[Federal Register Volume 65, Number 166 (Friday, August 25, 2000)]
[Rules and Regulations]
[Pages 51758-51763]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-21693]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 71, 170, and 171

[Docket No. 95N-0220]
RIN 0910-AA58


Substances Approved for Use in the Preparation of Meat and 
Poultry Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations on petitions for the use of food ingredients and sources of 
radiation. This regulatory change will permit an efficient, joint 
review by both FDA and the Food Safety and Inspection Service (FSIS), 
U.S. Department of Agriculture (USDA), of petitions for approval to use 
a food ingredient or source of radiation in or on meat or poultry 
products.

DATES: This rule is effective August 25, 2000, except for the 
amendments to Secs. 71.1 and 171.1 (21 CFR 71.1 and 171.1), which 
contain collection of information provisions subject to review and 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (the PRA). The amendments to these 
sections will be made effective after OMB approval is received, at 
which time, FDA will announce the effective date in the Federal 
Register. Submit written comments on the collection of information 
provisions by October 24, 2000.

ADDRESSES: Submit written comments on the information collection 
provisions of this final rule to the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Arletta M. Beloian, Center for Food 
Safety and Applied Nutrition (HFS-206), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3082.

SUPPLEMENTARY INFORMATION:

I. Background

    In theFederal Register of December 29, 1995 (60 FR 67459), FSIS 
proposed to amend the Federal meat and poultry products inspection 
regulations containing the procedures for reviewing the safety and 
suitability of food and color additives used in meat and poultry 
products. In that same issue of the Federal Register (60 FR 67490), FDA 
proposed to make changes to its regulations regarding submission of 
petitions for the use of food ingredients and sources of radiation to 
accommodate a simultaneous review by the two agencies. Those proposals 
reflected interagency coordination to ease the burden on regulated 
industries and consumers. Such a coordinated effort by the two 
agencies, through streamlining the Government's food ingredient 
approval process, showed a commitment to achieving goals for the

[[Page 51759]]

Reinventing Food Regulations part of the President's National 
Performance Review.
    FDA received seven comments to the proposal during the comment 
period that closed on March 14, 1996. In response to a request for 
additional time to submit comments, and for consistency with an FSIS 
comment period extension, the FDA comment period was reopened for 60 
days, closing June 3, 1996. Two comments were received during the 
extension period. The comments all generally supported FDA's proposal 
but added specific comments on issues of regulatory authority, policy, 
and the procedures that both agencies will use to harmonize the review 
of petitions to authorize the use of substances in meat and poultry 
products.
    Over the years, FDA and FSIS have conferred and cooperatively 
addressed food ingredient issues on an as needed, substance-specific, 
case-by-case basis. Nonetheless, because the agencies have different 
statutory mandates, the regulations of the two agencies that govern the 
use of food and color additives and generally recognized as safe (GRAS) 
substances added to meat and poultry products sometimes include 
conditions, formats, and terms that are not fully consistent with one 
another. This absence of consistency may cause difficulty and 
inconvenience people who need to comply with both agencies' laws and 
regulations on use of substances in meat and poultry products.
    Section 409 of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 348) requires FDA to evaluate the safety and regulate the 
use of food additives in or on all foods; section 721 of the act (21 
U.S.C. 379e) provides FDA with comparable authority over color 
additives. The Federal Meat Inspection Act (FMIA) and the Poultry 
Products Inspection Act (PPIA) (21 U.S.C. 601(m)(2) and 21 U.S.C. 
453(g)(2)) authorize the administrator of FSIS to determine the 
suitability and regulate the use of ingredients and sources of 
radiation in or on meat and poultry products in federally inspected 
facilities. Under the current process, FDA and FSIS conduct separate, 
sequential reviews, each agency applying its respective procedures to 
ascertain that a substance is lawful for the use intended in or on meat 
or poultry products. Both agencies agree that their respective 
regulations may be harmonized and simplified.
    FDA and FSIS have developed a memorandum of understanding (MOU) for 
handling submissions on the use of food ingredients in meat and poultry 
products. Under the terms of the MOU, FDA will be the petitioner's 
regulatory contact and conduct a safety review, and FSIS will 
simultaneously conduct a suitability determination. On completion of 
its determination, FSIS will provide FDA with its review on 
suitability, describing its conclusions in terms of any restrictions or 
conditions of use that FSIS determines to be necessary to comply with 
its various regulations and policies with regard to meat and poultry 
products. When issuing a new regulation or amending an existing one in 
title 21 of the Code of Federal Regulations (CFR), FDA will carefully 
and fully consider the FSIS recommendations and will specify in the 
regulation whether use of a substance is allowed in meat and poultry 
products along with any necessary restrictions or conditions of use.
    Current FDA regulations provide a petition procedure for interested 
parties to obtain affirmation by FDA that the use of a substance is 
GRAS and, thus, exempt from the requirement for premarket approval that 
applies to food additives. This rule amends those regulations by 
establishing specific procedures regarding petitions to affirm the use 
of ingredients in meat or poultry products as GRAS. On April 17, 1997 
(62 FR 18938), FDA proposed to replace the GRAS affirmation process 
with a GRAS notification procedure. This procedure would allow a 
manufacturer to make a determination that the use of a substance in 
food is GRAS and to notify FDA of such determination along with a 
submission of summary information that provides support for that 
determination. If FDA adopts the GRAS notification proposal as a final 
rule, the section listed below in 21 CFR 170.35 would be revoked. Under 
the MOU, if and when GRAS notification becomes FDA's established 
practice, FDA and FSIS will consult with each other on GRAS 
notifications for use of an ingredient in meat and poultry products, as 
necessary and appropriate. The notifier will be informed of any 
concerns about the suitability of the use of the substance in meat and 
poultry products and, when applicable, will be informed of any 
restrictions or conditions of use in meat and poultry products required 
by the act.

II. Response to Comments

A. Regulatory Authority

    (Comment 1) Several comments stated that one agency should have 
exclusive responsibility for determining whether a substance may or may 
not be used in meat and poultry products. The comments stated that 
because FDA has the scientific staff, institutional expertise, and 
regulatory structure for reviewing the safety of food ingredients, 
FDA's broad jurisdiction over foods should be extended to cover 
substances in meat and poultry products. In support of this opinion, 
one comment argued that if the FSIS conducts their review out of 
synchronization with FDA's review, the goal of streamlining the 
approval process would fail. Another argued that requiring concurrent 
reviews does not necessarily eliminate review time but is really a 
layering of one agency's approvals on top of the other agency's 
approvals.
    Under the act, FDA is authorized to evaluate the safety of 
substances added to food, including the addition to meat and poultry, 
and to approve the safe use of food and color additives. This rule has 
no effect on that authority. However, the laws that FSIS administers 
(FMIA and PPIA) may preclude the use of a substance in meat or poultry 
products for reasons other than safety. In particular, provisions 
regarding efficacy and suitability of substances for use in meat and 
poultry products are the province of FSIS. For instance, there are 
cases where the use of a substance, even if safe, may promote deception 
when used in a meat or poultry product and, accordingly, such use would 
be prohibited by FSIS. For example, although paprika is considered GRAS 
by FDA and is also listed for use as a color additive, FSIS regulations 
prohibit the use of this spice on fresh, uncooked meat products because 
such use adds color that may make the meat appear fresher than it 
actually is.
    FDA and FSIS have concluded that a single submission, joint review, 
and single rulemaking procedure will eliminate duplicate review and 
reduce the time it takes to authorize a food ingredient for use in meat 
and poultry products.

B. Reporting Procedures and Requirements

    (Comment 2) One comment asserted that when FDA approves a substance 
for use in food generally, with no limitation other than good 
manufacturing practice, the general use of the food ingredient should 
also include the use in meat and poultry components.
    The agency agrees with this comment with respect to safety under 
the act. However, safety is not the only criterion governing the lawful 
use of an ingredient in foods subject to FMIA or PPIA. Historically, 
food and color additive petitions generally were reviewed and 
regulations were written without input from FSIS regarding any

[[Page 51760]]

regulatory issues raised under FMIA or PPIA. Thus, the ingredients were 
subjected to a second review by FSIS after FDA review was completed. To 
make the review process more efficient, FDA concludes that future 
petition reviews should address explicitly the concern raised by the 
comment. Therefore, a new substance to be listed by FDA for general 
food use would require an explicit request for the use in meat and 
poultry products, accompanied by appropriate supporting data so both 
agency reviews can occur concurrently.
    (Comment 3) One comment expressed concern that the petition format 
for FDA food additive petition review is more complicated and extensive 
than that currently used by FSIS and its completion is expected to be 
more time consuming. The comment asked what modifications in procedure 
and reporting requirements would be made for simultaneous review of 
petitions for use of food and color additives in meat and poultry 
products. The comment also asked whether FDA's regulations would be 
modified to reflect the FSIS product classes relevant to the use of 
substances in meat and poultry products.
    First, this rule does not impose any reviews that have not been 
required previously. Second, the issues in petitions addressed by FDA 
and FSIS are different, in that FDA primarily addresses safety, while 
the FSIS addresses efficacy and suitability. Substances whose uses 
would have required a safety review by FDA in the past would require, 
under this final rule, the submission of the same safety data. At this 
time, FDA sees no need to modify its regulations or to impose new 
requirements for the review of petitions regarding the use of 
substances in meat and poultry products with one exception. That is, if 
a petition seeks approval of the use of a substance in meat and poultry 
products, the petitioner should state that fact explicitly and should 
submit to FDA appropriate data in support of such use as part of the 
petition rather than to FSIS separately. This procedure will facilitate 
a more expeditious review of the petition by both agencies. If, after 
some experience is gained with this procedure, FDA and FSIS see a need 
for additional specific information, FDA will revise its guidance 
documents for petitioners.

C. GRAS Determination

    (Comment 4) Several comments pointed out that numerous substances 
that have been accepted as GRAS by FDA for use in food generally are 
not listed in Title 21 CFR. One comment urged that a clear allowance 
for a self-determined GRAS status of substances for use in meat and 
poultry products be included in the interagency MOU.
    FDA acknowledges that not all uses of substances that are GRAS are 
listed in Title 21 of FDA's regulations. This results from the fact 
that substances whose use is GRAS are excepted from the definition of a 
food additive and, therefore, do not require approval by FDA. As noted 
above, under the interagency MOU, FDA and FSIS are developing 
operational procedures to review GRAS notices and to identify which 
agency will be responsible for different aspects of the review.

D. Other Comments

    (Comment 5) Some comments objected to FSIS continuing to be 
responsible for assessing, independently of FDA, a manufacturer's basis 
for determining that use of a substance is GRAS on the basis that such 
a procedure would be in conflict with streamlining the approval process 
and would continue the duplicative review by both agencies.
    FDA finds that because these comments relate specifically to FSIS 
statutory obligations and role regarding food ingredients intended for 
use in meat and poultry products, they are outside the scope of FDA's 
proposal. Indeed, FSIS has responded to similar comments in their final 
rule published in the Federal Register of December 23, 1999 (64 FR 
72168).

III. Conforming Amendments

    Current FDA regulations require that a petition for approval of the 
use of a food additive or a color additive be submitted in triplicate. 
This final rule amends Secs. 71.1(a) and 171.1(a) of the agency's 
regulations to require the submission of one additional copy of a 
petition where the proposed use includes use in meat or poultry; this 
additional copy will be provided to FSIS so that FDA and FSIS can 
perform concurrent reviews. This final rule also provides that FDA will 
list any uses of food and color additives that are suitable for use in 
meat or poultry and will describe conditions of use under which the 
substances may be safely used.
    In preparing this final rule, FDA became aware that Secs. 71.1(a) 
and 171.1(a) also describe the number of copies of a petition to be 
submitted to FDA. This final rule also amends Secs. 71.1(a) and 
171.1(a) to require the submission of petitions in quadruplicate where 
the proposed use includes use in meat or poultry. Although FDA did not 
explicitly propose to amend these two provisions of the regulations, 
the substance of the change was proposed. Therefore, FDA is amending 
Secs. 71.1(a) and 171.1(a) to make them consistent with other 
provisions of the regulations, as amended.

IV. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) 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.

V. Analysis of Impacts

A. Requirement of Cost-Benefit Analysis

    FDA has examined the impacts of this final rule to amend 21 CFR 
parts 71, 170, and 171 under Executive Order 12866, the Unfunded 
Mandates Reform Act of 1995 (UMRA), the Small Business Regulatory 
Enforcement Fairness Act of 1996 (SBREFA), and the Regulatory 
Flexibility Act (RFA) (Public Law 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, 
and other advantages; distributive impacts; and equity). Executive 
Order 12866 classifies a rule as significant if it meets any one of a 
number of specified conditions, including having an annual effect on 
the economy of $100 million, adversely affecting a sector of the 
economy in a material way, adversely affecting competition, or 
adversely affecting jobs. A regulation is also considered a significant 
regulatory action if it raises novel legal or policy issues.
    UMRA (Public Law 104-4) requires certain cost-benefit and other 
analyses; section 1531(a) defines a significant rule as ``a Federal 
mandate that may result in the expenditure by State, local, and tribal 
governments in the aggregate, or by the private sector, of $100 million 
(adjusted annually for inflation) in any one year.''
    SBREFA (Public Law 104-121) defines a major rule for the purpose of 
congressional review as having caused or being likely to cause one or 
more of the following: An annual effect on the economy of $100 million; 
a major increase in costs or prices; significant effects on 
competition, employment, productivity, or innovation; or significant 
effects on the ability of

[[Page 51761]]

United States-based enterprises to compete with foreign-based 
enterprises in domestic or export markets.
    RFA (5 U.S.C. 601-612) requires agencies to analyze regulatory 
options that would lessen the economic effect of a rule on small 
entities if a rule has a significant economic impact on a substantial 
number of small entities.
    Under the guidelines of Executive Order 12866, UMRA, SBREFA, and 
RFA, FDA finds that this final rule would not have a significant 
adverse economic impact. However, the Office of Information and 
Regulatory Affairs (OIRA) of OMB has determined this rule to be a 
significant regulatory action as defined by section 3(f)(4) of 
Executive Order 12866 because it raises novel legal or policy issues 
arising out of the President's priorities, namely the reinvention of 
Government and regulatory reform initiatives. Therefore, this final 
rule has been formally reviewed by OIRA in accordance with the 
provisions of Executive Order 12866.

B. The Costs and Benefits of This Rule

1. Costs
    FDA believes that there are no significant new costs associated 
with this rule.
2. Benefits
    This rule will benefit the regulated industry, the Federal 
Government, and consumers. Administrative costs for both industry and 
the Federal Government will fall with the elimination of duplicative 
approval processes. Also, this rule will benefit both industry and 
consumers by facilitating the more timely introduction of safe food 
additives, color additives, and other substances lawfully used in food.
    One effect of this rule is to eliminate the current duplicative 
administrative costs of the additive approval process for the Federal 
Government. Under the current regulatory framework, firms seeking to 
use food additives or color additives in meat or poultry must 
sequentially seek the approval of the FDA and then FSIS. This rule 
simplifies the process by requiring that only one petition be submitted 
to the FDA for the entire Federal Government.
    Industry will also benefit from this rule. As with the Federal 
Government, the industry's administrative costs will fall with the 
implementation of this rule. Fewer required petitions translate into 
lower overall costs. Furthermore, having a more efficient approval 
process will increase the expected profits from the use and sale of the 
food and color additives that are the subject of this process. The 
resulting increase in expected profits could act as an incentive to 
increase effort in the research and development of new food and color 
additives with a net result of an increase in the quantity and quality 
of additives on the market.
    Having an increased number of safe additives on the market sooner 
will also benefit consumers. First, the introduction of new additives 
will increase consumer choice. Thus, the typical consumer will be 
better off. Second, the expected cost of a product using an additive of 
a given quality level will fall. This is because greater innovation 
will lead to more low cost alternatives and a competitive industry will 
use its lowest cost alternative.
3. Summary
    FDA believes that this rule is economically justified because this 
rule has no costs and has positive benefits. In fact, consumers, 
industry, and government will all benefit from this rule.

VI. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are 
subject to review by OMB under the PRA (44 U.S.C. 3501-3520). The 
title, description, and respondent description of the information 
collection provisions are shown below with an estimate of the annual 
reporting burden. Included in the estimate is the time for reviewing 
instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing each 
collection of information.
    Title: Petition for Approval of Substances for Use in the 
Preparation of Meat and Poultry Products.
    Description: The act (sections 409 and 721) requires FDA to 
evaluate the safety and regulate the use of food and color additives 
used as ingredients in or on all foods. These sections also authorize 
FDA to accept petitions for approval of food and color additives. FMIA 
and PPIA (21 U.S.C. 601(m)(2) and 21 U.S.C. 453(g)(2)) authorize the 
administrator of FSIS, USDA, to determine the suitability of the use of 
a substance in meat and poultry products. Regulations of the two 
agencies at times include conditions, formats, and terms that are not 
fully consistent with one another because of the different statutory 
mandates. Under the current process FDA and FSIS conduct separate, 
sequential reviews, each agency applying its respective procedures to 
ascertain that a substance is lawful for the use intended in or on 
products containing meat or poultry.
    This final rule requires applicants that petition for approval for 
the use of substances in meat and poultry products to provide four 
copies of the petition to FDA, rather than the three copies as 
currently specified in Secs. 71.1 and 171.1. FDA will then forward a 
copy of the petition or relevant portions of the petition to FSIS so 
that both agencies can perform the necessary reviews simultaneously, 
thus reducing the time it takes to authorize an ingredient for use in 
meat and poultry products. The rule does not require petitioners to 
submit any new information to either FDA or FSIS.
    This final rule results from a coordinated effort by the two 
agencies to ease the paperwork burden on regulated industries through 
streamlining the Government's food ingredient approval process for 
substances used in meat and poultry products.
    Description of Respondents: Businesses or other for profit.

                         Table 1.--Estimated Annual Increase in Reporting Hour Burden 1
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                                                      Annual                        Increase in
         21 CFR Section              Number of     Frequency of    Total Annual      Hours per    Total Increase
                                    Respondents      Response        Responses       Response         in Hours
----------------------------------------------------------------------------------------------------------------
71.1 and 171.1                         10               1              10               2             20
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on FDA's past experience with food and color additive 
petitions and on discussions with FSIS about its past experience, it 
will receive 10 petitions annually that request approval for use of a 
substance in meat and poultry products. Submission of a petition for 
the use of a substance in meat and poultry products is a one-time 
event.

[[Page 51762]]

FDA estimates that the respondent would expend 2 hours to make a fourth 
photocopy of the petition, necessary for FDA to send to FSIS to conduct 
a simultaneous review. FDA, therefore, estimates that the total burden 
of data collection under Secs. 71.1 and 171.1 will increase by 20 hours 
per year because of the requirement to submit a fourth copy of 
petitions for use of a substance in meat or poultry products.
    The December 29, 1995 (60 FR 67490), proposed rule provided a 
general comment period that closed on March 14, 1996, and reopened for 
another 60 days ending June 3, 1996. However, because of an oversight, 
FDA did not specifically solicit comments on the information collection 
provisions of the proposed rule, as required by the PRA. Therefore, FDA 
is providing an opportunity for public comment under the PRA at this 
time. FDA now invites comments on: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology. Individuals and 
organizations may submit comments on the information collection 
provisions of this final rule by October 24, 2000. Comments should be 
sent to the Dockets Management Branch (address above).
    At the close of the 60-day comment period, FDA will review the 
comments received, revise the information collection provisions as 
necessary, and submit these provisions to OMB for review. FDA will 
publish a notice in the Federal Register when the information 
collection provisions are submitted to OMB, and an opportunity for 
public comment to OMB will be provided at that time. Prior to the 
effective date of this final rule, FDA will publish in the Federal 
Register a notice of OMB's decision to approve, modify, or disapprove 
the information collection provisions. An agency may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number.

VII. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the order and, consequently, a federalism 
summary impact statement is not required.

VIII. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the information collection 
provisions of this final rule by October 24, 2000. 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 Dockets Management Branch 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.

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, 21 CFR parts 
71, 170, and 171 are amended as follows:

PART 71--COLOR ADDITIVE PETITIONS

    1. The authority citation for 21 CFR part 71 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 348, 351, 355, 360, 360b-360f, 
360h-360j, 361, 371, 379e, 381; 42 U.S.C. 216, 262.


    2. Section 71.1 is amended in paragraph (a) by revising the third 
sentence, in paragraph (c) in the petition by revising the introductory 
paragraph preceding paragraph A., and by adding paragraph (j) to read 
as follows:


Sec. 71.1  Petitions.

    (a) * * * The petition shall be submitted in triplicate 
(quadruplicate, if intended uses include uses in meat, meat food 
product, or poultry product). * * *
* * * * *
    (c) * * *
    Attached hereto, in triplicate (quadruplicate, if intended uses 
include uses 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 the 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 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 the 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: 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.

* * * * *

[[Page 51763]]

    (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: 21 U.S.C. 321, 342, 348, 371.


    7. Section 171.1 is amended in paragraph (a) by revising the first 
sentence, in paragraph (c) in the petition by revising the introductory 
paragraph preceding paragraph A., and by adding paragraph (n) to read 
as follows:


Sec. 171.1  Petitions.

    (a) Petitions to be filed with the Commissioner under the 
provisions of section 409(b) of the Federal Food, Drug, and Cosmetic 
Act (the act) shall be submitted in triplicate (quadruplicate, if 
intended uses include use in meat, meat food product, or poultry 
product). * * *
* * * * *
    (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 the 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: August 18, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-21693 Filed 8-24-00; 8:45 am]
BILLING CODE 4160-01-F