Ecolab Inc.; Pesticide Tolerance Petition Filing

Note: EPA no longer updates this information, but it may be useful as a reference or resource.
 [Federal Register: January 14, 1998 (Volume 63, Number 9)]
[Notices]               
[Page 2235-2237]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14ja98-70]

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ENVIRONMENTAL PROTECTION AGENCY
[PF-784; FRL-5759-7]
 
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 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 H₂O₂produces 
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 H₂O₂solution 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
Ecolab Inc.; Pesticide Tolerance Petition Filing

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