Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements, 18799-18802 [2014-07550]
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Final rule.
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
SUMMARY:
Food and Drug Administration
21 CFR Part 1
TKELLEY on DSK3SPTVN1PROD with RULES
[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.
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ER04AP14.029
ACTION:
ER04AP14.028
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ER04AP14.027
BILLING CODE 6717–01–P
ER04AP14.026
[FR Doc. 2014–07121 Filed 4–3–14; 8:45 am]
18799
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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 (https://www.cdc.gov/
foodborneburden/2011-foodborneestimates.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 preventionand 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
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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-
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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
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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
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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)
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18801
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
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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.
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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
Accordingly, the interim rule
amending 21 CFR part 1, which was
■
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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
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R05–OAR–2013–0646; FRL–9908–72–
Region 5]
Approval and Promulgation of Air
Quality Implementation Plans;
Michigan; PSD Rules for PM2.5
Environmental Protection
Agency (EPA).
ACTION: Direct Final Rule.
AGENCY:
The Environmental Protection
Agency (EPA) is approving revisions to
Michigan’s Prevention of Significant
Deterioration (PSD) Program rules and
definitions, including revisions to Parts
1 and 18 of Michigan’s Air Pollution
Control Rules into Michigan’s State
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rules address the Federal requirements
for significant emission levels, and
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(PM2.5). The Michigan Department of
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submitted these revisions to EPA on
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2013.
DATES: This direct final rule is effective
June 3, 2014, unless EPA receives
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informing the public that the rule will
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ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–R05–
OAR–2013–0646, by one of the
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1. www.regulations.gov: Follow the
on-line instructions for submitting
comments.
2. Email: damico.genevieve@epa.gov.
3. Fax: (312) 886–0968.
4. Mail: Genevieve Damico, Chief, Air
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(AR–18J), U.S. Environmental
Protection Agency, 77 West Jackson
Boulevard, Chicago, Illinois 60604.
5. Hand Delivery: Genevieve Damico,
Chief, Air Permits Section, Air Programs
Branch (AR–18J), U.S. Environmental
Protection Agency, 77 West Jackson
Boulevard, Chicago, Illinois 60604.
SUMMARY:
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Such deliveries are only accepted
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of operation, and special arrangements
should be made for deliveries of boxed
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Instructions: Direct your comments to
Docket ID No. EPA–R05–OAR–2013–
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received will be included in the public
docket without change and may be
made available online at
www.regulations.gov, including any
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the comment includes information
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which means EPA will not know your
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you provide it in the body of your
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Agencies
[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.
-----------------------------------------------------------------------
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
(https://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