the subject of this document 
would not establish criteria or metrics for verifyin g 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 A pproval 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 severa l years, thousands of food products have been recalled as a result 
of contamination of raw mate rials or ingredients with pathogens such as Salmonella
 spp. and E. 
coli O157:H7.  The ingredients included peanut -derived ingredients (Ref. 19) (Ref. 20),  
pistachio-derived ingredients (Ref . 152), instant nonfat dried milk, whey protein, fruit stabilizers 
(Ref. 21) Ref. 22) (Ref. 155) and hydr olyzed vegetable protein (Ref. 153).  
The incident involving Salmonella  spp. in hydrolyzed vegetabl e protein illustrates the 
impact one supplier can have on the food industry (Ref. 60).  A r eceiving facility (manufacturer) 
detected Salmonella  spp. in verification testing of finished  product. In determining the source of 
the contamination, the manuf acturer detected Salmonella  spp. in samples of a hydrolyzed 
vegetable protein ingredient and reported the finding th rough FDA’s RFR.  After FDA 
determined that the ingredient was a reportabl e food, FDA requested that the supplier notify the 
immediate subsequent recipients of the reported hydrolyzed vegetable prot ein 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.  Th e 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).   661 
 
  FDA recently reviewed CGMP-related food r ecall information from 2008-2009 to assess 
potential root causes for the contamination even ts. We determined that 36.9 percent of the 960 
Class I and Class II recalls were di rectly linked to lack of supplier controls (Ref. 59).  The recent 
large recalls of foods containi ng 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 anothe r product (Ref. 20) (Ref. 24) (Ref. 22) .  The application of preventive 
approaches by the entire supply chain (including ingredient vendors, brok ers 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 ve rification program is part of a preventive 
approach. Because many facilities acting as supplie rs procure their raw materials and ingredients 
from other suppliers, there is ofte n a chain of suppliers before a ra w material or other ingredient 
reaches the manufacturer/processor.  To ensu re safe food and minimize the potential for 
contaminated food to reach the consumer, each s upplier 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 material s or ingredients from a supplier 
must ensure that the supplier (or a supplier to the supplier) has implemente d 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 ingredie nt 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 662 
 
  appropriate programs in place, including those re lated to the safety of the raw materials and 
ingredients. A supplier approval program can ensu re a methodical approach to identifying such 
suppliers.  A supplier verification program provi des initial and ongoing assu rance that suppliers 
are complying with practices to achieve adequa te control of hazards in raw materials or 
ingredients.  
Supplier approval and verificati on is widely accepted in the domestic and international 
food safety community.  The NACMCF HACCP guide lines 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 A ssociation 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, re commends that all suppliers in the food chain 
consider approval programs for th eir own suppliers; such supplier approval programs consist of a 
collection of appropriate programs, specificati ons, policies, and procedures (Ref. 246). GMA 
recommends a number of verification activities th at suppliers can take in its Food Supply Chain 
Handbook, including self-auditing, third-party auditing and product testing. GMA’s handbook 
also references verification act ivities that a supplier’s custom ers might take, including second-
party audits (done by an employee of the cu stomer) or third-part y (independent) audits 
(conducted by persons who do not work for either th e supplier or the custom er).  Codex specifies 
that no raw material or ingred ient should be accepted by an establishment if it is known to 
contain parasites, undesirable microorganisms, pes ticides, veterinary drugs or toxic, decomposed 
or extraneous substances which would not be reduced to an acceptable level by normal sorting 663 
 
  and/ or processing (Ref. 44). Code x also specifies that, where a ppropriate, specifications for raw 
materials should be identified a nd applied and that, where necessa ry, laboratory tests should be 
made to establish fitne ss for use (Ref. 44).   
Supplier verification activities include audi ting a supplier to ensure the supplier is 
complying with applicable food safety requiremen ts, such as CGMP requirements of current part 
110. Audit activities may include a range of act ivities, such as on-site examinations of 
establishments, review of records, review of quality assurance systems, and examination or 
laboratory testing of product sa mples (Ref. 248).  Other supplier verification activities include 
conducting testing or requiring s upplier 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 requiri ng, as a condition of doing business, that their 
suppliers, both foreign and dome stic, become certified as meeting safety (as well as other) 
standards. In addition, domestic and foreign supp liers (such as producers,  co-manufacturers, or 
re-packers) are increasingly l ooking to third-party cer tification programs to assist them in 
meeting U.S. regulatory requirements (Ref. 248). There are many established third-party 
certification programs designed fo r various reasons that are cu rrently being used by industry. 
Many third party audit schemes used to assess the industry’s food safety management systems 
incorporate requirements for manufacturers a nd processors to esta blish 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 deliv ering equivalence and convergence between 664 
 
  effective food safety management systems a nd managing cost in the global food system by 
eliminating redundancy and improving operational e fficiency (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 recogni tion, the requirements 
to be put in place for a food safety scheme s eeking recognition by GFSI, and the key elements 
for production of safe food or feed, or for servi ce provision (e.g., contract sanitation services or 
food transportation) in relation to food safe ty (Ref. 249). This benchmark document has 
provisions relevant to supplier approval and verifi cation programs.  For example, it specifies that 
a food safety standard must require that the or ganization control purchasi ng 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 safe ty standard must require that the organization 
establish, implement, and maintain procedur es 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 re quirements.  The GFSI guidance document also 
requires audit scheme owners to have a clea rly 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 doe s not have details about  how facilities should 
comply with the elements.  This type of inform ation is found in the food safety schemes that are 
the basis for certification programs. For exam ple, the Safe Quality Food (SQF) 2000 Code, a 665 
 
  HACCP-based supplier assurance code for the f ood industry, specifies th at raw materials and 
services that impact on finished product safe ty 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 impl emented, and that a register of Approved 
Suppliers and records of inspec tions and audits of Approved S uppliers be maintained. SQF 2000 
requires that the Approved Supp lier Program contain, among other items, agreed specifications; 
methods for granting Approved Supplier status; me thods and frequency of monitoring Approved 
Suppliers; and details of certificat es of analysis if required.  
According to SQF, the monitoring of Approve d 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 .) 666 
 
  1.  National Advisory Committee on Microb iological Criteria for Foods, "Hazard 
Analysis and Critical Control Point Principles and Application Guidelin es," Journal of Food 
Protection , 61:1246-1259, 1998. 
2.  Codex Alimentarius Commission, "Pri nciples for the Establishment and 
Application of Microbiol ogical Criteria for Foods, CAC/GL 21 - 1997," 1997. 
3.  International Commission on Microb iological Specifications for Foods, 
"Microbiological Hazards and Th eir Control," 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, a nd M. B. Cole, New York, Chapter 1, pp. 1-21, 
Kluwer Academic / Plenum Publishers, 2002. 
4.  International Commission on Microb iological 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, a nd 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 Pean ut-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. 667 
 
  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: Mi nimizing 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 Pr actices to Minimize Salmonella  Contamination and Growth," 
Food Protection Trends , 29:435-445, 2009. 
10.  California Department of Public H ealth, "Union International Food Company 
Recall Widened Again," ( http://www.cdph.ca.gov/Pages/NR2009-23.aspx ), April 4, 2009. 
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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 Reportabl e Food Registry: A New Approach to 
Targeting Inspection Resources and Identifying Patterns of A dulteration. First Annual Report: 
September 8, 2009 - September 7, 2010," (http://www.fda.gov/downloads /Food/FoodSafety/FoodSaf etyPrograms/RFR/UCM240647.pdf
), 
January, 2011. Accessed a nd printed on August 29, 2011. 668 
 
  14.  FDA and USDA, "Listeria monocytogenes  Risk Assessment: VII. Interpretation 
and Conclusions," (http://www.fda.gov/Food/Scienc eResearch/ResearchAreas/Ris kAssessmentSafetyAssessment/u
cm185289.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 Microb iological Specifications for Foods, 
"Sampling to Assess Control of the Envir onment," 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 Post-Processi ng 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 Li steria monocytogenes  in 
Food Industry Equipment and Premises," In ternational 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. 669 
 
  22.  CDC, "Foodborne Outbreak Onlin e Database (FOOD). Search Results 
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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 Onlin e Database (FOOD). Search Results 
Highlighted for 2006-2007 Salmonella  Tennessee Outbreak in P eanut 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/Maj orProductRecalls/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/Maj orProductRecalls/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. Meye r, 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. 670 
 
  Tauxe, I. T. Williams, and C. Barton Behravesh, "Salmonella  Typhimurium Infections 
Associated with Peanut Products,"  New England Jour nal of Medicine , 365:601-610, 2011. 
30.  FDA, "Amended Form 483 (Inspectional Ob servations) for Peanut Corporation of 
America, Blakely, GA, 02/05/2009," (http://www.fda.gov/downloads/AboutFDA/Cent ersOffices/ORA/ORAEl ectronicReadingRoom/
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/Cent ersOffices/ORA/ORAEl ectronicReadingRoom/
UCM114852.pdf ), February 26, 2009. Accessed and printed on October 17, 2011. 
32.  CDC, "Foodborne Outbreak Onlin e Database (FOOD). Search Results 
Highlighted for 2008 Salmonella  Typhimurium Outbreak in Pea nut 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 I nvestigating; No Link to Human Illnesses at This Time," 
(http://www.fda.gov/NewsEvents/N ewsroom/PressAnnouncements/ucm169471.htm ), June 28, 
2009. Accessed and printed on September 9, 2011. 
34.  FDA, "FDA Form 483 (Inspectional Obse rvations) for Plainview Milk Products 
Cooperative," (http://www.fda.gov/downloads/AboutFDA/Cent ersOffices/ORA/ORAEl ectronicReadingRoom/
UCM173030.pdf ), July 15, 2009. Accessed and printed on September 9, 2011. 671 
 
  35.  FDA, "Peanut Butter and Other Pea nut Containing Products Recall List," 
(http://www.accessdata.fda.gov/scri pts/peanutbutterrecall/index.cfm ), October 28, 2009. 
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36.  Jackson, K. A., M. Biggerstaff, M. Tobin- D'Angelo, D. Sweat, R. Klos, J. Nosari, 
O. Garrison, E. Boothe, L. Saathoff-Huber, L. Hainstock, and R. P. Fagan, "Multistate Outbreak 
of Listeria monocytogenes  Associated with Mexican-Style Ch eese Made from Pasteurized Milk 
Among Pregnant, Hispanic Women,"  Journal of Food Protection , 74:949-953, 2011. 
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, 
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38.  FDA, "FDA Form 483 (Inspectional Ob servations) for Sangar Fresh Cut Produce 
Co., LLC," (http://www.fda.gov/downloads/AboutFDA/Cent ersOffices/ORA/ORAEl ectronicReadingRoom/
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39.  FDA, "FDA Lab Results Positive for Listeria  at SanGar Fresh Produce," 
(http://www.fda.gov/Food/FoodSafety/Product-
SpecificInformation/FruitsVe getablesJuices/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/FoodSaf ety/CORENetwork/ucm272372.htm ), January 9, 2012. 
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  41.  CDC, "Multistate Outbreak of Listeriosis Linked to Whole Cantaloupes from 
Jensen Farms, Colorado," ( http://www.cdc.gov/listeria/outbr eaks/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/Scienc eResearch/ResearchAreas/Ris kAssessmentSafetyAssessment/u
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43.  Lyytikäinen, O., T. Autio, R. Maija la, P. Ruutu, T. Honkanen-Buzalski, M. 
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Butter in Finland," Journa l of Infectious Diseases , 181:1838-1841, 2000. 
44.  Fretz, R., J. Pichler, U. Sagel, P. Muc h, W. Ruppitsch, A. T. Pietzka, A. Stoeger, 
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2009-2010," Eurosurveillance , 15:2, 2010. 
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on October 26, 2011. 
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Health Risk," ( http://www.fda.gov/Safety/Recalls/ucm272268.htm ), September 16, 2010. 
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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/Safe ty/Recalls/ucm271686.htm
), September 13, 2011. Accessed and printed 
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Hinds, L. Post, L. Smoot, S. Hood, J. Shebuski, and J. Banks, "Control of Salmonella  in Low-
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to the Questions Posed by FSIS Regarding Performa nce Standards with Particular Reference to 
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218-219, Springer, 2011. 
73.  International Commission on Microbiol ogical Specifications for Foods, "Spice, 
Dry Soups and Asian Flavorings,"  In: Microorganisms in Food s 8. Use of Data for Assessing 
Process Control and Product Acceptance , edited by K. M. J. Swanson, R. L. Buchanan, M. B. 
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York, Chapter 14, pp. 199, Springer, 2011. 
74.  International Commission on Microbiol ogical Specifications for Foods, "Cereal 
and Cereal Products," In: Microorganisms in Fo ods 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, 677 
 
  R. S. Flowers, L. G. M. Gorris, M. H. Tani waki, and R. B. Tompkin, New York, Chapter 15, pp. 
216, Springer, 2011. 
75.  International Commission on Microbiol ogical Specifications for Foods, "Nuts, 
Oilseeds, Dried Legumes and Coffee," In: Microorganisms in Foods 8. Use of Data for 
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[FR Doc. 2013-00125 Filed 01/04/2013 at 11: 15 am; Publication Date: 01/16/2013]