[Federal Register Volume 63, Number 9 (Wednesday, January 14, 1998)]
[Notices]
[Pages 2232-2235]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-928]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-783; FRL-5759-6]


Ecolab Inc.; Pesticide Tolerance Petition Filing

AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of filing.

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SUMMARY: This notice announces the filing of a pesticide petition 
proposing the exemption from the requirement of a tolerance for 
residues of peroxyacetic acid in or on raw agricultural commodities, in 
processed commodities, and in or on meat and meat byproducts of cattle, 
sheep, hogs, goats, horses, and poultry, milk, and eggs when such 
residues result from the use of peroxyacetic acid as an antimicrobial 
agent on fruits, vegetables, tree nuts, cereal grains, herbs, and 
spices.
DATES: Comments, identified by the docket control number [PF-783] must 
be received on or before February 13, 1998.
ADDRESSES: By mail submit written comments to: Public Information and 
Records Integrity Branch, Information Resources and Services Division 
(7502C), Office of Pesticides Programs, Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460. In person bring comments 
to: Rm. 1132,

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CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Comments and data may also be submitted electronically by following 
the instructions under ``SUPPLEMENTARY INFORMATION.'' No confidential 
business information should be submitted through e-mail.
    Information submitted as a comment concerning this document may be 
claimed confidential by marking any part or all of that information as 
``Confidential Business Information'' (CBI). CBI should not be 
submitted through e-mail. Information marked as CBI will not be 
disclosed except in accordance with procedures set forth in 40 CFR part 
2. A copy of the comment that does not contain CBI must be submitted 
for inclusion in the public record. Information not marked confidential 
may be disclosed publicly by EPA without prior notice. All written 
comments will be available for public inspection in Rm. 1132 at the 
address given above, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: Dennis H. Edwards, Jr., Chief, 
Regulatory Management Branch I, Antimicrobials Division (7510W), Office 
of Pesticide Programs, U.S. Environmental Protection Agency, 401 M St., 
SW., Washington, DC 20460, 703-308-6411, e-mail: 
[email protected].
SUPPLEMENTARY INFORMATION: EPA has received a pesticide petition [PP 
7F4808] from Ecolab Inc. proposing, pursuant to section 408(d) of the 
Federal Food, Drug and Cosmetic Act, (FFDCA) 21 U.S.C. 346a(d), to 
amend 40 CFR part 180 by establishing an exemption from tolerance for 
residues of peroxyacetic acid in or on raw agricultural commodities, in 
processed commodities, and in or on meat and meat byproducts of cattle, 
sheep, hogs, goats, horses, and poultry, milk, and eggs when such 
residues result from the use of peroxyacetic acid as an antimicrobial 
agent on fruits, vegetables, tree nuts, cereal grains, herbs, and 
spices.
    The proposed analytical method is titration. Pursuant to the 
section 408(d)(2)(A)(i) of the FFDCA, as amended, Ecolab Inc. has 
submitted the following summary of information, data and arguments in 
support of their pesticide petition. This summary was prepared by 
Ecolab Inc. and EPA has not fully evaluated the merits of the petition. 
EPA edited the summary to clarify that the conclusions and arguments 
were the petitioner's and not necessarily EPA's and to remove certain 
extraneous material.

I. Petition Summary

    This section has been arranged to provide a justification for this 
tolerance exemption and a summary of available data.
    The request is to exempt from the requirement of a tolerance, 
residues of peroxyacetic acid in or on raw agricultural commodities, in 
processed commodities, and in or on meat and meat byproducts of cattle, 
sheep, hogs, goats, horses, and poultry, milk, and eggs when such 
residues result from the use of peroxyacetic acid as an antimicrobial 
agent on fruits, vegetables, tree nuts, cereal grains, herbs, and 
spices.
    The residues which do remain are not of toxicological significance.

A. Residue Chemistry

    Residues of peroxyacetic acid are not expected because peroxyacetic 
acid reacts rapidly on contact with materials such as food and is 
degraded to moieties which present no toxicological concern 
(Reregistration Eligibility Decision, Peroxy Compounds. U.S. EPA. EPA 
738-R-93-030). The degradation products of peroxyacetic acid are acetic 
acid (which is generally regarded as safe in food up 0.15%, 21 CFR 
184.1005), water, oxygen and hydrogen peroxide 
(H2O2). The degradation products of peroxyacetic 
acid are not of significant toxicological concern.
    Adequate analytical methodology is available through titration to 
determine the amounts of peroxyacetic acid in or on raw agricultural 
commodities, in processed commodities, and in or on meat and meat 
byproducts of cattle, sheep, hogs, goats, horses, and poultry, milk, 
and eggs.

B. Toxicological Profile

    Peroxyacetic acid is a moderately acutely toxic material with an 
oral LD50 of approximately 1,540 mg/kg in rats (1993 RED). 
The toxicity is highly dependent on the concentration of the solution 
administered. In concentrated solutions, systemic toxicity may occur, 
but the hazard is more likely to be due to the corrosivity. At lower 
concentrations of peroxyacetic acid the lethal dose may be 
significantly higher due to the lack of the corrosive effects. At these 
concentrations peroxyacetic acid would produces primarily an irritant 
effect, especially following repeated doses.
    No reliable long term toxicological data is available on this 
material. Structurally, this molecule resembles 
H2O2 with the presence of an acetyl group. 
Although peroxyacetic acid is a stronger oxidizing agent than 
H2O2, the mechanism of biocidal and toxicological 
action of peroxyacetic acid is anticipated to be similar to that of 
H2O2 and other peroxides. By this mechanism, the 
toxicological effects of peroxyacetic acid would likely resemble that 
of H2O2.
    In chemical reactions, the degradation products of peroxyacetic 
acid are acetic acid, water, oxygen and H2O2. 
Acetic acid, water and oxygen are not a toxicological concern and 
H2O2 is not considered toxicologically 
significant at low concentrations.
    H2O2 is a moderately toxic material with an 
oral LD50 of approximately 2,000 mg/kg (1993 RED). The 
toxicity is highly dependent on the concentration of the solution 
administered. At concentrations in the range of 30% or higher, systemic 
toxicity may occur, but the hazard is more likely to be due to the 
corrosivity. At lower concentrations of H2O2 the 
lethal dose of H2O2 may be significantly higher 
due to the lack of the corrosive effects. At concentrations in the 
range of 3%, and below, H2O2 produces primarily 
an irritant effect, especially following repeated doses.
    Few chronic studies suitable for toxicological evaluation have been 
conducted. In one study, approximately 100 mice per group were given 0, 
0.1% or 0.4% H2O2 in their drinking water for 100 
weeks. At the conclusion of the study, there was one adenoma of the 
duodenum in controls, six adenomas and one carcinoma of the duodenum in 
the low dose, and two adenomas and five carcinoma of the duodenum in 
the high dose. The incidence was significantly higher in the treated 
animals, however this may reflect a corrosive effect of the test 
material leading to a hyperplastic response rather than genotoxic 
effect.
    In another study mice were given 0.4% H2O2 
(4,000 ppm) in drinking water for 108 weeks. Results from interim 
sacrifices demonstrated gastric irritation and ``erosion'' was evident 
throughout the course of the study. This is expected based on the long 
term exposure. Duodenal and gastric hyperplastic nodules were noted in 
treated animals at all interim sacrifices from day 90 to the end of the 
study. There was a 5% incidence in duodenal carcinoma compared to 0% in 
the controls. Again, this may reflect a corrosive effect of the test 
material leading to a hyperplastic response rather than genotoxic 
effect. Since only one treatment group was used, this provides only 
limited evidence of the oncogenicity of this material. In a follow-up 
experiment, mice were given 0.4% H2O2 in drinking 
water for up to 180 days followed by a recovery period

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of up to 30 days. The stomach lesions regressed completely but a few of 
the duodenal lesions persisted. This further demonstrated the 
corrosivity of the test material.
    In mutagenicity studies equivocal and conflicting results were 
found. H2O2 was mutagenic to strain TA92. 
Positive and negative results have been demonstrated in other 
Salmonella assays. Overall, there is limited evidence that 
H2O2 is mutagenic.

C. Aggregate Exposure

    1. Dietary exposure. There are no established U.S. food tolerances 
for peroxyacetic acid. According to the 1993 RED, peroxyacetic acid is 
used in dairy/cheese processing plants, on food-processing equipment 
and in pasteurizers in breweries, wineries and beverage plants. While 
some contact may occur between treated equipment and food, no residues 
are expected since only trace amounts would come in contact with food 
having contacted treated equipment and the compound degrades rapidly 
(in air) primarily to acetic acid (which is generally regarded as safe 
in food up 0.15%, see 21 CFR 184.1005), oxygen, water and 
H2O2. In addition, peroxyacetic acid may be 
safely used on food-processing equipment, utensils, and other food-
contact articles according to the Food and Drug Administration (21 CFR 
178.1010, Sanitizing Solutions).
    Dietary exposure from these uses is possible; however, peroxyacetic 
acid reacts instantly upon contact with materials such as food and 
degrades to moieties which present no significant toxicological 
concern. The addition to dietary aggregate exposure of peroxyacetic 
acid as described in this petition is minimal.
    2. Drinking water exposure. There is no concern about the potential 
for transfer of peroxyacetic acid residues (both the parent pesticide 
and any degradates) to human drinking water because the use sites for 
peroxyacetic acid listed in the 1993 RED include indoor food, indoor 
non-food, indoor medical, and indoor residential. Peroxyacetic acid is 
proposed for use as an antimicrobial agent on fruits, vegetables, tree 
nuts, cereal grain, herbs, and spices. It is unlikely that residues 
from these uses will transfer peroxyacetic acid residues (both the 
parent and any degradates) to any sources of human drinking water. In 
addition, the degradation products of peroxyacetic acid in aqueous 
solutions are acetic acid (which is generally regarded as safe in food 
up 0.15%, see 21 CFR 184.1005), water and oxygen. These degradation 
products are not of toxicological concern.
    Because of the physical chemistry of this pesticide, it is unlikely 
that any States are conducting water monitoring programs for 
peroxyacetic acid.
    3. Non-occupational exposure. The estimated non-occupational 
exposure to peroxyacetic acid has been evaluated based on its proposed 
use pattern.
    According to the 1993 RED, the compound, in the form of a soluble 
concentrate/liquid, is used in industrial and commercial settings.
    Peroxyacetic acid is highly reactive and short-lived because of the 
inherent instability of the peroxide bond (O-O bond) and, because the 
peroxide bond is weak, transformation to acetic acid, water, oxygen and 
peroxide is very highly favored thermodynamically (1993 RED). The 
degradation products of peroxyacetic acid in aqueous solutions are 
acetic acid (which is generally regarded as safe in food up 0.15%, see 
21 CFR 184.1005), water, oxygen and H2O2. The 
generation of H2O2 is the only potential 
degradate of concern.
    H2O2 use in homes is medicinal and exposures 
are expected to be infrequent and at extremely short topical duration; 
however, it is important to put into perspective the typical medicinal 
dose of H2O2 versus a biocidal dose. Commercially 
available 3% H2O2  ( 30,000 ppm) can be purchased 
for use as a topical and oral disinfectant. When using this product as 
a oral cavity disinfectant, a typical use scenario would be rinsing the 
mouth three times a day. In a typical mouth rinse application, some of 
the rinsing agent is normally ingested; a conservative estimate of 3 ml 
is used in the following example. Assuming that a 70 kg person ingests 
only 3 ml. of the H2O2 solution during each 
rinse, he will be exposed to approximately 3.9 mg/kg 
H2O2 in a single day. This treatment has been 
done millions of times without any adverse effects with the possible 
exception of slight irritation to the oral cavity.
    The potential for significant non-occupational exposure to 
peroxyacetic acid under the use proposed in this petition to the 
general population (including children) is unlikely. Peroxyacetic acid 
is proposed in this petition to be used only at commercial 
establishments (including farms) and is not to be used in or around the 
home.

D. Cumulative Effects

    When used as proposed, peroxyacetic acid dissipates quickly; there 
is no reasonable expectation that residues of these compounds will 
remain in human food items in accordance with 40 CFR 180.3. The mode of 
action of this pesticide is oxidation. Other chemicals that may fall 
into this category are H2O2 acid and potassium 
peroxymonosulfate sulfate as listed in the 1993 RED. Combining 
exposures to these compounds is appropriate; however, each degrades 
rapidly (due to the peroxy bond, the O-O bond) into compounds that are 
not toxicologically significant (including water, oxygen, and carbon 
dioxide).

E. Safety Determination

    1. U.S. general population. Peroxyacetic acid naturally degrades to 
acetic acid (which is generally regarded as safe in food up 0.15%, see 
21 CFR 184.1005), water and oxygen which would not pose a health risk 
to the U.S. general population. These degradation products are not of 
toxicological concern. Small quantities of H2O2 
can also be generated.
    Residues of peroxyacetic acid are not expected on treated 
commodities (whether raw agricultural commodities or processed) and the 
residues are not expected to bioaccumulate in livestock and/or poultry 
that consume treated feedstuffs because peroxyacetic acid is highly 
reactive and short-lived due to the inherent instability of the 
peroxide bond (O-O bond). Because the peroxide bond is weak, 
transformation to acetic acid, water and oxygen is very highly favored 
thermodynamically (1993 RED). The degradation of peroxyacetic acid is 
rapid, therefore, exposure of the pesticide chemical (from the use 
proposed in this petition) to the U.S. general population should not 
occur.
    2. Infants and children. Peroxyacetic acid naturally degrades to 
acetic acid (which is generally regarded as safe in food up 0.15%, see 
21 CFR 184.1005), water and oxygen which would not pose a health risk 
to the U.S. population subgroup of infants and children. These 
degradation products are not of toxicological concern.
    Residues of peroxyacetic acid are not expected on treated 
commodities (whether raw agricultural commodities or processed) and the 
residues are not expected to bioaccumulate in livestock and/or poultry 
that consume treated feedstuffs because peroxyacetic acid is highly 
reactive and short-lived due to the inherent instability of the 
peroxide bond (O-O bond). Because the peroxide bond is weak, 
transformation to acetic acid, water, oxygen and 
H2O2 is very highly favored thermodynamically 
(1993 RED). Therefore, exposure of the pesticide chemical (from the use 
proposed in this petition) to the U.S.

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population subgroup of infants and children should not occur.

F. International Tolerances

    The petitioner understands that there are no current established 
Maximum Residue Levels for peroxyacetic acid.

G. Information on Endocrine Effects

    Peroxyacetic acid does not act like hormones or inhibit hormonal 
activity.

II. Public Record and Electronic Submissions

    The official record for this notice of filing, as well as the 
public version, has been established for this notice of filing under 
docket control number [PF-783] (including comments and data submitted 
electronically as described below). A public version of this record, 
including printed, paper versions of electronic comments, which does 
not include any information claimed as CBI, is available for inspection 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The official record is located at the address in 
``ADDRESSES'' at the beginning of this document.
    Electronic comments can be sent directly to EPA at:
    [email protected]

    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption. Comment and data 
will also be accepted on disks in Wordperfect 5.1/6.1 file format or 
ASCII file format. All comments and data in electronic form must be 
identified by the docket number [PF-783] and appropriate petition 
number. Electronic comments on this notice may be filed online at many 
Federal Depository Libraries.

List of Subjects

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Food additives, Feed additives, Pesticides 
and pests, Reporting and recordkeeping requirements.

    Dated: December 16, 1997.

 Frank Sanders,

Director, Antimicrobials Division, Office of Pesticide Programs.

[FR Doc. 98-928 Filed 1-13-98; 8:45 am]
BILLING CODE 6560-50-F