[Federal Register Volume 60, Number 250 (Friday, December 29, 1995)]
[Proposed Rules]
[Pages 67490-67492]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-31491]
[[Page 67489]]
_______________________________________________________________________
Part V
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Part 71, et al.
Substances Approved for Use in the Preparation of Meat and Poultry
Products; Food Standards of Identity, Quality and Fill of Container;
Common or Usual Name Regulations; Proposed Rules
Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 /
Proposed Rules
[[Page 67490]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 71, 170, and 171
[Docket No. 95N-0220]
RIN 0910-AA66
Substances Approved for Use in the Preparation of Meat and
Poultry Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its regulations governing the review of petitions for the approval of
food and color additives and substances generally recognized as safe
(GRAS) to provide for joint review of such petitions by the Food Safety
and Inspection Service (FSIS), U.S. Department of Agriculture (USDA),
when meat or poultry product uses are proposed. By agreement between
USDA and FDA, such listings would eliminate the need for a separate
FSIS rulemaking to allow the use in meat and poultry products of FDA-
approved substances.
DATES: Written comments by March 14, 1996.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: George H. Pauli, Center for Food
Safety and Applied Nutrition (HFS-200), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3090.
SUPPLEMENTARY INFORMATION:
I. Background
FDA, under the Federal Food, Drug, and Cosmetic Act (the act), is
responsible for regulating foods generally. FSIS, under the Federal
Meat Inspection Act (FMIA) and the Poultry Products Inspection Act
(PPIA), regulates products consisting wholly or in part of meat or
poultry.
Over the years, FDA has generally deferred to FSIS in matters
concerning the regulation of meat and meat food products (hereinafter
referred to collectively as meat products) and poultry products,
despite FDA's 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 has primary jurisdiction over meat and poultry
products and is tasked with ensuring that all those products are
inspected before they are permitted in commerce. FSIS regulations and
guidelines govern all aspects of meat and poultry products 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 act, 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 meat and poultry
products. FDA regulates food additives and color additives through a
premarket approval system established respectively by sections 409 and
721 of the act
(21 U.S.C. 348 and 379e). 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. The act requires that
both food additives and color additives be shown to be safe before
marketing
(21 U.S.C. 348(c)(3) and 379e(b)(4)). In addition, FDA may not approve
any use of a food additive that would ``promote deception of the
consumer * * * or would otherwise result in adulteration or misbranding
of food * * * '' (21 U.S.C. 348(c)(3)(B)). Similarly, a color additive
must also be shown to be suitable for its intended use (21 U.S.C.
379e(b)(1)).
Over the years, the two agencies have cooperated on food ingredient
issues on an as-needed, substance-specific, and 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 absence of consistency causes difficulty and
inconvenience to persons who need to refer to both agencies'
regulations on approved substances and substance 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 approval of the use of substances in
food 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 those seeking
approval of a substance for use in or on meat or poultry products first
establish that the substance is safe for the intended use under section
409 or section 721 of the act, 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, sequential reviews and
rulemakings before a new meat or poultry use can be permitted. Many
years can elapse between the time a manufacturer petitions FDA for the
approval of a food additive or a color additive under the act and the
appearance in FSIS's regulations of approval for meat and poultry uses.
FDA and FSIS have also concluded that their respective regulations
concerning food and color additives and other substances that may be
added to meat and poultry products should be more consistent with one
another and easier to use and access.
II. The Proposal
This proposed rule, together with an FSIS proposed rule appearing
elsewhere in this issue of the Federal Register, would require a single
petition, joint reviews, and a single rulemaking procedure to replace
the current time consuming, duplicative, sequential rulemaking
procedures governing the use in meat or poultry products of food
additives, color additives, and GRAS substances. It is intended to
clarify the two agencies' responsibilities and regulatory interests.
Future FSIS listings for meat and poultry uses would be harmonized with
those of FDA and incorporated into FDA's regulations in Title 21 of the
Code of Federal Regulations (CFR), providing a basis for the eventual
elimination of FSIS's separate listings from Title 9 CFR.
Substances would be authorized for use in products under the
jurisdiction of FSIS on the basis of FDA's regulations permitting such
uses. For a substance not authorized for meat or poultry use under
existing FDA regulations, only one petition for rulemaking--to FDA--
would be required. Future FDA food additive, color additive, and GRAS
substance listings would specify any approved meat or poultry product
uses, and any conditions of such uses, in accord with FSIS
recommendations, to the extent those recommendations are consistent
with the act.
Substances whose use is GRAS, however, are exempt from the
premarket approval requirements of the act and need not be listed in
FDA's regulations in 21 CFR. For a substance that is not affirmed by
FDA as GRAS or otherwise listed in part 182 or 184 (21 CFR part 182 or
184) of FDA's regulations, or for a GRAS substance listed by FDA for
general food use, where meat or poultry uses are neither specified nor
prohibited, FSIS would continue to
[[Page 67491]]
consider a manufacturer's basis for claiming GRAS status and
suitability for use in meat or poultry products. In such cases, FSIS
would make the determination in consultation with FDA as needed to
ensure that appropriate advice is given and that FDA has notice of the
determination.
This proposal would require, and lead to, greater harmonization,
i.e., closer and more consistent cooperation, between FDA and FSIS. The
agencies propose to enter into a memorandum of understanding (MOU)
concerning the specifics of the agencies' working relationship under
the proposed regulations. A draft of the MOU is appended to the FSIS
proposal appearing elsewhere in this issue of the Federal Register.
FSIS and FDA believe that the public will be better served by
having all permitted uses for food additives, color additives, and GRAS
substances consolidated in one place--in Title 21 CFR--and intend to
work toward that end. However, existing regulations on specific
substances and substance uses in Titles 9 and 21 CFR would not be
immediately affected by this proposal. Because of resource constraints,
current FDA regulations would be amended to accommodate meat and
poultry uses only in response to a food additive, color additive, or
GRAS petition. FSIS will review its listings accordingly and eliminate
those that are redundant with FDA's Title 21 listings.
This proposed rule would amend FDA regulations to provide for: (1)
Specifying any meat, meat food product, or poultry product uses of
substances approved by FDA for food use and listed in 21 CFR; and (2)
petitioning FDA for listing in 21 CFR of substances intended to be used
in meat, meat food products, or poultry products. FDA's regulations
would be amended so that all petitions to permit new substances, new
uses, or new use levels of substances in meat, meat food products, or
poultry products would be filed only with FDA. FDA's regulations
governing color additive petitions, petitions to affirm substances as
GRAS, and food additive petitions in parts 71, 170, and 171 (21 CFR
parts 71, 170, and 171), respectively, would be revised to provide for
joint review by FSIS of petitions filed with FDA that propose use of
the substance in meat or poultry products. (In the agencies' view, it
is the petitioner's burden to identify the intended meat and poultry
uses of a substance.)
III. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(8) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
IV. Analysis of Impacts
FDA has examined the impacts of the proposed rule to amend 21 CFR
parts 71, 170, and 171 under Executive Order 12866 and the Regulatory
Flexibility Act (Pub. L. 96-354). 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 effects; distributive impacts;
and equity). The Regulatory Flexibility Act requires analysis of
options for regulatory relief for small entities.
The principal benefit of this proposed rule is to eliminate
duplicative Federal effort. Under the proposed amendments and
amendments FSIS is concurrently proposing to its regulations published
elsewhere in this issue of the Federal Register, separate petitions to
FSIS for use of substances in meat or poultry products would no longer
be required. 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.
With this proposed rule, 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
as GRAS by FDA or otherwise listed in 21 CFR part 182 or 184, or a
substance listed by FDA for general food use, FSIS would continue to
consider the manufacturer's basis for claiming GRAS status of the
substance and its suitability for a specified use in meat or poultry
products.) 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.
Therefore, FDA finds that this proposed rule would not have a
significant adverse economic impact. In addition, FDA certifies that
there is not a significant impact on a substantial number of small
entities.
Nevertheless, this proposed rule has been deemed by the Office of
Information and Regulatory Affairs (OIRA) of the Office of Management
and Budget to be a significant regulatory action as defined by section
3(f)(4) of Executive Order 12866 because it raises novel legal and/or
policy issues arising out of the President's priorities, namely the
reinvention of government and regulatory reform initiatives. Therefore,
this proposed rule has been formally reviewed by OIRA in accordance
with the provisions of Executive Order 12866.
V. Paperwork Reduction Act of 1995
This proposed rule contains information collections which are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (Pub. L. 104-13). Information
collection requirements have been approved by OMB for color additive
petitions, petitions to affirm substances as GRAS, and food additive
petitions under OMB Nos. 0910-0185, 0910-0132, and 0910-0016,
respectively. FDA has determined that the proposed rulemaking would
entail no new information collection from the regulated industry or
other private entities. Persons seeking Federal Government approval of
substances for use in meat or poultry foods would not have to submit
any information not currently required for approval. However, such
persons would only have to submit petitions to FDA, rather than to both
FDA and FSIS, as they do now. Thus, a current, duplicative information
collection requirement would be eliminated.
FDA requests comments regarding its tentative conclusions on the
paperwork burden.
VI. Comments
Interested persons may, on or before March 14, 1996, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. Two copies of any comments are to be submitted, except
that individuals may submit one 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 office above between 9
a.m. and 4 p.m., Monday through Friday.
List of Subjects
21 CFR Part 71
Administrative practice and procedure, Color additives,
Confidential business information, Cosmetics, Drugs, Reporting and
recordkeeping requirements.
[[Page 67492]]
21 CFR Part 170
Administrative practice and procedure, Food additives, Reporting
and recordkeeping requirements.
21 CFR Part 171
Administrative practice and procedure, Food additives.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR parts 71, 170, and 171 be amended as follows:
PART 71--COLOR ADDITIVE PETITIONS
1. The authority citation for 21 CFR part 71 continues to read as
follows:
Authority: Secs. 201, 402, 409, 501, 505, 506, 507, 510, 512-
516, 518-520, 601, 701, 721, 801 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 342, 348, 351, 355, 356, 357, 360,
360b-360f, 360h-360j, 361, 371, 379e, 381); secs. 215, 351 of the
Public Health Service Act (42 U.S.C. 216, 262).
2. Section 71.1 is amended in paragraph (c) in the petition by
revising the introductory paragraph preceding paragraph A., and by
adding new paragraph (j) to read as follows:
Sec. 71.1 Petitions.
* * * * *
(c) * * *
Attached hereto in triplicate (quadruplicate, if intended uses
include use in meat, meat food product, or poultry product), and
constituting a part of this petition are the following:
* * * * *
(j)(1) If intended uses of the color additive include uses in meat,
meat food product, or poultry product subject to regulation by the U.S.
Department of Agriculture (USDA) under the Poultry Products Inspection
Act (PPIA) (21 U.S.C. 451 et seq.) or Federal Meat Inspection Act
(FMIA) (21 U.S.C. 601 et seq.), FDA shall, upon filing of the petition,
forward a copy of the petition or relevant portions thereof to the Food
Safety and Inspection Service, USDA, for simultaneous review under the
PPIA and FMIA.
(2) FDA will ask USDA to advise whether the proposed meat and
poultry uses comply with the FMIA and PPIA, or if not, whether use of
the substance would be permitted in products under USDA jurisdiction
under specified conditions or restrictions.
3.Section 71.20 is amended by adding new paragraph (a)(3) to read
as follows:
Sec. 71.20 Publication of regulation.
* * * * *
(a) * * *
(3) The regulation shall list any use or uses in meat, meat food
product, or poultry product subject to the Federal Meat Inspection Act
(FMIA)(21 U.S.C. 601 et seq.) or Poultry Products Inspection (PPIA)(21
U.S.C. 451 et seq.) for which the color additive has been found
suitable and for which it may safely be employed.
* * * * *
PART 170--FOOD ADDITIVES
4. The authority citation for 21 CFR part 170 continues to read as
follows:
Authority: Secs. 201, 401, 402, 408, 409, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 342, 346a, 348,
371).
5. Section 170.35 is amended by redesignating paragraphs (c)(3)
through (c)(6) as paragraphs (c)(4) through (c)(7), respectively, and
by adding new paragraph (c)(3) to read as follows:
Sec. 170.35 Affirmation of generally recognized as safe (GRAS) status.
* * * * *
(c) * * *
(3)(i) If intended uses of the substance include uses in meat, meat
food product, or poultry product subject to regulation by the U. S.
Department of Agriculture (USDA) under the Poultry Products Inspection
Act (PPIA) (21 U.S.C. 451 et seq.) or Federal Meat Inspection Act
(FMIA) (21 U.S.C. 601 et seq.), FDA shall, upon filing of the petition,
forward a copy of the petition or relevant portions thereof to the Food
Safety and Inspection Service, USDA, for simultaneous review under the
PPIA and FMIA.
(ii) FDA will ask USDA to advise whether the proposed meat and
poultry uses comply with the FMIA and PPIA, or if not, whether use of
the substance would be permitted in products under USDA jurisdiction
under specified conditions or restrictions.
* * * * *
PART 171--FOOD ADDITIVE PETITIONS
6. The authority citation for 21 CFR part 171 continues to read as
follows:
Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321, 342, 348, 371).
7. Section 171.1 is amended in paragraph (c) in the petition by
revising the introductory paragraph preceding paragraph A., and by
adding new paragraph (n) to read as follows:
Sec. 171.1 Petitions.
* * * * *
(c) * * *
Attached hereto, in triplicate (quadruplicate, if intended uses
include use in meat, meat food product, or poultry product), and
constituting a part of this petition, are the following:
* * * * *
(n) (1) If intended uses of the food additive include uses in meat,
meat food product, or poultry product subject to regulation by the U.S.
Department of Agriculture (USDA) under the Poultry Products Inspection
Act (PPIA) (21 U.S.C. 451, et seq.) or Federal Meat Inspection Act
(FMIA) (21 U.S.C. 601, et seq.), FDA shall, upon filing of the
petition, forward a copy of the petition or relevant portions thereof
to the Food Safety and Inspection Service, USDA, for simultaneous
review under the PPIA and FMIA.
(2) FDA will ask USDA to advise whether the proposed meat and
poultry uses comply with the FMIA and PPIA, or if not, whether use of
the substance would be permitted in products under USDA jurisdiction
under specified conditions or restrictions.
8. Section 171.100 is amended by redesignating paragraph (b) as
paragraph (c) and by adding new paragraph (b) to read as follows:
Sec. 171.100 Regulation based on petition.
* * * * *
(b) The regulation shall describe the conditions under which the
substance may be safely used in any meat product, meat food product, or
poultry product subject to the Federal Meat Inspection Act (FMIA) (21
U.S.C. 601 et seq.) or the Poultry Products Inspection Act (PPIA) (21
U.S.C. 451 et seq.).
* * * * *
Dated: October 11, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-31491 Filed 12-26-95; 3:37 pm]
BILLING CODE 4160-01-F
