[Federal Register Volume 76, Number 87 (Thursday, May 5, 2011)]
[Rules and Regulations]
[Pages 25538-25542]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-10953]
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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: Interim final rule; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations on administrative detention of food for human or animal
consumption. As required by the FDA Food Safety Modernization Act
(FSMA), FDA is issuing this interim final rule to change the criteria
for ordering administrative detention of human or animal food. Under
the new criteria, FDA can order administrative detention if there is
reason to believe that an article of food is adulterated or misbranded.
This will further help FDA prevent potentially harmful food from
reaching U.S. consumers and thereby improve the safety of the U.S. food
supply.
DATES: Effective date: This interim final rule is effective July 3,
2011.
Comment date: Interested persons may submit either electronic or
written comments on this interim final rule by August 3, 2011.
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.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0197 and/or RIN number 0910-AG67, 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.
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, FDA can order administrative
detention if there is reason to believe that an article of food is
adulterated or misbranded. Decisions regarding
[[Page 25539]]
whether FDA has a ``reason to believe'' a food is adulterated or
misbranded would be made on a case by case basis because such decisions
are fact specific. Section 207 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 FSMA and provides that the amendment made by section 207 takes
effect 180 days after the date of enactment, which is July 3, 2011.
B. Brief History of Administrative Detention
The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188), was
signed into law on June 12, 2002. Among other things, the Bioterrorism
Act amended the FD&C Act by adding subsection (h) to section 304. This
provision provided FDA the authority to order the detention of any
article of food if during an inspection, examination, or investigation
an FDA officer or qualified employee finds there is credible evidence
or information indicating that the article of food presents a threat of
serious adverse health consequences or death to humans or animals. The
Bioterrorism Act also amended the FD&C Act by adding subsection (bb) to
section 301 (21 U.S.C. 331), making it a prohibited act to move an
article of food in violation of a detention order or to remove or alter
any mark or label required by a detention order that identifies an
article of food as detained.
In accordance with the Bioterrorism Act, FDA issued a notice of
proposed rulemaking (proposed rule) in the Federal Register of May 9,
2003 (68 FR 25242), proposing procedures for the administrative
detention of an article of food. In the Federal Register of June 4,
2004 (69 FR 31660), the Agency issued the final rule establishing the
procedures for administrative detention, including among other
provisions the criteria for ordering administrative detention. The
administrative detention regulations have been codified at Title 21,
Code of Federal Regulations (CFR) Part 1, Subpart K (21 CFR part 1,
subpart K). This interim final rule amends those regulations.
Specifically, the interim final rule is amending Sec. Sec. 1.378 and
1.393(a) by replacing the existing criteria used to order
administrative detention with the new criteria required by section 207
of FSMA.
II. Executive Order 12866 and Executive Order 13563: Cost Benefit
Analysis
FDA has examined the impacts of this interim final rule under
Executive Order 12866, Executive Order 13563, the Regulatory
Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform
Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct
Agencies to assess all costs and benefits of available regulatory
alternatives and, when regulation is necessary, to select regulatory
approaches that maximize net benefits (including potential economic,
environmental, public health and safety, and other advantages;
distributive impacts; and equity). Executive Order 13563 emphasizes the
importance of quantifying both costs and benefits, of reducing costs,
of harmonizing rules, and of promoting flexibility. OMB has determined
that this is a significant regulatory action as defined by the
Executive Orders.
The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. 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 $135 million, using the most current (2009) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
interim final rule to result in any 1-year expenditure that would meet
or exceed this amount.
In the 2003 proposed rule, FDA analyzed the economic impact of the
proposed rule to provide procedures for administrative detention of
food for human or animal consumption under the Bioterrorism Act (68 FR
25242 at 25250). The Economic Impact Analysis of the June 4, 2004,
final rule (69 FR 31660 at 31685) revised the analysis set forth in the
2003 proposed rule. The 2004 analysis 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 the 2004 analysis, FDA noted that
because administrative detention was a new enforcement tool, we were
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 be likely to
choose administrative detention only if it were the most effective
enforcement tool available in a particular situation.
This Economic Impact Analysis explains and further revises the
analysis set forth in the 2004 final rule by addressing the economic
impact of the new requirement in section 207 of FSMA.
A. Need for Regulation
The need for this interim final rule arises from section 207 of
FSMA which changed the criteria for ordering administrative detention
of human or animal food. The current criteria in section 304(h)(1)(A)
of the FD&C Act provide FDA the authority to order the detention of an
article of food if during an inspection, examination, or investigation,
an FDA officer or qualified employee finds there is credible evidence
or information indicating that the article of food presents a threat of
serious adverse health consequences or death to humans or animals.
Section 207 of FSMA changes the criteria to allow the Agency to order
detention if there is reason to believe that an article of food is
adulterated or misbranded. The new criteria provide FDA enhanced
authority to detain articles of food that may be adulterated or
misbranded for 20 calendar days with a possible 10 calendar day
extension if needed to initiate legal action under section 304 or 302
of the FD&C Act (21 U.S.C. 332). This authority will further help the
Agency prevent potentially harmful food from reaching U.S. consumers
and thereby improve the safety of the food supply in the United States.
This interim final rule implements section 207 of FSMA by amending 21
CFR part 1, subpart K, which is already in effect.
B. Costs
The economic impact analysis of the 2004 final rule estimated the
costs of taking administrative detention actions relative to the costs
of other
[[Page 25540]]
enforcement tools already available to FDA. Using these existing tools
FDA could do the following: (1) Request a voluntary recall of the
suspected product; (2) move directly to seize the food; or (3) refer
the matter to State authorities. The 2004 analysis explained that the
estimated number of potential events that would trigger an
administrative detention could also trigger the existing enforcement
actions. The number of actions was estimated as a range between 0 and
223 actions per year. The upper bound (223) is the sum of 184 Class I
recalls, 16 direct seizures, and 23 or 10 percent of the referrals to
State authorities in fiscal year 2002. This sum (223 actions)
represents the upper bound number of times FDA anticipated using
administrative detention, and the lower bound of 0 suggests the
possibility that FDA may not order administrative detention at all in a
given year. In the analysis FDA explained that the main costs of
administrative detention are from the potential loss of the value of
products detained that are not in fact adulterated. Although FDA did
not know the fraction of detained food products that would prove not to
be adulterated, FDA used 48 percent as an upper bound. This number
represents the fraction of imported foods that we detain and later
release. The lower bound used was 0 percent because FDA might only
administratively detain adulterated food products. The total annual
costs for the 2004 final rule were estimated to be between $0, if FDA
never orders administrative detention, and $50 million, if FDA orders
administrative detention against food products 48 percent of which are
later determined not to be adulterated.
Since the Agency has had administrative detention authority, we
have never administratively detained an article of food. Under the new
criteria, we believe that we are more likely to use administrative
detention against articles of food in situations which include, among
others, where the use of, or exposure to, a violative product may cause
temporary or medically reversible adverse health consequences or where
the probability of serious adverse health consequences is remote. These
situations are analogous to the situations for ordering Class II
recalls. FDA may choose to order administrative detention in a variety
of situations, including Class II situations, therefore FDA has used
the number of Class II recalls to estimate the costs and benefits of
this interim final rule. Chart 1 below shows the number of Class II
food recall actions reported in the last 14 years ranging from 65 to
195 (annual average of 160).
[GRAPHIC] [TIFF OMITTED] TR05MY11.127
To the extent that the changes made by this interim final rule
provide FDA enhanced enforcement abilities in addition to other
existing enforcement tools, the maximum number of times we can
reasonably expect to order administrative detention in situations
involving an article of food that meets the criteria for Class II
recalls is bounded by the highest known number of times we have ordered
a Class II recall. The highest number of Class II recall events in the
last 14 years was 195 and the lowest number was 65. However, it is
still possible that we may not use administrative detention in the
event of a Class II recall situation. Therefore we estimate that the
number of times we are likely to order administrative detention could
range between 0 and 195 times per year. Although the 2004 cost
estimates were based on the expectation that FDA would use
administrative detention no more than 223 times per year, FDA has not
used administrative detention as an enforcement tool. The upper bound
cost
[[Page 25541]]
in the 2004 analysis was over estimated and given our present
knowledge, we believe it is still likely to be an overestimate. By
changing the criteria under which we can order administrative
detention, we further reason that FDA will be more likely to order
administrative detention a number of times greater than 0 but less than
195 times during any given year. We reason that any new potential costs
attributable to this interim final rule are likely to be somewhat less
than the upper bound costs previously estimated in the 2004 analysis,
which were $50 million.
C. Benefits
The benefits of using administrative detention as a new enforcement
tool were discussed in the Economic Impact Analysis of the 2004 final
rule (68 FR 31660 at 31685) but were not definitively quantified
because it was difficult to directly estimate how often FDA would order
administrative detention of food. The primary benefits of
administrative detention as described in the 2004 analysis are the
value of the illnesses or deaths prevented because the Agency
administratively detained food suspected of being adulterated. These
benefits are generated if the following two conditions hold: (1) The
food is in fact adulterated and (2) administrative detention prevents
more illnesses or deaths than would have been prevented had we relied
on our other enforcement tools. The more often these conditions hold,
and the larger the amount of adulterated food administratively
detained, the larger the estimated benefits of the final rule. The 2004
final rule analysis also discussed that additional benefits may be
achieved in terms of deterrence to the extent that as the number of
ordered administrative detentions increases so does the likelihood that
adulterated products will not be shipped in the future. As described in
the 2004 final rule, the expected benefits from new administrative
detention authority depend upon FDA using administrative detention as
an enforcement tool. Likewise, the expected benefits from this interim
rule also depend on FDA using this authority. As mentioned in the cost
analysis section, under the new criteria, FDA may choose to order
administrative detention in a variety of situations, including Class II
situations. We also reasoned that the expected number of future
administrative detentions could increase as much as the number of Class
II situations per year, which could be as many as 195. Either way, if
FDA orders administrative detention 195 times in one year, the expected
upper bound benefits are likely to be somewhat less than those
described in the 2004 analysis as a result. At the same time, it is
still possible that FDA will not use administrative detention as an
enforcement tool in all of these situations, in which case the benefits
would likely be 0 which is the same lower bound for benefits described
in the 2004 analysis.
III. Small Entity Analysis (or Final Regulatory Flexibility 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. 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
FDA concludes that the requirements of this interim final rule are
not subject to review by the Office of Management and Budget because
they do not constitute a ``collection of information'' under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3220).
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 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 1.378 is revised to read as follows:
Sec. 1.378 What criteria does FDA use to order a detention?
An officer or qualified employee of FDA may order the detention of
any article of food that is found during an inspection, examination, or
investigation under the act if the officer or qualified employee has
reason to believe that the article of food is adulterated or
misbranded.
0
3. Section 1.393 is amended by revising paragraph (a) to read as
follows:
Sec. 1.393 What information must FDA include in the detention order?
(a) FDA must issue the detention order in writing, in the form of a
detention notice, signed and dated by the officer or qualified employee
of FDA who has reason to believe that such
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article of food is adulterated or misbranded.
* * * * *
Dated: April 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-10953 Filed 5-4-11; 8:45 am]
BILLING CODE 4160-01-P