
[Federal Register Volume 76, Number 87 (Thursday, May 5, 2011)]
[Rules and Regulations]
[Pages 25542-25545]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-10955]


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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: Interim final rule; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations on prior notice of imported food. As required by the FDA 
Food Safety Modernization Act, FDA is issuing this interim final rule 
to require an additional element of information in a prior notice of 
imported food. This change 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 new 
information can help FDA make better informed decisions in managing the 
potential risks of imported food into the United States.

DATES: This interim final rule is effective July 3, 2011. Interested 
persons may submit either electronic or written comments on this 
interim final rule by August 3, 2011. Submit comments on information 
collection issues under the Paperwork Reduction Act of 1995 by June 6, 
2011 (see the ``Paperwork Reduction Act of 1995'' section of this 
document (section IV of this document).

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.

ADDRESSES: You may submit comments on this interim final rule, 
identified by Docket No. FDA-2011-N-0179 and/or RIN number 0910-AG65 by 
any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name 
and docket number and Regulatory Information Number (RIN) for this 
rulemaking. All comments received may be posted without change to 
http://www.regulations.gov, including any personal information 
provided. For additional information on submitting comments, see the 
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this 
document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

SUPPLEMENTARY INFORMATION: 

I. Background

A. Legal Background

    Each year about 48 million people (1 in 6 Americans) are sickened, 
128,000 are hospitalized, and 3,000 die from food borne diseases, 
according to recent data from the Centers for Disease Control and 
Prevention. 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 amends section 801(m) of the Federal Food, 
Drug, and Cosmetic Act (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 of FSMA also requires the 
Secretary of Health and Human Services to issue an interim final rule 
implementing this statutory change no later than 120 days following the 
date of enactment of the legislation and provides that the amendment 
made by section 304 of FSMA takes effect 180 days after the date of 
enactment, which is July 3, 2011.

B. 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. Among other things, the Bioterrorism Act 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 interim

[[Page 25543]]

final rule (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 (ABI) of the 
Automated Commercial System (ACS) or the FDA Prior Notice System 
Interface (PNSI). 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 the 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 interim 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 2010, 10,116,018 prior notices were submitted, 8,570,497 
of which were submitted through the CBP system with the remaining 
1,545,521 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 describes the information that must be 
submitted in a prior notice. This interim final rule amends those 
regulations as required by section 304 of FSMA. Specifically, the 
interim final rule is amending 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.

II. Executive Orders 12866 and 13563: Cost Benefit Analysis

    FDA has examined the impacts of this interim 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. OMB has determined that this is a significant 
regulatory action as defined by the Executive Orders.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. 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 $135 million, using the most current (2009) 
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.
    The Economic Impact Analysis of the 2008 Final Rule: (1) Responded 
to comments received on the economic analysis of the 2003 IFR, (2) 
revised the analysis set forth in the 2003 IFR using new data, (3) 
presented an economic analysis of the leading alternative to the 2003 
IFR using new data, and (4) explained the marginal benefits and costs 
of the final rule itself, relative to the 2003 IFR.
    This Economic Impact Analysis further revises the analysis set 
forth in the 2008 final rule by addressing the economic impact of the 
new statutory requirement in FSMA.

A. Need for Regulation

    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. Requiring notice 
of prior refusals allows FDA to better identify imported food shipments 
that may pose safety and security risks to U.S. consumers. This 
additional knowledge can further help FDA to make better informed 
decisions in managing the potential risks of imported food shipments 
into the United States. This interim final rule implements section 304 
of FSMA by amending the rule that is already in effect.

B. Costs

    In the 2003 IFR (68 FR 58974 at 59027), FDA estimated that it takes 
1 hour on average to submit the prior notices for each import entry, 
and this estimate was not revised for the 2008 final rule. In the final 
rule (73 FR 66294 at 66386), FDA estimated that, on average, one import 
entry includes 3.6 distinct food articles or lines and thus requires 
3.6 prior notices per import entry. For the final rule the estimated 
cost of submitting prior notice was $75 per entry assuming 3.6 lines 
per entry. This estimate includes 45 minutes of an administrative 
worker's time to gather information to initially complete the prior 
notice, and then 15 minutes of a manager's time to verify that the 
information is correct.
    Additional costs associated with implementing changes in this 
interim final rule will be borne by all persons who submit prior notice 
for an article of food that is imported or offered for import into the 
United States. These costs are estimated as the additional time it will 
take for a person to gather and verify the information about whether 
the article was refused entry and to enter the information into an 
electronic system. To the extent that the information is readily 
available and verifiable, we reason that it could take as few as 7 
seconds to as many as 108 seconds per entry to do this. In 2010, FDA 
received 10,116,018 prior notices. In the 2008 economic analysis, FDA 
estimated an average of 3.6 prior notices (lines) per entry. For 
purposes of this analysis we consider 3.6 to be a likely approximation 
of the current number of lines per entry. By dividing the number of 
prior notices by the 3.6 lines per entry we estimate that there are 
currently 2.8 million imported food entries (10,116,018 divided by 
3.6). By multiplying the number of entries by the additional seconds, 
we estimate the additional number of hours to provide the additional 
information for all prior notice submitters to be an average of about 
45,000 hours per year. Table 1 of this document shows the possible 
additional time ranges that submitters may need in order to comply with 
this interim final rule. The economic impact analysis of the 2008 final 
rule estimated that the prior notice submissions for some entries (3.6 
prior notices per entry) can take more than 1 hour to complete and 
others may take less than 1 hour. The amount of time needed to complete 
the submission for an entry can reasonably vary by several minutes. As 
seen in table 1 of this document, the

[[Page 25544]]

additional average time of 58 seconds required to provide this 
information is estimated as the average of 7 and 108 seconds 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.

               Table 1--Estimated Range of Time Needed for Reading and/or Entering New Information
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                                              Calculation
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(A) Number of prior notices (lines)    A........................      10,116,018      10,116,018      10,116,018
 in 2010 *.
(B) Lines per entry **...............  B........................             3.6             3.6             3.6
(C) Food entries per year............  C = A/B..................       2,810,005       2,810,005       2,810,005
(D) Number of submitters ***.........  D........................         129,757         129,757         129,757
(E) Entries per submitter............  E = C/D..................              22              22              22
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                                                                    Lower bound       Average       Upper bound
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(F) Additional time per line           F........................               2              16              30
 (seconds).
(G) Additional time per entry          G = B x F................               7              58             108
 (seconds).
(H) Additional hours per entry.......  H = G/3,600..............           0.002           0.016           0.030
(I) Additional hours per submitter     I = H x E................            0.04            0.35            0.65
 per year.
(J) Additional hours per year for all  J = C x H................           5,620          44,960          84,300
 submitters.
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* Data from FDA Prior Notice Center.
** Based on estimate in the Federal Register of November 7, 2008 (73 FR 66294 at 66386).
*** OASIS 2010 data.

C. Benefits

    FDA's prior notice system provides us with enhanced knowledge of 
what articles of food are being imported or offered for import into the 
United States. Requiring prior notice of imported food shipments and 
defining the required data improves our ability to detect accidental 
and deliberate contamination of food and to deter deliberate 
contamination.
    Before prior notice was required, FDA received almost no advance 
notice information about food products entering the United States from 
foreign sources, or the location of the food's anticipated port of 
arrival. With the information required by prior notice, FDA does know 
what articles of food are being imported or offered for import before 
they arrive at the port. In the event of a credible threat for a 
specific product or a specific manufacturer or processor, for example, 
FDA will be able to mobilize and assist in the detention and removal of 
products that may pose a serious health threat to humans or animals.
    FDA's Prior Notice Center reviews prior notices and assesses the 
risk related to imported food shipments. FDA will be able to use the 
additional information from this interim final rule to better identify 
imported food shipments that may pose a safety or security risk to U.S. 
consumers. Personnel at 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.

III. Small Entity Analysis

    FDA examined the economic implications of this interim final rule 
as required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a 
rule has a significant economic impact on a substantial number of small 
entities, the Regulatory Flexibility Act requires us to analyze 
regulatory options that would lessen the economic effect of the rule on 
small entities.
    The Regulatory Flexibility Act requires analyzing options for 
regulatory relief for small businesses. Because the compliance costs 
are negligible, FDA finds that this interim final rule is not a 
significant regulatory action as defined by Executive Order 12866. In 
compliance with the Regulatory Flexibility Act this interim final rule 
will not have a significant impact on a substantial number of small 
businesses.

IV. Paperwork Reduction Act of 1995

    This interim final rule contains information collection 
requirements that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The title, description, and respondent description of these 
requirements are shown below with an estimate of the annual reporting 
burden. Included in the estimate is the time for reviewing 
instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing each 
collection of information.
    FDA invites comments on: (1) Whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.
    Title: Information Required in Prior Notice of Imported Food.
    Description: FDA is issuing regulations to require 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.'' Persons 
submitting prior notice will gather and verify information about 
whether the article was refused entry to any country and enter the 
information into an electronic system.
    Description of Respondents: All persons who submit prior notice for 
an article of food that is imported or offered for import into the 
United States. FDA estimated that in 2010 there were about 129,757 
prior notice submitters.
    Burden: FDA estimates the burden of this collection of information 
as follows:

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                                 Table 2--Estimated Annual Reporting Burden \1\
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                                                                                      Average
                                  Number of       Number of       Total annual      burden per
        21 CFR section           respondents    responses per      responses       response  (in    Total hours
                                                 respondent                           hours)
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1.281........................         129,757              22  2.8 million......           0.016          44,960
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The number of annual responses is equivalent to the annual number 
of entries that are submitted. In 2010, FDA received 10,116,018 prior 
notices. By dividing the number of prior notices by the average number 
of lines per entry, we estimate 2.8 million entries. By further 
dividing the number of entries by the number of respondents, we 
estimate the average annual frequency per response to be 22. We 
estimate that it would take on average about 58 seconds (0.016 hours) 
for each respondent to submit the additional information as part of 
prior notice. By multiplying the number of entries by the additional 58 
seconds, we estimate the total number of hours to provide the 
additional information to be an average of approximately 45,000 hours 
per year which also translates to about 20 minutes (0.35 hours) per 
year per respondent.
    The information collection provisions for this interim final rule 
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.
    Interested persons are requested to fax comments regarding 
information collection by June 6, 2011, to the Office of Information 
and Regulatory Affairs, OMB. To ensure that comments on the information 
collection are received, OMB recommends that written comments be faxed 
to the Office of Information and Regulatory Affairs, OMB, Attn: FDA 
Desk Officer, FAX: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All comments should be identified with the 
title, Information Required in Prior Notice of Imported Food.

V. 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.

VI. 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.

VII. Comments

    The requirements in this interim final rule will be in effect on 
July 3, 2011. FDA invites public comment on this interim final rule, 
and will consider modifications to it based on comments made during the 
comment period. Interested persons may submit to the Division of 
Dockets Management (see ADDRESSES) either electronic or written 
comments regarding this document. It is only necessary to send one set 
of comments. It is no longer necessary to send two copies of mailed 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

List of Subjects in 21 CFR Part 1

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

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
1 is amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for 21 CFR part 1 continues to read as 
follows:

    Authority: 15 U.S.C. 1453, 1454, 1455; 19 U.S.C. 1490, 1491; 21 
U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 350d, 352, 355, 
360b, 362, 371, 374, 381, 382, 393; 42 U.S.C. 216, 241, 243, 262, 
264.

0
2. Section 1.281 is amended by adding paragraphs (a)(18), (b)(12), and 
(c)(19) to read as follows:

Sec.  1.281  What information must be in a prior notice?

    (a) * * *
    (18) Any country to which the article has been refused entry.
    (b) * * *
    (12) Any country to which the article has been refused entry.
    (c) * * *
    (19) Any country to which the article has been refused entry.

    Dated: April 29, 2011.
Janet Napolitano,
Secretary of Homeland Security.
    Dated: April 29, 2011.
Kathleen Sebelius,
Secretary of Health and Human Services.
[FR Doc. 2011-10955 Filed 5-4-11; 8:45 am]
BILLING CODE 4160-01-P


