[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:
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 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
