[Federal Register: January 20, 2000 (Volume 65, Number 13)]

[Rules and Regulations]               

[Page 3121-3123]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr20ja00-1]                         





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Rules and Regulations

                                                Federal Register

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[[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) * * *



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

       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.



*                  *                  *                  *                  *                  *

                                                        *

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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]

BILLING CODE 3410-DM-P