[Federal Register Volume 60, Number 71 (Thursday, April 13, 1995)]
[Rules and Regulations]
[Pages 18739-18740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-9089]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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
Sec. 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 (Sec. 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 already-regulated
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
already-regulated 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
Sec. 178.1010(b)(3), (b)(10), and (b)(37). On the basis of the data
submitted in support of the already-regulated 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).
[[Page 18740]]
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 Sec. 178.1010 as set forth below.
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 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:
Sec. 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 food-processing equipment and
utensils, this solution may be used on dairy-processing 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