[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]]
_______________________________________________________________________
Part III
Department of Agriculture
_______________________________________________________________________
Food Safety and Inspection Service
_______________________________________________________________________
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
