vinclozolin (Ronilan) Order Denying Objections to Issuance of Tolerance 5/00
[Federal Register: May 23, 2000 (Volume 65, Number 100)]
[Rules and Regulations]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Vinclozolin; Order Denying Objections to Issuance of Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final order.
SUMMARY: EPA is denying the objections filed by the Natural Resources
Defense Council to a final rule issued July 18, 1997, which announced
the issuance of a tolerance for use of vinclozolin on succulent (snap)
beans under section 408 of the Federal Food, Drug, and Cosmetic Act.
The objections are denied because the tolerances have expired and
consequently the objections are now moot.
DATES: This denial of the objections is effective on May 23, 2000.
FOR FURTHER INFORMATION CONTACT: Deanna Scher, Reregistration Division
(7508C), Office of Pesticide Programs, Environmental Protection Agency,
Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 308-7043; fax number: (703) 308-7042; e-mail
I. General Information
A. Does This Action Apply to Me?
This action is directed to the public in general. However, this
action is of particular interest to Earthjustice Legal Defense Fund,
the organization that filed objections to the vinclozolin tolerance
granted for snap beans in 1997 on behalf of Natural Resources Defense
Council, American Federation of Labor and Congress of Industrial
Organizations, Environmental Working Group, Pineros y Campesinos Unidos
del Noroeste, and Northwest Coalition for Alternatives to Pesticides.
This action is also of interest to BASF Corporation, the manufacturer
of vinclozolin, as well as users of vinclozolin products. Since various
different entities may be interested in this action, the Agency has not
attempted to describe all the specific entities that may be affected by
this action. If you have any questions regarding the applicability of
this action to a particular entity, consult the person listed in the
FOR FURTHER INFORMATION CONTACT section.''
B. How Can I Get Additional Information, Including Copies of This
Document and Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations'' and then look up the entry for this document under the
``Federal Register--Environmental Documents.'' You can also go directly
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
2. In person. The Agency has established an official record for
this action under docket control number OPP-300507A. The official
record consists of the documents specifically referenced in this
action, any public comments received during an applicable comment
period, and other information related to this action, including any
information claimed as confidential business information (CBI). This
official record includes the documents that are physically located in
the docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period, is available
for inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
A. What Action Is the Agency Taking?
On September 15, 1997, the Natural Resources Defense Council
(``NRDC'') filed a series of objections and hearing requests in regard
to EPA's issuance of a tolerance for the pesticide vinclozolin on
succulent (snap) beans under section 408 of the Federal Food, Drug, and
Cosmetic Act (``FFDCA''), 21 U.S.C. 346a. Because that tolerance
expired on October 1, 1999, those objections are now moot and are
denied on that ground.
B. What Is the Agency's Authority for Taking This Action?
Section 408 of the FFDCA authorizes the establishment by regulation
of maximum permissible levels of pesticides in foods. Such regulations
commonly referred to as ``tolerances.'' Without such a tolerance or an
exemption from the requirement of a tolerance, a food containing a
pesticide residue is ``adulterated'' under section 402 of the FFDCA and
may not be legally moved in interstate commerce. 21 U.S.C. 331, 342.
Monitoring and enforcement of pesticide tolerances are carried out by
the U.S. Food and Drug Administration (FDA) and the U.S. Department of
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance 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 dietary exposure through food and drinking
water and exposure other than dietary that occurs in non-occupational
settings. In making safety determinations, EPA is required to consider,
among other things, ``available information concerning the cumulative
effects of the pesticide chemical residue and other substances that
have a common mechanism of toxicity.'' 21 U.S.C. 346a(b)(2)(D)(v).
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. . . .'' 21 U.S.C.
346a(b)(2)(C). For pesticides that pose a threshold effect, EPA is
directed to apply ``an additional tenfold margin of safety . . . to
take into account potential pre- and post-natal toxicity and
completeness of the data with respect to exposure and toxicity to
infants and children.'' [hereinafter referred to as ``the children's
safety factor''] Id. This provision additionally specifies that EPA
``may use a different margin of safety for the pesticide chemical
residue only if, on the basis of reliable data, such margin will be
safe for infants and children.'' Id.
The procedure for establishing tolerance regulations is generally
initiated by pesticide manufacturers through the filing with EPA of a
petition requesting the establishment of a tolerance. See 21 U.S.C.
346a(d). EPA is required to publish notice of this petition as well as
a summary of the petition prepared by the petitioner. Id. 346a(d)(3).
After evaluation of the petition, EPA may issue a final tolerance
regulation, a proposed tolerance regulation, or an order denying the
petition. Id. 346a(d)(4). Once a final tolerance regulation is issued,
any person may, within 60 days, file written objections to any aspect
of this regulation and may also request a hearing on issues of fact
raised by the objections. Id. 346a(g).
EPA regulations specify that if a hearing is requested, the
objections must include a statement of the factual issues on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the requestor. 40 CFR 178.27. A
request for a hearing will be granted if the Administrator determines
that the material submitted shows the following: There is 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 in the manner sought by the requestor
would be adequate to justify the action requested. 40 CFR 178.32. EPA's
regulations specify that if no hearing is requested, or a requested
hearing is denied, EPA will publish in the Federal Register its
determination on each objection submitted. 40 CFR 178.37(a).
III. Regulatory and Procedural History
Vinclozolin is a fungicide produced by BASF Corporation.
Vinclozolin is registered under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq., for use on various
fruits and vegetables and corresponding tolerances have been
established under the FFDCA. For many years prior to 1997, vinclozolin
was approved for use on succulent beans in several states under an
emergency exemption under FIFRA. Prior to 1997, vinclozolin was also
registered for use on turf in residential areas as well as parks,
school grounds, and recreational areas.
In July 1997, in response to a petition submitted by BASF
Corporation, EPA issued a tolerance for vinclozolin on succulent beans
(62 FR 38464, July 18, 1997) (FRL-5727-9). That tolerance contained an
expiration/revocation date of October 1, 1999. In connection with the
establishment of the succulent bean tolerance, BASF requested that EPA
terminate BASF's vinclozolin FIFRA registrations on tomatoes, grapes,
and plums including plums grown for prunes as well as on residential
turf and turf in parks, school grounds, and recreational areas (except
for golf courses) and to revoke associated FFDCA tolerances. See 62 FR
43327, August 13, 1997.
On September 15, 1997, NRDC filed two objections to this tolerance
and requested a hearing regarding several issues raised by its
objections. NRDC's two objections were that EPA failed:
(1) To use the statutorily mandated tenfold safety factor to
account for infants' and children's exposures to and toxic risks from
(2) To incorporate into its assessment of noncancer risks the
available information on cumulative exposures to other similar
chemicals. Objections at 16.
NRDC argued that EPA was required to use the tenfold safety factor
because, among other reasons, there exist data gaps concerning
vinclozolin's neuro-behavioral effects. Objections at 23-24.
On January 16, 1998, EPA provided an initial response to NRDC's
hearing requests. EPA stated that an initial review of the hearing
requests indicated that requests would have to be denied under EPA's
regulations. EPA noted that the issues on which NRDC had sought a
hearing ``rather than being factual claims accompanied by contentions
as required by the regulations, are more in the nature of
interrogatories or discovery requests.'' EPA made clear that ``[t]he
purpose of an evidentiary hearing is to `receive factual evidence
relevant to material issues of fact raised by the objections,' FFDCA
section 408(g)(2)(B), not to determine whether such evidence or issues
of fact exist.'' Nonetheless, because NRDC claimed it had not had
access to the full administrative record for the tolerance, EPA made
that record available and gave NRDC 60 days to withdraw or revise its
hearing requests. In response, NRDC, in a filing dated March 31, 1998,
submitted revised hearing requests on its original objections.
Subsequent to EPA's initial response, several important
developments occurred in connection with EPA's FIFRA reregistration
efforts as to vinclozolin that impact the vinclozolin succulent bean
tolerance. First, EPA scientists recommended that EPA use the
additional tenfold safety factor for the protection of children in
conducting its assessment of in utero acute risk to the human fetus.
Second, BASF requested that EPA terminate FIFRA registrations for
vinclozolin on stone fruits and strawberries and revoke the associated
tolerances. See 63 FR 40710, June 30, 1998. Additionally, during the
FIFRA reregistration process EPA had altered its conclusion regarding
the dose at which no adverse effects had
occurred in a critical developmental study. On July 31, 1998, EPA
requested both NRDC and BASF to comment on whether these developments
affected the revised hearing requests. In separate letters dated
September 9, 1998, BASF and NRDC took opposite positions on the
viability of the hearing requests. NRDC contended that these
developments ``have virtually no effect on the pending objections and
hearing request.'' BASF argued that the hearing requests were either
moot or not justified.
In August 1999, NRDC filed two declarations that NRDC asserted
``substantiated the data gaps described in NRDC's submissions.'' In a
letter accompanying these declarations, NRDC stated that the
declarations made an evidentiary hearing on its objections unnecessary.
Accordingly, by that letter, NRDC withdrew its hearing requests and
asked that EPA rule on its objections as submitted.
IV. Order Responding to Objections
The tolerance for vinclozolin on succulent beans to which NRDC
filed objections has now expired. NRDC's objections to that tolerance
are thus moot and are therefore denied.
The fact that EPA did not substantively respond to NRDC's
objections during the existence of the tolerance does not mean that EPA
did not consider these objections. To the contrary, NRDC's objections
related directly to changes in the way EPA now assesses the risk
vinclozolin poses. For example, the centerpiece of NRDC's objections
was a challenge to EPA's decision in approving the tolerance that the
additional tenfold factor for the protection of infants and children
was unnecessary to assure to safety to infants and children. Following
NRDC's objections, that decision has been revised on two occasions
since the issuance of the succulent bean tolerance. First, as detailed
in EPA's July 31, 1998 letter to NRDC, EPA scientists recommended that
EPA use the additional tenfold safety factor for the protection of
children in conducting its assessment of in utero acute risk to the
human fetus. That position remained unsatisfactory to NRDC and its
August 1999 declarations, in essence, argued that the tenfold factor
should be applied more broadly. After considering the declarations and
the attached scientific literature, EPA scientists recommended that due
to, among other things, the lack of neurotoxicity data, the additional
tenfold factor should be used in all risk assessments for vinclozolin.
V. Regulatory Assessment Requirements
As indicated previously, this action announces the Agency's final
decision regarding an objection filed under section 408 of FFDCA. As
such, this action is an adjudication and not a rule. The regulatory
assessment requirements imposed on rulemakings do not, therefore, apply
to this action.
VI. 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, does not
apply because this action is not a rule for purposes of 5 U.S.C.
List of Subjects in 40 CFR Part 180
Dated: May 19, 2000.
Marcia E. Mulkey,
Director, Office of Pesticide Programs.
[FR Doc. 00-12962 Filed 5-22-00; 8:45 am]
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