[Federal Register Volume 79, Number 148 (Friday, August 1, 2014)]
[Notices]
[Pages 44785-44787]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-18109]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0505]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Recordkeeping and Reporting Requirements for Human
Food and Cosmetics Manufactured From, Processed With, or Otherwise
Containing Material From Cattle
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed revision of an existing collection of information, and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on the information collection provisions of existing
FDA regulations concerning FDA-regulated human food, including dietary
supplements, and cosmetics manufactured from, processed with, or
otherwise containing material derived from cattle.
DATES: Submit either electronic or written comments on the collection
of information by September 30, 2014.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, [email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed revision of an existing collection of information, before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (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.
Recordkeeping and Reporting Requirements for Human Food and Cosmetics
Manufactured From, Processed With, or Otherwise Containing Material
From Cattle--21 CFR 189.5 and 700.27 (OMB Control Number 0910-0623)--
Revision
FDA's regulations in Sec. Sec. 189.5 and 700.27 (21 CFR 189.5 and
700.27) set forth bovine spongiform encephalopathy (BSE)-related
restrictions applicable to FDA-regulated human food and cosmetics. The
regulations designate certain materials from cattle as ``prohibited
cattle materials,'' including specified risk materials (SRMs), the
small intestine of cattle not otherwise excluded from being a
prohibited cattle material, material from nonambulatory disabled
cattle, and mechanically separated (MS) beef. Sections 189.5(c) and
700.27(c) set forth the requirements for recordkeeping and records
access for FDA-regulated human food, including dietary supplements, and
cosmetics manufactured from, processed with, or otherwise containing
material derived from cattle. The FDA issued these recordkeeping
regulations under the adulteration provisions in sections 402(a)(2)(C),
(a)(3), (a)(4), (a)(5), 601(c), and 701(a) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21 U.S.C. 342(a)(2)(C), (a)(3),
(a)(4), (a)(5), 361(c), and 371(a)). Under section 701(a) of the FD&C
Act, the FDA is authorized to issue regulations for the FD&C Act's
efficient enforcement. With regard to records concerning imported human
food and cosmetics, the FDA relied on its authority under sections
701(b) and 801(a) of the FD&C Act (21 U.S.C. 371(b) and 381(a)).
Section 801(a) of the FD&C Act provides requirements with regard to
imported human food and cosmetics and provides for refusal of admission
of human food and cosmetics that appear to be adulterated into the
United States. Section 701(b) of the FD&C Act authorizes the
Secretaries of Treasury and Health and Human Services to jointly
prescribe regulations for the efficient enforcement of section 801 of
the FD&C Act.
[[Page 44786]]
These requirements are necessary because once materials are
separated from an animal it may not be possible, without records, to
know the following: (1) Whether cattle material may contain SRMs (SRMs
include brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral
column (excluding the vertebrae of the tail, the transverse processes
of the thoracic and lumbar vertebrae and the wings of the sacrum), and
dorsal root ganglia from animals less than 30 months old and tonsils
and distal ileum of the small intestine from all animals of all ages);
(2) whether the source animal for cattle material was inspected and
passed; (3) whether the source animal for cattle material was
nonambulatory disabled or MS beef; and (4) whether tallow in human food
or cosmetics contain less than 0.15 percent insoluble impurities.
FDA's regulations in Sec. Sec. 189.5(c) and 700.27(c) require
manufacturers and processors of human food and cosmetics manufactured
from, processed with, or otherwise containing material from cattle
establish and maintain records sufficient to demonstrate that the human
food or cosmetics are not manufactured from, processed with, or
otherwise containing prohibited cattle materials. These records must be
retained for 2 years at the manufacturing or processing establishment
or at a reasonably accessible location. Maintenance of electronic
records is acceptable, and electronic records are considered to be
reasonably accessible if they are accessible from an onsite location.
Records required by these sections and existing records relevant to
compliance with these sections must be available to FDA for inspection
and copying. Existing records may be used if they contain all of the
required information and are retained for the required time period.
Because FDA does not easily have access to records maintained at
foreign establishments, FDA regulations in Sec. Sec. 189.5(c)(6) and
700.27(c)(6), respectively, require that when filing for entry with
U.S. Customs and Border Protection, the importer of record of human
food or cosmetics manufactured from, processed with, or otherwise
containing cattle material must affirm that the human food or cosmetics
were manufactured from, processed with, or otherwise containing cattle
material and must affirm that the human food or cosmetics were
manufactured in accordance with the applicable requirements of
Sec. Sec. 189.5 or 700.27. In addition, if human food or cosmetics
were manufactured from, processed with, or otherwise containing cattle
material, the importer of record must provide within 5 business days
records sufficient to demonstrate that the human food or cosmetics were
not manufactured from, processed with, or otherwise containing
prohibited cattle material, if requested.
Upon review of the information collection requests supporting these
BSE-related regulations, FDA found that the burdens associated with the
requirements for recordkeeping and records access found in Sec. Sec.
189.5(c) and 700.27(c) are in use without current OMB approval. This
collection of information was previously approved by OMB under control
number 0910-0597. FDA submitted a timely information collection request
to extend the approval of 0910-0597, but the request was denied. To
most appropriately streamline this information collection and to
eliminate redundancy in information collection requests, FDA seeks to
revise the 0910-0623 collection to include the reporting and
recordkeeping elements of 0910-0597. FDA has included these elements in
the burden estimates and discussion in this document.
Under FDA's regulations, FDA may designate a country from which
cattle materials inspected and passed for human consumption are not
considered prohibited cattle materials, and their use does not render
human food or cosmetics adulterated. Sections 189.5(e) and 700.27(e)
provide that a country seeking to be designated must send a written
request to the Director of the Center for Food Safety and Applied
Nutrition (CFSAN Director). The information the country is required to
submit includes information about a country's BSE case history, risk
factors, measures to prevent the introduction and transmission of BSE,
and other information relevant to determining whether SRMs, the small
intestine of cattle not otherwise excluded from being a prohibited
cattle material, material from nonambulatory disabled cattle, or MS
beef from the country seeking designation should be considered
prohibited cattle materials. FDA uses the information to determine
whether to grant a request for designation and to impose conditions if
a request is granted.
Sections 189.5 and 700.27 further state that countries designated
under Sec. Sec. 189.5(e) and 700.27(e) will be subject to future
review by FDA to determine whether their designations remain
appropriate. As part of this process, FDA may ask designated countries
to confirm their BSE situation and the information submitted by them,
in support of their original application, has remained unchanged. FDA
may revoke a country's designation if FDA determines that it is no
longer appropriate. Therefore, designated countries may respond to
periodic FDA requests by submitting information to confirm their
designations remain appropriate. FDA uses the information to ensure
their designations remain appropriate.
Description of Respondents: Respondents to this information
collection include manufacturers, processors, and importers of FDA-
regulated human food, including dietary supplements, and cosmetics
manufactured from, processed with, or otherwise containing material
derived from cattle, as well as, with regard to Sec. Sec. 189.5(e) and
700.27(e), foreign governments seeking designation under those
regulations.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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189.5(c)(6) and 700.27(c)(6).. 54,825 1 54,825 .033 (2 minutes) 1,809
189.5(e) and 700.27(e); 1 1 1 80.............. 80
request for designation.
189.5(e) and 700.27(e); 1 1 1 26.............. 26
response to request for
review by FDA.
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Total..................... .............. .............. .............. ................ 1,915
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 44787]]
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of
21 CFR 189.5(c) and 700.27(c) Number of records per Total annual Average burden Total hours
recordkeepers recordkeeper records per recordkeeper
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Domestic facilities........... 697 52 36,244 0.25 (15 9,061
minutes).
Foreign facilities............ 916 52 47,632 0.25 (15 11,908
minutes).
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Total..................... .............. .............. .............. ................ 20,969
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\1\ There are no capital or operating and maintenance costs associated with this collection of information.
Except where otherwise noted, this estimate is based on FDA's
estimate of the number of facilities affected by the final rule
entitled, ``Recordkeeping Requirements for Human Food and Cosmetics
Manufactured From, Processed With, or Otherwise Containing Material
From Cattle,'' published in the Federal Register of October 11, 2006
(71 FR 59653).
Reporting
FDA's regulations in Sec. Sec. 189.5(c)(6) and 700.27(c)(6) impose
a reporting burden on importers of human food and cosmetics
manufactured from, processed with, or otherwise containing cattle
material. Importers of these products must affirm that the human food
or cosmetics are not manufactured from, processed with, or otherwise
contain prohibited cattle materials and must affirm that the human food
or cosmetics were manufactured in accordance with the applicable
requirements of Sec. Sec. 189.5 or 700.27. The affirmation is made by
the importer of record to the FDA through FDA's Operational and
Administrative System for Import Support. Affirmation by importers is
expected to take approximately 2 minutes per entry line. Table 2 shows
54,825 lines of human food and cosmetics likely to contain cattle
materials are imported annually. The reporting burden of affirming
whether import entry lines contain cattle-derived materials is
estimated to take 1,809 hours annually (54,825 lines multiplied by 2
minutes per line).
FDA's estimate of the reporting burden for designation under
Sec. Sec. 189.5 and 700.27 is based on its experience and the average
number of requests for designation received in the past 3 years. In the
last 3 years, FDA has not received any requests for designation. Thus,
FDA estimates that one or fewer will be received annually in the
future. Based on this experience, FDA estimates the annual number of
new requests for designation will be one. FDA estimates that preparing
the information required by Sec. Sec. 189.5 and 700.27 and submitting
it to FDA in the form of a written request to the CFSAN Director will
require a burden of approximately 80 hours per request. Thus, the
burden for new requests for designation is estimated to be 80 hours
annually, as shown in Table 1, row 1.
Under Sec. Sec. 189.5(e) and 700.27(e), designated countries are
subject to future review by FDA and may respond to periodic FDA
requests by submitting information to confirm their designations remain
appropriate. In the last 3 years, FDA has not requested any reviews.
Thus, FDA estimates that one or fewer will occur annually in the
future. FDA estimates that the designated country undergoing a review
in the future will need one-third of the time it took preparing its
request for designation to respond to FDA's request for review, or 26
hours (80 hours x 0.33 = 26.4 hours, rounded to 26). The annual burden
for reviews is estimated to be 26 hours, as shown in Table 1, row 2.
The total reporting burden for this information collection is estimated
to be 1,915 hours annually.
Recordkeeping
FDA estimates that there are 697 domestic facility relationships
and 916 foreign facility relationships consisting of the following
facilities: An input supplier of cattle-derived materials that requires
records (the upstream facility) and a purchaser of cattle-derived
materials requiring documentation (this may be a human food or
cosmetics manufacturer or processor). The recordkeeping burden of FDA's
regulations in Sec. Sec. 189.5(c) and 700.27(c) is the burden of
sending, verifying, and storing documents regarding shipments of cattle
material that is to be used in human food and cosmetics.
In this estimate of the recordkeeping burden, FDA treats these
recordkeeping activities as shared activities between the upstream and
downstream facilities. It is in the best interests of both facilities
in the relationship to share the burden necessary to comply with the
regulations; therefore, FDA estimates the time burden of developing
these records as a joint task between the two facilities. Thus, FDA
estimates that this recordkeeping burden will be about 15 minutes per
week, or 13 hours per year, and FDA assumes that the recordkeeping
burden will be shared between 2 entities (i.e., the ingredient supplier
and the manufacturer of finished products). Therefore, the total
recordkeeping burden for domestic facilities is estimated to be 9,061
hours (13 hours multiplied by 697), and the total recordkeeping burden
for foreign facilities is estimated to be 11,908 hours (13 hours
multiplied by 916), as shown in Table 1.
Dated: July 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18109 Filed 7-31-14; 8:45 am]
BILLING CODE 4164-01-P