[Federal Register Volume 60, Number 250 (Friday, December 29, 1995)]
[Proposed Rules]
[Pages 67459-67469]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-31390]
Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 /
Proposed Rules
[[Page 67459]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 310, 318, 319, and 381
[Docket No. 88-026P]
RIN 0583-AB02
Substances Approved for Use in the Preparation of Meat and
Poultry Products
AGENCY: Food Safety and Inspection Service (FSIS), USDA.
ACTION: Proposed rule.
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SUMMARY: FSIS is proposing to amend the Federal meat and poultry
inspection regulations to harmonize and improve the efficiency of the
procedures used by FSIS and the Food and Drug Administration (FDA) for
reviewing and approving the use of substances in meat and poultry
products. Under the proposed procedures, FSIS would no longer issue its
own regulations listing substances it finds suitable for use in meat
and poultry products. Instead, by agreement between USDA and the FDA,
future FDA regulations would specify whether a substance approved for
use in foods under the Federal Food, Drug, and Cosmetic Act (FFDCA) may
be used in or on meat or poultry products. Current FDA regulations that
approve the use of substances in foods generally and do not preclude
meat and poultry uses will confer authority to use such substances in
meat and poultry products unless expressly prohibited by USDA
regulation.
Requests for meat and poultry uses of substances not permitted
under title 9 or title 21 of the Code of Federal Regulations (CFR)
would have to be made to FDA in the form of a petition for FDA
approval. FDA is simultaneously publishing in this issue of the Federal
Register a proposal that would amend the FDA regulations governing the
review of petitions for the approval of food additives to provide for
simultaneous review of such petitions by FSIS when meat or poultry
product uses are indicated. This would permit FDA listings to specify
whether, and if so under what conditions, such substances may be used
in USDA-inspected meat and poultry products. Such listings would
eliminate the need for separate FSIS rulemaking.
FSIS would limit any future, substance-specific rulemaking to
prohibitions or limitations on meat or poultry uses of specific
substances that may be necessary to protect the public under the
Federal Meat Inspection Act (FMIA) or Poultry Products Inspection Act
(PPIA). FSIS would continue to provide evaluations upon request as to
whether substances permitted for general use under current regulations
are suitable for specific uses in meat and poultry products.
FSIS proposes to adopt the position that substances that are listed
in title 21, CFR, Parts 182 and 184, as generally recognized as safe
(GRAS) for use in food generally, with no limitation other than good
manufacturing practice, would be accepted by USDA as GRAS for use in
meat, meat food products, and poultry products generally, unless
otherwise restricted for such use by regulation in title 9, CFR. Other
GRAS substances currently permitted for general food use would be
evaluated by FSIS as to their suitability for specified uses in meat
food products and poultry products on a case-by-case basis, in
consultation with FDA as appropriate.
DATES: Comments must be received by February 27, 1996.
ADDRESSES: Written comments to: Diane Moore, Docket Clerk, Room 4352,
South Agriculture Building, Food Safety and Inspection Service, U.S.
Department of Agriculture, Washington, DC 20250. Oral comments, as
provided under the Poultry Products Inspection Act (PPIA), should be
directed to Mr. Ralph Stafko at (202) 720-8168. (See also ``Comments''
under SUPPLEMENTARY INFORMATION.)
FOR FURTHER INFORMATION CONTACT: Mr. Ralph Stafko, Deputy Director,
Policy Evaluation and Planning Staff, Food Safety and Inspection
Service, U.S. Department of Agriculture, Washington, DC 20250; (202)
720-8168.
SUPPLEMENTARY INFORMATION:
Comments
Interested persons are invited to submit comments concerning this
proposal. An original and two copies of written comments should be sent
to the Docket Clerk's office at the address shown above and should
refer to docket number 88-026P. Any person desiring opportunity for
oral presentation of views, as provided under the PPIA, should make
such request to Mr. Stafko at (202) 720-8168 so that arrangements may
be made for such views to be presented. Copies of all comments
submitted in response to this proposal will be available for public
inspection in the office of the Docket Clerk between 8:30 and 1:00 a.m.
and between 2:00 and 4:00 p.m., Monday through Friday.
Background
FDA and FSIS are both regulatory agencies mandated to protect
consumers from adulterated or misbranded food products. FDA, under the
FFDCA, is responsible for regulating foods generally. FSIS, under the
FMIA and the PPIA, regulates products consisting wholly or in part of
meat or poultry.
Products regulated by FSIS, for the most part, include those
containing at least 2 percent cooked or 3 percent raw poultry or red
meat. Products that contain meat or poultry only in condimental
quantities or that historically have not been regarded as meat or
poultry products are not regulated under the inspection Acts. Examples
of such products are some cheese spreads with meat, close-faced
sandwiches, bouillon cubes, and dried or dehydrated meat soups.
Even though FDA and FSIS have a common food safety mission, they
have differing statutory mandates and carry out their individual
statutory mandates in different ways. FDA relies primarily on the
promulgation of and compliance with regulations to implement its
mandate concerning substances intentionally added to food, such as food
additives and color additives. FDA also relies on inspections of food
manufacturing and storage facilities to enforce its statutory mandates
relating to sanitation and conditions of manufacture and storage.
Detection and seizure of violative products, and sanctions imposed on
producers or manufacturers responsible for violations are based on
evidence that violative product (or a component of the product) was
introduced into interstate commerce.
The FMIA and PPIA (21 U.S.C. 601 et seq.; 21 U.S.C. 451 et seq.)
require that meat and poultry products be inspected, and USDA
inspection program personnel inspect such products before the products
are placed in commerce. The USDA mark of inspection is placed only on
those products found by USDA to be unadulterated and properly labeled.
Thus, FSIS's primary enforcement activity is the conduct of inspection
activities designed to prevent the production and distribution of
adulterated or misbranded products. FSIS regulations on products under
its jurisdiction are enforced primarily by inspectors and inspection
program support staff on a plant-by-plant basis. Inplant FSIS personnel
may retain suspect product and condemn adulterated product. In
egregious cases, FSIS may withdraw inspection from plants.
This different approach to regulation, based on the statutes
governing the activities of the respective agencies, has required FSIS
and FDA, and their predecessor agencies, to work together closely to
minimize the potential for
[[Page 67460]]
conflict, duplication of effort, or gaps in their regulatory schemes
that could result in inadequate or inappropriate regulation.
Over the years, FDA has generally deferred to FSIS in matters
concerning the regulation of meat, meat food products, and poultry
products, despite its broad jurisdiction over all food. This approach
is consistent with the proposition that in cases of possible
jurisdictional overlap, an agency with a broad grant of statutory
authority will normally defer to an agency with a more specific grant
of authority. FSIS employs veterinarians, trained inspectors, and
technical support staff to carefully and continuously oversee the
production of these products. FSIS regulations and guidelines govern
all aspects of meat and poultry food product that are subject to such
inspection. These include regulations and guidance on substances that
may be added to those products.
Since the 1958 Food Additives Amendment to the FFDCA, FSIS has come
to rely on FDA in most matters concerning the safety of food and color
additives and other substances that may be used in foods--including
meat and poultry products. FDA has developed the scientific staff, the
institutional expertise, and the regulatory structure to ensure the
safety of substances that may be added to foods.
Over the years, FDA and FSIS have cooperated on food-ingredient
issues on an as-needed, substance-specific, case-by-case basis.
Nonetheless, because of their different regulatory needs, the two
agencies' regulations governing the use of these substances in foods
are cast in formats and terms that are not fully consistent with one
another. This inconsistency causes difficulty and inconvenience to
persons who need to refer to both agencies' regulations on approved
substances and approved uses.
Furthermore, it is not clear from the regulations where one
agency's jurisdiction ends and the other's begins. The public
frequently sends FSIS requests for the use of new substances or new
uses of substances that must be referred to FDA, and sends FDA requests
involving meat or poultry uses that must be referred to FSIS.
Finally, FSIS's current regulations require that substances used in
meat or poultry products be listed in FSIS regulations for those uses.
The regulations further require that those wishing to establish a rule
permitting meat or poultry product uses of a substance first must
establish that it is safe for the intended use under the FFDCA, and
second, that it is suitable for the intended use under the FMIA or PPIA
(9 CFR 318.7(a) and 381.147(f)). As a result, both agencies conduct
separate reviews and undertake separate rulemakings, sequentially,
before a new meat or poultry use of a substance can be permitted. This
proposed rule and a concurrent FDA proposed rule, appearing elsewhere
in this issue of the Federal Register, are intended to harmonize and
simplify the agencies' regulations on food ingredients by allowing FSIS
to rely on FDA's listings for food ingredients, and to provide a basis
for the eventual elimination of FSIS's separate listings from the CFR.
There would be a single petition, joint reviews, and a single
rulemaking procedure, as well as continuing consultation on related
issues, to replace the current time-consuming, duplicative, sequential
rulemaking procedures. The agencies would enter into a Memorandum of
Understanding (MOU) concerning the specifics of the agencies' working
relationship. A draft of this MOU appears as an appendix to this notice
of proposed rulemaking.
The following review of the laws and regulations of the two
agencies explains in more detail the agencies' relationship in this
area of regulation.
History of Food Additive Regulation
The Food and Drugs Act of 1906 declared that food containing ``any
added poisonous or other added deleterious ingredient which may render
such article injurious to health'' was adulterated (PL 59-384, 34 Stat.
770), and that sale of adulterated food was a violation of law. The
Meat Inspection Act, passed at the same time as companion legislation,
mandated Federal inspection of meat and meat food products.
Responsibility for implementing and enforcing both these laws was
vested in the Secretary of Agriculture.
In 1938, the FFDCA expanded the scope of the Food and Drugs Act by,
among other things, prohibiting the sale of foods that may be
adulterated by substances other than added ingredients, such as by
environmental contaminants, that could render the food injurious to the
health of the consumer.
In 1940, responsibility for implementation and enforcement of the
FFDCA was removed from the Secretary of Agriculture and was vested in
the Administrator of the Federal Security Agency, which later became
the Department of Health, Education, and Welfare (today, the Department
of Health and Human Services). However, the authority to implement the
meat inspection system was retained by USDA.
By the 1950's, it had become apparent that there were certain
limitations in the authorities provided by the FFDCA. Among these was
the lack of a provision requiring industry to pretest substances
intended for use in food to determine the safety of such use. Also, in
an enforcement action against a violative food, the burden of proof was
on the Government to show that use of a food additive caused the food
to be adulterated or misbranded.
To correct these and other problems, the Food Additives Amendment
was passed in 1958. Processors were thenceforth required to prove that
food additives were safe for their intended use before they could be
used in food. FDA was required to determine the safety of food
additives and regulate their use in foods.
The Food Additives Amendment of 1958 applies to substances added to
all foods, including meat and poultry products subject to USDA
inspection under the FMIA and the PPIA. The FMIA (21 U.S.C. 601 et
seq.) and the PPIA (21 U.S.C. 451 et seq.) give USDA primary
jurisdiction over meat and poultry products to a ensure product
entering commerce is not adulterated or misbranded. FSIS has
interpreted the Food Additives Amendment as giving FDA primary
jurisdiction for the approval of food additives for use in meat and
poultry products, while not precluding continued exercise of USDA/FSIS
jurisdiction to further regulate the use of those substances in meat
and poultry products under the FMIA and PPIA.
Section 1(m)(2) of the FMIA (21 U.S.C. 601(m)(2)) and section
4(g)(2) of the PPIA (21 U.S.C. 453(g)(2)) provide the Secretary of
Agriculture with authority to regulate the use of food and color
additives in meat and poultry products. Section 1(m)(2)(C) of the FMIA
and section 4(g)(2)(C) of the PPIA provide that any meat or poultry
carcass, part, or product is adulterated ``if it bears or contains any
food additive which is unsafe within the meaning of section 409 of the
Federal Food, Drug, and Cosmetic Act (FFDCA).'' Under section 409 of
the FFDCA (21 U.S.C. 348), all food additives are deemed unsafe unless
the FDA finds, by regulation, that they are safe for a particular use.
Section 1(m)(2)(D) of the FMIA (21 U.S.C. 601(m)(2)(D)) and section
4(g)(2)(D) of the PPIA (21 U.S.C. 453(g)(2)(D)) provide that any meat
or poultry carcass, part, or product is adulterated ``if it bears or
contains any color additive which is unsafe within the meaning of
section 721 of the
[[Page 67461]]
FFDCA.'' Under section 721 of the FFDCA (21 U.S.C. 379e), all color
additives are deemed unsafe unless the FDA finds, by regulation, that
they are safe for a particular use. Section 1(m)(2) of the FMIA (21
U.S.C. 601(m)(2)) and section 4(g)(2) of the PPIA (21 U.S.C. 453(g)(2))
also provide that the Secretary of Agriculture may issue regulations
prohibiting the use of a food additive or color additive in a meat or
poultry article in establishments receiving Federal meat or poultry
inspection services.
The Secretary of Agriculture's authority under the FMIA to prohibit
the use of substances in meat products that are otherwise permitted in
foods by FDA was tested in Chip Steak Co. v. Clifford Hardin (332 F.
Supp. 1084 (N.D. Cal. 1971), aff'd., 467 F.2d 481 (9th Cir. 1972)). The
plaintiffs demanded injunctive relief from the prohibition at 9 CFR
318.7(d)(2) against the use of sorbic acid and sorbates in cooked
sausage. The court held that the legislative history of the FMIA showed
that it was the intent of Congress to vest the Secretary of Agriculture
with the authority to prohibit the use of substances in meat food
products notwithstanding their designation as GRAS. The court noted
that under the FMIA, the Secretary had the power to prohibit a
substance for use in meat and meat products even if the substance is
not adulterative under the food additive provisions of the FFDCA. Thus,
the Secretary of Agriculture could impose restrictions for food
ingredients in meat and meat food products that exceeded restrictions
imposed by the Secretary of HHS.
At about the same time that this case was in progress, the Agency
was involved in rulemaking to implement the Wholesome Meat Act (81
Stat. 584) and the Wholesome Poultry Products Act (82 Stat 791-808).
Among the provisions in the new regulations were requirements for
listing substances in the 9 CFR regulations before they could be used
in meat, meat food, or poultry products. The relevant provisions, at 9
CFR 318.7(a)(1) and 381.147(f)(1) in the existing regulations, were
adopted October 3, 1970, and May 16, 1972, respectively. They had the
effect, along with the favorable district court decision, of
strengthening the Administrator's authority to control the use of
substances in meat and poultry products. Nothing in the current
proposal would diminish that authority.
FDA Regulations
Meat and poultry product ingredients are subject to regulation by
the FDA under the FFDCA. Such ingredients may be food additives,
substances that are generally recognized as safe (GRAS) for use in
food, color additives, or ingredients covered by prior sanctions.
The FFDCA defines a food additive as ``any substance the intended
use of which results or may reasonably be expected to result, directly
or indirectly, in its becoming a component or otherwise affecting the
characteristics of any food * * *'' (21 U.S.C. 321(s)). Anyone wishing
to use a new food additive must petition the FDA and obtain approval
before using the substance in food. The sponsor must provide FDA with
information demonstrating safety under the proposed conditions of use.
The extent or amount of the data submitted will depend primarily on the
nature of the substance and its intended uses.
FDA's food additive regulations are codified in several parts of
title 21 of the Code of Federal Regulations. Part 170 contains general
provisions. Part 171 specifies how food additive petitions are
submitted and processed. Part 172 lists food additives approved for
direct addition to food. Part 173 lists food additives permitted in
food, e.g., enzyme preparation, microorganisms, solvents, and
lubricants. Part 179 covers sources of radiation used to process food,
included in the statutory definition of a food additive (21 U.S.C.
321(s)). Part 180 lists certain food additives to be used on an interim
basis until such time as studies can be completed and data made
available to resolve those safety issues if the Commissioner of Food
and Drugs determines that the continued use of those substances
presents no public health concern.
The definition of ``food additive'' excludes certain substances
that are ``prior sanctioned,'' ``generally recognized as safe,'' or
``color additive'' substances. Prior sanctioned ingredients are those
used in accordance with explicit sanctions or approvals granted prior
to the enactment of the Food Additives Amendment in 1958. These prior
sanctions may have been granted by FDA under the FFDCA (21 U.S.C.
321(s)(4)) or by USDA under the FMIA or the PPIA. Such ingredients,
e.g., nitrites used in cured pork products, are exempt from the food
additive provisions of the FFDCA.
A second exemption from the definition of ``food additive'' is
``generally recognized as safe'' or ``GRAS'' substances. These are
defined by the FFDCA as substances generally recognized as safe among
experts qualified by scientific training and experience to evaluate
their safety. Designation as GRAS can come about in either of two ways:
(1) By demonstration of common use of the substance in food prior to
1958 or (2) by scientific procedures.
GRAS substances include a variety of common food ingredients.
Although FDA advises that it would be impracticable to list all
substances that are generally recognized as safe for their intended
use, many GRAS substances are specifically listed in Part 182 of title
21. In addition, FDA has formally affirmed certain substances as GRAS,
and has listed their GRAS uses in Part 184 of title 21.
FDA may also find that a substance or a particular use of a
substance is not generally recognized by qualified experts as safe for
use in food. Such substances or uses may continue to be used under an
``interim food additive'' regulation (21 CFR 180) while specified
studies are performed to resolve the safety question.
A ``color additive'' is a material that, `` * * * when added or
applied to a food, drug, * * * or cosmetic, or to the human body or any
part thereof, is capable * * * of imparting color thereto'' (21 U.S.C.
321(t)). As with food additives, only those color additives listed for
use in food may be so used. Petitions must be submitted to FDA for any
new color additive or uses along with appropriate safety data and other
pertinent information.
FSIS Regulations
FSIS inspectors oversee the production of meat and poultry products
and must assure that product is not adulterated or misbranded by the
addition of unsafe or otherwise improper ingredients, or by
contamination with substances used for other purposes in the plant. To
assist in this activity, FSIS headquarters staff reviews and approves
substances that may be used in meat and poultry products regulated
under the FMIA and PPIA.
Substances added directly to products are strictly regulated. FSIS
regulations provide that no substance may be used in the preparation of
any meat or poultry product unless the use of the substance is approved
by the Administrator and listed in the regulations, or the
Administrator has approved use of the substance in a specific case (9
CFR 318.7(a)(1) and 381.147(f)(1)). The tables of substances in 9 CFR
318.7 and 381.147 list a variety of substances along with their general
classification (e.g., ``antioxidant''), their intended function, the
categories of products in which they may be used, and the permitted use
levels. The tables supplement or complement the product
[[Page 67462]]
standards set forth in 9 CFR 319 and 9 CFR 381.155-171. In order to add
a new substance to these listings, increase the permitted use level, or
expand the category of products in which an approved substance may be
used, FSIS amends these listings by notice-and-comment rulemaking.
FSIS provides guidance on the regulatory status of substances used
in inspected establishments. In the course of day-to-day operations,
FSIS staffs must respond to inquiries, from inspectors and others,
about new uses of substances already approved, or the use of new
substances not previously approved, and must determine whether such
substances are safe and suitable before they are used in specific meat
food or poultry products. Responses to these inquiries generally are
made after review by FSIS's Product Assessment Division (PAD), or, if
appropriate, the Facilities, Equipment, and Sanitation Division (FESD).
The PAD will assess the safety and suitability of direct and
indirect additives. Its assessment involves primarily a determination
of whether the substance has been previously approved for safety by FDA
or USDA. If the substance is a food additive or color additive the safe
use of which has not been approved by FDA, the inquiring party is
directed to petition FDA. If it is a GRAS substance or is asserted to
be prior-sanctioned, a determination of its status is made by PAD, in
consultation with FDA, if appropriate.
PAD will also determine the functionality of substances proposed to
be added to meat or poultry products, and reviews data on amounts
needed to achieve the intended technical effect. PAD looks at the
consistency of the proposed use with standards of identity that may
apply, and whether the substance may be misused in some way to make
product adulterated or misbranded. The Division will restrict uses as
appropriate to prevent adulteration or misbranding.
PAD reviews labels for compliance with FSIS regulations, including
ingredient and additive requirements, and must approve them before they
are used on the packaging of meat and poultry products (9 CFR 317.4,
381.132). The Division is thus in a position to monitor, by looking at
formulations, the ingredients intended to be used with each product. In
addition, the Division conducts a voluntary review of proprietary mixes
intended for use in meat food or poultry products.
Similarly, PAD reviews food-contact materials, such as processing
aids, scalding agents, and chill tank additives. If these substances
are found to be food additives or color additives as defined by the
FFDCA, they also must be approved by FDA before USDA will approve them
for use with inspected products. Other substances, some of which are
not regulated under the FFDCA's food additive provisions, are
nonetheless reviewed by FSIS on an ``as needed'' basis, before their
use in or about inspected products is sanctioned. Inspectors, meat and
poultry processors, food chemical and equipment manufacturers, and
others require guidance on whether inspectors may view substances as
potential adulterants of inspected product. Prior review by FSIS's
technical staff normally will resolve the question. For example, review
and approval for use in official establishments of specific sanitizing
and cleaning agents, and of food-contact equipment and utensils, is
done by the FESD.
FDA Rulemaking Processes
Current FDA rulemaking for food additive and GRAS listings is
essentially a four-part process:
1. A petition for use of a new food additive, a new use or use
level of an existing food additive is received with data demonstrating
the safety of the intended use of the substance, or a petition for
affirmation of a substance as GRAS is received with data or information
demonstrating that the substance is GRAS;
2. A notice of proposed rulemaking (or a notice of the filed
petition--the functional equivalent of a proposed rule) is published in
the FR;
3. A review for safety and technical effect of the new substance,
new use, or new use level of the substance is conducted by the FDA;
and,
4. A final rule is published if FDA determines that the food
additive use or use level is safe or if the substance is GRAS.
FDA listings normally do not specify whether permitted uses include
uses in meat and poultry products or, if so, what conditions or
restrictions apply to such uses. Because USDA has always (prior to the
1958 food additive amendments) regulated the safe use of substances in
meat and poultry products, and because of the need for inspected
establishments, inspection program personnel and others to have uniform
guidance on what substances may be added to inspected product, USDA has
historically listed such substance uses in its own regulations in title
9 of the CFR.
FSIS Rulemaking Procedures
Before July 1983, FSIS conducted its own notice-and-comment
rulemaking, as needed, for the listing of substances approved for use
in meat and poultry products. Industry representatives complained that
these FSIS rulemakings largely duplicate FDA rulemaking. They asserted
that FDA's food additive and GRAS substance affirmation proceedings
address and fully resolve all questions regarding safety, if not
functionality, of ingredients intended to be used in meat and poultry
products. They argued that additional rulemaking by FSIS generated
needless delays and expense, and often resulted in the withholding of
ingredients from the marketplace for months or even years after all
serious questions of safety had been resolved.
Furthermore, notice-and-comment rulemaking by FSIS duplicated FDA's
rulemaking (concerning safety), resulting in needless expenditure of
USDA resources. FSIS concluded that these complaints had merit and
that, if a substance was already listed in title 21, the safety of such
uses had, by law, already been determined by competent authority. The
addition of a substance to title 9 should not require a full
reassessment for the safety of such use by USDA. For those reasons,
FSIS proposed to amend its procedures.
In July 1983, FSIS issued a final rule, ``Meat and Poultry
Products; Approval of Substances'' (proposed June 2, 1982, 47 FR 23941;
final July 19, 1983, 48 FR 32749). Under this rule, full notice-and-
comment rulemaking was no longer required for FSIS to list in its
regulations substance uses or use levels if such uses or use levels
were consistent with those already approved by FDA. A final rule
listing the substance use or use-levels could be promulgated without
first proposing it for comment, provided that:
1. The substance was an approved food additive, color additive, or
substance affirmed as GRAS and permitted for use in food under title
21;
2. The intended use was in accordance with any conditions specified
in the FDA approval and would not violate any other applicable FDA
requirement; and,
3. The Administrator of FSIS determined:
a. That FSIS concurred with FDA regarding the safety of the
substance;
b. That the available data indicated that the use of the substance
would have an appropriate technical effect on the product; and,
c. That the available data indicated that the substance would be
used only in the amount reasonably required to accomplish its intended
technical effect. (9 CFR 318.7 and 381.147.)
[[Page 67463]]
All products in which the substance would be used would be required
to be properly labeled and subject to other applicable requirements of
the meat and poultry products inspection regulations.
This ``fast-track'' listing procedure did result in time and
resource savings by both FSIS and the industry. In August 1988,
however, FSIS discontinued its fast-track procedures because of
concerns that the procedures might not satisfy the requirements of the
Administrative Procedure Act.
While reverting to notice-and-comment procedures for these
rulemaking proceedings, FSIS also decided to investigate other means of
reducing the rulemaking burden. FSIS concluded that duplicative
rulemaking could be avoided if all relevant FMIA and PPIA issues could
be resolved in the context of the rulemaking proceeding already
required under the FFDCA and conducted by FDA. This proposed rule was
conceived at that time, was agreed upon in principle by FDA, and is now
being published for public comment.
Comments submitted in response to USDA's February 25, 1992, notice
(57 FR 6483) requesting public comments on how Departmental regulations
can be improved, updated, or streamlined, support the Agency's decision
to initiate this proposed rulemaking. In a March 13, 1992, letter, the
American Meat Institute (AMI), an organization representing meat
packers and processors of meat and meat food products, noted that the
``industry's current inability to use a wide variety of safe food
ingredients'' because of the Agency's regulatory procedures prevents
the use of least-cost formulations and impedes product development. The
organization estimated that ``direct costs associated with pursuing
unnecessary regulatory changes may exceed $100,000, and such
proceedings generally delay introductions of new products for several
years.''
Proposed New Policy
FDA and FSIS have agreed on a proposed new procedure for regulating
substances intended for use in meat and poultry products. Under this
new procedure, FSIS inspection program personnel will permit meat and
poultry use of substances if such uses are permitted under FDA
regulations, unless otherwise restricted or prohibited by other FDA
regulations or FSIS regulations.
FSIS will no longer issue regulations to list substances found by
the Agency to be acceptable for certain uses in meat and poultry
product. Instead, the Agency will refer to FDA regulations in order to
determine whether a substance may legally be used in or on a meat or
poultry product.
A key point of this new procedure, reflecting provisions of the
FMIA and PPIA and the intent of previous rulemakings, is that
substances added to meat and poultry products, including GRAS or prior-
sanctioned substances, must be permitted under the FFDCA and be used
consistently with any applicable regulations.
Under the proposed procedure, FSIS will be exercising the same
authority and continuing the same reviews that it has been conducting
all along.
FSIS, in carrying out the mandates of the FMIA and PPIA, has
published regulatory requirements and guidelines in the areas of
facilities, equipment, sanitation, and production and process controls
that apply to establishments where meat, meat food, and poultry
products are prepared for distribution in interstate or foreign
commerce. As it has in the past, when FSIS must decide on the
acceptability of a substance approved by FDA for general food use, it
will seek FDA concurrence.
In its future regulatory listings of substances and after
consultation with FSIS, FDA will include, as appropriate, the amounts
and uses of substances permitted for use in meat and poultry products.
This is consistent with current FDA listing format. FDA's
determination of the acceptability of any food additive or GRAS
substance use is conditioned on the substance being used in accordance
with GMP. The general regulations for determining GMP criteria are set
forth in 21 CFR part 110. These regulations set minimum general
requirements for buildings, facilities, equipment, sanitation, and
production and process controls to be observed in food plants where
products are prepared for distribution in interstate or foreign
commerce. Further GMP criteria are set forth in 21 CFR part 172 for
food additives, 21 CFR part 182 for GRAS substances, and 21 CFR part
184 for substances affirmed as GRAS.
FSIS's title 9 listing of authorized substances is incomplete,
inconsistent with, and duplicative of FDA's listings. The Agency plans
to eliminate its current listings over time by rulemaking, as listings
are determined to be duplicative of FDA regulations. However, FSIS will
retain its own regulations on specific substance use prohibitions and
will add new prohibitions as necessary.
To provide guidance to its inspectors, inspected establishments,
and other interested persons, FSIS will maintain a comprehensive
listing, in its directive system, of substances authorized for meat and
poultry uses under title 9 or title 21, CFR. FSIS's listing will
include:
a. Substances currently listed in title 9;
b. Substances currently listed for meat or poultry uses in FDA food
additive, GRAS, or prior-sanction listings;
c. Approved color additives currently listed in 21 CFR Parts 73,
74, and 82, food additives listed in 21 CFR Parts 172-173 and 180,
prior sanctioned substances listed under part 181, GRAS substances
listed in 21 CFR 182 and 184, if permitted for general use in or on
foods (which includes meat and poultry) in accordance with good
manufacturing practice, unless meat or poultry uses of the substances
are otherwise precluded;
d. GRAS substances found by FSIS to be suitable for specified meat
and poultry uses on the basis of information and data submitted by
petitioners to FSIS. Factors affecting FSIS findings of suitability
include:
(1) Existing FDA GRAS listings, which need not explicitly permit
but may not preclude the specific use in meat or poultry products; and
(2) Concurrence of FSIS with the petitioner and FDA acceptance of
FSIS's determination.
e. FDA food additive, color additive, GRAS, and prior-sanctioned
substance listings promulgated after this proposal becomes final that
provide for meat and poultry uses.
Requests for use of substances not authorized for use in meat and
poultry products must be made to FDA in the form of a petition to amend
FDA food additive, color additive, or GRAS affirmation regulations, as
appropriate. Specifically, this is required when the substance: (1) is
not expressly listed for meat and poultry uses in title 9, CFR, or in
title 21, CFR, Parts 172-180; (2) is not a GRAS substance listed in
Part 182 or 184 of title 21 for general use in foods; and (3) cannot be
demonstrated to FSIS to be GRAS for particular meat or poultry uses.
The working relationship between the two agencies, as set forth in
the memorandum of understanding (MOU) between them, would ensure FDA
and FSIS collaboration on any petition that includes a use in meat or
poultry products.
The Administrator of FSIS would retain legal authority to prohibit
or restrict the use of specific substance(s) in meat or poultry
products by notice-and-comment rulemaking, but is not expected to have
to exercise that authority on a regular basis because FDA's statutory
authority, exercised in
[[Page 67464]]
accord with the MOU, would provide a basis for appropriate limitations
on uses in meat and poultry products.
The Proposed Rule
Under this proposal, FSIS would discontinue duplicative rulemaking
activity regarding food additive and GRAS substance uses in meat and
poultry products. FSIS would amend the Federal meat and poultry
products inspection regulations in 9 CFR, Parts 310, 318, 319, and 381
to include appropriate cross-references to title 21 listings of food
additive and GRAS substances permitted for use in meat and poultry
products.
Substances whose use is GRAS are exempt from the premarket approval
requirements of the FFDCA and need not be listed in title 21 of the
Code of Federal Regulations. For substances that have not been listed
by FDA as GRAS in Parts 182 or 184 of title 21, FSIS will continue to
consider, in consultation with FDA, a manufacturer's basis for claiming
GRAS status and suitability for use in meat, meat food, or poultry
products. Likewise, a manufacturer has the option of seeking advice
from FSIS regarding the suitability for specific uses in meat, meat
food, or poultry products for substances listed in title 21 only for
general use in foods, or for use in meat, meat food, or poultry
products generally. FSIS's responses and related correspondence would
be available to the public, except that the formulation and process
data for proprietary mixtures would be kept confidential. Parties
requesting such evaluations would be advised to petition FDA when the
requested use is not permitted under FDA's regulations.
In keeping with this approach, FSIS proposes that, as a matter of
policy, all substances currently listed by FDA as GRAS in title 21 of
the CFR, Parts 182 and 184, for use in food generally, with no
limitation other than good manufacturing practice, be considered by
USDA to be GRAS for use in meat, meat food product, and poultry
product, unless otherwise restricted for such use by regulation in
title 9 of the CFR. Uses of substances may be restricted by FSIS
standards of identity or composition, or in specific cases where the
inspection program determines that use may adulterate the product.
Existing FSIS regulations in 9 CFR 318.7 and 381.147 listing
substances for various meat and poultry uses would not be immediately
affected. However, FSIS plans to review its title 9 listings within the
next 3 to 5 years, and to eliminate those that duplicate FDA's title 21
listings. FSIS and FDA believe that the public will be better served by
having all permitted uses for food additives and GRAS substances
consolidated in one place--listings in title 21 of the CFR--and intend
to work toward that end. Because of resource constraints, at the
present time FDA regulations in title 21 will be amended to accommodate
meat and poultry uses only in response to a food additive, color
additive, or GRAS affirmation petition.
All petitions for rulemaking to permit new substances or new uses
or use levels of substances in foods--including meat and poultry
products--would be sent to FDA. FDA would evaluate the petitions in
consultation with FSIS if any prospective use of a food additive, color
additive, or GRAS substance includes use in meat, meat food, or poultry
products.
The proposed revisions of 9 CFR 310.20 and 318.1 are intended only
for the purpose of including appropriate references to substance
listings in title 21, CFR. They would not change the substantive
requirements governing the saving of livestock blood or the labeling of
containers. Similarly, the proposed revision of 9 CFR 318.7(d)(2) is
intended only for the purpose of adding a reference to title 21, CFR,
and would not change the prohibitions of and restrictions on the
substance uses provided in that paragraph.
The proposed 9 CFR 318.7(a)(4), 318.7(a)(5) and 381.147(f)(2)(iv)
are intended to provide addresses for inquiries concerning food or
color additive status of substances intended for use in or in contact
with meat or poultry products. The proposed 9 CFR 318.79(a)(5) and
381.147(f)(2)(v) are intended to provide addresses for inquiries on the
suitability for use in meat or poultry products, of substances not
listed in the title 21 regulations. These provisions are not intended
as requirements for a petitioning or petition review process.
Appended to this proposed regulation is a copy of the draft
Memorandum of Understanding between FDA and FSIS, which would provide
for the administration of these provisions.
Executive Order 12866
This proposed rule has been reviewed under Executive Order 12866
and found to be significant, but not economically significant, within
the meaning of the Executive Order (sec. 3(f)). It is significant
because it is a novel, collaborative, inter-Agency approach to
streamlining regulation. It decreases regulatory and paperwork burdens
on society by proposing an alternative to the current Government
process of approving substances for use in foods.
This proposal would replace the current Government processes for
approving substances and their uses in meat and poultry products,
involving consecutive rulemakings by FDA and FSIS, with a ``one-stop''
procedure whereby sponsors of new food additive or other substance uses
in meat and poultry products would have to petition only the FDA. FDA
would conduct any required rulemaking on the matter in consultation
with FSIS. FDA's rule would then specify any uses or use restrictions
unique to meat or poultry products, thereby permitting use of the
substance under the FMIA and PPIA.
This proposal embodies the regulatory philosophy and principles of
Section 1 of the Executive Order and was the result of a review of
existing regulations consistent with the direction in section 5. It
modifies existing FSIS regulations concerning the approval of
substances to be added to meat, meat food, and poultry products that
have been found to result in needless duplication of effort and
expenditures by Government and the regulated industry. These
regulations necessitate sequential rulemakings by FDA and FSIS to
permit a new substance or a new use of a previously approved substance
to be used in meat, meat food, or poultry products. The costs to
industry and Government of these rulemaking procedures includes the
costs to industry arising from a several years' delay in the
introduction of new food additives or new food products. These costs
create a disincentive for technological innovation and new product
development. The existing process, therefore, has a negative effect on
economic growth.
Benefit-Cost Assessment
The public benefits conferred by the rulemaking include,
principally, those associated with the more timely regulatory approval
of substances added to foods and the benefits of the substances
themselves. The benefits of substances added to meat and poultry
products include the technical effects on the characteristics of food
products, the uses of the substances in food processing, and a greater
variety of foods in the marketplace. Public health benefits can include
the greater availability of food through preservation techniques and
improved food safety through, for example, antimicrobial treatment of
raw product and the use of curing solutions in processed products. The
benefits conferred by the availability of substances and their uses
would be marginally increased by this rulemaking.
[[Page 67465]]
The public benefits of regulating food additives generally would
not change. These include, principally, the prevention of adulteration
or misbranding of food products. Consumers are provided assurance that
the products they buy do not contain substances whose use ought, for
various reasons, to be prohibited, or substances that have been
approved have not been used improperly in foods. Such benefits would
not be affected by this proposed rulemaking because FDA would continue
to conduct food safety reviews of substances proposed for use in foods,
including--in consultation with FSIS--meat and poultry products, and
FSIS would continue to exercise its in-plant inspection and other
regulatory authorities to prevent the marketing of adulterated or
misbranded meat and poultry products.
Therefore, elimination of the duplicative FSIS rulemaking process
involved in approving substances for use in meat and poultry products
could save the regulated industry about $600,000 a year over and above
the savings the Government itself would realize in administrative
costs.
Other, albeit less calculable benefits arise through the removal of
a disincentive to innovate. With the potential expansion of uses of
approved food additives and other substances that could result from the
easing of the current regulatory burden, new product development and
marketing could be encouraged.
Executive Order 12778
This proposed rule has been reviewed pursuant to Executive Order
12778, Civil Justice Reform. This proposed rule would provide for the
use in meat and poultry products of substances approved by FDA and
listed in 21 CFR for such uses, and would eliminate the requirement in
the current 9 CFR 318.7(a) and 381.147(a) listing of such uses in 9 CFR
318.7(c)(4) or 381.147(f)(4).
States and local jurisdictions are preempted under the Federal Meat
Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA)
from imposing any requirements with respect to federally inspected
premises and facilities, and operations of such establishments, that
are in addition to, or different than, those imposed under the FMIA or
PPIA. States and local jurisdictions are also preempted under the FMIA
and PPIA from imposing any marking, labeling, packaging, or ingredient
requirements on federally inspected meat or poultry products that are
in addition to, or different than, those imposed under the FMIA or the
PPIA. States and local jurisdictions may, however, exercise concurrent
jurisdiction over meat and poultry products that are outside official
establishments for the purpose of preventing the distribution of meat
or poultry products that are misbranded or adulterated under the FMIA
or PPIA or, in the case of imported articles, which are not at such an
establishment, after their entry into the United States. States and
local jurisdictions may also make requirements or take other actions
that are consistent with the FMIA and PPIA, with respect to any other
matters regulated under the FMIA and PPIA.
Under the FMIA and the PPIA, States that maintain meat and poultry
inspection programs must impose requirements on State-inspected
products and establishments that are at least equal to those required
under the FMIA or PPIA. These States may, however, impose more
stringent requirements on such State-inspected products and
establishments.
In the event of its adoption, no retroactive effect would be given
to this proposed rule, and applicable administrative procedures must be
exhausted before any judicial challenge to the application of these
provisions. Those administrative procedures are set forth in 9 CFR
306.5, 318.21(h), 381.35, and 381.153(h).
Effect on Small Entities
The Administrator, FSIS, has determined that the proposed
amendments would not have a significant economic impact on a
substantial number of small entities. Obtaining approval for the use in
meat and poultry products of new substances or for new uses of
previously approved substances would be simpler, faster, and less
costly for both industry and the Federal Government than under the
current system.
FSIS now may approve for use in meat or poultry products only those
substances that have been previously reviewed for safety and approved
for such use by FDA. Under the proposed amendments, separate petitions
to FSIS would no longer have to be submitted. FSIS would permit
substances to be used in products under its jurisdiction on the basis
of FDA's title 21 regulations permitting such uses. Those substances
not authorized for meat and poultry use under existing FDA regulations
would require only one petition for rulemaking--to FDA. (For a
substance that is not affirmed by FDA as GRAS or otherwise listed in 21
CFR part 182 or 184, or a substance listed by FDA for general food use,
manufacturers would have the option of requesting that FSIS evaluate
the manufacturer's assertion of the GRAS status of the substance and
its suitability for a specified use in meat and poultry products.)
FSIS is currently receiving about six petitions per year for the
approval of substances for use in meat and poultry products. Most of
these petitions are from large commercial entities. Although the
reduction in costs from the proposed rule would be significant, but
unknown, for prospective petitioners, the number of such entities is
not substantial. Therefore, the proposed amendments would not have a
significant effect on a substantial number of small entities.
Furthermore, all users of the Federal regulations concerning the
addition of substances to foods should benefit by having fewer, clearer
regulations. Thus, there would be a reduction in the duplication of
effort and attendant costs for all concerned.
Paperwork Reduction Act
FSIS has determined that the proposed rulemaking would entail no
new information collection from the regulated industry or other private
entities. Rather, the effect of the rulemaking would be to
substantially reduce the information collection from private sources
concerning proposed uses of substances in meat or poultry products.
Persons seeking Federal Government approval of substances for use in
meat or poultry foods would only have to petition FDA, rather than both
FDA and FSIS, as they now do. Thus, a current, duplicative information
collection requirement would be eliminated.
List of Subjects
9 CFR Part 310
Animal diseases, Meat inspection.
9 CFR Part 318
Food additives, Meat inspection.
9 CFR Part 319
Food grades and standards, Meat inspection.
9 CFR Part 381
Food grades and standards, Meat inspection, Poultry and poultry
products.
For the reasons set forth in the preamble, FSIS proposes to amend
Parts 310, 318, 319, and 381 of title 9, Code of Federal Regulations,
as follows:
PART 310--POST-MORTEM INSPECTION
1. The authority citation for Part 310 would be revised to read as
follows:
[[Page 67466]]
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
2. Section 310.20 would be revised to read as follows:
Sec. 310.20 Saving of blood from livestock as an edible product.
Blood may be saved for edible purposes at official establishments
provided it is derived from livestock, the carcasses of which are
inspected and passed, and the blood is collected, defibrinated, and
handled in a manner so as not to render it adulterated under the
Federal Meat Inspection Act and regulations issued pursuant thereto.
The defibrination of blood intended for human food purposes shall not
be done with the hands. Anticoagulants specified in title 21 of the
Code of Federal Regulations or in this subchapter may be used in lieu
of defibrination.
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND
PREPARATION OF PRODUCTS
3. The authority citation for Part 318 would be revised to read as
follows:
Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR
2.18, 2.53.
4. Section 318.1(d) would be revised to read as follows:
Sec. 318.1 Products and other articles entering official
establishments.
* * * * *
(d) Containers of preparations which enter any official
establishment for use in hog scalding water or in denuding of tripe
shall bear labels showing the chemical names of the preparations. In
the case of any preparation containing any of the chemicals which are
specifically limited by title 21 of the Code of Federal Regulations,
Parts 73, 74, 81, 172, 173, 179, 182, or 184, or by a regulation in
this subchapter, as to amount permitted to be used, the labels on the
containers must also show the percentage of each such chemical in the
preparation and must provide dilution directions which prescribe the
maximum allowable use concentration of the preparations.
* * * * *
5. Section 318.7 would be amended by revising the heading,
paragraph (a) and paragraph (d)(2) to read as follows:
Sec. 318.7 Restrictions on the use of substances in meat and meat food
products.
(a) (1) Substances permitted for use in meat and meat food product
in title 21, CFR, shall be permitted for such use under this
subchapter, subject to declaration requirements in Parts 316 and 317 of
this subchapter, unless precluded from such use or further restricted
in Parts 318 or 319 of this subchapter, or by the Administrator in
specific cases.
(2) (i) No substance may be used in the preparation of any product,
for any purpose, unless its use is authorized under title 21, CFR, as a
direct food additive (Part 172), a secondary direct food additive (Part
173), source of radiation (Part 179), an interim-listed direct food
additive (Part 180), a prior-sanctioned substance (Part 181), or listed
as a Generally Recognized As Safe (GRAS) substance or (Part 182 or
184), or by a regulation in this subchapter.
(ii) No substance the intended use of which is to impart color in
any product shall be used unless such use is authorized under title 21,
CFR, as a color additive (Parts 73, 74, and 81), or by a regulation in
this subchapter.
(3) Petitions to amend title 21 regulations to provide for meat or
meat food product uses of substances used in the preparation of
product, or substances used to impart color to product, shall be filed
with the Food and Drug Administration, in accordance with the
provisions of title 21 CFR part 71 or 171, as appropriate.
(4) Inquiries concerning the regulatory status under the Federal
Food, Drug, and Cosmetic Act of any articles intended for use as
components of, or in contact with, meat or meat food product, should be
addressed to the Department of Health and Human Services, Food and Drug
Administration, Center for Food Safety and Applied Nutrition, 200 C
Street, SW., Washington, DC 20204.
(5) Inquiries concerning the suitability for use in specific meat
or meat food products of substances that are not affirmed by FDA as
GRAS or otherwise listed in 21 CFR part 182 or part 184, or of
substances listed in title 21 regulations for general use in foods, or
for use in meat or meat food products generally, including mixtures of
such substances, should be addressed in writing to the Department of
Agriculture, Food Safety and Inspection Service, Product Assessment
Division, USDA, FSIS, RP, West End Court Building, Washington, DC
20250-3700. Copies of such correspondence, except for information on
proprietary mixtures, will be placed in the public record. A list of
proprietary substances and non-food compounds determined suitable for
specified uses also may be obtained from the Product Assessment
Division, at the same address.
* * * * *
(d) * * *
(2) Sorbic acid, calcium sorbate, sodium sorbate, and other salts
of sorbic acid shall not be used in cooked sausage or any other
product; sulfurous acid and salts of sulfurous acid shall not be used
in or on any product, and niacin or nicotinamide shall not be used in
or on fresh product, except that potassium sorbate, propylparaben
(propyl p-hydroxybenzoate), calcium propionate, sodium propionate,
benzoic acid, and sodium benzoate may be used in or on any product only
as provided in 21 CFR or by a regulation in this subchapter.
* * * * *
PART 319--DEFINITIONS AND STANDARDS OF IDENTITY OR COMPOSITION
6. The authority citation for 9 CFR Part 319 would be revised to
read as follows:
Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR
2.18, 2.53.
Sec. 319.100 [Amended]
7. Section 319.100 would be amended by removing ``Sec. 318.7(c) (1)
and (4) of this subchapter'' in the first sentence and replacing it
with ``a regulation permitting that use in this subchapter or in 21 CFR
Chapter I, Subchapter B.''
Sec. 319.106 [Amended]
8. Section 319.106 would be amended by removing ``in accordance
with 318.7(c)(4) of this subchapter'' in paragraph (d)(2) and replacing
it with ``a regulation permitting that use in this subchapter or in 21
CFR Chapter I, Subchapter B.''
Sec. 319.140 [Amended]
9. Section 319.140 would be amended by removing ``Sec. 318.7(c)(4)
of this subchapter'' in the second and third sentences and replacing it
with ``a regulation permitting that use in this subchapter or in 21 CFR
Chapter I, Subchapter B.''
Sec. 319.145 [Amended]
10. Section 319.145 would be amended by removing ``in the chart
following Sec. 318.7(c)(4),'' in paragraph (a)(4) and replacing it with
``in a regulation permitting that use in this subchapter or in 21 CFR
Chapter I, Subchapter B'' and in paragraph (b)(6) by removing ``the
chart of substances in Sec. 318.7(c)(4) of this subchapter.'' and
replacing it with ``a regulation permitting that use in this subchapter
or in 21 CFR Chapter I, Subchapter B.''
Sec. 319.180 [Amended]
11. Section 319.180 would be amended by removing ``Sec. 318.7(c)(4)
of
[[Page 67467]]
this chapter,'' in the first sentence of paragraph (a) and the first
sentence of paragraph (b) and replacing it with ``a regulation
permitting that use in this subchapter or in 21 CFR Chapter I,
Subchapter B.'' and by removing ``Sec. 318.7(c)(4) of this
subchapter.'' in the first sentence of paragraph (e) and replacing it
with ``a regulation permitting that use in this subchapter or in 21 CFR
Chapter I, Subchapter B.''
Sec. 319.303 [Amended]
12. Section 319.303 would be amended by removing ``Sec. 318.7(c)(4)
of this subchapter'' from the second sentence of paragraph (a)(3) and
replacing it with ``a regulation permitting that use in this subchapter
or in 21 CFR Chapter I, Subchapter B.''
Sec. 319.700 [Amended]
13. Section 319.700 would be amended by removing ``Sec. 318.7(c)(4)
of this chapter'' in paragraph (a)(4), paragraph (a)(5), and paragraph
(a)(6), and replacing it with ``a regulation permitting that use in
this subchapter or in 21 CFR Chapter I, Subchapter B''; by removing
``Sec. 318.7(c)(4) of this chapter,'' from the first sentence of
paragraph (a)(7) and replacing it with ``21 CFR Parts 73, 74, or 82,'';
and removing ``Sec. 318.7(c)(4) of this chapter,'' from the first
sentence of paragraph (a)(9) and the first sentence of paragraph
(a)(10) and replacing it with ``a regulation permitting that use in 21
CFR Chapter I, Subchapter B.''
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
14. The authority citation for 9 CFR Part 381 would be revised to
read as follows:
Authority: 21 U.S.C. 450, 21 U.S.C. 451-470, 7 CFR 2.18, 2.53.
15. Section 381.147 would be amended by revising paragraph (f) to
read as follows:
Sec. 381.147 Restrictions on the use of substances in poultry
products.
* * * * *
(f)(1) Substances permitted for use in poultry product in 21 CFR
chapter I shall be permitted for such use under this subchapter,
subject to declaration requirements in Subparts M and N of this
subchapter, unless precluded from such use or further restricted in
Subparts O and P of this subchapter, or by the Administrator in
specific cases.
(2)(i) No substance may be used in the preparation of any product,
for any purpose, unless its use is permitted under 21 CFR chapter I as
a direct food additive (Part 172), a secondary direct food additive
(Part 173), a source of radiation (Part 179), an interim-listed direct
food additive (Part 180), or is a prior-sanctioned substance (Part
181), or is a GRAS substance listed in Part 182 or Part 184, or is
otherwise permitted by a regulation in this subchapter.
(ii) No substance the intended use of which is to impart color in
any product shall be used unless such use is authorized under 21 CFR
chapter I as a color additive (Parts 73, 74, and 82), or by a
regulation in this subchapter.
(iii) Petitions to amend title 21 regulations to provide for
poultry product uses of substances used in the preparation of product,
or substances used to impart color to product, should be sent to FDA,
in accordance with the provisions of 21 CFR part 71 or 171, as
appropriate.
(iv) Inquiries concerning the food or color additive status under
the Federal Food, Drug, and Cosmetic Act of any articles intended for
use as components of, or in contact with, poultry product, should be
addressed to the Department of Health and Human Services, Food and Drug
Administration, Center for Food Safety and Applied Nutrition, 200 C
St., SW, Washington, DC 20204.
(v) Inquiries concerning the suitability for use in specific
poultry products of substances that are not affirmed by FDA as GRAS or
otherwise listed in 21 CFR part 182 or part 184, or of substances
listed in title 21 regulations for general use in foods, or for use in
poultry products generally, including mixtures of such substances,
should be addressed in writing to the Department of Agriculture, Food
Safety and Inspection Service, Product Assessment Division, USDA, FSIS,
RP, West End Court Building, Washington DC 20250. Copies of such
correspondence will be placed in the public record, except for
correspondence concerning proprietary mixtures. A list of proprietary
substances and non-food compounds determined suitable for specified
uses may be obtained from the Product Assessment Division, at the same
address.
* * * * *
Sec. 381.120 [Amended]
16. Section 381.120 would be amended by removing ``Sec. 381.147''
from the fourth sentence and from the sixth sentence and replacing it
with ``a regulation permitting that use in this subchapter or in 21 CFR
Chapter I, Subchapter B.''
Sec. 381.132 [Amended]
17. Section 381.132 would be amended by removing ``Sec. 381.147''
from paragraph (c)(3)(iii)(D) and replacing it with ``a regulation
permitting that use in this subchapter or in 21 CFR Chapter I,
Subchapter B.''
Sec. 381.171 [Amended]
18. Section 381.171 would be amended by removing ``Sec. 381.147 of
this part'' from the first and second sentences of paragraph (b) and
replacing it with ``a regulation permitting that use in this subchapter
or in 21 CFR Chapter I, Subchapter B.''
Done, at Washington, DC, on: December 21, 1995.
Michael R. Taylor,
Acting Under Secretary for Food Safety.
Appendix
Note: This appendix will not appear in the Code of Federal
Regulations.
Memorandum of Understanding (MOU) Between the Food Safety and
Inspection Service (FSIS), U.S. Department of Agriculture (USDA) and
the U.S. Food And Drug Administration (FDA), U.S. Department of Health
and Human Services (USDHHS)
Regarding the Approval of Food Additives, Color Additives, and
other Substances Used in Meat and Poultry Products
I. Purpose
This agreement establishes the working relationship and
procedures to be followed by FSIS and FDA in responding to requests
for the approval of the use of substances subject to regulation by
the FDA and intended for use in meat and meat food products
(hereinafter known collectively as meat products) and poultry
products regulated by FSIS.
II. Background
The Federal Meat Inspection Act (FMIA) and the Poultry Products
Inspection Act (PPIA), and the Federal Food, Drug, and Cosmetic Act
(FFDCA) provide FSIS and FDA, respectively, with the authority to
determine the safety, wholesomeness, and accurate labeling of foods.
The Food Additives Amendment of 1958 to the FFDCA (21 U.S.C. 348)
gives FDA the authority to determine the safety of food additives
prior to their marketing. The Color Additives Amendment of 1960 (21
U.S.C. 379e) grants FDA premarket review authority comparable with
these amendments to the FFDCA for color additives intended for use
in foods, drugs, cosmetics, and medical devices. FDA has assumed
primary authority over the approval of the use of food additives and
color additives used in foods. FSIS has retained authority under the
FMIA and PPIA to further regulate uses of such FDA-approved
substances in meat and poultry products, respectively, as needed, to
ensure inspected products are not adulterated or misbranded.
The process for documenting approved uses of substances intended
for use in meat and poultry products has required that such
ingredients first be reviewed and approved by FDA (in the form of an
FDA regulation), and then subsequently be reviewed and incorporated
into FSIS regulations. FDA's
[[Page 67468]]
approval of food additives and color additives is based on reviews of
data and other information establishing the safety of the substance
for its intended use in food. To approve a food additive, the Agency
must also determine that the food additive achieves its intended
technical effect; to approve a color additive, the Agency must also
determine that the color additive is suitable for its indended use.
However, these criteria are not sufficient to establish the
suitability of such additives for use in meat or poultry products.
Subsequent FSIS approval is based primarily on review of data
regarding the efficacy and suitability of the substance for its
intended use in meat and poultry products that FSIS regulates under
the FMIA and PPIA. FSIS requires data that support the lowest level
of the subject substance(s) needed to achieve the intended effect.
FSIS is charged with ensuring the safety of inspected products.
However, with respect to the safety of food and color additives that
may be used in those products, FSIS defers to FDA determinations
under the FFDCA.
In light of the foregoing regulatory context, FDA and USDA/FSIS
have concluded:
A. The duplicative, sequential approval process for substances
intended for use in meat and poultry products is unnecessarily
cumbersome, time-consuming, and costly to all parties involved, and
has fostered confusion over the relationship between FDA and FSIS
regulations.
B. Consolidation and harmonization of the Agencies' approvals in
this regard will result in fewer and more consistent Federal
approval regulations for substances used in food, and will provide
simpler and less expensive procedures for petitioners seeking
approval of substances under the FMIA and PPIA.
C. This Memorandum of Understanding should clarify the Agencies'
working relationship and, in particular, provide procedures whereby:
1. In situations where FSIS's Title 9 and FDA's Title 21
regulations do not specifically address the intended use of a
particular substance for meat or poultry products, any interested
party may request that FSIS evaluate the status of such use. FSIS
will conduct a review and determine whether the use is acceptable in
meat or poultry products, including whether the use is approved
under the FFDCA. Under the terms of this MOU, FSIS would seek FDA's
concurrence with FSIS's review and conclusions. If FDA does not
concur that the use is approved under the FFDCA, the petitioner
would be required to submit a food additive or color additive
petition to FDA requesting that FDA's regulations be amended to
accommodate the requested use.
2. In situations in which FDA receives a petition for the use of
a substances or a use of a substance that is not approved under the
FFDCA, a petitioner shall prepare and submit a food additive
petition or a color additive petition only to FDA. FDA will consult
with FSIS regarding petitions for meat and poultry use and, under
the terms of this MOU, FSIS concurrence would be required for the
approval of the use of substances intended for use in meat and
poultry and that are codified in Title 21 of the Code of Federal
Regulations.
D. This agreement and these procedures are not intended to erode
the existing authority of FDA or of FSIS to provide guidance on the
status and conditions of use of substances intended for use in meat
and poultry.
III. Scope
This agreement between FSIS and FDA concerns procedures for
Federal approval of food additives, color additives, and other food
ingredients that are regulated by FDA under the FFDCA and may be
used in meat and poultry products that are subject to the FMIA and
the PPIA. This agreement further provides for the review and
classification, as needed, of substances asserted to be exempt from
regulation under the FFDCA because they are generally recognized as
safe, or are covered by a prior sanction.
IV. Collaborative FSIS--FDA Approvals of Substances Intended for Use in
Meat and Poultry Products
A. Petitions for FDA approval of Substances Intended for Use in
Meat and Poultry Products.
Relevant portions of petitions submitted to FDA for the use of
new substances or new uses of approved substances will be shared
with FSIS by FDA when the proposed use specifically includes use in
meat and poultry products. FSIS will provide advice to FDA, in
writing, on any criteria, restrictions, conditions of use, or
prohibitions FSIS believes necessary concerning use of the substance
in products subject to the FMIA and the PPIA.
B. Requests for FSIS Determination on Acceptability of Substance
Uses in Meat and Poultry Products.
FSIS routinely provides advice and counsel to individuals and
issues guidance on the status and conditions of use of substances in
products under its regulatory purview. Requests for a determination
of the acceptability of substances may result in the need for
rulemaking when: (1) FSIS standards of identity and composition
preclude the use of a substance; or (2) there is concern about the
suitability of a substance for the intended use because the
substance has never been used in meat or poultry before, or the
applications of the substance are new, e.g., a new meat, meat food,
or poultry product category.
Requests for a determination of acceptability of new substances
and new uses of substances in meat and poultry products are
currently submitted by the requester (e.g., an ingredient
manufacturer, meat or poultry processor, or trade group) to FSIS.
FSIS will continue to require that a request for an acceptability
determination for the use of a new substance in meat or poultry or
for the new use of an approved substance be supported by information
and technical data that establish that: (1) the use of the substance
will not render the product in which it is used adulterated or
misbranded and (2) the proposed use of the substance is at the
lowest level necessary to accomplish the intended technical
effect(s) in each category of the product in which the substance
will be used.
Under the terms of this memorandum, when FSIS receives a request
for a determination on whether the use of a substance in meat or
poultry will be permitted, FSIS will evaluate the request and render
a determination of acceptability (i.e., safety and suitability). In
instances where the use of the requested substance is not explicitly
authorized by FDA regulations, FSIS will consult with FDA concerning
FSIS's evaluation of the regulatory status of the food ingredient.
If FDA has no objection to FSIS's determination, FSIS, through its
Product Assessment Division (PAD), will amend Agency directives and
other guidance materials to reflect the approved use. If FDA objects
to FSIS's determination, the request will be denied and the
requester will be advised to petition FDA to amend FDA's regulations
to permit the use of the substance at issue.
V. The Agreement
A. FSIS will:
1. Receive requests for evaluation of the acceptability of new
substances and new uses of approved substances for use in meat and
poultry products subject to the FMIA and PPIA.
2. Through the activities of the PAD, review all data submitted
in support of requests for ingredient use and, in consultation with
FDA, make acceptability determinations on use in meat and poultry
products. FSIS's Regulatory Programs will seek written concurrence
from FDA's Center for Food Safety and Applied Nutrition on FSIS
acceptability determinations before use is granted and the substance
is listed in FSIS directives or other guidance material. If use of a
substance is not found to be acceptable, the requester will be
advised to submit a petition to FDA to approve the use of substance
in meat or poultry products.
3. Forward to FDA all food and color additive petitions and
petitions for affirmation of GRAS status for use of such substances
in meat or poultry products.
4. Respond in a timely manner to inquiries from FDA regarding
petitions or requests for approval of the use of food additives,
color additives, or GRAS substances or new uses of such substances
in meat and poultry products regulated under the FMIA and PPIA.
5. Continue to provide advice and counsel on, and clarification
of, the acceptability and uses permitted under the FMIA and PPIA of
substances used in meat and poultry products.
B. FDA will:
1. Receive petitions for approval of substances intended for use
in foods, including meat or poultry products regulated under the
FMIA and PPIA.
2. Advise interested persons if a petition is needed to amend
FDA regulations to accommodate the requested uses.
3. Advise FSIS of any new substance listings in Title 21
concerning use restrictions or conditions of use, and common or
usual names of substances intended for use, in meat or poultry
products.
4. Provide FSIS, PAD, with copies of relevant information from
petitions and accompanying data submitted by petitioners
[[Page 67469]]
requesting approval of the use of substances in meat or poultry
products.
5. When petitioned, conduct rulemaking that would permit under
the FFDCA use of a substance in meat or poultry, including those
restrictions or conditions of use in meat or poultry products that
are recommended in writing by FSIS, and for which there are data or
other information establishing that the use of the substance is safe
and not deceptive. FDA will also consult with FSIS on any comments
received on petitions regarding meat or poultry uses.
C. FSIS and FDA jointly agree:
1. That the officials of the two Agencies responsible for
implementing the Agreement are:
At FSIS: the Administrator and Deputy Administrators (as may be
designated); Director, Product Assessment Division; Branch Chief,
Food Standards and Ingredients Branch.
At FDA: Director, Center for Food Safety and Applied Nutrition;
Director, Office of Pre-Market Approval.
2. That the responsible officials will concur on rulemaking
documents that, when published by FDA, will list or amend listings
of substances permitted for use in meat and poultry products.
3. That the Administrator of FSIS and the Director, CFSAN, FDA,
shall resolve problems and make decisions by consensus in areas of
disagreement.
VI. Conflict Resolution
Each Agency reserves the authority to review, independently of
the other, matters of concern to their respective authorities.
However, written notice will be provided to the Commissioner of Food
and Drugs and to the Under Secretary for Food Safety, USDA, of any
rulemaking initiative not in keeping with the provisions of this MOU
or about which there is an interagency disagreement, prior to public
announcement of the rulemaking.
VII. Other Agreements
A. The provisions of this MOU are not intended to add to or
detract from any of the authorities provided to either FDA or FSIS
by the FFDCA, FMIA, or the PPIA, or the regulations by which these
laws are implemented.
B. FSIS and FDA may enter into additional, separate agreements
with each other as they deem appropriate to achieve the objectives
of this MOU.
VIII. Duration of MOU
This Agreement becomes effective upon acceptance by both
Agencies and will continue indefinitely. It may be modified by
mutual written consent or terminated by either agency with a 30-day
written notice to the other agency.
Signed:
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Director, CFSAN, FDA
----------------------------------------------------------------------
Date
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Administrator, FSIS
Guidelines for Acceptability Determinations for New Substances and New
Uses of Substances in Meat and Poultry Products
The evaluation by FSIS of the acceptable use of a new substance
or new use of a substance in meat and poultry products subject to
this MOU will be based on the following conditions that must be
addressed by the requester. The conditions set forth are in
accordance with the provisions for use of substances in 9 CFR and 21
CFR.
1. The substance has a documented history of use in foods.
2. The substance is derived from food or a food ingredient and
is not considered to be a chemical or synthesized additive.
3. The process for manufacturing the substance does not result
in a severe alteration of the molecular structure resulting in the
formation of a chemical residue whose safety has not been shown.
4. The safety of the substance has been evaluated by an
independent authority and adequate safety data have been presented.
5. The suitability and efficacy of the substance have been shown
through adequate data submission. The lowest level of the substance
necessary to achieve the intended functional effect must be shown
and the use cannot render the products to which the substance is
intended for use adulterated or misbranded.
6. The FDA has determined the common or usual name of the
substance(s).
7. FDA must concur with FSIS's determination of acceptability in
order to allow use.
[FR Doc. 95-31390 Filed 12-26-95; 3:36 pm]
BILLING CODE 3410-DM-P
