[Federal Register Volume 61, Number 120 (Thursday, June 20, 1996)]
[Rules and Regulations]
[Pages 31395-31397]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15726]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 92F-0339]


Indirect Food Additives: Adjuvants, Production Aids, and 
Sanitizers

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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[[Page 31396]]

SUMMARY: The Food and Drug Administration (FDA) is amending the food 
additive regulations to provide for the safe use of an aqueous solution 
of chlorine dioxide and related oxychloro species, generated by 
acidification of an aqueous solution of sodium chlorite with a solution 
of sodium gluconate, citric acid, phosphoric acid, and sodium mono- and 
didodecylphenoxybenzenedisulfonate, 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 Rio Linda 
Chemical Co.

DATES: Effective June 20, 1996 written objections and requests for a 
hearing by July 22, 1996. The Director of the Office of the Federal 
Register approves the incorporation by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51 of a publication listed in 
Sec. 178.1010 (21 CFR 178.1010), effective June 20, 1996.

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: Mitchell Cheeseman, Center for Food 
Safety and Applied Nutrition (HFS-217), 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 September 22, 1992 (57 FR 43741), FDA announced that a food 
additive petition (FAP 2B4334) had been filed by Rio Linda Chemical 
Co., c/o 1414 Fenwick Lane, Silver Spring, MD 20910. 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 
an aqueous solution of chlorine dioxide and related oxychloro species, 
generated by acidification of an aqueous solution of sodium chlorite 
with sodium gluconate, citric acid, phosphoric acid, and sodium 
alkylphenoxybenzenedisulfonate, as a sanitizing solution to be used on 
food-contact surfaces, food-processing equipment, and utensils. Based 
on information in the food additive petition, FDA has determined that a 
more specific and therefore more appropriate name for the form of 
sodium alkylphenoxybenzenedisulfonate used to generate the subject 
sanitizing solution is sodium mono- and 
didodecylphenoxybenzenedisulfonate. This more specific name will be 
used throughout the remainder of this document.

I. Safety and Functional Effect of Petitioned Use of the Additive

    -Sanitizing solutions are mixtures of chemicals that function 
together to sanitize food-contact surfaces and are regulated as such. 
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. The subject sanitizing solution is 
an aqueous solution of chlorine dioxide and related oxychloro species, 
generated by acidification of an aqueous solution of sodium chlorite 
with a solution of sodium gluconate, citric acid, phosphoric acid, and 
sodium mono- and didodecylphenoxybenzenedisulfonate. The functions of 
these components, and the basis for FDA's determination of the safety 
of these components in the subject sanitizer, are described below.

A. Chlorine Dioxide

     Chlorine dioxide functions as an antimicrobial agent in the 
subject sanitizing solution. Chlorine dioxide is regulated for use in 
sanitizing solutions under Sec. 178.1010(b)(34) and is regulated for 
use as an antimicrobial agent in water used in poultry processing under 
21 CFR 173.69. On the basis of the data submitted in support of the 
already-regulated uses of chlorine dioxide, the data contained in the 
food additive petition submitted in support of this sanitizing 
solution, and studies in the scientific literature, FDA finds that the 
use of chlorine dioxide in the subject sanitizing solution is safe 
(Ref. 1).

B. Sodium Gluconate

    -Sodium gluconate functions as a sequestering agent in the subject 
sanitizing solution. Sodium gluconate is listed as GRAS for use in food 
as a sequestering agent under 21 CFR 182.6757. In addition, FDA 
regulations permit the addition to a sanitizing solution of any 
substance that is GRAS for use in food (Sec. 178.1010(b)). On the basis 
of the data supporting the GRAS status of sodium gluconate, FDA finds 
that the use of sodium gluconate in the subject sanitizing solution is 
safe (Ref. 1).

 C. Citric Acid

    Citric acid functions as a sequestering agent in the subject 
sanitizing solution. Citric acid is affirmed as GRAS for use in food 
under 21 CFR 184.1033. In addition, as stated in the previous 
paragraph, 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 
supporting the GRAS status of citric acid, FDA finds that the use of 
citric acid in the subject sanitizing solution is safe (Ref. 1).

D. Phosphoric Acid

    -Phosphoric acid functions as an activator in the subject 
sanitizing solution. Phosphoric acid is listed as GRAS for use in food 
under 21 CFR 182.1073. In addition, 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 supporting the GRAS status of phosphoric acid, 
FDA finds that the use of phosphoric acid in the subject sanitizing 
solution is safe (Ref. 1).

 E. Sodium Mono- and Didodecylphenoxybenzenedisulfonate

    -Sodium mono- and didodecylphenoxybenzenedisulfonate functions as a 
surfactant in the subject sanitizing solution. Sodium mono- and 
didodecylphenoxybenzenedisulfonate is regulated for use as an 
emulsifier and surface active agent in the manufacture of food-contact 
materials under the listing for sodium mono- and 
dialkylphenoxybenzenedisulfonate in 21 CFR 178.3400(c). On the basis of 
the data submitted in support of the already-regulated use of sodium 
mono- and didodecylphenoxybenzenedisulfonate and the data contained in 
the food additive petition submitted in support of this sanitizing 
solution, FDA finds that the use of sodium mono- and 
didodecylphenoxybenzenedisulfonate in the subject sanitizing solution 
is safe (Ref. 1).

 F. Conclusion on Safety

    -As discussed above, FDA has evaluated data on the antimicrobial 
efficacy of the entire sanitizing solution and data in the petition and 
other relevant materials on the safety of each of the components of the 
sanitizing solution. On the basis of this evaluation, the agency 
concludes that these data and materials establish the safety and 
efficacy of the additive for use as a sanitizing solution on food-
processing equipment and utensils including dairy-processing equipment, 
and that the regulations should be amended 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

[[Page 31397]]

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 ``FOAM ADD 10--A terminal no-rinse 
sanitizer--Manufactured by Rio Linda Chemical Corp.,'' dated June 
10, 1994.

 IV. Filing of Objections

    Any person who will be adversely affected by this regulation may at 
any time on or before July 22, 1996 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, Incorporation by reference.
    -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)(46) 
and (c)(40) to read as follows:


Sec. 178.1010  Sanitizing solutions.

 * * * * *
     (b) * * *
     (46) An aqueous solution of chlorine dioxide and related oxychloro 
species generated by acidification of an aqueous solution of sodium 
chlorite with a solution of sodium gluconate, citric acid, phosphoric 
acid, and sodium mono- and didodecylphenoxybenzenedisulfonate. In 
addition to use on food-processing equipment and utensils, this 
solution may be used on dairy-processing equipment.
 * * * * *
    (c) * * *
    (40) The solution identified in paragraph (b)(46) of this section 
shall provide, when ready for use, at least 100 parts per million and 
not more than 200 parts per million of chlorine dioxide as determined 
by the method developed by Bio-cide International, Inc., entitled, 
``Iodometric Method for the Determination of Available Chlorine Dioxide 
(50-250 ppm Available ClO2),'' dated June 11, 1987, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies of this method are available from the Division of 
Petition Control, Center for Food Safety and Applied Nutrition (HFS-
215), Food and Drug Administration, 200 C St. SW., Washington, DC 
20204, and may be examined at the Center for Food Safety and Applied 
Nutrition's Library, Food and Drug Administration, 200 C St. SW., rm. 
3321, Washington, DC, or at the Office of the Federal Register, 800 
North Capitol St. NW., suite 700, Washington, DC; at least 380 parts 
per million and not more than 760 parts per million of sodium 
gluconate; and at least 960 parts per million and not more than 1,920 
parts per million of sodium mono- and 
didodecylphenoxybenzenedisulfonate. Other components listed under 
paragraph (b)(46) of this section shall be used in the minimum amount 
necessary to produce the intended effect.
 * * * * *

    Dated: June 7, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-15726 Filed 6-19-96; 8:45 am]
BILLING CODE 4160-01-F