[Federal Register Volume 64, Number 246 (Thursday, December 23, 1999)]
[Rules and Regulations]
[Pages 72168-72194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-32659]



[[Page 72167]]

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Part III





Department of Agriculture





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Food Safety and Inspection Service



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9 CFR Part 310, et al.



Food Ingredients and Sources of Radiation Listed or Appproved for Use 
in the Production of Meat and Poultry Products; Final Rule

  Federal Register / Vol. 64, No. 246 / Thursday, December 23, 1999 / 
Rules and Regulations  

[[Page 72168]]



DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 310, 318, 319, 381 and 424

[Docket No. 88-026F]
RIN 0583-AB02


Food Ingredients and Sources of Radiation Listed or Approved for 
Use in the Production of Meat and Poultry Products

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the 
Federal meat and poultry products inspection regulations to harmonize 
and improve the efficiency of the procedures used by FSIS and the Food 
and Drug Administration (FDA) for reviewing and listing or approving 
the use of food ingredients and sources of radiation in the production 
of meat and poultry products. Except in very limited circumstances, FDA 
will list in its regulations in title 21 of the Code of Federal 
Regulations (CFR) food ingredients and sources of radiation that are 
safe for use in the production of meat and poultry products. Requests 
for approval to use food ingredients and sources of radiation not 
currently permitted under title 9 or title 21 of the CFR in the 
production of meat and poultry products will have to be submitted to 
FDA.
    This action will eliminate the need for separate FSIS rulemakings. 
FSIS will limit substance-specific rulemakings under the authority of 
the Federal Meat Inspection Act (FMIA) or the Poultry Products 
Inspection Act (PPIA) to those necessary to establish specific 
prohibitions or limitations on the use of food ingredients and sources 
of radiation in the production of meat or poultry products. Such 
rulemakings might be necessary where a standard of identity or 
composition prohibits or limits the use of an ingredient, when use of 
the ingredient is not expected in the product, e.g., adding milk to 
hamburger, or use of the ingredient would result in the product being 
adulterated or misbranded.
    FSIS is also consolidating various existing regulations on food 
ingredients and sources of radiation into a single, new part, 9 CFR 
Part 424, applicable to both meat and poultry establishments. This will 
include combining the separate listings of food ingredients approved 
for use in meat and poultry products into a single table (9 CFR 
424.22(c)) and eliminating unnecessary differences in the listings. 
FSIS has not made any substantive changes in the consolidated language.

EFFECTIVE DATE: January 24, 2000.

FOR FURTHER INFORMATION CONTACT: Robert C. Post, Ph.D., Labeling and 
Additives Policy Division, Office of Policy, Program Development and 
Evaluation, Food Safety and Inspection Service, U.S. Department of 
Agriculture, Washington, DC 20250-3700; (202) 205-0279.

SUPPLEMENTARY INFORMATION:

Current FDA/FSIS Process for Listing Food Ingredients and Sources 
of Radiation for Use in the Production of Meat and Poultry Products

    Food ingredients and sources of radiation used during the 
production of meat and poultry products are subject to regulation by 
FDA under the Federal Food, Drug, and Cosmetic Act (FFDCA). However, 
FSIS also has jurisdiction to regulate the use of those food 
ingredients and sources of radiation used in the production of meat and 
poultry products under the FMIA and the PPIA (see 21 U.S.C. 601(m)(2) 
and 21 U.S.C. 453(g)(2)).
    Under the current system, someone interested in using a new food 
additive or color additive, or a new use or use level of a regulated 
food ingredient or source of radiation in the production of a meat or 
poultry product, must submit a petition to FDA requesting the listing 
of that use. The petition must contain data demonstrating the safety of 
the intended use of the food ingredient or source of radiation. FDA 
reviews the petition to determine the safety of the use of the food 
ingredient or source of radiation, and considers whether it has its 
intended technical effect at the requested level of use. After 
completing its review, FDA provides FSIS with an advisory opinion on 
whether the food ingredient or source of radiation is safe for the 
requested use in the production of meat or poultry products. At that 
point, FSIS reviews the suitability of the food ingredient or source of 
radiation for use in the production of meat or poultry products and 
conducts notice-and-comment rulemaking.
    The process being adopted in this final rule will provide the same 
level of consumer protection without the delays inherent in the current 
system. It was in recognition of these delays that FSIS and FDA 
initiated this rulemaking and the companion FDA rulemaking.

Background

    On December 29, 1995, FSIS published a proposed rule in the Federal 
Register titled ``Substances Approved for Use in the Preparation of 
Meat and Poultry Products'' (60 FR 67459). In it, FSIS proposed to 
amend the Federal meat and poultry products inspection regulations 
containing the procedures for reviewing the safety and suitability of 
substances used in meat and poultry products so they would correspond 
with the procedures used by FDA. Under the proposal, FSIS's regulations 
would have reflected the fact that it and FDA would simultaneously 
review petitions for the listing of substances for use in the 
production of meat and poultry products. In the same issue of the 
Federal Register (60 FR 67490), FDA proposed to make parallel changes 
to its regulations.
    FSIS proposed to stop adding, in most cases, to its own regulations 
that list substances suitable for use in the production of meat and 
poultry products. Instead, the proposal envisioned that future FDA 
regulations would specify whether a substance listed or approved for 
use in foods under the FFDCA could be used in the production of meat or 
poultry products. In addition, under the proposal, current FDA 
regulations that list the use of a substance in foods generally, and 
that do not preclude meat and poultry product uses, would confer 
authority to use those substances in the production of meat and poultry 
products unless expressly prohibited by FSIS. In place of its own 
regulations, FSIS proposed to amend 9 CFR Parts 310, 318, 319, and 381 
to include appropriate cross-references to the listings of substances 
permitted for use in the production of meat and poultry products in 
title 21 of the CFR.
    FSIS stated that, as a matter of policy, all substances listed by 
FDA as Generally Recognized as Safe (GRAS) for general use in food in 
21 CFR Parts 182 and 184 would be considered by USDA to be acceptable 
for use in meat and poultry products, unless restricted for such use by 
FSIS. For substances not listed by FDA as GRAS in 21 CFR Parts 182 or 
184, FSIS proposed to continue to evaluate, in consultation with FDA, a 
manufacturer's basis for claiming that the food ingredient is GRAS and 
is suitable for use in meat or poultry products. FSIS also proposed to 
continue to offer advice to manufacturers regarding the suitability for 
specific uses of substances listed in title 21 of the CFR for general 
use in the production of foods or for use in meat or poultry products 
only. Except for formulation and processing procedure data for 
proprietary mixtures, which would be kept confidential, FSIS stated

[[Page 72169]]

that it intended to make its responses and related correspondence 
available to the public.
    Under the proposal, all petitions for rulemaking to permit new 
substances or new uses or use levels of substances in the production of 
foods--including meat and poultry products--would be sent to FDA. The 
proposal reflected the fact that a petition needs to be submitted when 
a substance: (1) is not expressly listed for meat or poultry product 
uses in title 9 of the CFR, or in title 21 of the CFR, Parts 172-180; 
(2) is not a GRAS substance listed in Part 182 or 184 of title 21 of 
the CFR for general use in foods; or (3) cannot be demonstrated to 
FSIS, which consults with FDA as necessary, to be GRAS for particular 
meat or poultry product uses. It stated that FDA would evaluate the 
petitions in consultation with FSIS if any prospective use of a food 
additive, color additive, or GRAS substance, would be in meat or 
poultry products.
    FSIS stated that it intended to review its listings in title 9 of 
the CFR of substances, within three to five years of a final rule in 
this proceeding, to eliminate those listings that duplicate FDA's 
listings in title 21 of the CFR. Because of current and anticipated 
resource constraints, FDA proposed to amend its regulations in title 21 
of the CFR to provide that it would include meat and poultry product 
uses only in response to a petition, i.e., a food additive, color 
additive, or GRAS affirmation petition, and that it would not move 
wholesale FSIS's listings of substances from title 9 of the CFR to 
title 21 of the CFR.
    FSIS proposed to continue regulating the use of substances in meat 
and poultry products and to conduct the same reviews that it has been 
conducting, if and when necessary. For example, FSIS standards of 
identity or composition, in specific cases, could restrict uses of 
substances, or FSIS could determine that the use of a substance could 
adulterate a particular product or lead to a misbranded product. FSIS 
tentatively found that its ability to continue to regulate food 
ingredients was important so that it could prohibit or restrict the use 
of specific food ingredients in meat or poultry products. However, FSIS 
does not expect that it will have to take such action regularly because 
FDA's statutory authority, exercised according to the Memorandum of 
Understanding (MOU) between FDA and FSIS, will provide a means of 
imposing appropriate limitations on uses of food ingredients in meat 
and poultry products. (A draft version of the MOU was published as an 
appendix to the proposal. See 60 FR 67467.)
    To provide direction to its inspection program personnel, FSIS 
proposed to maintain a comprehensive listing in its directive system of 
substances authorized for use in the production of meat and poultry 
products under title 9 or title 21 of the CFR. FSIS proposed to include 
in the listing:
    a. Substances listed in title 9 of the CFR;
    b. Substances listed for meat or poultry product uses in FDA food 
additive, color additive, GRAS, or prior-sanction listings;
    c. Approved color additives in 21 CFR Parts 73, 74, and 82, food 
additives listed in 21 CFR Parts 172-173 and 180, prior-sanctioned 
substances approved by part 181, and GRAS substances approved by 21 CFR 
182 and 184, if permitted for general use in or on foods (including 
meat and poultry products) in accordance with good manufacturing 
practice, unless meat or poultry product uses of these additives or 
substances are otherwise precluded; and
    d. FDA food additive, color additive, GRAS, and prior-sanctioned 
substance listings that provide for meat and poultry product uses and 
are promulgated after the proposal becomes final.
    FSIS also proposed to provide similar information to inspected 
establishments and other interested persons in the form of guidelines.

Memorandum of Understanding

    FDA and FSIS have entered into an MOU establishing procedures to 
jointly respond to petitions to use food ingredients and sources of 
radiation in the production of meat and poultry products. Under the 
terms of the MOU, petitions to use a food or color additive or GRAS 
substance in the production of meat or poultry products will be 
evaluated for safety by FDA and for suitability by FSIS. FDA will be 
the submitter's regulatory contact. A copy of the MOU is appended to 
this final rule.

Discussion of Comments

    FSIS received 22 comments in response to the proposed rule. Trade 
associations submitted eleven, industry eight, and a governmental 
organization, professional association, and consulting firm each 
submitted one. Most commenters generally favored the proposal and 
supported the efforts of FSIS and FDA to streamline the system to list 
or approve food ingredients used in meat and poultry products. Two 
commenters opposed the proposal. The following is a discussion of the 
relevant issues raised in the comments.
    1. Despite the general support for the proposal, many commenters 
took issue with FSIS's proposal to prohibit the use of GRAS substances 
in meat and poultry products unless the substance is listed in parts 
182 or 184 of title 21 of the CFR or in title 9 of the CFR. They stated 
that FSIS's prohibition of the use of unlisted GRAS substances in meat 
and poultry products is unreasonable because FDA has said that it is 
impractical to list all such substances in FDA regulations. The 
commenters maintained that all GRAS food substances, whether or not 
listed in FDA or FSIS regulations, should be permitted in meat and 
poultry products, provided that they are used in accordance with good 
manufacturing practice. One commenter requested that the policy 
currently in place for the self-determination of GRAS status of 
substances used in FDA-regulated foods be applied to food ingredients 
used in FSIS-regulated meat and poultry products. Another commenter 
expressed concern that permitting firms to make GRAS self-
determinations would allow the use of unknown food ingredients in meat 
and poultry products.
    Self-determinations of GRAS status present significantly different 
problems for FSIS than FDA. FDA's regulatory authority over products 
that contain an ingredient that a manufacturer views as GRAS begins 
when such products enter commerce and requires that FDA find that such 
products are adulterated. In contrast, FSIS must be able to find that a 
product is not adulterated before it will apply the mark of inspection 
that is necessary for the product to enter commerce. Thus, while a 
manufacturer of an FDA-regulated product may determine that use of a 
substance is GRAS, taking a calculated risk that FDA will not disagree, 
the manufacturer of an FSIS-regulated product which uses the same 
substance will not be eligible for the mark of inspection if FSIS has 
no basis for concluding that use of the substance would not adulterate 
the product. To be eligible for the mark of inspection for its 
products, a manufacturer must show that the use of the ingredients in 
its products has been shown to be safe under some provision of FDA law 
or has a history of safe use.
    On April 17, 1997, FDA published in the Federal Register a proposal 
to replace the current GRAS affirmation petition process with a 
notification procedure. Under the proposed notification procedure, any 
person may notify FDA that he/she has determined that a particular use 
of a substance is GRAS. Upon receiving such a notification, FDA will 
evaluate whether the submitted notice provides a sufficient basis for a 
determination that

[[Page 72170]]

the use is GRAS, and whether information in the notice or otherwise 
available to FDA raises issues that lead FDA to question whether use of 
the substance is GRAS. If FDA elects not to question the determination, 
it will send the person a letter to that effect.
    In the near future, FSIS intends to publish a proposal that will 
reflect FDA's GRAS notification proposal as it implicates GRAS food 
ingredients permitted for use in meat and poultry products. If both 
proposals are adopted, FSIS will accept self-determinations of GRAS 
status if an establishment that relies on the determination has on file 
in the establishment a copy of a letter from FDA that states that FDA 
does not question the determination, and the establishment makes the 
letter available to FSIS inspection program personnel. However, FSIS is 
retaining the right to evaluate self-determinations of GRAS status for 
suitability and will do so if it deems such an evaluation is required 
for any reason. FSIS is currently continuing to perform evaluations of 
self-determined GRAS substances to ascertain that the substances are 
suitable for use in meat and poultry products.
    2. Many commenters asserted that food ingredients listed or 
approved for general food use under FDA regulations should be permitted 
for use in meat and poultry products unless otherwise restricted by 
other FDA or FSIS regulations.
    FSIS agrees. As stated in the proposal, color additives approved by 
21 CFR Parts 73, 74, and 82; food additives listed in 21 CFR Parts 172-
173 and 180; prior-sanctioned substances approved by part 181; and GRAS 
substances approved in 21 CFR 182 and 184 may be used in meat and 
poultry products provided that the food ingredient is permitted for 
general use in or on foods (which includes meat and poultry products) 
and is used in accordance with good manufacturing practice, unless the 
meat or poultry product uses of the food ingredient are otherwise 
specifically precluded or not specifically allowed by product 
standards.
    3. Many commenters that supported the efforts of FSIS and FDA to 
streamline the system for listing or approving food ingredients used in 
meat and poultry products stated that FSIS should participate in FDA's 
process to regulate food ingredients to ensure that such ingredients 
listed or approved for use in or on meat and poultry products are 
appropriate for such use. However, a few felt that FSIS should be 
completely eliminated from this process. One commenter stated that FSIS 
is not equipped to perform a separate safety evaluation for food 
ingredients, and that FSIS's review would be inconsistent with the goal 
of streamlining the review process. Others felt that dual evaluations 
would significantly lengthen the review process, and therefore, one 
agency or the other should conduct evaluations entirely, but not both.
    Most commenters felt that FDA, not FSIS, should be responsible for 
reviewing food ingredient petitions, despite concerns that ``the FDA 
petition process system is burdensome and slow, because FDA is required 
to evaluate all substances for use in food, including meat and poultry 
products.'' One commenter lamented the loss of a quick response by FSIS 
to submitters, while another suggested that FSIS accept ``informal 
advisory letters'' from FDA. This commenter suggested that FSIS could 
use these letters, which prescribe the appropriate use of food 
ingredients, to determine the appropriate use of such ingredients 
without requiring a rulemaking proceeding to be completed before the 
ingredient may be used in meat and poultry products.
    FDA has broad jurisdiction over all food, except to the extent 
exceptions have been created by statute, and primary authority for 
determining the safety of food ingredients for use in meat and poultry 
products. FSIS's jurisdiction is more specific: It is limited to 
regulating the production and distribution of meat, poultry, and egg 
products. Because of its extensive statutory authority to regulate the 
safety of food ingredients and sources of radiation that may be used 
the production of food, FDA has developed the scientific staff, the 
institutional expertise, and the regulatory structure to ensure that 
food ingredients and sources of radiation that may be used in the 
production of foods are safe. Therefore, FDA and FSIS have agreed that 
FDA is the agency to whom manufacturers should submit petitions for the 
use of food ingredients and sources of radiation.
    Requiring petitions to be submitted to FDA will not delay the 
listing of food ingredients or sources of radiation for use in meat and 
poultry products. Instead, the single petition, joint review, and 
single rulemaking procedure should decrease the time it takes to list 
or approve a food ingredient or source of radiation for use in meat or 
poultry products by eliminating the current time-consuming, 
duplicative, sequential rulemaking process.
    Currently, food additives, as defined in 21 U.S.C. 321(s), may not 
be used in meat or poultry products unless they are listed for use 
under the FFDCA. A manufacturer is first required to petition FDA to 
list the food additive for its intended conditions of use or for use in 
food in general. In response to the petition, FDA amends its 
regulations in title 21 of the CFR to provide for the use of the 
substance. Once FDA has acted, the manufacturer must then petition FSIS 
for approval of the food additive for use specifically in meat or 
poultry products, unless the manufacturer has submitted data supporting 
its use in such products in its original petition to FDA (see 9 CFR 
318.7(a)(2)). In such a case, use is generally permitted unless a 
standard of identity or other regulation precludes it. After FSIS has 
completed its evaluation and approved the food additive for use in meat 
and poultry products, FSIS must amend its regulations in title 9 to 
include the permitted use before the food additive can actually be used 
in a meat or poultry product.
    Sometimes, however, a manufacturer does not submit a food additive 
petition to FDA for use of a substance in meat or poultry products. 
Instead, it contacts FSIS directly, asking that FSIS approve the use of 
the food additive in meat or poultry products. When this happens, FSIS, 
rather than the submitter, is put in the position of having to approach 
FDA to obtain approval for the use of the food additive in food 
generally under the FFDCA. Therefore, though FSIS, and not the 
submitter, approaches FDA, FDA still conducts a safety evaluation of 
the food additive and amends its regulations as necessary under the 
FFDCA before FSIS begins its own process. Duplicative reviews and 
rulemaking cannot be avoided under the current system.
    The new system will eliminate the need for a manufacturer to submit 
two petitions, one to each agency, for the listing or approval to use a 
food additive or color additive, or source of radiation, in the 
production of meat or poultry products. Manufacturers will tender only 
one petition, to FDA, as they have always had to do under the tenets of 
the FFDCA. After FDA has completed its general food safety evaluation, 
it will inform FSIS of its determination. Consistent with the 
requirements that FDA's statutory authority has always necessitated, 
FDA, not FSIS, will amend its regulations to provide for the use of the 
food or color additive or other substance, when such regulation is 
necessary. FSIS will, as indicated, modify its directive and guidelines 
to reflect the new food ingredient or source of radiation or its new 
use or level. These new procedures will speed up the review process and 
eliminate the need

[[Page 72171]]

for duplicative listings in FSIS's regulations.
    4. One commenter asked why inquiries regarding substances that are 
not affirmed or listed as GRAS in title 21 of the CFR should be sent to 
FSIS if FDA will ultimately be required to issue a GRAS regulation 
before the substance may be used.
    At the time of the proposal, FDA and FSIS determined that FSIS is 
best suited to provide advice regarding whether a substance could be 
used in meat or poultry products. Therefore, the agencies tentatively 
decided that inquiries about the use of unlisted or unaffirmed GRAS 
substances in meat and poultry products should be directed to FSIS.
    After further discussions with FDA, the two agencies have decided 
that because the statutes under which FDA operates require FDA approval 
of ingredients whose use is not GRAS, FDA is better suited than FSIS to 
provide advice regarding whether a substance not listed as GRAS is safe 
for use in meat or poultry products. Therefore, inquiries concerning 
the use in specific meat or poultry products of substances that are not 
affirmed by FDA as GRAS or otherwise listed in 21 CFR Part 182 or 184, 
or of food and color additives listed or approved in title 21 
regulations for general use in foods, or for use in meat or poultry 
products generally, including mixtures of such food and color 
additives, should be addressed in writing to FDA.
    5. In the proposed rulemaking, FSIS stated that it would review its 
lists of food ingredients and sources of radiation approved for use in 
meat and poultry products in title 9 of the CFR over the next three to 
five years and eliminate those that duplicate FDA's listing in title 21 
of the CFR. However, FSIS also declared its intention to retain those 
regulations that prohibit uses of specific food ingredients to protect 
the public health and consumers from product adulteration and 
misbranding under the FMIA and PPIA; and to promulgate new prohibitions 
or limitations as necessary.
    While one commenter favored this dual approach, five others felt 
that FDA should cover all past, present, and ``future ingredient 
approvals and restrictions'' for use in meat and poultry products in 
title 21 of the CFR. A third group of commenters requested that FSIS 
maintain a comprehensive listing of food ingredients approved for use 
in meat and poultry products either under title 9 of the CFR or in 
another FSIS publication as guidance to inspection program personnel 
and industry. One commenter who opposed the proposal stated that while 
the ``new food additive approval system'' might decrease the 
bureaucracy involved in getting food ingredients listed for use in meat 
and poultry products, it could also negatively affect traditional 
products produced by smaller processors because such processors rely on 
FSIS staff to guide them in properly using FDA-approved food 
ingredients in their products.
    FSIS generally agrees with those commenters who stated that FSIS's 
tables of approved substances in title 9 of the CFR should be 
eliminated because they are not as complete as FDA's food ingredient 
listings. FSIS has decided, however, to retain them in title 9 of the 
CFR until FDA completes the amendments of its regulations in title 21 
of the CFR to include all food ingredient and sources of radiation uses 
in meat and poultry products. While this may not happen for some time, 
due to current and anticipated resource constraints within FDA, FSIS 
believes it is the best way to ensure that food ingredients not listed 
or approved for use in meat and poultry products will not be used. FSIS 
will also publish a directive for inspection program personnel, and a 
set of guidelines for members of both the meat and poultry industry and 
the public, that will contain the food ingredients listed or approved 
for use in meat and poultry products.
    6. One commenter recommended that FSIS conduct a total review of 
all existing ``food additive'' limitations and restrictions before the 
proposal is finalized, to determine their efficacy. All current food 
additive limitations and restrictions are based on scientific data that 
were reviewed by FSIS and FDA before each additive was listed or 
approved for use in meat and poultry products. The commenter presented 
no basis for concern about the reviews that were done. Therefore, there 
is no basis for changes to the limitations or restrictions unless new 
data are presented that support modifying a listed or approved use. It 
would take years of effort to review all of the actual data supporting 
each limitation or restriction, and FSIS has no intention of conducting 
a total review of existing substance limitations and restrictions.
    7. A commenter stated that it was unclear whether FSIS's review 
process for processing chemicals not regulated under the FFDCA, such as 
sanitizing and cleaning agents for food-contact equipment and utensils, 
will continue once this final rule is adopted.
    It will not. On February 13, 1998, FSIS announced in the Federal 
Register that it is eliminating its prior approval requirements for 
nonfood compounds and proprietary substances. ``Proprietary 
substances'' contain a combination of ingredients, some of which are 
not identified on the containers by common or chemical name, or by some 
other means. While approval of nonfood compounds and proprietary 
substances before their intended use provides some assurance to meat 
and poultry product processors that the use of these compounds and 
substances would not result in the adulteration of food products, 
provided they are properly used, this type of prior approval program is 
inconsistent with the new food safety strategy and approach set forth 
in the ``Pathogen Reduction; Hazard Analysis and Critical Control Point 
(HACCP) Systems'' (61 FR 38806).
    Under these regulations, meat and poultry establishments are 
responsible for developing and implementing HACCP plans incorporating 
the controls necessary and appropriate to produce safe meat and poultry 
products. Consequently, establishments, not FSIS, will be responsible 
for ensuring that the nonfood compounds and proprietary substances they 
use are lawful, safe, and effective.
    FSIS intends to maintain a small staff with expertise in nonfood 
compounds and proprietary substances. This staff will be responsible 
for issuing technical guidance, particularly to small and very small 
meat and poultry establishments, as the need arises. FSIS began 
eliminating the prior approval system for nonfood compounds and 
proprietary substances in autumn 1998.
    8. A commenter suggested that FSIS eliminate the Proprietary Mix 
Committee (PMC) and set up third-party review of ``food additives.'' 
The PMC provides a voluntary identification service to ingredient 
manufacturers. The PMC evaluates the proprietary formula and process 
for making an ingredient mix, confirms the identity and regulatory use 
status of the ingredients, and identifies appropriate labeling and use 
requirements for the mix. The PMC then sends the information, in 
writing, back to the requestor. This ``PMC letter,'' which is used 
during the prior label approval process by meat and poultry product 
processors manufacturing products containing proprietary mixes, 
provides verification of the appropriate ingredient labeling 
information to FSIS.
    Ingredient manufacturers are not required by the meat and poultry 
regulations to have a PMC letter before getting meat and poultry 
product labels approved by FSIS. It is a voluntary service offered by 
FSIS. For this reason, and because the PMC works in

[[Page 72172]]

conjunction with the prior label approval system, it will continue to 
function as long as FSIS has a prior label approval system. If, and 
when, FSIS eliminates that system and replaces it with a generic label 
approval system (which was discussed in the final rule on prior label 
approval, 60 FR 67443), FSIS will also consider eliminating the PMC.
    9. One commenter, who provided qualified support for the proposal, 
felt that 9 CFR 318.1(d), which would require labels for preparations 
containing ``chemicals'' limited by 21 CFR 73, etc., or by 9 CFR 
Chapter III, Subchapter A, to show the percentage of the ``chemical'' 
in the preparation, was unnecessary and should be deleted. The 
commenter contended that such a requirement conflicts with FDA's 
regulations for labeling GRAS substances (21 CFR 184.1(f)(2)), which 
permit proprietary composition information to be excluded from the 
label if other information on the label will enable the user to comply 
with the given regulatory limitations. According to the commenter, 
proposed 9 CFR 318.1(d) would require the manufacturer to reveal 
confidential information to FSIS-inspected establishments or to decline 
to sell the preparation to them. The commenter asserted that if the 
information on the label instructs the user how to properly use the 
product and to comply with the regulatory limits, then public health 
and safety are not compromised. Therefore, the commenter contended, the 
regulation is not necessary. The commenter suggested that deletion of 9 
CFR 318.1(d) will make FDA's and FSIS's regulations consistent and will 
allow manufacturers to use the same label on identical products 
destined for both FSIS-inspected establishments and FDA-regulated 
establishments.
    To some extent, FSIS agrees with the commenter. Contrary to the 
commenter's assertion, however, section 318.1(d) does not require the 
ingredient manufacturer to disclose proprietary information to FSIS-
inspected establishments. It requires that labels on containers of 
preparations used in hog scalding water or the denuding of tripe bear 
the common or chemical name of the preparation. If the preparation 
contains a chemical that is specifically limited by current section 
318.7(c)(4), the label must show the percentage of the chemical in the 
preparation.
    After further consideration, FSIS believes that 9 CFR 318.1(d), as 
currently written, is a command-and-control provision because it tells 
chemical manufacturers what information they must provide on the labels 
of their products. This is inconsistent with FSIS's announced policy of 
removing command-and-control provisions wherever feasible.
    Therefore, FSIS has decided to amend section 318.1(d) to require 
that labels or labeling on containers of hog scald water or tripe 
denuding preparations bear adequate directions to ensure use in 
compliance with any limitations prescribed in 9 CFR or 21 CFR. This 
action will make FDA's and FSIS's regulations consistent and will allow 
manufacturers to use the same label on identical products destined for 
both FSIS-inspected establishments and FDA-regulated establishments.
    10. The commenters that did not support the proposal expressed 
concern that FDA's petition system is more complicated and confusing 
than FSIS's system. One commenter stated that it would be confusing and 
time-consuming to have to search through five parts of title 21 of the 
CFR to find the status of a food ingredient.
    While FDA and FSIS acknowledge that some confusion may arise from 
the placement of listed or approved food ingredients and sources of 
radiation in different parts of title 21 of the CFR, the public will be 
better served by having the permitted uses consolidated in one title of 
the CFR. Rather than searching through two separate titles of the CFR, 
9 and 21, to find the permitted uses of a food ingredient or source of 
radiation, interested parties will only have to survey one, title 21.

Combined Language

    For the past several years, FSIS has been reviewing its regulatory 
procedures and requirements to determine which are still needed and 
which ought to be modified, streamlined or eliminated (see FSIS Docket 
No. 95-008A, ``FSIS Agenda for Change: Regulatory Review''; 60 FR 
67469). This review is an integral part of FSIS's initiative to 
modernize its food safety regulations and reflects FSIS's commitment to 
achieving its goal of having fewer, clearer, and user-friendly 
regulations.
    In the course of drafting this final rule, FSIS identified various 
meat and poultry regulations that, within the context of FSIS's 
regulatory streamlining initiative, need revision. FSIS decided to 
consolidate some of those regulations. The consolidation did not 
involve any substantive changes.
    FSIS added a new Part 424, titled Preparation and Processing 
Operations. This new part, to the extent possible, combines the meat 
and poultry products inspection regulations affected by this rule. As a 
result, these rules are the same for both meat and poultry products, 
unless there is a specific reason for having different rules or 
language.

The Final Rule

    Under this final rule, FSIS is ending duplicative rulemaking 
activities regarding the use of food ingredients and sources of 
radiation in the production of meat and poultry products. FSIS is 
amending 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 (Chapter I, Subchapter A and Subchapter B) 
listings of food additives, GRAS substances, color additives, and 
prior-sanctioned substances permitted for use in meat and poultry 
products.
    As amended, 9 CFR 310.20 includes appropriate references to food 
ingredient listings and approvals in title 21 of the CFR. The 
requirements governing the saving of livestock blood have not been 
changed. The new amendment to 9 CFR 318.1 eliminates the requirement 
that labels on hog scalding or tripe denuding preparation containers 
show the percentage of chemicals in the preparations that are 
specifically limited as to amount permitted to be used, if any, by 21 
CFR or 9 CFR. The labels will need to bear only adequate use directions 
to ensure that such use is in compliance with all provisions of 21 CFR 
or 9 CFR.
    Section 318.7(d)(2) of 9 CFR is amended to add a reference to title 
21 of the CFR. In addition, this section has now been transferred to a 
new part and renumbered. (See Part 424, Preparation and Processing 
Operations, section 424.23, Prohibited uses, paragraph (a)(3).) As in 
the proposal, the paragraph does not change the prohibitions of and 
restrictions on the food ingredient uses in meat.
    Proposed 9 CFR 318.7(a)(4) and 381.147(f)(2)(iv) listed addresses 
for inquiries concerning the status of food ingredients intended for 
use in or in contact with meat or poultry products. Proposed 9 CFR 
318.7(a)(5) and 381.147(f)(2)(v) listed addresses for inquiries 
concerning the use in meat or poultry products of food ingredients not 
listed in the title 21 regulations. In this final rule, these 
provisions have been combined and moved to section 424.21, Use of 
substances, paragraphs (b)(5) and (b)(6). No substantive changes have 
been made to these provisions.
    Proposed 9 CFR 318.7(a)(1)-(3) and 9 CFR 381.147(f)(1) and (2) have 
also been combined in this final rule and placed in section 424.21, 
paragraphs (b)(1)-(3).

[[Page 72173]]

Again, no substantive changes have been made.
    Section 318.7(b), Use of nitrite and sodium ascorbate or sodium 
erythorbate (isoascorbate) in bacon, has been moved in its entirety to 
section 424.22, Certain other permitted uses, paragraph (b), while 
section 318.7(c) has been moved in its entirety to section 424.22(c) 
and combined with section 381.147(f)(4) to create one list of food 
ingredients approved for use in meat and poultry products. Where 
possible, FSIS has combined meat and poultry listings for a specific 
chemical into one listing. No substantive changes have been made to 
these provisions.
    New part 424 prescribes the rules for the preparation or processing 
of meat and poultry products (see section 424.1, Purpose and Scope). 
The rules are intended to prevent the adulteration and misbranding of 
meat and poultry products at official establishments. The statements 
contained in section 424.1 merely advise the public of the purpose and 
scope of the rules FSIS administers.
    FSIS is also including in Part 424 section 424.22 (formerly 9 CFR 
318.7(b) and (c), and 9 CFR 381.147(f)(4)), which covers certain other 
permitted uses of ingredients in meat, and section 424.23, which lists 
prohibited uses of ingredients in meat and poultry products (formerly 9 
CFR 318.7(d)).

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. States and local jurisdictions are preempted by 
the Federal Meat Inspection Act (FMIA) and the Poultry Products 
Inspection Act (PPIA) from imposing any marking, labeling, packaging, 
or ingredient requirements on federally inspected meat and poultry 
products that are in addition to, or different from, those imposed by 
the FMIA and the PPIA. States and local jurisdictions may, however, 
exercise concurrent jurisdiction over meat and poultry products that 
are within their jurisdiction and outside official establishments for 
the purpose of preventing the distribution of meat and poultry products 
that are misbranded or adulterated under the FMIA and PPIA, or, in the 
case of imported articles, that are not at such an establishment, after 
their entry into the United States.
    This rule is not intended to have retroactive effect.
    Under this rule, administrative proceedings will not be required 
before parties may file suit in court challenging this rule.

Executive Order 12866 and Regulatory Flexibility Act

    This final rule has been determined to be significant and has been 
reviewed by OMB under Executive Order 12866. In accordance with 5 
U.S.C. 603, FSIS has also conducted a regulatory flexibility analysis 
regarding the impact of the rule on small entities.
    This final rule will replace the current government process for 
listing or approving the use of food ingredients and sources of 
radiation in meat and poultry products, which involves consecutive 
rulemakings by FDA and FSIS, with a ``one-stop'' procedure under which 
sponsors of new food or color additives, other substance uses, or 
sources of radiation in meat and poultry products will have to petition 
only FDA under the requirements of the FFDCA. FDA has always had the 
statutory authority for approving ingredients. FDA will conduct any 
required rulemaking on the matter in consultation with FSIS. FDA's rule 
will specify any uses or use restrictions unique to meat or poultry 
products.
    This final rule modifies existing FSIS regulations concerning the 
listing or approval of food ingredients and sources of radiation used 
in the production of meat and poultry products that needlessly 
duplicate effort and expenditures by government and the regulated 
industry. These existing regulations require sequential rulemakings by 
FDA and FSIS to permit a new food ingredient and source of radiation, 
or a new use of a previously approved food ingredient or source of 
radiation to be used in meat or poultry products. The cost to industry 
and government of these rulemaking procedures includes the costs to 
industry arising from the delay in the introduction of new ingredients, 
or new food products. These costs create a disincentive for 
technological innovation and new product development. The existing 
process, therefore, negatively affects economic growth.

Benefit-Cost Assessment

    The public benefits conferred by this rulemaking include, 
principally, those associated with the more timely regulatory listing 
or approval of food ingredients and sources of radiation used in the 
production of foods and those associated with having the ingredients 
themselves available for use more quickly. The benefits of ingredients 
added to meat and poultry products include the technical effects on the 
characteristics of food products, the uses of the ingredients in food 
processing, and a greater variety of foods in the marketplace. Public 
health benefits include the greater availability of food through 
preservation techniques and improved food safety through, for example, 
antimicrobial treatments of raw product and the use of curing solutions 
in processed products. The benefits conferred by the availability of 
ingredients and this rulemaking will marginally increase the 
ingredients' uses.
    The public benefits of regulating food ingredients and sources of 
radiation, generally, will not change. These include, principally, the 
prevention of adulteration or misbranding of food products. Consumers 
are provided assurances that the products they buy do not contain food 
ingredients whose use(s) ought, for various reasons, to be prohibited, 
and food ingredients that have been listed or approved have not been 
used improperly in foods. This final rulemaking will not affect such 
benefits because (1) FDA will continue to approve food ingredients and 
sources of radiation, and conduct safety reviews (when required by the 
FFDCA) of food ingredients and sources of radiation proposed for use in 
the production of foods, including--in consultation with FSIS--meat and 
poultry products, and (2) FSIS will 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 
listing or approving food ingredients or sources of radiation for use 
in meat and poultry products will probably save the regulated industry 
between $400,000 and $600,000 a year over and above the savings the 
government itself will realize in administrative costs. (According to 
industry representatives, the cost of filing one food ingredient 
petition is approximately $100,000. This includes research and 
administrative costs.)
    Other less calculable benefits arise through the removal of a 
disincentive to innovate. With the potential expansion of uses of 
listed or approved food ingredients that will result from the easing of 
the current regulatory burden, new product development and marketing 
are encouraged.
    This final rule will not have a significant economic impact on a 
substantial number of small entities. Obtaining approval for the use in 
the production of meat and poultry products of new food ingredients or 
sources of radiation, or for new uses of previously listed or approved 
food ingredients or sources of radiation, will

[[Page 72174]]

be simpler, faster, and less costly for both industry and the Federal 
government than under the current system.
    Under the final rule, separate petitions to FSIS will no longer 
have to be submitted. FSIS will permit food ingredients and sources of 
radiation to be used in products under its jurisdiction based on FDA's 
title 21 regulations permitting such uses. Those food additives and 
color additives not approved for meat and poultry product use under 
current FDA regulations will require only one petition for rulemaking--
to FDA.
    FSIS currently receives only four to six petitions per year for the 
listing or approval of food ingredients for use in meat and poultry 
products. Approximately 75 percent of these petitions are from large 
commercial entities. Therefore, the final rule will not have a 
significant effect on a substantial number of small entities. 
Furthermore, all users of the Federal regulations concerning the 
addition of food ingredients to foods will benefit by having fewer, 
clearer regulations. Thus, there will be a reduction in the duplication 
of effort and attendant costs for all concerned.

Public Notification and Request for Data

    The public is asked to provide additional information on the effect 
of this final rule on minority ownership and operation of affected 
establishments, employment, and consumers, and other related impacts. 
The information being requested includes professional journal articles, 
research reports, industry data, and other similarly reliable 
information. Public involvement in all segments of rulemaking and 
policy development is important. Consequently, in an effort to better 
ensure that minorities, women, and persons with disabilities are aware 
of this final rule, FSIS will announce the publication of this final 
rule in the Federal Register in the FSIS Constituent Update.
    FSIS provides a weekly FSIS Constituent Update, which is 
communicated via fax to over 300 organizations and individuals. In 
addition, the update is available on line through the FSIS web page 
located at http://www.fsis.usda.gov. The update is used to provide 
information regarding FSIS policies, procedures, regulations, Federal 
Register notices, FSIS public meetings, recalls, and any other types of 
information that could affect or would be of interest to our 
constituents/stakeholders. The constituent fax list consists of 
industry, trade, and farm groups, consumer interest groups, allied 
health professionals, scientific professionals, and other individuals 
that have requested to be included. Through these various channels, 
FSIS is able to provide information to a much broader, more diverse 
audience. For more information and to be added to the constituent fax 
list, fax your request to the Congressional and Public Affairs Office, 
at (202) 720-5704.

Paperwork Requirements

    No new paperwork requirements are associated with this final rule. 
The effect of the rulemaking will be to substantially reduce the 
information collection from private sources concerning proposed uses of 
food ingredients in meat or poultry products. Persons seeking Federal 
government listing or approval of food additives and color additives 
for use in the production of meat or poultry products will have to 
petition only FDA, rather than both FDA and FSIS, as they now do. Thus, 
the current, duplicative information collection requirement will be 
eliminated.

List of Subjects

9 CFR Part 310

    Meat inspection.

9 CFR Part 318

    Food additives, Food packaging, Meat inspection.

9 CFR Part 381

    Food additives, Food packaging, Poultry and poultry products.

9 CFR Part 424

    Food additives, Food packaging, Meat inspection, Poultry and 
poultry products.

    For the reasons set out in the preamble, 9 CFR parts 310, 318, 319 
and 381, are amended, and part 424 is added, to read as follows:

PART 310--POST-MORTEM INSPECTION

    1. The authority citation for part 310 continues to read as 
follows:

    Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.

    2. Section 310.20 is 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 may be used in accordance with 
21 CFR Chapter I, Subchapter A and Subchapter B, or by regulation in 9 
CFR Chapter III, Subchapter A or Subchapter E.

PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND 
PREPARATION OF PRODUCTS

    3. The authority citation for part 318 continues 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) is revised to read as follows:


Sec. 318.1  Products and other articles entering official 
establishments.

* * * * *
    (d) To ensure the safe use of preparations used in hog scalding 
water or in the denuding of tripe, the label or labeling on containers 
of such preparations shall bear adequate directions to ensure use in 
compliance with any limitations prescribed in 21 CFR Chapter I, 
Subchapter A or Subchapter B, or 9 CFR Chapter III, Subchapter A or 
Subchapter E.
* * * * *


Sec. 318.7  [Removed]

    5. Section Sec. 318.7 is removed.

PART 319--DEFINITIONS AND STANDARDS OF IDENTITY OR COMPOSITION

    6. The authority citation for 9 CFR Part 319 continues 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. The first sentence of Sec. 319.100 is amended by removing 
``Sec. 318.7(c)(1) and (4) of this subchapter'' and adding in its place 
``a regulation permitting that use in this subchapter or 9 CFR Chapter 
III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter 
B.''


Sec. 319.106  [Amended]

    8. Paragraph (d)(2) of Sec. 319.106 is amended by removing ``in 
accordance with Sec. 318.7(c)(4) of this subchapter'' and adding in its 
place ``a regulation permitting that use in this subchapter or 9 CFR 
Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or 
Subchapter B.''

[[Page 72175]]

Sec. 319.140  [Amended]

    9. The second and third sentences of Sec. 319.140 are amended by 
removing ``Sec. 318.7(c)(4) of this subchapter'' and adding in its 
place ``a regulation permitting that use in this subchapter or in 9 CFR 
Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or 
Subchapter B.''


Sec. 319.145  [Amended]

    10. Section 319.145 is amended as follows:
    A. In paragraph (a)(4), remove ``in the chart following 
Sec. 318.7(c)(4),'' and add in its place ``in a regulation permitting 
that use in this subchapter or 9 CFR Chapter III, Subchapter E, or in 
21 CFR Chapter I, Subchapter A or Subchapter B'';
    B. In paragraph (b)(6), remove ``the chart of substances in 
Sec. 318.7(c)(4) of this subchapter.'' and add in its place ``a 
regulation permitting that use in this subchapter or 9 CFR Chapter III, 
Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B.''


Sec. 319.180  [Amended]

    11. Section 319.180 is amended as follows:
    A. In the first sentence of paragraph (a), remove 
``Sec. 318.7(c)(4) of this chapter,'' and add in its place ``a 
regulation permitting that use in this subchapter or 9 CFR Chapter III, 
Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B.'';
    B. In the first sentence of paragraph (b), remove 
``Sec. 318.7(c)(4) of this chapter,'' and add in its place ``a 
regulation permitting that use in this subchapter or 9 CFR Chapter III, 
Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B.'';
    C. In the first sentence of paragraph (e), remove 
``Sec. 318.7(c)(4) of this subchapter.'' and add in its place ``a 
regulation permitting that use in this subchapter or 9 CFR Chapter III, 
Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B.''


Sec. 319.303  [Amended]

    12. The second sentence of paragraph (a)(3) of Sec. 319.303 is 
amended by removing ``Sec. 318.7(c)(4) of this subchapter'' and adding 
in its place ``a regulation permitting that use in this subchapter or 9 
CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or 
Subchapter B.''


Sec. 319.700  [Amended]

    13. Section 319.700 is amended as follows:
    A. In paragraphs (a)(4), (a)(5), and (a)(6), remove 
``Sec. 318.7(c)(4) of this chapter'' and add in its place ``a 
regulation permitting that use in this subchapter or 9 CFR Chapter III, 
Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B.'';
    B. In the first sentence of paragraph (a)(7), remove 
``Sec. 318.7(c)(4) of this chapter,'' and add in its place ``a 
regulation permitting that use in this subchapter or 9 CFR Chapter III, 
Subchapter E, or in 21 CFR Parts 73, 74, 81, or 82,'';
    C. In the first sentences of paragraphs (a)(9) and (a)(10), remove 
``Sec. 318.7(c)(4) of this chapter,'' and add in its place ``a 
regulation permitting that use in this subchapter or 9 CFR Chapter III, 
Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B.''

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

    14. The authority citation for 9 CFR Part 381 continues to read as 
follows:

    Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 451-470; 7 CFR 2.18, 
2.53.


Sec. 381.120  [Amended]

    15. The fourth and sixth sentences of Sec. 381.120 are amended by 
removing ``Sec. 381.147'' and adding in its place ``a regulation 
permitting that use in this subchapter or 9 CFR Chapter III, Subchapter 
E, or in 21 CFR Chapter I, Subchapter A or Subchapter B.''
    16-17. Section 381.145, paragraph (i), is revised to read as 
follows:


Sec. 381.145  Poultry products and other articles entering or at 
official establishments; examination and other requirements.

* * * * *
    (i) To ensure the safe use of preparations used in poultry scald 
water, the label or labeling on containers of such preparations shall 
bear adequate directions to ensure use in compliance with any 
limitations prescribed in 21 CFR Chapter I, Subchapter A or Subchapter 
B or 9 CFR Chapter III, Subchapter A or Subchapter E.


Sec. 381.147  [Removed]

    18. Section 381.147 is removed.


Sec. 381.171  [Amended]

    19. The first and second sentences of Sec. 381.171, paragraph (b), 
are amended by removing ``Sec. 381.147 of this part'' and adding in its 
place ``a regulation permitting that use in this subchapter or 9 CFR 
Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or 
Subchapter B.''

SUBCHAPTER E--REGULATORY REQUIREMENTS UNDER THE FEDERAL MEAT INSPECTION 
ACT AND THE POULTRY PRODUCTS INSPECTION ACT

    20. Subchapter E is amended by adding a new Part 424 to read as 
follows:

PART 424--PREPARATION AND PROCESSING OPERATIONS

Subpart A--General

Sec.
424.1  Purpose and scope.

Subpart C--Food Ingredients and Sources of Radiation

424.21  Use of food ingredients and sources of radiation.
424.22  Certain other permitted uses.
424.23  Prohibited uses.

    Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 451-470, 601-695; 
7 CFR 2.18, 2.53.

Subpart A-General


Sec. 424.1  Purpose and scope.

    This part of the regulations prescribes rules for the preparation 
of meat and the processing of poultry products. The rules in this part 
further the purposes of the Federal Meat Inspection Act (FMIA) and the 
Poultry Products Inspection Act (PPIA) by, among other things, 
preventing the adulteration or misbranding of meat and poultry products 
at official establishments. 9 CFR Chapter III, Subchapter A, Parts 318 
and 319, Subpart C of this part, and 21 CFR Chapter I, Subchapter A or 
Subchapter B, specify rules for the use of certain food ingredients 
(e.g., food additives and color additives) and sources of radiation 
that may render meat or poultry products adulterated or misbranded.

Subpart C--Food Ingredients and Sources of Radiation


424.21  Use of food ingredients and sources of radiation.

    (a)(1) General. No meat or poultry product shall bear or contain 
any food ingredient that would render it adulterated or misbranded, or 
which is not approved in this part, part 318 or part 319 of this 
chapter, or by the Administrator in specific cases.
    (2)(i) Poultry products and poultry broth used in the processing of 
poultry products shall have been processed in the United States only in 
an official establishment or imported from a foreign country listed in 
Sec. 381.196(b), and have been inspected and passed in accordance with 
the regulations. Detached ova and offal shall not be used in the 
processing of any poultry products, except that poultry feet may be 
processed for use as human food in

[[Page 72176]]

a manner approved by the Administrator in specific cases and detached 
ova may be used in the processing of poultry products if the processor 
demonstrates that such ova comply with the requirements of the Federal 
Food, Drug, and Cosmetic Act.
    (ii) Liquid, frozen, and dried egg products used in the processing 
of any poultry product shall have been prepared under inspection and be 
so marked in accordance with the Egg Products Inspection Act.
    (3)(i) Carcasses, parts thereof, and products of cattle, sheep, 
swine, goats, or equines may be used in the processing of poultry 
products only if they were prepared in the United States in an official 
meat packing establishment or imported from a foreign country listed in 
Sec. 327.2(b), were inspected and passed in accordance with the Federal 
Meat Inspection Act and the regulations under such Act (subchapter A of 
this chapter), and are so marked.
    (ii) Pork from carcasses or carcass parts used as an ingredient in 
poultry products that has been found free of trichinae, as described 
under Sec. 318.10 (a)(2), (e) and (f) of the Federal meat inspection 
regulations (9 CFR 318.10 (a)(2), (e) and (f)), is not required to be 
treated for the destruction of trichinae.
    (iii) Poultry products containing pork muscle tissue which the 
Administrator determines at the time the labeling for the product is 
submitted for approval in accordance with part 381 of the regulations 
in subchapter A or upon subsequent reevaluation of the product would be 
prepared in such a manner that the product might be eaten rare or 
without thorough cooking because of the appearance of the finished 
product or otherwise, shall be effectively heated, refrigerated, or 
cured to destroy any possible live trichinae, as prescribed in 
Sec. 318.10(c) of this chapter, at the official establishment where 
such products are prepared. In lieu of such treatment of poultry 
products containing pork, the pork ingredient may be so treated.
    (b)(1) Food ingredients and sources of radiation. Food ingredients 
and sources of radiation listed or approved for use in the production 
of meat or poultry products in 21 CFR Chapter I, Subchapter A or 
Subchapter B, shall be listed for such use under this chapter, subject 
to declaration requirements in parts 316 and 317, or Subparts M and N, 
of Part 381 of this chapter, unless precluded from such use or further 
restricted in parts 318 or 319, or Subparts O and P, of Part 381 of 
this chapter, or unless such use otherwise results in the adulteration 
or misbranding of meat or poultry products. Food ingredients and 
sources of radiation listed or approved for use in the production of 
meat or poultry products in 21 CFR Chapter I, Subchapter A or 
Subchapter B, may be listed or approved for such use under this chapter 
by the Administrator in Sec. 424.21, subject to declaration 
requirements in parts 316 and 317, or Subparts M and N, of Part 381 of 
this chapter.
    (2) No food ingredients or sources of radiation may be used in the 
preparation of any meat or poultry product, for any purpose, unless the 
use is listed or approved in 21 CFR Chapter I as a direct food additive 
(21 CFR Part 172), a secondary direct food additive (21 CFR Part 173), 
indirect food additive (21 CFR Parts 174-178), radiation source (21 CFR 
Part 179), an interim-listed direct food additive (21 CFR Part 180), a 
prior-sanctioned substance (21 CFR Part 181), a Generally Recognized As 
Safe (GRAS) substance (21 CFR Parts 182 or 184), or by a regulation in 
this chapter. Part 319 of this chapter also specifies other food 
ingredients that are acceptable in preparing specified products.
    (3) No food ingredient, the intended use of which is to impart 
color in any meat or poultry product, shall be used unless such use is 
approved in 21 CFR Chapter I as a color additive (21 CFR Parts 73, 74, 
81, and 82) or in a regulation in this chapter.
    (4) Petitions to amend 21 CFR Chapter I to provide for uses of food 
additives, or other substances or sources of radiation necessary in the 
preparation of meat or poultry products, or food ingredients used to 
impart color to product, should be sent to the Food and Drug 
Administration, in accordance with the provisions of 21 CFR Parts 71 or 
171, as appropriate.
    (5) 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 poultry products, may be 
addressed to the Food and Drug Administration, Center for Food Safety 
and Applied Nutrition, 200 C Street, SW, Washington, DC 20204, or the 
Department of Agriculture, Food Safety and Inspection Service, Office 
of Policy, Program Development and Evaluation, Washington, DC 20250-
3700.
    (6) Inquiries concerning the use in specific meat or poultry 
products of substances that are not affirmed by the Food and Drug 
Administration as Generally Recognized as Safe (GRAS) or otherwise 
listed in 21 CFR Part 182 or Part 184, or of food or color additives 
listed in 21 CFR regulations for general use in foods or for use in 
meat, or poultry products, generally, including mixtures of such 
substances or additives, should be addressed to the Department of 
Agriculture, Food Safety and Inspection Service, Office of Policy, 
Program Development and Evaluation, Washington, DC 20250-3700.
    (c) The food ingredients specified in the following chart are 
approved for use in the preparation of meat products, provided they are 
used for the purposes indicated, within the limit of the amounts 
stated, and under other conditions specified in this part and Part 317 
of this chapter. Part 319 of this chapter specifies other food 
ingredients that are acceptable in preparing specified meat products. 
This chart also contains food ingredients that are acceptable for use 
in poultry products, provided they are used for the purpose indicated, 
within the limits of the amounts stated and under other conditions 
specified in this part. No meat or poultry product shall bear or 
contain any food ingredient that would render it adulterated or 
misbranded, or which is not approved in this part, or by the 
Administrator in specific cases.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
            Class of substance                             Substance                                   Purpose                                  Products                          Amount
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Acidifiers...............................  Acetic acid..............................  To adjust acidity.......................  Various meat and poultry products \2\...  Sufficient for
                                                                                                                                                                           purpose.\3\
                                           Citric acid..............................  ......do................................  ......do................................      Do.
                                           Glucono delta-lactone....................  ......do................................  ......do................................      Do.
                                           Lactic acid..............................  ......do................................  ......do................................      Do.
                                           Phosphoric acid..........................  ......do................................  ......do................................      Do.
                                           Tartaric acid............................  ......do................................  ......do................................      Do.

[[Page 72177]]

 
Anti-coagulants..........................  Citric acid..............................  To prevent clotting.....................  Fresh blood of livestock................  0.2 percent with or
                                                                                                                                                                           without water. When
                                                                                                                                                                           water is used to make
                                                                                                                                                                           a solution of citric
                                                                                                                                                                           acid added to the
                                                                                                                                                                           blood of livestock,
                                                                                                                                                                           not more than 2 parts
                                                                                                                                                                           of water to 1 part of
                                                                                                                                                                           citric acid shall be
                                                                                                                                                                           used.
                                           Sodium citrate...........................  ......do................................  ......do................................  Not to exceed 0.5
                                                                                                                                                                           percent based on the
                                                                                                                                                                           ingoing weight of the
                                                                                                                                                                           product. When water
                                                                                                                                                                           is used to make a
                                                                                                                                                                           solution of sodium
                                                                                                                                                                           citrate added to
                                                                                                                                                                           livestock blood, not
                                                                                                                                                                           more than 2 parts of
                                                                                                                                                                           water to 1 part of
                                                                                                                                                                           sodium citrate shall
                                                                                                                                                                           be used.
Antifoaming agent........................  Methyl polysilicone......................  To retard foaming.......................  Soups (meat and poultry)................  10 ppm.
                                                                                      ......do................................  Rendered fats (meat and poultry)........      Do.
                                                                                      ......do................................  Curing pickle (meat and poultry)........  50 ppm.
Antimicrobial agents.....................  Trisodium phosphate......................  To reduce microbial levels..............  Raw, chilled poultry carcasses..........  8 to 12 percent;
                                                                                                                                                                           solution to be
                                                                                                                                                                           maintained at 45
                                                                                                                                                                           deg.F. to 55  deg.F.
                                                                                                                                                                           and applied by
                                                                                                                                                                           spraying or dipping
                                                                                                                                                                           carcasses for up to
                                                                                                                                                                           15 seconds when used
                                                                                                                                                                           in accordance with 21
                                                                                                                                                                           CFR 182.1778.
Antioxidants and oxygen interceptors.....  Ascorbyl palmitate.......................  To retard rancidity.....................  Margarine or oleomargarine..............  0.02 percent (by wt.
                                                                                                                                                                           of finished product)
                                                                                                                                                                           individually or in
                                                                                                                                                                           combination with
                                                                                                                                                                           other antioxidants
                                                                                                                                                                           approved for use in
                                                                                                                                                                           margarine.
                                           Ascorbyl stearate........................


                                       BHA (butylated hydroxyanisole).......  ......do............................  Dry sausage.........................  0.003 based on      0.006 percent in
                                                                                                                                                           total weight.       combination with
                                                                                                                                                                               other anti-
                                                                                                                                                                               oxidants for use
                                                                                                                                                                               in meat.
                                                                              ......do............................  Rendered animal fat or a combination  0.01 percent......  0.02 percent in
                                                                                                                     of such fat and vegetable fat.                            combination with
                                                                                                                                                                               other anti-
                                                                                                                                                                               oxidants for use
                                                                                                                                                                               in meat.
                                                                              ......do............................  Fresh pork, sausage, brown and serve  0.01 percent based  0.02 percent in
                                                                                                                     sausages, fresh Italian sausage       on fat content.     combination with
                                                                                                                     products, pregrilled beef patties,                        other anti-
                                                                                                                     fresh sausage made from beef or                           oxidants for use
                                                                                                                     beef and pork, cooked or raw pizza                        in meat, based on
                                                                                                                     topping and cooked or raw meatballs.                      fat content.
                                                                              ......do............................  Dried meats.........................  0.01 percent based  0.01 percent in
                                                                                                                                                           on total weight.    combination with
                                                                                                                                                                               other anti-
                                                                                                                                                                               oxidants for use
                                                                                                                                                                               in meat.


                                                                                      ......do................................  Margarine or oleomargarine..............  0.02 percent (by wt.
                                                                                                                                                                           of the finished
                                                                                                                                                                           product) individually
                                                                                                                                                                           or in combination
                                                                                                                                                                           with other
                                                                                                                                                                           antioxidants approved
                                                                                                                                                                           for use in margarine.

[[Page 72178]]

 
                                                                                      ......do................................  Various poultry products................  0.01 percent based on
                                                                                                                                                                           fat content (0.02
                                                                                                                                                                           percent in
                                                                                                                                                                           combination with any
                                                                                                                                                                           other antioxidant for
                                                                                                                                                                           use in poultry) based
                                                                                                                                                                           on fat content.


                                       BHT (butylated hydroxytoluene).......  ......do............................  Dry sausage.........................  0.003 percent       0.006 percent in
                                                                                                                                                           based on total      combination with
                                                                                                                                                           weight.             other anti-
                                                                                                                                                                               oxidants for use
                                                                                                                                                                               in meat.
                                                                              ......do............................  Rendered animal fat or a combination  0.01 percent......  0.02 percent in
                                                                                                                     of such fat and vegetable fat.                            combination with
                                                                                                                                                                               other anti-
                                                                                                                                                                               oxidants for use
                                                                                                                                                                               in meat.
                                                                              ......do............................  Fresh pork, sausage, brown and serve  0.01 percent based  0.02 percent in
                                                                                                                     sausages, fresh Italian sausage       on fat content.     combination with
                                                                                                                     products, pregrilled beef patties,                        other anti-
                                                                                                                     fresh sausage made from beef or                           oxidants for use
                                                                                                                     beef and pork, cooked or raw pizza                        in meat, based on
                                                                                                                     topping and cooked or raw meatballs.                      fat content.
                                                                              ......do............................  Dried meats.........................  0.01 percent based  0.01 percent in
                                                                                                                                                           on total weight.    combination with
                                                                                                                                                                               other anti-
                                                                                                                                                                               oxidants for use
                                                                                                                                                                               in meat.


                                                                                      ......do................................  Margarine or oleomargarine..............  0.02 percent (by wt.
                                                                                                                                                                           of the finished
                                                                                                                                                                           product) individually
                                                                                                                                                                           or in combination
                                                                                                                                                                           with other
                                                                                                                                                                           antioxidants approved
                                                                                                                                                                           for use in margarine.
                                                                                      ......do................................  Various poultry products................  0.01 percent based on
                                                                                                                                                                           fat content (0.02
                                                                                                                                                                           percent in
                                                                                                                                                                           combination with any
                                                                                                                                                                           other antioxidant for
                                                                                                                                                                           use in poultry) based
                                                                                                                                                                           on fat content.
                                           Dodecyl gallate..........................  ......do................................  Margarine or oleomargarine..............  0.02 percent (by wt.
                                                                                                                                                                           of the finished
                                                                                                                                                                           product) individually
                                                                                                                                                                           or in combination
                                                                                                                                                                           with other
                                                                                                                                                                           antioxidants approved
                                                                                                                                                                           for use in margarine.


                                       Glycine..............................  ......do............................  Rendered animal fat or a combination  0.01 percent......  0.02 percent in
                                                                                                                     of such fat and vegetable fat.                            combination with
                                                                                                                                                                               other anti-
                                                                                                                                                                               oxidants for use
                                                                                                                                                                               in meat.


                                           Octyl gallate............................  ......do................................  Margarine or oleomargarine..............  0.02 percent (by wt.
                                                                                                                                                                           of the finished
                                                                                                                                                                           product) individually
                                                                                                                                                                           or in combination
                                                                                                                                                                           with other
                                                                                                                                                                           antioxidants approved
                                                                                                                                                                           for use in margarine.


                                       Propyl gallate.......................  ......do............................  Dry sausage.........................  0.003 percent       0.006 percent in
                                                                                                                                                           based on total      combination with
                                                                                                                                                           weight.             other anti-
                                                                                                                                                                               oxidants for use
                                                                                                                                                                               in meat.

[[Page 72179]]

 
                                                                              ......do............................  Rendered animal fat or a combination  0.01 percent......  0.02 percent in
                                                                                                                     of such fat and vegetable fat.                            combination with
                                                                                                                                                                               other anti-
                                                                                                                                                                               oxidants for use
                                                                                                                                                                               in meat.
                                                                              ......do............................  Fresh pork, sausage, brown and serve  0.01 percent based  0.02 percent in
                                                                                                                     sausages, fresh Italian sausage       on fat content.     combination with
                                                                                                                     products, pregrilled beef patties,                        other anti-
                                                                                                                     fresh sausage made from beef or                           oxidants for use
                                                                                                                     beef and pork, cooked or raw pizza                        in meat, based on
                                                                                                                     topping and cooked or raw meatballs.                      fat content.
                                                                              ......do............................  Dried meats.........................  0.01 percent based  0.01 percent in
                                                                                                                                                           on total weight.    combination with
                                                                                                                                                                               other anti-
                                                                                                                                                                               oxidants for use
                                                                                                                                                                               in meat.


                                                                                      ......do................................  Margarine or oleo-margarine.............  0.02 percent (by wt.
                                                                                                                                                                           of the finished
                                                                                                                                                                           product) individually
                                                                                                                                                                           or in combination
                                                                                                                                                                           with other
                                                                                                                                                                           antioxidants approved
                                                                                                                                                                           for use in margarine.
                                                                                      ......do................................  Various poultry products................  0.01 percent based on
                                                                                                                                                                           fat content (0.02
                                                                                                                                                                           percent in
                                                                                                                                                                           combination with any
                                                                                                                                                                           other antioxidant for
                                                                                                                                                                           use in poultry,
                                                                                                                                                                           except TBHQ, based on
                                                                                                                                                                           fat content).


                                       Resin guaiac.........................  ......do............................  Rendered animal fat or a combination  0.01 percent......  0.02 percent in
                                                                                                                     of such fat and vegetable fat.                            combination with
                                                                                                                                                                               other
                                                                                                                                                                               antioxidants for
                                                                                                                                                                               use in meat.
                                       TBHQ (tertiary butylhydroquinone)....  ......do............................  Dry sausage.........................  0.003 percent       0.006 percent in
                                                                                                                                                           based on weight.    combina-tion only
                                                                                                                                                                               with BHA and/or
                                                                                                                                                                               BHT.
                                                                              ......do............................  Rendered animal fat or a combination  0.01 percent......  0.02 percent in
                                                                                                                     of such fat and vegetable fat.                            combina-tion only
                                                                                                                                                                               with BHA or BHT.
                                                                              ......do............................  Fresh pork, sausage, brown and serve  0.01 percent based  0.02 percent in
                                                                                                                     sausages, fresh Italian sausage       on fat content.     combin-ation only
                                                                                                                     products, pregrilled beef patties,                        with BHA and/ or
                                                                                                                     fresh sausage made from beef or                           BHT, based on fat
                                                                                                                     beef and pork, cooked or raw pizza                        content.
                                                                                                                     topping and cooked or raw meatballs.
                                                                              ......do............................  Dried meats.........................  0.01 percent based  0.01 percent in
                                                                                                                                                           on total weight.    combina-tion only
                                                                                                                                                                               with BHA and/or
                                                                                                                                                                               BHT.


                                                                                      ......do................................  Margarine or oleo-margarine.............  0.02 percent alone or
                                                                                                                                                                           in combination only
                                                                                                                                                                           with BHA and/or BHT,
                                                                                                                                                                           based on oil or fat
                                                                                                                                                                           content.
                                                                                      ......do................................  Various poultry products................  0.01 percent based on
                                                                                                                                                                           fat content (0.02
                                                                                                                                                                           percent in
                                                                                                                                                                           combination only with
                                                                                                                                                                           BHA and/or BHT, based
                                                                                                                                                                           on fat content).

[[Page 72180]]

 
                                           Tocopherols..............................  ......do................................  Rendered animal fat or a combination of   0.03 percent. A 30
                                                                                                                                 such fat and vegetable fat.               percent concentration
                                                                                                                                                                           of tocopherols in
                                                                                                                                                                           vegetable oils shall
                                                                                                                                                                           be used when added as
                                                                                                                                                                           an antioxidant to
                                                                                                                                                                           products designated
                                                                                                                                                                           as ``lard'' or
                                                                                                                                                                           ``rendered pork
                                                                                                                                                                           fat.''
                                                                                      ......do................................  Dry sausage, semidry sausage, dried       Not to exceed 0.03
                                                                                                                                 meats, uncooked or cooked fresh sausage   percent based on fat
                                                                                                                                 made with beef and/or pork, uncooked or   content. Not used in
                                                                                                                                 cooked Italian sausage products,          combination with
                                                                                                                                 uncooked or cooked meatballs, uncooked    other antioxidants.
                                                                                                                                 or cooked meat pizza toppings, brown
                                                                                                                                 and serve sausages, pregrilled beef
                                                                                                                                 patties, and restructured meats.
                                                                                      ......do................................  Various poultry products................  0.03 percent based on
                                                                                                                                                                           fat content (0.02
                                                                                                                                                                           percent in
                                                                                                                                                                           combination with any
                                                                                                                                                                           other antioxidant for
                                                                                                                                                                           use in poultry,
                                                                                                                                                                           except TBHQ, based on
                                                                                                                                                                           fat content).
Artificial Sweeteners....................  Saccharin................................  To sweeten product......................  Bacon...................................  0.01 percent.
Binders and Extenders....................  Agar-agar................................  To stabilize and thicken................  Thermally processed canned and jellied    0.25 percent of
                                                                                                                                 meat food products.                       finished product.
                                           Algin....................................  To extend and stabilize product.........  Breading mix; sauces (meat only) and      Sufficient for purpose
                                                                                                                                 various poultry products.                 in accordance with 21
                                                                                                                                                                           CFR 172.5.
                                           A mixture of sodium alginate, calcium      To bind meat pieces.....................  Restructured meat food products.........  Sodium alginate not to
                                            carbonate and calcium lactate/lactic                                                                                           exceed 1.0 percent;
                                            acid (or glucono delta lactone).                                                                                               calcium carbonate not
                                                                                                                                                                           to exceed 0.2
                                                                                                                                                                           percent; and lactic
                                                                                                                                                                           acid/calcium lactate
                                                                                                                                                                           (or glucono delta-
                                                                                                                                                                           lactone) not to
                                                                                                                                                                           exceed 0.3 percent of
                                                                                                                                                                           product formulation.
                                                                                                                                                                           Added mixture may not
                                                                                                                                                                           exceed 1.5 percent of
                                                                                                                                                                           product at
                                                                                                                                                                           formulation. Mixture
                                                                                                                                                                           ingredients must be
                                                                                                                                                                           added dry.
                                           A mixture of sodium alginate, calcium      To bind poultry pieces..................  Ground and formed raw or cooked poultry   Sodium alginate not
                                            carbonate, lactic acid, and calcium                                                  pieces.                                   more than 0.8
                                            lactate.                                                                                                                       percent, calcium
                                                                                                                                                                           carbonate not more
                                                                                                                                                                           than 0.15 percent;
                                                                                                                                                                           lactic acid and
                                                                                                                                                                           calcium lactate, in
                                                                                                                                                                           combination, not more
                                                                                                                                                                           than 0.6 percent of
                                                                                                                                                                           product formulation.
                                                                                                                                                                           Added mixture may not
                                                                                                                                                                           exceed 1.55 percent
                                                                                                                                                                           of product at
                                                                                                                                                                           formulation. The
                                                                                                                                                                           mixture must be added
                                                                                                                                                                           in dry form.
                                           Bread....................................  To bind and extend product..............  Bockwurst...............................  3.5 percent
                                                                                                                                                                           individually or
                                                                                                                                                                           collectively with
                                                                                                                                                                           other binders for use
                                                                                                                                                                           in meat.
                                                                                      ......do................................  Chili con carne, chili con carne with     8 percent individually
                                                                                                                                 beans.                                    or collectively with
                                                                                                                                                                           other binders for use
                                                                                                                                                                           in meat.
                                                                                      ......do................................  Spaghetti with meat balls and sauce,      12 percent
                                                                                                                                 spaghetti with meat and sauce and         individually or
                                                                                                                                 similar products.                         collectively with
                                                                                                                                                                           other binders for use
                                                                                                                                                                           in meat.
                                           Carboxymethyl cellulose (cellulose gum)..  To extend and stabilize product.........  Baked pies (meat only) and various        Sufficient for purpose
                                                                                                                                 poultry products.                         in accordance with 21
                                                                                                                                                                           CFR 172.5.
                                           Carrageenan..............................  To extend and stabilize product.........  Breading mix; sauces (meat only) and      Sufficient for purpose
                                                                                                                                 various poultry products.                 in accordance with 21
                                                                                                                                                                           CFR 172.5.
                                                                                      To prevent purging of brine solution....  Cured pork products as provided in 9 CFR  Not to exceed 1.5
                                                                                                                                 319.104(d).                               percent of product
                                                                                                                                                                           formulation;
                                                                                                                                                                           permitted in
                                                                                                                                                                           combination only with
                                                                                                                                                                           soy protein
                                                                                                                                                                           concentrate,
                                                                                                                                                                           combination not to
                                                                                                                                                                           exceed 1.5 percent of
                                                                                                                                                                           product formulation;
                                                                                                                                                                           in accordance with 21
                                                                                                                                                                           CFR 172.620, 172.623,
                                                                                                                                                                           and 172.626.

[[Page 72181]]

 
                                           Carrageenan, Locust bean gum, and Xanthan  ......do................................  ......do................................  In combination, not to
                                            gum blend.                                                                                                                     exceed 0.5 percent of
                                                                                                                                                                           formulation; not
                                                                                                                                                                           permitted in
                                                                                                                                                                           combination with
                                                                                                                                                                           other binders
                                                                                                                                                                           approved for use in
                                                                                                                                                                           cured pork products;
                                                                                                                                                                           in accordance with 21
                                                                                                                                                                           CFR 172.620, 172.623,
                                                                                                                                                                           172.626, 184.1343,
                                                                                                                                                                           and 172.695.
                                           Cereal...................................  To bind and extend product..............  Sausages as provided in 9 CFR Part 319,   3.5 percent
                                                                                                                                 bockwurst.                                individually or
                                                                                                                                                                           collectively with
                                                                                                                                                                           other binders for use
                                                                                                                                                                           in meat.
                                                                                      ......do................................  Chili con carne, chili con carne with     8 percent individually
                                                                                                                                 beans.                                    or collectively with
                                                                                                                                                                           other binders for use
                                                                                                                                                                           in meat.
                                           Dried milk...............................  ......do................................  Sausages as provided for in 9 CFR Part    3.5 percent
                                                                                                                                 319.                                      individually or
                                                                                                                                                                           collectively with
                                                                                                                                                                           other binders for use
                                                                                                                                                                           in meat
                                           Dried skim milk, calcium reduced.........  ......do................................  Sausages as provided in 9 CFR 9 CFR Part      Do.
                                                                                                                                 319.
                                                                                      ......do................................  Chili con carne, chili con carne with     8 percent individually
                                                                                                                                 beans.                                    or collectively with
                                                                                                                                                                           other binders for use
                                                                                                                                                                           in meat.
                                           Enzyme (rennet) treated with calcium       ......do................................  Sausages as provided for in 9 CFR Part    3.5 percent total
                                            reduced dried skim milk and calcium                                                  319.                                      finished product
                                            lactate.                                                                                                                       (calcium lactate
                                                                                                                                                                           required at rate of
                                                                                                                                                                           10 percent of
                                                                                                                                                                           binder.)
                                                                                      ......do................................  Imitation sausages; nonspecific loaves;   Sufficient for purpose
                                                                                                                                 soups, stews (meat only) and various      in accordance with 21
                                                                                                                                 poultry products.                         CFR 172.5 (calcium
                                                                                                                                                                           lactate required at a
                                                                                                                                                                           rate of 10 percent of
                                                                                                                                                                           binder).
                                           Enzyme (rennet) treated with sodium        ......do................................  Imitation sausages; nonspecific loaves;   Sufficient for purpose
                                            caseinate and calcium lactate.                                                       soups, stews (meat only) and various      in accordance with 21
                                                                                                                                 poultry products.                         CFR 172.5 (calcium
                                                                                                                                                                           lactate required at a
                                                                                                                                                                           rate of 25 percent of
                                                                                                                                                                           binder).
                                           Food starch modified.....................  To prevent purging of brine solution....  Cured pork products as provided for in 9  Not to exceed 2
                                                                                                                                 CFR 319.104(d).                           percent of product
                                                                                                                                                                           formulation in ``Ham
                                                                                                                                                                           Water Added'' and
                                                                                                                                                                           ``Ham with Natural
                                                                                                                                                                           Juices'' products;
                                                                                                                                                                           not to exceed 3.5
                                                                                                                                                                           percent of product
                                                                                                                                                                           formulation in ``Ham
                                                                                                                                                                           and Water Product--X
                                                                                                                                                                           percent of Weight is
                                                                                                                                                                           Added Ingredients''
                                                                                                                                                                           products; permitted
                                                                                                                                                                           in combination only
                                                                                                                                                                           with soy protein
                                                                                                                                                                           concentrate, with
                                                                                                                                                                           combination of
                                                                                                                                                                           modified food starch
                                                                                                                                                                           at 3 percent of
                                                                                                                                                                           product formulation
                                                                                                                                                                           and soy protein
                                                                                                                                                                           concentrate at 0.5
                                                                                                                                                                           percent of product
                                                                                                                                                                           formulation; in
                                                                                                                                                                           accordance with 21
                                                                                                                                                                           CFR 172.892.
                                           Gelatin..................................  To bind and extend product..............  Various poultry products................  Sufficient for purpose
                                                                                                                                                                           in accordance with 21
                                                                                                                                                                           CFR 172.5.
                                           Gums, vegetable..........................  ......do................................  Egg roll (meat only) and various poultry  Sufficient for purpose
                                                                                                                                 products.                                 in accordance with 21
                                                                                                                                                                           CFR 172.5.
                                           Isolated soy protein.....................  ......do................................  Sausage as provided for in 9 CFR Part     2 percent.
                                                                                                                                 319, bockwurst.
                                                                                      ......do................................  Imitation sausages; nonspecific loaves;   Sufficient for purpose
                                                                                                                                 soups; stews (meat only) and various      in accordance with 21
                                                                                                                                 poultry products.                         CFR 172.5.
                                                                                      ......do................................  Chili con carne, chili con carne with     8 percent individually
                                                                                                                                 beans.                                    or collectively with
                                                                                                                                                                           other binders for use
                                                                                                                                                                           in meat.
                                                                                      ......do................................  Spaghetti with meatballs and sauce,       12 percent
                                                                                                                                 spaghetti with meat and sauce and         individually or
                                                                                                                                 similar products.                         collectively with
                                                                                                                                                                           other binders and
                                                                                                                                                                           extenders for use in
                                                                                                                                                                           meat.
                                                                                      To prevent purging of brine solution....  Cured pork products as provided for in 9  Not to exceed 2
                                                                                                                                 CFR 319.104(d).                           percent of product
                                                                                                                                                                           formulation, not
                                                                                                                                                                           permitted in
                                                                                                                                                                           combination with
                                                                                                                                                                           other binders
                                                                                                                                                                           approved for use in
                                                                                                                                                                           cured pork products.

[[Page 72182]]

 
                                           Methyl cellulose.........................  To extend and stabilize product (also     Meat and vegetable patties; various       0.15 percent.
                                                                                       carrier).                                 poultry products.
                                           Sodium caseinate.........................  To bind and extend product..............  Imitation sausages, nonspecific loaves,   Sufficient for purpose
                                                                                                                                 soups, stews (meat only).                 in accordance with 21
                                                                                                                                                                           CFR 182.1748 and 21
                                                                                                                                                                           CFR 172.5.
                                                                                      ......do................................  Sausages as provided for in 9 CFR Part    2 percent in
                                                                                                                                 319.                                      accordance with 21
                                                                                                                                                                           CFR 182.1748.
                                                                                      ......do................................  Chili con carne, chili con carne with     8 percent individually
                                                                                                                                 beans.                                    or collectively with
                                                                                                                                                                           other binders and
                                                                                                                                                                           extenders for use in
                                                                                                                                                                           meat in accordance
                                                                                                                                                                           with 21 CFR 182.1748.
                                                                                      ......do................................  Spaghetti with meatballs and sauce,       12 percent
                                                                                                                                 spaghetti with meat and sauce and         individually or
                                                                                                                                 similar products.                         collectively with
                                                                                                                                                                           other binders and
                                                                                                                                                                           extenders for use in
                                                                                                                                                                           meat in accordance
                                                                                                                                                                           with 21 CFR 182.1748.
                                                                                      To prevent purging of brine solution....  Cured pork products as provided for in 9  Not to exceed 2
                                                                                                                                 CFR 319.104(d).                           percent of product
                                                                                                                                                                           formulation; not
                                                                                                                                                                           permitted in
                                                                                                                                                                           combination with
                                                                                                                                                                           other binders
                                                                                                                                                                           approved for use in
                                                                                                                                                                           cured pork products,
                                                                                                                                                                           in accordance with 21
                                                                                                                                                                           CFR 182.1748.
                                                                                      To bind and extend product..............  Various poultry products................  3 percent in cooked
                                                                                                                                                                           product, 2 percent in
                                                                                                                                                                           raw product, in
                                                                                                                                                                           accordance with 21
                                                                                                                                                                           CFR 172.5 and
                                                                                                                                                                           182.1748.
                                           Soy flour................................  ......do................................  Sausages as provided for in 9 CFR Part    3.5 percent
                                                                                                                                 319, bockwurst.                           individually or
                                                                                                                                                                           collectively with
                                                                                                                                                                           other binders and
                                                                                                                                                                           extenders for use in
                                                                                                                                                                           meat.
                                                                                      ......do................................  Chili con carne, chili con carne with     8 percent individually
                                                                                                                                 beans.                                    or collectively with
                                                                                                                                                                           other binders and
                                                                                                                                                                           extenders for use in
                                                                                                                                                                           meat.
                                                                                      ......do................................  Spaghetti with meatballs and sauce,       12 percent
                                                                                                                                 spaghetti with meat and sauce and         individually or
                                                                                                                                 similar products.                         collectively with
                                                                                                                                                                           other binders and
                                                                                                                                                                           extenders for use in
                                                                                                                                                                           meat.
                                           Soy protein concentrate..................  ......do................................  Sausage as provided for in 9 CFR Part     3.5 percent
                                                                                                                                 319, bockwurst.                           individually or
                                                                                                                                                                           collectively with
                                                                                                                                                                           other binders and
                                                                                                                                                                           extenders for use in
                                                                                                                                                                           meat.
                                                                                      ......do................................  Chili con carne, chili con carne with     8 percent individually
                                                                                                                                 beans.                                    or collectively with
                                                                                                                                                                           other binders and
                                                                                                                                                                           extenders for use in
                                                                                                                                                                           meat.
                                                                                      ......do................................  Spaghetti with meatballs and sauce,       12 percent
                                                                                                                                 spaghetti with meat and sauce and         individually or
                                                                                                                                 similar products.                         collectively with
                                                                                                                                                                           other binders and
                                                                                                                                                                           extenders for use in
                                                                                                                                                                           meat.
                                                                                      To prevent purging of brine solution....  Cured pork products as provided for in 9  Not to exceed 3.5
                                                                                                                                 CFR 319.104(d).                           percent of product
                                                                                                                                                                           formulation;
                                                                                                                                                                           permitted in
                                                                                                                                                                           combination only with
                                                                                                                                                                           modified food starch,
                                                                                                                                                                           with combination of
                                                                                                                                                                           modified food starch
                                                                                                                                                                           at 3 percent of
                                                                                                                                                                           product formulation
                                                                                                                                                                           and soy protein
                                                                                                                                                                           concentrate at 0.5
                                                                                                                                                                           percent of product
                                                                                                                                                                           formulation; in
                                                                                                                                                                           combination only with
                                                                                                                                                                           carrageenan,
                                                                                                                                                                           combination not to
                                                                                                                                                                           exceed 1.5 percent of
                                                                                                                                                                           product formulation.
                                           Starchy vegetable flour..................  To bind and extend product..............  Sausage as provided for in 9 CFR Part     3.5 percent
                                                                                                                                 319, bockwurst.                           individually or
                                                                                                                                                                           collectively with
                                                                                                                                                                           other binders and
                                                                                                                                                                           extenders for use in
                                                                                                                                                                           meat.
                                                                                      ......do................................  Chili con carne, chili con carne with     8 percent individually
                                                                                                                                 beans.                                    or collectively with
                                                                                                                                                                           other binders and
                                                                                                                                                                           extenders for use in
                                                                                                                                                                           meat.

[[Page 72183]]

 
                                           Tapioca dextrin..........................  ......do................................  Sausage as provided for in 9 CFR Part     3.5 percent
                                                                                                                                 319, bockwurst.                           individually or
                                                                                                                                                                           collectively with
                                                                                                                                                                           other binders and
                                                                                                                                                                           extenders for use in
                                                                                                                                                                           meat, in accordance
                                                                                                                                                                           with 21 CFR 184.1277.
                                                                                      ......do................................  Chili con carne, chili con carne with     8 percent individually
                                                                                                                                 beans.                                    or collectively with
                                                                                                                                                                           other binders and
                                                                                                                                                                           extenders for use in
                                                                                                                                                                           meat, in accordance
                                                                                                                                                                           with 21 CFR 184.1277.
                                                                                      ......do................................  Spaghetti with meatballs and sauce,       12 individually or
                                                                                                                                 spaghetti with meat and sauce and         collectively with
                                                                                                                                 similar products.                         other binders and
                                                                                                                                                                           extenders for use in
                                                                                                                                                                           meat, in accordance
                                                                                                                                                                           with 21 CFR 184.1277.
                                                                                      ......do................................  Various poultry products................  Sufficient for purpose
                                                                                                                                                                           in accordance with 21
                                                                                                                                                                           CFR 184.1277.
                                           Vegetable starch.........................  ......do................................  Sausage as provided for in 9 CFR Part     3.5 percent
                                                                                                                                 319, bockwurst.                           individually or
                                                                                                                                                                           collectively with
                                                                                                                                                                           other binders and
                                                                                                                                                                           extenders for use in
                                                                                                                                                                           meat.
                                                                                      ......do................................  Chili con carne, chili con carne with     8 percent individually
                                                                                                                                 beans.                                    or collectively with
                                                                                                                                                                           other binders and
                                                                                                                                                                           extenders for use in
                                                                                                                                                                           meat.
                                           Wheat gluten.............................  To bind and extend product..............  Sausage as provided for in 9 CFR Part     3.5 percent
                                                                                                                                 319, bockwurst.                           individually or
                                                                                                                                                                           collectively with
                                                                                                                                                                           other binders and
                                                                                                                                                                           extenders for use in
                                                                                                                                                                           meat, in accordance
                                                                                                                                                                           with 21 CFR 184.1322.
                                                                                      ......do................................  Chili con carne, chili con carne with     8 percent individually
                                                                                                                                 beans.                                    or collectively with
                                                                                                                                                                           other binders for use
                                                                                                                                                                           in meat, in
                                                                                                                                                                           accordance with 21
                                                                                                                                                                           CFR 184.1322.
                                                                                      ......do................................  Spaghetti with meatballs and sauce,       12 percent
                                                                                                                                 spaghetti with meat and sauce and         individually or
                                                                                                                                 similar products.                         collectively with
                                                                                                                                                                           other binders and
                                                                                                                                                                           extenders for use in
                                                                                                                                                                           meat, in accordance
                                                                                                                                                                           with 21 CFR 184.1322.
                                                                                      ......do................................  Various poultry products................  Sufficient for purpose
                                                                                                                                                                           in accordance with 21
                                                                                                                                                                           CFR 184.1322.
                                           Whey, Dry or dried.......................  To bind or thicken......................  Sausage as provided for in 9 CFR Part     3.5 percent
                                                                                                                                 319, bockwurst.                           individually or
                                                                                                                                                                           collectively with
                                                                                                                                                                           other binders and
                                                                                                                                                                           extenders for use in
                                                                                                                                                                           meat.
                                                                                      ......do................................  Imitation sausages, nonspecific loaves,   8 percent individually
                                                                                                                                 soups, stews (meat only).                 or collectively with
                                                                                                                                                                           other binders and
                                                                                                                                                                           extenders for use in
                                                                                                                                                                           meat.
                                                                                      ......do................................  Chili con carne, chili con carne with     8 percent individually
                                                                                                                                 beans, pork or beef with barbecue sauce.  or collectively with
                                                                                                                                                                           other binders and
                                                                                                                                                                           extenders for use in
                                                                                                                                                                           meat.
                                                                                      ......do................................  Various poultry products................  Sufficient for purpose
                                                                                                                                                                           in accordance with 21
                                                                                                                                                                           CFR 184.1322.
                                           Whey, Reduced lactose....................  To bind or thicken......................  Sausage as provided for in 9 CFR Part     3.5 percent
                                                                                                                                 319, bockwurst.                           individually or
                                                                                                                                                                           collectively with
                                                                                                                                                                           other binders and
                                                                                                                                                                           extenders for use in
                                                                                                                                                                           meat.
                                                                                      ......do................................  Imitation sausages, nonspecific loaves,   Sufficient for purpose
                                                                                                                                 soups, stews (meat only).                 in accordance with 21
                                                                                                                                                                           CFR 172.5.
                                                                                      ......do................................  Chili con carne, chili con carne with     8 percent individually
                                                                                                                                 beans, pork or beef with barbecue sauce.  or collectively with
                                                                                                                                                                           other binders and
                                                                                                                                                                           extenders for use in
                                                                                                                                                                           meat.
                                           Whey, Reduced minerals...................  ......do................................  Sausage as provided for in 9 CFR Part     3.5 percent
                                                                                                                                 319, bockwurst.                           individually or
                                                                                                                                                                           collectively with
                                                                                                                                                                           other binders and
                                                                                                                                                                           extenders for use in
                                                                                                                                                                           meat.
                                                                                      ......do................................  Imitation sausages, nonspecific loaves,   Sufficient for purpose
                                                                                                                                 soups, stews (meat only).                 in accordance with 21
                                                                                                                                                                           CFR 172.5.
                                                                                      ......do................................  Chili con carne, chili con carne with     8 percent individually
                                                                                                                                 beans, pork or beef with barbecue sauce.  or collectively with
                                                                                                                                                                           other binders and
                                                                                                                                                                           extenders for use in
                                                                                                                                                                           meat.

[[Page 72184]]

 
                                           Whey protein concentrate.................  ......do................................  Sausage as provided in 9 CFR Part 319,    3.5 percent
                                                                                                                                 bockwurst.                                individually or
                                                                                                                                                                           collectively with
                                                                                                                                                                           other binders and
                                                                                                                                                                           extenders for use in
                                                                                                                                                                           meat, in accordance
                                                                                                                                                                           with 21 CFR
                                                                                                                                                                           184.1979c.
                                                                                      ......do................................  Imitation sausages, nonspecific loaves,   Sufficient for purpose
                                                                                                                                 soups, stews.                             in accordance with 21
                                                                                                                                                                           CFR 184.1979c.
                                                                                      ......do................................  Chili con carne, chili con carne with     8 percent individually
                                                                                                                                 beans, pork or beef with barbecue sauce.  or collectively with
                                                                                                                                                                           other binders and
                                                                                                                                                                           extenders for use in
                                                                                                                                                                           meat, in accordance
                                                                                                                                                                           with 21 CFR 184.1979c
                                                                                      To bind meat pieces.....................  Restructured meat food products, whole    3.5 percent
                                                                                                                                 muscle meat cuts.                         individually or
                                                                                                                                                                           collectively with
                                                                                                                                                                           other binders and
                                                                                                                                                                           extenders for use in
                                                                                                                                                                           meat, in accordance
                                                                                                                                                                           with 21 CFR
                                                                                                                                                                           184.1979c.
                                           Xanthan gum..............................  To maintain: uniform viscosity;           Meat sauces, gravies or sauces and        Sufficient for purpose
                                                                                       suspension of particulate matter,         meats, canned or frozen and/or            in accordance with 21
                                                                                       emulsion stability; freeze-thaw           refrigerated meat salads, canned or       CFR 172.5.
                                                                                       stability.                                frozen meat stews, canned chili or
                                                                                                                                 chili with beans, pizza topping mixes
                                                                                                                                 and batter or breading mixes.
                                                                                      ......do................................  Various poultry products, except          Sufficient for purpose
                                                                                                                                 uncooked products or sausages or other
                                                                                                                                 products with a moisture limitation
                                                                                                                                 established by Subpart P of Part 381.
Bleaching Agent..........................  Hydrogen peroxide........................  To remove color.........................  Tripe (substance must be removed from     Sufficient for
                                                                                                                                 product by rinsing with clear water).     purpose.
Catalysts (substances must be eliminated   Nickel...................................  To accelerate chemical reaction.........  Rendered animal fats or a combination of      Do.
 during process).                                                                                                                such fats and vegetable fats.
                                           Sodium amide.............................  Rearrangement of fatty acid radicals....  ......do................................      Do.
                                           Sodium methoxide.........................  ......do................................  ......do................................  ......................
Chilling Media...........................  Salt (NaCl)..............................  To aid in chilling......................  Raw poultry products....................  700 lbs. to 10,000
                                                                                                                                                                           gallons of water.
Coloring Agents (artificial).............  Coal tar dyes (FD&C certified)...........  To color products.......................  Various poultry products................  Sufficient for
                                                                                                                                                                           purpose.
                                           Color additives listed in 21 CFR Part 74,  To color casings or rendered fats;        Sausage casings, oleomargarine,           Sufficient for purpose
                                            Subpart A of Part 82, Subpart B            marking and branding product.             shortening, marking or branding ink on    (may be mixed with
                                            (operator must furnish evidence to                                                   product (meat only).                      approved natural
                                            inspector in charge that color additive                                                                                        coloring matters or
                                            has been certified for use in connection                                                                                       harmless inert
                                            with foods by the Food and Drug                                                                                                material such as
                                            Administration).                                                                                                               common salt and
                                                                                                                                                                           sugar).
                                           Titanium oxide...........................  To whiten...............................  Canned ham salad spread and creamed-type  0.5 percent.
                                                                                                                                 canned meat products. Poultry salads
                                                                                                                                 and poultry spreads.
Coloring Agents (natural)................  Alkanet, annatto, carotene, cochineal,     To color casings or rendered fats;        Sausage casings, oleomargarine,           Sufficient for purpose
                                            green chlorophyll, saffron and tumeric.    marking and branding product.             shortening, marking or branding ink on    (may be mixed with
                                                                                                                                 product (meat only).                      approved artificial
                                                                                                                                                                           dyes or harmless
                                                                                                                                                                           inert material such
                                                                                                                                                                           as common salt and
                                                                                                                                                                           sugar).
                                           Annatto, carotene........................  To color products.......................  Various poultry products................  Sufficient for
                                                                                                                                                                           purpose.
Curing accelerators (must be used only in  Ascorbic acid............................  To accelerate color fixing or preserve    Cured pork and beef cuts, cured poultry,  75 oz to 100 gal
 combination with curing agents).                                                      color during storage.                     cured comminuted poultry and meat food    pickle at 10 percent
                                                                                                                                 products.                                 pump level; \3/4\ oz
                                                                                                                                                                           to 100 lb meat, meat
                                                                                                                                                                           byproduct or poultry
                                                                                                                                                                           product; 10 percent
                                                                                                                                                                           solution to surfaces
                                                                                                                                                                           of cured meat cuts or
                                                                                                                                                                           poultry products
                                                                                                                                                                           prior to packaging.
                                                                                                                                                                           (The use of such
                                                                                                                                                                           solution shall not
                                                                                                                                                                           result in the
                                                                                                                                                                           addition of a
                                                                                                                                                                           significant amount of
                                                                                                                                                                           moisture to the
                                                                                                                                                                           product).

[[Page 72185]]

 
                                           Citric acid or sodium citrate............  To accelerate color fixing or preserve    Cured pork and beef cuts, cured           May be used in cured
                                                                                       color during storage.                     comminuted meat food product, cured       meat products or in
                                                                                                                                 comminuted poultry or poultry products.   10 percent solution
                                                                                                                                                                           used to spray
                                                                                                                                                                           surfaces of cured
                                                                                                                                                                           meat cuts prior to
                                                                                                                                                                           packaging to replace
                                                                                                                                                                           up to 50 percent of
                                                                                                                                                                           the ascorbic acid,
                                                                                                                                                                           erythorbic acid,
                                                                                                                                                                           sodium ascorbate, or
                                                                                                                                                                           sodium erythorbate
                                                                                                                                                                           that is used. May be
                                                                                                                                                                           used in cured poultry
                                                                                                                                                                           products to replace
                                                                                                                                                                           50 percent of the
                                                                                                                                                                           ascorbic acid or
                                                                                                                                                                           sodium ascorbate that
                                                                                                                                                                           is used.
                                           Erythorbic acid..........................  To accelerate color fixing or preserve    Cured pork and beef cuts, cured poultry,  75 oz to 100 gal
                                                                                       color during storage.                     cured comminuted poultry and meat food    pickle at 10 percent
                                                                                                                                 products.                                 pump level; 3/4 oz to
                                                                                                                                                                           100 lb meat, meat
                                                                                                                                                                           byproduct or poultry
                                                                                                                                                                           product; 10 percent
                                                                                                                                                                           solution to surfaces
                                                                                                                                                                           of cured meat cuts or
                                                                                                                                                                           poultry products
                                                                                                                                                                           prior to packaging.
                                                                                                                                                                           (The use of such
                                                                                                                                                                           solution shall not
                                                                                                                                                                           result in the
                                                                                                                                                                           addition of a
                                                                                                                                                                           significant amount of
                                                                                                                                                                           moisture to the
                                                                                                                                                                           product).
                                           Fumaric acid.............................  ......do................................  Cured, comminuted meat, poultry or meat   0.065 percent (or 1 oz
                                                                                                                                 and poultry products.                     to 100 lb) of the
                                                                                                                                                                           weight of the meat,
                                                                                                                                                                           poultry or the meat
                                                                                                                                                                           or poultry byproducts
                                                                                                                                                                           before processing.
                                           Glucono delta lactone....................  ......do................................  Cured, comminuted meat or meat food       8 oz to each 100 lb of
                                                                                                                                 product.                                  meat or meat
                                                                                                                                                                           byproduct.
                                                                                      ......do................................  Genoa salami............................  16 oz to 100 lb of
                                                                                                                                                                           meat (1.0 percent).
                                           Sodium acid pyrophosphate................  ......do................................  Frankfurters, wieners, vienna, bologna,   Not to exceed alone or
                                                                                                                                 garlic bologna, knockwurst and similar    in combination with
                                                                                                                                 products.                                 other curing
                                                                                                                                                                           accelerators for use
                                                                                                                                                                           in meat the
                                                                                                                                                                           following: 8 oz in
                                                                                                                                                                           100 lb of meat, or
                                                                                                                                                                           meat and meat
                                                                                                                                                                           byproducts, content
                                                                                                                                                                           of the formula; nor
                                                                                                                                                                           0.5 percent in the
                                                                                                                                                                           finished product.
                                           Sodium ascorbate.........................  To accelerate color fixing or preserve    Cured pork and beef cuts, cured           87.5 oz to 100 gal
                                                                                       color during storage.                     comminuted meat food product, cured       pickle at 10 percent
                                                                                                                                 comminuted poultry or poultry products.   pump level; \7/8\ oz
                                                                                                                                                                           to 100 lb meat, meat
                                                                                                                                                                           byproduct or poultry
                                                                                                                                                                           product; 10 percent
                                                                                                                                                                           solution to surfaces
                                                                                                                                                                           of cured meat cuts or
                                                                                                                                                                           poultry products
                                                                                                                                                                           prior to packaging.
                                                                                                                                                                           (The use of such
                                                                                                                                                                           solution shall not
                                                                                                                                                                           result in the
                                                                                                                                                                           addition of a
                                                                                                                                                                           significant amount of
                                                                                                                                                                           moisture to the
                                                                                                                                                                           product).
                                           Sodium erythorbate.......................  To accelerate color fixing or preserve    Cured pork and beef cuts, cured           87.5 oz to 100 gal
                                                                                       color during storage.                     comminuted meat food products, cured      pickle at 10 percent
                                                                                                                                 comminuted poultry or poultry products.   pump level; \7/8\ oz
                                                                                                                                                                           to 100 lb meat, meat
                                                                                                                                                                           byproduct or poultry
                                                                                                                                                                           product; 10 percent
                                                                                                                                                                           solution to surfaces
                                                                                                                                                                           of cured meat cuts or
                                                                                                                                                                           poultry products
                                                                                                                                                                           prior to packaging.
                                                                                                                                                                           (The use of such
                                                                                                                                                                           solution shall not
                                                                                                                                                                           result in the
                                                                                                                                                                           addition of a
                                                                                                                                                                           significant amount of
                                                                                                                                                                           moisture to the
                                                                                                                                                                           product.)
Curing Agents............................  Sodium or potassium nitrate..............  Source of nitrite.......................  Cured meat products other than bacon.     7 lb to 100 gal
                                                                                                                                 Nitrates may not be used in baby,         pickle; 3\1/2\ oz to
                                                                                                                                 junior, and toddler foods. Cured,         100 lb meat or
                                                                                                                                 comminuted poultry or poultry products.   poultry product (dry
                                                                                                                                                                           cure); 2\3/4\ oz to
                                                                                                                                                                           100 lb chopped meat
                                                                                                                                                                           or poultry.

[[Page 72186]]

 
                                           Sodium or potassium nitrite (supplies of   To fix color............................  Cured meat and poultry products.          2 lb to 100 gal pickle
                                            sodium nitrite and potassium nitrite and                                             Nitrites may not be used in baby,         at 10 percent pump
                                            mixtures containing them must be kept                                                junior, or toddler foods.                 level; 1 oz to 100 lb
                                            under the care of a responsible employee                                                                                       meat or poultry
                                            of the establishment. The specific                                                                                             product (dry cure);
                                            nitrite content of such supplies must be                                                                                       \1/4\ oz to 100 lb
                                            known and clearly marked accordingly).                                                                                         chopped meat, meat
                                                                                                                                                                           byproduct or poultry
                                                                                                                                                                           product. The use of
                                                                                                                                                                           nitrites, nitrates or
                                                                                                                                                                           combination shall not
                                                                                                                                                                           result in more than
                                                                                                                                                                           200 ppm of nitrite,
                                                                                                                                                                           calculated as sodium
                                                                                                                                                                           nitrite in finished
                                                                                                                                                                           product, except that
                                                                                                                                                                           nitrites may be used
                                                                                                                                                                           in bacon only in
                                                                                                                                                                           accordance with
                                                                                                                                                                           paragraph (b) of this
                                                                                                                                                                           section.
Denuding Agents (may be used in            Lime (calcium oxide, calcium hydroxide)..  To denude mucous membranes..............  Tripe...................................  Sufficient for
 combination. Must be removed from tripe                                                                                                                                   purpose.
 by rinsing with potable water.).
                                           Sodium carbonate.........................  ......do................................  ......do................................      Do.
                                           Sodium citrate...........................  ......do................................  ......do................................      Do.
                                           Sodium gluconate.........................  ......do................................  ......do................................      Do.
                                           Sodium hydroxide.........................  ......do................................  ......do................................      Do.
                                           Sodium persulfate........................  ......do................................  ......do................................      Do.
                                           Sodium silicates (ortho, meta, and         ......do................................  ......do................................      Do.
                                            sesqui).
                                           Trisodium phosphate......................  ......do................................  ......do................................      Do.
Emulsifying Agents.......................  Actylated monoglycerides.................  To emulsify product.....................  Shortening and various poultry products.  Sufficient for
                                                                                                                                                                           purpose.
                                           Diacetyl tartaric acid esters of mono-and  ......do................................  ......do................................      Do.
                                            diglycerides.
                                           Glycerol-lacto stearate, oleate, or        ......do................................  ......do................................      Do.
                                            palmitate.
                                           Lecithin.................................  To emulsify product (also as an           Oleomargarine, shortening, various meat   0.5 percent in
                                                                                       antioxidant).                             and poultry products.                     oleomargarine, use in
                                                                                                                                                                           other products--
                                                                                                                                                                           sufficient amount for
                                                                                                                                                                           emulsification.
                                           Mono and diglycerides (glycerol            To emulsify product.....................  Rendered animal fat or a combination of   Sufficient for purpose
                                            palmitate, etc.).                                                                    such fat with vegetable fat;              in lard and
                                                                                                                                 oleomargarine.                            shortening; 0.5
                                                                                                                                                                           percent in
                                                                                                                                                                           oleomargarine.
                                                                                      ......do................................  Various poultry products................  Sufficient for
                                                                                                                                                                           purpose.
                                           Mono and diglycerides of fatty acids       ......do................................  Margarine or oleomargarine..............  0.5 percent.
                                            esterified with any of the following
                                            acids: acetic, acetyltartaric, citric,
                                            lactic, tartaric, and their sodium and
                                            calcium salts; the sodium sulfoacetate
                                            derivatives of these mono and
                                            diglycerides.
                                           Polyglycerol esters of fatty acids         ......do................................  Rendered animal fat or a combination of   Sufficient for purpose
                                            (polyglycerol esters of fatty acids are                                              such fat with vegetable fat when use is   for rendered animal
                                            restricted to those up to and including                                              not precluded by standards of identity    fat or combination
                                            the decaglycerol esters and otherwise                                                of composition; oleomargarine.            with vegetable fat;
                                            meeting the requirements of Sec.                                                                                               0.5 percent for
                                            172.854(a) of the Food Additive                                                                                                oleomargarine.
                                            Regulations).
                                           Polysorbate 60 (polyoxyethylene (20)       ......do................................  Shortening for use in nonstandardized     1 percent when used
                                            sorbitan monostearate).                                                              baked goods, baking mixes, icings,        alone. If used with
                                                                                                                                 fillings, and toppings and in the         polysorbate 80 the
                                                                                                                                 frying of foods (meat only). Rendered     combined total shall
                                                                                                                                 poultry fat or a combination of such      not exceed 1 percent.
                                                                                                                                 fat with vegetable fat.
                                           Polysorbate 80 (polyoxyethylene (20)       ......do................................  Shortening for use in nonstandardized     1 percent when used
                                            sorbitan monooleate).                                                                baked goods, baking mixes, icings,        alone. If used with
                                                                                                                                 fillings, and toppings and in the         polysorbate 60 the
                                                                                                                                 frying of foods (meat only). Various      combined total shall
                                                                                                                                 poultry products.                         not exceed 1 percent.
                                           1,2-propylene glycol esters of fatty       ......do................................  Margarine or oleomargarine..............  2.0 percent.
                                            acids.
                                           Propylene glycol mono and diesters of      ......do................................  Rendered animal or poultry fat or a       Sufficient for
                                            fats and fatty acids.                                                                combination of such fat with vegetable    purpose.
                                                                                                                                 fat.
                                           Stearyl-2-lactylic acid..................  ......do................................  Shortening to be used for cake icings     3.0 percent.
                                                                                                                                 and fillings (meat only).

[[Page 72187]]

 
                                           Stearyl monoglyceridyl citrate...........  ......do................................  Shortening..............................  Sufficient for purpose
Film Forming Agents......................  A mixture consisting of water, sodium      To reduce cooler shrinkage and help       Freshly dressed meat carcasses. Such      Formulation may not
                                            alginate, calcium chloride, sodium         protect surface.                          carcasses must bear a statement           exceed 1.5 percent of
                                            carboxymethyl-cellulose, and corn syrup                                              ``Protected with a film of water, corn    hot carcass weight
                                            solids.                                                                              syrup solids, sodium alginate, calcium    when applied. Chilled
                                                                                                                                 chloride and sodium carboxymethyl-        weight may not exceed
                                                                                                                                 cellulose.''.                             hot weight.
Flavoring Agents; Protectors and           Artificial smoke flavoring...............  To flavor product.......................  Various (meat and poultry) \2\..........  Sufficient for
 Developers.                                                                                                                                                               purpose.
                                           Autolyzed yeast extract..................  ......do................................  ......do................................      Do.
                                           Benzoic acid (sodium, potassium and        To retard flavor reversion..............  Margarine or oleomargarine..............  0.1 percent
                                            calcium salts).                                                                                                                individually, or if
                                                                                                                                                                           used in combination
                                                                                                                                                                           with other flavoring
                                                                                                                                                                           agents for use in
                                                                                                                                                                           meat or with sorbic
                                                                                                                                                                           acid and its salts,
                                                                                                                                                                           0.2 percent
                                                                                                                                                                           (expressed as the
                                                                                                                                                                           acids in the wt. of
                                                                                                                                                                           the finished foods).
                                           Calcium lactate..........................  To protect flavor.......................  Cooked semi-dry and dry products          0.6 percent in product
                                                                                                                                 including sausage, imitation sausage,     formulation.
                                                                                                                                 and nonspecific meat food sticks.
                                           Citric acid..............................  ......do................................  Various poultry products................  Sufficient for
                                                                                                                                                                           purpose.
                                                                                      Flavoring...............................  Chili con carne.........................      Do.
                                           Corn syrup solids; corn syrup; glucose     To flavor product.......................  Various poultry products, sausage,            Do.
                                            syrup.                                                                               hamburger, meat loaf, luncheon meat,
                                                                                                                                 chopped or pressed ham.
                                           Dextrose.................................  ......do................................  Sausage, ham and cured products.........      Do.
                                           Diacetyl.................................  ......do................................  Oleomargarine...........................      Do.
                                           Disodium guanylate.......................  ......do................................  Various meat and poultry products.\2\
                                           Disodium inosinate.......................  ......do................................  ......do................................      Do.
                                           Harmless bacteria starters of the          To develop flavor.......................  Dry sausage, pork roll, thuringer,        0.5 percent.
                                            acidophilus type, lactic acid starter or                                             lebanon bologna, cervelat, and salami.
                                            culture of Pediococcus cerevisiae.
                                           Harmless lactic acid producing bacteria..  To prevent the growth of Clostridium      Bacon...................................  Sufficient for
                                                                                       botulinum.                                                                          purpose.
                                           Hydrolyzed plant protein.................  To flavor product.......................  Various meat and poultry products.\2\         Do.
                                           Isopropyl citrate........................  To protect flavor.......................  Oleomargarine...........................  0.02 percent.
                                           Malt syrup...............................  To flavor product.......................  Cured meat products.....................  2.5 percent.
                                                                                      ......do................................  Various poultry products................  Sufficient for
                                                                                                                                                                           purpose.
                                           Milk protein hydrolysate.................  ......do................................  Various meat and poultry products.\2\         Do.
                                           Monoammonium glutamate...................  ......do................................  ......do................................      Do.
                                           Monosodium glutamate.....................  ......do................................  ......do................................      Do.
                                           Potassium lactate........................  ......do................................  Various meat and meat food products,      Not to exceed 2
                                                                                                                                 poultry and poultry food products,        percent of
                                                                                                                                 except infant formula and infant          formulation; in
                                                                                                                                 food.\2\                                  accordance with 21
                                                                                                                                                                           CFR 184.1639.
                                           Smoke flavoring..........................  To flavor product.......................  Various meat and poultry products.......  Sufficient for
                                                                                                                                                                           purpose.
                                           Sodium acetate...........................  ......do................................  Various meat and poultry products.......  Not to exceed 0.12
                                                                                                                                                                           percent of formulate
                                                                                                                                                                           in accordance with 21
                                                                                                                                                                           CFR 184.1721.
                                           Sodium diacetate.........................  ......do................................  ......do................................  Not to exceed 0.1
                                                                                                                                                                           percent of formulate
                                                                                                                                                                           in accordance with 21
                                                                                                                                                                           CFR 184.1754.
                                           Sodium lactate...........................  ......do................................  Various meat and meat food products,      Not to exceed 2
                                                                                                                                 poultry and poultry food products,        percent of
                                                                                                                                 except infant formula and infant          formulation in
                                                                                                                                 food.\2\                                  accordance with 21
                                                                                                                                                                           CFR 184.1768.
                                           Sodium sulfoacetate derivative of mono     ......do................................  Various meat and poultry products.\2\     0.5 percent.
                                            and diglycerids.
                                           Sodium tripolyphosphate..................  To help protect flavor..................  ``Fresh Beef,'' \2\ ``Beef for further    0.5 percent of total
                                                                                                                                 cooking, ``Cooked Beef,'' Beef Patties,   product.
                                                                                                                                 Meat Loaves, Meat Toppings, and similar
                                                                                                                                 products derived from pork, lamb, veal,
                                                                                                                                 mutton, and goat meat which are cooked
                                                                                                                                 or frozen after processing.

[[Page 72188]]

 
                                           Sodium tripolyphosphate and sodium         ......do................................  ......do................................      Do.
                                            mixtures, metaphosphate, insoluble; and
                                            sodium polyphosphates, glassy.
                                           Sorbitol.................................  To flavor, to facilitate the removal of   Cooked sausage labeled frankfurter,       Not to exceed 2
                                                                                       casings from product, and to reduce       frank, furter, wiener, and knockwurst;    percent of the weight
                                                                                       caramelization and charring.              cured pork and pork products, as          of the formula
                                                                                                                                 provided for in 9 CFR Part 319.           excluding the formula
                                                                                                                                                                           weight of water or
                                                                                                                                                                           ice, when used in
                                                                                                                                                                           accordance with 21
                                                                                                                                                                           CFR 184.1835.
                                           Starter distillate.......................  To help protect flavor..................  Oleomargarine...........................  Sufficient for
                                                                                                                                                                           purpose.
                                           Stearyl citrate..........................  ......do................................  ......do................................  0.15 percent.
                                           Sugars (sucrose and dextrose)............  To flavor product.......................  Various meat and poultry products.......  Sufficient for
                                                                                                                                                                           purpose.
Gases....................................  Carbon dioxide liquid....................  Contact freezing........................  Various poultry products................      Do.
                                           Carbon dioxide solid (dry ice)...........  To cool product.........................  Chopping of meat, packing of product....  Sufficient for
                                                                                                                                                                           purpose.
                                                                                      To cool product or facilitate chopping    Various poultry products................      Do.
                                                                                       or packaging.
                                           Nitrogen.................................  To exclude oxygen from sealed containers  Various meat and poultry products.......      Do.
                                           Nitrogen, liquid.........................  Contact freezant........................  ......do................................      Do.
Hog Scald Agents (must be removed by       Caustic soda.............................  To remove hair..........................  Hog carcasses...........................  Sufficient for
 subsequent cleaning operations).                                                                                                                                          purpose.
                                           Dicotyl sodium sulfosuccinate............  ......do................................  ......do................................      Do.
                                           Dimethylpolysiloxane.....................  ......do................................  ......do................................      Do.
                                           Disodium-calcium ethylenediaminetetra-     ......do................................  ......do................................      Do.
                                            acetate.
                                           Disodium phosphate.......................  ......do................................  ......do................................      Do.
                                           Ethylenediaminetetra-acetic acid (sodium   ......do................................  ......do................................      Do.
                                            salts).
                                           Lime (calcium oxide, calcium hydroxide)..  ......do................................  ......do................................      Do.
                                           Potassium hydroxide......................                                                                                          Do.
                                           Propylene glycol.........................  ......do................................  ......do................................      Do.
                                           Soap (prepared by the reaction of          ......do................................  ......do................................      Do.
                                            calcium, potassium, or sodium with rosin
                                            or fatty acids of natural fats and oils).
                                           Sodium acid pyrophosphate................  ......do................................  ......do................................      Do.
                                           Sodium carbonate.........................  ......do................................  ......do................................      Do.
                                           Sodium dodecylbenzene sulfonate..........  ......do................................  ......do................................      Do.
                                           Sodium gluconate.........................  ......do................................  ......do................................      Do.
                                           Sodium hexametaphosphate.................  ......do................................  ......do................................      Do.
                                           Sodium lauryl sulfate....................  ......do................................  ......do................................      Do.
                                           Sodium mono and dimethylnaphthalene        ......do................................  ......do................................      Do.
                                            sulfonate (molecular weight 245-260).
                                           Sodium n-alkylbenzene sulfonate (alkyl     ......do................................  ......do................................      Do.
                                            group predominantly C12 and C13 and not
                                            less than 95 percent C10 and C16).
                                           Sodium pyrophosphate.....................  ......do................................  ......do................................      Do.
                                           Sodium silicates (ortho, meta, and         ......do................................  ......do................................      Do.
                                            sesqui).
                                           Sodium sulfate...........................  ......do................................  ......do................................      Do.
                                           Sodium tripolyphosphate..................  ......do................................  ......do................................      Do.
                                           Sucrose..................................  ......do................................  ......do................................      Do.
                                           Triethanolamine dodecylbenzene sulfonate.  ......do................................  ......do................................      Do.
                                           Trisodium phosphate......................  ......do................................  ......do................................      Do.
Miscellaneous............................  Adipic acid..............................  To acidify..............................  Margarine or oleomargarine..............  Sufficient for
                                                                                                                                                                           purpose.

[[Page 72189]]

 
                                           Ascorbic acid, erythorbic acid, citric     To delay discoloration..................  Fresh beef cuts, fresh lamb cuts, fresh   Not to exceed, singly
                                            acid, sodium ascorbate and sodium                                                    pork cuts.                                or in combination,
                                            citrate singly or in combination, under                                                                                        500 ppm or 1.8 mg/sq.
                                            quality control.                                                                                                               inch of product
                                                                                                                                                                           surface of ascorbic
                                                                                                                                                                           acid (in accordance
                                                                                                                                                                           with 21 CFR
                                                                                                                                                                           182.3013), erythorbic
                                                                                                                                                                           acid (in accordance
                                                                                                                                                                           with 21 CFR 182.3041)
                                                                                                                                                                           or sodium ascorbate
                                                                                                                                                                           (in accordance with
                                                                                                                                                                           21 CFR 182.3731); and/
                                                                                                                                                                           or not to exceed,
                                                                                                                                                                           singly or in
                                                                                                                                                                           combination, 250 ppm
                                                                                                                                                                           or 0.9 mg/sq. inch of
                                                                                                                                                                           product surface of
                                                                                                                                                                           citric acid (in
                                                                                                                                                                           accordance with 21
                                                                                                                                                                           CFR 182.6033), or
                                                                                                                                                                           sodium citrate (in
                                                                                                                                                                           accordance with 21
                                                                                                                                                                           CFR 182.6751).
                                           Calcium disodium, EDTA (calcium disodium   To preserve product and to protect        Margarine or oleomargarine..............  75 ppm by weight of
                                            ethylene-diaminetetraacetate.              flavor.                                                                             the finished
                                                                                                                                                                           oleomargarine or
                                                                                                                                                                           margarine.
                                           Calcium propionate.......................  To retard mold growth...................  Pizza crust.............................  0.32 percent alone or
                                                                                                                                                                           in combination based
                                                                                                                                                                           on weight of the
                                                                                                                                                                           flour brace used.
                                                                                      ......do................................  Fresh pie dough (poultry only)..........  0.3 percent of calcium
                                                                                                                                                                           propionate or sodium
                                                                                                                                                                           propionate alone, or
                                                                                                                                                                           in combination, based
                                                                                                                                                                           on weight of flour
                                                                                                                                                                           used.
                                           Citric acid..............................  To preserve cured color during storage..  Cured pork cuts.........................  Not to exceed 30
                                                                                                                                                                           percent in water
                                                                                                                                                                           solution used to
                                                                                                                                                                           spray surfaces of
                                                                                                                                                                           cured cuts, prior to
                                                                                                                                                                           packaging, in
                                                                                                                                                                           accordance with 21
                                                                                                                                                                           CFR 184.1033. (The
                                                                                                                                                                           use of such solution
                                                                                                                                                                           shall not result in
                                                                                                                                                                           the addition of a
                                                                                                                                                                           significant amount of
                                                                                                                                                                           moisture to the
                                                                                                                                                                           product and shall be
                                                                                                                                                                           applied only once to
                                                                                                                                                                           product).
                                           Citric acid (sodium and potassium salts).  To acidify..............................  Margarine and oleomargarine.............  Sufficient for
                                                                                                                                                                           purpose.
                                           d- and dl-alpha-tocopherol...............  To inhibit nitrosamine formation........  Pump-cured bacon........................  500 ppm; by injection
                                                                                                                                                                           or surface
                                                                                                                                                                           application.
                                           Dipotassium phosphate....................  To decrease the amount of cooked out      Meat food products except where           For meat food
                                                                                       juices.                                   otherwise prohibited by the meat          products, 5 percent
                                                                                                                                 inspection regulations and poultry food   of phosphate in
                                                                                                                                 products except where otherwise           pickle at 10 percent
                                                                                                                                 prohibited by the poultry products        pump level; 0.5
                                                                                                                                 inspection regulations..                  percent of phosphate
                                                                                                                                                                           in meat food product
                                                                                                                                                                           (only clear solution
                                                                                                                                                                           may be injected into
                                                                                                                                                                           meat food product).
                                                                                                                                                                           For poultry food
                                                                                                                                                                           products, 0.5 percent
                                                                                                                                                                           of total product.
                                           Disodium phosphate.......................  ......do................................  ......do................................      Do.
                                           Glycerine................................  Humectant...............................  Shelf stable meat snacks................  Not to exceed 2
                                                                                                                                                                           percent of the
                                                                                                                                                                           formulation weight of
                                                                                                                                                                           the product in
                                                                                                                                                                           accordance with 21
                                                                                                                                                                           CFR 182.1320.
                                           Hydrochloric acid........................  To acidify..............................  Margarine or oleomargarine..............  Sufficient for
                                                                                                                                                                           purpose.
                                           Lactic acid (sodium and potassium salts).  ......do................................  ......do................................      Do.
                                           L-Tartaric acid (sodium and sodium         ......do................................  ......do................................      Do.
                                            potassium salts).
                                           Monopotassium phosphate..................  To decrease the amount of cooked out      Meat food products except where           For meat food
                                                                                       juices.                                   otherwise prohibited by the meat          products, 5 percent
                                                                                                                                 inspection regulations and poultry food   of phosphate in
                                                                                                                                 products except where otherwise           pickle at 10 percent
                                                                                                                                 prohibited by the poultry products        pump level; 0.5
                                                                                                                                 inspection regulations..                  percent of phosphate
                                                                                                                                                                           in meat food product
                                                                                                                                                                           (only clear solution
                                                                                                                                                                           may be injected into
                                                                                                                                                                           meat food product).
                                                                                                                                                                           For poultry products,
                                                                                                                                                                           0.5 percent of total
                                                                                                                                                                           product.
                                           Monosodium phosphate.....................  ......do................................  ......do................................      Do.
                                           Phosphoric acid..........................  To acidify..............................  Margarine or oleomargarine..............  Sufficient for
                                                                                                                                                                           purpose.
                                           Potassium bicarbonate....................  To alkalize.............................  Margarine or oleomargarine..............  Sufficient for
                                                                                                                                                                           purpose.
                                           Potassium carbonate......................  ......do................................  ......do................................      Do.

[[Page 72190]]

 
                                           Potassium pyrophosphate..................  To decrease the amount of cooked out      Meat food products except where           5 percent of phosphate
                                                                                       juices.                                   otherwise prohibited by the meat          in pickle at 10
                                                                                                                                 inspection regulations and poultry food   percent pump level;
                                                                                                                                 products except where otherwise           0.5 percent of
                                                                                                                                 prohibited by the poultry products        phosphate in meat
                                                                                                                                 inspection regulations..                  food product (only
                                                                                                                                                                           clear solution may be
                                                                                                                                                                           injected into meat
                                                                                                                                                                           food product). For
                                                                                                                                                                           poultry food
                                                                                                                                                                           products, 0.5 percent
                                                                                                                                                                           of total product.
                                           Potassium sorbate........................  To retard mold growth...................  Dry sausage.............................  10 percent in water
                                                                                                                                                                           solution may be
                                                                                                                                                                           applied to casings
                                                                                                                                                                           after stuffing or
                                                                                                                                                                           casings may be dipped
                                                                                                                                                                           in solution prior to
                                                                                                                                                                           stuffing.
                                           Potassium tripolyphosphate...............  To decrease the amount of cooked out      Meat food products except where           5 percent of phosphate
                                                                                       juices.                                   otherwise prohibited by the meat          in pickle at 10
                                                                                                                                 inspection regulations and poultry food   percent pump level;
                                                                                                                                 products except where otherwise           0.5 percent of
                                                                                                                                 prohibited by the poultry products        phosphate in meat
                                                                                                                                 inspection regulations.                   food product (only
                                                                                                                                                                           clear solution may be
                                                                                                                                                                           injected into meat
                                                                                                                                                                           food product). For
                                                                                                                                                                           poultry food
                                                                                                                                                                           products, 0.5 percent
                                                                                                                                                                           of total product.
                                           Propyl paraben (propyl p-hydroxy-          To retard mold growth...................  Dry sausage.............................  3.5 percent in water
                                            benzoate).                                                                                                                     solution may be
                                                                                                                                                                           applied to casings
                                                                                                                                                                           after stuffing or
                                                                                                                                                                           casings may be dipped
                                                                                                                                                                           in solution prior to
                                                                                                                                                                           stuffing.
                                           Silicon dioxide..........................  Processing aid/dispersant...............  Tocopherol containing bacon curing mixes  At level not to exceed
                                                                                                                                                                           4.0 percent in the
                                                                                                                                                                           dry mix.
                                           Sodium acid pyrophosphate................  To decrease the amount of cooked out      Meat food products except where other     For meat food
                                                                                       juices.                                   prohibited by the meat inspection         products, 5 percent
                                                                                                                                 regulations and poultry food products     of phosphate in
                                                                                                                                 except where otherwise prohibited by      pickle at 10 percent
                                                                                                                                 the poultry products inspection           pump level; 0.5
                                                                                                                                 regulations..                             percent of phosphate
                                                                                                                                                                           in meat food product
                                                                                                                                                                           (only clear solution
                                                                                                                                                                           may be injected into
                                                                                                                                                                           meat food product).
                                                                                                                                                                           For poultry products,
                                                                                                                                                                           0.5 percent of total
                                                                                                                                                                           product.
                                           Sodium bicarbonate.......................  To neutralize excess acidity, cleaning    Rendered fats, soups, curing pickle       Sufficient for
                                                                                       vegetables.                               (meat and poultry).                       purpose.
                                                                                      To alkalize.............................  Margarine or oleomargarine..............      Do.
                                           Sodium carbonate.........................  ......do................................  ......do................................      Do.
                                           Sodium citrate buffered with citric acid   To inhibit the growth of micro-organisms  Cured and uncured, processed whole        Not to exceed 1.3
                                            to a pH of 5.6.                            and retain product flavor during          muscle meat and poultry food products,    percent of the
                                                                                       storage.                                  e.g., ham, chicken breasts.               formulation weight of
                                                                                                                                                                           the product in
                                                                                                                                                                           accordance with 21
                                                                                                                                                                           CFR 184.1751.
                                           Sodium hydroxide.........................  To alkalize.............................  Margarine or oleomargarine..............  Sufficient for
                                                                                                                                                                           purpose.
                                                                                      To decrease the amount of cooked out      Poultry food products containing          May be used only in
                                                                                       juices.                                   phosphates.                               combination with
                                                                                                                                                                           phosphate in a ratio
                                                                                                                                                                           not to exceed one
                                                                                                                                                                           part sodium hydroxide
                                                                                                                                                                           to four parts
                                                                                                                                                                           phosphate.
                                                                                      ......do................................  Meat food products containing phosphates  May be used only in
                                                                                                                                                                           combination with
                                                                                                                                                                           phosphates in a ratio
                                                                                                                                                                           not to exceed one
                                                                                                                                                                           part sodium hydroxide
                                                                                                                                                                           to four parts
                                                                                                                                                                           phosphate; the
                                                                                                                                                                           combination shall not
                                                                                                                                                                           exceed 5 percent in
                                                                                                                                                                           pickle at 10 percent
                                                                                                                                                                           pump level; 0.5
                                                                                                                                                                           percent in product.
                                           Sodium metaphosphate, insoluble..........  ......do................................  Meat food products except where other     For meat food
                                                                                                                                 prohibited by the meat inspection         products, 5 percent
                                                                                                                                 regulations, and poultry food products    of phosphate in
                                                                                                                                 except where otherwise prohibited by      pickle at 10 percent
                                                                                                                                 the poultry products inspection           pump level; 0.5
                                                                                                                                 regulations.                              percent of phosphate
                                                                                                                                                                           in meat food product
                                                                                                                                                                           (only clear solution
                                                                                                                                                                           may be injected into
                                                                                                                                                                           meat food product).
                                                                                                                                                                           For poultry products,
                                                                                                                                                                           0.5 percent of total
                                                                                                                                                                           product.
                                           Sodium polyphosphate, glassy.............  ......do................................  ......do................................      Do.
                                           Sodium proprionate.......................  To retard mold growth...................  Pizza crust.............................  0.32 percent alone or
                                                                                                                                                                           in combination based
                                                                                                                                                                           on weight of the
                                                                                                                                                                           flour brace used.

[[Page 72191]]

 
                                                                                      ......do................................  Fresh pie dough (poultry only)..........  0.3 percent of calcium
                                                                                                                                                                           proprionate or sodium
                                                                                                                                                                           proprionate alone, or
                                                                                                                                                                           in combination, based
                                                                                                                                                                           on weight of flour
                                                                                                                                                                           used.
                                           Sodium pryophosphate.....................  To decrease the amount of cooked out      Meat food products except where           For meat food
                                                                                       juices.                                   otherwise prohibited by the meat          products, 5 percent
                                                                                                                                 inspection regulations and poultry food   of phosphate in
                                                                                                                                 products except where otherwise           pickle at 10 percent
                                                                                                                                 prohibited by the poultry products        pump level; 0.5
                                                                                                                                 inspection regulations.                   percent of phosphate
                                                                                                                                                                           in meat food product
                                                                                                                                                                           (only clear solution
                                                                                                                                                                           may be injected into
                                                                                                                                                                           meat food product).
                                                                                                                                                                           For poultry products,
                                                                                                                                                                           0.5 percent of total
                                                                                                                                                                           product.
                                           Sodium tripolyphosphate..................  ......do................................  ......do................................      Do.
                                           Sorbic acid (sodium, potassium, and        To preserve product and to retard mold    Margarine or oleomargarine..............  0.1 percent
                                            calcium salts).                            growth.                                                                             individually, or if
                                                                                                                                                                           used in combination
                                                                                                                                                                           or with benzoic acid
                                                                                                                                                                           or its salts, 0.2
                                                                                                                                                                           percent (expressed as
                                                                                                                                                                           the acids in the wt.
                                                                                                                                                                           of the finished
                                                                                                                                                                           foods).
                                           Tricalcium phosphate.....................  To preserve product color during          Mechanically deboned chicken to be        Not to exceed 2
                                                                                       dehydration process.                      dehydrated.                               percent of the weight
                                                                                                                                                                           of the mechanically
                                                                                                                                                                           deboned chicken prior
                                                                                                                                                                           to dehydration, in
                                                                                                                                                                           accordance with 21
                                                                                                                                                                           CFR 182.1217.
Poultry scald agents (must be removed by   Alpha-hydro-omega-hydroxy-poly             To remove feathers......................  Poultry carcasses.......................  Not to exceed 0.05
 subsequent cleaning operations).           (oxyethylene) poly (oxypropylene)                                                                                              percent by weight in
                                            (minimum 15 moles) poly (oxyethylene)                                                                                          scald water.
                                            block copolymer (poloxamer).
                                           Dimethylpolysiloxane.....................  ......do................................  ......do................................  Sufficient for
                                                                                                                                                                           purpose.
                                           Dioctyl sodium sulfosuccinate............  ......do................................  ......do................................      Do.
                                           Dipotassium phosphate....................  ......do................................  ......do................................      Do.
                                           Ethylenediaminetetra-acetic acid (sodium   ......do................................  ......do................................      Do.
                                            salts).
                                           Lime (calcium oxide, calcium hydroxide)..  ......do................................  ......do................................      Do.
                                           Polyoxyethylene (20) sorbitan monooleate.  ......do................................  ......do................................  Not to exceed 0.0175
                                                                                                                                                                           percent in scald
                                                                                                                                                                           water.
                                           Potassium hydroxide......................  ......do................................  ......do................................  Sufficient for
                                                                                                                                                                           purpose.
                                           Propylene glycol.........................  ......do................................  ......do................................      Do.
                                           Sodium acid phosphate....................  ......do................................  ......do................................      Do.
                                           Sodium acid pyrophosphate................  ......do................................  ......do................................      Do.
                                           Sodium bicarbonate.......................  ......do................................  ......do................................      Do.
                                           Sodium carbonate.........................  ......do................................  ......do................................      Do.
                                           Sodium dodecylbenzene-sulfonate..........  ......do................................  ......do................................      Do.
                                           Sodium-2-ethylhexyl sulfate..............  ......do................................  ......do................................      Do.
                                           Sodium hexametaphosphate.................  ......do................................  ......do................................      Do.
                                           Sodium hydroxide.........................  ......do................................  ......do................................      Do.
                                           Sodium lauryl sulfate....................  ......do................................  ......do................................      Do.
                                           Sodium phosphate (mono-, di-, tribasic)..  ......do................................  ......do................................      Do.
                                           Sodium pyrophosphate.....................  ......do................................  ......do................................      Do.
                                           Sodium sesquicarbonate...................  ......do................................  ......do................................      Do.
                                           Sodium sulfate...........................  ......do................................  ......do................................      Do.
                                           Sodium tripolyphosphate..................  ......do................................  ......do................................      Do.
                                           Tetrasodium pyrophosphate................  ......do................................  ......do................................      Do.
Proteolytic Enzymes......................  Aspergillus flavus oryzae group..........  To soften tissue........................  Raw poultry muscle tissue of hen, cock,   Solutions consisting
                                                                                                                                 mature turkey, mature duck, mature        of water and approved
                                                                                                                                 goose, and mature guinea, and raw meat    proteolytic enzyme
                                                                                                                                 cuts.                                     applied or injected
                                                                                                                                                                           into raw meat or
                                                                                                                                                                           poultry tissue shall
                                                                                                                                                                           not result in a gain
                                                                                                                                                                           of more than 3
                                                                                                                                                                           percent above the
                                                                                                                                                                           weight of the
                                                                                                                                                                           untreated product.
                                           Aspergillus oryzae.......................  ......do................................  ......do................................      Do.
                                           Bromelin.................................  ......do................................  ......do................................      Do.
                                           Ficin....................................  ......do................................  ......do................................      Do.
                                           Papain...................................  ......do................................  ......do................................      Do.
Refining Agents (must be eliminated        Acetic acid..............................  To separate fatty acids and glycerol....  Rendered fats (meat only)...............  Sufficient for
 during process of manufacturing).                                                                                                                                         purpose.
                                           Bicarbonate of soda......................  ......do................................  ......do................................      Do.
                                           Carbon (purified charcoal)...............  To aid in refining of animal fats.......  ......do................................      Do.
                                           Caustic soda (sodium hydroxide)..........  To refine fats..........................  ......do................................      Do.
                                           Diatomaceous earth; Fuller's earth.......  ......do................................  ......do................................      Do.

[[Page 72192]]

 
                                           Sodium carbonate.........................  ......do................................  ......do................................      Do.
                                           Tannic acid..............................  ......do................................  ......do................................      Do.
Rendering agents.........................  Tricalcium phosphate.....................  To aid rendering........................  Animal fats.............................      Do.
                                           Trisodium phosphate......................  ......do................................  ......do................................      Do.
Synergists (used in combination with       Citric acid..............................  To increase effectiveness of              Any meat product permitted to contain     Not to exceed 0.01
 antioxidants).                                                                        antioxidants.                             antioxidants as provided for in this      percent based on fat
                                                                                                                                 part.                                     content.
                                                                                      ......do................................  Poultry fats............................  0.01 percent alone or
                                                                                                                                                                           in combination with
                                                                                                                                                                           antioxidants in
                                                                                                                                                                           poultry fats.
                                           Malic acid...............................  ......do................................  Lard and shortening.....................  0.01 percent based on
                                                                                                                                                                           total weight in
                                                                                                                                                                           combination with
                                                                                                                                                                           antioxidants for use
                                                                                                                                                                           in meat products
                                                                                                                                                                           only.
                                                                                      ......do................................  Poultry fats............................  0.01 percent alone or
                                                                                                                                                                           in combination with
                                                                                                                                                                           antioxidants in
                                                                                                                                                                           poultry fats.
                                           Monoglyceride citrate....................  ......do................................  Lard, shortening, fresh pork sausage,     0.02 percent.
                                                                                                                                 dried meats and poultry fats.
                                           Monoisopropyl citrate....................  ......do................................  Lard, shortening, oleomargarine, fresh        Do.
                                                                                                                                 pork sausage, dried meats.
                                                                                      ......do................................  Poultry fats............................  0.01 percent poultry
                                                                                                                                                                           fats.
                                           Phosphoric acid..........................  ......do................................  Lard, shortening, and poultry fats......  0.01 percent.
Tenderizing agents.......................  Aspergillus flavus oryzae group..........  To soften tissue........................  Raw poultry muscle tissue of hen, cock,   Solutions consisting
                                                                                                                                 mature turkey, mature duck, mature        of water and approved
                                                                                                                                 goose, and mature guinea, and raw meat    proteolytic enzyme
                                                                                                                                 cuts.                                     applied or injected
                                                                                                                                                                           into raw meat or
                                                                                                                                                                           poultry tissue shall
                                                                                                                                                                           not result in a gain
                                                                                                                                                                           of more than 3
                                                                                                                                                                           percent above the
                                                                                                                                                                           weight of the
                                                                                                                                                                           untreated product.
                                           Aspergillus oryzae.......................  ......do................................  ......do................................  Not more than 3
                                                                                                                                                                           percent of a of a 0.8
                                                                                                                                                                           molar solution.
                                           Bromelin.................................  ......do................................  ......do................................      Do.
                                           Calcium chloride.........................  ......do................................  ......do................................      Do.
                                           Magnesium chloride.......................  ......do................................  ......do................................      Do.
                                           Papain...................................  To soften tissue........................  Raw poultry muscle tissue of hen, cock,   Solutions consisting
                                                                                                                                 mature turkey, mature duck, mature        of water and approved
                                                                                                                                 goose, and mature guinea, and raw meat    proteolytic enzyme
                                                                                                                                 cuts.                                     applied or injected
                                                                                                                                                                           into raw meat or
                                                                                                                                                                           poultry tissue shall
                                                                                                                                                                           not result in a gain
                                                                                                                                                                           of more than 3
                                                                                                                                                                           percent above the
                                                                                                                                                                           weight of the
                                                                                                                                                                           untreated product.
                                           Potassium chloride.......................  ......do................................  ......do................................  Not more than 3
                                                                                                                                                                           percent of a 2.0
                                                                                                                                                                           molar solution.
                                           Potassium, magnesium or calcium chloride.  ......do................................  ......do................................  A solution of approved
                                                                                                                                                                           inorganic chlorides
                                                                                                                                                                           injected into or
                                                                                                                                                                           applied to raw meats
                                                                                                                                                                           or poultry cuts shall
                                                                                                                                                                           not result in a gain
                                                                                                                                                                           of more than 3
                                                                                                                                                                           percent above the
                                                                                                                                                                           weight of the
                                                                                                                                                                           untreated product.
\1\ [RESERVED]
\2\ Information as to the specific products for which use of this additive is approved may be obtained upon inquiry addressed to the Labeling and Additives Policy Division, Food Safety and
  Inspection Service, U.S. Department of Agriculture, Washington, DC 20250.
\3\ Provided, that its use is functional and suitable for the product and it is permitted for use at the lowest level necessary to accomplish the desired technical effect as determined in
  specific cases prior to label approval under Secs.  317.4 or 381.32.
\4\ Special labeling requirements are prescribed in 381.120 for raw poultry chilled in a medium with more than 70 lbs. of salt to 10,000 gals. of water.

Sec. 424.22  Certain other permitted uses.

    (a) Under appropriate declaration as required in parts 316 and 317 
of this chapter, the following substances may be added to meat:
    (1) General. Common salt, approved sugars (sucrose, cane or beet 
sugar), maple sugar, dextrose, invert sugar, honey, corn syrup solids 
(corn syrup, glucose syrup and fructose), wood smoke, vinegar, 
flavorings, spices, sodium nitrate, sodium nitrite, potassium nitrate, 
potassium nitrite, and other food and color additives specified in the 
chart in paragraph (c) of this section may be added to meat under 
conditions, if any, specified in this part or in part 317 of this 
chapter.
    (2) Artifical flavorings. Other harmless artificial flavorings may 
be added to meat, with the approval of the Administrator in specific 
cases.
    (3) Coloring matter and dyes. Coloring matter and dyes, other than 
those specified in a regulation permitting that use in this chapter or 
in 21 CFR Chapter I, Subchapter A and Subchapter B, may be applied to 
meat mixed with rendered fat, applied to natural and artificial 
casings, and applied to such casings enclosing products, if approved by 
the Administrator in specific cases. When any coloring matter or dye is 
applied to casings, there shall be no penetration of coloring into the 
product.
    (b) Use of nitrite and sodium ascorbate or sodium erythorbate 
(isoascorbate) in bacon.
    (1) Pumped bacon. With respect to bacon injected with curing 
ingredients and massaged bacon, sodium nitrite shall be used at 120 
parts per million (ppm) ingoing or an equivalent amount of potassium 
nitrite shall be used (148 ppm ingoing); and 550 ppm of sodium

[[Page 72193]]

ascorbate or sodium erythorbate (isoascorbate) shall be used. Sodium 
ascorbate or sodium erythorbate have a molecular weight of 
approximately 198. Hydrated forms of these substances shall be adjusted 
to attain the equivalent of 550 ppm of sodium ascorbate or sodium 
erythorbate.
    (i) The Department shall collect samples of pumped bacon from 
producing plants and analyze them for the level of nitrosamines by the 
Thermal Energy Analyzer (TEA). In the event that a TEA analysis 
indicates that a confirmable level of nitrosamines might be present, 
additional samples shall be collected and analyzed by gas 
chromatography. Presumptive positive results must be confirmed by mass 
spectrometry before being considered positive. If during the interval 
required for the Department to analyze the confirmatory samples by gas 
chromatography and mass spectrometry, changes are made in processing 
procedures which are expected to result in no confirmable levels of 
nitrosamines in pumped bacon produced by these new procedures, an 
establishment may submit samples to USDA for analysis upon prior 
notification and arrangements with USDA. If, however, an establishment 
furnishes USDA with laboratory results from testing five consecutive 
lots of pumped bacon produced under the new procedures and the testing 
is performed by the USDA methodology and procedures, those results will 
be utilized in making the determination concerning the product produced 
under the new procedures. Should the results of these tests reveal that 
confirmable levels of nitrosamines are not indicated in any of the five 
consecutive lots, the confirmation analysis by USDA shall be terminated 
and the establishment shall revert to normal monitoring status. In the 
event the test results continue to indicate nitrosamines, however, USDA 
shall proceed in its confirmation analysis on the original samples 
taken for confirmation. If any one of the original samples collected by 
USDA for confirmation is found to contain confirmable levels of 
nitrosamines, all pumped bacon in the producing establishment and all 
future production will be retained. The Department shall sample and 
analyze such retained pumped bacon for nitrosamines on a lot by lot 
basis. A production lot shall be that pumped bacon produced by the 
establishment in any single shift. Samples from any lot of pumped bacon 
under retention found to contain nitrosamines at a confirmable level 
shall cause the lot of pumped bacon to be disposed of in a manner to 
ensure it will not form nitrosamines when cooked. Such disposal may 
include incorporation of the uncooked pumped bacon as an ingredient of 
another meat provided it is processed for eating without further 
preparation in a manner to preclude the formation of nitrosamines. 
Bacon subsequently produced shall not be retained because of 
nitrosamines if the operator of the establishment makes adjustments in 
the processing of the product and laboratory results obtained by TEA 
analysis of samples from five consecutive normal sized lots of pumped 
bacon indicates that the product being produced contains no confirmable 
levels of nitrosamines. These tests from five consecutive normal sized 
lots of pumped bacon shall be conducted by the Department. However, if 
the establishment furnishes the Department with the results of tests 
conducted under the methodology and procedures used by the Department, 
such test results will be utilized in making the determination 
concerning the nitrosamine content of the product. All tests of pumped 
bacon for nitrosamines under this paragraph (b)(1)(i) shall be made on 
pumped bacon cooked at 340 degrees F. for 3 minutes on each side. In 
order to determine that no confirmable levels of nitrosamines are 
present in a sample tested, the testing must be performed by 
methodology and procedures that would detect the presence of any 
nitrosamines at 10 ppb.
    (ii) Notwithstanding the provisions of paragraph (b)(1)(i) of this 
section, sodium nitrite may be used at:
    (A) 100 ppm ingoing (potassium nitrite at 123 ppm ingoing); and 500 
ppm sodium ascorbate or sodium erythorbate (isoascorbate) shall be 
used, provided the establishment has a partial quality control program 
as provided in Sec. 318.4(d) that results in compliance with this 
provision, or
    (B) A predetermined level between 40 and 80 ppm (potassium nitrite 
at a level between 49 and 99 ppm); 550 ppm sodium ascorbate or sodium 
erythorbate (isoascorbate); and additional sucrose or other similar 
fermentable carbohydrate at a minimum of 0.7 percent and an inoculum of 
lactic acid producing bacteria such as Pediococcus acetolactii or other 
bacteria demonstrated to be equally effective in preventing the growth 
of botulinum toxin at a level sufficient for the purpose of preventing 
the growth of botulinum toxin, provided the establishment has a partial 
quality control program as provided in Sec. 318.4(d) that results in 
compliance with this provision.
    (C) The Department shall collect samples of bacon from 
establishments producing under paragraph (b)(1)(ii) of this section and 
analyze them for the level of nitrosamines. Samples shall be randomly 
selected throughout the production of a lot. The actual sampling plans 
and methods of analysis that are used will result in approximately the 
same likelihood as under paragraph (b)(1)(i) of this section of having 
a presumptive positive result when the true mean level of nitrosamines 
in a production lot is 10 ppb. In the event of a presumptive positive 
result, the establishment shall become subject to the provisions of 
paragraph (b)(1)(i) of this section.
    (2) Immersion cured bacon. Immersion cured bacon may be placed in a 
brine solution containing salt, nitrite and flavoring material or in a 
container with salt, nitrite and flavoring material. Sodium nitrite 
shall not exceed 120 ppm ingoing or an equivalent amount of potassium 
nitrite (148 ppm ingoing) based on the actual or estimated skin-free 
green weight of the bacon bellies.
    (3) Bacon made with dry curing materials. With respect to bacon 
made with dry curing materials, the product shall be cured by applying 
a premeasured amount of cure mixture to the bacon belly surfaces, 
completely covering the surfaces. Sodium nitrite shall not exceed 200 
ppm ingoing or an equivalent amount of potassium nitrite (246 ppm 
ingoing) in dry cured bacon based on the actual or estimated skin-free 
green weight of the bacon belly.


Sec. 424.23  Prohibited uses.

    (a) Substances that conceal damage or inferiority or make products 
appear better or of greater value. No substance may be used in or on 
any meat if it conceals damage or inferiority or makes the product 
appear to be better or of greater value than it is. Therefore:
    (1) Paprika or oleoresin paprika may not be used in or on fresh 
meat, such as steaks, or comminuted fresh meat, such as chopped and 
formed steaks or patties; or in any other meat consisting of fresh meat 
(with or without seasoning).
    (2) Paprika or oleoresin paprika may be used in or on chorizo 
sausage and other meat in which paprika or oleoresin paprika is 
permitted as an ingredient in a standard of identity or composition in 
part 319 of this subchapter.
    (3) Sorbic acid, calcium sorbate, sodium sorbate, and other salts 
of sorbic acid shall not be used in cooked sausages or any other meat; 
sulfurous acid and salts of sulfurous acid shall not be used in or on 
any meat; and niacin

[[Page 72194]]

or nicotinamide shall not be used in or on fresh meat 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 9 CFR 
Chapter III.
    (b) Nitrates. Nitrates shall not be used in curing bacon.

    Done at Washington, DC, on December 13, 1999.
Thomas J. Billy,
Administrator.
[FR Doc. 99-32659 Filed 12-22-99; 8:45 am]
BILLING CODE 3410-DM-P