Notice of Hearing Concerning a Request to Reduce Pre-Harvest Interval for EBDC Fungicides on Potatoes; Amendment to Statement of Issues, 70586-70589 [E7-23948]
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70586
Federal Register / Vol. 72, No. 238 / Wednesday, December 12, 2007 / Notices
TABLE—REGISTRATION REVIEW DOCKETS OPENING
Registration Review Case Name and Number
Nosema locustae, Case 4104
EPA–HQ–OPP–2007–0997
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EPA is also announcing that it will
not be opening a docket for dried blood
because this pesticide is undergoing a
voluntary cancellation. Dried blood
(CAS No. 68911–49–9, PC Code 000611
and Registration Review Case No. 4030)
was first registered by EPA in 1971. The
Registrant of the last product containing
this active ingredient has requested
voluntary cancellation of the product’s
registration. The Agency will inform the
public of the Registrant’s intent to
voluntarily cancel the product
registration through a Federal Register
notice which is expected to be
published early in 2008. If the Agency
receives no comments from the public
during the public comment period, the
registration will be cancelled. There is
no tolerance or an exemption from the
requirement of a tolerance for this active
ingredient.
The Agency will take separate actions
to cancel any remaining FIFRA section
24(c) Special Local Needs registrations
with this or any other active ingredient
in these dockets and to propose
revocation of any affected tolerances
that are not supported for import
purposes only.
B. Docket Content
1. Review dockets. The registration
review dockets contain information that
the Agency may consider in the course
of the registration review. The Agency
may include information from its files
including, but not limited to, the
following information:
• An overview of the registration
review case status.
• A list of current product
registrations and registrants.
• Federal Register notices regarding
any pending registration actions.
• Federal Register notices regarding
current or pending tolerances or
pending exemptions from tolerances.
• Risk assessments.
• Bibliographies concerning current
registrations.
• Summaries of incident data.
• Any other pertinent data or
information.
Each docket contains a document
summarizing what the Agency currently
knows about the pesticide case and a
preliminary work plan for anticipated
data and assessment needs. Additional
documents provide more detailed
information. During this public
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Pesticide Docket ID Number
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(703) 347–8920, kausch.jeannine@epa.gov
comment period, the Agency is asking
that interested persons identify any
additional information they believe the
Agency should consider during the
registration reviews of these pesticides.
The Agency identifies in each docket
the areas where public comment is
specifically requested, though comment
in any area is welcome.
2. Other related information. More
information on these cases, including
the active ingredients for each case, may
be located in the registration review
schedule on the Agency’s website at
https://www.epa.gov/oppsrrd1/
registration_review/schedule.htm.
Information on the Agency’s registration
review program and its implementing
regulation may be seen at https://
www.epa.gov/oppsrrd1/
registration_review.
3. Information submission
requirements. Anyone may submit data
or information in response to this
document. To be considered during a
pesticide’s registration review, the
submitted data or information must
meet the following requirements:
• To ensure that EPA will consider
data or information submitted,
interested persons must submit the data
or information during the comment
period. The Agency may, at its
discretion, consider data or information
submitted at a later date.
• The data or information submitted
must be presented in a legible and
useable form. For example, an English
translation must accompany any
material that is not in English and a
written transcript must accompany any
information submitted as an
audiographic or videographic record.
Written material may be submitted in
paper or electronic form.
• Submitters must clearly identify the
source of any submitted data or
information.
• Submitters may request the Agency
to reconsider data or information that
the Agency rejected in a previous
review. However, submitters must
explain why they believe the Agency
should reconsider the data or
information in the pesticide’s
registration review.
• As provided in 40 CFR 155.58, the
registration review docket for each
pesticide case will remain publicly
accessible through the duration of the
registration review process; that is, until
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Regulatory Action Leader (RAL), Telephone
Number, E-mail Address
all actions required in the final decision
on the registration review case have
been completed.
List of Subjects
Environmental protection, Pesticides
and pests.
Dated: December 4, 2007.
Janet L. Andersen,
Director, Biopesticides and Pollution
Prevention Division, Office of Pesticide
Programs.
[FR Doc. E7–24086 Filed 12–11–07; 8:45 am]
BILLING CODE 6560–50–S
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
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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 preharvest 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; email address: costello.kevin@epa.gov or
Michele Knorr, Office of General
Counsel, Pesticides and Toxic
Substances Law Office (2333A),
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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:
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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
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reassess how it evaluated pesticide
registration actions.1
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 PreHearing Order on September 19, 2007,
1The Food Quality Protection Act of 1996
amended FIFRA and the FFDCA.
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70587
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
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
2On October 29, 2007, Judge Biro issued an Order
granting the extension of time to file pre-hearing
exchanges, but deferred the request for a prehearing conference. Docket No. EPA–HQ–OPP–
2007–0181.
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Federal Register / Vol. 72, No. 238 / Wednesday, December 12, 2007 / Notices
docket materials are available either in
the electronic docket athttps://
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
https://www.epa.gov/fedrgstr.
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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?
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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 § 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
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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
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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.
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
3The 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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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
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
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2007–0937; FRL–8153–1]
Para-dichlorobenzene; Reregistration
Eligibility Decision for Low-Risk
Pesticide; Notice of Availability
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
4The presence of late blight nationwide and the
need for EBDC fungicides is not relevant to the riskonly finding that the court must make in order to
determine whether the earlier cancellation order
must be modified.
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70589
SUMMARY: This notice announces the
availability of EPA’s Reregistration
Eligibility Decision (RED) for the
pesticide para-dichlorobenzene, and
opens a public comment period on this
document, related risk assessments, and
other support documents. EPA has
reviewed the low-risk pesticide paradichlorobenzene through a modified,
streamlined version of the public
participation process that the Agency
uses to involve the public in developing
pesticide reregistration and tolerance
reassessment decisions. Through these
programs, EPA is ensuring that all
pesticides meet current health and
safety standards.
DATES: Comments must be received on
or before February 11, 2008.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2007–0937, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
Instructions: Direct your comments to
docket ID number EPA–HQ–OPP–2007–
0937. EPA’s policy is that all comments
received will be included in the docket
without change and may be made
available on-line at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
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E:\FR\FM\12DEN1.SGM
12DEN1
Agencies
[Federal Register Volume 72, Number 238 (Wednesday, December 12, 2007)]
[Notices]
[Pages 70586-70589]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-23948]
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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 https://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