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70586 Federal Register / Vol. 72, No.

238 / Wednesday, December 12, 2007 / Notices

TABLE—REGISTRATION REVIEW DOCKETS OPENING


Regulatory Action Leader (RAL), Telephone
Registration Review Case Name and Number Pesticide Docket ID Number Number, E-mail Address

Nosema locustae, Case 4104 EPA–HQ–OPP–2007–0997 (703) 347–8920, kausch.jeannine@epa.gov

EPA is also announcing that it will comment period, the Agency is asking all actions required in the final decision
not be opening a docket for dried blood that interested persons identify any on the registration review case have
because this pesticide is undergoing a additional information they believe the been completed.
voluntary cancellation. Dried blood Agency should consider during the
(CAS No. 68911–49–9, PC Code 000611 registration reviews of these pesticides. List of Subjects
and Registration Review Case No. 4030) The Agency identifies in each docket Environmental protection, Pesticides
was first registered by EPA in 1971. The the areas where public comment is and pests.
Registrant of the last product containing specifically requested, though comment
this active ingredient has requested in any area is welcome. Dated: December 4, 2007.
voluntary cancellation of the product’s 2. Other related information. More Janet L. Andersen,
registration. The Agency will inform the information on these cases, including Director, Biopesticides and Pollution
public of the Registrant’s intent to the active ingredients for each case, may Prevention Division, Office of Pesticide
voluntarily cancel the product be located in the registration review Programs.
registration through a Federal Register schedule on the Agency’s website at [FR Doc. E7–24086 Filed 12–11–07; 8:45 am]
notice which is expected to be http://www.epa.gov/oppsrrd1/ BILLING CODE 6560–50–S
published early in 2008. If the Agency registration_review/schedule.htm.
receives no comments from the public Information on the Agency’s registration
during the public comment period, the review program and its implementing ENVIRONMENTAL PROTECTION
registration will be cancelled. There is regulation may be seen at http:// AGENCY
no tolerance or an exemption from the www.epa.gov/oppsrrd1/ [EPA–HQ–OPP–2007–0181; FRL–8341–7]
requirement of a tolerance for this active registration_review.
ingredient. 3. Information submission Notice of Hearing Concerning a
The Agency will take separate actions requirements. Anyone may submit data Request to Reduce Pre-Harvest
to cancel any remaining FIFRA section or information in response to this Interval for EBDC Fungicides on
24(c) Special Local Needs registrations document. To be considered during a Potatoes; Amendment to Statement of
with this or any other active ingredient pesticide’s registration review, the Issues
in these dockets and to propose submitted data or information must
revocation of any affected tolerances meet the following requirements: AGENCY: Environmental Protection
that are not supported for import • To ensure that EPA will consider Agency (EPA).
purposes only. data or information submitted, ACTION: Notice.
interested persons must submit the data
B. Docket Content or information during the comment SUMMARY: EPA is amending its July 11,
period. The Agency may, at its 2007 Notice of Hearing (July Notice)
1. Review dockets. The registration
discretion, consider data or information document concerning a request to
review dockets contain information that
submitted at a later date. reduce the pre-harvest interval for the
the Agency may consider in the course
• The data or information submitted use of EBDC fungicides on potatoes. The
of the registration review. The Agency
must be presented in a legible and July Notice set forth EPA’s
may include information from its files
useable form. For example, an English determination, the rationale for that
including, but not limited to, the
translation must accompany any determination, a description of the
following information:
• An overview of the registration material that is not in English and a issues of fact and law to be adjudicated
review case status. written transcript must accompany any in the hearing, and a schedule for the
• A list of current product information submitted as an hearing. EPA’s determination in the July
registrations and registrants. audiographic or videographic record. Notice that a hearing was appropriate
• Federal Register notices regarding Written material may be submitted in was in response to the EBDC/ETU Task
any pending registration actions. paper or electronic form. Force’s (Task Force) petition requesting
• Federal Register notices regarding • Submitters must clearly identify the that the 1992 cancellation order be
current or pending tolerances or source of any submitted data or amended to allow for a 3–day pre-
pending exemptions from tolerances. information. harvest interval (PHI) nationwide for
• Risk assessments. • Submitters may request the Agency use of EBDC pesticides on potatoes.
• Bibliographies concerning current to reconsider data or information that FOR FURTHER INFORMATION CONTACT:
registrations. the Agency rejected in a previous Kevin Costello, Special Review and
• Summaries of incident data. review. However, submitters must Reregistration Division (7508P), Office
• Any other pertinent data or explain why they believe the Agency of Pesticide Programs, Environmental
information. should reconsider the data or Protection Agency, 1200 Pennsylvania
Each docket contains a document information in the pesticide’s Ave., NW., Washington, DC 20460–
mstockstill on PROD1PC66 with NOTICES

summarizing what the Agency currently registration review. 0001; telephone number: (703) 305–
knows about the pesticide case and a • As provided in 40 CFR 155.58, the 5026; fax number: (703) 305–7070; e-
preliminary work plan for anticipated registration review docket for each mail address: costello.kevin@epa.gov or
data and assessment needs. Additional pesticide case will remain publicly Michele Knorr, Office of General
documents provide more detailed accessible through the duration of the Counsel, Pesticides and Toxic
information. During this public registration review process; that is, until Substances Law Office (2333A),

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Environmental Protection Agency, 1200 reassess how it evaluated pesticide directing the parties, among other
Pennsylvania Ave., NW., Washington, registration actions.1 things, to file pre-hearing exchanges.
DC 20460–0001; telephone number: Because EPA had not yet acted on the EPA, the Task Force and NPC (Movants)
(202) 564–5631; fax number: (202) 564– 1996 petition, on August 25, 2003, the filed a motion requesting an extension
5631; e-mail address: Task Force resubmitted its request to the of time to file the pre-hearing exchanges
knorr.michele@epa.gov. Agency as part of the EBDC as well as a request for a pre-hearing
reregistration process. Subsequently, the conference (Motion). NRDC contested a
SUPPLEMENTARY INFORMATION:
Agency informed the Task Force that portion of the Movants’ motion and
I. General Information EPA had to consider the impact of the Movants replied to NRDC’s response.
In 1992, EPA issued a Notice of Intent Food Quality Protection Act of 1996 The Movant’s Motion explained that
to Cancel (NOIC) registrations (FQPA) amendments to the Federal there appeared to be a concrete
containing EBDC’s for use on certain Insecticide, Fungicide, and Rodenticide disagreement among the parties as to the
crops. The crop at issue for this hearing Act (FIFRA) and the Federal Food, Drug, scope of the hearing. Two issues were
is potatoes. The NOIC stated that use of and Cosmetic Act (FFDCA) before any discussed in the Movants’ Motion and
EBDC’s on potatoes would be canceled action could be taken on the request. Reply. First, the July Notice incorrectly
Under 40 CFR part 164, subpart D, the identified an issue of law to be
unless the registrants modified their
Agency treated the Task Force adjudicated by the Court. Second, the
pesticide product labels. For a product
submission as a petition to modify the Notice did not provide a sufficiently
to remain registered for use on potatoes,
final cancellation order concerning clear explanation of the scope of the
the NOIC required that registrants
EBDC pesticide products. Such a issues to be considered in thehearing.2
amend their labels to incorporate certain
petition may not be granted without an In light of the two issues stated above,
directions for use, including maximum
opportunity for a formal adjudicatory EPA is amending the Statement of
application rates, maximum number of
hearing in front of an Administrative Issues by consolidating the issues of fact
applications per season, application
Law Judge (ALJ). EPA concluded that and law into the two relevant questions
interval, and PHI. For certain states, the
the submissions by the Task Force could that must be determined by the ALJ
NOIC required a minimum 14–day PHI consistent with 40 CFR 164.132 and the
provide an adequate basis for a hearing.
and, for others, the NOIC allowed a 1992 cancellation action. EPA believes
Therefore, in the Federal Register of
minimum 3–day PHI due to disease the amended statement of issues
July 11, 2007 (72 FR 37771) (FRL–8118–
pressures caused by late blight. (57 FR provides necessary clarifications that
4), EPA issued a notice of hearing that
7484, March 2, 1992). will allow for a more efficient and
set forth the Agency determination on
In response to the NOIC, EBDC effective hearing.
the registrants’ request to modify the
registrants and some non-registrants This amendment does not alter EPA’s
1992 cancellation order.
requested a hearing. However, there was That Notice: (1) Announced that EPA previous determination under 40 CFR
never a formal hearing; the parties has decided to hold a hearing regarding 164.131. (72 FR 37771) Additionally,
reached a settlement which included, the petition to modify the existing NRDC does not need to file a new
among other things, an agreement to cancellation order as it applied to the request for hearing.
amend labels to extend the PHI to 14 use of products containing EBDC’s
days for EBDC use on potatoes in all A. Does this Action Apply to Me?
(mancozeb, maneb, and metiram) on
states other than Connecticut, Delaware, potatoes and the allowance of a 3–day, You may be potentially affected by
Florida, Maine, Massachusetts, rather than a 14–day PHI, nationwide, this action if you are a party to this
Michigan, New Hampshire, New York, (2) specified the issues of fact and law hearing process, however, it may also be
Ohio, Pennsylvania, Rhode Island, to be considered at that hearing, (3) of interest to the public in general, and
Vermont, and Wisconsin. In these identified what steps interested persons a wide range of stakeholders including
named states, EPA agreed to allow a 3– need to take if they wish to participate environmental, human health, and
day PHI because of the presence of late in the hearing, and (4) established a agricultural advocates; the chemical
blight. This settlement was approved by schedule for the hearing. The Agency industry; pesticide users; and members
Judge Harwood in an order issued June did not determine as part of the Notice of the public interested in the sale,
16, 1992. FIFRA Docket number 646 et that the new information in fact distribution, or use of pesticides. Since
al. (Accelerated Decision and Order, warrants an amendment to the previous others also may be interested, the
June 16, 1992). cancellation order. That determination Agency has not attempted to describe all
On December 26, 1996, the Task Force is the subject of the hearing provided for the specific entities that may be affected
submitted its first request to modify the in 40 CFR part 164, subpart D. by this action. If you have any questions
existing cancellation order for the use of In response to the July Notice, the regarding the applicability of this action
three products containing EBDC on Natural Resources Defense Council to a particular entity, consult the person
potatoes: Mancozeb, maneb, and (NRDC) filed a request for hearing on listed under FOR FURTHER INFORMATION
metiram. In that petition, the Task Force August 10, 2007. EPA and the EBDC/ CONTACT.
requested that the PHI be reduced from ETU Task Force (Task Force) are B. How Can I Get Copies of this
14 days to 3 days nationwide to address automatically parties to this hearing. Document and Other Related
the spread of late blight disease The National Potato Council (NPC) Information?
(Phytophthora infestans) in potatoes. requested and was granted leave to
Late blight is a fungal disease that 1. Docket. EPA has established a
intervene in the hearing on September
caused the infamous ‘‘Irish Potato docket for this action under docket
18, 2007.
Famine’’ in the 1840’s. If not adequately The Honorable Susan L. Biro, Chief identification (ID) number EPA–HQ–
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controlled, this disease is capable of ALJ, was designated to preside over this OPP–2007–0181. Publicly available
destroying the crop in the field (foliar proceeding. Judge Biro issued a Pre- 2On October 29, 2007, Judge Biro issued an Order
blight phase) and/or in storage (tuber rot Hearing Order on September 19, 2007, granting the extension of time to file pre-hearing
phase). EPA delayed acting on this exchanges, but deferred the request for a pre-
petition because intervening statutory 1The Food Quality Protection Act of 1996 hearing conference. Docket No. EPA–HQ–OPP–
amendments required the Agency to amended FIFRA and the FFDCA. 2007–0181.

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70588 Federal Register / Vol. 72, No. 238 / Wednesday, December 12, 2007 / Notices

docket materials are available either in B. Why is the Agency Taking this substantial new evidence requires reversal or
the electronic docket athttp:// Action? modification of the existing cancellation or
www.regulations.gov, or, if only suspension order.
As required by 40 CFR 164.131(c), if
available in hard copy, at the Office of the Administrator determines that a The regulation at 40 CFR 164.132(a)
Pesticide Programs (OPP) Regulatory hearing is warranted, the Administrator does not include the ‘‘due diligence’’
Public Docket in Rm. S–4400, One must publish a notice in the Federal determination as one of the issues to be
Potomac Yard (South Bldg.), 2777 S. Register. The notice must set forth the resolved at the hearing. Additionally, in
Crystal Dr., Arlington, VA. The hours of issues of fact and law to be adjudicated the preamble to these regulations, EPA
operation of this Docket Facility are at the hearing. Because the issues set stated:
from 8:30 a.m. to 4 p.m., Monday forth by the Administrator in the notice For the following reasons, EPA is adopting
through Friday, excluding legal a new Subpart D to the Rules of Practice (40
of hearing establish the scope of the CFR Part 164) setting forth the procedures to
holidays. The Docket Facility telephone hearing, it is important that those issues
number is (703) 305–5805. be followed in the case of an application
be clear. After discussions with other under FIFRA sections 3 or 18 which requests
2. Electronic access. You may access parties to this proceeding and review of use of a pesticide on a site and on a pest for
this Federal Register document the ALJ’s orders, EPA determined that which registration has been finally cancelled
electronically through the EPA Internet its earlier notice contained an error or suspended. These revised procedures
under the ‘‘Federal Register’’ listings at concerning what factors are to be require that in any such case the
http://www.epa.gov/fedrgstr. considered by the judge (i.e. ‘‘due Administrator will initially determine, on the
basis of the application and supporting data,
II. Background diligence’’) and that other changes
whether there is substantial new evidence
would clarify and better focus the which may materially affect the prior order
A. What Action is the Agency Taking? relevant issues for this hearing. and whether such evidence could not have
Pursuant to 40 CFR 164.23(b), EPA is First, EPA is amending the statement been discovered by due diligence on the part
amending its statement of issues for the of issues to correct a misstatement by of the parties to the original proceeding. If it
hearing that the Agency announced in EPA in the July Notice. In that Notice, is determined that there is no such evidence,
the July 11, 2007 Notice. (See 72 FR at EPA identified as an issue of law to be then the application will be denied. If it is
37778, Unit VII.) In the July Notice, EPA adjudicated the following: ‘‘If it is determined that there is such evidence, then
identified among the facts to be substantial new evidence, could the a formal hearing will be convened to
adjudicated certain questions associated determine whether such evidence materially
applicant, through due diligence, have
affects the prior order and requires its
with late blight on potatoes. Among the discovered this information prior to the modification. This determination will be
issues to be adjudicated in the issuance of the cancellation order?’’ (72 made on the basis of the record in the hearing
proceeding, EPA identified the question FR at 37778) and the recommendations of the
of whether the substantial new evidence Whether or not the applicant met this administrative law judge presiding over the
could with due diligence have been ‘‘due diligence’’ test is an issue for the hearing, taking into account the human and
discovered prior to issuance of the 1992 Administrator to determine before environmental risks found by the
cancellation order and whether a issuing the Notice of Hearing, not for the Administrator in his prior order and the
nationwide PHI of 3 days for EBDC use Court to determine at hearing. 40 CFR cumulative impact of past, present, and
on potatoes would meet the standard of anticipated uses in the future. [emphasis
164.131(a) sets forth the standard for
added] (53 FR 12261, 12264).
section 2(bb) of FIFRA. EPA believes determining whether, as a threshold
amending the statement of issues is matter, a petition to amend a As the preamble and regulatory text
necessary. Therefore, EPA is amending cancellation order has merit. This make clear, the determination of
the July Notice by replacing all the regulation states that the Administrator whether the petitioner could have
issues for hearing identified in that will reconsider the merits of a prior discovered and submitted the
Notice with the following issues to be cancellation order when the information during the original
adjudicated in this proceeding: Administrator finds that: proceeding is one for the Administrator
1. Is there substantial new evidence (1) The applicant has presented substantial to make before any hearing is convened.
not considered in the 1992 cancellation new evidence which may materially affect This ‘‘due diligence’’ provision prevents
that relates to whether the dietary risks the prior cancellation or suspension order registrants from wasting Agency
associated with nationwide use of and which was not available to the resources and continually relitigating
EBDCs on potatoes with a 3–day PHI Administrator at the time he made his final cancellation cases by allowing the
cancellation or suspension determination
satisfy the relevant statutory standard Administrator to summarily reject
and, (2) such evidence could not, through the
for registration under FIFRA? For the exercise of due diligence, have been applications that are based on factual
purposes of this hearing, the relevant discovered by the parties to the cancellation information that should have been
portion of the FIFRA standard for or suspension proceeding prior to the presented in the earlier proceeding. In
registration is whether the human issuance of the final order. [emphasis added] contrast, the focus of the subpart D
dietary risk meets the safety standard in hearing itself is on whether the earlier
In contrast, 40 CFR 164.132(a) sets
section 408(b)(2) of FFDCA. cancellation decision is still correct in
forth the issues for the ALJ to decide in
2. Does the substantial new evidence light of the new information. This is
the hearing. The purpose of the hearing
with respect to dietary risk require the similar to the focus of the original
is not to determine whether to
modification of the existing cancellation cancellation hearing—whether the
reconsider the earlier order, but rather
order, i.e., does it support a finding that pesticide at issue meets the applicable
to determine whether or not the earlier
the dietary risks associated with standard for registration under FIFRA.
order should in fact be modified. The
nationwide use of EBDCs on potatoes Because the ‘‘due diligence’’ test is
relevant subsection of this regulation
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with a 3–day PHI satisfy the relevant one to be determined before


states:
statutory standard for registration under The burden of proof in the hearing commencement of a subpart D hearing,
FIFRA? In other words, do the residues convened pursuant to § 164.131 shall be on EPA is amending the statement of issues
that result from EBDCs on potatoes meet the applicant and he shall proceed first. The to delete this issue.
the safety standard in section 408(b)(2) issues in the hearing shall be whether: (1) Second, EPA is amending the
of FFDCA? substantial new evidence exists and (2) such statement of issues to reflect the fact

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that risk issues unrelated to the dietary will result from aggregate exposure to SUMMARY: This notice announces the
risk of EBDC use on potatoes are not the pesticide chemical residue, availability of EPA’s Reregistration
relevant for this hearing. Typically, the including all anticipated dietary Eligibility Decision (RED) for the
scope of the subpart D hearing would be exposures.’’ FFDCA section pesticide para-dichlorobenzene, and
determined by a detailed cancellation 408(b)(2)(A)(ii). Since this standard is a opens a public comment period on this
order from the earlier proceeding. risk-only evaluation, EPA determined document, related risk assessments, and
However, as described above, there was that it was necessary to amend the other support documents. EPA has
no prior hearing because the parties to statement of issues to reflect the correct reviewed the low-risk pesticide para-
the earlier proceeding agreed to a statutory standard and to eliminate the dichlorobenzene through a modified,
settlement. Had there been a hearing consideration of factual issues, such as streamlined version of the public
and subsequent detailed cancellation the need for the pesticide, that are not participation process that the Agency
order, the scope of this subpart D relevant to the applicable standard.4 uses to involve the public in developing
hearing would have been determined by pesticide reregistration and tolerance
C. What is the Agency’s Authority for
that order. Since there was no detailed reassessment decisions. Through these
Taking this Action?
cancellation order, EPA’s 1992 NOIC (as programs, EPA is ensuring that all
it relates to EBDC use on potatoes) must EPA regulation at 40 CFR 164.132 pesticides meet current health and
be used to determine the issues to be states that the procedures for the safety standards.
considered in the present hearing hearing ‘‘shall follow the Rules of
DATES: Comments must be received on
because it is the best evidence of what Practice set forth in subparts A and B.’’
or before February 11, 2008.
issues would have been presented at the In subpart B, specifically 40 CFR
164.23(b), the Administrator has the ADDRESSES: Submit your comments,
cancellation hearing had it taken place.
authority to amend the statement of identified by docket identification (ID)
(57 FR 7484, March 2, 1992).
The NOIC was the result of a issues EPA set forth in a Notice of number EPA–HQ–OPP–2007–0937, by
regulatory process known as ‘‘Special Hearing at any time prior to the one of the following methods:
Review.’’3 The NOIC stated that the commencement of the public hearing. • Federal eRulemaking Portal: http://
basis for the initiation of the Special Pursuant to these provisions, and the www.regulations.gov. Follow the on-line
Review for the uses of EBDC fungicides. fact that a public hearing has not yet instructions for submitting comments.
Specifically, for potatoes, the following commenced, EPA is amending the • Mail: Office of Pesticide Programs
issues were of concern: ‘‘carcinogenic, statement of issues it issued in its July (OPP) Regulatory Public Docket (7502P),
developmental, and thyroid effects 2007 Notice of Hearing to ensure that Environmental Protection Agency, 1200
caused by ethylenethiourea (ETU).’’ (57 the hearing is focused on the issues that Pennsylvania Ave., NW., Washington,
FR at 7487). Had a cancellation hearing are relevant to the risk-only DC 20460–0001.
been held, these would have been the determination. In light of this • Delivery: OPP Regulatory Public
issues for the hearing. Only information amendment, the ALJ may determine that Docket (7502P), Environmental
related to these three risks, or to dietary additional time is necessary to permit Protection Agency, Rm. S–4400, One
exposures associated with these three the parties to prepare for matters raised Potomac Yard (South Bldg.), 2777 S.
risks, is material to the issue of whether in this amendment; and, upon such Crystal Dr., Arlington, VA. Deliveries
the 1992 cancellation order should be determination, the hearing shall be are only accepted during the Docket’s
modified to allow for a shorter PHI than delayed for appropriate period. See 40 normal hours of operation (8:30 a.m. to
called for in theNOIC. CFR 164.23(b). 4 p.m., Monday through Friday,
The relevant statutory standard for excluding legal holidays). Special
determining whether dietary risks are List of Subjects arrangements should be made for
acceptable under FIFRA is not the same Environmental protection, EBDC deliveries of boxed information. The
today as it was in 1992. At the time of fungicides, Pesticides and pests. Docket Facility telephone number is
the 1992 cancellation proceedings, the Dated: November 30, 2007.
(703) 305–5805.
presence of late blight in the New Instructions: Direct your comments to
Steven Bradbury,
England states was relevant to a reduced docket ID number EPA–HQ–OPP–2007–
Director, Special Review and Reregistration
PHI of 3 days being allowed in those 0937. EPA’s policy is that all comments
Division, Office of Pesticide Programs.
states. At this time, however, whether received will be included in the docket
[FR Doc. E7–23948 Filed 12–11–07; 8:45 am]
late blight has spread nationwide and without change and may be made
BILLING CODE 6560–50–S
whether EBDCs are necessary are not available on-line at http://
appropriate for consideration by the ALJ www.regulations.gov, including any
when determining whether the 1992 personal information provided, unless
ENVIRONMENTAL PROTECTION
cancellation order must be modified. the comment includes information
AGENCY
The 1996 Food Quality Protection Act claimed to be Confidential Business
amendments to FIFRA and FFDCA [EPA–HQ–OPP–2007–0937; FRL–8153–1] Information (CBI) or other information
require that dietary risks associated with whose disclosure is restricted by statute.
a pesticide chemical’s residue on food Para-dichlorobenzene; Reregistration Do not submit information that you
now be evaluated under the risk-only Eligibility Decision for Low-Risk consider to be CBI or otherwise
safety standard as set forth in FFDCA Pesticide; Notice of Availability protected through regulations.gov or e-
section 408(b). The safety determination AGENCY: Environmental Protection mail. The regulations.gov website is an
that now must be made is whether there Agency (EPA). ‘‘anonymous access’’ system, which
is a ‘‘reasonable certainty that no harm ACTION: Notice. means EPA will not know your identity
mstockstill on PROD1PC66 with NOTICES

or contact information unless you


3The purpose of Special Review is to help the provide it in the body of your comment.
Agency determine whether to initiate procedures to 4The presence of late blight nationwide and the
If you send an e-mail comment directly
cancel, deny, or reclassify registration of a pesticide need for EBDC fungicides is not relevant to the risk-
product because uses of that product may cause only finding that the court must make in order to
to EPA without going through
unreasonable adverse effects on the environment. determine whether the earlier cancellation order regulations.gov, your e-mail address
See 40 CFR part 154. must be modified. will be automatically captured and

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