[Federal Register Volume 63, Number 184 (Wednesday, September 23, 1998)]
[Notices]
[Pages 50901-50903]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25084]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-834; FRL-6028-4]
Notice of Filing of Pesticide Petition
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the initial filing of a pesticide
petition proposing the establishment of regulations for residues of a
certain pesticide chemical in or on various food commodities.
DATES: Comments, identified by the docket control number PF-834, must
be received on or before October 23, 1998.
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
[[Page 50902]]
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: Anne S. Ball, Biopesticides and
Pollution Prevention Division (7511W), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW, Washington, DC 20460.
Office location, telephone number, and e-mail address: Rm. 5th. FL,
Crystal Station #1, 2800 Jefferson Davis Highway, Arlington, VA 22202,
(703) 308-8717; e-mail: ball.anne@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA has received a pesticide petition as
follows proposing the establishment and/or amendment of regulations for
residues of certain pesticide chemical 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-834] (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-834] 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: September 8, 1998.
Kathleen D. Knox
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.
Summary of Petition
The petitioner 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.
Biosafe Systems
PP 8F4996
EPA has received a pesticide petition 8F4996 from Biosafe Systems,
45 E. Woodthrush Trail, East Medford, NJ 08055, proposing pursuant to
section 408(d) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.
346a(d), to amend 40 CFR part 180 to establish an exemption from the
requirement of a tolerance for the biochemical pesticide hydrogen
peroxide in or on all food commodities.
Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended,
Biosafe Systems has submitted the following summary of information,
data and arguments in support of their pesticide petition. This summary
was prepared by Biosafe Systems and EPA has not fully evaluated the
merits of the petition. The summary may have been edited by EPA if the
terminology used was unclear, the summary contained extraneous
material, or the summary was not clear that it reflected the conclusion
of the petitioner and not necessarily EPA.
A. Product Name and Proposed Use Practices
ZeroTol Broad Spectrum Algicide/Fungicide; Oxidate Broad Spectrum
Algicide/Fungicide. Biosafe has already registered ZeroTol for use as
an algicide, bactericide and fungicide to control plant pathogenic
diseases on ornamentals and turf. Biosafe intends to pursue the same
use pattern for Oxidate (bactericide, fungicide) as a plant dip, soil
drench and foliar spray on food crops in greenhouse and agricultural
use sites (such as nurseries). Both products contain 27% hydrogen
peroxide by weight as the active ingredient. The food crops are as
follows: apples, bananas, beans, broccoli, cabbage, cauliflower,
cherries, cucurbits, filberts, grapes, nectarines, onions, peaches,
peppers, plums, potatoes (including seed potatoes), prunes, and
tomatoes.
B. Product Identity/Chemistry
1. Identity of the pesticide. Zerotol and Oxidate Algicide/
Fungicide both contain 27% hydrogen peroxide as the active ingredient
which is a colorless, moderately pungent liquid and is soluble in
water. The pH is 1.05 at 25 deg.C, and it is non-flammable and non-
explosive. In storage it is unstable at 50 deg.C at 30 days, is
moderately corrosive and its viscosity is 0.78 cS at 22 deg.C. The
boiling point is 100 deg.C and the specifie gravity is 1.091 at 22
deg.C.
2. Magnitude of residue at the time of harvest. Biosafe believes
that hydrogen peroxide reacts on contact with a surface on which it is
applied, and rapidly degrades to oxygen and water, neither of which are
of toxicological concern. Biosafe quotes a Federal Register notice of
May 6, 1998 (63 FR 24949) (FRL 5789-2) in which the EPA established an
exemption from the requirement of a tolerance for residues of the
antimicrobial pesticide hydrogen peroxide up to 120 ppm, in or on raw
agricultural commodities, in processed commodities, when such residues
result from the use of hydrogen peroxide as an antimicrobial agent on
fruits, tree nuts, cereal grains, herbs and spices. `` Therefore, the
lack of residues of toxicological concern and the existence of
toxicological effects only at high dose levels (HDL) in experimental
animals minimizes any concern for exposure to the very low doses that
may be present as a result of the proposed uses.''
3. A statement of why an analytical method for detecting and
measuring the levels of the pesticide residue are not needed. Biosafe
has quoted the same Federal Register notice of May 6, 1998
[[Page 50903]]
as follows: `` Hydrogen peroxide is highly reactive and short lived
because of the inherent instability of the peroxide bond (i.e., the O-O
bond). Agitation or contact with rough surfaces, sunlight, organics and
metals accelerates decomposition. The instability of hydrogen peroxide
to exist as itself, along with detoxifying enzymes found in cells (e.g.
catalase, glutathione peroxidase), makes it very difficult to find any
residues in or on foods (at proposed use levels) by conventional
analytical methods.''
C. Mammalian Toxicological Profile
BioSafe Systems proposes products containing 27% hydrogen peroxide
by weight. In all cases the product is diluted with water at a rate of
1:50, 1:100 or 1:300, which results in a concentration of 0.25% to
1.50% hydrogen peroxide in the product that is applied. BioSafe Systems
has cited open literature with respect to toxicity data which shows
that hydrogen peroxide is toxic at high levels; that at a 1.5%
concentration it has no impact on human skin, eyes or respiratory
system; that the concentrate has a pH of 1.05 and thus has been
categorized in Toxicity Category I for skin and eye irritation; that
for the oral route of exposure, a concentration of 0.5% hydrogen
peroxide was determined not to present a possible adverse effect due to
the fact that hydrogen peroxide at concentrations of 0.04 and 0.05% has
been classified as GRAS by FDA and USDA for use as a food additive,
toothpaste or mouthwash. Biosafe summarized open literature pertaining
to toxicology as follows:
Solutions containing 6% hydrogen peroxide have an acute oral
LD50 >5,000 milligram/kilogram (mg/kg) in rats (Toxicity
Category III), an acute dermal LD50 > 10,000 mg/kg in
rabbits (Toxicity Category IV), and an inhalation LC50 of 4
mg/l (Toxicity Category IV). Such solutions are mild irritants to
rabbit skin and cause severe, irreversible corneal injury in half of
the exposed rabbits (Toxicity Category I).
Solutions containing 50% hydrogen peroxide have an acute oral
LD50 > 500 mg/kg in rats (Toxicity Category II) and an acute
dermal LD50 >1,000 mg/kg in rabbits (Toxicity Category II).
No deaths resulted after an 8-hour exposure of rats to saturated vapors
of 90% hydrogen peroxide, LC50 is 4 mg/l (2,000 ppm).
Solutions containing 50% hydrogen peroxide are also extremely
irritating (corrosive) to rabbit eyes (Toxicity Category I).
D. Aggregate Exposure
1. Dietary exposure-- Food. BioSafe has asserted that dietary
exposure from use of hydrogen peroxide, as proposed is minimal since
hydrogen peroxide reacts rapidly on contact with surfaces such as food
and degrades into oxygen and water, neither of which are of
toxicologial concern.
2. Drinking water. BioSafe states that the proposed use may result
in the transfer of minor amounts of residues to potential drinking
water sources, however there is no concern for exposure due to the fact
that the residues of hydrogen peroxide are oxygen and water, neither of
which are of toxicological concern. Biosafe quotes the existing
exemption'' the EPA Office of Water indicates that when used for
potable disinfection, no residues of hydrogen peroxide are present by
the time the water is pumped through a distribution system.'' 40 CFR
180.1197.
3. Non-dietary exposure. BioSafe states that the potential for non-
dietary exposure to the general population including infants and
children is unlikely as the proposed use sites are commercial,
agricultural and horticultural settings and that non-dietary exposures
would not be expected pose any quantifiable risk due to lack of
residues of toxicological concern.
E. Cumulative Exposure
BioSafe states that it is not expected that, when used as proposed,
hydrogen peroxide would result in residues that would remain in human
food items since hydrogen peroxide reacts on contact and degrades
rapidly into compounds that are not of toxicological concern.
F. Safety Determination
1. U.S. population. Biosafe quotes from the established exemption
from the requirement of a tolerance that EPA has concluded that no
endpoint exists to suggest any evidence of significant toxicity from
acute, short-term or intermediate-term exposures from the proposed food
contact uses of hydrogen peroxide''. BioSafe states that since hydrogen
peroxide degrades rapidly on contact into residues that are not of
toxicological concern, chronic risk from dietary exposure is not
anticipated and since residues of hydrogen peroxide are not expected on
agricultural commodities, exposure to the general U.S. population from
the proposed uses is not anticipated.
2. Infants and children. BioSafe states that, as mentioned above,
residues of hydrogen peroxide are not expected on agricultural
commodities and that hydrogen peroxide degrades rapidly on contact into
residues that are of no toxicological concern and that there is a
reasonable certainty of no harm for infants and children from exposure
to hydrogen peroxide from the proposed uses.
G. Effects on the Immune and Endocrine Systems
BioSafe has cited open literature in that weak direct mutagenicity
responses were seen for hydrogen peroxide in Ames tests with Salmonella
typhimurium strains TA97, TA98, TA102, and TA1537 in a 20 minute
preincubation test and in a liquid incubation modification using strain
TA1537. Biosafe states that there is additional information regarding
immunotoxicity, developmental toxicity and chronic toxicity in the open
literature.
H. Existing Tolerances
An exemption from the requirement of a tolerance has been
established for residues of hydrogen peroxide up to 120 ppm in or on
raw agricultural commodities, in processed commodities, when such
residues result from the use of hydrogen peroxide as an antimicrobial
agent on fruits, tree nuts, cereal grains, herbs and spices (40 CFR
180.1197).
I. International Tolerances
There is no Codex Alimentarium Commision Maximum Residue Level
(MRL) for hydrogen peroxide.
[FR Doc. 98-25084 Filed 9-22-98; 8:45 am]
BILLING CODE 6560-50-F
