[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]



 ========================================================================
 Rules and Regulations
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains regulatory documents 
 having general applicability and legal effect, most of which are keyed 
 to and codified in the Code of Federal Regulations, which is published 
 under 50 titles pursuant to 44 U.S.C. 1510.
 
 The Code of Federal Regulations is sold by the Superintendent of Documents. 
 Prices of new books are listed in the first FEDERAL REGISTER issue of each 
 week.
 
 ========================================================================
 

  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.

-----------------------------------------------------------------------

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) * * *

----------------------------------------------------------------------------------------------------------------
       Class of substance              Substance            Purpose            Products             Amount
----------------------------------------------------------------------------------------------------------------
 
*                  *                  *                  *                  *                  *
                                                        *
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.
 
*                  *                  *                  *                  *                  *
                                                        *
----------------------------------------------------------------------------------------------------------------


    Done at Washington, DC, on: December 23, 1999.
Thomas J. Billy,
Administrator.
[FR Doc. 00-1220 Filed 1-19-00; 8:45 am]
BILLING CODE 3410-DM-P