18736 Federal Register / Vol. 60, No. 71 / Thursday, April 13, 1995 / Rules and Regulations

2. Form G–FIN–4 is amended to revise

Item 5, Item 17 and the general

instructions to read as follows:

Note: The text of Form G–FIN–4 does not

appear in the Code of Federal Regulations.

Form G–FIN–4—Disclosure Form for

Person Associated with a Financial

Institution Government Securities

Broker or Dealer:

Item 5

Item 17

General Instructions

* * * * *

In Item 5, ‘‘Federal Home Loan Bank

Board’’ is deleted and ‘‘Director, Office

of Thrift Supervision’’ is added so that

the modified question reads: ‘‘To be

filed with the following (indicate one):

Board of Governors of the Federal

Reserve System * * * Comptroller of

the Currency * * * Federal Deposit

Insurance Corporation * * * Director,

Office of Thrift Supervision * * *

Securities and Exchange Commission.’’

In Item 17, Definitions, the term

‘‘Foreign Financial Regulatory

Authority’’ is added with the following

meaning: ‘‘Foreign Financial Regulatory

Authority—Includes any (A) foreign

securities authority; (B) other

governmental body or foreign equivalent

of a self-regulatory organization

empowered by a foreign government to

administer or enforce its laws relating to

the regulation of investment or

investment-related activities; or (C)

membership organization, a function of

which is to regulate the participation of

its members in the activities listed

above.’’

Item 17.A., ‘‘in a domestic or foreign

court’’ is added so that the modified

question reads: ‘‘Have you, within the

10 years preceding the date of this

filing, been convicted of or plead guilty

or nolo contendere (‘‘no contest’’) in a

domestic or foreign court to:’’

Item 17.B., ‘‘domestic or foreign’’ is

added so that the modified question

reads: ‘‘Has any domestic or foreign

court ever:’’

Item 17.C.(5) is added to read as

follows: ‘‘(5) imposed a civil money

penalty on you, or ordered you to cease

and desist from any activity?’’

Item 17.D., ‘‘foreign financial

regulatory authority’’ is added so that

the modified question reads: ‘‘Has any

other federal regulatory agency, any

state regulatory agency or foreign

financial regulatory authority ever:’’

Item 17.F., ‘‘other than as reported in

Items 17.A., B., or D.’’ is added so that

the modified question reads: ‘‘Has any

foreign government, court, regulatory

agency, or exchange ever entered an

order against you related to investments

or fraud other than as reported in Items

17.A., B., or D.?’’

In the general instructions to Form GFIN–4, Items 3.b., 3.c., and 3.d. are

revised to read as follows:

3.b. ‘‘The Board of Governors of the

Federal Reserve System, in the case of

a State member bank of the Federal

Reserve System, a foreign bank, an

uninsured State branch or State agency

of a foreign bank, a commercial lending

company owned or controlled by a

foreign bank (as such terms are used in

the International Banking Act of 1978),

or a corporation organized or having an

agreement with the Board of Governors

of the Federal Reserve System pursuant

to section 25 or section 25A of the

Federal Reserve Act;’’

3.c. ‘‘The Federal Deposit Insurance

Corporation, in the case of a bank

insured by the Federal Deposit

Insurance Corporation (other than a

member of the Federal Reserve System

or a Federal savings bank) or an insured

State branch of a foreign bank (as such

terms are used in the International

Banking Act of 1978);’’

3.d. ‘‘The Director of the Office of

Thrift Supervision, in the case of a

savings association (as defined in

section 3(b) of the Federal Deposit

Insurance Act) the deposits of which are

insured by the Federal Deposit

Insurance Corporation; and’’

Dated: April 3, 1995.

Frank N. Newman,

Deputy Secretary.

[FR Doc. 95–9056 Filed 4–12–95; 8:45 am]

BILLING CODE 4810–39–W

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. 87C–0316]

Listing of Color Additives Exempt

From Certification; Astaxanthin

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

color additive regulations to provide for

the safe use of astaxanthin as a color

additive in the feed of salmonid fish to

enhance the color of their flesh. This

action is in response to a petition filed

by Hoffmann-La Roche, Inc.

DATES: Effective May 16, 1995, except as

to any provisions that may be stayed by

the filing of proper objections; written

objections and request 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:

James C. Wallwork, Center for Food

Safety and Applied Nutrition (HFS–

217), Food and Drug Administration,

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

202–418–3078.

SUPPLEMENTARY INFORMATION:

I. Background

In a notice published in the Federal

Register of December 2, 1987 (52 FR

45867), FDA announced that a color

additive petition (CAP 7C0211) had

been filed by Hoffmann-La Roche, Inc.,

340 Kingsland St., Nutley, NJ 07110–

1199. The petition requested that the

color additive regulations in part 73 (21

CFR part 73) be amended to provide for

the safe use of astaxanthin as a color

additive in the feed of salmonid fish.

The petition was filed under section

706(d) (now section 721(d)) of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 376(d) (now

379e(d)).

II. Safety of the Petitioned Use

Astaxanthin is 3, 3′-dihydroxy-β, βcarotene-4, 4′-dione. Pure crystalline

astaxanthin must be stored in the

absence of light, heat, and oxygen to

minimize chemical changes and

decomposition that would result in loss

of color. Thus, it is necessary to produce

a stabilized form of astaxanthin for it to

be marketed for addition to salmonid

feed for the purpose of coloring the fish

flesh.

The petitioner manufactures

crystalline astaxanthin in a stabilized

beadlet form and has presented

evidence in the petition to establish the

length of the shelf-life of this beadlet.

Under § 70.25(a)(4) (21 CFR 70.25(a)(4)),

expiration dates for the product in

sealed and open containers must be

stated on the label of a color additive.

FDA finds that, given the concerns

about shelf life, the expiration dates are

a material fact that must be disclosed on

the label of the product under sections

201(n) and 403(a)(1) of the act (21 U.S.C.

321(n) and 343(a)(1).

Astaxanthin occurs in the flesh of

wild salmon at levels ranging from

about 4 to 34 parts per million and is

responsible for its pink or red coloration

(Ref. 1). Wild salmon consume

astaxanthin as a component of their

natural diet and deposit a portion of the

astaxanthin unchanged in their flesh
Federal Register / Vol. 60, No. 71 / Thursday, April 13, 1995 / Rules and Regulations 18737

(Ref. 2). The amount of astaxanthin that

FDA is permitting for use in finished

feed (80 milligrams per kilogram (mg/

kg), 72 grams (g) per ton) (§ 73.35(c)(2))

will result in depositions of the color

additive in the flesh that will produce

a coloration comparable to that in the

flesh of wild salmon. This conclusion is

supported by the similar values reported

for astaxanthin levels in the flesh of

aquacultured salmon used in the

pigmenting experiments in the petition

and in the flesh of wild salmon (Ref. 2).

FDA has estimated that this level of

astaxanthin in fish flesh, whether

caught in the wild or aquacultured, will

result in a mean consumer exposure of

15 micrograms/person/day (μ/p/d) and a

90th percentile exposure of 29 μ/p/d.

FDA has evaluated the data in the

petition and other relevant information

on astaxanthin and concludes that the

petitioned use of the color additive is

safe. This conclusion is based on the

following facts: (1) The very small

amount of astaxanthin deposited in

salmonid flesh that will result from the

petitioned use; (2) synthetic astaxanthin

differs only in its optical isomeric

distribution from astaxanthin present in

the flesh of wild salmon; and (3) human

exposure to astaxanthin from

consumption of aquacultured salmon

fed synthetic astaxanthin is comparable

to the exposure to astaxanthin from wild

salmon. In addition, the petitioner has

submitted results from short-term and

long-term toxicity studies using

synthetic astaxanthin. The results of

these studies support the conclusion

that there is a reasonable certainty of no

harm from the petitioned use of

astaxanthin (Ref. 3).

FDA is adopting an identity and

specifications for the color additive in

§ 73.35(a) and (b) to characterize the

additive that has been evaluated and to

ensure its safe manufacture and use.

III. Comments on the Petition

Beginning in late 1992, FDA received

a total of 21 letters that were submitted

as comments on the petition. One

comment from a State agency and one

comment from a trade association

endorsed the petitioned use of

astaxanthin. A manufacturer of Phaffia

yeast, a source of astaxanthin used in

some foreign countries, submitted a

series of five comments containing

considerable information on Phaffia

yeast and requested that the agency also

grant approval for this source, and all

other safe and suitable sources, of

astaxanthin. The comment also

requested that FDA grant authority for

other parties to make independent

determinations that other sources of

astaxanthin may be considered safe and

suitable sources of the color additive for

use in aquaculture.

The remaining 14 comments from a

trade association, a foreign national

organization, 4 commercial companies,

and 8 academic and research institutes,

generally supported the view that the

regulation for astaxanthin should be

written to include all safe and suitable

sources of the color additive. One of the

comments requested that the regulation

listing astaxanthin for use in salmonid

feed be written to include the

comment’s strain of Phaffia yeast as a

source of astaxanthin.

As justification for these requests, the

comments asserted that there should be

no safety concerns with the use of

astaxanthin for coloring the flesh of fish

because astaxanthin occurs in nature,

coloring the flesh of wild salmonids,

and also because it occurs in a variety

of sources in nature that are consumed

without harm as food by wild fish and

other wild animals. The comments also

suggested that it would be advantageous

to the aquaculture# industry to be able

to use as many sources of astaxanthin as

possible, and that it would be an

efficient use of the industry and FDA’s

resources if petitions for these products

did not have to be submitted and

reviewed individually by the agency. In

the event that FDA was unable or

unwilling to expand the final regulation

as requested, one comment requested

that the agency modify the

specifications for astaxanthin requested

by the petitioner to authorize the use of

other sources of astaxanthin, including

the source of astaxanthin used by the

comment. The comment specifically

requested that the proposed

specifications for astaxanthin be

modified to include a higher percentage

of the cis isomer and a 10-fold increase

in carotenoids other than astaxanthin.

FDA has reviewed these comments

and finds that two of the comments

fully support the petition, and that none

of the comments has raised concerns

about the safety of astaxanthin or about

its technical effectiveness for the

petitioned use. Thus, the agency

concludes that all the comments fully

support FDA’s conclusions regarding

the safety of astaxanthin for the

petitioned use.

FDA has considered whether it

should expand the scope of the listing

regulation to include Phaffia yeast and

other materials containing astaxanthin.

The regulation set forth below does not

specify the source of astaxanthin or the

manufacturing process because the

agency has made its safety

determination based on the chemical

similarity of synthetic astaxanthin to

astaxanthin from natural sources.

Therefore, any source could be used to

produce the color additive as long as the

astaxanthin meets the identity,

specifications, and stability

requirements defined in § 73.35, and it

is manufactured in accordance with

good manufacturing practice. However,

the specifications are listed to convey

the fact that FDA has evaluated only a

particular form of the color additive.

Several of the comments have

requested that they be allowed to use a

product derived from an organism such

as Phaffia rhodozyma as a color additive

without isolating the astaxanthin. Thus,

they wish to market a biomass product

that contains only a small amount of

astaxanthin with the rest of the material

being residues from the organism. The

agency is concerned that deleterious

materials may be included in fish feed

from these sources because they are not

found in the habitat of salmonids. Thus,

interested parties should submit

information supporting the safety of

these products, and that they perform

their intended effect, in the form of a

new color additive petition to

demonstrate that provision for these

materials should be made in § 73.35.

FDA also concludes that it cannot

expand the scope of this petition

because an expanded review would

require additional time to evaluate the

safety and suitability of other materials

containing astaxanthin. Such a review

would cause an avoidable delay in the

issuance of a final rule for the petitioned

use of the color additive. FDA believes

that such a delay would be unfair to the

petitioner. The petitioner has stated that

it would be unwilling to acquiesce in

such a delay. Any such delay could

cause significant economic loss to the

petitioner and could be responsible for

a significant delay in the use of

astaxanthin by the United States

aquaculture industry. Thus, FDA

concludes that it is appropriate to

require that those parties who wish to

use astaxanthin products that do not

comply with the listing regulation

submit their own color additive

petitions for such use.

Regarding the requested modifications

in the specifications for astaxanthin, the

agency cannot include the 10-fold

increase in carotenoids other than

astaxanthin in the regulation because a

color additive with such a broad

specification could be substantially

different from the astaxanthin that the

agency evaluated for safety.

Regarding the comment on allowing a

higher percentage of cis isomers,

astaxanthin can exist as different

geometric isomers, known as cis- or

trans-isomers. In the cis configuration,

the largest functional groups on either
18738 Federal Register / Vol. 60, No. 71 / Thursday, April 13, 1995 / Rules and Regulations

end of a double bond are on the same

side of the molecule. In the trans

configuration, they are on the opposite

sides of the molecule. In the case of

astaxanthin, there are nine double

bonds that can have cis or trans

configurations to give a bent or nearly

linear molecular geometry. These

isomers can be easily interconverted to

give an equilibrium mixture.

The requested specification for the

cis-astaxanthin level is unnecessary

because no safety concerns have been

demonstrated with regard to the

proportions of the cis and trans isomers

of astaxanthin. Furthermore, the

isomeric forms are readily

interconverted (Ref. 1), occur in wild

salmon, and color the flesh of

salmonids. There is no evidence to

suggest that the ratio of isomeric forms

would affect the safety of astaxanthin.

The proportion of cis/trans isomers of

astaxanthin in the petitioned color

additive lies within the range of the

ratios found in astaxanthin extracted

from the flesh of wild salmon (Ref. 4).

Therefore, the regulation presented

below does not contain a specification

for the amount of cis-astaxanthin.

IV. 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. Schiedt, K., F. J. Leuenberger, and M.

Vecchi, ‘‘Natural Occurrence of Enantiomeric

and meso-Astaxanthin,’’ Helvitica Chimica

Acta, 64:449–457, 1981.

2. Meyers, S. P., and H-M Chen,

‘‘Astaxanthin and its Role in Fish Culture,’’

From The Proceedings of Warmwater Fish

Culture Workshop. Special Publication No. 3,

pp. 153–165, 1992.

3. Welsh, J. J., Memorandum entitled

‘‘Final Toxicology Memo on CAP 7C0211

(Astaxanthin in Fish Feed)’’ from the

Additives Evaluation Branch (HFS–227) to

the Direct Additives Branch (HFS–217),

Center for Food Safety and Applied

Nutrition, FDA, May 26, 1993.

4. Turujman, S. A., ‘‘Rapid Direct

Resolution of the Stereoisomers of All-trans

Astaxanthin on a Pirkle Covalent L-Leucine

Column,’’ Journal of Chromatography,

631:197 (abstract), 1993; Poster presented at

the 106th Annual AOAC International

Meeting, Cincinnati, OH, August 31 to

September 3, 1992.

V. Conclusions

FDA has evaluated the data in the

petition and other relevant material and

concludes that astaxanthin that meets

the specifications in § 73.35(b) is safe

and suitable for use in salmonid feed to

pigment their flesh, and that part 73

should be amended as set out below. In

addition, based upon the factors listed

in § 71.20(b) (21 CFR 71.20(b)), the

agency concludes that certification of

astaxanthin is not necessary for the

protection of the public health. To

ensure its safe use, FDA has limited the

amount of astaxanthin that can be

incorporated into the finished fish feed

to 80 mg/kg (72 g/ton).

To prevent economic fraud in

salmonid fish containing added

astaxanthin, the regulation requires

declaration of the presence of the color

additive in accordance with

§§ 101.22(k)(2), 101.100(a)(2), and 501.4

(21 CFR 101.22(k)(2), 101.100(a)(2), and

501.4) for labeling of bulk foods. Section

501.4 is referenced in § 73.35(d)(2) to

ensure that the presence of astaxanthin

in the fish feed will be declared on the

ingredient label. Sections 101.22(k)(2)

and 101.100(a)(2) are referenced in

§ 73.35(d)(3) to ensure that, at the retail

level, the presence of astaxanthin in the

fish will be declared, and that the

labeling of the bulk fish container,

including a list of ingredients on the

container or a counter card with similar

information, will be displayed,

respectively. Several examples are given

in § 101.22(k)(2) for an acceptable

statement of declaration of the presence

of astaxanthin, e.g., ‘‘Artificial Color,’’

‘‘Artificial Color Added,’’ or ‘‘Color

Added.’’

VI. Inspection of Documents

In accordance with § 71.15(a) (21 CFR

71.15(a)), 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 (address above)

by appointment with the information

contact person listed above. As

provided in § 71.15(b), the agency will

delete from the documents any

materials that are not available for

public disclosure before making the

documents available for inspection.

VII. 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.

VIII. Objections

Any person who will be adversely

affected by this regulation may at any

time on or before May 15, 1995, file

with 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. FDA will publish notice

of the objections that the agency has

received or lack thereof in the Federal

Register.

List of Subjects in 21 CFR Part 73

Color additives, Cosmetics, Drugs,

Medical devices.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR 21 part 73

is amended as follows:

PART 73—LISTING OF COLOR

ADDITIVES EXEMPT FROM

CERTIFICATION

1. The authority citation for 21 CFR

part 73 continues to read as follows:

Authority: Secs. 201, 401, 402, 403, 409,

501, 502, 505, 601, 602, 701, 721 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321, 341, 342, 343, 348, 351, 352, 355,

361, 362, 371, 379e).

2. New § 73.35 is added to subpart A

to read as follows:

§ 73.35 Astaxanthin.

(a) Identity. (1) The color additive

astaxanthin is 3, 3′-dihydroxy-β, βcarotene-4, 4′-dione.

(2) Astaxanthin may be added to the

fish feed only as a component of a
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).