Aminoethoxyvinylglycine; Temporary Tolerance

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 36477-36481]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12jy01-16]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301144; FRL-6788-7]
RIN 2070-AB78

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

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SUMMARY: This regulation establishes a temporary tolerance of 0.170
part per million (ppm) for residues of aminoethoxyvinylglycine (AVG) in
or on the stone fruit crop group when applied/used as a plant
regulator. Valent BioSciences Corporation submitted a petition to EPA
under the Federal Food, Drug, and Cosmetic Act, as amended by the Food
Quality Protection Act of 1996 requesting the temporary tolerance. The
temporary tolerance will expire on December 21, 2003.

DATES: This regulation is effective June 25, 2001. Objections and
requests for hearings, identified by docket control number OPP-301144,
must be received by EPA on or before September 10, 2001.

[[Page 36478]]

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 V. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301144 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: Denise Greenway, c/o Product Manager
(PM) 90, Biopesticides and Pollution Prevention Division (7511C),
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/. A frequently updated electronic
version of 40 CFR part 180 is available at http://www.access.gpo.gov/
nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently
under development.
2. In person. The Agency has established an official record for
this action under docket control number OPP-301144. 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, 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 theFederal 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 (FQPA) (Public Law 104-170) announcing the
filing of a pesticide tolerance petition (PP 9G5048, transferred from
Abbott Laboratories) by Valent BioSciences Corporation, 870 Technology
Way, Suite 100, Libertyville, IL 60048. This notice included a summary
of the petition prepared by the petitioner Valent BioSciences
Corporation. There were no comments received in response to the notice
of filing.
New data summarized by Valent BioSciences Corporation were from 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.
The petition requested that 40 CFR 180.502 be amended by extending
the 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) at 0.170 part per million (ppm). Instead,
the Agency is establishing a temporary tolerance for which the
tolerance will expire on December 21, 2003.
Under section 408(g)(1) of the FFDCA, a regulation issued under
subsection (d)(4) shall take effect upon publication unless the
regulation specifies otherwise. In this case, the temporary tolerance
will be effective on June 25, 2001.
This pesticide is only applied once during the growing season, and
this must be done 7-14 days prior to the beginning of the harvest
period. The harvest season for certain stone fruits is very early in
the year. Many of the tests sites for these stone fruits are located in
the Southern region of the United States. Thus, in order to provide for
the sale and distribution of certain stone fruit produce with residues
of this pesticide in 2001, and to optimize the benefits of the
experimental use of the pesticide, approval of the use was necessary in
the Spring of this year. Furthermore, the Agency has provided notice
and comment for this rulemaking action and no comments were received.
The Agency is also providing a 60-day period to file objections to this
final rule as required by section 408(g)(2) of the FFDCA. See Unit V.
of this preamble for further information. Thus, further notice and
public procedure are unnecessary. The Agency finds that this
constitutes good cause to provide for an immediate effective date
pursuant to 5 U.S.C. 808(2).
New 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

[[Page 36479]]

certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue. . . .''
Additionally, section 408(b)(2)(D) requires that the Agency consider
``available information concerning the cumulative effects of a
particular pesticide's residues'' and ``other substances that have a
common mechanism of toxicity.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.

III. Toxicological Profile

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action and considered its validity, completeness and
reliability and the relationship of this information 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 June 10, 1999 (64 FR 31124) (FRL-6080-
4), EPA issued a final rule pursuant to section 408 of the FFDCA, 21
U.S.C. 346a, as amended by the Food Quality Protection Act (FQPA)
(Public Law 104-170) establishing a temporary tolerance level of 0.170
ppm for residues of aminoethoxyvinylglycine (AVG) in or on food
commodities of the stone fruit crop group (40 CFR 180.502). This final
rule included a summary of the Agency's assessment of the health
effects data submitted in support of the establishment of the temporary
numeric tolerance. 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. The
temporary tolerance 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 of June 10,
1999, in a final rule document establishing the temporary tolerance.
Although the Agency has not completed its assessment of the rat 2-
generation reproduction study, based on the previously submitted data
outlined in the June 10, 1999, 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 from the current experimental use program. This
includes all anticipated dietary exposures and all other exposures for
which there is reliable information.
Therefore, the temporary tolerance, to expire December 21, 2003, is
established for residues of aminoethoxyvinylglycine in or on food
commodities of the stone fruit crop group at 0.170 ppm.

IV. Other Considerations

A. Analytical Method(s)

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, PIRIB, IRSD (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. Office location and telephone number: Rm 101FF,
Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-
5229.

B. Codex Maximum Residue Level

There are no Codex Alimentarius Commission (Codex) Maximum Residue
Levels (MRLs) for residues of aminoethoxyvinylglycine.

V. 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-301144 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-

[[Page 36480]]

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 control number OPP-301144, 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).

VI. Regulatory Assessment Requirements

This final rule establishes a temporary tolerance 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 under 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 temporary tolerance in this final rule, do not 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.

VII. 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.

[[Page 36481]]

Dated: June 25, 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), (346a) and 371.

2. Section 180.502 is amended by revising the entry for ``Stone
fruit crop group'' in the table to paragraph (a) to read as follows:

Sec. 180.502 Aminoethoxyvinylglycine; tolerances for residues.

(a) General. * * *

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Parts per
Commodity million Expiration/Revocation Date
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* * * * *
Stone fruit crop group................... 0.170 12/21/03
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[FR Doc. 01-17473 Filed 7-11-01; 8:45 am]
BILLING CODE 6560-50-S

Aminoethoxyvinylglycine; Temporary Tolerance

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