[Federal Register Volume 77, Number 36 (Thursday, February 23, 2012)]
[Rules and Regulations]
[Pages 10658-10662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4165]


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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.

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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.

[[Page 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:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
    <bullet> FAX: 301-827-6870.
    <bullet> 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-by-case 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

[[Page 10660]]

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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 
Sec.  1.361 in accordance with the new records access authority in 
section 414(a) of the FD&C Act, which

[[Page 10661]]

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 Sec.  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

[[Page 10662]]

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

0
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.

0
2. Section 1.361 is revised to read as follows:


Sec.  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