[Federal Register Volume 64, Number 46 (Wednesday, March 10, 1999)]
[Notices]
[Pages 11872-11874]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-5817]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-866; FRL-6067-5]
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-866, must
be received on or before April 9, 1999.
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 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: Denise Greenway, Biopesticides and
Pollution Prevention Division (7511C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW, Washington, DC 20460.
Office location, telephone number, and e-mail address: Rm. 902W43,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA 22202,
(703) 308-8263; e-mail:greenway.denise@epamail.epa.gov.
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
[[Page 11873]]
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-866] (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:
opp-docket@epamail.epa.gov
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-866) 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: March 2, 1999.
Janet L. Andersen,
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.
Abbott Laboratories
PP 9G5048
EPA has received a pesticide petition [PP 9G5048] from Abbott
Laboratories, Chemical and Agricultural Products Division, 1401
Sheridan Road, North Chicago, IL 60064, 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 by establishing a temporary tolerance
for residues of the biochemical pesticide aminoethoxyvinylglycine (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).
Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended,
Abbott Laboratories has submitted the following summary of information,
data, and arguments in support of their pesticide petition. This
summary was prepared by Abbott Laboratories 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
Recommended application method and rate(s), frequency of
application, and timing of application for ReTainR. The
proposed experimental use program will be conducted in Alabama,
California, Georgia, Illinois, Maryland, Massachusetts, Michigan,
Montana, New Jersey, New York, North Carolina, Ohio, Oregon,
Pennsylvania, South Carolina, Texas, Utah, Virginia, and Washington.
The purpose is to evaluate AVG on stone fruit crops. The proposed
experimental program would utilize 47 pounds of active ingredient on
427 acres. AVG will be applied as a single application by airblast
sprayer at a maximum rate of 50 grams active ingredient per acre during
the season at 7-14 days prior to anticipated harvest.
B. Product Identity/Chemistry
1. Identity of the pesticide and corresponding residues.
Aminoethoxyvinylglycine (AVG) is a fermentation product derived from a
naturally occurring soil microbe. AVG inhibits endogenous production of
ethylene in plants, which impacts ripening and senescence. AVG was
registered as a plant growth regulator in 1997, and a time-limited
tolerance to expire on April 1, 2001, has been established at 0.080 ppm
of AVG on food commodities of apples, and pears (40 CFR 180.502). AVG
is formulated into a soluble powder and dissolved in water for
application. Product chemistry data including specifications and
physical/chemical properties are well-characterized and previously
provided to the Agency.
2. Magnitude of residue at the time of harvest and method used to
determine the residue. The magnitude of residues was evaluated in/on
peaches at proposed and exaggerated label rates. After application of
proposed label rates, residue levels were below the level of
quantitation, if detectable at all, within 5 days of application.
Exaggerated rates demonstrated rapid decline of residues to below
quantifiable levels by 14 days after application. Abbott Laboratories
has developed an analytical method for detection of AVG in/on peaches.
A high performance liquid chromotography (HPLC) method has been
validated by an outside laboratory. The limit of quantitation (LOQ) is
0.170 part per million (ppm) and the limit of detection (LOD) is 0.050
ppm.
C. Mammalian Toxicological Profile
1. Acute toxicity. The following acute toxicity studies with AVG
have been conducted and reviewed: an acute oral toxicity study in rats,
an acute dermal toxicity study in rabbits, an acute inhalation toxicity
study in rats, a primary eye irritation study in rabbits, a dermal
irritation study in rabbits, and a dermal sensitization study in guinea
pigs. Results of the acute toxicity studies indicate that both AVG and
its end product are Toxicity Category III or IV and pose no significant
human health risks. Acute oral study with AVG indicated the
LD50 = 6,400 milligrams active ingredient per kilogram of
body weight (mg a.i./kg bwt) in rats. Acute dermal toxicity in rabbit
indicated an LD50 > 2,000 mg/kg. The 4-hour LC50
= 1.13 g/m3 for AVG in an acute inhalation study with rats.
AVG produced slight irritation in eye and dermal irritation studies
with rabbits. A dermal sensitization study with guinea pigs indicated
that AVG is not a sensitizer.
2. Genotoxicity. AVG did not demonstrate mutagenic potential in an
Ames Salmonella gene mutation assay with or without activation. No
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mutagenic activity was associated with AVG in cultures of mouse
lymphoma cells with or without metabolic activation. In an in vivo rat
bone marrow cell micronucleus test, there was no indication that AVG
was genotoxic.
3. Developmental toxicity. In a developmental toxicity study in
rats by oral gavage, a no observable adverse effect level (NOAEL) of
1.77 mg a.i./kg bwt day was determined for both developmental and
maternal toxicity. Two-generation reproduction study (rat) data are
pending, as a condition of the section 3 registration. Interim data on
the first generation have been submitted to the Agency.
4. Subchronic toxicity. A reference dose (RfD) of 0.002 mg a.i./kg
bwt/day was derived from a 90 day feeding study in rats in which there
was decreased food consumption, body weight and food efficiency (body
weight gain/food consumption), and fatty changes in kidney and liver at
dosage levels of 9 mg a.i./kg bwt/day or higher. The NOAEL in this
study was assigned as 2.2 mg a.i./kg bwt/day. In a 21 day dermal
toxicity study in rats, the NOAEL was greater than 1,000 mg a.i./kg/
day. In a 28 day dietary immunotoxicity study in rats with a NOAEL of 5
mg a.i./kg/day, decreases in several immune response parameters are
considered secondary to the decreased food consumption, body weight,
and food efficiency in the treated rats.
D. Aggregate Exposure
1. Dietary exposure--i. Food. Expected dietary exposure from
residues of AVG may occur through the current uses on apple and pear,
and the proposed uses on stone fruit. Residue studies conducted with
peaches indicate that at proposed label rates, AVG residue levels, if
detectable, are below the level of quantitation at harvest. Because of
the low rate of application and rapid decline rate, residues in or on
treated stone fruit commodities are considered negligible, if
detectable at all. However, for risk assessment purposes, maximum
anticipated residues were assigned as the limit of quantitation.
ii. Drinking water. Residues of AVG are unlikely to occur in
drinking water based on its use pattern, low application rates, and
expected microbial degradation. There are no registered applications of
AVG to water. However, for risk assessment purposes, worst-case
assumptions of drift and persistence were incorporated to account for
exposure through water consumption.
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
(EUP).
E. Cumulative Exposure
AVG is a structurally unique biochemical compound and is a
naturally-occurring L-amino acid. It does not exhibit a toxic mode of
action in its target crops. It is used to regulate the growth and
development of the crop. It is used at low application rates and is
derived from a naturally-occurring soil microbe. No risks from
cumulative exposure have been identified for AVG.
F. Safety Determination
1. U.S. population. Based on a NOAEL of 2.2 mg/kg bwt/day from the
subchronic toxicity study and an uncertainty factor of 1,000, the U.S.
EPA established an RfD of 0.002 mg/kg/day to assess the current time-
limited tolerance. For the proposed temporary tolerance on stone fruit,
theoretical dietary exposure analyses were conducted using the current
RfD and conservative assumptions, such as peach residue values at the
LOQ, and 100% of all stone fruit treated. In addition, conservative
assumptions of drift and exposure through potable water were included
to address water consumption. Results indicated a reasonable certainty
of no harm from the use of AVG on stone fruit. The addition of stone
fruit to the existing uses on apple and pear totals 5.7% of the RfD for
the general U.S. population. The addition of potable water brings the
aggregate RfD for the general U.S. population to 7.7%.
2. Infants and children. The risks to infants and children have
been evaluated based on a developmental study in rats as well as the
use of a 10-fold uncertainty factor. Results indicate that there is a
reasonable certainty of no harm to infants and children from the use of
AVG on stone fruit. Stone fruit plus the existing uses on apple and
pear totals 43.8% of the RfD for the most highly exposed sub-
population, non-nursing infants less than 1-year old.
G. Effects on the Immune and Endocrine Systems
Abbott Laboratories has no information to suggest that AVG will
adversely affect the immune or endocrine systems.
H. Existing Tolerances
U.S. EPA has established a time-limited tolerance to expire April
1, 2001, for the residues of aminoethoxyvinylglycine at a level of 0.08
ppm in apple, and pear commodities, as noted in 40 CFR 180.502.
I. International Tolerances
No international or CODEX MRLs or exemptions have been established
for aminoethoxyvinylglycine.
[FR Doc. 99-5817 Filed 3-9-99; 8:45 am]
BILLING CODE 6560-50-F
