[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