10658 Federal Register / Vol. 77, No. 36 / Thursday, February 23, 2012 / Rules and Regulations 

determined that these final rules meet 

the criteria for a significant regulatory 

action under Executive Order 12866 as 

supplemented by Executive Order 

13563. Thus, OMB reviewed these final 

rules. 

Regulatory Flexibility Act 

We certify that these final rules will 

not have a significant economic impact 

on a substantial number of small entities 

as they affect individuals only. 

Therefore, a regulatory flexibility 

analysis is not required under the 

Regulatory Flexibility Act, as amended. 

Paperwork Reduction Act 

These rules do not create any new or 

affect any existing collections and, 

therefore, do not require OMB approval 

under the Paperwork Reduction Act. 

(Catalog of Federal Domestic Assistance 

Program Nos. 96.001, Social Security— 

Disability Insurance; 96.002, Social 

Security—Retirement Insurance; 96.004, 

Social Security—Survivors Insurance; 

96.006, Supplemental Security Income.) 

List of Subjects 

20 CFR Part 404 

Administrative practice and 

procedure; Blind, Disability benefits; 

Old-age, Survivors and disability 

insurance; Reporting and recordkeeping 

requirements; Social Security. 

20 CFR Part 416 

Administrative practice and 

procedure; Reporting and recordkeeping 

requirements; Supplemental Security 

Income (SSI). 

Michael J. Astrue, 

Commissioner of Social Security. 

For the reasons stated in the 

preamble, we are amending subpart J of 

part 404 and subpart N of part 416 of 

title 20 of the Code of Federal 

Regulations as set forth below: 

PART 404—FEDERAL OLD-AGE, 

SURVIVORS AND DISABILITY 

INSURANCE (1950– ) 

Subpart J—[Amended] 

■ 1. The authority citation for subpart J 

of part 404 continues to read as follows: 

Authority: Secs. 201(j), 204(f), 205(a), (b), 

(d)–(h), and (j), 221, 223(i), 225, and 702(a)(5) 

of the Social Security Act (42 U.S.C. 401(j), 

404(f), 405(a), (b), (d)–(h), and (j), 421, 423(i), 

425, and 902(a)(5)); sec. 5, Pub. L. 97–455, 96 

Stat. 2500 (42 U.S.C. 405 note); secs. 5, 6(c)– 

(e), and 15, Pub. L. 98–460, 98 Stat. 1802 (42 

U.S.C. 421 note); sec. 202, Pub. L. 108–203, 

118 Stat. 509 (42 U.S.C. 902 note). 

■ 2. Amend § 404.937 by revising the 

second sentence of paragraph (b)(1) to 

read as follows: 

§ 404.937 Protecting the safety of the 

public and our employees in our hearing 

process. 

* * * * * 

(b)(1) * * * The Hearing Office Chief 

Administrative Law Judge will find that 

a claimant or other individual poses a 

threat to the safety of our employees or 

other participants in the hearing when 

he or she determines that the individual 

has made a threat and there is a 

reasonable likelihood that the claimant 

or other individual could act on the 

threat or when evidence suggests that a 

claimant or other individual poses a 

threat. * * * 

* * * * * 

PART 416—SUPPLEMENTAL 

SECURITY INCOME FOR THE AGED, 

BLIND, AND DISABLED 

Subpart N—[Amended] 

■ 3. The authority citation for subpart N 

continues to read as follows: 

Authority: Secs. 702(a)(5), 1631, and 1633 

of the Social Security Act (42 U.S.C. 

902(a)(5), 1383, and 1383b); sec. 202, Pub. L. 

108–203, 118 Stat. 509 (42 U.S.C. 902 note). 

■ 4. Amend § 416.1437 by revising the 

second sentence of paragraph (b)(1) to 

read as follows: 

§ 416.1437 Protecting the safety of the 

public and our employees in our hearing 

process. 

* * * * * 

(b)(1) * * * The Hearing Office Chief 

Administrative Law Judge will find that 

a claimant or other individual poses a 

threat to the safety of our employees or 

other participants in the hearing when 

he or she determines that the individual 

has made a threat and there is a 

reasonable likelihood that the claimant 

or other individual could act on the 

threat or when evidence suggests that a 

claimant or other individual poses a 

threat. * * * 

* * * * * 

[FR Doc. 2012–4178 Filed 2–22–12; 8:45 am] 

BILLING CODE 4191–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 1 

[Docket No. FDA–2002–N–0153] (Formerly 

Docket No. 2002N–0277) 

RIN 0910–AG73 

Establishment, Maintenance, and 

Availability of Records: Amendment to 

Record Availability Requirements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Interim final rule; request for 

comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending its 

regulations on establishment, 

maintenance, and availability of 

records. FDA is issuing this interim 

final rule (IFR) to amend FDA’s 

regulation on the record availability 

requirements to implement the 

amendments to the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) made 

by the FDA Food Safety Modernization 

Act (FSMA). The FSMA amendment 

expands FDA’s former records access 

authority beyond records relating to the 

specific suspect article of food to 

records relating to any other article of 

food that the Secretary of Health and 

Human Services (the Secretary) 

reasonably believes is likely to be 

affected in a similar manner. In 

addition, the FSMA amendment permits 

FDA to access records relating to articles 

of food for which the Secretary believes 

that there is a reasonable probability 

that the use of or exposure to the article 

of food, and any other article of food 

that the Secretary reasonably believes is 

likely to be affected in a similar manner, 

will cause serious adverse health 

consequences or death to humans or 

animals. This expanded records access 

authority will further help improve 

FDA’s ability to respond to, and further 

contain threats of serious adverse health 

consequences or death to humans or 

animals. 

DATES: Effective date: This interim final 

rule is effective March 1, 2012. 

Comment date: Interested persons 

may submit either electronic or written 

comments on this interim final rule by 

May 23, 2012. 

FOR FURTHER INFORMATION CONTACT: 

William A. Correll, Jr., Office of 

Compliance (HFS–607), Center for Food 

Safety and Applied Nutrition, Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 240– 

402–1611. 


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Federal Register / Vol. 77, No. 36 / Thursday, February 23, 2012 / Rules and Regulations 10659 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2002–N– 

0153 (formerly Docket No. 2002N–0277) 

and/or Regulatory Information Number 

(RIN) 0910–AG73 by any of the 

following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the Agency name, docket 

number and RIN for this rulemaking. All 

comments received may be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Legal Background 

Each year about 48 million people (1 

in 6 Americans) get sick, 128,000 are 

hospitalized, and 3,000 die from food 

borne diseases, according to recent data 

from the Centers for Disease Control and 

Prevention (CDC) (Estimates of 

Foodborne Illness in the United States— 

CDC 2011 Estimates, available at 

http://www.cdc.gov/foodborneburden). 

This is a significant public health 

burden that is largely preventable. 

FSMA (Pub. L. 111–353), 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. 

It enables FDA to focus more on 

preventing food safety problems rather 

than relying primarily on reacting to 

problems after they occur. The law also 

provides FDA with new enforcement 

authorities to help it achieve higher 

rates of compliance with prevention and 

risk-based food safety standards and to 

better respond to and contain problems 

when they do occur. The law also gives 

FDA important new tools to better 

ensure the safety of imported foods and 

directs FDA to build an integrated 

national food safety system in 

partnership with State and local 

authorities. 

Section 101 of FSMA amends section 

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

350c(a)). Section 414 was added to the 

FD&C Act by the Public Health Security 

and Bioterrorism Preparedness and 

Response Act of 2002 (the Bioterrorism 

Act) (Pub. L. 107–188). As amended 

section 414(a) of the FD&C Act expands 

FDA’s access to records. Specifically, 

FDA’s access to records was expanded 

beyond records relating to the specific 

suspect article of food to records 

relating to any other article of food that 

the Secretary (by delegation FDA) 

reasonably believes is likely to be 

affected in a similar manner. In 

addition, FDA can now access records if 

FDA believes that there is a reasonable 

probability that the use of or exposure 

to an article of food, and any other 

article of food that FDA reasonably 

believes is likely to be affected in a 

similar manner, will cause serious 

adverse health consequences or death to 

humans or animals. Decisions regarding 

whether FDA ‘‘reasonably believes’’ a 

food is affected in a similar manner to 

cause serious adverse health 

consequences or death to humans or 

animals would be made on a case-bycase basis because such decisions are 

fact-specific. Section 414(a) of the FD&C 

Act further provides that, at the request 

of an officer or employee duly 

designated by FDA, each person 

(excluding farms and restaurants) who 

manufactures, processes, packs, 

distributes, receives, holds, or imports 

such article shall permit such officer or 

employee to have access to and copy all 

records relating to such article and any 

other article of food that FDA 

reasonably believes is likely to be 

affected in a similar manner. FDA shall 

have access to the records that are 

needed to assist FDA in determining 

whether there is a reasonable 

probability that the use of or exposure 

to the food will cause serious adverse 

health consequences or death to humans 

or animals. To gain access to these 

records, the officer or employee must 

present appropriate credentials and a 

written notice to such person, at 

reasonable times and within reasonable 

limits and in a reasonable manner. The 

Bioterrorism Act also amended section 

704(a)(1)(B) of the FD&C Act (21 U.S.C. 

374(a)(1)(B)) to include a cross-reference 

to section 414 of the FD&C Act. Section 

101 of FSMA amends this section by 

updating the cross-reference to refer to 

the amended version of section 414(a). 

The amendments made by section 101 

of FSMA to the FD&C Act were effective 

upon enactment of the law (January 4, 

2011). 

B. Brief History of Establishment, 

Maintenance, and Availability of 

Records 

Among other things, section 306(a) of 

the Bioterrorism Act amended the FD&C 

Act by adding section 414(a) to the 

FD&C Act, which provided FDA with 

the authority to access records if FDA 

has a reasonable belief that an article of 

food is adulterated and presents a threat 

of serious adverse health consequences 

or death to humans or animals, persons 

who manufacture, process, pack, 

distribute, receive, hold, or import food 

must provide access to records related 

to the food that are needed to assist FDA 

in determining whether the food is 

adulterated and presents a threat of 

serious adverse health consequences or 

death to humans or animals. The statute 

provided for such records to be 

provided under certain conditions, 

including at reasonable times. 

In addition, section 306(a) of the 

Bioterrorism Act added a new section 

414(b) to the FD&C Act that provided, 

in part, that FDA may by regulation 

establish requirements regarding 

establishment and maintenance, for not 

longer than 2 years, of records by 

persons (excluding farms and 

restaurants) who manufacture, process, 

pack, transport, distribute, receive, hold, 

or import food. The records that are 

required to be kept by these regulations 

are those needed by FDA for inspection 

to allow FDA to identify the immediate 

previous sources and immediate 

subsequent recipients of food. 

Section 306(b) of the Bioterrorism Act 

also amended section 704(a) of the 

FD&C Act to authorize FDA inspections 

of all records and other information 

described in section 414 of the FD&C 

Act, when FDA has a reasonable belief 

that an article of food is adulterated and 

presents a threat of serious adverse 

health consequences or death to humans 

or animals. 

Further, section 306(c) of the 

Bioterrorism Act amended section 301 

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

it a prohibited act to refuse to permit 

access to, or copying of, any record as 

required by section 414 or 704(a) of the 

FD&C Act; or to fail to establish or 


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10660 Federal Register / Vol. 77, No. 36 / Thursday, February 23, 2012 / Rules and Regulations 

maintain any record as required by 

section 414(b) of the FD&C Act; or to 

refuse to permit access to, or verification 

or copying of, any such required record; 

or for any person to use to his own 

advantage, or to reveal, other than to 

FDA or officers or employees of the 

Department of Health and Human 

Services, or to the courts when relevant 

in any judicial proceeding under the 

FD&C Act, any information acquired 

under authority of section 414 of the 

FD&C Act. 

In accordance with the Bioterrorism 

Act, FDA issued a proposed rule in the 

Federal Register on May 9, 2003 (68 FR 

25188) (the 2003 proposed rule), 

proposing to require the establishment 

and maintenance of records to identify 

the immediate previous sources and 

immediate subsequent recipients of food 

and the record availability 

requirements. On December 9, 2004, 

FDA issued a final rule in the Federal 

Register (69 FR 71562) (the 2004 final 

rule) specifying the requirements for the 

establishment and maintenance of 

records, including among other 

provisions the record availability 

requirements. The establishment, 

maintenance, and availability of records 

regulations have been codified at part 1, 

subpart J (21 CFR part 1, subpart J). 

The current regulation at § 1.361 

primarily tracks the language of section 

414(a) of the FD&C Act prior to the 

amendments made by FSMA. However, 

the regulation does specify the 

timeframe in which the records must be 

provided in that requested records and 

information must be made available as 

soon as possible, not to exceed 24 hours, 

from the time of receipt of an official 

request. As specified by the statute, the 

request must be from an officer or 

employee designated by the Secretary 

who presents appropriate credentials 

and a written notice. 

This IFR amends § 1.361 by replacing 

the current text with language that 

reflects the language of section 414 of 

the FD&C Act as amended by section 

101 of FSMA. This amendment 

conforms the regulation to the statute 

that is now in effect. Upon publication 

of this IFR, records requested by FDA 

under amended section 414(a)(1) and 

(a)(2) of the FD&C Act will fall within 

the scope of the availability 

requirements in the regulation. 

C. Justification for Interim Final 

Rulemaking 

In accordance with the provisions of 

the Administrative Procedure Act at 5 

U.S.C. 553(b)(3)(B) and FDA’s 

administrative practices and procedures 

regulations at § 10.40(e)(1) (21 CFR 

10.40(e)(1)), FDA finds for good cause 

that use of prior notice and comment 

procedures for issuing this IFR is 

contrary to the public interest. This IFR 

modifies § 1.361 to be consistent with 

the current statutory language in section 

414(a) of the FD&C Act and to require 

that records and other information be 

provided as soon as possible, but no 

later than 24 hours from the receipt of 

an official records request. Because 

FDA’s expanded records access 

authority was effective upon the 

enactment of FSMA, it is contrary to the 

public interest to require those members 

of the public whose records are 

requested under FDA’s expanded 

authority to produce records without 

regulations explaining how to comply 

with FDA’s new authority. Thus, in the 

interest of protecting the public health 

and eliminating any possible confusion 

about how to comply with FDA’s 

expanded authority, FDA is dispensing 

with the need for prior notice and 

comment and is issuing this IFR. 

Further, under 5 U.S.C. 553(d)(3) and 

§ 10.40(d), we find good cause to make 

this IFR effective immediately. As stated 

previously in this document, to protect 

the public health it is necessary that we 

act quickly to make the regulation at 

issue consistent with the current 

statutory provisions in order to 

eliminate any possible confusion that 

may arise during the time that the 

regulation and statute are inconsistent. 

As discussed later in this document, 

FDA invites public comment on this 

IFR. 

II. Analysis of Impacts 

FDA has examined the impacts of this 

IFR under Executive Order 12866, 

Executive Order 13563, the Regulatory 

Flexibility Act (5 U.S.C. 601–612), and 

the Unfunded Mandates Reform Act of 

1995 (Pub. L. 104–4). Executive Orders 

12866 and 13563 direct Agencies to 

assess all costs and benefits of available 

regulatory alternatives and, when 

regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). The 

Office of Management and Budget 

(OMB) has determined that this IFR is 

a significant regulatory action as defined 

by Executive Order 12866. 

The Regulatory Flexibility Act 

requires Agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because the additional costs 

per entity of this IFR are negligible if 

any, the Agency also concludes that this 

IFR will not have a significant economic 

impact on a substantial number of small 

entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4) requires that Agencies prepare a 

written statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $136 

million, using the most current (2010) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this IFR to result in any 1-year 

expenditure that would meet or exceed 

this amount. 

In the 2003 proposed rule, FDA 

analyzed the economic impact of the 

proposed rule to require the 

establishment and maintenance of 

records and record availability 

requirements under the Bioterrorism 

Act (68 FR 25188). The Economic 

Impact Analysis of the 2004 final rule 

(69 FR 71562 at 71611) revised the 

analysis set forth in the 2003 proposed 

rule in response to comments on the 

proposed rule and to account for the 

changes between the proposed and final 

rules. The Economic Impact Analysis in 

this IFR explains and further revises the 

analysis set forth in the 2004 final rule 

by addressing the economic impact of 

the amendments made by section 101 of 

FSMA. 

A. Need for Regulation 

The need for this IFR arises from 

section 101 of FSMA which expands 

FDA’s access to records beyond records 

relating to the specific suspect article of 

food to records relating to any other 

article of food that FDA reasonably 

believes is likely to be affected in a 

similar manner. In addition, the FSMA 

amendment provides FDA additional 

access to records relating to articles of 

food for which FDA believes that there 

is a reasonable probability that the use 

of or exposure to the article of food, and 

any other article of food that FDA 

reasonably believes is likely to be 

affected in a similar manner, will cause 

serious adverse health consequences or 

death to humans or animals. This 

amendment will further help the 

Agency prevent potentially harmful 

food from reaching consumers and 

thereby improve the safety of the food 

supply in the United States. This IFR 

amends the record availability 

requirements in § 1.361 in accordance 

with the new records access authority in 

section 414(a) of the FD&C Act, which 


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became effective immediately upon the 

enactment of FSMA. 

B. Costs 

FDA expects the costs related to this 

IFR to be negligible. According to the 

2004 final rule analysis, the final rule 

covered more than 1 million entities, 

and this IFR covers those same entities. 

Because, as a standard business 

practice, most firms were already 

capable of providing records access 

within 24 hours of a request, records 

access planning costs and records 

retention (which include storage and 

retrieval) costs were estimated to be zero 

in the 2004 final rule and were not 

reported in the total costs estimate. 

As this IFR only affects FDA’s 

authority to access already existing 

records, most records management 

procedures will not change. As stated in 

the 2004 final rule (69 FR 71562 at 

71635), the estimated records access 

costs are based on the private costs of 

planning for a records access request. 

The costs to plan for a records access 

request are the same under this IFR as 

they were under the 2004 final rule, 

regardless of the number of records 

requested. FDA does not estimate the 

probability of a records access request. 

To the extent that FDA would have 

access to additional records that we 

previously could not access, the 

following potential costs could be 

incurred by both FDA and businesses: 

1. Costs to FDA: Costs incurred by 

FDA could result from the additional 

time it would take to analyze records in 

order to complete an investigative visit. 

On average, records access times 

depend, in part, on how records are 

stored and maintained; average travel 

times, length of overnight stays required 

for completing an investigative visit; 

and average records analysis times. 

According to the 2004 final rule, the 

time required to analyze records 

depends on the quality of the records 

(69 FR 71562 at 71616). Potential costs 

to the Agency from this IFR in terms of 

additional time needed to analyze more 

records than under the 2004 final rule 

are expected to be small. 

2. Costs to businesses: Costs incurred 

by businesses could result from an FDA 

access request requiring them to retrieve 

a larger number of records than they 

would have otherwise retrieved under 

the current authority. Similar to the 

costs of planning for a records access 

request, the 2004 final rule estimated 

records retrieval costs are also based on 

the private costs of retrieving records 

(69 FR 71562 at 71635). This IFR does 

not require firms to make any changes 

in records retention practices beyond 

the requirement in the 2004 final rule 

(69 FR 71562 at 71654), and thus the 

marginal cost is estimated to be 

negligible. 

Since neither the FDA nor firms are 

able to predict the number of records 

requested to complete an investigation 

under the current authority or the new 

authority, additional costs to retrieve 

any number of additional records are 

estimated to be the same under this IFR 

as they were under the 2004 final rule, 

regardless of the number of records 

requested. 

FDA would use this new authority in 

a targeted fashion and it is unlikely that 

FDA would request all records from a 

suspect facility. The records FDA will 

access and copy will be focused on 

addressing the immediate needs of the 

inspection. 

To the extent that FDA requests 

access to more records than it was 

previously allowed to access under 

similar circumstances, businesses may 

incur additional retrieval costs per 

record. However, the costs of retrieving 

one or more additional records from any 

number of records still remain part of 

the private costs for records retention 

which are determined by a firm’s 

business plan. Thus, any potential costs 

to businesses from this IFR in terms of 

retrieving more records than under the 

2004 final rule are also expected to be 

small. 

C. Benefits 

In the 2004 final rule analysis, FDA 

estimated the number of illnesses 

prevented (excluding those associated 

with food security) to be approximately 

1,204 (69 FR 71562 at 71616). Averted 

illnesses in the 2004 final rule were 

attributed to having quicker access to 

records (24-hour time period) to initiate 

an investigation and also due to an 

increased ability to complete 

investigations that previously would 

have been prematurely terminated due 

to poor records quality (69 FR 71562 at 

71614). 

Similarly, the expected benefits from 

this IFR will be from minimizing 

consumer exposure to potentially 

dangerous foods. These benefits will be 

achieved by FDA having access to 

records beyond those relating only to 

the specifically suspect article of food. 

By expanding the current records access 

authority to include records relating to 

any other article of food that FDA 

reasonably believes is likely to be 

affected in a similar manner, FDA can 

now access additional information that 

can enhance FDA’s food safety efforts. 

FDA has not quantified any additional 

benefits from this IFR, but because this 

IFR enhances food safety and security 

efforts, we reason that any benefits 

resulting from this IFR are likely to be 

in addition to benefits already estimated 

in the 2004 final rule. 

III. Small Entity Analysis (or Final 

Regulatory Flexibility Analysis) 

FDA examined the economic 

implications of this IFR as required by 

the Regulatory Flexibility Act (5 U.S.C. 

601–612). If a rule has a significant 

economic impact on a substantial 

number of small entities, the Regulatory 

Flexibility Act requires us to analyze 

regulatory options that would lessen the 

economic effect of the rule on small 

entities. 

The Regulatory Flexibility Act 

requires analyzing options for regulatory 

relief for small businesses. In 

compliance with the Regulatory 

Flexibility Act this IFR will not have a 

significant impact on a substantial 

number of small businesses. 

IV. Paperwork Reduction Act of 1995 

This interim final rule contains 

information collection provisions that 

are subject to the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520). 

We conclude that these information 

collection provisions are exempt from 

OMB review under 44 U.S.C. 

3518(c)(1)(B)(ii) and 5 CFR 1320.4(a)(2) 

as collections of information obtained 

during the conduct of a civil action to 

which the United States or any official 

or agency thereof is a party, or during 

the conduct of an administrative action, 

investigation, or audit involving an 

agency against specific individuals or 

entities. The regulations in 5 CFR 

1320.3(c) provide that the exception in 

5 CFR 1320.4(a)(2) applies during the 

entire course of the investigation, audit 

or action, but only after a case file or 

equivalent is opened with respect to a 

particular party. Such a case file would 

be opened as part of the request to 

access records under § 1.361. 

V. Analysis of Environmental Impact 

The Agency has carefully considered 

the potential environmental effects of 

this action. FDA has determined under 

21 CFR 25.30(h) that this action is of a 

type that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

VI. Federalism 

FDA has analyzed this IFR in 

accordance with the principles set forth 

in Executive Order 13132. FDA has 

determined that the IFR does not 

contain policies that have substantial 

direct effects on the States, on the 


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10662 Federal Register / Vol. 77, No. 36 / Thursday, February 23, 2012 / Rules and Regulations 

relationship between the National 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Accordingly, the 

Agency concludes that the IFR does not 

contain policies that have federalism 

implications as defined in the Executive 

order and, consequently, a federalism 

summary impact statement is not 

required. 

VII. Comments 

The requirements in this IFR will be 

in effect immediately upon publication 

in the Federal Register. FDA invites 

public comment on this IFR and will 

consider modifications to it based on 

comments made during the comment 

period when FDA issues the final rule. 

FDA intends to finalize this IFR 1 year 

from the close of the comment period. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

List of Subjects in 21 CFR Part 1 

Cosmetics, Drugs, Exports, Food 

labeling, Imports, Labeling, Reporting 

and recordkeeping requirements. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 1 is 

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. 1453, 1454, 1455; 19 

U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 333, 

334, 335a, 343, 350c, 350d, 352, 355, 360b, 

362, 371, 374, 381, 382, 387, 387a, 393; 42 

U.S.C. 216, 241, 243, 262, 264. 

■ 2. Section 1.361 is revised to read as 

follows: 

§ 1.361 What are the record availability 

requirements? 

When FDA has a reasonable belief 

that an article of food, and any other 

article of food that FDA reasonably 

believes is likely to be affected in a 

similar manner, is adulterated and 

presents a threat of serious adverse 

health consequences or death to humans 

or animals, or when FDA believes that 

there is a reasonable probability that the 

use of or exposure to an article of food, 

and any other article of food that FDA 

reasonably believes is likely to be 

affected in a similar manner, will cause 

serious adverse health consequences or 

death to humans or animals, any records 

and other information accessible to FDA 

under section 414 or 704(a) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 350c and 374(a)) must be 

made readily available for inspection 

and photocopying or other means of 

reproduction. Such records and other 

information must be made available as 

soon as possible, not to exceed 24 hours 

from the time of receipt of the official 

request, from an officer or employee 

duly designated by the Secretary of 

Health and Human Services who 

presents appropriate credentials and a 

written notice. 

Dated: February 17, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4165 Filed 2–22–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 1 

[Docket No. FDA–2011–D–0598] 

Guidance for Industry: Questions and 

Answers Regarding Establishment and 

Maintenance of Records by Persons 

Who Manufacture, Process, Pack, 

Transport, Distribute, Receive, Hold, or 

Import Food (Edition 5) 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of guidance availability. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled 

‘‘Questions and Answers Regarding 

Establishment and Maintenance of 

Records by Persons Who Manufacture, 

Process, Pack, Transport, Distribute, 

Receive, Hold, or Import Food (Edition 

5).’’ This guidance provides updated 

information pertaining to the 

establishment and maintenance of 

records by persons who manufacture, 

process, pack, transport, distribute, 

receive, hold, or import food in the 

United States under the Federal Food, 

Drug, and Cosmetic Act (FD&C Act), as 

amended by the FDA Food Safety and 

Modernization Act (FSMA) of January 4, 

2011. 

DATES: February 23, 2012. Submit either 

electronic or written comments on 

Agency guidances at any time. 

ADDRESSES: Submit electronic 

comments on the guidance to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

written requests for single copies of the 

guidance to the Outreach and 

Information Center (HFS–009), Center 

for Food Safety and Applied Nutrition, 

Food and Drug Administration, 5100 

Paint Branch Pkwy., College Park, MD 

20740. Send two self-addressed 

adhesive labels to assist that office in 

processing your request. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance. 

FOR FURTHER INFORMATION CONTACT: 

William A. Correll, Jr., Center for Food 

Safety and Applied Nutrition (HFS– 

607), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740, 240–402–1611. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance entitled ‘‘Questions and 

Answers Establishment and 

Maintenance of Records by Persons 

Who Manufacture, Process, Pack, 

Transport, Distribute, Receive, Hold, or 

Import Food (Edition 5),’’ which 

replaces the fourth edition of a guidance 

of the same title issued in September 

2006. The guidance is intended for 

persons who manufacture, process, 

pack, hold, or import human or animal 

foods intended for distribution to 

consumers, institutions, or food 

processors. 

In the Federal Register of December 9, 

2004 (69 FR 71562), FDA published a 

final rule implementing sections 414 

and 704 of FD&C Act (21 U.S.C. 350c 

and 374) as amended by section 306 of 

the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002. The final rule 

requires the establishment and 

maintenance of records by persons who 

manufacture, process, pack, transport, 

distribute, receive, hold, or import food 

in the United States. Such records are to 

allow for the identification of the 

immediate previous sources and the 

immediate subsequent recipients of 

food. FSMA, signed into law on January 

4, 2011 (Pub. L. 111–353), amended 

sections 414 and 704 of the FD&C Act 

by expanding FDA’s access to records 

relating to foods that may cause serious 

adverse health consequences or death to 

humans or animals. In February 2012, 

FDA issued an interim final rule that 

revises § 1.361 (21 CFR 1.361) to reflect 

the FSMA amendments to the FD&C 


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