[Federal Register: December 12, 2007 (Volume 72, Number 238)]
[Notices]
[Page 70586-70589]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12de07-39]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2007-0181; FRL-8341-7]
Notice of Hearing Concerning a Request to Reduce Pre-Harvest
Interval for EBDC Fungicides on Potatoes; Amendment to Statement of
Issues
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA is amending its July 11, 2007 Notice of Hearing (July
Notice) document concerning a request to reduce the pre-harvest
interval for the use of EBDC fungicides on potatoes. The July Notice
set forth EPA's determination, the rationale for that determination, a
description of the issues of fact and law to be adjudicated in the
hearing, and a schedule for the hearing. EPA's determination in the
July Notice that a hearing was appropriate was in response to the EBDC/
ETU Task Force's (Task Force) petition requesting that the 1992
cancellation order be amended to allow for a 3-day pre-harvest interval
(PHI) nationwide for use of EBDC pesticides on potatoes.
FOR FURTHER INFORMATION CONTACT: Kevin Costello, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 305-5026; fax
number: (703) 305-7070; e-mail address: costello.kevin@epa.gov or
Michele Knorr, Office of General Counsel, Pesticides and Toxic
Substances Law Office (2333A),
[[Page 70587]]
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (202) 564-5631; fax
number: (202) 564-5631; e-mail address: knorr.michele@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
In 1992, EPA issued a Notice of Intent to Cancel (NOIC)
registrations containing EBDC's for use on certain crops. The crop at
issue for this hearing is potatoes. The NOIC stated that use of EBDC's
on potatoes would be canceled unless the registrants modified their
pesticide product labels. For a product to remain registered for use on
potatoes, the NOIC required that registrants amend their labels to
incorporate certain directions for use, including maximum application
rates, maximum number of applications per season, application interval,
and PHI. For certain states, the NOIC required a minimum 14-day PHI
and, for others, the NOIC allowed a minimum 3-day PHI due to disease
pressures caused by late blight. (57 FR 7484, March 2, 1992).
In response to the NOIC, EBDC registrants and some non-registrants
requested a hearing. However, there was never a formal hearing; the
parties reached a settlement which included, among other things, an
agreement to amend labels to extend the PHI to 14 days for EBDC use on
potatoes in all states other than Connecticut, Delaware, Florida,
Maine, Massachusetts, Michigan, New Hampshire, New York, Ohio,
Pennsylvania, Rhode Island, Vermont, and Wisconsin. In these named
states, EPA agreed to allow a 3-day PHI because of the presence of late
blight. This settlement was approved by Judge Harwood in an order
issued June 16, 1992. FIFRA Docket number 646 et al. (Accelerated
Decision and Order, June 16, 1992).
On December 26, 1996, the Task Force submitted its first request to
modify the existing cancellation order for the use of three products
containing EBDC on potatoes: Mancozeb, maneb, and metiram. In that
petition, the Task Force requested that the PHI be reduced from 14 days
to 3 days nationwide to address the spread of late blight disease
(Phytophthora infestans) in potatoes. Late blight is a fungal disease
that caused the infamous ``Irish Potato Famine'' in the 1840's. If not
adequately controlled, this disease is capable of destroying the crop
in the field (foliar blight phase) and/or in storage (tuber rot phase).
EPA delayed acting on this petition because intervening statutory
amendments required the Agency to reassess how it evaluated pesticide
registration actions.\1\
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\1\The Food Quality Protection Act of 1996 amended FIFRA and the
FFDCA.
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Because EPA had not yet acted on the 1996 petition, on August 25,
2003, the Task Force resubmitted its request to the Agency as part of
the EBDC reregistration process. Subsequently, the Agency informed the
Task Force that EPA had to consider the impact of the Food Quality
Protection Act of 1996 (FQPA) amendments to the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and
Cosmetic Act (FFDCA) before any action could be taken on the request.
Under 40 CFR part 164, subpart D, the Agency treated the Task Force
submission as a petition to modify the final cancellation order
concerning EBDC pesticide products. Such a petition may not be granted
without an opportunity for a formal adjudicatory hearing in front of an
Administrative Law Judge (ALJ). EPA concluded that the submissions by
the Task Force could provide an adequate basis for a hearing.
Therefore, in the Federal Register of July 11, 2007 (72 FR 37771) (FRL-
8118-4), EPA issued a notice of hearing that set forth the Agency
determination on the registrants' request to modify the 1992
cancellation order.
That Notice: (1) Announced that EPA has decided to hold a hearing
regarding the petition to modify the existing cancellation order as it
applied to the use of products containing EBDC's (mancozeb, maneb, and
metiram) on potatoes and the allowance of a 3-day, rather than a 14-day
PHI, nationwide, (2) specified the issues of fact and law to be
considered at that hearing, (3) identified what steps interested
persons need to take if they wish to participate in the hearing, and
(4) established a schedule for the hearing. The Agency did not
determine as part of the Notice that the new information in fact
warrants an amendment to the previous cancellation order. That
determination is the subject of the hearing provided for in 40 CFR part
164, subpart D.
In response to the July Notice, the Natural Resources Defense
Council (NRDC) filed a request for hearing on August 10, 2007. EPA and
the EBDC/ETU Task Force (Task Force) are automatically parties to this
hearing. The National Potato Council (NPC) requested and was granted
leave to intervene in the hearing on September 18, 2007.
The Honorable Susan L. Biro, Chief ALJ, was designated to preside
over this proceeding. Judge Biro issued a Pre-Hearing Order on
September 19, 2007, directing the parties, among other things, to file
pre-hearing exchanges. EPA, the Task Force and NPC (Movants) filed a
motion requesting an extension of time to file the pre-hearing
exchanges as well as a request for a pre-hearing conference (Motion).
NRDC contested a portion of the Movants' motion and Movants replied to
NRDC's response. The Movant's Motion explained that there appeared to
be a concrete disagreement among the parties as to the scope of the
hearing. Two issues were discussed in the Movants' Motion and Reply.
First, the July Notice incorrectly identified an issue of law to be
adjudicated by the Court. Second, the Notice did not provide a
sufficiently clear explanation of the scope of the issues to be
considered in thehearing.\2\
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\2\On October 29, 2007, Judge Biro issued an Order granting the
extension of time to file pre-hearing exchanges, but deferred the
request for a pre-hearing conference. Docket No. EPA-HQ-OPP-2007-
0181.
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In light of the two issues stated above, EPA is amending the
Statement of Issues by consolidating the issues of fact and law into
the two relevant questions that must be determined by the ALJ
consistent with 40 CFR 164.132 and the 1992 cancellation action. EPA
believes the amended statement of issues provides necessary
clarifications that will allow for a more efficient and effective
hearing.
This amendment does not alter EPA's previous determination under 40
CFR 164.131. (72 FR 37771) Additionally, NRDC does not need to file a
new request for hearing.
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are a party
to this hearing process, however, it may also be of interest to the
public in general, and a wide range of stakeholders including
environmental, human health, and agricultural advocates; the chemical
industry; pesticide users; and members of the public interested in the
sale, distribution, or use of pesticides. Since others also may be
interested, 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 under FOR FURTHER INFORMATION CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPP-2007-0181. Publicly
available
[[Page 70588]]
docket materials are available either in the electronic docket athttp://www.regulations.gov
, or, if only available in hard copy, at the Office
of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The
hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
Facility 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.
II. Background
A. What Action is the Agency Taking?
Pursuant to 40 CFR 164.23(b), EPA is amending its statement of
issues for the hearing that the Agency announced in the July 11, 2007
Notice. (See 72 FR at 37778, Unit VII.) In the July Notice, EPA
identified among the facts to be adjudicated certain questions
associated with late blight on potatoes. Among the issues to be
adjudicated in the proceeding, EPA identified the question of whether
the substantial new evidence could with due diligence have been
discovered prior to issuance of the 1992 cancellation order and whether
a nationwide PHI of 3 days for EBDC use on potatoes would meet the
standard of section 2(bb) of FIFRA. EPA believes amending the statement
of issues is necessary. Therefore, EPA is amending the July Notice by
replacing all the issues for hearing identified in that Notice with the
following issues to be adjudicated in this proceeding:
1. Is there substantial new evidence not considered in the 1992
cancellation that relates to whether the dietary risks associated with
nationwide use of EBDCs on potatoes with a 3-day PHI satisfy the
relevant statutory standard for registration under FIFRA? For the
purposes of this hearing, the relevant portion of the FIFRA standard
for registration is whether the human dietary risk meets the safety
standard in section 408(b)(2) of FFDCA.
2. Does the substantial new evidence with respect to dietary risk
require the modification of the existing cancellation order, i.e., does
it support a finding that the dietary risks associated with nationwide
use of EBDCs on potatoes with a 3-day PHI satisfy the relevant
statutory standard for registration under FIFRA? In other words, do the
residues that result from EBDCs on potatoes meet the safety standard in
section 408(b)(2) of FFDCA?
B. Why is the Agency Taking this Action?
As required by 40 CFR 164.131(c), if the Administrator determines
that a hearing is warranted, the Administrator must publish a notice in
the Federal Register. The notice must set forth the issues of fact and
law to be adjudicated at the hearing. Because the issues set forth by
the Administrator in the notice of hearing establish the scope of the
hearing, it is important that those issues be clear. After discussions
with other parties to this proceeding and review of the ALJ's orders,
EPA determined that its earlier notice contained an error concerning
what factors are to be considered by the judge (i.e. ``due diligence'')
and that other changes would clarify and better focus the relevant
issues for this hearing.
First, EPA is amending the statement of issues to correct a
misstatement by EPA in the July Notice. In that Notice, EPA identified
as an issue of law to be adjudicated the following: ``If it is
substantial new evidence, could the applicant, through due diligence,
have discovered this information prior to the issuance of the
cancellation order?'' (72 FR at 37778)
Whether or not the applicant met this ``due diligence'' test is an
issue for the Administrator to determine before issuing the Notice of
Hearing, not for the Court to determine at hearing. 40 CFR 164.131(a)
sets forth the standard for determining whether, as a threshold matter,
a petition to amend a cancellation order has merit. This regulation
states that the Administrator will reconsider the merits of a prior
cancellation order when the Administrator finds that:
(1) The applicant has presented substantial new evidence which
may materially affect the prior cancellation or suspension order and
which was not available to the Administrator at the time he made his
final cancellation or suspension determination and, (2) such
evidence could not, through the exercise of due diligence, have been
discovered by the parties to the cancellation or suspension
proceeding prior to the issuance of the final order. [emphasis
added]
In contrast, 40 CFR 164.132(a) sets forth the issues for the ALJ to
decide in the hearing. The purpose of the hearing is not to determine
whether to reconsider the earlier order, but rather to determine
whether or not the earlier order should in fact be modified. The
relevant subsection of this regulation states:
The burden of proof in the hearing convened pursuant to Sec.
164.131 shall be on the applicant and he shall proceed first. The
issues in the hearing shall be whether: (1) substantial new evidence
exists and (2) such substantial new evidence requires reversal or
modification of the existing cancellation or suspension order.
The regulation at 40 CFR 164.132(a) does not include the ``due
diligence'' determination as one of the issues to be resolved at the
hearing. Additionally, in the preamble to these regulations, EPA
stated:
For the following reasons, EPA is adopting a new Subpart D to
the Rules of Practice (40 CFR Part 164) setting forth the procedures
to be followed in the case of an application under FIFRA sections 3
or 18 which requests use of a pesticide on a site and on a pest for
which registration has been finally cancelled or suspended. These
revised procedures require that in any such case the Administrator
will initially determine, on the basis of the application and
supporting data, whether there is substantial new evidence which may
materially affect the prior order and whether such evidence could
not have been discovered by due diligence on the part of the parties
to the original proceeding. If it is determined that there is no
such evidence, then the application will be denied. If it is
determined that there is such evidence, then a formal hearing will
be convened to determine whether such evidence materially affects
the prior order and requires its modification. This determination
will be made on the basis of the record in the hearing and the
recommendations of the administrative law judge presiding over the
hearing, taking into account the human and environmental risks found
by the Administrator in his prior order and the cumulative impact of
past, present, and anticipated uses in the future. [emphasis added]
(53 FR 12261, 12264).
As the preamble and regulatory text make clear, the determination
of whether the petitioner could have discovered and submitted the
information during the original proceeding is one for the Administrator
to make before any hearing is convened. This ``due diligence''
provision prevents registrants from wasting Agency resources and
continually relitigating cancellation cases by allowing the
Administrator to summarily reject applications that are based on
factual information that should have been presented in the earlier
proceeding. In contrast, the focus of the subpart D hearing itself is
on whether the earlier cancellation decision is still correct in light
of the new information. This is similar to the focus of the original
cancellation hearing--whether the pesticide at issue meets the
applicable standard for registration under FIFRA.
Because the ``due diligence'' test is one to be determined before
commencement of a subpart D hearing, EPA is amending the statement of
issues to delete this issue.
Second, EPA is amending the statement of issues to reflect the fact
[[Page 70589]]
that risk issues unrelated to the dietary risk of EBDC use on potatoes
are not relevant for this hearing. Typically, the scope of the subpart
D hearing would be determined by a detailed cancellation order from the
earlier proceeding. However, as described above, there was no prior
hearing because the parties to the earlier proceeding agreed to a
settlement. Had there been a hearing and subsequent detailed
cancellation order, the scope of this subpart D hearing would have been
determined by that order. Since there was no detailed cancellation
order, EPA's 1992 NOIC (as it relates to EBDC use on potatoes) must be
used to determine the issues to be considered in the present hearing
because it is the best evidence of what issues would have been
presented at the cancellation hearing had it taken place. (57 FR 7484,
March 2, 1992).
The NOIC was the result of a regulatory process known as ``Special
Review.''\3\ The NOIC stated that the basis for the initiation of the
Special Review for the uses of EBDC fungicides. Specifically, for
potatoes, the following issues were of concern: ``carcinogenic,
developmental, and thyroid effects caused by ethylenethiourea (ETU).''
(57 FR at 7487). Had a cancellation hearing been held, these would have
been the issues for the hearing. Only information related to these
three risks, or to dietary exposures associated with these three risks,
is material to the issue of whether the 1992 cancellation order should
be modified to allow for a shorter PHI than called for in theNOIC.
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\3\The purpose of Special Review is to help the Agency determine
whether to initiate procedures to cancel, deny, or reclassify
registration of a pesticide product because uses of that product may
cause unreasonable adverse effects on the environment. See 40 CFR
part 154.
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The relevant statutory standard for determining whether dietary
risks are acceptable under FIFRA is not the same today as it was in
1992. At the time of the 1992 cancellation proceedings, the presence of
late blight in the New England states was relevant to a reduced PHI of
3 days being allowed in those states. At this time, however, whether
late blight has spread nationwide and whether EBDCs are necessary are
not appropriate for consideration by the ALJ when determining whether
the 1992 cancellation order must be modified.
The 1996 Food Quality Protection Act amendments to FIFRA and FFDCA
require that dietary risks associated with a pesticide chemical's
residue on food now be evaluated under the risk-only safety standard as
set forth in FFDCA section 408(b). The safety determination that now
must be made is whether there is a ``reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures.'' FFDCA section
408(b)(2)(A)(ii). Since this standard is a risk-only evaluation, EPA
determined that it was necessary to amend the statement of issues to
reflect the correct statutory standard and to eliminate the
consideration of factual issues, such as the need for the pesticide,
that are not relevant to the applicable standard.\4\
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\4\The presence of late blight nationwide and the need for EBDC
fungicides is not relevant to the risk-only finding that the court
must make in order to determine whether the earlier cancellation
order must be modified.
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C. What is the Agency's Authority for Taking this Action?
EPA regulation at 40 CFR 164.132 states that the procedures for the
hearing ``shall follow the Rules of Practice set forth in subparts A
and B.'' In subpart B, specifically 40 CFR 164.23(b), the Administrator
has the authority to amend the statement of issues EPA set forth in a
Notice of Hearing at any time prior to the commencement of the public
hearing. Pursuant to these provisions, and the fact that a public
hearing has not yet commenced, EPA is amending the statement of issues
it issued in its July 2007 Notice of Hearing to ensure that the hearing
is focused on the issues that are relevant to the risk-only
determination. In light of this amendment, the ALJ may determine that
additional time is necessary to permit the parties to prepare for
matters raised in this amendment; and, upon such determination, the
hearing shall be delayed for appropriate period. See 40 CFR 164.23(b).
List of Subjects
Environmental protection, EBDC fungicides, Pesticides and pests.
Dated: November 30, 2007.
Steven Bradbury,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E7-23948 Filed 12-11-07; 8:45 am]
BILLING CODE 6560-50-S