Potassium Hydroxide as a Hog Scald Agent

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the final rulemaking notice will be withdrawn and a proposed rulemaking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

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* * * * * *

*

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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