Direct and Secondary Direct Food Additives; Sodium Mono- and Dimethyl Naphthalene Sulfonates

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 172 and 173

[Docket No. 96F-0076]

Direct and Secondary Direct Food Additives; Sodium Mono- and

Dimethyl Naphthalene Sulfonates

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the food

additive regulations to provide for the safe use of sodium mono- and

dimethyl naphthalene sulfonates as an aid in the steam/scald vacuum

peeling of tomatoes without a subsequent potable water wash. This

action is in response to a petition filed by Enviro Tech Chemical

Services, Inc. In conjunction with this action, the agency is also

amending the food additive regulations by broadening a section heading

to cover the new application and by removing the redundant cross-

reference to a section.

DATES: Effective February 12, 1998; written objections and requests for

a hearing by March 16, 1998.

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: Martha D. Peiperl, Center for Food

Safety and Applied Nutrition (HFS-215), Food and Drug Administration,

200 C St. SW., Washington, DC 20204, 202-418-3077.

SUPPLEMENTARY INFORMATION:

In a notice published in the Federal Register of March 19, 1996 (61

FR 11214), FDA announced that a food additive petition (FAP 6A4487) had

been filed by Enviro Tech Chemical Services, Inc., P.O. Box 577470,

Modesto, CA 95357. The petition proposed to amend the food additive

regulations in Sec. 172.824 Sodium mono- and dimethyl naphthalene

sulfonates (21 CFR 172.824) to provide for the safe use of sodium mono-

and dimethyl naphthalene sulfonates as an aid in peeling tomatoes

without a potable water wash.

Sodium mono- and dimethyl naphthalene sulfonates are currently

approved in Sec. 172.824 as an anticaking agent in sodium nitrite, for

use in the crystallization of sodium carbonate intended for use in

potable water systems to reduce hardness and aid in sedimentation and

coagulation and by cross-reference to Sec. 173.315 Chemicals used in

washing or to assist in the lye peeling of fruits and vegetables (21

CFR 173.315), in the washing or to assist in the lye peeling of fruits

and vegetables. The subject additive is defined in Sec. 172.824 and, as

cross-referenced in Sec. 172.824(b)(3), may be used in the washing or

to assist in the lye peeling of fruits and vegetables as prescribed in

Sec. 173.315, only when this use is followed by rinsing with potable

water to remove, to the extent possible, residues of the chemicals.

Therefore, the action requested by this petition is more appropriately

addressed by amending Sec. 173.315 to allow the use of the subject

additive in the steam/scald vacuum peeling of tomatoes without a

subsequent potable water wash. Although only an amendment to

Sec. 172.824 was cited in the filing notice for this petition, the

action currently being taken was accurately described at that time.

In addition, FDA is amending the section heading of Sec. 173.315 by

removing the word ``lye.'' This action is being taken to broaden

Sec. 173.315 to cover the new application for steam/scald vacuum

peeling in addition to lye peeling. This action is simply a technical

change because the current limitations continue to be stated in

paragraphs (a)(2) and newly redesignated (a)(4).

In continuation of FDA's efforts to implement the President's March

4, 1995 ``Reinventing Government'' initiative, FDA is also removing as

redundant Sec. 172.824(b)(3), because this paragraph is an unnecessary

cross-reference to the regulation of the additive under Sec. 173.315.

This action is also a technical change because the approved uses of the

subject additive are not changed by virtue of the deletion.

FDA has evaluated data in the petition and other relevant material.

As part of its review, FDA evaluated data on the use of the subject

additive in peeling tomatoes using steam or scalding water instead of

lye, including analytical evidence that no residues of the additive

were detected in five production samples of tomato paste prepared from

tomatoes treated with the additive prior to peeling, but with no

subsequent potable water rinse. Based on this information, as well as

certain toxicological data, the agency concludes that the additive will

have the intended technical effect and is safe under the proposed

conditions of use. Therefore, the agency is amending the food additive

regulations to provide for the requested use.

In accordance with Sec. 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 Sec. 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.

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

[[Page 7069]]

p.m., Monday through Friday. No comments were received during the 30-

day comment period specified in the filing notice for comments on the

environmental assessment submitted with the petition.

Any person who will be adversely affected by this regulation may at

any time on or before March 16, 1998, 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

21 CFR Part 172

Food additives, Reporting and recordkeeping requirements.

21 CFR Part 173

Food additives.

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 parts 172 and 173 are amended as follows:

PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR

HUMAN CONSUMPTION

1. The authority citation for 21 CFR part 172 continues to read as

follows:

Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.

Sec. 172.824 [Amended]

2. Section 172.824 Sodium mono- and dimethyl naphthalene

sulfonates is amended by removing paragraph (b)(3).

PART 173--SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR

HUMAN CONSUMPTION

3. The authority citation for 21 CFR part 173 continues to read as

follows:

Authority: 21 U.S.C. 321, 342, 348.

4. Section 173.315 is amended by revising the section heading; by

removing from the introductory text the word ``lye;'' by amending the

table in paragraph (a)(2) by revising the entries for

``Polyacrylamide,'' ``Potassium bromide,'' and ``Sodium hypochlorite;''

and the entry for Sodium mono- and di-methyl napthalene sulfonates * *

*'' is amended by removing the hyphen in ``di-methyl'' under the

``Substances'' column; by redesignating paragraph (a)(3) as paragraph

(a)(4) and by adding a new paragraph (a)(3); by amending the first

sentence of newly redesignated paragraph (a)(4) by removing ``(a)(3)''

and adding in its place ``(a)(4);'' and by revising paragraph (c) to

read as follows:

Sec. 173.315 Chemicals used in washing or to assist in the peeling of

fruits and vegetables.

* * * * *

(a) * * *

(2) * * *

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Substances Limitations

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* * * *

* * *

Polyacrylamide......................... Not to exceed 10 parts per

million in wash water.

Contains not more than 0.2

percent acrylamide monomer.

May be used in the washing of

fruits and vegetables.

Potassium bromide...................... May be used in the washing or

to assist in the lye peeling

of fruits and vegetables.

* * * *

* * *

Sodium hypochlorite.................... May be used in the washing or

to assist in the lye peeling

of fruits and vegetables.

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(3) Sodium mono- and dimethyl naphthalene sulfonates (mol. wt. 245-

260) may be used in the steam/scald vacuum peeling of tomatoes at a

level not to exceed 0.2 percent in the condensate or scald water.

* * * * *

(c) The use of the chemicals listed under paragraphs (a)(1),

(a)(2), and (a)(4) is followed by rinsing with potable water to remove,

to the extent possible, residues of the chemicals.

* * * * *

Dated: February 2, 1998.

L. Robert Lake,

Director, Office of Policy, Planning and Strategic Initiatives, Center

for Food Safety and Applied Nutrition.

[FR Doc. 98-3497 Filed 2-11-98; 8:45 am]

BILLING CODE 4160-01-F