[Federal Register Volume 77, Number 36 (Thursday, February 23, 2012)]
[Rules and Regulations]
[Pages 10658-10662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4165]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1
[Docket No. FDA-2002-N-0153] (Formerly Docket No. 2002N-0277)
RIN 0910-AG73
Establishment, Maintenance, and Availability of Records:
Amendment to Record Availability Requirements
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 establishment, maintenance, and availability of records.
FDA is issuing this interim final rule (IFR) to amend FDA's regulation
on the record availability requirements to implement the amendments to
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) made by the FDA
Food Safety Modernization Act (FSMA). The FSMA amendment expands FDA's
former records access authority beyond records relating to the specific
suspect article of food to records relating to any other article of
food that the Secretary of Health and Human Services (the Secretary)
reasonably believes is likely to be affected in a similar manner. In
addition, the FSMA amendment permits FDA to access records relating to
articles of food for which the Secretary believes that there is a
reasonable probability that the use of or exposure to the article of
food, and any other article of food that the Secretary reasonably
believes is likely to be affected in a similar manner, will cause
serious adverse health consequences or death to humans or animals. This
expanded records access authority will further help improve FDA's
ability to respond to, and further contain threats of serious adverse
health consequences or death to humans or animals.
DATES: Effective date: This interim final rule is effective March 1,
2012.
Comment date: Interested persons may submit either electronic or
written comments on this interim final rule by May 23, 2012.
FOR FURTHER INFORMATION CONTACT: William A. Correll, Jr., Office of
Compliance (HFS-607), Center for Food Safety and Applied Nutrition,
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740, 240-402-1611.
[[Page 10659]]
ADDRESSES: You may submit comments, identified by Docket No. FDA-2002-
N-0153 (formerly Docket No. 2002N-0277) and/or Regulatory Information
Number (RIN) 0910-AG73 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 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, docket number and 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) get sick,
128,000 are hospitalized, and 3,000 die from food borne diseases,
according to recent data from the Centers for Disease Control and
Prevention (CDC) (Estimates of Foodborne Illness in the United States--
CDC 2011 Estimates, available at http://www.cdc.gov/foodborneburden).
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 101 of FSMA amends section 414(a) of the FD&C Act (21
U.S.C. 350c(a)). Section 414 was added to the FD&C Act by the Public
Health Security and Bioterrorism Preparedness and Response Act of 2002
(the Bioterrorism Act) (Pub. L. 107-188). As amended section 414(a) of
the FD&C Act expands FDA's access to records. Specifically, FDA's
access to records was expanded beyond records relating to the specific
suspect article of food to records relating to any other article of
food that the Secretary (by delegation FDA) reasonably believes is
likely to be affected in a similar manner. In addition, FDA can now
access records if FDA believes that there is a reasonable probability
that the use of or exposure to an article of food, and any other
article of food that FDA reasonably believes is likely to be affected
in a similar manner, will cause serious adverse health consequences or
death to humans or animals. Decisions regarding whether FDA
``reasonably believes'' a food is affected in a similar manner to cause
serious adverse health consequences or death to humans or animals would
be made on a case-by-case basis because such decisions are fact-
specific. Section 414(a) of the FD&C Act further provides that, at the
request of an officer or employee duly designated by FDA, each person
(excluding farms and restaurants) who manufactures, processes, packs,
distributes, receives, holds, or imports such article shall permit such
officer or employee to have access to and copy all records relating to
such article and any other article of food that FDA reasonably believes
is likely to be affected in a similar manner. FDA shall have access to
the records that are needed to assist FDA in determining whether there
is a reasonable probability that the use of or exposure to the food
will cause serious adverse health consequences or death to humans or
animals. To gain access to these records, the officer or employee must
present appropriate credentials and a written notice to such person, at
reasonable times and within reasonable limits and in a reasonable
manner. The Bioterrorism Act also amended section 704(a)(1)(B) of the
FD&C Act (21 U.S.C. 374(a)(1)(B)) to include a cross-reference to
section 414 of the FD&C Act. Section 101 of FSMA amends this section by
updating the cross-reference to refer to the amended version of section
414(a).
The amendments made by section 101 of FSMA to the FD&C Act were
effective upon enactment of the law (January 4, 2011).
B. Brief History of Establishment, Maintenance, and Availability of
Records
Among other things, section 306(a) of the Bioterrorism Act amended
the FD&C Act by adding section 414(a) to the FD&C Act, which provided
FDA with the authority to access records if FDA has a reasonable belief
that an article of food is adulterated and presents a threat of serious
adverse health consequences or death to humans or animals, persons who
manufacture, process, pack, distribute, receive, hold, or import food
must provide access to records related to the food that are needed to
assist FDA in determining whether the food is adulterated and presents
a threat of serious adverse health consequences or death to humans or
animals. The statute provided for such records to be provided under
certain conditions, including at reasonable times.
In addition, section 306(a) of the Bioterrorism Act added a new
section 414(b) to the FD&C Act that provided, in part, that FDA may by
regulation establish requirements regarding establishment and
maintenance, for not longer than 2 years, of records by persons
(excluding farms and restaurants) who manufacture, process, pack,
transport, distribute, receive, hold, or import food. The records that
are required to be kept by these regulations are those needed by FDA
for inspection to allow FDA to identify the immediate previous sources
and immediate subsequent recipients of food.
Section 306(b) of the Bioterrorism Act also amended section 704(a)
of the FD&C Act to authorize FDA inspections of all records and other
information described in section 414 of the FD&C Act, when FDA has a
reasonable belief that an article of food is adulterated and presents a
threat of serious adverse health consequences or death to humans or
animals.
Further, section 306(c) of the Bioterrorism Act amended section 301
of the FD&C Act (21 U.S.C. 331) to make it a prohibited act to refuse
to permit access to, or copying of, any record as required by section
414 or 704(a) of the FD&C Act; or to fail to establish or
[[Page 10660]]
maintain any record as required by section 414(b) of the FD&C Act; or
to refuse to permit access to, or verification or copying of, any such
required record; or for any person to use to his own advantage, or to
reveal, other than to FDA or officers or employees of the Department of
Health and Human Services, or to the courts when relevant in any
judicial proceeding under the FD&C Act, any information acquired under
authority of section 414 of the FD&C Act.
In accordance with the Bioterrorism Act, FDA issued a proposed rule
in the Federal Register on May 9, 2003 (68 FR 25188) (the 2003 proposed
rule), proposing to require the establishment and maintenance of
records to identify the immediate previous sources and immediate
subsequent recipients of food and the record availability requirements.
On December 9, 2004, FDA issued a final rule in the Federal Register
(69 FR 71562) (the 2004 final rule) specifying the requirements for the
establishment and maintenance of records, including among other
provisions the record availability requirements. The establishment,
maintenance, and availability of records regulations have been codified
at part 1, subpart J (21 CFR part 1, subpart J).
The current regulation at Sec. 1.361 primarily tracks the language
of section 414(a) of the FD&C Act prior to the amendments made by FSMA.
However, the regulation does specify the timeframe in which the records
must be provided in that requested records and information must be made
available as soon as possible, not to exceed 24 hours, from the time of
receipt of an official request. As specified by the statute, the
request must be from an officer or employee designated by the Secretary
who presents appropriate credentials and a written notice.
This IFR amends Sec. 1.361 by replacing the current text with
language that reflects the language of section 414 of the FD&C Act as
amended by section 101 of FSMA. This amendment conforms the regulation
to the statute that is now in effect. Upon publication of this IFR,
records requested by FDA under amended section 414(a)(1) and (a)(2) of
the FD&C Act will fall within the scope of the availability
requirements in the regulation.
C. Justification for Interim Final Rulemaking
In accordance with the provisions of the Administrative Procedure
Act at 5 U.S.C. 553(b)(3)(B) and FDA's administrative practices and
procedures regulations at Sec. 10.40(e)(1) (21 CFR 10.40(e)(1)), FDA
finds for good cause that use of prior notice and comment procedures
for issuing this IFR is contrary to the public interest. This IFR
modifies Sec. 1.361 to be consistent with the current statutory
language in section 414(a) of the FD&C Act and to require that records
and other information be provided as soon as possible, but no later
than 24 hours from the receipt of an official records request. Because
FDA's expanded records access authority was effective upon the
enactment of FSMA, it is contrary to the public interest to require
those members of the public whose records are requested under FDA's
expanded authority to produce records without regulations explaining
how to comply with FDA's new authority. Thus, in the interest of
protecting the public health and eliminating any possible confusion
about how to comply with FDA's expanded authority, FDA is dispensing
with the need for prior notice and comment and is issuing this IFR.
Further, under 5 U.S.C. 553(d)(3) and Sec. 10.40(d), we find good
cause to make this IFR effective immediately. As stated previously in
this document, to protect the public health it is necessary that we act
quickly to make the regulation at issue consistent with the current
statutory provisions in order to eliminate any possible confusion that
may arise during the time that the regulation and statute are
inconsistent. As discussed later in this document, FDA invites public
comment on this IFR.
II. Analysis of Impacts
FDA has examined the impacts of this IFR 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).
The Office of Management and Budget (OMB) has determined that this IFR
is a significant regulatory action as defined by Executive Order 12866.
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 IFR
are negligible if any, the Agency also concludes that this IFR 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 $136 million, using the most current (2010)
Implicit Price Deflator for the Gross Domestic Product. FDA does not
expect this IFR 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 require the establishment and maintenance of records
and record availability requirements under the Bioterrorism Act (68 FR
25188). The Economic Impact Analysis of the 2004 final rule (69 FR
71562 at 71611) revised the analysis set forth in the 2003 proposed
rule in response to comments on the proposed rule and to account for
the changes between the proposed and final rules. The Economic Impact
Analysis in this IFR explains and further revises the analysis set
forth in the 2004 final rule by addressing the economic impact of the
amendments made by section 101 of FSMA.
A. Need for Regulation
The need for this IFR arises from section 101 of FSMA which expands
FDA's access to records beyond records relating to the specific suspect
article of food to records relating to any other article of food that
FDA reasonably believes is likely to be affected in a similar manner.
In addition, the FSMA amendment provides FDA additional access to
records relating to articles of food for which FDA believes that there
is a reasonable probability that the use of or exposure to the article
of food, and any other article of food that FDA reasonably believes is
likely to be affected in a similar manner, will cause serious adverse
health consequences or death to humans or animals. This amendment will
further help the Agency prevent potentially harmful food from reaching
consumers and thereby improve the safety of the food supply in the
United States. This IFR amends the record availability requirements in
Sec. 1.361 in accordance with the new records access authority in
section 414(a) of the FD&C Act, which
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became effective immediately upon the enactment of FSMA.
B. Costs
FDA expects the costs related to this IFR to be negligible.
According to the 2004 final rule analysis, the final rule covered more
than 1 million entities, and this IFR covers those same entities.
Because, as a standard business practice, most firms were already
capable of providing records access within 24 hours of a request,
records access planning costs and records retention (which include
storage and retrieval) costs were estimated to be zero in the 2004
final rule and were not reported in the total costs estimate.
As this IFR only affects FDA's authority to access already existing
records, most records management procedures will not change. As stated
in the 2004 final rule (69 FR 71562 at 71635), the estimated records
access costs are based on the private costs of planning for a records
access request. The costs to plan for a records access request are the
same under this IFR as they were under the 2004 final rule, regardless
of the number of records requested. FDA does not estimate the
probability of a records access request. To the extent that FDA would
have access to additional records that we previously could not access,
the following potential costs could be incurred by both FDA and
businesses:
1. Costs to FDA: Costs incurred by FDA could result from the
additional time it would take to analyze records in order to complete
an investigative visit. On average, records access times depend, in
part, on how records are stored and maintained; average travel times,
length of overnight stays required for completing an investigative
visit; and average records analysis times. According to the 2004 final
rule, the time required to analyze records depends on the quality of
the records (69 FR 71562 at 71616). Potential costs to the Agency from
this IFR in terms of additional time needed to analyze more records
than under the 2004 final rule are expected to be small.
2. Costs to businesses: Costs incurred by businesses could result
from an FDA access request requiring them to retrieve a larger number
of records than they would have otherwise retrieved under the current
authority. Similar to the costs of planning for a records access
request, the 2004 final rule estimated records retrieval costs are also
based on the private costs of retrieving records (69 FR 71562 at
71635). This IFR does not require firms to make any changes in records
retention practices beyond the requirement in the 2004 final rule (69
FR 71562 at 71654), and thus the marginal cost is estimated to be
negligible.
Since neither the FDA nor firms are able to predict the number of
records requested to complete an investigation under the current
authority or the new authority, additional costs to retrieve any number
of additional records are estimated to be the same under this IFR as
they were under the 2004 final rule, regardless of the number of
records requested.
FDA would use this new authority in a targeted fashion and it is
unlikely that FDA would request all records from a suspect facility.
The records FDA will access and copy will be focused on addressing the
immediate needs of the inspection.
To the extent that FDA requests access to more records than it was
previously allowed to access under similar circumstances, businesses
may incur additional retrieval costs per record. However, the costs of
retrieving one or more additional records from any number of records
still remain part of the private costs for records retention which are
determined by a firm's business plan. Thus, any potential costs to
businesses from this IFR in terms of retrieving more records than under
the 2004 final rule are also expected to be small.
C. Benefits
In the 2004 final rule analysis, FDA estimated the number of
illnesses prevented (excluding those associated with food security) to
be approximately 1,204 (69 FR 71562 at 71616). Averted illnesses in the
2004 final rule were attributed to having quicker access to records
(24-hour time period) to initiate an investigation and also due to an
increased ability to complete investigations that previously would have
been prematurely terminated due to poor records quality (69 FR 71562 at
71614).
Similarly, the expected benefits from this IFR will be from
minimizing consumer exposure to potentially dangerous foods. These
benefits will be achieved by FDA having access to records beyond those
relating only to the specifically suspect article of food. By expanding
the current records access authority to include records relating to any
other article of food that FDA reasonably believes is likely to be
affected in a similar manner, FDA can now access additional information
that can enhance FDA's food safety efforts.
FDA has not quantified any additional benefits from this IFR, but
because this IFR enhances food safety and security efforts, we reason
that any benefits resulting from this IFR are likely to be in addition
to benefits already estimated in the 2004 final rule.
III. Small Entity Analysis (or Final Regulatory Flexibility Analysis)
FDA examined the economic implications of this IFR 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. In compliance with the
Regulatory Flexibility Act this IFR 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 provisions
that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C.
3501-3520).
We conclude that these information collection provisions are exempt
from OMB review under 44 U.S.C. 3518(c)(1)(B)(ii) and 5 CFR
1320.4(a)(2) as collections of information obtained during the conduct
of a civil action to which the United States or any official or agency
thereof is a party, or during the conduct of an administrative action,
investigation, or audit involving an agency against specific
individuals or entities. The regulations in 5 CFR 1320.3(c) provide
that the exception in 5 CFR 1320.4(a)(2) applies during the entire
course of the investigation, audit or action, but only after a case
file or equivalent is opened with respect to a particular party. Such a
case file would be opened as part of the request to access records
under Sec. 1.361.
V. Analysis of Environmental Impact
The Agency has carefully considered the potential environmental
effects of this action. FDA has determined 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 IFR in accordance with the principles set
forth in Executive Order 13132. FDA has determined that the IFR does
not contain policies that have substantial direct effects on the
States, on the
[[Page 10662]]
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 concludes that the IFR 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 IFR will be in effect immediately upon
publication in the Federal Register. FDA invites public comment on this
IFR and will consider modifications to it based on comments made during
the comment period when FDA issues the final rule. FDA intends to
finalize this IFR 1 year from the close of 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. 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, 333, 334, 335a, 343, 350c, 350d, 352, 355, 360b,
362, 371, 374, 381, 382, 387, 387a, 393; 42 U.S.C. 216, 241, 243,
262, 264.
0
2. Section 1.361 is revised to read as follows:
Sec. 1.361 What are the record availability requirements?
When FDA has a reasonable belief that an article of food, and any
other article of food that FDA reasonably believes is likely to be
affected in a similar manner, is adulterated and presents a threat of
serious adverse health consequences or death to humans or animals, or
when FDA believes that there is a reasonable probability that the use
of or exposure to an article of food, and any other article of food
that FDA reasonably believes is likely to be affected in a similar
manner, will cause serious adverse health consequences or death to
humans or animals, any records and other information accessible to FDA
under section 414 or 704(a) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 350c and 374(a)) must be made readily available for
inspection and photocopying or other means of reproduction. Such
records and other information must be made available as soon as
possible, not to exceed 24 hours from the time of receipt of the
official request, from an officer or employee duly designated by the
Secretary of Health and Human Services who presents appropriate
credentials and a written notice.
Dated: February 17, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-4165 Filed 2-22-12; 8:45 am]
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