[Federal Register Volume 76, Number 87 (Thursday, May 5, 2011)]
[Rules and Regulations]
[Pages 25542-25545]
From the Federal Register Online via the Government Publishing 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
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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 [email protected]. 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]
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