aminoethoxyvinylglycine hydrochloride - AVG (ReTain) Pesticide Petition Filing 3/01
ENVIRONMENTAL PROTECTION AGENCY
Notice of Filing Pesticide Petitions to Establish Tolerances for
a Certain Pesticide Chemical in or on Food
AGENCY: Environmental Protection Agency (EPA).
SUMMARY: This notice announces the initial filing of pesticide
petitions 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-1007, must be
received on or before April 27, 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-1007 in the subject line on the first page of your
FOR FURTHER INFORMATION CONTACT: By mail: Linda Hollis, Biopesticides
and Pollution Prevention Division (7511C), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 308-8263; e-mail address:
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:
Categories NAICS codes potentially
Industry 111 Crop production
112 Animal production
311 Food 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
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 Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations'' 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-1007. 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-1007 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@example.com, 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-1007. 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
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
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
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
II. What Action is the Agency Taking?
EPA has received pesticide petitions 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 these petitions contain 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 petitions. Additional data
may be needed before EPA rules on the petitions.
List of Subjects
Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
Dated: March 15, 2001.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Summaries of Petitions
The petitioner summaries of the pesticide petitions are printed
below as required by section 408(d)(3) of the FFDCA. The summaries of
the petitions were prepared by the petitioner and represent the view of
the petitioner. The petition summaries announce 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.
2. Valent BioSciences Corporation
EPA has received a request from Valent BioSciences Corporation, 870
Technology Way, Suite 100, Libertyville, IL 60048, referencing
pesticide petition PP 9G5048 (transferred from Abbott Laboratories),
proposing pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d),
to amend 40 CFR 180.502 by extending the temporary tolerance for
residues of the biochemical pesticide AVG in or on food commodities of
the stone fruit crop group 12, including apricot, cherry (sweet and
tart), nectarine, peach, plum, chickasaw plum, damson plum, Japanese
plum, plumcot, and prune (fresh) at 0.170 ppm. EPA issued a final rule,
published in the Federal Register of June 10, 1999 (64 FR 31124) (FRL-
6080-4), which announced that it established a temporary tolerance for
residues of the plant regulator AVG in or on food commodities of the
stone fruit crop group at 0.170 ppm, with an expiration date of April
1, 2001. This rule also announced that, in considering the sensitivity
of infants and children, the thousand-fold safety factor includes
an additional uncertainty factor of 10 for incompleteness of data until
a rat 2-generation reproduction study was completed. The study was a
condition of registration of the subject active ingredient, and was
submitted to the Agency by Abbott Laboratories on September 27, 1999.
Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended,
Abbott Laboratories submitted a summary of information, data, and
arguments in support of their pesticide petition which was published in
the Federal Register of March 10, 1999 (64 FR 11872) (FRL-6067-5). EPA
has not republished the summary of information initially submitted by
Abbott Laboratories and published in the March 10, 1999 Federal
Register, except where EPA believes such information would be helpful
in understanding the new data. Valent BioSciences Corporation is,
however, relying on the previously submitted information in addition to
the new data summarized below in support of this pesticide petition to
extend the temporary tolerance. EPA will take into account all
available data when giving due consideration to Valent BioSciences
Corporation's petition. Pursuant to section 408(d)(2)(A)(i) of the
FFDCA, as amended, Valent BioSciences Corporation has submitted the
following summary of new information, data, and arguments in support of
their pesticide petition. This summary was prepared by Valent
BioSciences Corporation 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
A. Product Name and Proposed Use Practices
AVG is a plant regulator useful in the management practices of
stone fruit. It is applied once during the season at low rates (50
grams active ingredient per acre) using airblast sprayers. The product
is recommended to be applied to stone fruit 7-14 days prior to the
beginning of normal harvest. The proposed, amended, experimental use
program will be conducted in Alabama, Arkansas, California, Georgia,
Maryland, Massachusetts, Michigan, New Jersey, New York, North
Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Virginia
and Washington. The proposed, amended, experimental program would
utilize 146 pounds of active ingredient on 1,325 acres, in each year of
the proposed 2-year program.
B. Mammalian Toxicological Profile
1. Reproductive toxicity. AVG was evaluated in a rat 2-generation
reproduction study submitted by Abbott Laboratories. Rats were dosed at
levels of 0, 0.8, 2.5, 4.0, and 8.0 mg ai/kg bwt/day. Based on
reductions in body weight, changes in organ weights, and increased
incidence of microscopic findings, the parental LOEL was established at
2.5 mg ai/kg bwt/day. The parental NOAEL was established at 0.8 mg ai/
kg bwt/day. The NOAEL for reproductive toxicity was established at 4.0
mg ai/kg bwt/day. The NOAEL for neonatal toxicity was established at
2.5 mg ai/kg bwt/day.
C. Aggregate Exposure
1. Dietary exposure--i. Food. Expected dietary exposures from
residues of AVG would occur through raw and processed commodities of
treated stone fruit. There are no home and garden uses for AVG. Based
on the additional information derived from the rat 2-generation
reproduction study, Valent BioSciences Corporation proposes that the
NOAEL of 0.8 mg ai/kg bwt/day and a safety factor of 100 be
incorporated into the chronic risk assessment. The resulting RfD is
0.008 mg ai/kg bwt/day. The proposed temporary tolerance on stone fruit
in addition to tolerances on apples and pears would utilize
approximately 1.7% RfD for the U.S. population in general, and
approximately 12.7% for the non-nursing infants.
ii. Drinking water. Spray drift may potentially lead to exposure to
residues in drinking water.
2. Non-dietary exposure. The only non-dietary exposure expected is
to applicators. Exposure to AVG resulting from its application
according to label directions is not expected to present risks of
adverse health or environmental effects, based on its toxicology
profile and occupational risk assessment. Non-occupational exposures
(home/garden uses) are not applicable to this experimental use permit.
D. Safety Determination
1. U.S. population. AVG is an amino acid derived from a naturally
occurring soil microorganism. Based on the toxicology profile and the
low to no detectable residues in the agricultural commodities, Valent
BioSciences Corporation concludes that there is a reasonable certainty
of no harm resulting from aggregate exposure of AVG to the general
2. Infants and children. The effects demonstrated in the
developmental and immune toxicity studies are considered secondary to
the adverse effects upon body weight gain, food consumption and food
efficiency in the treated rats. In the rat reproduction study,
decreased neonatal survival, decreased pup body weights and other
effects associated with reduced pup weights were observed only at doses
greater than those producing effects on the parental animals. The NOAEL
for neonates in the reproduction study, 2.5 mg ai/kg bwt/day, was 3
times greater than the NOAEL for parental animals, 0.8 mg ai/kg bwt/day
NOAEL, providing an additional built-in safety factor of 3 for the
subpopulation of infants and children. The company concludes that there
is reasonable certainty that no harm will result to infants and
children from aggregate exposure.
[FR Doc. 01-7639 Filed 3-27-01; 8:45 am]