[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]]

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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.

-----------------------------------------------------------------------

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