[Federal Register Volume 61, Number 108 (Tuesday, June 4, 1996)]
[Rules and Regulations]
[Pages 28051-28053]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-13982]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 178
[Docket No. 93F-0136]
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 hydrogen peroxide, acetic acid, peroxyacetic acid, octanoic acid,
peroxyoctanoic acid, sodium 1-octanesulfonate, and 1-hydroxyethylidene-
1,1-diphosphonic acid as a sanitizing solution for use on food
processing equipment and utensils, including food-contact surfaces in
public eating places. This action responds to a petition filed by
Ecolab, Inc.
DATES: Effective June 4, 1996; written objections and requests for a
hearing by July 5, 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 A. 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 May 17, 1993 (58 FR 28882), FDA announced that a food
additive petition (FAP 3B4371) had been filed by Ecolab, Inc., 840
Sibley Memorial Hwy., St. Paul, MN 55118. The petition proposed to
amend the food additive regulations in Sec. 178.1010 Sanitizing
solutions (21 CFR 178.1010) to provide for the safe use of an aqueous
solution of hydrogen peroxide, acetic acid, peroxyacetic acid, octanoic
acid, peroxyoctanoic acid, sodium 1-octanesulfonate, and
hydroxyethylene diphosphonic acid as a sanitizing solution for use on
food processing equipment and utensils, including food-contact surfaces
in public eating places.
While the agency used the term hydroxyethylene diphosphonic acid in
the notice of filing, the agency has determined that a more specific
and therefore more appropriate name for the substance is 1-
hydroxyethylidene-1,1-diphosphonic acid. This more specific name will
be used in the remainder of this document and in the regulation.
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;
however, the agency evaluates data on the antimicrobial efficacy of the
entire sanitizing solution. In addition, FDA regulations require that
food-contact surface sanitizing solutions be labeled in accordance with
the Federal Insecticide, Fungicide, and Rodenticide Act
(Sec. 178.1010(d)). The subject sanitizing solution is an aqueous
solution of hydrogen peroxide, acetic acid, peroxyacetic acid, octanoic
acid, peroxyoctanoic acid, sodium 1-octanesulfonate, and 1-
hydroxyethylidene-1,1-diphosphonic acid. The functions of these
components and the basis for FDA's determination of the safety of these
components in the subject sanitizing solution are described below.
A. Hydrogen Peroxide-
Hydrogen peroxide functions as an antimicrobial agent in the
subject sanitizing solution. Hydrogen peroxide is permitted as an
ingredient in sanitizing solutions under Sec. 178.1010(b)(30) and
(b)(38), and it is affirmed as generally recognized as safe (GRAS) for
use in food with specific limitations under 21 CFR 184.1366. On the
basis of the data submitted in support of the already-regulated uses of
hydrogen peroxide and the data contained in the food additive petition
submitted in support of this sanitizing solution, FDA finds that the
use of hydrogen peroxide in the subject sanitizing solution is safe
(Refs. 1 and 2).
B. Acetic Acid -
Acetic acid functions as an acidifier in the subject sanitizing
solution. Acetic acid is permitted as as ingredient in sanitizing
solutions under Sec. 178.1010(b)(30) and (b)(38), and it is affirmed as
GRAS for use in food under 21 CFR 184.1005. On the basis of the data
submitted in support of the already-regulated uses of acetic acid and
the data contained in the food additive petition submitted in support
of this sanitizing solution, FDA finds that the use of acetic acid in
the subject sanitizing solution is safe (Refs. 1 and 2).
[[Page 28052]]
C. Peroxyacetic Acid-
Peroxyacetic acid (POA) functions as an antimicrobial agent in the
subject sanitizing solution. POA is permitted as an ingredient in
sanitizing solutions under Sec. 178.1010(b)(30) and (b)(38). On the
basis of the data submitted in support of the already-regulated uses of
POA and the data contained in the food additive petition submitted in
support of this sanitizing solution, FDA finds that the use of POA in
the subject sanitizing solution is safe (Refs. 1 and 2).
D. Octanoic Acid-
Octanoic acid functions as a synergist in the subject sanitizing
solution. Octanoic acid is permitted as an ingredient in sanitizing
solutions under Sec. 178.1010(b)(27), (b)(35), (b)(36), and (b)(39),
and it is approved for direct use in food under 21 CFR 172.860
(caprylic acid). On the basis of the data submitted in support of the
already-regulated uses of octanoic acid and the data contained in the
food additive petition submitted in support of this sanitizing
solution, FDA finds that the use of octanoic acid in the subject
sanitizing solution is safe (Refs. 1 and 2).
E. Peroxyoctanoic Acid-
Peroxyoctanoic acid (POOA) is a by-product of hydrogen peroxide and
octanoic acid. Because of the highly reactive nature of POOA, the
actual dietary concentration of POOA is likely to be close to zero.
Based on the likely dietary concentration and information submitted in
the petition, FDA finds that the use of POOA in the subject sanitizing
solution is safe (Refs. 1 and 2).
F. Sodium 1-Octanesulfonate
Sodium 1-octanesulfonate (SOS) functions as a surfactant in the
subject sanitizing solution. SOS is permitted as as ingredient in
sanitizing solutions under Sec. 178.1010(b)(27) and (b)(42). On the
basis of the data submitted in support of the already-regulated uses of
SOS and the data contained in the food additive petition submitted in
support of this sanitizing solution, FDA finds that the use of SOS in
the subject sanitizing solution is safe (Refs. 1 and 2).
G. 1-Hydroxyethylidene-1,1-Diphosphonic Acid-
1-Hydroxyethylidene-1,1-diphosphonic acid functions as a stabilizer
in the subject sanitizing solution. 1-Hydroxyethylidene-1,1-
diphosphonic acid is permitted as as ingredient in sanitizing solutions
under Sec. 178.1010(b)(30). On the basis of the data submitted in
support of this regulated use of 1-hydroxyethylidene-1,1-diphosphonic
acid and the data contained in the food additive petition submitted in
support of this sanitizing solution, FDA finds that the use of 1-
hydroxyethylidene-1,1-diphosphonic acid in the subject sanitizing
solution is safe (Refs. 1 and 2).
H. 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 food-contact surfaces in
public eating places, 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 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. References
The following references have 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 ``Safety Review of Hydrogen Peroxide,
Acetic Acid, Peroxyacetic Acid, Octanoic Acid, Peroxyoctanoic Acid,
Sodium 1-Octanesulfonate, and Hydroxyethylidene Diphosphonic Acid as
Sanitizer Components,'' dated June 12, 1995.
2. Memorandum entitled ``FAP 3B4371 (MATS #704 M2.1): KX-6094 -
Sanitizer Formulation Consisting of Hydrogen Peroxide, Octanoic
Acid, Peroxyoctanoic Acid, Sodium 1-Octanesulfonate, and 1-
Hydroxyethylidene-1,1-Diphosphonic Acid. Klenzade submission of 3/9/
93,'' dated October 20, 1993.
IV. Filing of Objections
Any person who will be adversely affected by this regulation may at
any time on or before July 5, 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.
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)(45) and
(c)(39) to read as follows:
[[Page 28053]]
Sec. 178.1010 Sanitizing solutions.
* * * * *
(b) * * *
(45) An aqueous solution of hydrogen peroxide, acetic acid,
peroxyacetic acid, octanoic acid, peroxyoctanoic acid, sodium 1-
octanesulfonate, and 1-hydroxyethylidene-1,1-diphosphonic acid. In
addition to use on food-processing equipment and utensils, this
solution may be used on food-contact surfaces in public eating places,
subject to the limitations in paragraph (c)(39) of this section.
* * * * *
(c) * * *
(39)(i) The solution identified in paragraph (b)(45) of this
section, when used on food processing equipment and utensils, including
dairy and beverage-processing equipment but excluding food-contact
surfaces in public eating places and dairy and beverage containers,
shall provide when ready for use at least 72 parts per million and not
more than 216 parts per million of hydrogen peroxide; at least 46 parts
per million and not more than 138 parts per million of peroxyacetic
acid; at least 40 parts per million and not more than 122 parts per
million of octanoic acid (including peroxyoctanoic acid); at least 281
parts per million and not more than 686 parts per million of acetic
acid; at least 7 parts per million and not more than 34 parts per
million of 1-hydroxyethylidene-1,1-diphosphonic acid; and at least 36
parts per million and not more than 109 parts per million of sodium 1-
octanesulfonate.
(ii) The solution identified in paragraph (b)(45) of this section,
when used on food-contact equipment and utensils in warewashing
machines, including warewashing machines in public eating places, at
temperatures no less than 120 deg.F (49 deg.C) shall provide when
ready for use at least 30 parts per million and not more than 91 parts
per million of hydrogen peroxide; at least 19 parts per million and not
more than 58 parts per million of peroxyacetic acid; at least 17 parts
per million and not more than 52 parts per million of octanoic acid
(including peroxyoctanoic acid); at least 119 parts per million and not
more than 290 parts per million of acetic acid; at least 3 parts per
million and not more than 14 parts per million of 1-hydroxyethylidene-
1,1-diphosphonic acid; and at least 15 parts per million and not more
than 46 parts per million of sodium 1-octanesulfonate.
(iii) The solution identified in paragraph (b)(45) of this section,
when used on dairy or beverage containers, shall provide when ready for
use at least 36 parts per million and not more than 108 parts per
million of hydrogen peroxide; at least 23 parts per million and not
more than 69 parts per million of peroxyacetic acid; at least 20 parts
per million and not more than 61 parts per million of octanoic acid
(including peroxyoctanoic acid); at least 140 parts per million and not
more than 343 parts per million of acetic acid; at least 3 parts per
million and not more than 17 parts per million of 1-hydroxyethylidene-
1,1-diphosphonic acid; and at least 18 parts per million and not more
than 55 parts per million of sodium 1-octanesulfonate.
* * * * *
Dated: May 24, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-13982 Filed 6-3-96; 8:45 am]
BILLING CODE 4160-01-F
