[Federal Register Volume 75, Number 16 (Tuesday, January 26, 2010)]
[Notices]
[Pages 4077-4079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-1436]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0505]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 that a
proposed collection of information has been submitted to the
[[Page 4078]]
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
February 25, 2010.
ADDRESSES: 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: 202-395-7285, or e-mailed to [email protected]. All
comments should be identified with the OMB control number 0910-0597.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3793.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Recordkeeping and Reporting Requirements for Human Food and Cosmetics
Manufactured From, Processed With, or Otherwise Containing, Material
From Cattle--21 CFR 189.5(c) and 700.27(c) (OMB Control Number 0910-
0597)--Extension
Sections 189.5(c) and 700.27(c) of FDA's regulations (21 CFR
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 that are manufactured from, processed with,
or otherwise contain, material derived from cattle. FDA issued these
recordkeeping regulations under the adulteration provisions in sections
402(a)(2)(C), (a)(3), (a)(4), (a)(5), 601(c), and under section 701(a)
of the Federal Food, Drug, and Cosmetic Act (the 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 act, FDA is authorized to issue regulations for
the act's efficient enforcement. With regard to records concerning
imported human food and cosmetics, FDA relied on its authority under
sections 801(a) and 701(b) of the act (21 U.S.C. 381(a) and 371(b)).
Section 801(a) of the act provides requirements with regard to imported
food and cosmetics and provides for refusal of admission into the
United States of human food and cosmetics that appear to be
adulterated. Section 701(b) of the act authorizes the Secretaries of
Treasury and Health and Human Services to jointly prescribe regulations
for the efficient enforcement of section 801 of the act.
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 specified
risk materials (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 mechanically separated
beef; and (4) whether tallow in a human food or cosmetic contains less
than 0.15 percent insoluble impurities.
These regulations implement recordkeeping for the provisions of
FDA's interim final rule entitled ``Use of Materials Derived From
Cattle in Human Food and Cosmetics'' (the IFR) (69 FR 42256, July 14,
2004). FDA's regulations in Sec. Sec. 189.5(c) and 700.27(c) require
that manufacturers and processors of human food and cosmetics that are
manufactured from, processed with, or otherwise contain, material from
cattle establish and maintain records sufficient to demonstrate that
the human food or cosmetic is not manufactured from, processed with, or
does not otherwise contain, 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 Sec. Sec. 189.5(c) and 700.27(c) 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 we do 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 a human
food or cosmetic manufactured from, processed with, or otherwise
containing, cattle material must affirm that the human food or cosmetic
was manufactured from, processed with, or otherwise contains, cattle
material and must affirm that the human food or cosmetic was
manufactured in accordance with the applicable requirements of
Sec. Sec. 189.5 or 700.27. In addition, if a human food or cosmetic is
manufactured from, processed with, or otherwise contains, cattle
material, then the importer of record must, if requested, provide
within 5 business days records sufficient to demonstrate that the human
food or cosmetic is not manufactured from, processed with, or does not
otherwise contain, prohibited cattle material.
In the Federal Register of October 23, 2009 (74 FR 54827), FDA
published a 60-day notice requesting public comment. No comments were
received.
FDA estimates the burden of this collection of information as
follows:
This estimate is based on FDA's estimate of the number of
facilities affected by the final rule published in the Federal Register
of October 11, 2006 (71 FR 59653 at 59667), entitled ``Recordkeeping
Requirements for Human Food and Cosmetics Manufactured From, Processed
With, or Otherwise Containing, Material From Cattle.''
Table 1.--Estimated Annual Recordkeeping Burden\1\
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No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours
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Domestic Facilities 697 52 36,244 0.25 9,061
189.5(c) and 700.27(c)
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Foreign Facilities 916 52 47,632 0.25 11,908
189.5(c) and 700.27(c)
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[[Page 4079]]
Total 20,969
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that there are 697 domestic facility relationships
(71 FR 59653 at 59667), and 916 foreign facility relationships (71 FR
59653 at 59663), 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 cosmetic
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, we treat 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, we estimate the time burden of developing these
records as a joint task between the two facilities. Thus, we estimate
that this recordkeeping burden will be about 15 minutes per week, or 13
hours per year (71 FR 59653 at 59667), and we assume that the
recordkeeping burden will be shared between two entities (i.e., the
ingredient supplier and the manufacturer of finished products).
Therefore, the total recordkeeping burden for domestic facilities is
estimated to be 13 hours x 697 = 9,061 hours, and the total
recordkeeping burden for foreign facilities is estimated to be 13 hours
x 916 = 11,908 hours, as shown in Table 1 of this document.
Table 2.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
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189.5(c)(6) and 54,825 1 54,825 0.033 1,809
700.27(c)(6)
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
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 that are
manufactured from, processed with, or otherwise contain, cattle
material. Importers of these products must affirm that the food or
cosmetic is manufactured from, processed with, or does not otherwise
contain, prohibited cattle materials and must affirm that the human
food or cosmetic was 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 FDA through the agency's Operational and
Administrative System for Import Support (OASIS). Affirmation by
importers is expected to take approximately 2 minutes per entry line.
Table 2 of this document shows that 54,825 lines of food and cosmetics
that likely contain cattle materials are imported annually (71 FR 59653
at 59667). The annual reporting burden of affirming whether import
entry lines contain cattle-derived materials is estimated to take 1,809
hours annually (54,825 lines x 2 minutes per line).
Dated: January 20, 2010.
David Dorsey
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-1436 Filed 1-25-10; 8:45 am]
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