
[Federal Register Volume 78, Number 104 (Thursday, May 30, 2013)]
[Rules and Regulations]
[Pages 32359-32362]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-12833]



[[Page 32359]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2011-N-0179]
RIN 0910-AG65


Information Required in Prior Notice of Imported Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule 
that adopts, without change, the interim final rule (IFR) entitled 
``Information Required in Prior Notice of Imported Food'' that 
published in the Federal Register (76 FR 25542; May 5, 2011) (2011 
IFR). This final rule adopts the IFR's requirement of an additional 
element of information in a prior notice of imported food, specifically 
that a person submitting prior notice of imported food, including food 
for animals, must report the name of any country to which the article 
has been refused entry.

DATES: This rule is effective May 30, 2013.

FOR FURTHER INFORMATION CONTACT: Anthony C. Taube, Office of Regulatory 
Affairs, Office of Regional Operations, Food and Drug Administration, 
12420 Parklawn Dr., ELEM-4051, Rockville, MD 20857, 866-521-2297.

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.
    The FDA Food Safety Modernization Act (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 304 of FSMA amended section 801(m) of the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 381(m)) to require 
that additional information be provided in a prior notice of imported 
food submitted to FDA. This change requires a person submitting prior 
notice of imported food, including food for animals, to report, in 
addition to other information already required, ``any country to which 
the article has been refused entry.'' Section 304 also required the 
Secretary of Health and Human Services to 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 304 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 that implemented section 304 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.
    To the extent that 5 U.S.C. 553 applies to this action, the 
Agency's implementation of this action with an 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. Brief History of Prior Notice

    The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (the Bioterrorism Act) was signed into law on June 
12, 2002, and among other things, it amended the FD&C Act by adding 
section 801(m). This provision created the requirement that FDA receive 
certain information about imported foods before arrival in the United 
States. It also provided that an article of food imported or offered 
for import is subject to refusal of admission into the United States if 
adequate prior notice has not been provided to FDA. The Secretary of 
Health and Human Services was directed to issue implementing 
regulations, after consultation with the Secretary of the Treasury, by 
December 12, 2003, requiring prior notice of imported food.
    In accordance with the Bioterrorism Act, the Department of Health 
and Human Services (HHS) and the Department of the Treasury jointly 
published a notice of proposed rulemaking (proposed rule) in the 
Federal Register of February 3, 2003 (68 FR 5428), proposing 
requirements for submission of prior notice for human and animal food 
that is imported or offered for import into the United States. On 
October 10, 2003, HHS and the Department of Homeland Security (DHS) \1\ 
issued the prior notice IFR (2003 IFR) (68 FR 58974) (corrected by a 
technical amendment on February 2, 2004; 69 FR 4851). The 2003 IFR 
required that prior notice be submitted to FDA electronically using 
either the U.S. Customs and Border Protection (CBP) Automated Broker 
Interface of the Automated Commercial System or the FDA Prior Notice 
System Interface. The 2003 IFR also set forth the timeframes within 
which prior notice must be submitted.
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    \1\ On May 15, 2003, the Treasury Department issued Treasury 
Department Order Number No. 100-16 delegating to DHS its authority 
related to the customs revenue functions, with certain delineated 
exceptions in which the Treasury Department retained its authority. 
See Appendix to 19 CFR Part 0. The Treasury Department transferred 
to DHS its regulatory authority relating to the requirements for 
prior notices. Thus the Secretary of HHS issued the regulations 
implementing section 801(m) of the FD&C Act (21 U.S.C. 381(m)) 
jointly with the Secretary of Homeland Security. Similarly, this 
final rule is being issued jointly with the Secretary of Homeland 
Security.
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    In the Federal Register of November 7, 2008 (73 FR 66294), HHS and 
DHS published a final rule that made a number of changes to the 2003 
IFR, including changes to certain provisions containing definitions, 
submission timeframes, and the information that must be submitted in a 
prior notice. The final rule went into effect on May 6, 2009. In 
calendar year 2011, 10,537,372 prior notices were submitted, 9,054,230 
of which were submitted through the CBP system with the remaining 
1,483,142 being submitted through the FDA system.
    The prior notice regulations are codified at Title 21, Code of 
Federal Regulations (CFR) part 1, subpart I (21 CFR 1.276 to 1.285). 
Section 1.281 of the regulations (21 CFR 1.281) describes the 
information that must be submitted in a prior notice. The 2011 IFR 
amended those regulations as required by section 304 of FSMA. 
Specifically, the 2011 IFR amended paragraphs (a), (b), and (c) of 
Sec.  1.281 to require that the prior notice include the identity of 
any country to which an article of food has been refused entry. This 
final rule adopts these changes to Sec.  1.281.

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III. Comments on the Interim Final Rule

    FDA received 15 comments in response 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 these comments are 
summarized and responded to in this document. 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 among 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 requested that FDA clarify the scope 
of the term ``refused entry'' in the requirement to report in a prior 
notice the name of ``any country to which an article of food has been 
refused entry''. Many comments stated that refusals can occur for 
various reasons (e.g., labeling, noncompliance with wood packing 
materials/pallets or food safety reasons) and suggested limiting the 
reporting requirement to refusals due to food safety-related reasons. 
One comment noted that only requiring reporting of refusals associated 
with safety risks will avoid an influx of nonmission-critical data and 
enable FDA's Division of Food Defense Targeting (formerly known as the 
Prior Notice Center) to allocate its resources in a manner that is 
effective and consistent with FDA's goal to ensure the safety and 
security of the U.S. food supply.
    (Response) For purposes of this regulation, FDA considers ``refused 
entry'' to mean a refusal of entry or admission of human or animal food 
based on food safety reasons, such as intentional or unintentional 
contamination of an article of food. FDA agrees that only refusals for 
food safety reasons should be reported. This is consistent with the 
intent of the provision, which is to provide FDA with additional 
information to better identify imported food shipments that may pose a 
safety or security risk to U.S. consumers. FDA plans to explain the 
meaning of refused entry in its guidance on the prior notice rule and 
this should prevent confusion regarding the term.
    (Comment 2) Several comments suggested including information 
regarding the reason for refusal in the prior notice to facilitate and 
better inform FDA's decisionmaking process. One comment recommended the 
use of affirmation of compliance codes for various types of refusals, 
using the country identifier as the affirmation of compliance 
qualifier.
    (Response) At this time, FDA is not requiring the reason for 
refusal to be submitted along with the identity of the country. As FDA 
reviews the prior notice submission information, it may contact the 
submitter or other parties to obtain further information to assist with 
its review.
    (Comment 3) Several comments requested that FDA clarify the scope 
of the term ``article of food'' in the requirement to report in a prior 
notice the name of any country to which an ``article of food'' has been 
refused entry. In particular, comments suggested clarifying whether 
''article of food'' refers to a specific shipment of food that is the 
subject of a specific prior notice, or to food within the same lot or 
batch numbers that may be sent to other countries. Two comments 
recommended limiting the scope of the term ``article of food'' to a 
specific article of food that is the subject of a specific prior notice 
so that compliance with the rule does not create a burden on industry.
    (Response) For purposes of this regulation, FDA considers the term 
``article of food'' to refer only to the specific food item for which 
prior notice is being submitted. As such, FDA does not consider 
``article of food'' to refer to food from the same batch or lot that is 
not being imported or offered for import into the United States and for 
which prior notice will not be submitted, or to refer to food of a 
similar type that was previously refused entry by a country. As an 
example, consider a situation where some of the food from a batch or 
lot is shipped to the United States and at the same time the rest of 
the food is shipped to Country A. If Country A refuses entry, this fact 
is not submitted as part of prior notice for the portion that had been 
shipped to the United States. However, if the food that was originally 
shipped to Country A is subsequently shipped to the United States, then 
the prior notice for this shipment must include Country A as the 
country to which the article has been refused entry.
    (Comment 4) One comment suggested that FDA clearly define the term 
``any country'' as that term is used in the requirement to report in a 
prior notice the name of ``any country'' to which an article of food 
has been refused entry.
    (Response) FDA considers this term sufficiently clear and thus is 
not defining it in the regulation. For the purpose of the prior notice 
requirements and reporting the name of ``any country'' to which an 
article of food has been refused as required by 21 CFR 1.281(a)(18), 
(b)(12), and (c)(19), ``any country'' refers to the country or 
countries, including the United States, where an Agency or 
representative of the government of the country has refused entry to 
the article of food.
    (Comment 5) A few comments suggested that FDA clarify what 
documentation or verification is required to support the declaration or 
nondeclaration in a prior notice of imported food the name of any 
country to which the article of food has been refused entry.
    (Response) The prior notice regulation does not contain any 
specific requirements regarding documentation of the information 
submitted as part of prior notice. However, in some circumstances FDA 
may request documents or other information pertaining to the refusal to 
facilitate FDA's review of the prior notice. In addition, FDA may 
request such information to help inform its admissibility decisions.
    (Comment 6) One comment suggested that FDA provide clear guidance 
on the criteria being used when admissibility decisions are made about 
an article of food that has been refused entry by another country.
    (Response) FDA uses prior notice information to make decisions 
about which imported food shipments to inspect at the time of arrival. 
Currently, we target foods which, based on the information submitted 
and our further review, may pose a significant risk to public health. 
In addition, the fact that another country has refused admission can 
help inform FDA's admissibility decisions. When the article of food has 
been refused entry by another country, it may have been for a reason 
that would also constitute a violation of U.S. law. Even if it is not, 
this fact will be considered with other information in determining 
whether a product is subject to refusal of admission in the United 
States.
    (Comment 7) Two comments expressed the importance of ensuring that 
the new regulations do not become a barrier to trade.
    (Response) The comments did not assert that the new requirement is 
a barrier to trade, and FDA believes it is consistent with the 
obligations of the United States under applicable trade agreements.
    (Comment 8) One comment stated that it is unreasonable to hold 
importers liable for what could later be found to be a false 
declaration because importers or their agents, through no fault of 
their

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own, may be unaware the article of food had been refused entry by a 
country.
    (Response) Per Sec.  1.278, prior notice must be submitted by a 
person with knowledge of the required information. When there is a 
violation of the prior notice regulations, FDA will look at the 
totality of the circumstances in determining whether and how to enforce 
the violation. FDA has guidance on enforcing the requirements for 
submitting prior notice, contained in a compliance policy guide 
entitled ``Sec. 110.310 Prior Notice of Imported Food Under the Public 
Health Security and Bioterrorism Preparedness and Response Act of 
2002'' (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/FoodDefense/ucm153055.htm). It 
explains, for example, that ``FDA and CBP's strategy for enforcing 
violations of [prior notice] is to take into account the severity of 
the violations, whether they are flagrant, and whether the person has 
had previous violations, particularly if they were similar types of 
violations''.

IV. Executive Orders 12866 and 13563: Cost Benefit Analysis

    FDA has examined the impacts of this final rule under Executive 
Orders 12866 and 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 not 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 costs per entity of this rule are small, 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 (Pub. L. 
104-4) requires that Agencies prepare a written statement, which 
includes an assessment of anticipated costs and benefits, before 
proposing ``any rule that includes any Federal mandate that may result 
in the expenditure by State, local, and tribal governments, in the 
aggregate, or by the private sector, of $100,000,000 or more (adjusted 
annually for inflation) in any one year.'' The current threshold after 
adjustment for inflation is $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.
    Section 304 of FSMA requires a person submitting prior notice of 
imported food, including food for animals, to report the name of any 
country to which the article has been refused entry. The 2011 IFR 
implemented section 304 of FSMA by amending the prior notice regulation 
that had been in effect. This final rule adopts, without making any 
changes, the regulatory requirements established in the IFR.
    In the 2003 IFR, FDA analyzed the economic impact of the 
requirements for submitting prior notice for human and animal food that 
is imported or offered for import into the United States. The Economic 
Impact Analysis of the 2008 final rule (73 FR 66294 at 66386) revised 
the analysis set forth in the 2003 IFR using new data and explained the 
marginal benefits and costs of the final rule itself, relative to the 
2003 IFR.
    Based on the analysis set forth in the 2008 final rule, the 
Economic Impact Analysis of the 2011 IFR estimated the marginal 
benefits and costs of the new statutory requirement in section 304 of 
FSMA. The 2011 analysis explained that any additional costs are from 
the additional time it will take submitters to read and enter the new 
information. The time needed for reading or entering new information 
was estimated as the average between 7 and 108 seconds per entry or 58 
seconds (on average) per entry. Since the additional time required to 
provide the new information is a small fraction of the variation in 
time it can take to complete the prior notice for an entry, the 
marginal cost for the additional 58 seconds (on average) that it would 
take to provide the additional information would be negligible.
    The 2011 analysis did not quantify potential benefits from the 2011 
IFR. However, potential benefits can result from FDA's ability to use 
the additional information to better identify imported food shipments 
that may pose a safety or security risk to U.S. consumers. Personnel at 
the Division of Food Defense Targeting (formerly known as the Prior 
Notice Center) decide on a case-by-case basis whether the article of 
food needs to be held for examination upon arrival at the port. Having 
notice of an article of food imported or offered for import into the 
United States before it reaches a U.S. port allows FDA personnel to be 
ready at any time to respond to shipments that appear to pose a 
significant health risk to humans or animals.
    FDA did not receive any comments that would warrant further 
revising the economic analysis of the 2011 IFR. Thus, this economic 
analysis confirms the economic impact analysis of the 2011 IFR. For a 
full explanation of the economic impact analysis of this final rule, 
interested persons are directed to the text of the 2011 (76 FR 25542 at 
25543) and the 2008 (73 FR 66294 at 66386) economic impact analyses.

V. Small Entity Analysis

    A regulatory flexibility analysis is required only when the Agency 
must publish a notice of proposed rulemaking (5 U.S.C. 603, 604). 
Section 304 of FSMA directed us to issue an IFR implementing that 
statutory provision, and FDA published the 2011 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. FDA concludes that this final rule 
will not have a significant impact on a substantial number of small 
businesses.

VI. Paperwork Reduction Act of 1995

    This final rule contains information collection requirements that 
are subject to review by OMB under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501-3520). The collections of information in Sec.  1.281 
have been submitted to OMB for review as required by section 3507(d) of 
the Paperwork Reduction Act of 1995. The requirements were approved and 
assigned OMB control number 0910-0683. This approval expires April 30, 
2014. An Agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number.

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    FDA did not receive comments that would affect the Paperwork 
Reduction Act burden estimates made in the 2011 IFR (76 FR 25542 at 
25544). Therefore the estimated Paperwork Reduction Act burden for this 
final rule is the same as the estimated burden in the 2011 IFR.

VII. 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.

VIII. 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 76 FR 25542 on May 5, 2011, is adopted as a final rule 
without change.

    Dated: May 22, 2013.
Kathleen Sebelius,
Secretary of Health and Human Services.
    Dated: May 22, 2013.
Janet Napolitano,
Secretary of Homeland Security.
[FR Doc. 2013-12833 Filed 5-29-13; 8:45 am]
BILLING CODE 4160-01-P


