[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,
[[Page 2233]]
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:
edwards.dennis@epamail.epa.gov.
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:
opp-docket@epamail.epa.gov
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
