Aminoethoxyvinylglycine (AVG); Time-Limited Pesticide Tolerances

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: July 12, 2001 (Volume 66, Number 134)]
[Rules and Regulations]
[Page 36481-36484]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12jy01-17]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301147; FRL-6790-7]
RIN 2070-[AB78]

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances of 0.08
part per million (ppm) for residues of aminoethoxyvinylglycine (AVG),
in or on apples and pears. Valent BioSciences Corporation requested
these tolerances under the Federal Food, Drug, and Cosmetic Act, as
amended by the Food Quality Protection Act of 1996. The tolerances will
expire on December 21, 2003.

DATES: This regulation is effective July 12, 2001. Objections and
requests for hearings, identified by docket control number OPP-301147,
must be received by EPA on or before September 10, 2001.

ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301147 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Denise Greenway,
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; and
e-mail address: greenway.denise@epa.gov.

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'', ``Regulations and Proposed Rules,'' 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 OPP-301147. The official record
consists of the documents specifically referenced in this action, 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, (CM #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.

II. Background and Statutory Findings

In the Federal Register of March 28, 2001 (66 FR 16931) (FRL-6775-
1), EPA issued a notice pursuant to section 408 of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food
Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing
the filing of a pesticide petition (PP 6F4632, transferred from Abbott
Laboratories) for tolerances by Valent BioSciences Corporation, 870
Technology Way, Suite 100,

[[Page 36482]]

Libertyville, IL 60048. This notice included a summary of the petition
prepared by Valent BioSciences Corporation, the registrant. There were
no comments received in response to the notice of filing.
New data summarized by Valent BioSciences Corporation in that
petition were a rat 2-generation reproduction study. 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.
Other new data also summarized in the March 28, 2001 notice were
internationally-generated residue data in apples, submitted by Valent
BioSciences Corporation on May 23, 2000.
Subsequent to the March 28, 2001 notice, the Agency received from
Valent BioSciences Corporation a substantial number of supplementary
data in support of aminoethoxyvinylglycine. These new data have been
placed in the public docket. OPP-301147.
The petition requested that 40 CFR 180.502 be amended by
establishing permanent tolerances for the biochemical pesticide
aminoethoxyvinylglycine, in or on apples and pears at 0.08 part per
million (ppm). Instead, because the Agency has not completed its
assessment of the conditional rat 2-generation reproduction study, the
Agency is establishing time-limited tolerances for which the tolerances
will expire on December 21, 2003.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for time-limited tolerances for apples and pears at 0.08
ppm. EPA's assessment of the dietary exposures and risks associated
with establishing the tolerances follows.

Toxicological Profile

EPA has previously evaluated the available toxicity data and
considered its validity, completeness, and reliability as well as the
relationship of the results of the studies to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.
In the Federal Register of May 7, 1997 (62 FR 24835) (FRL-5713-5),
EPA established time-limited tolerances for residues of the plant
regulator aminoethoxyvinylglycine (AVG) in or on the food commodities
apples and pears at 0.08 ppm. This final rule included a summary of the
Agency's assessment of the health effects data submitted in support of
the establishment of the time-limited tolerances. 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. 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.'' This correction did not affect the
tolerance levels. The time limited tolerances expired on April 1, 2001.
Summaries of the toxicological profile and other relevant health
effects data, to comply with the requirements of the FFDCA, as amended
by the FQPA of 1996, were reported in the Federal Register publication
of the final rule of May 7, 1997, establishing the time-limited
tolerances. Although the Agency has not completed its assessment of the
rat 2-generation reproduction study, based on the previously submitted
data outlined in the May 7, 1997, Federal Register final rule, and
based on the same rationale included therein, EPA concludes that there
is a reasonable certainty that no harm will result from aggregate
exposure to the U.S. population, including infants and children, to
aminoethoxyvinylglycine. This includes all anticipated dietary
exposures and all other exposures for which there is reliable
information.

IV. Other Considerations

A. Analytical Enforcement Methodology

The submitted analytical method, High Performance Liquid
Chromatography (HPLC)/Fluorescence detector, is acceptable; it is also
verified and validated.
Adequate enforcement methodology is available to enforce the
tolerance expression. The method may be requested from: Calvin Furlow,
PRRIB, IRSD (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., N.W., Washington, DC 20460.
Office location and telephone number: Rm 101FF, CM #2, 1921 Jefferson
Davis Hwy., Arlington, VA, (703) 305-5229.

B. International Residue Limits

There are no Codex Alimentarius Commission (CODEX) Maximum Residue
Levels (MRLs) for residues of aminoethoxyvinylglycine on apples or
pears, or on any other crops.

V. Conclusion

A data gap currently exists for a rat 2-generation reproduction
study, because the Agency has not concluded its assessment of the data,
which were submitted by Abbott Laboratories on September 27, 1999. All
tolerances are time-limited because of this data gap. The Agency also
has not completed its assessment of the new internationally-generated
apple residue data, which were submitted by Valent BioSciences
Corporation on May 23, 2000, and, the supplementary data received after
the publication of the March 28, 2001, notice. The time limitation
allows for review of the data. Based on the available toxicological
data, the thousandfold uncertainty factor, and the levels of exposure,
the EPA has determined that there is a reasonable certainty that no
harm will result to the U.S. population, including infants and
children, from aggregate exposure to the pesticide (AVG) and its
residues during the period of the time-limited tolerances.

[[Page 36483]]

Based on the information and rationale cited in the final rule of
May 7, 1999, the Agency has determined that the establishment of the
time-limited tolerances by amending 40 CFR 180.502 will be safe;
therefore the time-limited tolerances are established for apples and
pears at 0.08 ppm.

VI. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-301147 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before September
10, 2001.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential 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. A copy of the
information 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.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket number OPP-301147, to: Public Information
and Records Integrity Branch, Information Resources and Services
Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).

VII. Regulatory Assessment Requirements

This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any special considerations as required by Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under FFDCA section 408(d), such as the tolerances in this
final rule, do not

[[Page 36484]]

require the issuance of a proposed rule, the requirements of the
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.
In addition, the Agency has determined that this action will not have a
substantial direct effect on States, on the relationship between the
national government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires EPA to develop an accountable
process to ensure ``meaningful and timely input by State and local
officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4).
For these same reasons, the Agency has determined that this rule
does not have any ``tribal implications'' as described in Executive
Order 13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 6, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal government and Indian tribes.'' This rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.''

VIII. Submission to Congress and the Comptroller General

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

Dated: July 2, 2001.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

1. The authority citation for part 180 continues to read as
follows:

Authority: 21 U.S.C. 321(q), 346(a) and 371.

2. Section 180.502 is amended by revising the Expiration/revocation
date for the commodities Apples and Pears in the table in paragraph (a)
to read as follows:

Sec. 180.502 Aminoethoxyvinylglycine; tolerances for residues.

(a) * * *

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Expiration/revocation
Commodity Parts per million date
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Apples........................................................ 0.08 12/21/03
Pears......................................................... 0.08 12/21/03
* * * * *
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[FR Doc. 01-17472 Filed 7-11-01; 8:45 am]
BILLING CODE 6560-50-S

Aminoethoxyvinylglycine (AVG); Time-Limited Pesticide Tolerances

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