[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:[email protected].
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:
    [email protected]


    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

[[Page 11874]]

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