[Federal Register: March 31, 2004 (Volume 69, Number 62)]
[Notices]
[Page 16925-16929]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31mr04-86]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2004-0006; FRL-7342-4]
Reynoutria Sachalinensis; 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 identification (ID) number OPP-
2004-0006, must be received on or before April 30, 2004.
ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier. Follow the detailed instructions as
provided in Unit I. of the SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: Driss Benmhend, Biopesticides and
Pollution Prevention Division (7511C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-9525; e-mail
address: benmhend.driss@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS 111)
Animal production (NAICS 112)
Food manufacturing (NAICS 311)
Pesticide manufacturing (NAICS 32532)
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 this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
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 Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket ID number OPP-2004-0006. The official public docket
consists of the documents specifically referenced in this action, any
public comments received, and other information related to this action.
Although a part of the
[[Page 16926]]
official docket, the public docket does not include Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. The official public docket is the collection of
materials that is available for public viewing at the Public
Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall
2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The docket telephone number is (703) 305-
5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
Certain types of information will not be placed in EPA's Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA's electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the
document is available for viewing in EPA's electronic public docket.
Although not all docket materials may be available electronically, you
may still access any of the publicly available docket materials through
the docket facility identified in Unit I.B.1. EPA intends to work
towards providing electronic access to all of the publicly available
docket materials through EPA's electronic public docket.
For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.
C. How and to Whom Do I Submit Comments?
You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number in the subject line on the first page of
your comment. Please ensure that your comments are submitted within the
specified comment period. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to consider
these late comments. If you wish to submit CBI or information that is
otherwise protected by statute, please follow the instructions in Unit
I.D. Do not use EPA Dockets or e-mail to submit CBI or information
protected by statute.
1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/
, and follow the online instructions for submitting comments.
Once in the system, select ``search,'' and then key in docket ID number
OPP-2004-0006. The system is an ``anonymous access'' system, which
means EPA will not know your identity, e-mail address, or other contact
information unless you provide it in the body of your comment.
ii. E-mail. Comments may be sent by e-mail to opp-docket@epa.gov,
Attention: Docket ID Number OPP-2004-0006. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included as
part of the comment that is placed in the official public docket, and
made available in EPA's electronic public docket.
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
2. By mail. Send your comments to: Public Information and Records
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2004-0006.
3. By hand delivery or courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket
ID Number OPP-2004-0006. Such deliveries are only accepted during the
docket's normal hours of operation as identified in Unit I.B.1.
[[Page 16927]]
D. How Should I Submit CBI to the Agency?
Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
mark the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is 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 docket and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person listed 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
ID 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 Cosmetic Act (FFDCA), 21 U.S.C. 346a.
EPA has determined that this petition contains data or information
regarding the elements set forth in FFDCA 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.
List of Subjects
Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: March 24, 2004.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
Summary of Petition
The petitioner's summary of the pesticide petition is printed below
as required by FFDCA section 408(d)(3). The summary of the petition was
prepared by the petitioner and represents the view of the petitioner.
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.
Interregional Research Project Number 4 (IR-4)
PP 3E6751
EPA has received a pesticide petition (3E6751) from Interregional
Research Project Number 4 (IR-4), New Jersey Agricultural Experiment
Station, Technology Center of New Jersey, Technology Centre of New
Jersey, 681 U.S. Highway 1 South, North Brunswick, NJ 08902-
3390, on behalf of KHH BioSci Inc., 920 Campus Drive, Suite 101,
Raleigh, NC 27606 proposing pursuant to section 408(d) of the FFDCA, 21
U.S.C. 346a(d) to establish a tolerance exemption for the biochemical
pesticide Reynoutria sachalinensis in all food commodities.
Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, the
aforesaid IR-4, on behalf of KHH BioSci Inc., has submitted the
following summary of information, data, and arguments in support of the
pesticide petition. This summary was prepared by IR-4 on behalf of KHH
BioSci 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
Reynoutria sachalinensis, is an extract of a naturally occurring
plant of that botanical name, and is proposed for use to reduce the
incidence of plant diseases. When applied just prior to disease
incidence, Reynoutria sachalinensis induces plant defenses making
treated plants more resistant to certain diseases. Reynoutria
sachalinensis is applied to ornamental and food crops in a 0.5 to 1%
solution at a rate of up to 100 gallons of solution per acre. The
pesticide is registered for use in non-food crops (EPA Registration
72179-2). This petition proposes to establish a permanent
exemption from the requirement of a tolerance for residues of
Reynoutria sachalinensis in or on all food commodities.
B. Product Identity/Chemistry
1. Identity of the pesticide and corresponding residues. The
pesticide and corresponding residues are identified as Reynoutria
sachalinensis, a plant extract. Residues resulting from the use of
Reynoutria sachalinensis extract on food crops could be difficult to
characterize since many of the same phenolic compounds promoted by
Reynoutria sachalinensis extract, are already present in vegetables. A
waiver has been requested for nature of the residue studies on
Reynoutria sachalinensis extract.
2. Magnitude of residue at the time of harvest and method used to
determine the residue. Reynoutria sachalinensis is a plant extract. An
analytical method for detecting residues was not submitted as this
petition proposes an exemption from the requirement of a tolerance.
3. A statement of why an analytical method for detecting and
measuring the levels of the pesticide residue are not needed. An
analytical method for enforcement purposes to detect residues was not
submitted as this petition proposes an exemption from the requirement
of a tolerance.
C. Mammalian Toxicological Profile
Acute toxicity studies on the technical active ingredient
(manufacturing use product) and formulated material have been submitted
and reviewed in support of the existing product registration for
[[Page 16928]]
greenhouse, non-food use. These studies and EPA's conclusions are
summarized below.
An acute oral toxicity test was performed using the manufacturing
use product, Milsana Bioprotectant (technical active ingredient). Based
on a lack of mortality observed in albino rats, the oral lethal dose
(LD)50 of the technical active ingredient product, was
>5,000 milligrams/kilogram (mg/kg); toxicity category IV.
An acute oral toxicity study of Milsana Bioprotectant Concentrate
(Milsana[reg], a formulated end-use product) was conducted.
Based on a lack of mortality observed in albino rats, the oral
LD50 of the end-use product was >5,000 mg/kg; toxicity
category IV.
An acute dermal toxicity study was conducted using the
manufacturing use product, Milsana Bioprotectant (technical active
ingredient). Based on a lack of mortality observed in albino rabbits,
the LD50 was >2,000 mg/kg; toxicity category III.
An acute dermal toxicity study of Milsana Bioprotectant Concentrate
(Milsana[reg], formulated end-use product) was conducted.
Based on a lack of mortality observed in albino rabbits, the
LD50 was >2,000 mg/kg; toxicity category III.
An acute inhalation toxicity study of Milsana[reg], a
formulated end-use product was conducted in albino rats. The conclusion
was that the lethal concentration (LC)50 is >2.6 milligram/
Liter (mg/L); toxicity category IV.
An acute eye irritation study of Milsana Bioprotectant Concentrate
Milsana[reg], a formulated end-use product) was conducted.
The study demonstrated that a dose of 0.1 milliliter (mL) resulted in
the highest average ocular irritation index was 23.3, recorded 1-hour
after instillation of the test substance into the eyes of albino
rabbits. This classifies Milsana[reg] as moderately
irritating with a toxicity category II. However, when the technical
grade of the active ingredient (TGAI) was used as a test material, the
highest average ocular irritation recorded was 12.2, toxicity category
III. Therefore, it is reasonable to conclude that the formulated end
use product contains an eye irritant.
An acute dermal irritation study of Milsana Bioprotectant
Concentrate (Milsana[reg], formulated end-use product) was
conducted in albino rabbits. The conclusion was that dermal application
of 0.5 gram (g) of liquid product did not cause any dermal irritation
symptoms up to 72 hours post dosing; toxicity category IV.
A skin sensitization study of Milsana Bioprotectant Concentrate
(Milsana [reg], formulated end-use product) was conducted
with albino guinea pigs. The conclusion was that the test substance is
not considered to be a contact sensitizer in guinea pigs by the Buehler
method.
Based on these studies, we concluded that Reynoutria sachalinensis
does not present an acute toxicity risk to mammals. Since no adverse
effects were observed in the Tier I acute toxicity studies, data
waivers were requested for the following toxicology studies:
Genotoxicity study, immune response, mutagenicity, chronic toxicity,
and developmental toxicity. In addition, the following rationales were
used as a basis for the data waiver requests:
1. Researchers, manufacturers, and other workers have worked with
Reynoutria sachalinensis and it is currently used in greenhouse
production without report of any adverse health effects.
2. Reynoutria sachalinensis is widely distributed in the
environment.
3. The label will require applicators and other handlers to wear
personal protective equipment (PPE), to mitigate against exposure.
D. Aggregate Exposure
1. Dietary exposure--i. Food. Dietary exposure to Reynoutria
sachalinensis, should not be of concern due to the low toxicity shown
in the acute toxicity studies previously submitted. In addition,
Reynoutria sachalinensis is widespread throughout the United States,
Europe, and Asia and is already found in foods, animals feeds, and
medicines (MRID 44821916). Reynoutria sachalinensis activates phenolics
in plants which can be found in a wide variety of commonly consumed
vegetables and herbs. No adverse health issues for man, animals, or
plants have been associated with the plant. Exposure to the active
ingredient from its pesticidal use is anticipated to be very low due to
the low application rate which results in negligible residues compared
to consumption of Reynoutria sachalinensis as a food.
ii. Drinking water. Reynoutria sachalinensis is a naturally
occurring plant that is already widespread in the environment. It
commonly grows along rivers and is not considered to be a risk to
drinking water. Percolation through soil and municipal treatment of
drinking water would reduce the possibility of exposure of Reynoutria
sachalinensis through the drinking water. The formulated end use
product is an extract of this plant, and any residues that may result
from its pesticidal use would be expected to behave similarly to
leachates of leaf litter and plant exudates in the environment.
2. Non-dietary exposure. The potential for non-occupational, non-
dietary exposure to the general population is not expected to be
significant and is not expected to present any risk of adverse health
effects.
E. Cumulative Exposure
There are no other products-registered for food use containing
Reynoutria sachalinensis as the active ingredient, so dietary exposure
from other pesticidal uses is not likely. The plant has been consumed
in the human diet in Japan for generations without any known adverse
effects. Researchers, manufacturers, and other workers have applied
Reynoutria sachalinensis under greenhouse production without report of
any adverse health effects to greenhouse workers. In addition, the
label will require pesticide applicators and other handlers to wear
personal protective equipment (PPE), to mitigate exposure.
F. Safety Determination
1. U.S. population. Reynoutria sachalinensis is a naturally
occurring plant. This plant has low toxicity as demonstrated by the
acute oral toxicity study in rats. Based on this information, IR-4 is
of the opinion that the aggregate exposure to Reynoutria sachalinensis
over a lifetime should not change with application of Reynoutria
sachalinensis. Thus, there is a reasonable certainty that no harm will
result from aggregate exposure to Reynoutria sachalinensis. The data
requirements for granting the greenhouse nonfood use registration under
section 3(c)(5) of FIFRA has been reviewed by BPPD. The mammalian
toxicology and ecological effects data requirements for Reynoutria
sachalinensis extract have been fulfilled for the nonfood greenhouse
use. Additional waivers have been developed for the food use. Product
analysis data requirements have adequately satisfied EPA registrations
for the greenhouse, nonfood use of the end use product, (EPA
Registration 72719-2) and the manufacturing use product (EPA
Registration 72719-1) which were approved on September 29,
2000. The composition of the products in the existing registration and
this registration are identical.
2. Infants and children. Based on the lack of toxicity and low
exposure, there is reasonable certainty that no harm to infants,
children, or adults will result from aggregate exposure to Reynoutria
sachalinensis. In addition, Reynoutria sachalinensis is widespread
throughout
[[Page 16929]]
the United States, Europe, and Asia and is already found in foods,
animals feeds, and in medicines (MRID 44821916). The plant has been
consumed in the human diet in Japan for generations without any known
adverse effects. The active components stimulated by Reynoutria
sachalinensis are phenolics which have health benefits and are already
present in vegetables. Exempting Reynoutria sachalinensis from the
requirement of a tolerance should pose no significant risk to humans or
the environment.
G. Effects on the Immune and Endocrine Systems
To date there is no evidence to suggest that Reynoutria
sachalinensis functions in a manner similar to any known hormone, or
that it acts as an endocrine disrupter.
H. Efficacy
When applied to certain crop plants, this product raises the plants
natural defense system by increasing the existing phenolic compounds in
the leaf tissue. Current research indicates that the plant diseases
affected by these natural phytoalexins are powdery mildews, gray mold,
and fire blight. These diseases are economically important problems in
both ornamental and food crop plants.
I. Existing Tolerances
There are no existing tolerances of any type for the extract of
Reynoutria sachalinensis in the United States.
J. International Tolerances
The IR-4 program and the registrant, KHH BioSci, Inc., are not
aware of any tolerances, exemptions from tolerance or maximum residue
levels (MRLs) issued for the extract of Reynoutria sachalinensis
outside of the United States. No MRLs have been established for the
extract of Reynoutria sachalinensis by the Codex Alimentarius
Commission.
[FR Doc. 04-7200 Filed 3-30-04; 8:45 am]
BILLING CODE 6560-50-S