Document ID: FDA-2002-N-0153-0133
Agency: fda
Document Type: Rule
Title: Establishment, Maintenance, and Availability of Records: Amendment to
Record Availability Requirements
Posted Date: 2014-04-04T04:00Z

[Federal Register Volume 79, Number 65 (Friday, April 4, 2014)]
[Rules and Regulations]
[Pages 18799-18802]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07550]

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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: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final 
regulation that adopts, without change, the interim final rule (IFR) 
entitled ``Establishment, Maintenance, and Availability of Records: 
Amendment to Record Availability Requirements.'' This final rule 
affirms the IFR's change to FDA's records access as required by the FDA 
Food Safety Modernization Act (FSMA). Prior to the passage of FSMA, the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) provided the 
Secretary (by delegation FDA) with access to records relating to food 
that

[[Page 18800]]

FDA reasonably believes to be adulterated and presents a threat of 
serious adverse health consequences or death to humans or animals. The 
FSMA amendment expands FDA's former records access authority beyond 
records relating to the specific suspect article of food to include 
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 permits FDA to access 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 final rule does not make any changes to the 
regulatory requirements established by the IFR. The final regulation 
also responds to comments submitted in response to the request for 
comments in the IFR.

DATES: This final rule is effective April 4, 2014.

FOR FURTHER INFORMATION CONTACT: William A. Correll, Jr., Office of 
Compliance, 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

    Each year about 48 million people (1 in 6 Americans) get sick from 
foodborne diseases, 128,000 are hospitalized, and 3,000 die, according 
to 2011 data from the Centers for Disease Control and Prevention 
(http://www.cdc.gov/foodborneburden/2011-foodborne-estimates.html). 
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 amended 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). Prior to the passage of FSMA, 
section 414(a) of the FD&C Act provided the Secretary (by delegation 
FDA) with access to records relating to food that FDA reasonably 
believes to be adulterated and presents a threat of serious adverse 
health consequences or death to humans or animals. As amended by FSMA, 
section 414(a)(1) of the FD&C Act expands FDA's access to records 
beyond records relating to the specific suspect article of food to 
include records relating to any other article of food that FDA 
reasonably believes is likely to be affected in a similar manner. In 
addition, FDA can now, under section 414(a)(2) of the FD&C Act, 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. Section 414(a)(1) and (2) of the FD&C Act both 
provide 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 [(the suspect food)] shall . . . permit such 
officer or employee . . . at reasonable times and within reasonable 
limits and in a reasonable manner, 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. 
. .'' The designated officer or employee shall have access to such 
records upon presentation of the appropriate credentials and a written 
notice to such person. FDA shall have access to the records 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 under section 414(a)(1) or whether there is a 
reasonable probability that use or exposure to the food will cause 
serious adverse health consequences or death to humans or animals under 
section 414(a)(2).
    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).
    On February 23, 2012, FDA issued an IFR (77 FR 10658) that 
implemented section 101 of FSMA by amending the relevant requirements 
in FDA's regulation on the establishment, maintenance, and availability 
of records and also contained a request for comments. The IFR became 
effective on March 1, 2012. This final rule adopts, without making any 
changes, the regulatory requirements established in the IFR.
    To the extent that 5 U.S.C. 553 applies to this action, the 
Agency's implementation of this action with immediate effective date 
comes within the good cause exception in 5 U.S.C. 553(d)(3) (21 CFR 
10.40(c)(4)(ii)). As this final rule imposes no new regulatory 
requirements, a delayed effective date is unnecessary.

II. Comments on the IFR

    FDA received two responsive comments to the IFR. After considering 
these comments, the Agency is not making any changes to the regulatory 
language included in the IFR. Relevant portions of the responsive 
comments are summarized and responded to in this document. The Agency 
did not consider nonresponsive comments in developing this final rule. 
To make it easier to identify comments and FDA's responses, the word 
``Comment,'' in parentheses, appears before the comment's description, 
and the word ``Response,'' in parentheses, appears before FDA's 
response. Each comment is numbered to help distinguish between 
different comments. The number assigned to each comment is purely for 
organizational purposes and does not signify the comment's value or 
importance.
    (Comment 1) Comments requested that the Agency clarify the meaning 
of the new records access authority in section 414(a) of the FD&C Act, 
and in particular, the phrases ``reasonably believes is likely to be 
affected in a similar manner'' and ``reasonable probability that the 
use of or exposure to an article of food will cause serious adverse 
health consequences or death.''
    (Response) As stated in the IFR (77 FR 10658 at 10659), decisions 
regarding whether FDA ``reasonably believes [a food] is likely to be 
affected in a similar manner'' to cause serious adverse health 
consequences or death to humans or

[[Page 18801]]

animals and whether there is a ``reasonable probability that the use of 
or exposure to an article of food will cause serious adverse health 
consequences or death'' will be made on a case-by-case basis because 
such decisions are fact-specific. The Agency will consider the 
individual facts in each particular situation to inform its decisions. 
Because such decisions are fact-specific, FDA has not, therefore, 
amended the regulation to provide additional explanation of the records 
access authority.
    (Comment 2) FDA received a comment asking that we address all 
costs, such as large costs (e.g., updating a records system), small 
costs (e.g., copying records), and cumulative costs (e.g., reassigning 
personnel from their normal activities in order to respond to a records 
access request from FDA), associated with providing FDA access to 
records, as these costs can be debilitating to small businesses.
    (Response) FDA does not expect firms to incur any large costs 
associated with this rule because, as stated in the IFR, this rule only 
affects FDA's records access and does not impose any new record 
maintenance requirements. Further, this rule only affects FDA's access 
to already existing records and as such, it neither requires firms to 
change or upgrade their current records management systems or 
procedures, nor does it require firms to make new records.
    Also, as stated in the economic impact analysis of the IFR, 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 (77 FR 10658 at 10661). Retrieval 
costs would include the time and opportunity costs of reassigning 
personnel from normal activities to retrieve, copy, or print records 
and can also include the costs of copying or printing equipment. 
However, the costs of retrieving one or more additional record from any 
number of records or the opportunity costs of reassigning personnel 
from regular duties to retrieve additional records in response to a 
records access request are considered part of a firm's private costs 
for planning for a records access request. These costs are determined 
by a firm's business plan. This business plan will vary by firm as each 
firm has its own policy on preparing for and responding to FDA records 
requests. Any potential changes to the business plan that a firm may 
make as a result of this rule are driven by internal firm decisions and 
thus, are not factored into the overall cost of the rule.
    Consequently, any potential costs to businesses from this rule in 
general and in terms of retrieving more records than under the final 
regulation on the establishment, maintenance, and availability of 
records, published in 2004 (69 FR 71562; December 9, 2004) are still 
expected to be small.

III. Executive Order 12866 and Executive Order 13563: Cost Benefit 
Analysis

    FDA has examined the impacts of this final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). Executive Order 13563 emphasizes the importance of quantifying 
both costs and benefits, of reducing costs, of harmonizing rules, and 
of promoting flexibility. OMB has determined that this is a significant 
regulatory action as defined by the Executive Orders.
    The Regulatory Flexibility Act requires Agencies to determine 
whether a final rule will have a significant impact on small entities 
when an Agency issues a final rule ``after being required . . . to 
publish a general notice of proposed rulemaking.'' Although we are not 
required to perform a regulatory flexibility analysis because we were 
not required to publish a proposed rule prior to this final rule, we 
have nonetheless conducted a regulatory flexibility analysis for this 
final rule. Because the additional costs per entity of this rule are 
negligible if any, the Agency also concludes that this final rule 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 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 $141 million, using the most current (2012) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.
    In 2003, FDA analyzed the economic impact of the proposed rule to 
require the establishment, maintenance, and availability of records 
requirements under the Bioterrorism Act (68 FR 25188 at 25199; May 9, 
2003). The rule finalizing these requirements, published in 2004, 
contained an Economic Impact Analysis (69 FR 71562 at 71611) which 
revised the analysis set forth in the 2003 proposed rule in response to 
comments received and to account for the changes between the proposed 
and final rules.
    In 2012, FDA issued the IFR amending certain requirements in the 
regulation on the establishment, maintenance, and availability of 
records to be consistent with changes to the FD&C Act made by section 
101 of FSMA. The Economic Impact Analysis in the 2012 IFR explained and 
further revised the analysis set forth in the 2004 final rule by 
addressing the economic impact of the changes to the regulation to be 
consistent with the amendments to the FD&C Act made by section 101 of 
FSMA. This final rule adopts, without making any changes, the 
regulatory requirements established in the IFR.
    FDA did not receive any comments that would warrant further 
revising the economic analysis of the IFR. Thus, this economic analysis 
affirms the economic impact analysis of the IFR. For a full explanation 
of the economic impact analysis of this final rule, interested persons 
are directed to the text of the economic impact analyses in the IFR (77 
FR 10658 at 10660) and the 2004 final rule (69 FR 71562 at 71611).

IV. Small Entity Analysis (or Final Regulatory Flexibility Analysis)

    A regulatory flexibility analysis is required only when an Agency 
must publish a notice of proposed rulemaking (5 U.S.C. 603, 604). FDA 
published the IFR without a notice of proposed rulemaking after finding 
good cause that the use of prior notice and comment procedures would be 
contrary to the public interest. Although FDA determined that it was 
not required to publish a notice of proposed rulemaking and, therefore, 
that no regulatory flexibility analysis is required, FDA has 
nonetheless conducted such an analysis and examined the economic 
implications of this final rule on small entities. Although this final 
rule is a significant regulatory action as defined by Executive Order 
12866, FDA also concludes that this final rule will not

[[Page 18802]]

have a significant impact on a substantial number of small entities.

V. Paperwork Reduction Act of 1995

    This 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 21 CFR 1.361.

VI. Analysis of Environmental Impact

    The Agency has carefully considered the potential environmental 
effects of this action. FDA has concluded 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.

VII. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the Agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the Executive Order and, consequently, a 
federalism summary impact statement is not required.

List of Subjects in 21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, 
Reporting and recordkeeping requirements.

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
Accordingly, the interim rule amending 21 CFR part 1, which was 
published at 77 FR 10658 (February 23, 2012), is adopted as a final 
rule without change.

    Dated: April 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07550 Filed 4-3-14; 8:45 am]
BILLING CODE 4160-01-P