[Federal Register Volume 61, Number 80 (Wednesday, April 24, 1996)]
[Rules and Regulations]
[Pages 18047-18049]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9980]



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 Rules and Regulations
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  Federal Register / Vol. 61, No. 80 / Wednesday, April 24, 1996 / 
Rules and Regulations  

[[Page 18047]]



DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 318 and 381

[Docket No. 95-001DF]
RIN 0583-AB97


Use of Sodium Citrate Buffered With Citric Acid in Certain Cured 
and Uncured Processed Meat and Poultry Products

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 permit the 
use of a solution of sodium citrate buffered with citric acid in cured 
and uncured processed whole-muscle meat and poultry products. This 
action is being taken in response to a petition requesting use of the 
solution to inhibit the growth of microorganisms, Clostridium botulinum 
in particular, and retain product flavor during storage.

DATES: This rule will be effective on June 24, 1996, unless adverse or 
critical comments are received on or before May 24, 1996. If adverse or 
critical comments are received, FSIS will publish a timely withdrawal 
of the final rule and a new proposed rule.

ADDRESSES: Send an original and two copies of written comments or 
notice of intent to submit adverse comments to: FSIS Docket Clerk, 
DOCKET #95-001DF, Room 4352, South Agriculture Building, 14th and 
Independence Avenue, SW., Food Safety and Inspection Service, U.S. 
Department of Agriculture, Washington, DC 20250-3700. Make oral 
comments, as provided for under the Poultry Products Inspection Act 
(PPIA), to Mr. Charles R. Edwards, (202) 254-2565, after prior 
arrangements have been made with his office. Data submitted by the 
petitioner and all comments received, including FSIS-prepared copies of 
oral comments, will be available for public inspection from 8:30 a.m. 
to 1:00 p.m., and from 2:00 p.m. to 4:30 p.m., Monday through Friday, 
Room 4352, in Room 4352, South Agriculture Building.

FOR FURTHER INFORMATION CONTACT: Charles R. Edwards, Director, Product 
Assessment Division, Regulatory Programs, Food Safety and Inspection 
Service, U.S. Department of Agriculture, Washington, DC 20250-3700, 
(202) 254-2565.

SUPPLEMENTARY INFORMATION: The Federal Meat Inspection Act (FMIA) (21 
U.S.C. 601 et seq.) and the PPIA (21 U.S.C. 451 et seq.) prohibit 
addition of any substance to meat or poultry food products that may 
render the products adulterated. Federal meat and poultry inspection 
regulations prohibit the use of any substance in the preparation of any 
product unless it is approved in the tables of approved substances in 9 
CFR 318.7(c)(4) and 381.147(f)(4).
    FSIS was petitioned to approve the use of sodium citrate buffered 
with citric acid in cured and uncured whole-muscle processed meat and 
poultry products to inhibit the growth of microorganisms, Clostridium 
botulinum in particular, and to retain product flavor during storage. 
The petitioner requested that FSIS amend the regulations to permit 
sodium citrate buffered with citric acid to a pH of 5.6 and used at a 
level of 1.3 percent of the product formulation weight. Data submitted 
by the petitioner showed that after whole-muscle product is immersed in 
a marinade or injected with the solution, microbial growth is inhibited 
and the product's flavor is retained during storage.
    The petitioner provided results of limited microbiological assays 
(total plate count, coliforms) and organoleptic (taste) tests conducted 
on products at least 6 weeks old. The results show that to effectively 
inhibit microbial growth, the sodium citrate must be buffered with 
citric acid to a pH of 5.6. The data, also, showed that proteins are 
destroyed and the product's appearance and texture becomes unacceptable 
to consumers when the buffered sodium citrate solution exceeds 1.3 
percent of the product formulation weight.
    After reviewing the petitioner's technical data, FSIS determined 
that the tables of approved substances in the meat and poultry 
regulations should be amended to allow the use of sodium citrate 
buffered with citric acid for the purposes and in the amounts requested 
by the petitioner. The technical data demonstrate the efficacy of 
buffered sodium citrate for these uses. Because sodium citrate and 
citric acid are generally recognized as safe (21 CFR 184.1033 and 21 
CFR 184.1751) when used in accordance with good manufacturing 
practices, the wholesomeness of the product will not be affected. 
Therefore, FSIS is amending the tables of approved substances in 9 CFR 
318.7(c)(4) and 381.147(f)(4) to allow the use of sodium citrate 
buffered with citric acid to a ph of 5.6 in cured and uncured processed 
whole-muscle meat and poultry products at a level not to exceed 1.3 
percent of the formulation weight of the product.
    FSIS expects no adverse public reaction resulting from this change 
in regulatory language. Therefore, unless the Agency receives adverse 
or critical comments, or a notice of intent to submit adverse comments 
within 30 days, the action will become final 60 days after publication 
in the Federal Register. If critical comments are received, the final 
rulemaking notice will be withdrawn and a proposed rulemaking notice 
will be published. The proposed rulemaking notice will establish a 
comment period.

Executive Order 12866 and Regulatory Flexibility Act

    This final rule has been determined to be not significant and, 
therefore, has not been reviewed by the Office of Management and 
Budget.
    The Administrator has made an initial determination 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). The direct final rule will permit the 
use of an additional, alternative means of inhibiting the growth of 
microorganisms. Use of the buffered sodium citrate solution is 
voluntary. Small manufacturers opting to use the solution will be 
required to revise their product labels. Decisions by individual 
manufacturers on whether to use sodium citrate buffered with citric 
acid

[[Page 18048]]

in this manner would be based on their conclusions that the benefits 
outweigh the implementation costs.

Executive Order 12778

    This direct final rule has been reviewed under Executive Order 
12778, Civil Justice Reform. States and local jurisdictions are 
preempted by the FMIA and PPIA from imposing any marking or packaging 
requirements on federally inspected meat and poultry products that are 
in addition to, or different than, those imposed under the FMIA or 
PPIA. States and local jurisdictions may, however, exercise concurrent 
jurisdiction over meat and poultry products that are outside official 
establishments for the purpose of preventing the distribution of meat 
and poultry products that are misbranded or adulterated under the FMIA 
or PPIA, or, in the case of imported articles, which are not at such an 
establishment, after their entry into the United States.
    This direct final rule is not intended to have retroactive effect.
    There are no applicable administrative procedures that must be 
exhausted prior to any judicial challenge to the provisions of this 
direct final rule. However, the administrative procedures specified in 
9 CFR Secs. 306.5 and 9 CFR 381.35, and 7 CFR Sec. 59.310 must be 
exhausted prior to any judicial challenge of the application of the 
provisions of this direct final rule, if the challenge involves any 
decision of an FSIS employee relating to inspection services provided 
under the FMIA, or PPIA.

Paperwork Requirements

    Abstract: FSIS has reviewed the paperwork and recordkeeping 
requirements in this direct final rule. This rule requires 
manufacturers that opt to use sodium citrate buffered with citric acid 
to revise their product labels and submit such labeling to FSIS for 
approval.
    Estimate of Burden: FSIS estimates that it takes 60 minutes to 
design and modify labels in accordance with these regulations. For 
label submissions, FSIS estimates a 15 minute response time to prepare 
the label application form, submit it, along with the label, to FSIS or 
to a label expediter who will deliver the form and label to FSIS.
    Respondents: Meat and poultry product establishments.
    Estimated Number of Respondents: 200.
    Estimated Number of Responses per Respondent: 25.
    Estimated Total Annual Burden on Respondents: 6,250 hours.
    Copies of this information collection assessment can be obtained 
from Lee Puricelli, Paperwork Specialist, Food Safety and Inspection 
Service, USDA, South Agriculture Building, Room 3812, Washington, DC 
20250-3700.
    Comments regarding the need for and usefulness of the requirements, 
the accuracy of FSIS's burden hour estimate, ways to minimize the 
estimated burden, including through the use of automated collection 
techniques or other forms of information collection technology, or any 
other aspect of this collection of information discussion, to Lee 
Puricelli, Paperwork Specialist, see address above, and Desk Officer 
for Agriculture, Office of Information and Regulatory Affairs, Office 
of Management and Budget, Washington, DC 20253.
    Comments are requested by June 24, 1996. To be most effective, 
comments should be sent to OMB within 30 days of the publication date 
of this direct final rule.

List of Subjects

9 CFR Part 318

    Food additives, Meat inspection.

9 CFR Part 381

    Food additives, Poultry inspection.

Final Rule

    For the reasons discussed in the preamble, FSIS is amending 9 CFR 
parts 318 and 381 as follows:

PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND 
PREPARATION OF PRODUCTS

    1. The authority citation for part 318 continues to read as 
follows:

    Authority: 7 U.S.C. 138F; 7 U.S.C. 450, 1901-1906; 21 U.S.C. 
601-695; 7 CFR 2.18, 2.53.

    2. In the chart in Sec. 318.7(c)(4), under the Class of substance 
``Miscellaneous,'' a new entry for the substance ``Sodium citrate 
buffered with citric acid to a pH of 5.6'' is added at the end to read 
as follows:


Sec. 318.7   Approval of substances for use in the preparation of 
products.

* * * * *
    (c) * * *
    (4) * * *

----------------------------------------------------------------------------------------------------------------
     Class of  substance          Substance            Purpose              Products               Amount       
----------------------------------------------------------------------------------------------------------------
                                                                                                                
      *                   *                   *                   *                   *                   *     
                                                           *                                                    
Miscellaneous                                                                                                   
                                                                                                                
      *                   *                   *                   *                   *                   *     
                                                           *                                                    
                               Sodium citrate   To inhibit the        Cured and uncured,    Not to exceed 1.3   
                                buffered with    growth of micro-      processed whole-      percent of the     
                                citric acid to   organisms and         muscle meat food      formulation weight 
                                a pH of 5.6.     retain product        products, e.g., ham.  of the product in  
                                                 flavor during                               accordance with 21 
                                                 storage.                                    CFR 184.1751.      
                                                                                                                
      *                   *                   *                   *                   *                   *     
                                                           *                                                    
----------------------------------------------------------------------------------------------------------------

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

    3. The authority citation for part 381 continues to read as 
follows:

    Authority: 7 U.S.C. 138F; 7 U.S.C. 450; 21 U.S.C. 451-470, 7 CFR 
2.18, 2.53.

    4. In the table in Sec. 381.147(f)(4), under the Class of substance 
``Miscellaneous,'' a new entry for the Substance ``Sodium Citrate 
buffered with citric acid to a pH of 5.6'' is added at the end to read 
as follows:


Sec. 381.147   Restrictions on the use of substances in poultry 
products.

* * * * *
    (f) * * *
    (4) * * *

[[Page 18049]]



----------------------------------------------------------------------------------------------------------------
     Class of  substance          Substance            Purpose              Products               Amount       
----------------------------------------------------------------------------------------------------------------
                                                                                                                
      *                   *                   *                   *                   *                   *     
                                                           *                                                    
Miscellaneous                                                                                                   
                                                                                                                
      *                   *                   *                   *                   *                   *     
                                                           *                                                    
                               Sodium citrate   To inhibit the        Cured and uncured,    Not to exceed 1.3   
                                buffered with    growth of micro-      processed whole-      percent of the     
                                citric acid to   organisms and         muscle poultry food   formulation weight 
                                a pH of 5.6.     retain product        products, e.g.,       of the product in  
                                                 flavor during         chicken breasts.      accordance with 21 
                                                 storage.                                    CFR 184.1751.      
                                                                                                                
      *                   *                   *                   *                   *                   *     
                                                           *                                                    
----------------------------------------------------------------------------------------------------------------

    Done at Washington, DC, on April 17, 1996.
Michael R. Taylor,
Acting Under Secretary for Food Safety.
[FR Doc. 96-9980 Filed 4-23-96; 8:45 am]
BILLING CODE 3410-DM-P