[Federal Register Volume 63, Number 9 (Wednesday, January 14, 1998)]
[Notices]
[Pages 2235-2237]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-929]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[PF-784; FRL-5759-7]
Ecolab Inc.; Pesticide Tolerance Petition Filing
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of filing.
-----------------------------------------------------------------------
SUMMARY: This notice announces the filing of a pesticide petition
proposing the exemption from the requirement of a tolerance for
residues of hydrogen peroxide (H2O2) 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
H2O2 as an antimicrobial agent on fruits,
vegetables, tree nuts, cereal grains, herbs, and spices.
DATES: Comments, identified by the docket control number [PF-784] 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, 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
7F4834) 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 H2O2 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
H2O2 as an antimicrobial agent on fruits,
vegetables, tree nuts, cereal grains, herbs, and spices. The proposed
analytical method is titration. Pursuant to 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 H2O2 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
H2O2 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 H2O2 are not expected because
H2O2 reacts 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 ``1993 RED''). The degradation products of
H2O2 in aqueous solutions are water and oxygen
(1993 RED). The degradation products of H2O2 are
not of toxicological concern.
Because this petition is for an exemption from the requirement of a
[[Page 2236]]
tolerance, an enforcement method for H2O2 is not
needed. However, a titration method to determine residues of
H2O2 has been submitted to the Agency.
B. Toxicological Profile
H2O2 is a moderately acutely toxic material
with an oral LD50 of approximately 2,000 mg/kg in mice (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 3%, and below, of 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 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 and
strain TA102. 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 H2O2. According to the 1993 RED,
H2O2 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) [remove primarily] to oxygen and
water. In addition, H2O2 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,
H2O2 reacts rapidly upon contact with materials
such as food and degrades to moieties which present no toxicological
concern. The addition to dietary aggregate exposure of
H2O2 as described in this petition is minimal.
2. Drinking water exposure. There is no concern about the potential
for transfer of H2O2 residues (both the parent
pesticide and any degradates) to human drinking water because the use
sites for H2O2 listed in the 1993 RED include
indoor food, indoor non-food, indoor medical, and indoor residential.
H2O2 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
H2O2 residues (both the parent and any
degradates) to any sources of human drinking water. In addition, the
degradation products of H2O2 in aqueous solutions
are water and oxygen. These degradation products are not of
toxicological concern.
Because of the physical chemistry of this biocide, it is unlikely
that any States are conducting water monitoring programs for
H2O2.
3. Non-occupational exposure. The estimated non-occupational
exposure to H2O2 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.
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.
H2O2 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 water and
oxygen is very highly favored thermodynamically (1993 RED). The
degradation products of H2O2 in aqueous solutions
are water and oxygen. The degradation products of
H2O2 are not of toxicological concern.
The potential for significant non-occupational exposure under the
use proposed in this petition to the general population (including
infants and children) is unlikely. H2O2 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, H2O2 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 peroxyacetic 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. H2O2 occurs
naturally in the earth's atmosphere. It is also generated in surface
water by the action of sunlight. It naturally degrades to water and
oxygen which would not pose a health
[[Page 2237]]
risk to the U.S. general population. These degradation products are not
of toxicological concern. The human body produces measurable quantities
of H2O2 during metabolism and specifically for
the destruction of pathogens by phagocytes. The body possess several
systems for the removal of H2O2 including
catalase and peroxidases including glutathione peroxidase.
Residues of H2O2 are not expected on treated
commodities (whether raw agricultural commodities or processed) and the
residues do not bioaccumulate in livestock and/or poultry that consume
treated feedstuffs because H2O2 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 water and oxygen is very highly favored
thermodynamically (1993 RED). The degradation products of hydrogen
peroxide are water and oxygen. 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. H2O2 naturally
degrades to 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 H2O2 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 H2O2 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 water and oxygen is very highly favored
thermodynamically (1993 RED). The degradation products of
H2O2 are water and oxygen. Therefore, exposure of
the pesticide chemical (from the use proposed in this petition) to the
U.S. 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 H2O2.
G. Information on endocrine effects
H2O2 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-784] (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 file format or ASCII
file format. All comments and data in electronic form must be
identified by the docket number (PF-784) 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. 98-929 Filed 1-13-98; 8:45 am]
BILLING CODE 6560-50-F
