Document ID: EPA-HQ-OPP-2007-0181-0016
Agency: epa
Document Type: Notice
Title: Notice of Hearing Concerning a Request to Reduce Pre-Harvest Interval for EBDC Fungicides on Potatoes; Amendment to Statement of Issues
Posted Date: 2007-12-12T05:00Z

[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