[Federal Register Volume 63, Number 29 (Thursday, February 12, 1998)]
[Rules and Regulations]
[Pages 7068-7069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3497]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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) * * *
------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
* * * *
* * *
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.
------------------------------------------------------------------------
(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
