Federal Register / Vol. 60, No. 71 / Thursday, April 13, 1995 / Rules and Regulations 18739

stabilized color additive mixture. Color

additive mixtures for fish feed use made

with astaxanthin may contain only

those diluents that are suitable and are

listed in this subpart as safe for use in

color additive mixtures for coloring

foods.

(b) Specifications. Astaxanthin shall

conform to the following specifications

and shall be free from impurities other

than those named to the extent that such

impurities may be avoided by good

manufacturing practice:

Physical state, solid.

0.05 percent solution in chloroform,

complete and clear.

Absorption maximum wavelength 484–493

nanometers (in chloroform).

Residue on ignition, not more than 0.1

percent.

Total carotenoids other than astaxanthin, not

more than 4 percent.

Lead, not more than 5 parts per million.

Arsenic, not more than 2 parts per million.

Mercury, not more than 1 part per million.

Heavy metals, not more than 10 parts per

million.

Assay, minimum 96 percent.

(c) Uses and restrictions. Astaxanthin

may be safely used in the feed of

salmonid fish in accordance with the

following prescribed conditions:

(1) The color additive is used to

enhance the pink to orange-red color of

the flesh of salmonid fish.

(2) The quantity of color additive in

feed is such that the color additive shall

not exceed 80 milligrams per kilogram

(72 grams per ton) of finished feed.

(d) Labeling requirements. (1) The

labeling of the color additive and any

premixes prepared therefrom shall bear

expiration dates for the sealed and open

container (established through generally

accepted stability testing methods),

other information required by § 70.25 of

this chapter, and adequate directions to

prepare a final product complying with

the limitations prescribed in paragraph

(c) of this section.

(2) The presence of the color additive

in finished fish feed prepared according

to paragraph (c) of this section shall be

declared in accordance with § 501.4 of

this chapter.

(3) The presence of the color additive

in salmonid fish that have been fed

feeds containing astaxanthin shall be

declared in accordance with

§§ 101.22(k)(2) and 101.100(a)(2) of this

chapter.

(e) Exemption from certification.

Certification of this color additive is not

necessary for the protection of the

public health, and therefore batches

thereof are exempt from the certification

requirements of section 721(c) of the act.

Dated: April 10, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–9178 Filed 4–12–95; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 178

[Docket No. 91F–0465]

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

citric acid, disodium

ethylenediaminetetraacetate (disodium

EDTA), sodium lauryl sulfate (SLS), and

monosodium phosphate as a sanitizing

solution to be used on food-processing

equipment and utensils, including

dairy-processing equipment. This action

responds to a petition filed by Gycor

International, Ltd.

DATES: Effective April 13, 1995; written

objections and requests for a hearing by

May 15, 1995.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Mitchell A. Cheeseman, Center for Food

Safety and Applied Nutrition (HFS–

216), 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

January 3, 1992 (57 FR 291), FDA

announced that a food additive petition

(FAP 2B4301) had been filed by Gycor

International Ltd., c/o Hogan & Hartson,

555 13th St. NW., Washington, DC

20004. The petition proposed that the

food additive regulations be amended in

§ 178.1010 Sanitizing solutions (21 CFR

178.1010) to provide for the safe use of

of citric acid, disodium EDTA, SLS, and

monosodium phosphate as components

of a sanitizing solution intended for

general use on food-contact surfaces.

The petitioner subsequently amended

the petition to limit use of the sanitizer

on only food-processing equipment and

utensils, including dairy processing

equipment.

I. Safety and Functional Effect of

Petitioned Use of the Additives

Sanitizing solutions are regulated as

mixtures of chemicals that function

together to sanitize food-contact

surfaces. Each listed component in a

sanitizing solution has a functional

effect, and the agency evaluates the data

submitted in support of the efficacy of

the entire sanitizing solution. In

addition, FDA regulations permit the

addition to a sanitizing solution of any

substance that is generally recognized as

safe (GRAS) for use in food

(§ 178.1010(b)). The subject sanitizing

solution is an aqueous solution of citric

acid, disodium EDTA, SLS, and

monosodium phosphate. The function

of these components and the basis for

FDA’s determination of the safety of

these components in the subject

sanitizer are described below.

A. Citric Acid

Citric acid functions as an

antimicrobial agent in the subject

sanitizing solution. Citric acid is listed

as GRAS for use in human food under

21 CFR 182.1033. FDA regulations

permit the addition to a sanitizing

solution of any substance that is GRAS

for use in food. On the basis of the data

submitted in support of the alreadyregulated uses of citric acid, and the

data contained in the food additive

petition submitted in support of this

sanitizing solution, FDA finds that the

use of citric acid in the subject

sanitizing solution is safe (Ref. 1).

B. Disodium

Ethylenediaminetetraacetate

Disodium EDTA functions as a

chelator in the subject sanitizing

solution. Disodium EDTA is regulated

as a direct food additive under 21 CFR

172.135. On the basis of the data

submitted in support of the alreadyregulated uses of disodium EDTA and

the data contained in the food additive

petition submitted in support of this

sanitizing solution, FDA finds that the

use of disodium EDTA in the subject

sanitizing solution is safe (Ref. 1).

C. Sodium Lauryl Sulfate

SLS functions as a surfactant in the

subject sanitizing solution. SLS is

present in regulated sanitizing solutions

under § 178.1010(b)(3), (b)(10), and

(b)(37). On the basis of the data

submitted in support of the alreadyregulated uses of SLS and the data

contained in the food additive petition

submitted in support of this sanitizing

solution, FDA finds that the use of SLS

in the subject sanitizing solution is safe

(Ref. 1).
18740 Federal Register / Vol. 60, No. 71 / Thursday, April 13, 1995 / Rules and Regulations

D. Monosodium Phosphate

Monosodium phosphate functions as

a buffer in the subject sanitizing

solution. Monosodium phosphate is

listed as GRAS for use in human food

under 21 CFR 182.1778. FDA

regulations permit the addition to a

sanitizing solution of any substance that

is GRAS for use in food. On the basis

of the data submitted in support of the

already-regulated uses of monosodium

phosphate and the data contained in the

food additive petition submitted in

support of this sanitizing solution, FDA

finds that the use of monosodium

phosphate in the subject sanitizing

solution is safe (Ref. 1).

E. Conclusion on Safety

As discussed above, FDA has

evaluated the data in the petition and

other relevant materials. On the basis of

this evaluation, the agency concludes

that these data and materials establish

the use of the additive as a sanitizing

solution on food-processing equipment

and utensils and on dairy-processing

equipment is safe and that it will have

its intended technical effect. Therefore,

FDA is amending its regulations 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. Reference

The following reference has 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 ‘‘Toxicological

Evaluation of Citric Acid, Disodium EDTA,

Sodium Lauryl Sulfate, and Monosodium

Phosphate as Sanitizer Components,’’ dated

March 24, 1994.

IV. Filing of Objections

Any person who will be adversely

affected by this regulation may at any

time on or before May 15, 1995, 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)(44) and

(c)(38) to read as follows:

§ 178.1010 Sanitizing solutions.

* * * * *

(b) * * *

(44) An aqueous solution of citric

acid, disodium

ethylenediaminetetraacetate, sodium

lauryl sulfate, and monosodium

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

solution may be used on dairyprocessing equipment.

* * * * *

(c) * * *

(38) The solution identified in

paragraph (b)(44) of this section shall

provide, when ready for use, at least

16,450 parts per million and not more

than 32,900 parts per million of citric

acid; at least 700 parts per million and

not more than 1,400 parts per million of

disodium ethylenediaminetetraacetate;

at least 175 parts per million and not

more than 350 parts per million of

sodium lauryl sulfate; and at least 175

parts per million and not more than 350

parts per million of monosodium

phosphate.

* * * * *

Dated: April 3, 1995.

L. Robert Lake,

Director, Office of Policy, Planning and

Strategic Initiatives, Center for Food Safety

and Applied Nutrition.

[FR Doc. 95–9089 Filed 4–12–95; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 558

New Animal Drugs; Technical

Amendments

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; technical

amendments.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect the

correct drug labeler code for Rhone

Poulenc, Inc. The agency codified an

incorrect drug labeler code. This

document corrects that error.

EFFECTIVE DATE: April 13, 1995.

FOR FURTHER INFORMATION CONTACT:

Judith M. O’Haro, Center for Veterinary

Medicine (HFV–238), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1737.

SUPPLEMENTARY INFORMATION: In the

Federal Register of June 28, 1994 (59 FR

33196), FDA published a document to

correct the drug labeler code for Hess &

Clark, Inc., from 011801 to 050749.

Several regulations were amended

including those for roxarsone used in

combinations in 21 CFR 558.95,

558.311, 558.355, and 558.550. This

amendment inadvertently created an

error in the regulations. However, in the