[Federal Register Volume 60, Number 204 (Monday, October 23, 1995)]
[Rules and Regulations]
[Pages 54295-54296]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26139]



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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service

9 CFR Part 318

[Docket No. 95-035F]
RIN 0583-AB96


Potassium Hydroxide as a Hog Scald Agent

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 inspection regulations to permit the use of potassium 
hydroxide in hog scald and hair removal processes. Hog scald and hair 
removal agents are used by meat processors to dehair hog carcasses. 
This regulation makes available to meat processors an additional, 
alternative hog scald formulation containing potassium hydroxide as an 
ingredient. Hog scald agents formulated with potassium hydroxide are as 
effective as other existing hog scald agents; however, because 
potassium hydroxide is quickly solubilized when added to water, its 
presence in a hog scald agent makes the agent easier to mix. Therefore, 
the potassium hydroxide-containing hog scald agent formula can be 
prepared and applied to hog carcasses more quickly than other similar 
hog scald agents.
    We expect no adverse public reaction resulting from this change in 
regulatory language. Therefore, unless adverse or critical comments are 
received 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the final rulemaking notice will be withdrawn and a proposed rulemaking 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.

DATES: This action will become effective December 22, 1995, unless 
adverse or critical comments are received within 30 days of 
publication.

ADDRESSES: Send an original and two copies of written comments to: FSIS 
Docket Clerk, DOCKET #95-035F, Room 4325, South Agriculture Building, 
Food Safety and Inspection Service, U.S. Department of Agriculture, 
Washington, DC 20250.

FOR FURTHER INFORMATION CONTACT: Dr. William James, Director, Slaughter 
Inspection Standards and Procedures Division, Science and Technology, 
Food Safety and Inspection Service, U.S. Department of Agriculture, 
Washington, DC 20250-3700, (202) 720-3219.

SUPPLEMENTARY INFORMATION:

Background

    Under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), FSIS 
provides mandatory inspection of meat and meat food products prepared 
for distribution in commerce. The Act prohibits the addition of any 
substance to any meat or meat food product that may render the product 
adulterated (21 U.S.C. 601). Section 318.7(a)(1) of the Federal meat 
inspection regulations (9 CFR 318.7) prohibits the use of any substance 
in the preparation of any product unless its use is approved in section 
318.7(c)(4) of the Federal meat inspection regulations, which is the 
chart of substances acceptable for use in the preparation of products, 
or unless it is approved elsewhere in the regulations or by the 
Administrator, FSIS.
    In 1995, ChemStation, a manufacturer of processing aids and other 
direct food ingredients, petitioned the Food and Drug Administration 
(FDA) and FSIS to approve potassium hydroxide for use as a hog scald 
and hair removal agent. Removal of hair from hog carcasses is a 
necessary step in the preparation of pork and pork products for use as 
human food. We reviewed the data and other information submitted by the 
petitioner and determined that the proposed use of potassium hydroxide 
did not result in product adulteration or misbranding. 

[[Page 54296]]

    FDA lists potassium hydroxide as generally recognized as safe when 
used in accordance with good manufacturing practice conditions of use 
(21 CFR 184.1631). In a May 2, 1995, letter to the petitioner, FDA 
reported this fact and stated that it ``does not object to the use of 
potassium hydroxide as an ingredient in hog scald agents consistent 
with good manufacturing practice conditions.'' 1

    \1\ A copy of this letter is available for review in the office 
of the FSIS Docket Clerk, U.S. Department of Agriculture, Food 
Safety and Inspection Service, Room 4352, South Agriculture 
Building, Washington, DC 20250-3700.
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    Therefore, we are amending section 318.7(c)(4) of the Federal meat 
inspection regulations to permit the use of potassium hydroxide as a 
hog scald and hair removal agent.

Executive Order 12866

    This final rule has been determined to be not significant and, 
therefore, has not been reviewed by OMB.

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 Federal Meat Inspection Act and the Poultry Products 
Inspection Act (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 the 
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 381.35 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 the PPIA.

Effect on Small Entities

    The Administrator has determined that this direct final rule will 
not have a significant impact on a substantial number of small 
entities, as defined by the Regulatory Flexibility Act (5 U.S.C. 601). 
Removal of hair from hog carcasses is a necessary step in the 
preparation of pork and pork products for use as human food. This 
regulation makes available to meat processors an additional, 
alternative hog scald formulation containing potassium hydroxide as an 
ingredient. Hog scald agents formulated with potassium hydroxide are as 
effective as other existing hog scald agents; however, because 
potassium hydroxide is quickly solubilized when added to water, its 
presence in a hog scald agent makes the agent easier to mix. Therefore, 
the potassium hydroxide-containing hog scald agent formula can be 
prepared and applied to hog carcasses more quickly than other similar 
hog scald agents.

List of Subjects in 9 CFR Part 318

    Food additives, Meat inspection.

    For the reasons set out in the preamble, 9 CFR part 318 is amended 
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. 450, 1901-1906; 21 U.S.C.601-695; 7 CFR 
2.17, 2.55.

    2. Section 318.7(c)(4) is amended by adding to the chart of 
substances, under the Class of Substance ``Hog scald agents; must be 
removed by subsequent cleaning operations.,'' the substance potassium 
hydroxide in alphabetical order as follows:


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

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

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        Class of substance               Substance            Purpose            Products            Amount     
----------------------------------------------------------------------------------------------------------------
                                                                                                                
*                  *                  *                  *                  *                  *                
                                                        *                                                       
Hog Scald Agents; Must be removed  Potassium Hydroxide.  ......do.........  ......do.........  Do.              
 by subsequent cleaning                                                                                         
 operations.                                                                                                    
                                                                                                                
                                                                                                                
*                  *                  *                  *                  *                  *                
                                                        *                                                       
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    Done at Washington, DC, on October 17, 1995.
Michael R. Taylor,
Acting Under Secretary for Food Safety.
[FR Doc. 95-26139 Filed 10-20-95; 8:45 am]
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