[Federal Register Volume 66, Number 212 (Thursday, November 1, 2001)]
[Notices]
[Pages 55175-55178]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-27469]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1047; FRL-6805-7]


Notice of Filing a Pesticide Petition to Establish a Tolerance 
for a Certain Pesticide Chemical in or on Food

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 docket control number PF-must be 
received on or before December 3, 2001.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number PF-1046 the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Linda Hollis, Biopesticides 
and Pollution Prevention Division, Registration Division (7505W), 
Office of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 
308-8733; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

 
------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production

[[Page 55176]]

 
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet homepage at http://www.epa.gov/. 
To access this document, on the homepage select ``Laws and 
Regulations'' `` Regulation and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number PF-1046. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, and other 
information related to this action, including any information claimed 
as confidential business information (CBI). This official record 
includes the documents that are physically located in the docket, as 
well as the documents that are referenced in those documents. The 
public version of the official record does not include any information 
claimed as CBI. The public version of the official record, which 
includes printed, paper versions of any electronic comments submitted 
during an applicable comment period, is available for inspection in the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number PF-1046 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket control number PF-000. Electronic comments may 
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI by marking any part or all of that information as 
CBI. Information so marked will not be disclosed except in accordance 
with procedures set forth in 40 CFR part 2. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the person identified under FOR FURTHER INFORMATION 
CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a 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 support granting of the petition. Additional data 
may be needed before EPA rules on the petition.

[[Page 55177]]

List of Subjects

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

    Dated: October 17, 2001.
Janet L. Anderson,
Director, Registration 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 view of the 
petitioners. EPA is publishing the petition summary verbatim without 
editing it 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, 
80 Commerce Street, Glastonbury, CT 06033], 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 amendment/
expansion of an existing tolerance exemption for the biochemical 
pesticide hydrogen peroxide in or on all postharvest agricultural food 
commodities at the rate of  1% hydrogen peroxide per application.
    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 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

    Hydrogen peroxide is for use to control plant pathogenic diseases 
on plants, food commodities, greenhouse surfaces and other agricultural 
use sites. BioSafe Systems maintains 2 registrations for 27.00% 
hydrogen peroxide end-use products, ZeroTol (EPA Reg. No. 70299-1) and 
Oxidate (EPA Reg. No. 70299-2), for these uses.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. Hydrogen 
peroxide reacts on contact with a surface on which it is applied, and 
rapidly degrades to oxygen and water, neither of which is of 
toxicological concern.
    2. Analytical method. An analytical method for the detection of 
residues of hydrogen peroxide is not applicable. Hydrogen peroxide is 
used in low concentrations and rapidly degrades into water and oxygen.

C. Mammalian Toxicological Profile

    Hydrogen peroxide at a concentration of 27% has a pH of 1.05, at 
which concentration the Agency assumes a toxicity category I for skin 
and eye irritation. BioSafe Systems has submitted toxicology 
information from open literature for aqueous solutions containing 6% 
and 50% hydrogen peroxide. The concentrate (27% hydrogen peroxide) will 
be diluted with water at the rate of 1:50 or 1:100 or 1:300 and thus, 
the concentration of hydrogen peroxide in the product at the time of 
application will range from 0.09% to 0.54%.
    The information from open literature demonstrated that solutions 
containing 6% hydrogen peroxide have an acute oral LD50 
5,000 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 milligrams per liter (mg/l) 
(toxicity category IV). The 6% hydrogen peroxide solutions are mild 
irritants to rabbit skin and cause sever irreversible corneal injury in 
half of the exposed rabbits (toxicity category I). Toxicology 
information from open literature demonstrated that solutions that 
contained 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 that contain 50% hydrogen peroxide are also extremely 
irritating (corrosive) to rabbit eyes (toxicity category I).
    EPA has concluded that for food use at an application rate of 
1% hydrogen peroxide, no apparent acute toxicity and 
subchronic toxicity end-points exist to suggest a significant toxicity. 
An RfD (chronic toxicity) for hydrogen peroxide has not been estimated 
because of its short half-life in the environment and lack of any 
residues of toxicological concern. For similar reasons, an additional 
safety factor was not judged necessary to protect the safety of infants 
and children. Additionally, hydrogen peroxide is listed by the Food and 
Drug Administration as Generally Recognized as Safe (GRAS).
    Additionally, hydrogen peroxide is used to treat food at a maximum 
level of 0.05% in milk used in cheese-making, 0.04% in whey, 0.15% in 
starch and corn syrup, and 1.25% in emulsifiers containing fatty acid 
esters as bleaching agents (21 CFR Part 184.1366). As a GRAS su stance, 
hydrogen peroxide may be used in washing or to assist in the lye 
peeling of fruits and vegetables (21 CFR 173.315).

D. Aggregate Exposure

    1. Dietary exposure--i. Food. For the proposed uses, the 
concentrate of hydrogen peroxide will be diluted with water ate the 
rate of 1:50, 1:100 or 1:300 corresponding to a low concentration of 
hydrogen peroxide in the product at the time of application (0.09% - 
0.54%). The solution, having a low concentration of hydrogen peroxide, 
reacts on contact with the surface on which it is sprayed, and degrades 
rapidly to oxygen and water. Therefore residues in or on treated food 
commodities (growing and postharvest crops) are expected to be 
negligible. Additional sources of the GRAS substance hydrogen peroxide 
in concentrations range from 0.04% to 1.25% in various foods as cited 
above (21 CFR Part 184.1366).
    ii. Drinking water. At the proposed application rates, the use of 
hydrogen peroxide to treat food commodities will result in minimal 
transfer of residues to potential drinking water sources. This is due 
to the low application rate and the rapid chemical degradation of 
hydrogen peroxide into oxygen and water, neither of which is of 
toxicological concern. The EPA Office of Water has stated that it has 
seen no new data that contradict the assessment previously given which 
is that low concentrations of hydrogen peroxide do not typically 
persist in drinking water at levels that pose a health risk.
    2. Non-dietary exposure. There will be minimal amounts of non-
dietary exposure to hydrogen peroxide, primarily through infrequent or 
short use of topical hydrogen peroxide products for treating minor skin 
injuries, and through use of oral mouthwashes. Exposure is expected to 
be minimal, and when used hydrogen

[[Page 55178]]

peroxide rapidly degradates into oxygen and water, neither of which is 
of toxicological concern.

E. Cumulative Exposure

    Because of the low use rates of hydrogen peroxide, its low toxicity 
and rapid degradation, EPA does not believe that there is any concern 
regarding the potential for cumulative effects of hydrogen peroxide 
with other substances due to a common mechanism of action. Because 
hydrogen peroxide is not known to have a common toxic metabolite with 
other substances, EPA has not assumed that hydrogen peroxide has a 
common mechanism of toxicity with other substances.

F. Safety Determination to the General U.S. Population, and Infants and 
Children

    Because hydrogen peroxide is of low toxicity, the proposed uses 
employ low concentrations of hydrogen peroxide, and hydrogen peroxide 
degrades rapidly following application, EPA concludes that this 
exemption from the requirement of a tolerance in or on all food 
commodities for hydrogen peroxide, when applied at 1%, will 
not pose a dietary risk under reasonably foreseeable circumstances. 
Further, the EPA Office of Water has stated that it has seen no new 
data that contradict the assessment previously given which is that low 
concentrations of hydrogen peroxide do not typically persist in 
drinking water at levels that pose a health risk. Accordingly EPA 
concluded that there is a reasonable certainty of no harm to consumers, 
including infants and children, from aggregate exposure to hydrogen 
peroxide.

G. Effects on the Immune and Endocrine Systems

    There is no evidence to suggest that hydrogen peroxide in the 
proposed concentrations will adversely affect the endocrine system.

H. Existing Tolerances

    An exemption from the requirement of a tolerance (40 CFR Part 
180.1197) is established for residues of hydrogen peroxide in or on all 
food commodities at the rate of  1% hydrogen peroxide per 
application on growing crops and postharvest potatoes when applied as 
an algaecide, fungicide and bactericide.

I. International Tolerances

    There is no Codex Alimentarium Commission Maximum Residue Level 
(MRL) for hydrogen peroxide.
[FR Doc. 01-27469 Filed 10-31-01; 8:45 am]
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