[Federal Register Volume 64, Number 22 (Wednesday, February 3, 1999)]
[Notices]
[Pages 5273-5277]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-2553]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-851; FRL-6052-1]


Notice of Filing; Pesticide Petitions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of pesticide 
petitions proposing the establishment of regulations for residues of 
certain

[[Page 5274]]

pesticide chemicals in or on various food commodities.

DATES: Comments, identified by the docket control number PF-851, must 
be received on or before March 5, 1999.

ADDRESSES: By mail submit written comments to: Information and Records 
Integrity Branch, Public Information and Services Divison (7502C), 
Office of Pesticides Programs, Environmental Protection Agency, 401 M 
St., SW., Washington, DC 20460. In person bring comments to: Rm. 119, 
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. 119 at the 
address given above, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: Marshall Swindell, Antimicrobial 
Division (7510C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW, Washington, DC 20460. Office 
location, telephone number, and e-mail address:, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA 22202, (703) 308-6411; e-
mail:swindell.marshall @epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA has received pesticide petitions as 
follows proposing the establishment and/or amendment of regulations for 
residues of certain pesticide chemicals in or on various food 
commodities under section 408 of the Federal Food, Drug, and Comestic 
Act (FFDCA), 21 U.S.C. 346a. EPA has determined that this petition 
contains data or information regarding the elements set forth in 
section 408(d)(2); however, EPA has not fully evaluated the sufficiency 
of the submitted data at this time or whether the data supports 
granting of the petition. Additional data may be needed before EPA 
rules on the petition.
    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-851] (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 control number (PF-851) and appropriate 
petition number. Electronic comments on this notice may be filed online 
at many Federal Depository Libraries.

List of Subjects

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

    Dated: January 13, 1999.

Frank Sanders,

Director, Antimicrobial Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner's summary of the pesticide petition is printed below 
as required by section 408(d)(3) of the FFDCA. The summary of the 
petition was prepared by the petitioner and represents the views of the 
petitioner. EPA is publishing the petition summaries verbatim without 
editing them in any way. The petition summary announces the 
availability of a description of the analytical methods available to 
EPA for the detection and measurement of the pesticide chemical 
residues or an explanation of why no such method is needed.

1. Ecolab Inc.

 9F5038

    EPA has received a pesticide petition (9F5038) from Ecolab Inc., 
370 Wabasha Street N., St. Paul, MN 55102, 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 to establish an exemption from 
the requirement of a tolerance for the residues of hydrogen peroxide in 
or on all foods when the residues are the result of the lawful 
application of a food contact surface sanitizer containing hydrogen 
peroxide up to 1,100 ppm as a sanitizing solution in food handling 
establishments.
    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 pesticide petition. The summary may have been edited by EPA if the 
terminology used was unclear, the summary contained extraneous 
material, or the summary unintentionally made the reader conclude that 
the findings reflected EPA's position and not the position of the 
petitioner.

A. Product Name and Proposed Use Practices

    The request is to exempt from the requirement of a tolerance, 
residues of hydrogen peroxide in or on all food when such residues 
result from the lawful use of hydrogen peroxide as a component in a 
food contact surface sanitizer.
    The residues which do remain are not of toxicological significance.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. Residues 
of hydrogen peroxide are not expected because hydrogen peroxide reacts 
immediately on contact with materials such as food, reducing agents and 
catalysts 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 ultimate degradation 
products of hydrogen peroxide are water and oxygen (1993 RED). The 
degradation products of hydrogen peroxide are not of toxicological 
concern.
    2. Magnitude of residue and method used to determine the hydrogen 
peroxide residue. Not applicable.
    3. A statement of why an analytical method for detecting and 
measuring the hydrogen peroxide levels of the pesticide residue are not 
needed. Because this petition is a request for an exemption and 
residues are not expected on food from use of hydrogen peroxide as a 
component of a food

[[Page 5275]]

contact surface sanitizer on food contact surfaces.

C. Mammalian Toxicological Profile

     Based on the current body of toxicological literature available, 
adverse effects are not expected when used in the proposed manner.

D. Aggregate Exposure

    1. Dietary exposure--i. Food. There are no established U.S. food 
tolerances for hydrogen peroxide. The U.S. EPA established an exemption 
from the requirement of a tolerance for residues of the antimicrobial 
pesticide hydrogen peroxide, in or on raw agricultural commodities, in 
processed commodities, when such residues result from the lawful use of 
hydrogen peroxide as an antimicrobial agent on fruits, vegetables, tree 
nuts, cereal grains, herbs, and spices up to 120 ppm. According to the 
1993 RED, hydrogen peroxide 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 and in contact with organic 
materials to oxygen and water. In addition, hydrogen peroxide may be 
safely used on food-processing equipment, utensils, and other food-
contact articles according to the Food and Drug Administration (FDA) 
(21 CFR 178.1010, Sanitizing Solutions).
    Dietary exposure from these uses is possible; however, hydrogen 
peroxide reacts instantly upon contact with materials such as food and 
degrades to moieties which present no toxicological concern. The 
addition to dietary aggregate exposure of hydrogen peroxide as 
described in this petition is expected to be zero.
    ii.  Drinking water. There is no concern about the potential for 
transfer of hydrogen peroxide residues (both the parent compound and 
any degradates) to human drinking water because the use sites for 
hydrogen peroxide listed in the 1993 RED include indoor food, indoor 
non-food, indoor medical, and indoor residential. Hydrogen peroxide is 
approved for use as an antimicrobial agent on fruits, vegetables, tree 
nuts, cereal grain, herbs, and spices. It is unlikely that residues 
from these uses or the proposed use will transfer hydrogen peroxide 
residues (both the parent and any degradates) to any sources of human 
drinking water. In addition, the degradation products of hydrogen 
peroxide in aqueous solutions are 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 hydrogen 
peroxide.
    iii. Non-dietary exposure. The estimated non-occupational exposure 
to hydrogen peroxide 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.
    Hydrogen peroxide use in homes is medicinal and exposures are 
expected to be infrequent and at extremely short duration as a topical 
antimicrobial agent or a mouthwash.
    Hydrogen peroxide 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 hydrogen peroxide in aqueous solutions are water and oxygen. The 
degradation products of hydrogen peroxide 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. Hydrogen peroxide 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.

E. Cumulative Exposure

    When used as proposed, hydrogen peroxide decomposes 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 share a 
similar mode of action are peroxyacetic acid and potassium 
peroxymonosulfate sulfate as listed in the 1993 RED. Combining 
exposures to these compounds could be 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).

F. Safety Determination

    1.  U.S. population. Hydrogen peroxide naturally degrades to water 
and oxygen which would not pose a health risk to the U.S. general 
population. These degradation products are not of toxicological 
concern.
    2. Infants and children. Hydrogen peroxide 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 are not expected on food 
from use of hydrogen peroxide as a component of a food contact surface 
sanitizer on food contact surfaces. The residues do not bioaccumulate 
in livestock and/or poultry that consume treated feedstuffs because 
hydrogen peroxide 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.

G. Effects on the Immune and Endocrine Systems

    Hydrogen peroxide is not structurally similar to any known chemical 
capable of producing adverse effect on the endocrine system.

H. International Tolerances

    The petitioner understands that there are no current established 
Maximum Residue Levels (MRLs) for hydrogen peroxide.

2. Ecolab Inc.

 PP 9F5039

    EPA has received a pesticide petition (9F5039) from Ecolab Inc., 
370 Wabasha Street, N., St. Paul, MN 55102, 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 to establish an exemption from 
the requirement of a tolerance for the residues of peroxyacetic acid in 
or on all foods when the residues are the results of the lawful 
application of a foods contact surface sanitizer containing 
peroxyacetic acid up to 500 ppm as a sanitizing solution in food 
handling establishments.
    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 pesticide petition. The summary may have been edited by EPA if the 
terminology used was unclear, the

[[Page 5276]]

summary contained extraneous material, or the summary unintentionally 
made the reader conclude that the findings reflected EPA's position and 
not the position of the petitioner.

A. Product Name and Proposed Use Practices

     The request is to exempt from the requirement of a tolerance, 
residues of peroxyacetic acid in or on all food when such residues 
result from the lawful use of peroxyacetic acid as a component in a 
food contact surface sanitizer.
    The residues which do remain are not of toxicological significance.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. Residues 
of peroxyacetic acid are not expected on food because peroxyacetic acid 
reacts immediately on contact with materials such as food, reducing 
agents and catalysts and is degraded to moieties which present no 
toxicological concern (Reregistration Eligibility Decision, Peroxy 
Compounds, U.S. EPA. EPA 738-R-93-030). The ultimate degradation 
products of peroxyacetic acid are acetic acid (which is generally 
regarded as safe in food up 0.15 %, 21 CFR 184.1,005), water and 
oxygen. The degradation products of peroxyacetic acid are not of 
toxicological concern.
    2. Magnitude of residue and method used to determine the 
peroxyacetic acid residue. Not Applicable.
    3. A statement of why an analytical method for detecting and 
measuring the peroxyacetic acid levels of the pesticide residue are not 
needed. Because this petition is a request for an exemption and 
residues are not expected on food from use of peroxyacetic acid as a 
component of a food contact surface sanitizer on food contact surfaces.

C. Mammalian Toxicological Profile

     Based on the current body of toxicological literature available, 
adverse effects are not expected when used in the proposed manner.

D. Aggregate Exposure

    Dietary exposure--i. Food. There are no established U.S. food 
tolerances for peroxyacetic acid. The U.S. EPA established an exemption 
from the requirement of a tolerance for residues of the antimicrobial 
pesticide peroxyacetic acid, in or on raw agricultural commodities, in 
processed commodities, when such residues result from the lawful use of 
peroxyacetic acid as an antimicrobial agent on fruits, vegetables, tree 
nuts, cereal grains, herbs, and spices up to 100 ppm. 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 and in contact with organic 
materials to acetic acid (which is generally regarded as safe in food 
up 0.15 %, see 21 CFR 184.1005), oxygen and water. 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 (FDA) (21 CFR 178.1010, Sanitizing Solutions).
    Dietary exposure from these uses is possible; however, peroxyacetic 
acid reacts immediately upon contact with materials such as food and 
degrades to moieties which present no toxicological concern. The 
addition to dietary aggregate exposure of peroxyacetic acid as 
described in this petition is expected to be zero.
    ii. Drinking water. There is no concern about the potential for 
transfer of peroxyacetic acid residues (both the parent compound 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 
approved for use as an antimicrobial agent on fruits, vegetables, tree 
nuts, cereal grain, herbs, and spices. It is essentially impossible 
that residues from these uses or the proposed use 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.
    iii. Non-dietary 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 and oxygen 
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 and oxygen. The degradation products of peroxyacetic 
acid are not of toxicological concern.
    The potential for any non-occupational exposure 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 proposed for use in or around the home.

E. Cumulative Exposure

     When used as proposed, peroxyacetic acid decomposes 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 share a 
similar mode of action are peroxyacetic acid and potassium 
peroxymonosulfate sulfate as listed in the 1993 RED. Combining 
exposures to these compounds could be 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).

F. Safety Determination

    1. U.S. 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.
    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 food from use of peroxyacetic 
acid as a component of a food contact surface sanitizer on food contact 
surfaces. The residues do not 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

[[Page 5277]]

peroxide bond is weak, transformation to acetic acid, water and oxygen 
is very highly favored thermodynamically (1993 RED). The degradation 
products of peroxyacetic acid are acetic acid (which is generally 
regarded as safe in food up 0.15%, see 21 CFR 184.1005), 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.

G. Effects on the Immune and Endocrine Systems

    Peroxyacetic acid is not structurally similar to any known chemical 
capable of producing adverse effect on the endocrine system.

H. International Tolerances

    The petitioner understands that there are no current established 
Maximum Residue Levels (MRL) for peroxyacetic acid.
[FR Doc. 99-2553 Filed 2-2-98; 8:45 am]
BILLING CODE 6560-50-F