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

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

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