[Federal Register Volume 65, Number 13 (Thursday, January 20, 2000)]
[Rules and Regulations]
[Pages 3121-3123]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-1220]
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Rules and Regulations
Federal Register
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Federal Register / Vol. 65, No. 13 / Thursday, January 20, 2000 /
Rules and Regulations
[[Page 3121]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Part 424
[Docket No. 99-028DF]
Food Additives for Use in Meat and Poultry Products: Sodium
Diacetate, Sodium Acetate, Sodium Lactate and Potassium Lactate
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Direct 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 increase
permissible levels of sodium acetate as a flavor enhancer in meat and
poultry products and of sodium diacetate as a flavor enhancer and as an
inhibitor of the growth of certain pathogens. FSIS is also permitting
the use of sodium lactate and potassium lactate in meat and poultry
products, except for infant formulas and infant food, for purposes of
inhibiting the growth of certain pathogens. FSIS is proceeding with
this direct final rule in response to petitions submitted by Armour
Swift-Ekrich and Purac America, Inc.
DATES: This rule will be effective March 20, 2000 unless FSIS receives
written adverse comments within the scope of this rulemaking or written
notice of intent to submit adverse comments within the scope of this
rulemaking on or before February 22, 2000.
ADDRESSES: Submit adverse comments or notice of intent to submit
adverse comments within the scope of this rulemaking to: FSIS Docket
Clerk, Docket #99-028DF, Department of Agriculture, Food Safety and
Inspection Service, Cotton Annex, Room 102, 300 12th Street, SW,
Washington, DC 20250-3700. Any written comments submitted in response
to this direct final rule and reference materials will be available for
public inspection in the FSIS Docket Room from 8:30 a.m. to 4:30 p.m.,
Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Robert Post, Director, 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:
Background
FSIS was petitioned by Armour Swift-Ekrich to amend the Federal
meat and poultry products inspection regulations to increase the amount
of sodium diacetate and sodium acetate that may be added to meat and
poultry products to levels up to 0.25 percent by weight of total
formulation. The reason for the requested increase was for the purpose
of inhibiting the growth of microorganisms, specifically Lm. The
petitioner also requested that the Agency expand the approval to
include potassium acetate and potassium diacetate.
The petitioner submitted data with the petition that it had
gathered over ten years from experiments in its laboratories. FSIS
determined that the data demonstrate that increasing the currently
approved level of sodium diacetate to 0.25 percent effectively inhibits
the growth of Lm in meat and poultry products. However, there was
insufficient data submitted with the petition to allow an increase in
the amount of sodium acetate to be used as an anti-microbial agent in
meat and poultry products. Also, the Food and Drug Administration (FDA)
has only approved sodium diacetate to be used as an anti-microbial in
accordance with 21 CFR 184.1754. Therefore, FSIS is only approving
sodium diacetate at a level up to .25 percent for anti-microbial use in
meat and poultry products.
In a June 9, 1995, letter to the petitioner, FDA stated that it had
no objection to sodium acetate and sodium diacetate to be used at
levels up to .25 percent as flavoring agents. Therefore, to reflect
FDA's action, FSIS will permit the use of sodium acetate and sodium
diacetate to a level of up to .25 percent as flavoring agents in meat
and poultry products.
FDA has not established a use level for potassium acetate or
potassium diacetate as either flavoring agents or anti-microbials. Nor
did the petitioner supply any data supporting the request for potassium
acetate or potassium diacetate. Consequently, the Agency cannot permit
the use of potassium acetate or potassium diacetate in meat and poultry
products at this time.
FSIS also received a petition from Purac America, Inc. The petition
requested that FSIS amend the Federal meat and poultry products
inspection regulations to permit the use of sodium lactate and
potassium lactate in fully cooked meat, meat food products, poultry,
and poultry food products, except for infant foods and formulas, at
levels up to 4.8 percent of total product formulation to inhibit the
growth of certain pathogens such as Lm and C. botulinum.
FSIS found that adequate information exists to accept the use of
sodium lactate and potassium lactate, singly or in combination, in all
fully cooked meat and poultry food products at a level up to 4.8
percent by weight of total formulation for purposes of inhibiting the
growth of certain pathogens. FDA has listed sodium lactate and
potassium lactate for use with no limitations as long as they are used
under good manufacturing practice as defined in 21 CFR 184.1(b). Both
are currently approved by FSIS at levels up to 2 percent of total
product formulation for use as flavors and flavor enhancers. FSIS will
permit the use of sodium lactate and potassium lactate at a level of
4.8 percent in meat and poultry products to inhibit the growth of
certain pathogens.
Because the use of these substances would change a product's
formulation, FSIS expects that establishments choosing to use any of
these substances will reassess their HACCP plans for the products in
which the substances will be used. Such a reassessment is specified in
9 CFR 417.4(a)(3). Accordingly, FSIS expects that establishments using
sodium diacetate, sodium lactate, or potassium lactate to inhibit the
growth of pathogens will modify their HACCP plans to establish the use
of the substance as a critical control point (CCP) or to incorporate
the use into an existing CCP. Also, establishments that use sodium
acetate, sodium diacetate, sodium lactate, or
[[Page 3122]]
potassium lactate in their products will need to revise the product's
label as specified in part 317 or 318, subpart N.
The use of these substances at the levels that are being provided
for by FSIS is not controversial, and FSIS expects no adverse comment
to result from the changes that it is making. Therefore, unless the
Agency receives written adverse comments within the scope of this
rulemaking, or a written notice of intent to submit adverse comments
within the scope of the rulemaking, within 30 days, the action will
become final 60 days after publication in the Federal Register. If
written adverse comments within the scope of the rulemaking are
received, the final rulemaking notice will be withdrawn, and the Agency
will publish a proposed rulemaking notice that includes a comment
period.
Executive Order 12988
This direct final rule has been reviewed under Executive Order
12988, Civil Justice Reform. This direct final rule: (1) Preempts all
state and local laws and regulations that are inconsistent with this
rule; (2) has no retroactive effect; and (3) does not require
administrative proceedings before parties may file suit in court
challenging this rule.
Executive Order 12866 and Regulatory Flexibility Act
This direct final rule has been determined to be not significant
and, therefore, has not been reviewed by OMB.
Effect on Small Entities
This direct final rule will permit the use of sodium acetate as a
flavor enhancer, sodium diacetate as a flavor enhancer and anti-
microbial, and sodium lactate and potassium lactate as anti-microbials
in meat and poultry products.
The use of these ingredients is voluntary. FSIS does not believe
that any costs involved with HACCP plan reassessments or modifications,
or changes to labels, will be significant. The decision by individual
establishments to use any of these ingredients will be based on their
conclusions that the benefits outweigh the implementation costs.
The Administrator, FSIS, has determined that this direct final rule
will not have a significant economic impact on a substantial number of
small entities, as defined by the Regulatory Flexibility Act (5 U.S.C.
601).
Additional Public Notification
Public awareness of 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
direct final rule, FSIS will announce it and provide copies of this
Federal Register publication 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
Abstract: FSIS has reviewed the paperwork and recordkeeping
requirements in this direct final rule in accordance with the Paperwork
Reduction Act and submitted an information collection request to the
Office of Management and Budget for emergency clearance. Establishments
that choose to use any of the substances approved by this direct final
rule will have to make changes to their product labels. Also, because
establishments using the substances will change their products'
formulations, they will have to reassess their HACCP plans that cover
production of the products, as specified in 417.4(a)(3). FSIS expects
that most establishments using the substances approved for
antimicrobials will most likely establish the use of the substance as a
critical control point (CCP) or incorporate its use into an existing
CCP.
Estimate of Burden: FSIS estimates that it will take 1 hour for
establishments to develop any new product labels. Establishments will
only need to make the label changes once. The Agency estimates that it
will take 1 hour for establishments to reassess their HACCP plans. For
purposes of this paperwork analysis, FSIS assumes that all of the
establishments it has estimated to use the substances will make changes
to one HACCP plan one time. The Agency estimates that an establishment
will spend about 5 minutes a day (250 days) completing 1 monitoring
record and 2 minutes a day filing the record for one HACCP plan.
Respondents: Meat and Poultry product establishments.
Estimated Number of Respondents: 1,000.
Estimated Number of Responses per Respondent: 1 for label changes,
1 for HACCP reassessment; 250 for monitoring records, and 250 for
filing the record.
Estimated Total Annual Burden on Respondents: 31,166.
Copies of this information collection assessment can be obtained
from Lee Puricelli, Paperwork Specialist, Food Safety and Inspection
Service, USDA, Room 109 Cotton Annex, Washington, DC 20250-3700.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Agency, including whether the information will have practical
utility; (b) the accuracy of the Agency's estimate of the burden of the
proposed collection of information including the validity of the method
and the assumptions used; (c) ways to enhance the quality, utility, and
clarity of the information to be collected; (d) ways to minimize the
burden of the collection of information on those who are to respond;
including through use of appropriate automated, electronic, mechanical,
or other technological collection techniques or other forms of
information technology. Comments may be sent to Lee Puricelli, see the
address above, and to the Desk Officer for Agriculture, Office of
Information and Regulatory Affairs, Office of Management and Budget
(OMB) Washington, DC 20253.
List of Subjects in 9 CFR Part 424
Food additives, Food packaging, Meat inspection, Poultry and
poultry products.
For the reasons discussed in the preamble, FSIS is amending 9 CFR
part 424 of the Federal meat and poultry products inspection
regulations as follows:
PART 424--PREPARATION AND PROCESSING OPERATIONS
1. The authority citation for part 424 continues to read as
follows:
Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 451-470; 601-695;
7 CFR 2.18, 2.53.
[[Page 3123]]
2. Section 424.21 is amended in the chart in paragraph (c) by
adding in alphabetical order new entries for ``potassium lactate,''
``sodium diacetate,'' and ``sodium lactate'' under the class
``Antimicrobial agents'' and by revising the entries for ``sodium
acetate'' and ``sodium diacetate'' under the class ``Flavoring agents''
to read as follows:
Sec. 424.21 Use of food ingredients and sources of radiation.
* * * * *
(c) * * *
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Class of substance Substance Purpose Products Amount
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* * * * * *
*
Antimicrobial Agents............ Potassium lactate. To inhibit Various meat and 4.8% by weight of
microbial growth. poultry products, total
except infant formulation.
formulas and
infant food.
Sodium diacetate.. ......do.......... ......do.......... 0.25% by weight of
total
formulation.
Sodium lactate.... ......do.......... ......do.......... 4.8% by weight of
total
formulation.
* * * * * *
*
Flavoring agents; Protectors and Sodium acetate.... To flavor products Various meat and Not to exceed
Developers. poultry products. 0.25% of
formulate in
accordance with
21 CFR 184.1721.
Sodium diacetate.. ......do.......... ......do.......... Not to exceed
0.25% of
formulate in
accordance with
21 CFR 184.1754.
* * * * * *
*
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Done at Washington, DC, on: December 23, 1999.
Thomas J. Billy,
Administrator.
[FR Doc. 00-1220 Filed 1-19-00; 8:45 am]
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