Federal Register / Vol. 61, No. 108 / Tuesday, June 4, 1996 / Rules and Regulations 28051

Substance Limitations

* * * * * * *

Petroleum hydrocarbon resins (cyclopentadiene-type) * * * .............. For use only as an adjuvant at levels not to exceed 30 percent by weight

in blends with: (1) Polypropylene complying with paragraph (c), item 1.1

of this section, or (2) a copolymer of propylene and ethylene containing

not less than 94 weight percent propylene and complying with paragraph

(c), item 3.2 of this section. The average thickness of the food-contact

film is not to exceed 0.1 millimeter (0.004 inch). The finished polymer

may be used in contact with (1) Food types I, II, IV–B, VI–A, VI–B, VII–

B, and VIII identified in Table 1 of § 176.170(c) of this chapter and under

conditions of use C through G described in Table 2 of § 176.170(c) of

this chapter; and (2) food types III, IV–A, V, VI–C, VII–A, and IX identified in Table 1 of § 176.170(c) of this chapter and under conditions of

use D through G described in Table 2 of § 176.170(c) of this chapter.

* * * * * * *

* * * * *

Dated: May 29, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–13983 Filed 6–3–96; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 178

[Docket No. 93F–0136]

Indirect Food Additives: Adjuvants,

Production Aids, and Sanitizers

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

food additive regulations to provide for

the safe use of an aqueous solution of

hydrogen peroxide, acetic acid,

peroxyacetic acid, octanoic acid,

peroxyoctanoic acid, sodium 1-

octanesulfonate, and 1-

hydroxyethylidene-1,1-diphosphonic

acid as a sanitizing solution for use on

food processing equipment and utensils,

including food-contact surfaces in

public eating places. This action

responds to a petition filed by Ecolab,

Inc.

DATES: Effective June 4, 1996; written

objections and requests for a hearing by

July 5, 1996.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Mitchell A. Cheeseman, Center for Food

Safety and Applied Nutrition (HFS–

217), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3083.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

May 17, 1993 (58 FR 28882), FDA

announced that a food additive petition

(FAP 3B4371) had been filed by Ecolab,

Inc., 840 Sibley Memorial Hwy., St.

Paul, MN 55118. The petition proposed

to amend the food additive regulations

in § 178.1010 Sanitizing solutions (21

CFR 178.1010) to provide for the safe

use of an aqueous solution of hydrogen

peroxide, acetic acid, peroxyacetic acid,

octanoic acid, peroxyoctanoic acid,

sodium 1-octanesulfonate, and

hydroxyethylene diphosphonic acid as a

sanitizing solution for use on food

processing equipment and utensils,

including food-contact surfaces in

public eating places.

While the agency used the term

hydroxyethylene diphosphonic acid in

the notice of filing, the agency has

determined that a more specific and

therefore more appropriate name for the

substance is 1-hydroxyethylidene-1,1-

diphosphonic acid. This more specific

name will be used in the remainder of

this document and in the regulation.

I. Safety and Functional Effect of

Petitioned Use of the Additive

Sanitizing solutions are mixtures of

chemicals that function together to

sanitize food-contact surfaces and are

regulated as such. Each listed

component in a sanitizing solution has

a functional effect; however, the agency

evaluates data on the antimicrobial

efficacy of the entire sanitizing solution.

In addition, FDA regulations require

that food-contact surface sanitizing

solutions be labeled in accordance with

the Federal Insecticide, Fungicide, and

Rodenticide Act (§ 178.1010(d)). The

subject sanitizing solution is an aqueous

solution of hydrogen peroxide, acetic

acid, peroxyacetic acid, octanoic acid,

peroxyoctanoic acid, sodium 1-

octanesulfonate, and 1-

hydroxyethylidene-1,1-diphosphonic

acid. The functions of these components

and the basis for FDA’s determination of

the safety of these components in the

subject sanitizing solution are described

below.

A. Hydrogen Peroxide

Hydrogen peroxide functions as an

antimicrobial agent in the subject

sanitizing solution. Hydrogen peroxide

is permitted as an ingredient in

sanitizing solutions under

§ 178.1010(b)(30) and (b)(38), and it is

affirmed as generally recognized as safe

(GRAS) for use in food with specific

limitations under 21 CFR 184.1366. On

the basis of the data submitted in

support of the already-regulated uses of

hydrogen peroxide and the data

contained in the food additive petition

submitted in support of this sanitizing

solution, FDA finds that the use of

hydrogen peroxide in the subject

sanitizing solution is safe (Refs. 1 and

2).

B. Acetic Acid

Acetic acid functions as an acidifier

in the subject sanitizing solution. Acetic

acid is permitted as as ingredient in

sanitizing solutions under

§ 178.1010(b)(30) and (b)(38), and it is

affirmed as GRAS for use in food under

21 CFR 184.1005. On the basis of the

data submitted in support of the

already-regulated uses of acetic acid and

the data contained in the food additive

petition submitted in support of this

sanitizing solution, FDA finds that the

use of acetic acid in the subject

sanitizing solution is safe (Refs. 1 and

2).
28052 Federal Register / Vol. 61, No. 108 / Tuesday, June 4, 1996 / Rules and Regulations

C. Peroxyacetic Acid

Peroxyacetic acid (POA) functions as

an antimicrobial agent in the subject

sanitizing solution. POA is permitted as

an ingredient in sanitizing solutions

under § 178.1010(b)(30) and (b)(38). On

the basis of the data submitted in

support of the already-regulated uses of

POA and the data contained in the food

additive petition submitted in support

of this sanitizing solution, FDA finds

that the use of POA in the subject

sanitizing solution is safe (Refs. 1 and

2).

D. Octanoic Acid

Octanoic acid functions as a synergist

in the subject sanitizing solution.

Octanoic acid is permitted as an

ingredient in sanitizing solutions under

§ 178.1010(b)(27), (b)(35), (b)(36), and

(b)(39), and it is approved for direct use

in food under 21 CFR 172.860 (caprylic

acid). On the basis of the data submitted

in support of the already-regulated uses

of octanoic acid and the data contained

in the food additive petition submitted

in support of this sanitizing solution,

FDA finds that the use of octanoic acid

in the subject sanitizing solution is safe

(Refs. 1 and 2).

E. Peroxyoctanoic Acid

Peroxyoctanoic acid (POOA) is a byproduct of hydrogen peroxide and

octanoic acid. Because of the highly

reactive nature of POOA, the actual

dietary concentration of POOA is likely

to be close to zero. Based on the likely

dietary concentration and information

submitted in the petition, FDA finds

that the use of POOA in the subject

sanitizing solution is safe (Refs. 1 and

2).

F. Sodium 1-Octanesulfonate

Sodium 1-octanesulfonate (SOS)

functions as a surfactant in the subject

sanitizing solution. SOS is permitted as

as ingredient in sanitizing solutions

under § 178.1010(b)(27) and (b)(42). On

the basis of the data submitted in

support of the already-regulated uses of

SOS and the data contained in the food

additive petition submitted in support

of this sanitizing solution, FDA finds

that the use of SOS in the subject

sanitizing solution is safe (Refs. 1 and

2).

G. 1-Hydroxyethylidene-1,1-

Diphosphonic Acid

1-Hydroxyethylidene-1,1-

diphosphonic acid functions as a

stabilizer in the subject sanitizing

solution. 1-Hydroxyethylidene-1,1-

diphosphonic acid is permitted as as

ingredient in sanitizing solutions under

§ 178.1010(b)(30). On the basis of the

data submitted in support of this

regulated use of 1-hydroxyethylidene1,1-diphosphonic acid and the data

contained in the food additive petition

submitted in support of this sanitizing

solution, FDA finds that the use of 1-

hydroxyethylidene-1,1-diphosphonic

acid in the subject sanitizing solution is

safe (Refs. 1 and 2).

H. Conclusion on Safety

As discussed above, FDA has

evaluated data on the antimicrobial

efficacy of the entire sanitizing solution

and data in the petition and other

relevant materials on the safety of each

of the components of the sanitizing

solution. On the basis of this evaluation,

the agency concludes that these data

and materials establish the safety and

efficacy of the additive for use as a

sanitizing solution on food-processing

equipment and utensils, including foodcontact surfaces in public eating places,

and that the regulations should be

amended in § 178.1010 as set forth

below.

In accordance with § 171.1(h) (21 CFR

171.1(h)), the petition and the

documents that FDA considered and

relied upon in reaching its decision to

approve the petition are available for

inspection at the Center for Food Safety

and Applied Nutrition by appointment

with the information contact person

listed above. As provided in 21 CFR

171.1(h), the agency will delete from the

documents any materials that are not

available for public disclosure before

making the documents available for

inspection.

II. Environmental Impact

The agency has carefully considered

the potential environmental effects of

this action. FDA has concluded that the

action will not have a significant impact

on the human environment, and that an

environmental impact statement is not

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

III. References

The following references have been

placed on display in the Dockets

Management Branch (address above)

and may be seen by interested persons

between 9 a.m. and 4 p.m., Monday

through Friday.

1. Memorandum entitled ‘‘Safety Review of

Hydrogen Peroxide, Acetic Acid,

Peroxyacetic Acid, Octanoic Acid,

Peroxyoctanoic Acid, Sodium 1-

Octanesulfonate, and Hydroxyethylidene

Diphosphonic Acid as Sanitizer

Components,’’ dated June 12, 1995.

2. Memorandum entitled ‘‘FAP 3B4371

(MATS #704 M2.1): KX–6094 - Sanitizer

Formulation Consisting of Hydrogen

Peroxide, Octanoic Acid, Peroxyoctanoic

Acid, Sodium 1-Octanesulfonate, and 1-

Hydroxyethylidene-1,1-Diphosphonic Acid.

Klenzade submission of 3/9/93,’’ dated

October 20, 1993.

IV. Filing of Objections

Any person who will be adversely

affected by this regulation may at any

time on or before July 5, 1996, file with

the Dockets Management Branch

(address above) written objections

thereto. Each objection shall be

separately numbered, and each

numbered objection shall specify with

particularity the provisions of the

regulation to which objection is made

and the grounds for the objection. Each

numbered objection on which a hearing

is requested shall specifically so state.

Failure to request a hearing for any

particular objection shall constitute a

waiver of the right to a hearing on that

objection. Each numbered objection for

which a hearing is requested shall

include a detailed description and

analysis of the specific factual

information intended to be presented in

support of the objection in the event

that a hearing is held. Failure to include

such a description and analysis for any

particular objection shall constitute a

waiver of the right to a hearing on the

objection. Three copies of all documents

shall be submitted and shall be

identified with the docket number

found in brackets in the heading of this

document. Any objections received in

response to the regulation may be seen

in the Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday.

List of Subjects in 21 CFR Part 178

Food additives, Food packaging.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Director, Center for Food Safety and

Applied Nutrition, 21 CFR part 178 is

amended as follows:

PART 178—INDIRECT FOOD

ADDITIVES: ADJUVANTS,

PRODUCTION AIDS, AND SANITIZERS

1. The authority citation for 21 CFR

part 178 continues to read as follows:

Authority: Secs. 201, 402, 409, 721 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321, 342, 348, 379e).

2. Section 178.1010 is amended by

adding new paragraphs (b)(45) and

(c)(39) to read as follows:
Federal Register / Vol. 61, No. 108 / Tuesday, June 4, 1996 / Rules and Regulations 28053

§ 178.1010 Sanitizing solutions.

* * * * *

(b) * * *

(45) An aqueous solution of hydrogen

peroxide, acetic acid, peroxyacetic acid,

octanoic acid, peroxyoctanoic acid,

sodium 1-octanesulfonate, and 1-

hydroxyethylidene-1,1-diphosphonic

acid. In addition to use on foodprocessing equipment and utensils, this

solution may be used on food-contact

surfaces in public eating places, subject

to the limitations in paragraph (c)(39) of

this section.

* * * * *

(c) * * *

(39)(i) The solution identified in

paragraph (b)(45) of this section, when

used on food processing equipment and

utensils, including dairy and beverageprocessing equipment but excluding

food-contact surfaces in public eating

places and dairy and beverage

containers, shall provide when ready for

use at least 72 parts per million and not

more than 216 parts per million of

hydrogen peroxide; at least 46 parts per

million and not more than 138 parts per

million of peroxyacetic acid; at least 40

parts per million and not more than 122

parts per million of octanoic acid

(including peroxyoctanoic acid); at least

281 parts per million and not more than

686 parts per million of acetic acid; at

least 7 parts per million and not more

than 34 parts per million of 1-

hydroxyethylidene-1,1-diphosphonic

acid; and at least 36 parts per million

and not more than 109 parts per million

of sodium 1-octanesulfonate.

(ii) The solution identified in

paragraph (b)(45) of this section, when

used on food-contact equipment and

utensils in warewashing machines,

including warewashing machines in

public eating places, at temperatures no

less than 120 °F (49 °C) shall provide

when ready for use at least 30 parts per

million and not more than 91 parts per

million of hydrogen peroxide; at least 19

parts per million and not more than 58

parts per million of peroxyacetic acid; at

least 17 parts per million and not more

than 52 parts per million of octanoic

acid (including peroxyoctanoic acid); at

least 119 parts per million and not more

than 290 parts per million of acetic acid;

at least 3 parts per million and not more

than 14 parts per million of 1-

hydroxyethylidene-1,1-diphosphonic

acid; and at least 15 parts per million

and not more than 46 parts per million

of sodium 1-octanesulfonate.

(iii) The solution identified in

paragraph (b)(45) of this section, when

used on dairy or beverage containers,

shall provide when ready for use at least

36 parts per million and not more than

108 parts per million of hydrogen

peroxide; at least 23 parts per million

and not more than 69 parts per million

of peroxyacetic acid; at least 20 parts

per million and not more than 61 parts

per million of octanoic acid (including

peroxyoctanoic acid); at least 140 parts

per million and not more than 343 parts

per million of acetic acid; at least 3 parts

per million and not more than 17 parts

per million of 1-hydroxyethylidene-1,1-

diphosphonic acid; and at least 18 parts

per million and not more than 55 parts

per million of sodium 1-

octanesulfonate.

* * * * *

Dated: May 24, 1996.

Fred R. Shank,

Director, Center for Food Safety and Applied

Nutrition.

[FR Doc. 96–13982 Filed 6–3–96; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Parts 40 and 48

[TD 8659]

RIN 1545–AR92

Gasoline and Diesel Fuel Excise Tax;

Registration Requirements; Correction

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Correction to final regulations.

SUMMARY: This document contains

corrections to final regulations [TD

8659] which were published in the

Federal Register for Thursday, March

14, 1996 (61 FR 10450). The final

regulations relate to the taxes on

gasoline and diesel fuel reflecting and

implementing certain changes made by

the Omnibus Budget Reconciliation Act

of 1993.

EFFECTIVE DATE: March 14, 1996.

FOR FURTHER INFORMATION CONTACT:

Frank Boland (202) 622–3130 (not a tollfree number).

SUPPLEMENTARY INFORMATION:

Background

The final regulations that are subject

to these corrections are under sections

4081 and 4101 of the Internal Revenue

Code.

Need for Correction

As published, [TD 8659] contains

errors that are in need of clarification.

Correction of Publication

Accordingly, the publication of final

regulations which are the subject of FR

Doc. 96–5586 is corrected as follows:

§ 48.4101–1 [Corrected]

On page 10460, column 2, paragraph

(f)(3)(ii)(D), lines 4 and 5 are corrected

by merging the two lines to read

‘‘paragraph (j) of this section, without

regard to’’.

Cynthia E. Grigsby,

Chief, Regulations Unit, Assistant Chief

Counsel (Corporate).

[FR Doc. 96–13721 Filed 6–3–96; 8:45 am]

BILLING CODE 4830–01–P

DEPARTMENT OF LABOR

Occupational Safety and Health

Administration

29 CFR Part 1952

[Docket No. T–015A]

North Carolina State Plan: Approval of

Revised Compliance Staffing

Benchmarks

AGENCY: Department of Labor,

Occupational Safety and Health

Administration (OSHA).

ACTION: Approval of revised State

compliance staffing benchmarks.

SUMMARY: This document amends

Subpart I of 29 CFR 1952 to reflect the

Assistant Secretary’s decision to

approve revised compliance staffing

benchmarks of 64 safety inspectors and

50 industrial hygienists for the North

Carolina State plan.

EFFECTIVE DATE: June 4, 1996.

FOR FURTHER INFORMATION CONTACT:

Anne Cyr, Acting Director, Office of

Information and Consumer Affairs,

Occupational Safety and Health

Administration, U.S. Department of

Labor, Room N–3637, 200 Constitution

Avenue, N.W., Washington, D.C. 20210,

(202) 219–8148.

SUPPLEMENTARY INFORMATION:

Background

Section 18 of the Occupational Safety

and Health Act of 1970 (‘‘the Act,’’ 29

U.S.C. 651 et seq.) provides that States

which desire to assume responsibility

for developing and enforcing

occupational safety and health

standards may do so by submitting, and

obtaining Federal approval of, a State

plan. Section 18(c) of the Act sets forth

the statutory criteria for plan approval,

and among these criteria is the

requirement that the State’s plan

provide satisfactory assurances that the