[Federal Register Volume 79, Number 65 (Friday, April 4, 2014)]
[Rules and Regulations]
[Pages 18799-18802]
From the Federal Register Online via the Government Publishing 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]
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