See Final Rule October 11, 2006.
[Federal Register: July 14, 2004 (Volume 69, Number 134)]
[Proposed Rules]
[Page 42275-42285]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14jy04-15]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 189 and 700
[Docket No. 2004N-0257]
RIN 0910-AF48
Recordkeeping Requirements for Human Food and Cosmetics
Manufactured From, Processed With, or Otherwise Containing, Material
From Cattle
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to require
that manufacturers and processors of human food and cosmetics that are
manufactured from, processed with, or otherwise contain, material from
cattle must establish and maintain records sufficient to demonstrate
the food or cosmetic is not manufactured from, processed with, or does
not otherwise contain, prohibited cattle materials. This is a companion
rulemaking to FDA's interim final rule entitled ``Use of Materials
Derived From Cattle in Human Food and Cosmetics,'' published in this
issue of the Federal Register. FDA is proposing recordkeeping
requirements because records documenting the absence of prohibited
cattle materials are needed by manufacturers and processors of human
food and cosmetics that contain cattle material to ensure that these
products do not contain prohibited cattle materials. In addition, such
records are necessary to help FDA ensure compliance with the
requirements of the interim final rule.
DATES: You may submit written or electronic comments on the proposed
rule by August 13, 2004. Submit written comments on the information
collection requirements by August 13, 2004.
ADDRESSES: You may submit comments, identified by Docket No. 2004N-
0257, by any of the following methods:
<bullet> Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
<bullet> Agency Web site: http://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
<bullet> E-mail: fdadockets@oc.fda.gov. Include Docket No. 2004N-
0257 in the subject line of your e-mail message.
<bullet> FAX: 301-827-6870.
<bullet> Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
Instructions: All submissions received must include the agency name and
Docket No. or Regulatory Information Number (RIN) for this rulemaking.
All comments received will be posted without change to
http://www.fda.gov/dockets/ecomments,
including any personal information
provided. For detailed instructions on submitting comments and
additional information on the rulemaking process, see the ``Effective
Date and Opportunity for Public Comment'' 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.fda.gov/dockets/ecomments and/or
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
Information Collection Provisions: Submit written comments on the
information collection provisions to the Office of Information and
Regulatory Affairs, Office of Management and Budget (OMB).
OMB is still experiencing significant delays in the regular mail,
including first class and express mail, and messenger deliveries are
not being accepted. 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: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Rebecca J. Buckner, Center for Food
Safety and Applied Nutrition (HFS-306), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1486.
SUPPLEMENTARY INFORMATION:
I. Background
In this issue of the Federal Register we are publishing an interim
final rule entitled ``Use of Materials Derived From Cattle in Human
Food and Cosmetics'' (referred to as the ``interim final rule'') to
prohibit the use of prohibited cattle materials in human food,
including dietary supplements, and cosmetics. Prohibited cattle
materials include specified risk materials (SRMs), small intestine of
all cattle, material from nonambulatory disabled cattle, material from
cattle not inspected and passed for human consumption, and mechanically
separated (MS)(Beef). SRMs are the 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 of cattle 30
months and older; and the tonsils and distal ileum of the small
intestine of all cattle. Prohibited cattle materials do not include
tallow that contains no more than 0.15 percent hexane-insoluble
impurities and tallow derivatives. The preamble to the interim final
rule describes the background and justification for the ban on
prohibited cattle materials in human food and cosmetics.
In this companion rulemaking, we are proposing that manufacturers
and processors of human food and cosmetics that are manufactured from,
processed with, or otherwise contain, material from cattle must
establish and maintain records sufficient to demonstrate the food or
cosmetic is not manufactured from, processed with, or does not
otherwise contain, prohibited cattle materials. We believe that records
documenting the absence of prohibited cattle materials in human food
and cosmetics are critical for manufacturers, processors, and FDA to
ensure compliance with the ban on the use of prohibited cattle
materials in the interim final rule. Once material is removed from
cattle, we may not be able to obtain the information necessary to
determine whether it is prohibited cattle material. There is currently
no way to test reliably for the presence of the bovine spongiform
encephalopathy (BSE) agent or for the presence of prohibited cattle
materials. Therefore, manufacturers and processors of human food and
cosmetics must depend on records from the suppliers of cattle material
to demonstrate that the supplier's cattle material does not contain
prohibited cattle materials.
Through these records, manufacturers and processors of human food
and cosmetics can ensure that prohibited cattle materials are not
included in their products. The agency believes that recordkeeping and
records access requirements are necessary immediately. The agency
recognizes, however, that recordkeeping systems cannot be put into
place immediately and, therefore, to include recordkeeping requirements
in the interim final rule could result in manufacturers and processors
immediately being in violation of the adulteration provisions of the
Federal Food, Drug, and Cosmetic Act (the act) with respect to food and
cosmetics because of their failure immediately to establish and
maintain the necessary records as of the effective date of the interim
final rule. For that reason, we are proposing record establishment and
maintenance
[[Page 42276]]
requirements in this separate rulemaking, rather than including them
in the interim final rule. In addition, the agency is seeking
information from the public regarding the types of records that may
already be available to document the absence of prohibited cattle
materials in human food and cosmetics and the types of records that
could be established to document the absence of prohibited cattle
materials in these FDA-regulated products. In the meantime, FDA is
ensuring that it can enforce the new prohibitions in the interim final
rule through the provisions in that rule requiring FDA be given access
to any existing records relevant to compliance with the ban on
prohibited cattle materials.
II. Definitions From the Interim Final Rule
The following definitions are from the interim final rule (new
Sec. Sec. 189.5(a) and 700.27(a) (21 CFR 189.5(a) and 700.27(a))) and
are included here because they are relevant to the proposed
recordkeeping provisions:
<bullet> Prohibited cattle materials means specified risk
materials, small intestine of all cattle, material from nonambulatory
disabled cattle, material from cattle not inspected and passed, or
MS(Beef). The phrase ``prohibited cattle materials'' includes all of
the individual categories of materials and tissues prohibited by this
rulemaking. Prohibited cattle materials do not include tallow that
contains no more than 0.15 percent hexane-insoluble impurities and
tallow derivatives.
<bullet> Inspected and passed means that the product has been
inspected and passed for human consumption by the appropriate
regulatory authority, and at the time it was inspected and passed, it
was found to be not adulterated. This definition is consistent with the
U.S. Department of Agriculture's (USDA's) definition in 9 CFR 301.2.
<bullet> Mechanically Separated (MS) (Beef) means a meat food
product that is finely comminuted, resulting from the mechanical
separation and removal of most of the bone from attached skeletal
muscle of cattle carcasses and parts of carcasses, that meets the
specifications contained in 9 CFR 319.5, the USDA regulation that
prescribes the standard of identity for MS (Species). This definition
of MS(Beef) is consistent with the term as used by USDA in its recent
BSE interim final rule (January 12, 2004, 69 FR 1862) prohibiting its
use in food.
<bullet> Nonambulatory disabled cattle means cattle that cannot
rise from a recumbent position or that cannot walk, including, but not
limited to, those with broken appendages, severed tendons or ligaments,
nerve paralysis, fractured vertebral column or metabolic conditions.
This definition of nonambulatory disabled cattle is consistent with the
definition of nonambulatory disabled livestock in USDA's BSE interim
final rule requiring nonambulatory disabled cattle be condemned and not
used as human food.
<bullet> Specified risk material (SRM) means the 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
of cattle 30 months and older and the tonsils and distal ileum of the
small intestine of all cattle. This definition of SRM is the same as
that used by USDA in its BSE interim final rule declaring SRMs to be
inedible and prohibiting their use in human food.
<bullet> Tallow means the rendered fat of cattle obtained by
pressing or by applying any other extraction process to tissues derived
directly from discrete adipose tissue masses or to other carcass parts
and tissues. Tallow must be free of prohibited cattle material or must
contain not more than 0.15 percent hexane-insoluble impurities as
determined by the method for ``hexane-insoluble matter'' in the 5th
edition of the Food Chemicals Codex, incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or another method
equivalent in accuracy, precision, and sensitivity. You may obtain a
copy of the above-referenced method from the Division of Dairy and Egg
Safety (HFS-306), Center for Food Safety and Applied Nutrition, Food
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740, or you may examine a copy at the Center for Food Safety and
Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD
or at the Office of the Federal Register, 800 North Capitol St., NW.,
suite 700, Washington, DC.
<bullet> Tallow derivative means any chemical obtained through
initial hydrolysis, saponification, or transesterification of tallow;
chemical conversion of material obtained by hydrolysis, saponification,
or transesterification may be applied to obtain the desired product.
III. The Proposed Recordkeeping Requirements
A. Proposed Recordkeeping Requirements
We are proposing in Sec. Sec. 189.5(c)(1) and 700.27(c)(1) 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 that demonstrate that the
material from cattle meets the requirements of the interim final rule.
Because there is currently no way to test reliably for the presence of
the BSE agent or for the presence of prohibited cattle materials,
manufacturers and processors of human food and cosmetics must depend on
records from the suppliers of cattle material to demonstrate that their
source material is free from prohibited cattle material. Similarly,
without adequate records, FDA may not know whether manufacturers and
processors of human food and cosmetics have complied with the
prohibitions against the use of prohibited cattle materials. Therefore,
we are proposing under Sec. Sec. 189.5(c)(1) and 700.27(c)(1) that
manufacturers and processors of human food and cosmetics that are
manufactured from, processed with, or otherwise contain, material from
cattle must establish and maintain records sufficient to demonstrate
that the human food and cosmetics do not contain prohibited cattle
materials and that such records must be made available to FDA for
inspection and copying.
For example, to satisfy the requirement in Sec. Sec. 189.5(c)(1)
and 700.27(c)(1) of this proposed rule that records must show the
absence of specified risk materials, manufacturers and processors of
human food and cosmetics that are manufactured with, processed from, or
otherwise contain, brain from cattle would have to establish and
maintain records to demonstrate, among other things, that the human
food or cosmetic was not manufactured with, processed from, or does not
otherwise contain, brain from cattle over 30 months of age.
In general, we would expect a manufacturer or processor of FDA-
regulated human food or cosmetics containing cattle material (e.g.,
soup containing beef broth, dietary supplements containing cattle brain
powder) to have the following types of records:
<bullet> A signed and dated affirmation (with contact information)
by the slaughter establishment that cattle material supplied by that
establishment in a particular shipment does not contain prohibited
cattle materials. If lots of cattle material from different slaughter
establishments are pooled into a final product, then a manufacturer or
processor would need to maintain records from each slaughter
establishment.
[[Page 42277]]
<bullet> For human food and cosmetics containing tallow, a
manufacturer or processor would need to maintain records from a
slaughter establishment affirming that the tallow was produced from
material containing no prohibited cattle materials or similar records
(i.e., signed, dated, with contact information) from the tallow
supplier affirming that the tallow contains no more than 0.15 percent
hexane-insoluble impurities.
We request comments on other ways in which the proposed
recordkeeping requirements might be satisfied. We also request comments
on whether existing recordkeeping practices include the required
information and, if not, what changes the proposal would necessitate.
We note that USDA is working toward the establishment of a national
database for animal identification, which should make maintaining
information about source animals less burdensome.
We are proposing in Sec. Sec. 189.5(c)(2) and 700.27(c)(2) that
records be retained for 2 years after the date the records were
created. We acknowledge that USDA in its BSE interim final rule is
requiring that records be retained for 1 year. However, FDA-regulated
human food, such as canned and dried foods and dietary supplements and
cosmetics have a longer shelf life than most USDA-regulated products,
which are primarily fresh meat. It is important for traceback and
recall purposes that records be retained for the likely shelf life of
the product. As discussed previously, records documenting the absence
of prohibited cattle materials in human food and cosmetics are
necessary to help FDA ensure compliance with the requirements of the
interim final rule. It is important for the records to be kept during
the shelf life of these products, so that FDA can ensure that products
on the market are not adulterated. Therefore, we have tentatively
concluded that records must be retained for 2 years.
We are proposing in Sec. Sec. 189.5(c)(3) and 700.27(c)(3) that
records be maintained at the manufacturing or processing establishment
or at a reasonably accessible location. Proposed Sec. Sec. 189.5(c)(4)
and 700.27(c)(4) provide that maintenance of electronic records is
acceptable and that electronic records are considered to be reasonably
accessible if they are accessible from an onsite location.
Proposed Sec. Sec. 189.5(c)(5) and 700.27(c)(5) provide that
records required by this subpart must be available to FDA for
inspection and copying.
Because we do not necessarily have access to records maintained at
foreign establishments, we are proposing in Sec. Sec. 189.5(c)(6) and
700.27(c)(6), respectively, that importers must electronically affirm
their compliance with the recordkeeping requirements in Sec. Sec.
189.5(c)(1) and 700.27(c)(1), respectively, at the time of entry into
the United States of human food or cosmetics manufactured from,
processed with, or otherwise containing, material from cattle and must
provide the required records within a reasonable time if requested. The
records we would expect are similar to those described above for
domestic products. In order for importers to electronically affirm
compliance, FDA intends to modify our electronic entry system to
provide a field where importers can tell us that they have the required
BSE records. Proposed Sec. Sec. 189.5(c)(7) and 700.27(c)(7) provide
that records established or maintained to satisfy the requirements of
this subpart that meet the definition of electronic records in 21 CFR
11.3(b)(6) of this chapter are exempt from the requirements of part 11
of this chapter. Under the proposed rule, records that satisfy the
requirements of this subpart but that are also required under other
applicable statutory provisions or regulations would remain subject to
part 11 of this chapter.
B. Legal Authority
Because this proposed rule is a companion rule to the interim final
rule, we are issuing this proposed rule under the authorities cited in
the interim final rule as well as sections 801(a) and 701(b) of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 381(a) and
371(b)). As we stated in the interim final rule, FDA is issuing these
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 act (21
U.S.C. 342(a)(2)(C), (a)(3), (a)(4), (a)(5), 361(c), and 371(a)). Under
section 402(a)(3) of the act, a food is deemed adulterated ``if it
consists in whole or in part of any filthy, putrid, or decomposed
substance, or if it is otherwise unfit for food.'' ``Otherwise unfit
for food'' is an independent clause in section 402(a)(3). It does not
seem to require that a food be filthy, putrid, or decomposed for it to
be ``otherwise unfit for food.'' We conclude that a food can be
``otherwise unfit for food'' based on health risks. We seek comments on
this interpretation. Because of the discovery of a BSE positive cow in
the United States and the possibility of disease transmission to humans
from exposure to material from infected cattle, prohibited cattle
materials (SRMs, small intestine of all cattle, MS(Beef), material from
nonambulatory disabled cattle, and material from cattle not inspected
and passed) these materials may present a risk to human health. Under
our interpretation of section 402(a)(3), these materials are unfit for
food. Under section 402(a)(4) of the act, a food is adulterated ``if it
has been prepared, packed, or held under insanitary conditions whereby
it may have become contaminated with filth, or whereby it may have been
rendered injurious to health.'' The failure to ensure that food is
prepared, packed, or held under conditions in which prohibited cattle
materials do not contaminate the food constitutes an insanitary
condition whereby it may have been rendered injurious to health and
thus renders the food adulterated under section 402(a)(4) of the act.
Under section 402(a)(5) of the act, food is deemed adulterated if
``it is, in whole or in part, the product * * * of an animal which has
died otherwise than by slaughter.'' Some cattle are not inspected and
passed because they have died before slaughter. Material from these
cattle that die otherwise than by slaughter is adulterated under
section 402(a)(5). We are also relying on the food additive provision
in section 402(a)(2)(C) of the act. As a result, because neither a food
additive regulation nor an exemption is in effect for prohibited cattle
materials intended for use in human food, such materials, with the
exception of dietary ingredients in dietary supplements, are
adulterated under section 402(a)(2)(C) of the act and their presence in
food renders the food adulterated. Under section 601(c) of the act, a
cosmetic is adulterated ``if it has been prepared, packed, or held
under insanitary conditions whereby it may have become contaminated
with filth, or whereby it may have been rendered injurious to health.''
The failure to ensure that a cosmetic is prepared, packed, or held
under conditions in which prohibited cattle materials do not
contaminate the cosmetic constitutes an insanitary condition whereby it
may have been rendered injurious to health and, thus, renders the
cosmetic adulterated under section 601(c) of the act.
Under section 701(a) of the act, FDA is authorized to issue
regulations for the act's efficient enforcement. A regulation that
requires measures to prevent human food from being unfit for food, from
being or bearing an unsafe food additive, from being the product of an
animal that died otherwise than by slaughter, and to prevent human food
and cosmetics from being held under insanitary conditions allows for
efficient enforcement of the act. These proposed regulations require
that manufacturers
[[Page 42278]]
and processors of human food and cosmetics that are manufactured from,
processed with, or otherwise contain material from cattle establish and
maintain records that document the absence of prohibited cattle
materials in such products and require that such records be made
available to FDA for inspection and copying.
Once material is removed from cattle, we may not be able to obtain
the information necessary to determine whether it is prohibited cattle
material. For example, we would not know from examination of a spinal
cord whether the source animal was over 30 months of age at the time of
slaughter, or whether it was inspected and passed. Because there is
currently no way to test reliably for the presence of the BSE agent or
for the presence of prohibited cattle materials, manufacturers and
processors of human food and cosmetics must depend on records from
their suppliers of cattle materials to ensure that their source
material does not contain prohibited cattle materials. Without records
documenting the absence of prohibited cattle materials in source
materials, manufacturers and processors of human food and cosmetics
cannot know whether they are adulterating their products by including
prohibited cattle materials. Therefore, a failure of manufacturers and
processors to establish and maintain such records results in human food
and cosmetics being prepared under insanitary conditions whereby they
may have been rendered injurious to health. Furthermore, without
adequate records, FDA cannot know whether manufacturers and processors
of human food have complied with the prohibitions against use of
prohibited cattle materials. Therefore, the proposed recordkeeping
requirements are necessary for the efficient enforcement of the interim
final rule. Under the proposed rule, failure to comply with the
recordkeeping requirements would render the affected human food and
cosmetics adulterated under sections 402(a)(4) and 601(a) of the act,
respectively.
We are also issuing the provisions of this proposed rule related to
records regarding imported human food and cosmetics under sections
801(a) and 701(b) of the act. 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. This proposed rule sets out requirements for imported
human food and cosmetics to ensure that only products that fully comply
with the requirements of the interim final rule are admitted into the
United States.
IV. Effective Date and Opportunity for Public Comment
We are proposing that any final rule based on this proposal be
effective 30 days after issuance of that final rule.
FDA invites public comment on this proposed rule. The agency will
consider modifications to this proposed rule based on comments made
during the comment period. Interested persons may submit to the
Division of Dockets Management (see ADDRESSES) written or electronic
comments regarding this proposed rule. Submit a single copy of
electronic comments or two paper copies of any mailed comments, except
that individuals may submit one paper copy. Comments are to be
identified 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.
V. Preliminary Regulatory Impact Analysis of the Proposed Rule
Recordkeeping Requirements on Materials Derived From Cattle in Human
Food and Cosmetics
A. Benefit-Cost Analysis
FDA has examined the economic implications of this proposed rule as
required by Executive Order 12866. Executive Order 12866 directs
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 12866 classifies a
rule as significant if it meets any one of a number of specified
conditions, including the following conditions: Having an annual effect
on the economy of $100 million, adversely affecting a sector of the
economy in a material way, adversely affecting competition, or
adversely affecting jobs. A regulation is also considered a significant
regulatory action if it raises novel legal or policy issues. FDA has
determined that this proposed rule is not an economically significant
regulatory action.
1. Need for Regulation
USDA's BSE interim final rule requires that specified risk
materials, small intestine of all cattle, tissue from nonambulatory
disabled cattle, and MS(Beef) not be used for human food. SRMs include
the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral
column (excluding the vertebrae of the tail, the transverse process of
the thoracic and lumbar vertebrae, and the wings of the sacrum), and
dorsal root ganglia of cattle 30 months and older, and the tonsils and
distal ileum of the small intestine of all cattle. USDA's BSE interim
final rule requires that all of the prohibited materials be destroyed
or sent to inedible rendering.
FDA, in response to the finding of an adult cow, imported from
Canada, that tested positive for BSE in the State of Washington and to
be consistent with USDA in regulating cattle products that could
potentially transmit BSE, is issuing an interim final rule for FDA-
regulated human food and cosmetics that contain cattle material. This
proposed recordkeeping rule is a companion to the interim final rule
and responds to the same public health concerns. This proposed rule
would not affect the incidence of BSE in cattle, which is addressed in
other FDA regulations. This proposed rule would serve as an additional
safeguard to reduce human exposure to the agent that causes BSE that
may be present in cattle-derived products from domestic and imported
sources.
2. Proposed Rule Coverage
This proposed rule would require recordkeeping to document
compliance with the provisions of the interim final rule that prohibit
the use of ``prohibited cattle materials.'' Prohibited cattle materials
include SRMs (brain, skull, eyes, trigeminal ganglia, spinal cord,
vertebral column (excluding the vertebrae of the tail, the transverse
process of the thoracic and lumbar vertebrae, and the wings of the
sacrum), and dorsal root ganglia of cattle 30 months and older, and the
tonsils and distal ileum of the small intestine of all cattle), small
intestine of all cattle, tissue from nonambulatory disabled cattle,
tissue from cattle not inspected and passed for human consumption, and
MS(Beef).
This proposed rule would require that manufacturers and processors
of human foods and cosmetics maintain records indicating that
prohibited cattle materials have not been used in the manufacture or
processing of a human food or cosmetic, and make such records available
to FDA for inspection
[[Page 42279]]
and copying. There are several reasons for the proposed requirements.
First, once cattle material such as brain or spinal cord is separated
from the source animal, it may not be possible to determine the age of
the animal from which the material came without records and, therefore,
whether it is an SRM. Second, without records it may not be possible to
determine whether a product contains material from cattle that were not
inspected and passed. Third, a product might contain MS(Beef) without
its presence being evident from the appearance of the product. Finally,
manufacturers and processors might not, without a legal requirement,
establish and maintain records to demonstrate that cattle material does
not contain prohibited cattle materials. We have tentatively concluded
that, to ensure that public health is protected, it is necessary that
manufacturers and processors keep records indicating that human food
and cosmetics are not manufactured from, processed with, or otherwise
contain, prohibited cattle materials. Because we do not necessarily
have access to records maintained at foreign establishments, we have
included in this proposed rule a requirement that importers of food or
cosmetics manufactured from, processed with, or otherwise containing,
cattle material electronically affirm their compliance with the
relevant recordkeeping requirements in this proposed rule at the time
of entry into the United States and provide required records if
requested.
3. Costs and Benefits of the Proposed Rule
This proposed rule would require manufacturers and processors of
FDA-regulated human food and cosmetics manufactured from, processed
with, or otherwise containing, cattle material to maintain records
demonstrating that prohibited cattle materials are not used in their
products. This proposed rule would require that the manufacturer or
processor retain records for 2 years after using the cattle material in
food or cosmetics. Records must be kept at the manufacturing or
processing establishment or another reasonably accessible location.
Manufacturers and processors must provide FDA with access to the
required records for inspection and copying.
a. Costs of proposed rule. FDA used establishment data from the FDA
Small Business Model (which includes information on all establishments
in a manufacturing sector regardless of size) (Ref. 1) to determine the
number of food manufacturers and processors that will need to comply
with the proposed recordkeeping requirements. The model contains
information on the number of establishments in certain food producing
sectors but does not have information on specific ingredients used by
the food establishments in making products. Data from the model
indicates that 181 establishments produce spreads, 127 establishments
produce flavoring extracts, 40 establishments produce canned soups and
stews, 625 establishments produce nonchocolate candy, 88 establishments
produce yogurt, and 451 establishments produce ice cream. FDA cannot
verify that all of these establishments actually use cattle materials
that fall under the jurisdiction of this proposed rule; many may not.
It is likely that all of the 132 establishments that produce fats and
oils currently use tallow derivatives, not tallow, so FDA assumes that
no records will be required to be kept by this establishment group. We
assume that only 25 percent of the establishments from the remaining
production sectors listed above actually produce food that is
manufactured from, processed with, or otherwise contains, material from
cattle and are therefore required to keep records. We include only 25
percent of the establishments in our estimates because most of the
manufacturers likely do not use cattle-derived materials in their
products. FDA requests comments on this assumption.
FDA research shows that 25 establishments with U.S. addresses
supply cattle-derived ingredients that are used in cosmetics (Ref. 2).
These cattle-derived ingredients include albumin, brain extract, brain
lipids, cholesterol and cholesterol compounds, fibronectin,
sphingolipids, spleen extract, tallow, and keratin and keratin
compounds. FDA research also shows that 22 foreign establishments may
export these cattle-derived ingredients to U.S. cosmetic manufacturers.
These foreign establishments would be required to provide records to
their U.S. cosmetic manufacturer customers. We therefore include these
foreign establishments when we estimate the recordkeeping costs.
Imported cosmetic products represent about 10 to 20 percent of the
cosmetic products on U.S. store shelves (Refs. 3, 4, and 5). However,
the burden of the interim final rule to foreign cosmetics input
suppliers and manufacturers will be less than the burden on domestic
cosmetics producers. The burden will be less for foreign cosmetics
manufacturers because Europe currently imposes some requirements
similar to this rule.
FDA does not have enough information on the precise cattle material
used by the 47 domestic and foreign cosmetics establishments to know
how often tallow derivatives (exempt from this proposed rulemaking) are
the only cattle-derived ingredient used in these products. We estimate
that 75 percent (or 35) of the 47 cosmetics establishments would have
to keep records for their cattle-derived ingredients. We estimate only
75 percent will keep records because many cosmetics use tallow
derivatives as their only cattle-derived material, and such materials
are not covered by the recordkeeping provisions. FDA requests comments
on this assumption.
From FDA's dietary supplement database (Ref. 6), we are able to
tell that there are 162 dietary supplement brand names that use cattle
material as ingredients in their products. We assume that each brand
name represents a facility that produces multiple dietary supplement
products containing cattle-derived ingredients; therefore we assess
recordkeeping costs for all 162 brand names. We do not have information
to determine if any of the dietary supplement manufacturers use tallow
derivatives (exempt from this recordkeeping requirement) as their only
cattle-derived ingredient.
b. Recordkeeping. USDA's BSE interim final rule requires those
establishments that slaughter cattle or that process the carcasses or
parts of carcasses of cattle maintain daily records sufficient to
document the implementation and monitoring of procedures for removal,
segregation, and disposition of SRMs. USDA's BSE interim final rule
requirements will reduce the startup costs of recordkeeping required by
this proposed rule.
Recordkeeping costs include one-time costs and recurring costs.
One-time costs include the costs of designing records and training
personnel in the maintenance of the records. The recurring costs are
the costs of ensuring that the records adequately document that the
shipment of cattle materials to an FDA-regulated facility is free of
prohibited cattle materials. The costs of retaining records and
planning for an FDA request for records access are estimated to be
zero. We estimate these costs to be zero because current business
practices already dictate that records are kept for at least 1 year for
tax purposes and product liability purposes; the marginal private
benefit of retaining records for a second year is assumed to be greater
than the marginal cost of doing so. Although there is no specific time
period for providing records when requested, FDA notes that records
requests costs are zero when
[[Page 42280]]
FDA gives the records submitter 24 hours to comply. These cost
estimates are consistent with cost estimates used in FDA's proposed
recordkeeping requirements in ``Establishment and Maintenance of
Records Under the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002'' (the Bioterrorism Act proposed recordkeeping
rule) (68 FR 25188, May 9, 2003).
We assume that the one-time training burden incurred for each
facility is approximately one-third of an hour. This time includes both
the training required for personnel to learn how to verify that the
appropriate records have been received and/or created, and also the
training required for personnel to learn how to file and maintain those
records. Given current business practices, we know personnel are
familiar with recordkeeping; therefore, the requirement to maintain
additional records is expected to be learned quickly. This training
burden for recordkeeping is consistent with the recordkeeping training
burden in the analysis for the Bioterrorism Act proposed recordkeeping
rule (68 FR 25188; May 9, 2003) and the records maintenance burden used
in the analysis of the juice HACCP rule (66 FR 6138; January 19, 2001).
Consistent with the analysis conducted for the Bioterrorism Act
proposed recordkeeping rule, FDA assumes an hourly cost of an
administrative worker, $25.10 per hour, which has been doubled from
$12.55 wage per hour to include overhead costs. This cost, $25.10 per
hour, applies to all labor costs.
We use the FDA Labeling Cost Model to estimate the one-time records
design costs per facility of $1,190 per stock keeping unit (SKU) (Ref.
7). It is likely that facilities using cattle-derived ingredients,
whether the ingredients are for human food or cosmetics, will take
advantage of their economies of scope and produce more than one product
with these ingredients. It is probable that each establishment has
several SKUs associated with products containing cattle-derived
ingredients that will now require recordkeeping. To account for
additional products and SKUs we take the record design costs per
facility times 1.5 for a total design cost per facility of $1,785
($1,095 in labor costs and $690 in capital costs).
We multiplied the cost per product per SKU by 1.5 to account for
the additional records design required for the additional SKUs. The
record design cost for the first affected product or SKU will be more
expensive than the marginal cost of adding records for additional SKUs.
This marginal cost of record design for additional SKUs could be
negligible or it could come close to doubling the costs; we therefore
pick 1.5, the midpoint of 1 and 2, to be the cost multiplier.
Consistent with the analysis conducted for the Bioterrorism Act
proposed recordkeeping rule, this record design cost is assumed to be
shared between two facilities--the upstream facility and the downstream
facility--as both will need to be involved in record production that
meets the needs of both the supplier and customer for the cattle-
derived ingredient.
Unlike the Bioterrorism Act proposed recordkeeping rule, we do not
have direct information on all the facilities covered; we do not have
data on the number of slaughter plants or renderers that supply cattle
material for the food and cosmetic manufacturers and processors under
FDA jurisdiction. FDA does, however, have some information on the
number and type of downstream facilities that receive this material.
Using information on the number of food and cosmetic manufacturers that
may use cattle-derived ingredients subject to the interim final rule
and this proposed rule, we can account for the total shared records
costs by assuming that each food manufacturer or processor facility
listed in table 1 of this document procures ingredients from one
upstream slaughter plant or renderer. It is likely that each
manufacturer or processor has a contractual relationship with an
upstream slaughterer or renderer. FDA requests comment on whether food
manufacturers and processors maintain contractual relationships with
one or several cattle-material input suppliers. Information on food
producing facilities in table 1 represents U.S. facilities; dietary
supplement numbers account for both domestic and foreign facilities;
cosmetics numbers account for both domestic and foreign input
suppliers.
Table 1.--First Year Records Costs
----------------------------------------------------------------------------------------------------------------
Number of Costs per
Facilities Costs per Facility for
Type of Product Using Cattle Material Estimated to Facility for Training (1/3 Total Setup Costs
Use /cattke Designing hour * $25.10
Materials Records per Hour)
----------------------------------------------------------------------------------------------------------------
Canned soups and stews 10 $1,785 $8.37 $17,934
----------------------------------------------------------------------------------------------------------------
Fats and oils none .............. .............. .....................
----------------------------------------------------------------------------------------------------------------
Flavoring extracts 32 $1,785 $8.37 $57,388
----------------------------------------------------------------------------------------------------------------
Spreads 45 $1,785 $8.37 $80,702
----------------------------------------------------------------------------------------------------------------
Candy 156 $1,785 $8.37 $279,766
----------------------------------------------------------------------------------------------------------------
Yogurt 22 $1,785 $8.37 $39,454
----------------------------------------------------------------------------------------------------------------
Ice cream 113 $1,785 $8.37 $202,651
----------------------------------------------------------------------------------------------------------------
Dietary supplements 162 $1,785 $8.37 $290,526
----------------------------------------------------------------------------------------------------------------
Cosmetics 35 $1,785 $8.37 $62,768
----------------------------------------------------------------------------------------------------------------
Color additives none .............. .............. .....................
----------------------------------------------------------------------------------------------------------------
Total 575 $1,785 $8.37 $1,031,189
----------------------------------------------------------------------------------------------------------------
[[Page 42281]]
The recurring recordkeeping cost is the cost of ensuring that
appropriate records document the absence of prohibited cattle materials
in human food and cosmetics. The framework for estimating the amount of
time required for FDA-regulated facilities to ensure adequate records
for each shipment of materials is based on the regulatory impact
analysis of the Bioterrorism Act proposed recordkeeping rule. In that
analysis we estimated that 30 minutes per week would be required to
ensure that records on each shipment to and from a facility contain
adequate information regarding the contents of the package, the
transporter, supplier, and receiver.
The recordkeeping requirements of this proposed rule would cover
only a small fraction of all ingredients used in the food and cosmetic
manufacturing processes and only require that records of cattle-derived
ingredient origin from the input supplier be verified and maintained by
the food or cosmetic manufacturer and processor. Because this
recordkeeping requirement is less complex than the recordkeeping
requirements under the Bioterrorism Act and affects fewer ingredients,
we estimate the per facility burden to be about one-half of the burden
estimated for the Bioterrorism Act proposed recordkeeping rule: 15
minutes per week, or 13 hours per year. FDA assumes that this
recordkeeping burden would be shared between two entities (i.e., the
slaughter plant and the manufacturer of finished products containing
cattle-derived ingredients).
Table 2 of this document shows the recurring recordkeeping costs
for food and cosmetics manufacturers that would be needed to comply
with this proposed rule. As stated earlier, information on food
producing facilities in table 2 represents U.S. facilities; dietary
supplement numbers account for both domestic and foreign facilities;
cosmetics numbers account for both domestic and foreign input
suppliers.
Table 2.--Recurring Annual Records Costs
----------------------------------------------------------------------------------------------------------------
Annual Costs per
Facility of Ensuring
that Appropriate
Type of Product (From Raw or Rendered Material Number of Records Accompany Total recurring annual
that Needs Accompanying Documentation) Facilities Each Shipment costs
Received (13 Hours *
$25.10 per Hour)
----------------------------------------------------------------------------------------------------------------
Canned soups and stews 10 $326.30 $3,263
----------------------------------------------------------------------------------------------------------------
Fats and oils none ..................... ......................
----------------------------------------------------------------------------------------------------------------
Flavoring extracts 32 $326.30 $10,442
----------------------------------------------------------------------------------------------------------------
Spreads 45 $326.30 $14,684
----------------------------------------------------------------------------------------------------------------
Candy 156 $326.30 $50,903
----------------------------------------------------------------------------------------------------------------
Yogurt 22 $326.30 $7,179
----------------------------------------------------------------------------------------------------------------
Ice cream 113 $326.30 $36,872
----------------------------------------------------------------------------------------------------------------
Dietary supplements 162 $326.30 $52,861
----------------------------------------------------------------------------------------------------------------
Cosmetics 35 $326.30 $11,421
----------------------------------------------------------------------------------------------------------------
Color additives none ..................... ......................
----------------------------------------------------------------------------------------------------------------
Total 575 $326.30 $187,625
----------------------------------------------------------------------------------------------------------------
c. Benefits of the proposed rule. The benefits of this proposed
rule are derived from the benefits of the interim final rule, which are
the value of the public health benefits. The public health benefit is
the reduction in the risk of the human illness associated with
consumption of the agent that causes BSE.
If we define the baseline risk as the expected annual number of
cases of variant Creutzfeldt-Jakob disease (vCJD) per year, then the
annual benefits of prohibiting prohibited cattle materials for use in
foods and cosmetics would be:
(baseline annual cases of vCJD--annual cases of vCJD under FDA
interim final rule) x (value of preventing a case of VCJD).
An alternative way to characterize benefits is:
Reduction in annual cases in vCJD under FDA interim final rule x
(value of preventing a case of vCJD).
We do not know the baseline expected annual number of cases. But
based on the epidemiology of vCJD in the United Kingdom, we anticipate
much less than one case of vCJD per year in the United States. Because
the interim final rule and this proposed rule would reduce rather than
eliminate risk of exposure to BSE infectious materials, the reduction
in the number of cases will be some fraction of the expected number.
The value of preventing a case of vCJD is the value of a statistical
life plus the value of preventing a year-long or longer illness that
precedes certain death for victims of vCJD. In a recent rule making
regarding labeling of trans fatty acids (68 FR 41434, July 11, 2003),
we used a range of $5 million to $6.5 million for the value of a
statistical life. The value of preventing a vCJD case would be even
higher because of the significant medical costs associated with the
illness (Ref. 8). We estimate that the value of preventing a single
case of vCJD ranges from $5.7 million to $7.1 million. This estimate
includes direct medical costs, reduced ability of the ill person to
function at home and at work, and the cost of premature death.
As discussed in the companion interim final rule, the Harvard-
Tuskegee study has stated that a ban on specified risk materials,
including cattle brains, spinal cord and vertebral column, from
[[Page 42282]]
inclusion in human and animal food would reduce the very few potential
BSE cases in cattle by a further 88 percent and potential human
exposure to infectivity in meat and meat products by a further 95
percent. The interim final rule, in conjunction with USDA's BSE interim
final rule, will help achieve this reduction in potential human
exposure. The interim final rule will also reduce potential human
exposure to BSE infectivity in other human food not covered by the
Harvard-Tuskegee study. This proposed rule would help ensure that the
provisions of the interim final rule are carried out. For example, this
proposed rule will require documentation that a domestically produced
or foreign-produced dietary supplement or ingredient contains cattle
material (e.g., brain) only from animals of an appropriate age.
d. Summary of costs and benefits of proposed rule. For this
proposed rule, the costs are to setup and then to maintain a
recordkeeping system to document all cattle-derived ingredients, except
tallow derivatives, used in FDA-regulated food and cosmetics. The setup
costs are about $1 million, and the annual costs of maintaining the
recordkeeping system are about $200,000. The benefit of this proposed
rule is that its requirements will--by requiring records that the
provisions of the interim final rule have been followed--provide an
additional safeguard against a case of vCJD occurring in humans.
B. Regulatory Flexibility Analysis
FDA has examined the economic implications of this proposed 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 agencies to analyze
regulatory options that would lessen the economic effect of the rule on
small entities. FDA finds that this proposed rule would have a
significant economic impact on a substantial number of small entities.
First year costs of this proposed rule are about $1,800 per
facility pair, with this cost divided between the upstream facility
(slaughterhouse or rendering plant) and downstream facilities
(manufacturers of food or cosmetics). FDA cannot determine if the cost
sharing between the two firms would be equal. If the cost sharing is
equal, then each facility would have to bear about a $900 first year
cost to comply with the recordkeeping required by the proposed rule; if
the cost sharing is not equal, then one facility in the partnership may
bear zero costs all the way up to the total first year costs of $1,800.
Recurring costs of this proposed rule are about $326 per facility
relationship, which may be borne by only one firm or may be shared
between facilities.
Using FDA's Small Business Model, we can estimate the number of
facilities, when recordkeeping costs are shared and when they are not
shared, that may go out of business as a result of this proposed rule.
Table 3 of this document shows that if facilities are only
responsible for one-half of the recordkeeping cost burden (the burden
is equally shared between the upstream and downstream facilities), then
only two very small facilities (less than 20 employees) may be
overburdened by having to comply with this proposed rule in a year's
time; if the recordkeeping cost burden is borne by only one facility in
the business relationship (either the upstream or the downstream firm),
then six very small facilities (less than 20 employees) may have
trouble complying with this interim final rule and staying in business.
Facilities with 20 to 499 employees and facilities with at least 500
employees that must comply with this proposed rule are not in danger of
having to stop operating as a result of the proposed rule.
Table 3.--Potential for Facility Shutdown
------------------------------------------------------------------------
Regulation
Estimated Burden on Each Number of
Number of Facility Facilities in
Industry Facilities (Shared Burden Industry That
Affected or Total May Shut Down
Burden)
------------------------------------------------------------------------
Canned soups and stews 10 $900 0
------------------------------------------------------------------------
Canned soups and stews 10 $1,800 0
------------------------------------------------------------------------
Flavoring extracts 32 $900 0
------------------------------------------------------------------------
Flavoring extracts 32 $1,800 0
------------------------------------------------------------------------
Spreads 45 $900 0
------------------------------------------------------------------------
Spreads 45 $1,800 1
------------------------------------------------------------------------
Candy 156 $900 1
------------------------------------------------------------------------
Candy 156 $1,800 2
------------------------------------------------------------------------
Yogurt 22 $900 0
------------------------------------------------------------------------
Yogurt 22 $1,800 0
------------------------------------------------------------------------
Ice cream 113 $900 0
------------------------------------------------------------------------
Ice cream 113 $1,800 1
------------------------------------------------------------------------
Dietary supplements 162 $900 1
------------------------------------------------------------------------
Dietary supplements 162 $1,800 2
------------------------------------------------------------------------
Cosmetics 35 $900 0
------------------------------------------------------------------------
[[Page 42283]]
Cosmetics 35 $1,800 0
------------------------------------------------------------------------
C. Unfunded Mandates
Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501
et seq.) requires cost-benefit and other analyses before any rule
making if the rule would include a ``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 1 year.'' The current inflation-adjusted
statutory threshold is $115 million. FDA has determined that this
proposed rule does not constitute a significant rule under the Unfunded
Mandates Reform Act.
D. The Small Business Regulatory Enforcement Fairness Act of 1996 Major
Rule
The Small Business Regulatory Enforcement Fairness Act of 1996
(Public Law 104-121) defines a major rule for the purpose of
congressional review as having caused or being likely to cause one or
more of the following: An annual effect on the economy of $100 million
or more; a major increase in costs or prices; significant adverse
effects on competition, employment, productivity, or innovation; or
significant adverse effects on the ability of United States-based
enterprises to compete with foreign-based enterprises in domestic or
export markets. In accordance with the Small Business Regulatory
Enforcement Fairness Act, OMB has determined that this proposed rule,
should it become final, would not be a major rule for the purpose of
congressional review.
VI. Paperwork Reduction Act Analysis
This proposed rule contains information collections that are
subject to review by OMB under the Paperwork Reduction act of 1995 (44
U.S.C. 3501-3520). A description of these provisions is given below
with an estimate of the annual recorkeeping 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 the following 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.
Title: Recordkeeping Requirements for Human Food and Cosmetics
Manufactured From, Processed With, or Otherwise Containing, Material
From Cattle
Description: This proposed rule would require records on FDA-
regulated human food, including dietary supplements, and cosmetics that
are manufactured from, processed with, or otherwise contain, material
derived from cattle. This proposed rule is a companion rulemaking to
FDA's interim final rule entitled ``Use of Materials Derived From
Cattle in Human Food and Cosmetics'' published in this issue of the
Federal Register. This proposed rule would require that manufacturers
and processors of human food and cosmetics manufactured from, processed
with, or that otherwise contain, material from cattle, maintain records
demonstrating that the food or cosmetic has not been manufactured from,
processed with, or does not otherwise contain, prohibited cattle
materials and make such records available to FDA for inspection and
copying. These proposed requirements are necessary because, once
materials are separated from an animal, it may not be possible without
records to know the following: (1) Whether the cattle materials
contains SRMs, (2) whether the material contains small intestine, (3)
whether the material was sourced from an animal that was inspected and
passed for human consumption, (4) whether the material was sourced from
a nonambulatory disabled animal, and (5) whether the product contains
MS(Beef). Under the proposed rule, manufacturers and processors must
retain records for 2 years at the manufacturing or processing
establishment or another reasonably accessible location.
Information Collection Burden Estimate
FDA estimates the burden for this information collection as
follows:
Table 4.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Capital Total Hours
Recordkeepers Record Records Record Costs
----------------------------------------------------------------------------------------------------------------
189.5(c), 575 1 575 44.33 $396,750 25,490
700.27(c)
----------------------------------------------------------------------------------------------------------------
189.5(c), 575 52 29,900 0.25 $0 7,475
700.27(c)
----------------------------------------------------------------------------------------------------------------
Total one time ............. .............. ................... .......... .............. 25,490
burden hours
----------------------------------------------------------------------------------------------------------------
Total recurring ............. .............. ................... .......... .............. 7,475
burden hours
----------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
[[Page 42284]]
Burden:
Hour Burden Estimate
FDA has determined that there are 575 facility relationships,
consisting of the following facilities: A producer of cattle materials
requiring records--this may be a slaughterhouse or renderer (the
upstream facility) and a purchaser of cattle materials requiring
documentation--this may be a human food or cosmetic manufacturer or
processor. Together, the upstream and downstream facilities are
responsible for designing records, verifying records, and storing
records that contain information on sources of cattle materials.
In this hour burden estimate, as in the economic analysis, 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 carry the burden necessary to comply
with this proposed rule; therefore we estimate the time burden of
developing these records as a joint task between the two facilities.
One Time Burden
The first year burden of the proposed recordkeeping requirement
consists of the facilities training their employees on how to keep the
records necessary to comply with this proposed rule and designing the
records. The one-time training burden incurred for each facility is
assumed to be the equivalent of 1 month's worth of on-the-job training
or approximately one-third of an hour. This time includes both the
training required for personnel to verify that appropriate records have
been received and/or created, and also the training required by
personnel to file and maintain those records. Therefore, the total one-
time training burden is 575 x 0.33 hrs = 190 hours.
We use the FDA Labeling Cost Model to estimate the one-time records
design costs per facility of $1,785. This cost includes the costs of
designing records for multiple products and consists $1,095 in labor
costs (and $690 in capital costs which we deal with in the next
section). Dividing the $1,095 of labor costs by the hourly wage for
workers of $25.10 (doubled to include overhead), we have a design-time
burden per facility of about 44 hours; we multiplied the burden per
facility by 575 facilities to get an estimated total training and
design burden of 25,490 hours.
Table 4 row 1 of this document shows the total hour burden from
training and records design to be 44.33 hours per facility x 575 record
keepers = 25,490 hours for the year.
Recurring Burden
The recurring recordkeeping burden is the burden of sending and
verifying documents regarding shipments of cattle material that is to
be used in human food and cosmetics.
We estimate this recurring recordkeeping burden will be about 15
minutes per week, or 13 hours per year. FDA assumes that this
recordkeeping burden will be shared between two entities (i.e., the
slaughter plant and the manufacturer of finished products containing
cattle-derived ingredients). Therefore the total recurring burden will
be 13 hrs x 575 = 7,475 hours, as shown in row 2 of table 4 of this
document.
Capital Cost and Operating and Maintenance Cost Burden
We use the FDA Labeling Cost Model to estimate the one-time records
design costs per facility of $1,875 per facility, based on the facility
producing multiple products with ingredients that now require records.
Over $1,000 of the record design cost is due to labor, but $690 of the
records design represents capital costs to each facility. The total
capital costs for records design for all facilities is $690 x 575 =
$396,750. These one time costs are shown in row 1 of table 4 of this
document.
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3507(d)), the agency has submitted the information collection
provisions of this proposed rule to OMB for review. Interested persons
are requested to fax comments regarding information collection to the
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota,
Desk Officer, FDA, FAX: 202-395-6974.
VII. Environmental Impact Analysis
The agency has determined under 21 CFR 25.30(h) that this action is
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.
VIII. Federalism
We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
the proposed 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,
we have tentatively concluded that the proposed 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.
IX. References
1. Model for Estimating the Impacts for Regulatory Costs on the
Survival of Small Businesses and its Application to Four FDA-
Regulated Industries, Final Report, Eastern Research Group, July
2002.
2. CTFA International Buyer's Guide, produced by the Cosmetics,
Toiletries, and Fragrances Association (CTFA) found on the Internet
at http://www.ctfa-buyersguide.org.
3. Memorandum of Telephone Conversation, Dr. Gerald McEwen,
Cosmetic, Toiletry, and Fragrance Association and Karen L. Carson,
Food and Drug Administration, June 29, 2004.
4. United States International Trade Commission Interactive
Tariff and Trade DataWeb, Essential Oils and Resinoids; Perfumery,
Cosmetic or Toilet Preparations. Accessed online at http://dataweb.usitc.gov.
5. U.S. Census Bureau, 1997 Economic Census: Bridge Between
NAICS and SIC Manufacturing. Accessed online at http://www.census.gov.
6. FDA Dietary Supplement Products with Animal Ingredients
Database (DSPD-A), September 2002, RTI International, contractor--
FDA Contract Number 06673.013
7. FDA Labeling Cost Model, Final Report, Muth, M. K., E. C.
Gledhill, and S. A. Karns, RTI, Health, Social, and Economics
Research, Research Triangle, NC, April 2002.
8. Memorandum to the Record, The Costs of a Case of Variant
Creutzfeldt-Jakob disease (vCJD), 2004.
List of Subjects
21 CFR Part 189
Food additives, Food packaging, Substances prohibited from use in
human food.
21 CFR Part 700
Cosmetics, Packaging and containers.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, the
Food and Drug Administration proposes to amend 21 CFR parts 189 and 700
as follows:
* * * * *
PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD
1. The authority citation for 21 CFR part 189 is revised to read as
follows:
Authority: 21 U.S.C. 321, 342, 348, 371, 381.
2. Section 189.5 is amended by revising paragraph (c) to read as
follows:
Sec. 189.5 Prohibited cattle materials.
* * * * *
(c)(1) Records. Manufacturers and processors of human food that is
manufactured from, processed with, or otherwise contains, material from
cattle
[[Page 42285]]
must establish and maintain records sufficient to demonstrate that the
food is not manufactured from, processed with, or does not otherwise
contain, prohibited cattle materials.
(2) Records must be retained for 2 years after the date the records
were created.
(3) Records must be retained at the manufacturing or processing
establishment or at a reasonably accessible location.
(4) The maintenance of electronic records is acceptable. Electronic
records are considered to be reasonably accessible if they are
accessible from an onsite location.
(5) Records required by this subpart must be available to FDA for
inspection and copying.
(6) Importers must electronically affirm their compliance with the
recordkeeping requirements in paragraph (c)(1) of this section at the
time of entry into the United States of human food manufactured from,
processed with, or otherwise containing, material from cattle and must,
if requested, provide the required records within a reasonable time.
(7) Records established or maintained to satisfy the requirements
of this subpart that meet the definition of electronic records in Sec.
11.3(b)(6) of this chapter are exempt from the requirements of part 11
of this chapter. Records that satisfy the requirements of this subpart
but that are also required under other applicable statutory provisions
or regulations remain subject to part 11 of this chapter.
* * * * *
PART 700--GENERAL
3. The authority citation for 21 CFR part 700 continues to read as
follows:
Authority: 21 U. S. C. 321, 331, 352, 355, 361, 362, 371, 374.
4. Section 700.27 is amended by revising paragraph (c) to read as
follows:
Sec. 700.27 Use of prohibited cattle materials from cattle in
cosmetic products.
* * * * *
(c)(1) Records. Manufacturers and processors of a cosmetic that is
manufactured from, processed with, or otherwise contains, material from
cattle must establish and maintain records sufficient to demonstrate
that the cosmetic is not manufactured from, processed with, or does not
otherwise contain, prohibited cattle materials.
(2) Records must be retained for 2 years after the date the records
were created.
(3) Records must be retained at the manufacturing or processing
establishment or at a reasonably accessible location.
(4) The maintenance of electronic records is acceptable. Electronic
records are considered to be reasonably accessible if they are
accessible from an onsite location.
(5) Records required by this subpart must be available to FDA for
inspection and copying.
(6) Importers must electronically affirm their compliance with the
recordkeeping requirements in paragraph (c)(1) of this section at the
time of entry into the United States of cosmetics manufactured from,
processed with, or otherwise containing, material from cattle and must,
if requested, provide the required records within a reasonable time.
(7) Records established or maintained to satisfy the requirements
of this subpart that meet the definition of electronic records in Sec.
11.3(b)(6) of this chapter are exempt from the requirements of part 11
of this chapter. Records that satisfy the requirements of this subpart
but that are also required under other applicable statutory provisions
or regulations remain subject to part 11 of this chapter.
* * * * *
Dated: July 8, 2004.
Lester M. Crawford,
Acting Commissioner of Food and Drugs.
[FR Doc. 04-15880 Filed 7-9-04; 11:00 am]
BILLING CODE 4160-01-S
Final Rule: Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle October 11, 2006
