[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: [email protected].
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:
    [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-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

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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