[Federal Register Volume 66, Number 134 (Thursday, July 12, 2001)]
[Rules and Regulations]
[Pages 36477-36481]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-17473]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301144; FRL-6788-7]
RIN 2070-AB78


Aminoethoxyvinylglycine; Temporary Tolerance

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: [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,'' ``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 [email protected], 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: [email protected]. 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
----------------------------------------------------------------------------------------------------------------
                                  *        *        *        *        *
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