[Federal Register Volume 66, Number 60 (Wednesday, March 28, 2001)]
[Notices]
[Pages 16931-16934]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-7639]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1007; FRL-6775-1]


Notice of Filing Pesticide Petitions to Establish Tolerances 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 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 
response.

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: 
[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
                                  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 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,

[[Page 16932]]

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 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-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 
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 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 
requirements.

    Dated: March 15, 2001.
  Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

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.

1. Valent BioSciences Corporation

PP 6F4632

    EPA has received a request from Valent BioSciences Corporation, 870 
Technology Way, Suite 100, Libertyville, IL 60048, referencing 
pesticide petition PP-6F4632 (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 establishing permanent tolerances for 
residues of the biochemical pesticide aminoethoxyvinylglycine (AVG) in 
or on the food commodities apples and pears at 0.08 part per million 
(ppm). EPA issued a final rule, published in the Federal Register of 
May 7, 1997 (62 FR 24835) (FRL-5713-5), which announced that it 
established time-limited tolerances for residues of the plant regulator 
AVG in or on the food commodities apples and pears at 0.08 ppm, with an 
expiration date of April 1, 2001. A correction to this rule was 
published in the Federal Register of October 29, 1997 (62 FR 56089) 
(FRL-5751-5), which announced the correction of the reference dose 
(RfD) appearing on page 24836, column three, third full paragraph, line 
11, from ``0.0002,'' to ``0.002.'' Because of a then-existing data gap, 
all initial tolerances were time-limited. The time limitation was 
established to provide sufficient time for the development and review 
of additional data, specifically a rat 2-generation reproduction study. 
Abbott Laboratories submitted such a study 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 February 20, 1997 (62 FR 7778) (FRL-

[[Page 16933]]

5589-4). EPA has not republished the summary of information initially 
submitted by Abbott Laboratories and published in the February 20, 1997 
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 establish permanent tolerances. 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 
petitioner.

A. Product Name and Proposed Use Practices

    AVG is a plant regulator useful in the management practices of 
apples and pears. 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 apples and pears 4 weeks prior to the 
beginning of normal harvest.

B. Product Identity/Chemistry

    1. Magnitude of residue at the time of harvest and method used to 
determine the residue. Residue data previously submitted by Abbott 
Laboratories and reviewed by EPA indicated that at the proposed use 
rates, no quantifiable residues were present in or on the food 
commodities at 21 days after treatment. Additional residue data 
generated internationally has been provided to EPA by Valent 
BioSciences Corporation. Trials conducted in New Zealand, Chile, and 
South Africa in various apple cultivars support the proposed permanent 
tolerances. Residue levels were below the proposed permanent tolerance 
at 21 days after application. Decline trials indicate rapid degradation 
of AVG residues among all the apple varieties and geographies 
evaluated.
    The analytical methods for detection of AVG in apple raw 
agricultural and processed commodities by high performance liquid 
chromatography were developed by Abbott Laboratories. A practical 
analytical method for detecting and measuring levels of AVG in or on 
commodities with a limit of quantitation (LOQ) that allows for 
monitoring of food, with the residues at or above the levels set in 
these tolerances has been submitted to EPA. EPA has provided 
information on this method to the Food and Drug Administration (FDA). 
The method is available to anyone interested in pesticide residue 
enforcement.

C. 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 milligrams active ingredient/
kilograms body weight/day (mg ai/kg bwt/day). Based on reductions in 
body weight, changes in organ weights, and increased incidence of 
microscopic findings, the parental lowest observed effect level (LOEL) 
was established at 2.5 mg ai/kg bwt/day. The parental no observed 
adverse effect level (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.

D. Aggregate Exposure

    1. Dietary exposure--i. Food. Expected dietary exposures from 
residues of AVG would occur through apples, pears, and processed apples 
and pears. 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 permanent tolerances would utilize approximately 9.1% RfD 
for non-nursing infants and approximately 0.85% for the general 
population.
    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.

E. 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 
population.
    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.

2. Valent BioSciences Corporation

PP 9G5048

    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

[[Page 16934]]

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 
petitioner.

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 
population.
    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]
BILLING CODE 6560-50-S