[Federal Register Volume 68, Number 189 (Tuesday, September 30, 2003)]
[Rules and Regulations]
[Pages 56184-56189]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-24782]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0311; FRL-7327-6]


Vinclozolin; Time-Limited Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation extends time-limited tolerances for combined 
residues of vinclozolin, 3-(3,5-dichlorophenyl)-5-ethenyl-5-methyl-2,4-
oxazolidinedione and its metabolites containing the 3,5-dichloroaniline 
moiety in or on succulent beans at 2.0 parts per million (ppm); canola 
at 1.0 ppm; eggs, milk, and the meat, fat and meat byproducts of 
cattle, goats, hogs, horses, and sheep at 0.05 ppm; and in the meat, 
fat, and meat byproducts of poultry at 0.1 ppm. BASF Corporation 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), as amended by the Food Quality Protection Act of 1996 
(FQPA). The tolerance for succulent beans will expire on September 30, 
2005 and the canola, eggs, milk, meat and meat-by-product tolerances 
will expire on November 30, 2008.

DATES: This regulation is effective September 30, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0311, 
must be received on or before December 1, 2003.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Mary L. Waller, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9354; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, pesticide manufacturer or 
formulator. Potentially affected entities may include, but are not 
limited to:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112
    [sbull] Food manufacturer (NAICS 311)
    [sbull] Pesticide manufacturer (NAICS 32532)
    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 this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
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 Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2003-0311. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The docket telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under 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. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Background and Statutory Findings

    In the Federal Register of March 26, 2003 (68 FR 14628) (FRL-7289-
2), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 
346a, as amended by the FQPA (Public Law 104-170), announcing the 
filing of a pesticide petition (PP 1F6278) by BASF Corporation, P.O. 
Box 13528, Research Triangle Park, NC 27709-3528. This notice included 
a summary of the petition prepared by BASF Corporation, the registrant. 
The Agency received comments from North Williamette Research and 
Extension Center at Oregon State University, Norpac Foods,

[[Page 56185]]

Inc., Washington State University Tri-Cities, Northern Canola Growers 
Association, and Earthjustice on behalf of the Northwest Coalition for 
Alternatives to Pesticides, the Natural Resources Defense Council and 
Farmworker Justice Fund. The comments from outside parties are 
summarized in Unit V. followed by the Agency's response.
    The petition requested that 40 CFR 180.380 be amended by extending 
the tolerances for the combined residues of the fungicide vinclozolin, 
3-(3,5-dichlorophenyl)-5-ethenyl-5-methyl-2,4-oxazolidinedione and its 
metabolites containing the 3,5-dichloroaniline moiety, in or on 
succulent beans at 2.0 ppm for two years. The petition also requested 
that 40 CFR 180.380 be amended by making the tolerances permanent for 
canola at 1.0 ppm; eggs, milk, and meat, fat, and meat byproducts of 
cattle, goats, hogs, horses, and sheep at 0.05 ppm; and in the meat, 
fat, and meat byproducts of poultry at 0.1 ppm.
    Several recent regulatory actions by EPA are pertinent to this 
petition. In the Federal Register of July 18, 2000 (65 FR 44453) (FRL-
6594-8), EPA established time-limited tolerances at the levels 
identified in Unit II. for use of vinclozolin on succulent beans, 
canola, eggs, milk, meat and meat-by products of cattle, goats, hogs, 
horses, sheep, and poultry. These tolerances were made time-limited 
because of the need for a developmental neurotoxicity study to 
determine whether vinclozolin which causes antiandrogenic effects 
shares a common mode of toxicity with other members of the imide group 
of the dicarboximide class of fungicides which are considered 
antiandrogenic and with other compounds outside of this class of 
fungicides that may also be considered antiandrogenic.
    The tolerances established July 18, 2000, were approved taking into 
consideration BASF's May 31, 2000 request to EPA to amend its 
vinclozolin registration to cancel uses on onions, raspberries, and 
ornamental plants immediately and to delete uses on kiwi, chicory, 
lettuce, and succulent beans over the following four years. See the 
Federal Register notice of September 20, 2000 (65 FR 56894)(FRL-6744-
2). As later approved by EPA these use cancellations contained an 
existing stocks provision which permitted legal use of vinclozolin on 
succulent beans until September 30, 2005. Id.
    Objections to the tolerances established in July, 2000, were filed 
on behalf of the Natural Resources Defense Council, the Environmental 
Working Group, the Pineros Campesinos Unidos del Noroeste, and the 
Northwest Coalition for Alternatives to Pesticides by Earthjustice 
Legal Defense Fund. These objections were withdrawn after EPA approved 
BASF's use cancellation request and EPA agreed to notify the objecting 
parties if any future requests were made for uses of vinclozolin under 
an emergency exemption from the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq., and consider the 
objecting parties comments on any such request.
    Also as part of BASF's May 31, 2000 cancellation request, BASF 
asked EPA to revoke tolerances permitting vinclozolin residues in 
cucumbers and peppers. See the Federal Register final rule of June 12, 
2002 (67 FR 40185)(FRL-6835-6). Earlier, in 1998, BASF had requested 
that EPA cancel vinclozolin use on strawberries and stonefruit. Id. 
Consistent with these two actions by BASF, EPA, on June 12, 2002, 
revoked tolerances for strawberries, stone fruit, cucumbers, and 
peppers, 67 FR 40185 (June 12, 2002). This present rulemaking further 
implements September, 2000 cancellation order by extending the 
vinclozolin succulent bean tolerance through the date as to which use 
remains legal on succulent beans, September 30, 2005. Extending the 
succulent bean tolerance in this manner means that vinclozolin which is 
legally used on succulent beans pursuant to the cancellation order will 
not render the treated crops adulterated as a matter of law. See 21 
U.S.C. 346a(l)(5). In a future action, EPA will be proposing to revoke 
the tolerances for vinclozolin on onions and raspberries given that 
those uses are now cancelled.
    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) of the FFDCA 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) of the FFDCA 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 of the FFDCA 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) of the FFDCA, 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) of the FFDCA, for tolerances for the combined residues of 
vinclozolin, 3-(3,5-dichlorophenyl)-5-ethenyl-5-methyl-2,4-
oxazolidinedione and its metabolites containing the 3,5-dichloroaniline 
moiety in or on succulent beans at 2.0 ppm; canola at 1.0 ppm; eggs, 
milk, and the meat, fat and meat byproducts of cattle, goats, hogs, 
horses, and sheep at 0.05 ppm; and in the meat, fat, and meat 
byproducts of poultry at 0.1 ppm.
    EPA completed a full risk assessment for vinclozolin as part of the 
July 18, 2000 tolerance action. July 18, 2000 (65 FR 44453). This risk 
assessment was updated later that year in connection with the release 
of the Reregistration Eligibility Document (RED) for vinclozolin. U.S. 
EPA, Reregistration Eligibility Document Vinclozolin (October 2000) 
(available at http://www.epa.gov/REDs/2740red.pdf). In its July 18, 
2000 tolerance decision, EPA concluded that the time-limited tolerances 
met FFDCA section 408's safety standard. (65 FR 44462). Since that time 
risks from vinclozolin exposure have declined as the strawberry and 
stone fruit tolerances have been revoked and the last date for legal 
use on raspberries and onions has passed by almost 2 years. The 
registration of vinclozolin for use on succulent beans and lettuce will 
be canceled on July 15, 2004 with the last legal use of existing stocks 
established as September 30, 2005. At that point, the only remaining 
uses for vinclozolin will be on belgian endive, canola, and wine 
grapes. Taking into account the risk assessments done in conjunction 
with the July 18, 2000 tolerance action and the vinclozolin RED and the 
reduction in exposure that has occurred as a result of the 
cancellations of use on strawberries, stone fruit, onions, and 
raspberries and the tolerance revocations for cucumbers and peppers,

[[Page 56186]]

EPA concludes that extending the succulent bean tolerance until 
September 30, 2005, and the canola tolerance until November 30, 2008 
meets the section 408 safety standard that is, there is a reasonable 
certainty of no harm to the general public, including infants and 
children, from aggregate exposure to vinclozolin.
    EPA has retained a time limitation on the canola tolerance because 
a developmental neurotoxicity study assessing anti-androgenic and 
neuro-endocrine endpoints has not been conducted. Completion of such a 
DNT study has been delayed both because EPA needs to investigate anti-
androgenic and neuro-endocrine endpoints, endpoints not previously 
examined in DNT studies, and because the results of the DNT study are 
critical to assessing whether vinclozolin shares a common mechanism of 
toxicity with other pesticides which may affect androgens. The Agency 
currently has no guidance for how this modified DNT study should be 
conducted, and what specific toxicity endpoints should be evaluated to 
capture anti-androgenic and neuro-endocrine effects. The Agency is 
currently examining the vinclozolin data base, as well as data for 
other chemicals which may effect the androgens. This data analysis 
extends to both data available in-house and in the literature. When 
this data analysis is complete, it may be necessary to present this 
information to the Agency's FIFRA Science Advisory Panel (SAP) to gain 
insight into whether the chemicals share a common mode of action, 
whether and how they should be considered in a cumulative risk 
assessment, and how a DNT study can help the Agency understand this 
common mechanism question. The data analysis, together with the SAP 
comments, will be useful in designing the required modified DNT study 
so that all pertinent toxicological endpoints are measured, and the 
study is properly conducted. Because the DNT study has not been 
conducted, EPA has retained the additional 10X FQPA safety factor for 
the protection of infants and children.

IV. Comments

    The Agency received five comments summarized below. The Agency's 
responses are at the conclusion of the comments.
    Comment 1. The North Williamette Research and Extension Center 
(NWR&EC) of Oregon State University expressed support for extending the 
tolerance for use of vinclozolin on succulent beans for two years. 
NWR&EC indicated that the additional time is needed in order to fully 
evaluate the efficacy of the potential replacement fungicides 
(fluazinam and BAS 510) in controlling Sclerotinia sclerotiorum under 
conditions of high disease pressure. Additionally, NWR&EC states that 
the consequences could be disastrous for a currently financially 
precarious agricultural industry if adequate time is not allowed for 
large scale testing of alternative fungicides to ensure efficacy 
comparable to vinclozolin.
    Comment 2. Norpac Foods Inc. (NFI) expressed support for extending 
the tolerance for use on succulent bean for two years. NFI indicated 
that vinclozolin has been very effective in controlling white mold 
(Sclerotinia sp.) on succulent beans and has significantly reduced the 
economic impact of the disease upon the industry. NFI believes that 
extension of the existing tolerance would allow the industry time to 
pursue alternative control measures that are currently undergoing 
evaluation.
    Comment 3. The Washington State Pest Management Resource Service 
(WSPMRS) of the Washington State University Tri-Cities expressed 
support for extending the tolerance for use of vinclozolin on succulent 
beans, and discussed the economic significance of succulent bean 
production to the state of Oregon. WSPMRS indicated that while there 
have been efforts to register alternative fungicides, researchers 
believe that field data gathered thus far has not been adequate to 
assure that the proposed replacement fungicides will prove as 
efficacious as vinclozolin in controlling white and gray mold.
    Comment 4. The Northern Canola Growers Association (NCGA)expressed 
support for making permanent the tolerances for use of vinclozolin on 
canola. NCGA discussed the economic importance of canola production to 
North Dakota, and noted that vinclozolin is a critical tool used by 
canola growers to combat the devastating effects of Sclerotinia 
sclerotiorum.
    Comment 5. Earthjustice commented on behalf of the Northwest 
Coalition for Alternatives to Pesticides, Natural Resources Defense 
Council, and Farmwork Justice Fund. Earthjustice discussed in detail 
three concerns. First, Earthjustice expressed concern that vinclozolin 
is an endocrine-disrupting chemical and a probable human carcinogen. 
Second, Earthjustice expressed concern that the notice of filing 
published in the Federal Register on March 26, 2003 did not describe 
the Agency's duty to cancel vinclozolin's tolerances for succulent 
beans. Earthjustice asserts that EPA should describe its legal 
obligations with vinclozolin in the final Federal Register notice 
responding to the registrant's petition. Third, Earthjustice states 
that EPA should fill data gaps before taking any regulatory action on 
vinclozolin. Earthjustice further states that the current data gaps are 
an extension of decades of data gaps, that EPA appears to be giving up 
on collecting or analyzing the required data, that EPA has failed to 
collect data on risks to drinking water, and that EPA admits to 
numerous other data gaps. Earthjustice concludes their comment by 
stating that EPA should only finalize the proposed tolerances after 
collecting required data, making the required findings and fully 
informing the public about the Agency's regulatory duties for 
vinclozolin.
    Agency response to comments 1-3. Considerations related to the 
beneficial impacts of a pesticide are cognizable under the FFDCA only 
in very narrow circumstances. See 21 U.S.C. 346a(b)(2)(B). Those 
circumstances have not been argued to be present here.
    Agency response to comment 4. Given the outstanding data, the 
Agency has decided not to make the vinclozolin tolerances on canola and 
the associated egg, milk, meat and meat-by-product tolerances permanent 
but instead has placed a 5 year time limitation on these tolerances. 
The Agency will reevaluate this issue after the data as identified in 
the October 2000 Vinclozolin Registration Eligibility Document are 
received and sufficiently evaluated.
    Agency response to comment 5. The Agency agrees with Earthjustice's 
discussion of the hazard assessment for vinclozolin in that it is an 
anti-androgen, and a Group C possible human carcinogen, an effect 
related to its anti-androgenic properties. These effects, however, were 
fully considered in the risk assessments conducted for the chemical. 
The Agency also agrees with Earthjustice that additional data are 
needed to fully characterize vinclozolin's hazard potential. These data 
were required as part of the October 2000 Vinclozolin Registration 
Eligibility Document. In order to account for the data deficiencies, 
the 10X FQPA safety factor was retained for vinclozolin risk 
assessments. This 10X factor results in a total safety factor of 1000X.
    As noted, the major data deficiency for vinclozolin is the modified 
developmental neurotoxicity (DNT) study in which antiandrogenic and 
neuroendocrine endpoints must be assessed. The design and execution of 
this study presents a host of difficult science issues, including how 
the study can be conducted in a manner to explore common mechanism 
questions

[[Page 56187]]

involving anti-androgenic chemicals. Significant work on this issue has 
been done. Although EPA in 2000 thought this issue could be resolved 
relatively quickly, that has not proven correct. Since 2000 EPA has 
completed a significant amount of work, some of which is currently 
ongoing. The Agency has completed an updated review of literature data 
for vinclozolin, and is currently examining in-house data for other 
chemicals, both those whose major toxic effects are related to androgen 
hormones, and those which have other major effects, but which still may 
be appropriate for inclusion in a cumulative risk assessment for 
androgen-related toxicity. Additional review of literature data for 
these chemicals is still required. The Office of Pesticide Programs 
(OPP) has also consulted with researchers in EPA's Office of Research 
and Development (ORD) who are conducting work for OPP in two areas. 
First, ORD is conducting experiments to determine whether the androgen-
related toxicity of compounds whose effects are caused by different 
molecular mechanisms are additive, synergistic, or neither. Secondly, 
ORD is doing both experimental work and mathematical modeling to 
support a Physiologically Based Pharmacokinetic (PBPK) model for anti-
androgenic compounds to support a cumulative risk assessment. Much of 
the work being done in ORD has been completed, although some remains 
ongoing. These data are important in assuring that the cumulative risk 
assessment for these chemicals is scientifically sound.
    With regard to the presence of vinclozolin metabolites in drinking 
water, on February 14, 2001 the Agency issued a data call-in notice to 
BASF Corporation. The data call-in notice required the submission of a 
small prospective ground water monitoring study and a surface water 
monitoring study. These studies are required to be submitted by March 
7, 2005 and March 8, 2004, respectively. The studies require that data 
be collected on vinclozolin and major degradation products. 
Additionally, on December 20, 2000, the Agency issued a data-call-in 
notice to BASF for an aerobic soil metabolism study and a soil column 
leaching/adsorption/desorption study to gain additional data on the 
persistence, biodegradation, and migration of vinclozolin in soil 
profile. These studies have been submitted to the Agency and are under 
review.
    Finally, Earthjustice alleges that EPA admitted to many other data 
gaps in publishing the Notice of Filing (NOF) pertaining to these 
tolerances. The language cited by NRDC, however, is merely the 
boilerplate added by EPA to all NOFs to indicate that EPA has not yet 
finished its review of the petition at the time the NOF is published.
    In response to Earthjustice's assertion that the Agency should 
fully describe the cancellation status of vinclozolin uses, EPA would 
note that the NOF for this tolerance action was prepared by the 
petitioner, BASF Corporation, as the statute requires. In this 
rulemaking document, EPA has fully and accurately described the status 
of the 2000 cancellation order and the agreement regarding NRDC's 
withdrawal of its objections to the 2000 tolerance action.

V. Conclusion

    Therefore, the tolerances are established for combined residues of 
vinclozolin, 3-(3,5-dichlorophenyl)-5-ethenyl-5-methyl-2,4-
oxazolidinedione and its metabolites containing the 3,5-dichloroaniline 
moiety, in or on succulent beans at 2.0 ppm; canola at 1.0 ppm; eggs, 
milk, and the meat, fat and meat byproducts of cattle, goats, hogs, 
horses, and sheep at 0.05 ppm; and in the meat, fat, and meat 
byproducts of poultry at 0.1 ppm. The tolerance for succulent beans 
will expire on September 30, 2005, and the canola, eggs, milk, meat and 
meat-by-product tolerances will expire on November 30, 2008.

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, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA 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 sections 408 and 409 of the FFDCA. 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 ID number OPP-2003-0311 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 December 
1, 2003.
    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 (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. 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 
(703) 603-0061.
    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 [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-
0001.

[[Page 56188]]

    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 20460-0001.
    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.1. Mail your 
copies, identified by docket ID number OPP-2003-0311, 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-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in Unit I.B.1. 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).

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of the 
FFDCA 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). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). 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 section 408(d) of the FFDCA, such as the 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 section 408(n)(4) of the FFDCA. 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. Congressional Review Act

    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 56189]]


    Dated: September 24, 2003.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.380 is amended by revising the expiration date for the 
following commodities in the table in paragraph (a) to read as follows:


Sec.  180.380  Vinclozolin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                           Parts per      Expiration/
                Commodity                   million     Revocation Date
------------------------------------------------------------------------
Bean, succulent.........................          2.0            9/30/05
                                * * * * *
Canola..................................          1.0           11/30/08
Cattle, fat.............................         0.05           11/30/08
Cattle, meat byproducts.................         0.05           11/30/08
Cattle, meat............................         0.05           11/30/08
                                * * * * *
Egg.....................................         0.05           11/30/08
Goat, fat...............................         0.05           11/30/08
Goat, meat byproducts...................         0.05           11/30/08
Goat, meat..............................         0.05           11/30/08
Hog, fat................................         0.05           11/30/08
Hog, meat byproducts....................         0.05           11/30/08
Hog, meat...............................         0.05           11/30/08
Horse, fat..............................         0.05           11/30/08
Horse, meat byproducts..................         0.05           11/30/08
Horse, meat.............................         0.05           11/30/08
                                * * * * *
Milk....................................         0.05           11/30/08
                                * * * * *
Poultry.................................          0.1           11/30/08
Poultry, meat byproducts................          0.1           11/30/08
Poultry, meat...........................          0.1           11/30/08
                                * * * * *
Sheep, fat..............................         0.05           11/30/08
Sheep, meat byproducts..................         0.05           11/30/08
Sheep, meat.............................         0.05           11/30/08
------------------------------------------------------------------------

* * * * *
[FR Doc. 03-24782 Filed 9-29-03; 8:45 am]
BILLING CODE 6560-50-S