[Federal Register Volume 78, Number 24 (Tuesday, February 5, 2013)]
[Rules and Regulations]
[Pages 7994-7997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-02497]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

RIN 0910-AG67
[Docket No. FDA-2011-N-0197]


Criteria Used To Order Administrative Detention of Food for Human 
or Animal Consumption

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 ``Criteria Used to Order Administrative Detention of Food for 
Human or Animal Consumption'' that published in the Federal Register on 
May 5, 2011, (the 2011 IFR). This final rule affirms the IFR's change 
to the criteria for ordering administrative detention of human or 
animal food as required by the FDA Food Safety Modernization Act 
(FSMA). Under the new criteria, FDA can order an administrative 
detention if there is reason to believe that an article of food is 
adulterated or misbranded. 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 February 5, 2013.

FOR FURTHER INFORMATION CONTACT: William A. Correll, Jr., Office of 
Compliance, Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-
436-1611.

SUPPLEMENTARY INFORMATION:

I. 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 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 207 of FSMA amends the criteria for ordering administrative 
detention of human or animal food in section 304(h)(1)(A) of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 
334(h)(1)(A)). Under the new criteria established by FSMA, FDA can 
order an administrative detention if there is reason to believe that an 
article of food is adulterated or misbranded. Section 207 of FSMA also 
requires that the Secretary of Health and Human Services issue an IFR 
implementing this statutory change no later than 120 days following the 
date of enactment of FSMA and further specified that the amendment made 
by section 207 take effect 180 days after the date of FSMA's January 4, 
2011, enactment, which was July 3, 2011. On May 5, 2011, FDA issued an 
IFR (76 FR 25538) that implemented section 207 of FSMA and contained a 
request for comments. The IFR became effective on July 3, 2011. This 
final rule adopts, without making any changes, the regulatory 
requirements established in the IFR.

[[Page 7995]]

    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 Interim Final Rule

    FDA received 12 responsive comments to the IFR. However, 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 parenthesis, appears before the comment's 
description, and the word ``Response,'' in parenthesis, 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) Several comments expressed support for the IFR, the 
food safety principles embodied in the new criteria for administrative 
detention, and FDA's use of this tool.
    (Response) FDA appreciates the sentiments expressed in these 
comments and intends to use this administrative tool in appropriate 
situations to temporarily hold food that the Agency has reason to 
believe is adulterated or misbranded. Administrative detention provides 
the Agency with a tool that can be used to prevent such articles of 
food from reaching the marketplace.
    (Comment 2) FDA received a number of comments requesting that the 
Agency clarify the meaning of the new criteria for ordering 
administrative detention in section 304(h)(1)(A) of the FD&C Act (21 
U.S.C. 334(h)(1)(A)), and in particular the phrase ``reason to believe 
that an article of human or animal food is adulterated or misbranded. 
''
    (Response) As stated in the IFR (76 FR 25538 at 25539), decisions 
regarding whether FDA has ``reason to believe'' that food is 
adulterated or misbranded 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 reason to 
believe that an article of food is adulterated or misbranded. Because 
such decisions are fact specific, FDA has not, therefore, amended the 
regulation to provide additional explanation of the criteria for 
ordering administrative detention.
    (Comment 3) Several comments stated that FDA should implement the 
new administrative detention criteria in a consistent, judicious way. 
Other comments stated that the Agency should restrict the use of 
administrative detention to food that significantly adversely affects 
human or animal health and that FDA would consider classifying as a 
Class 1 recall.\1\
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    \1\ See 21 CFR 7.3(m)(1) for definition of a Class I recall.
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    (Response) FDA intends to use administrative detention in a manner 
that is consistent with and furthers the prevention-based goals of FSMA 
and the Agency's public health mission. The Agency also is aware that 
the new criteria provide FDA with more flexibility in its use of 
administrative detention and intends to use this tool as appropriate. 
The Agency will also continue to use its advisory action tools, such as 
Warning Letters and untitled letters, to achieve voluntary compliance 
and voluntary corrective action to address adulteration or misbranding 
violations, as appropriate.
    (Comment 4) Several comments requested that the Agency amend the 
regulations to restrict the authority to authorize administrative 
detention to the FDA Commissioner or to the Directors of the Center for 
Food Safety and Applied Nutrition (CFSAN) or the Center for Veterinary 
Medicine (CVM). These comments stated that such a restriction was 
necessary to ensure that the new criteria for ordering administrative 
detention are applied consistently.
    (Response) FDA agrees that the new criteria for ordering 
administrative detention should be applied carefully and consistently 
when there is a reason to believe that an article of food is 
adulterated or misbranded. The Agency does not agree that the only way 
that goal can be achieved is by limiting the authority to order 
administrative detention to three Agency officials. FDA has a number of 
internal mechanisms to ensure that FDA will use administrative 
detention in a consistent manner across the District Offices. It is, 
therefore, unnecessary to change the IFR to adopt the restriction 
suggested by the comments.
    (Comment 5) Several comments emphasized the importance of 
transparency regarding administrative detention, including the need to 
simplify and streamline the process for appealing administrative 
detention orders, communicate information about the detention process 
to importers and exporters, and the suggestion that there be a contact 
person to provide such information.
    (Response) FDA agrees that it is important to be transparent 
regarding the administrative detention process and thus, the procedures 
for administrative detention, including the process for appealing and 
requesting an informal hearing on the matter, are clearly set forth in 
FDA's regulations in Title 21, Code of Federal Regulations (CFR) part 
1, subpart K and part 16. At this time, it is not necessary to make any 
changes to these procedures. The District Director of the involved FDA 
District Office serves as the contact for any administrative detention 
matter in that District Office. Additionally, FDA often makes 
information about actions taken under this authority publicly available 
through mechanisms such as press statements on enforcement actions.
    (Comment 6) Some comments noted that there could be confusion 
between the term administrative detention as used under section 304 of 
the FD&C Act and the term detention as used during the importation 
process, where a product is often referred to as detained when it 
appears the product may be subject to refusal of admission and the 
owner or consignee has been given an opportunity to present testimony 
regarding admissibility under 21 CFR 1.94.
    (Response) Given the procedural and substantive differences between 
administrative detention and detention that occurs during import 
admissibility review, confusion between the two is unlikely. Moreover, 
when the Agency gives written notice in either circumstance, it will 
make clear which type of detention is involved. For instance, FDA uses 
``Form FDA 2289 Detention Order'' for administrative detentions, 
including administrative detentions brought under section 304(h) of the 
FD&C Act. On this form FDA will clearly identify under which authority 
the administrative detention is ordered.
    (Comment 7) Two comments asked if FDA would issue a notice of 
termination of administrative detention on the same day as the decision 
is made.
    (Response) FDA intends to issue a notice of termination of 
administrative detention on the same day as the decision is made, 
whenever practicable. The Agency understands the importance of 
providing notice of a termination decision so that the article of food 
can reenter the stream of commerce in a timely manner. If FDA fails to 
issue a detention termination notice and the

[[Page 7996]]

detention period expires (a maximum of 30 days from the date the 
detention was ordered), the detention is deemed to be terminated (21 
CFR 1.384).
    (Comment 8) One comment asked the Agency to clarify which party 
will be responsible for the costs associated with an administrative 
detention (e.g., storage or moving costs) or with the disposal of the 
detained products (e.g., reconditioning, re-export, or destruction).
    (Response) As stated in its response to a comment to the 2004 
administrative detention final rule (69 FR 31660 at 31690, June 4, 
2004), the responsibility for paying the storage costs of 
administratively detained food is a matter to be resolved between the 
private parties involved. FDA is not liable for these costs. An owner, 
operator, or agent in charge of the place where the food is located can 
request modification of a detention order under 21 CFR 1.381 to allow 
the food to be moved or destroyed if they do not want to store it.

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. The Office of Management and Budget (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 $139 million, using the most current (2011) 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 issued a proposed rule on administrative detention 
(2003 proposed rule) (68 FR 25242 at 25250, May 9, 2003), in which the 
Agency analyzed the economic impact of the proposed procedures for 
administrative detention of food for human or animal consumption which 
were established to implement changes to the FD&C Act made by section 
303 of the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (Pub. L. 107-188). When FDA issued the 
administrative detention final rule in 2004 (2004 final rule) (69 FR 
31660 at 31685), the Agency revised the economic analysis set forth in 
the 2003 proposed rule. The analysis in the 2004 final rule explained 
that any costs and/or benefits of the rule can be generated only in 
those circumstances in which FDA would choose to order administrative 
detention instead of using other enforcement tools available to the 
Agency, such as requesting voluntary recall, instituting a seizure 
action, or referring the matter to State authorities. In this analysis, 
FDA noted that because administrative detention was a new enforcement 
tool, the Agency was not able to directly estimate how often it would 
be used. FDA indirectly estimated the number of potential events that 
would trigger an administrative detention as a subset of other existing 
enforcement actions at the time. The analysis assumed that FDA would 
likely choose administrative detention only if it were the most 
effective enforcement tool available in a particular situation.
    In 2011, FDA issued the IFR amending the criteria for ordering 
administrative detention. This final rule adopts, without making any 
changes, the regulatory requirements established in the IFR. The 
economic impact analysis of the IFR (76 FR 25538 at 25539) explained 
and further revised the analysis set forth in the 2004 final rule by 
addressing the economic impact of the new criteria in section 
304(h)(1)(A) of the FD&C Act.
    FDA did not receive any comments that would warrant further 
revising the economic analysis of the IFR. Thus, this economic analysis 
confirms 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 (76 FR 25538 at 25539) and the 2004 final rule (69 
FR 31660 at 31685).

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 and 604). 
Section 207 of FSMA directed us to issue an IFR implementing that 
statutory provision, and FDA published the IFR and this final rule 
without a notice of proposed rulemaking. Although FDA was not required 
to publish a notice of proposed rulemaking and, therefore, 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 have a significant impact 
on a substantial number of small businesses.

V. Paperwork Reduction Act of 1995

    FDA concludes that the requirements of this final rule are not 
subject to review by OMB because they do not constitute a ``collection 
of information'' under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3220).

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

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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 76 FR 25538 on May 5, 2011, is adopted as a final rule 
without change.

    Dated: January 31, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-02497 Filed 2-4-13; 8:45 am]
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