[Federal Register Volume 67, Number 60 (Thursday, March 28, 2002)]
[Notices]
[Pages 14948-14950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-7498]



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ENVIRONMENTAL PROTECTION AGENCY

[PF-1078; FRL-6828-9]


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 control number PF-1078, must be 
received on or before April 29, 2002.

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-1078 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-1078. 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 Hwy., 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-1078 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 Hwy., 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-1078. 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.

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    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 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 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 19, 2002.
  Kathleen D. Knox,
Acting 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 section 408(d)(3) of the FFDCA. The summary of the 
petition was prepared by the petitioner and represents the view of the 
petitioner. EPA is publishing the petition summary verbatim without 
editing it 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.

Valent BioSciences Corporation

PP 2G6378

    EPA has received a pesticide petition (2G6378) from Valent 
BioSciences Corporation, 870 Technology Way, Suite 100, Libertyville, 
IL 60048, 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, to expand an existing tolerance exemption for the biochemical 
pesticide 6-benzyladenine in or on agricultural commodities apples and 
pistachios.
    Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, 
Valent BioSciences Corporation has submitted the following summary of 
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

    6-Benzyladenine is a naturally occurring plant growth regulator 
used on certain fruit trees and certain ornamental lily tubers. In 
January 1990, the Agency classified 6-benzyladenine as a biochemical 
pesticide because it resembles natural plant regulators and it displays 
a nontoxic mode of action. The new use being proposed for 6-
benzyladenine (6-BA) is as an effective stand-alone fruitlet thinner 
when applied to apples in the post-bloom period at an application rate 
not to exceed 182 grams active ingredient/acre/season (g/ai/acre/
season). 6-Benzyladenine has also been shown to directly increase cell 
division of treated fruit, resulting in improvements in fruit size over 
what would be expected from the normal thinning effect. The frequency 
and timing of application will vary according to the specific growing 
conditions being treated.
    The second proposed new use is to reduce alternate bearing in 
pistachio and thus increase cumulative yield. The proposed maximum 
application rate for pistachio is 60 g/ai/acre/season.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. 6-
Benzyladenine N-(phenylmethyl)-1H-purin-6-amine has been tested and 
residue data generated have been provided to EPA by Valent BioSciences 
Corporation.
    2. Magnitude of residue at the time of harvest and method used to 
determine the residue. Trials conducted in various states (MI, NY, OR, 
PA, VA, and WA) and on various apple cultivars, support the proposed 
temporary exemption from the requirement of a tolerance. Residue levels 
following the maximum number (four) of applications on apple were very 
close to the limit of quantitation (LOQ) of 5 parts per billion (ppb) 
at normal harvest, which averaged 80 days after the last application. 
Trials indicate rapid degradation of 6-BA residues among all the apple 
varieties and geographies evaluated.
    The analytical methods for detection of 6-BA in apple raw 
agricultural and processed commodities are comprised of extraction, 
cleanup on a strong cation exchange (SCX) solid-phase extraction 
cartridge, derivitization and quantitation by gas chromatography (GC). 
These were developed by Valent BioSciences Corporation, constituting a 
practical analytical method for detecting and measuring levels of 6-BA 
in or on commodities with a limit of quantitation (LOQ) of 0.005 ppm 
that allows for monitoring of food, with the residues at or above the 
LOQ which has been submitted to EPA.
    Residue data on 6-BA use on pistachio have been provided to EPA by 
Valent BioSciences Corporation. Trials were conducted in locations 
representing the major pistachio production area in the United States. 
No residues were detected following the maximum number (two) of 
applications at normal harvest, which averaged 60 days after the last 
application.
    An analytical method based on extraction, clean up and 
derivitization of 6-BA followed by quantitation by GC was submitted to 
EPA for residue determination on pistachio. This GC method is adequate 
for determining residues in or on pistachios with a LOQ of 0.05 ppm.
    3. Analytical method. Usually, a request for an exemption from the 
requirement of a tolerance is not accompanied by residue data and an 
analytical method. Valent BioSciences Corporation has provided this 
information to the Agency in this case. The information demonstrates 
that any residue is detected at levels very close to the LOQ. Although 
a numeric tolerance could be established, it would be very difficult to 
enforce, as demonstrated by the risk characterization. Valent 
BioSciences Corporation proposes that the submitted residue data and 
analytical method support their conclusion that there is a

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reasonable certainty that no harm to humans or the environment will 
result from the experimental use of 6-BA on apples and pistachios.

C. Mammalian Toxicological Profile

    1. Acute toxicity. The oral LD50 of 6-benzyladenine is 
estimated by probit analysis at 1.3 grams/kilogram (g/kg) in the rat. 
The dermal LD50 in the rabbit is >5.0 g/kg. The acute 
inhalation LC50 in the rat is 5.2 milligrams/Liter/hour (mg/
L/hour). A primary eye irritation study in the rabbit showed moderate 
conjunctival effects which cleared within 7 days. A dermal irritation 
study in the rabbit showed slight dermal irritation, which lasted for 5 
days. Sensitization potential has been examined, and 6-benzyladenine 
(99% pure) was demonstrated not to be a dermal sensitizer in guinea 
pigs under conditions of the study.
    2. Genotoxicity. Mutagenicity studies including Ames test, mouse 
micronucleus assay, and unscheduled DNA synthesis (UDS) assay in rat 
were negative for mutagenic effects.
    3. Developmental toxicity. Developmental toxicity in rats fed 6-
benzyladenine (99% pure) was manifested as significantly decreased 
fetal body weight (bwt), increased incidence of hydrocephaly and 
unossified sternbrae, incompletely ossified phalanges, and malaligned 
sternbrae at 175 milligrams/kilogram body weight/day (mg/kg bwt/day). 
Maternal toxicity was also observed at 175 mg/kg bwt/day, which was 
manifested as significantly decreased body weight, weight gain, and 
food consumption. Thus the no observed adverse effect level (NOAEL) and 
lowest observed adverse effect level (LOAEL) for maternal and 
developmental toxicity were 50 and 175 mg/kg bwt/day, respectively.
    4. Subchronic toxicity. 6-Benzyladenine (99% pure) fed to rats for 
13 weeks produced decreased weight gain at 1,500 and 5,000 ppm (121 and 
322 mg/kg bwt/day) in females and 5,000 ppm (295 mg/kg bwt/day) in 
males. This decreased weight gain appeared to be related to decreased 
food consumption. Serum alkaline phosphatase activity and blood urea 
nitrogen levels were increased in both sexes receiving 5,000 ppm; thus, 
the NOAEL was 1,500 ppm (approximately 111 mg/kg bwt/day in both sexes 
combined) and the LOAEL was 5,000 ppm (approximately 304 mg/kg bwt/day 
in both sexes), based on the decreased body weight gain, food 
consumption, increased blood urea nitrogen, and minimal histological 
changes in the kidneys.

D. Aggregate Exposure

    1. Dietary exposure--i. Food. In conducting this exposure 
assessment, Valent BioSciences Corporation used very conservative 
assumptions; 100% of all commodities were assumed to be treated, and 
those residues would be at twice the LOQ -- which result in a large 
overestimate of human exposure. The analysis assumes that all residues 
have the same magnitude, and the treated commodity is 100% of a daily 
diet. Thus, in making a safety determination for these temporary 
tolerance exemptions, Valent BioSciences Corporation took into account 
this very conservative exposure assessment. The last application 
precedes harvest by approximately 2.5 months in apples; therefore, the 
potential for dietary exposure is considered negligible by Valent 
BioSciences Corporation. Application precedes harvest by approximately 
2 months in pistachios. Also pistachios have their hulls, which cover 
the shell, removed at harvest; therefore, the potential for dietary 
exposure is considered negligible by Valent BioSciences Corporation. 
Residues are below the LOQ (0.05 ppm) in pistachio.
    ii. Drinking water. The proposed uses on apples and pistachios are 
not expected to add potential exposure to drinking water. Soil leaching 
studies have suggested that 6-BA is relatively immobile, absorbing to 
sediment. Residues reaching surface waters from field runoff should 
quickly absorb to sediment particles and be partitioned from the water 
column. 6-Benzyladenine also has low solubility in water, 0.061 mg/mL, 
and detections in ground water are not expected. Valent BioSciences 
Corporation concludes that together these data indicate that residues 
are not expected in drinking water.
    2. Non-dietary exposure. The proposed uses involve application of 
6-BA to crops grown in an agriculture environment. The only non-dietary 
exposure expected is that to applicators. However, the protective 
measures prescribed by the product's label are expected to be adequate 
to minimize exposure and protect applicators of the chemical.

E. Cumulative Exposure

    No cumulative adverse effects are expected from long-term exposure 
to this chemical. There is no reliable information to indicate that 
toxic effects produced by 6-BA would be cumulative with those of any 
other pesticide chemical.

F. Safety Determination

    1. U.S. population. Chronic dietary exposure estimates were 
conducted for the overall U.S. population and 25 population subgroups, 
including infants and children. These estimated daily intakes were 
compared against a chronic population adjusted dose (cPAD) based on a 
NOAEL of 50 mg/kg bwt/day from a developmental study in rats. To 
account for intraspecies and interspecies variation and the use of an 
acute toxicological endpoint for a chronic assessment, an uncertainty 
factor (UF) of 1,000 was applied to the acute NOAEL. This resulted in a 
cPAD of 0.05 mg/kg bwt/day. Daily exposure for the overall U.S. 
population was estimated by Valent BioSciences Corporation to be 
0.000014 mg/kg bwt/day, representing less than 0.1% of the estimated 
cPAD.
    2. Infants and children. Estimated daily exposures from tolerance 
level residues on 100% of the apple and pistachio commodities for the 
most highly exposed population subgroup, non-nursing infants, was 
estimated to be 0.000085 mg/kg bwt/day, or 0.2% of the estimated cPAD.

G. Effects on the Immune and Endocrine Systems

    6-Benzyladenine is a naturally occurring cytokinin which has plant 
growth regulator properties. There is no indication that this plant 
growth regulator belongs to a class of chemicals known or suspected of 
having adverse effects on the immune and endocrine systems. It can be 
concluded that based upon the existing toxicology there would be no 
adverse effects on the immune or endocrine systems from the use of 6-
benzyladenine. Last, there is no evidence that 6-benzyladenine 
bioaccumulates in the environment.

H. Existing Tolerances

    The plant growth regulator 6-benzyladenine is exempt from the 
requirement of a tolerance when used as a fruit-thinning agent at an 
application rate not to exceed 30 grams of active ingredient per acre 
in or on apples.

I. International Tolerances

    There are no Codex, Canadian, or Mexican maximum residue limits for 
use of 6-benzyladenine on apples or pistachio.
[FR Doc. 02-7498 Filed 3-27-02; 8:45 am]
BILLING CODE 6560-50-S