Notice of Hearing on Request to Reduce Pre-Harvest Interval (PHI)
for EBDC Fungicides on Potatoes
[Federal Register: July 11, 2007 (Volume 72, Number 132)]
[Notices]
[Page 37771-37779]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11jy07-93]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2007-0181; FRL-8118-4]
Notice of Hearing on Request to Reduce Pre-Harvest Interval (PHI)
for EBDC Fungicides on Potatoes
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of Hearing.
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SUMMARY: The EPA is issuing this Hearing Notice under the authority set
forth in 40 CFR part 164 subpart D (subpart D hearing). A subpart D
hearing is required when a registrant wants to modify an existing
cancellation order that was issued after the opportunity for a hearing.
In 1992, EPA issued a Notice of Intent to Cancel (NOIC) registrations
containing EBDCs for use on certain crops. The crop at issue for this
hearing notice is potatoes. The NOIC stated that use of EBDCs on
potatoes would be canceled unless the registrants modified their
pesticide product labels. At issue in this notice is the 1992
requirement to extend the preharvest interval (PHI) to reduce the
dietary risk. EPA issued the 1992 NOIC with an opportunity for a
hearing. EPA and the registrants reached a settlement, including the
agreement to amend labels to extend the PHI to 14 days. The purpose of
this notice is to announce that EPA has determined that the petition
requesting a modification of the cancellation order has merit and to
announce an opportunity for a hearing.
DATES: Requests to participate in the hearing announced by this notice
must be received by the Office of the Hearing Clerk at the address
given below by August 10, 2007. A pre-hearing conference will be held
and the evidentiary hearing will commence as soon thereafter as
practicable, according the schedule outlined herein.
ADDRESSES: Submit your request to participate in the hearing,
identified by docket identification (ID) number EPA-HQ-OPP-2007-0181,
by the following method:
• Mail: Office of Hearing Clerk, USEPA, 1200 Pennsylvania
Ave., N.W., Washington, DC 20460.
• Hand delivery: Office of the Hearing Clerk, 1099 14th St.,
NW., Suite 350, Washington, DC 20005.
[[Page 37772]]
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) 308-7070; e-mail address: costello.kevin@epa.gov or
Michele Knorr, Office of General Counsel, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001;
telephone number: (202) 564-5631; fax number: e-mail address:
knorr.michele@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
The EPA is issuing this Hearing Notice under the authority set
forth in 40 CFR part 164 subpart D (subpart D hearing). A subpart D
hearing is required when a registrant wants to modify an existing
cancellation order that was issued after the opportunity for a hearing.
In 1992, EPA issued a NOIC registrations containing EBDCs\1\ for use on
certain crops. The crop at issue for this hearing notice is potatoes.
The NOIC stated that use of EBDCs on potatoes would be canceled unless
the registrants modified their pesticide product labels. At issue in
this notice is the 1992 requirement to extend the preharvest interval
(PHI)\2\ to reduce the dietary risk. EPA issued the 1992 NOIC with an
opportunity for a hearing. EPA and the registrants reached a settlement,
including the agreement to amend labels to extend the PHI to 14 days.
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\1\ EBDC refers to products containing ethylene
bisdithiocarbamate.
\2\ PHI refers to the number of days between the last
application of a pesticide and when the crop can be harvested.
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On December 26, 1996, the EBDC/ETU Task Force\3\ (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 order to reduce otherwise-unacceptable dietary
risks, the cancellation order restricted the PHI for potatoes to 14
days in 37 States.
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\3\ The EBDC Task Force represents registrants who hold EBDC
registrations. The current members of the Task Force are Dow
AgroSciences, DuPont, Griffin, Cerexagri, and BASF.
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In this request, the Task Force requested that the PHI be reduced
from 14 days to 3 days nationwide to address the spread of the late
blight disease (Phytophthora infestans) in potatoes. Late blight is a
fungal disease that caused the infamous ``Irish Potato Famine'' in the
1840s. If not adequately controlled, this disease is capable of totally
destroying the crop in the field (foliar blight phase) and/or in
storage (tuber rot phase). For the foliar phase of the disease, the
primary source of inoculum is infected tubers, which are present in
cull piles, or remain in the soil after harvest, or are used as seed-
pieces for new plantings. Spores produced on foliage and stems during
the foliar phase of the disease serve as the primary inoculum for tuber
infections, which generally occur prior to harvest. Infected potatoes
placed in storage lots can then serve as a source of inoculum for the
storage rot phase of the disease.
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. The Agency decided to consider the request after
completion of the Reregistration Eligibility Decision (RED) process for
the EBDCs\4\. To date, EPA has not taken any substantial actions on the
Task Force request. This Notice represents EPA's determination that the
2003 request to modify the existing cancellation order merits a subpart
D hearing.
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\4\ Mancozeb was first registered in 1948. Maneb was first
registered in 1962. Metiram was first registered in 1948.
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Under subpart D of 40 CFR part 164, the Task Force submission
constitutes 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. EPA has concluded that the submissions by the
Task Force provide a basis for modification of the order canceling EBDC
products. This Notice (1) announces that EPA has decided to hold a
hearing regarding the petition to modify the existing cancellation
order as it applies to the use of products containing EBDCs (mancozeb,
maneb, and metiram) on potatoes and the allowance of a 3-day, rather
than a 14-day PHI, (2) specifies the issues of fact and law to be
considered at that hearing, (3) identifies what steps interested
persons need to take if they wish to participate in the hearing, and
(4) establishes a schedule for the hearing.
A. Does this Action Apply to Me?
This action is directed to the public in general, and may be of
interest to 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 ID number EPA-HQ-OPP-2007-0181. Publicly Available docket
materials are available either in the electronic docket at
http://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 Building), 2777 S. Crystal Drive 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
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?
The purpose of this document is to announce that the Agency has
determined that the petition requesting a modification of the
cancellation order has merit and that an opportunity for a hearing is
being announced.
B. What is the Agency's Authority for Taking this Action?
When the Agency receives an application to permit use of a
pesticide in a manner inconsistent with a cancellation order issued
after a cancellation proceeding has commenced (i.e., after publication
of a notice of intent to cancel and receipt of a request for a hearing
on that notice), that application will be treated by the Agency as a
petition to modify the cancellation order. Because of the opportunity
for a formal adjudicatory hearing, which precedes entry of such a final
cancellation order, EPA has
[[Page 37773]]
determined that such an order should not be modified or rescinded
without affording interested parties a similar notice and opportunity
for hearing concerning such modification or rescission. The procedures
governing all applications to modify or reverse a previous final
cancellation order are set forth in 40 CFR part 164, subpart D, Sec.
164.130 through 164.133.
The Administrator has determined that the applicant has met the
criteria for a subpart D hearing. This notice sets forth the
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.
III. Regulatory History
EBDC fungicides currently registered under FIFRA for food uses
include mancozeb, maneb, and metiram. The following is a summary of the
regulatory history of the EBDCs.
In 1977, the Agency initiated a Rebuttable Presumption Against
Registration\5\ (RPAR), which later became the Special Review Program,
based on concerns that EBDCs and ethylene thiourea (ETU) posed
potential significant risks to humans and the environment. In 1982, EPA
concluded the RPAR and announced measures designed to mitigate
potential unreasonable adverse effects pending the development of
additional data. At that time, EPA deferred a decision on one risk of
concern, carcinogenicity. The decision was deferred to allow for the
development of residue data in order to better characterize the risk.
(See 61 FR 42244, August 14, 1996).
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\5\ RPAR was a regulatory review process used prior to Special
Review to consider potential risks that might warrant the
cancellation of the registration. The regulations were changed in
the mid-1980's to review pesticide products (leading to an ultimate
determination of whether their use or uses pose unreasonable adverse
effects to humans or the environment) and the procedures for the
Special Review process. The regulatory changes were based primarily
on changes made to FIFRA in 1978 and on the experience acquired by
EPA in regulating pesticides pursuant to the RPAR process. See 40
CFR part 154 for the procedures associated with Special Review.
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In 1987, the Agency placed the EBDCs into Special Review because of
concerns that the common metabolite, ETU, could cause carcinogenic and
adverse developmental and thyroid effects in humans. The EBDCs
metabolize to ETU in the body and all degrade to ETU in the
environment. (See 52 FR 27172, July 17, 1987).
In response to the Agency placing the EBDCs in Special Review, the
four technical registrants of mancozeb, maneb and metiram requested
that registrations be maintained for only 13 of the 55 food uses
registered at that time and that all other uses be canceled. (See 54 FR
50020, December 4, 1989) Shortly thereafter, the Agency approved the
requested amendments.
After the approval of the amendments, the Agency issued a Notice of
Preliminary Determination\6\ (PD 2/3) that proposed canceling the uses
on an additional three crops, including potatoes. The Agency received
comments in response that recommended mitigation options to allow
continued use of EBDCs on potatoes. Among these mitigation options was
to ``(e)xtend the preharvest interval to 14 days as most growers
already observe a 14-day interval,'' noting that ``(t)he 0-day
preharvest interval invites contamination of tubers with fungicide
residues,'' which could result in unacceptable dietary risks. (See 54
FR 52158, December 20, 1989). As a result of the PD 2/3, the EPA also
issued a proposal to revoke and reduce tolerances for the 42 deleted
uses plus the additional three uses proposed for cancellation. (See 55
FR 20416, May 16, 1990).
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\6\ The PD 2/3 is the Notice of Preliminary Determination, which
was based on information on risks and benefits received in public
comments and on additional analyses performed since the Special
Review process began. See 40 CFR 154.31.
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On March 2, 1992, the Agency issued the ``Notice of Intent to
Cancel and Conclusion of Special Review'' (PD 4)\7\ concluding that the
relatively high estimated dietary risk outweighed the relatively low
benefits of the use of EBDCs on potatoes. (See 57 FR 7484, March 2,
1992). In order to allow the use on potatoes to remain, the Agency
required certain mitigation language to be included on the label. This
included the 14-day PHI for all but nine potato-producing states.
Because of the presence of late blight in certain states (Connecticut,
Florida, Maine, Massachusetts, New Hampshire, New York, Pennsylvania,
Vermont, and Wisconsin), a 3-day PHI for use of EBDCs on potatoes was
allowed in those states. The Agency allowed the 3-day PHI in these
states because the data on late blight, efficacy of possible
alternatives, and residue data allowed EPA to find that the benefits
outweighed the risks. (See 57 FR 7484, 7526, March 2, 1992).
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\7\ A PD 4 is issued in accordance with 40 CFR 154.33.
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The adoption of the 14-day PHI was intended to be consistent with
common practice in the other potato growing states at the time. (Ref.
1). The tolerance for the EBDC fungicides was based on EBDC and ETU
residues detected in the Market Basket Survey\8\ (MBS) of 1989-1990. As
part of the Special Review, and in order to conduct a highly refined
dietary exposure assessment, the EBDC registrants conducted a large-
scale MBS to determine EBDC and ETU residues in a variety of foods as
close to the point of consumption as possible (i.e., grocery stores and
small markets). The survey was completed in 1990 and used in the
Special Review PD 4, which was completed in 1992. The distribution of
14-day and 3-day PHIs was designed to best replicate the conditions
under which the residues detected in the MBS occurred. (See 57 FR 7484,
March 2, 1992).
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\8\ Samples were purchased at consumer retail outlets and
shoppers were instructed to select blemish free commodities in
amounts similar to those purchased by typical consumers. The study
was conducted over a 1-year period to ensure that seasonal
differences in residues would be addressed. The samples were
analyzed using methods that are still in use at this time.
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Subsequently in 1996, the Agency allowed a 3-day PHI for use of
EBDCs on potatoes in four additional states (Delaware, Michigan, Ohio,
and Rhode Island). At the time the 1992 NOIC\9\ was issued, the Agency
had no information suggesting that Delaware, Michigan and Ohio had a
late blight problem and included those states among the states subject
to a minimum 14-day PHI. Subsequent to the NOIC being issued, a group
of registrants and growers submitted to the Agency information on late
blight supporting a minimum 3-day PHI for Delaware, Michigan, and Ohio.
This group requested a hearing to add these three states to the list of
states for which a 3-day PHI was permitted. Additionally, at the time
the Agency issued the NOIC, EPA believed that the ``New England''
states as well as some other states had a late blight problem and
allowed a minimum 3-day PHI for those states. Rhode Island was
erroneously omitted from the list of states. The Agency determined that
in the states with substantial late blight occurrence, the benefits
outweighed the risks associated with a 3-day PHI and amended the
cancellation order. (See 61 FR 42244, August 14, 1996).
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\9\ See, Settlement Agreement in In re: American Food Security
Coalition (AFSC) et al., FIFRA Docket Nos. 646, et al.
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During the reregistration process, EPA evaluated the 14- and 3-day
PHIs as part of the mancozeb, maneb, and metiram REDs, which were
completed by September 2005 as part of the FIFRA reregistration
process. (Refs. 2, 3, and 4)\10\. The REDs noted receipt of the
[[Page 37774]]
petition to allow for a 3-day PHI in all states, but the Agency did not
address whether the petition warranted a subpart D hearing or if the
registration amendment requests would be granted. Through the
reregistration process, EPA determined that the exposure that would
result from a nationwide 3-day PHI for potatoes would be safe under the
FFDCA reasonable certainty of no harm standard (Refs. 5, 6, and 7). In
that analysis, the Agency assumed 67% crop treated for the use of EBDCs
on potatoes. The 67% crop treated is a conservative overestimate for
the actual crop treated. Even assuming a greater conservative and
unlikely scenario of 100% crop treated, EPA believes the risk increase
would be insignificant.
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\10\ FIFRA section 4 requires EPA to make reregistration
eligibility determinations for all older chemicals (those registered
before November 1, 1984). The Agency announced these determinations
through REDs.
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IV. Statutory and Regulatory Background
A. Standards for Granting or Maintaining a Registration
A pesticide product may be registered or remain registered only if
it performs its intended pesticidal function without causing
``unreasonable adverse effects on the environment.'' (FIFRA section
3(c)(5)). ``Unreasonable adverse effects on the environment'' is
defined as ``(1) any unreasonable risk to man or the environment,
taking into account the economic, social, and environmental costs and
benefits of the use of the pesticide, or (2) a human dietary risk from
residues that result from a use of a pesticide in or on any food
inconsistent with the standard under section 408 of the [FFDCA].''
(FIFRA section 2(bb)).
Under FIFRA section 6, the Agency may issue a NOIC the registration
of a pesticide product whenever it is determined that the product no
longer satisfies the statutory criteria for registration. The Agency
may specify particular modifications in the terms and conditions of
registration, such as deletion of particular uses or revisions of
labeling, as an alternative to cancellation. If an adversely affected
person requests a hearing, the final order concerning cancellation of
the product is not issued until after a formal administrative hearing.
B. Subpart D Proceedings
When the Agency receives an application to permit use of a
pesticide in a manner inconsistent with a cancellation order issued
after a cancellation proceeding has commenced (i.e., after publication
of a NOIC and receipt of a request for a hearing on that notice), that
application will be treated by the Agency as a petition to modify the
cancellation order. Because of the opportunity for a formal
adjudicatory hearing, which precedes entry of such a final cancellation
order, EPA has determined that such an order should not be modified or
rescinded without affording interested parties a similar notice and
opportunity for hearing concerning such modification or rescission. The
procedures governing all applications to modify or reverse a previous
final cancellation order are set forth in 40 CFR part 164, subpart D,
Sec. 164.130 through 164.133.
As stated previously, 40 CFR 164.131(a) provides that the
Administrator will consider modifying a prior final cancellation order
when he 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.
In deciding whether or not to initiate a hearing, the Administrator
does not need to determine that the evidence submitted by the Task
Force would in fact justify modification of the prior order. Rather, a
decision to initiate a hearing means only that the Administrator has
determined that the evidence submitted, if substantiated on the record
in the hearing, may ``materially affect'' the evidentiary rationale
upon which the prior order was based. On the other hand, if the
evidence submitted, even if substantiated on the record, would be
unlikely to provide a basis for modification of the prior order, then a
hearing would serve no purpose.
If the Administrator determines that an applicant has met the
criteria for a subpart D hearing, the Administrator then publishes a
notice in the Federal Register setting forth the 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. The purpose of the hearing is to determine whether: (1)
Substantial new evidence exists and (2) such substantial new evidence
requires reversal or modification of the existing cancellation order.
For purposes of any decision in the hearing, those portions of the
substantive rationale for the existing order concerning which the
applicant did not submit substantial new evidence are assumed to be
correct. Thus, the scope of any subpart D hearing is intrinsically
narrower than the original cancellation proceeding.
If a hearing is requested, a notice of the hearing will be
published in the Federal Register announcing the formal public hearing
to be held in accordance with 5 U.S.C. 554. In such a hearing, the
Administrative Law Judge transmits a recommended decision to the
Administrator, who then issues a final decision retaining, modifying,
or reversing the existing order. (See 40 CFR 164.131).
V. Submissions - Substantial New Evidence Provided by Task Force
As stated above, the Task Forces submission constitutes a petition
to modify the EBDC cancellation order. In order for the Agency to find
that a subpart D hearing is warranted, it must determine:
(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. (See 40 CFR 164.131(a)).
The Task Forces 2003 petition to reduce the PHI for use of EBDCs on
potatoes from 14 days to 3 days nationwide included a number of points
described as ``substantial new evidence'' that could not have been
known at the time of the cancellation order. The asserted ``substantial
new evidence'' includes information on the spread of late blight to
additional potato-growing states, field trial data for mancozeb and
maneb use on potatoes and the Agency's revision of the cancer endpoint
for EBDC breakdown product, ETU.
A. Spread of Late Blight
The Agency has determined that the information submitted by the
Task Force concerning the spread of late blight fungal disease
nationally is substantial new evidence which supports the adoption of a
nationwide 3-day PHI for EBDCs on potatoes beyond the 13 states in
which the 3-day PHI is currently in effect. Late blight is a severe
fungal disease, which attacks leaves of potato plants in the field,
killing the leaves and decreasing the size and number of potato tubers.
Late blight also attacks tubers in storage, causing them to rot. Late
blight was once controlled by metalaxyl, until metalaxyl resistant
strains developed.
[[Page 37775]]
The disease spreads rapidly by spores, with a new disease cycle
occurring every 4 to 6 days. As mentioned above, the Agency was aware
of the presence of late blight in nine states when the NOIC was
published, and was made aware of its presence in four additional states
soon thereafter (Ref. 7), and consequently the Agency determined that
it was appropriate to reduce the PHI in those four states as well. The
Task Force has since submitted new information that late blight has now
spread nationwide. The following is background information on the
spread of late blight and why this information is material to allowing
a modification to the cancellation order.
Until 1989, late blight was very rarely of concern in any potato
producing state, due primarily to the fact that metalaxyl products
provided virtually 100% control of the foliar phase of the disease.
(Ref. 8). The Task Force indicated that by 2003, the Agency had granted
FIFRA section 18 emergency exemptions for the use of products to
control late blight in 23 states to which the disease had spread since
the issuance of the NOIC (Ref. 9). Pesticides for which exemptions were
granted included dimethomorph, cymoxanil, and propamocarb
hydrochloride. State crop specialists documented the distribution of
metalaxyl-resistant forms and grower crop damage incidents associated
with the failure of metalaxyl to provide adequate disease control
(Refs. 8 and 10). Metalaxyl was thus no longer regarded as an effective
control for late blight in potatoes.
If late blight is not adequately controlled, this disease is
capable of totally destroying a crop of potatoes in the field (foliar
blight phase) and\or in storage (tuber rot phase). Generally speaking,
the number of infected tubers present at harvest is primarily a
function of the level of foliar disease control attained during the
growing season, especially during the latter half of the season. At
present, even when low levels of tuber infection are detected in a
field at harvest, growers typically need to sell potatoes right away,
rather than store them and risk losing a large number of stored
potatoes (Refs. 8 and 10).
Once plants are initially infected, the foliar phase of the disease
can rapidly progress by producing multiple generations of spores, which
can be transported up to 150 miles in the air as well as locally in
water or air. One spore cycle can occur in a 4- to 6-day period. In
addition to destroying aboveground plant parts, the foliar blight phase
of the disease can cause a significant decrease in the size and number
of marketable potatoes. Accordingly, even the planting of a single
infected tuber can quickly result in extensive crop losses and a high
percentage of tuber infections over a large area (Refs. 8 and 10).
The foliar phase of the disease is favored by cool and moist
conditions, which commonly occur in most potato production states. Long
periods of high relative humidity (over 90%) with night temperatures of
50 to 60[deg]
F and day temperatures of 60 to 80[deg] F are favorable
for disease development. The spread and control of this disease is
complicated by the fact that most fungal forms are also capable of
infecting and reproducing on tomatoes as well as certain other
solanaceous plants (including certain weeds). It is suspected that the
new, sexually reproducing forms of late blight were introduced to the
United States through the importation of infected tomatoes from Mexico
(Ref.11). The potential for spreading the disease via infected tomato
transplants or fruits is of particular concern, in light of the widespread
homeowner gardening and composting practices associated with tomatoes.
Most of the harvested potatoes in the United States go directly
into storage and are gradually released into the marketplace over a
period of 1 to 10 months. Many of the existing storage facilities are
conducive to the rapid spread of tuber rot, especially during wet or
humid weather. Potato late blight specialists agree that, under these
storage conditions, even if only a small percentage of any lot of
stored potatoes is infected with tuber rot, it is likely that the
majority of them will spoil prior to their release into the
marketplace. When this occurs, the whole lot is generally considered
unmarketable. The stored tuber spoilage problem can be due solely to
late blight, or to a series of tuber rots initiated by late blight
infected tubers and followed by bacterial soft rots, which develop in
response to the anaerobic conditions created by the development of late
blight tuber rot (Refs. 8 and 10).
B. Field Trial Data
As mentioned above, the potential exposure to humans that could
result from the use of EBDCs on potatoes was considered during
reregistration and was found to meet the standard for reregistration.
EPA was able to make this determination because of the new information
submitted by the Task Force as well as revised risk assessment
methodologies. The residues detected in the 1989-1990 MBS were
considered to reflect common practices that included either 14-day or
3-day PHIs for potatoes treated with EBDC fungicides. Additional field
trial data submitted by the Task Force in support of its 2003 petition
are available for two of the three EBDCs, which further support the
establishment of a nationwide 3-day PHI. The following describes the
field trial data available for each EBDC chemical.
1. Mancozeb. The Mancozeb Task Force conducted residue trials on
potatoes in 1995-1996. A summary of relevant residue data for mancozeb
and ETU are presented in Table 1 below. The maximum mancozeb value
found in residue studies using the maximum seasonal rate for mancozeb
on potatoes with a 3-day PHI was 0.1 parts per million (ppm) and for a
14-day PHI was 0.02 ppm. The average mancozeb value with a 3-day PHI
was 0.02 ppm and with a 14-day PHI was 0.01 ppm.
From this newly submitted data, the Agency has now determined that
reduction of the PHI to 3 days for the entire United States would not
result in mancozeb residues exceeding the reassessed tolerance of 0.2
ppm for potatoes. A separate dietary risk assessment was not required
to support the PHI change request because existing dietary assessments
used for the EBDC REDs showed no appreciable differences in the residue
levels at different pre-harvest intervals. Additionally, as stated
earlier, even if the percent crop treated rose from 67% to 100% the
resulting increase in risk would be insignificant. Therefore, the
Agency found that the use of EBDCs on potatoes with a 3-day PHI would
meet the FFDCA safety determination (Ref. 12).
EPA used monitoring data from the MBS in the dietary risk
assessment for the reregistration eligibility decision. Based on these
new field trial data, EPA has now determined that the MBS is
representative of the residues that may be expected in potato tubers at
PHIs ranging from 3 to 14 days.
Low residues are expected because mancozeb is applied to the
foliage, and metabolism studies have not shown translocation of
mancozeb throughout the plant (Ref. 6). Therefore, it is not surprising
that there are minimal residues on the day of application, as the
residues would not transport from the potato leaves to the tubers below
the ground. The minimal residues that are present on the tubers may be
from some soil that adhered to the tuber when harvested.
[[Page 37776]]
Table 1.-- Summary of Mancozeb Residue Data for Potatoes (MRIDs 44167901, 40913301, and 41091601)
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Single Seasonal Pre-harvest Residues Found, ppm
Location Application Rate, No. of Application Rate, Intrerval, -------------------------------------
lb ai/A Applications lb ai/A days Mancozeb ETU
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CA 1.6 + 2.4 5 11.2 0 < 0.05 < 0.01
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CA 1.6 + 2.4 5 11.2 0 < 0.05 < 0.01
--------------------------------------------------------------------------------------------------------------------------------------------------------
WI 1.6 7 11.2 3 < 0.02 < 0.01
--------------------------------------------------------------------------------------------------------------------------------------------------------
FL 1.6 7 11.2 3 0.03 < 0.01
--------------------------------------------------------------------------------------------------------------------------------------------------------
FL 1.6 7 11.2 3 0.03 < 0.01
--------------------------------------------------------------------------------------------------------------------------------------------------------
PA 1.6 7 11.2 3 < 0.02 < 0.01
--------------------------------------------------------------------------------------------------------------------------------------------------------
PA 1.6 7 11.2 3 < 0.02 < 0.01
--------------------------------------------------------------------------------------------------------------------------------------------------------
MO 1.6 7 11.2 3 0.02 < 0.01
--------------------------------------------------------------------------------------------------------------------------------------------------------
MO 1.6 7 11.2 3 < 0.02 < 0.01
--------------------------------------------------------------------------------------------------------------------------------------------------------
MO 1.6 7 11.2 3 0.1 < 0.01
--------------------------------------------------------------------------------------------------------------------------------------------------------
MO 1.6 7 11.2 3 0.03 < 0.01
--------------------------------------------------------------------------------------------------------------------------------------------------------
NY 1.6 7 11.2 3 < 0.02 < 0.01
--------------------------------------------------------------------------------------------------------------------------------------------------------
MN 1.6 7 11.2 4 < 0.02 < 0.01
--------------------------------------------------------------------------------------------------------------------------------------------------------
MN 1.6 7 11.2 4 < 0.02 < 0.01
--------------------------------------------------------------------------------------------------------------------------------------------------------
CA 1.6 + 2.4 5 11.2 5 < 0.05 0.01
--------------------------------------------------------------------------------------------------------------------------------------------------------
CA 1.6 5 11.2 5 < 0.05 0.02
--------------------------------------------------------------------------------------------------------------------------------------------------------
CA 1.6 7 11.2 14 < 0.02 0.02
--------------------------------------------------------------------------------------------------------------------------------------------------------
CA 1.6 7 11.2 14 0.02 < 0.01
--------------------------------------------------------------------------------------------------------------------------------------------------------
WA 1.6 7 11.2 14 < 0.02 < 0.01
--------------------------------------------------------------------------------------------------------------------------------------------------------
CA 1.6 7 11.2 14 < 0.02 0.02
--------------------------------------------------------------------------------------------------------------------------------------------------------
UT 1.6 7 11.2 14 < 0.02 < 0.01
--------------------------------------------------------------------------------------------------------------------------------------------------------
UT 1.6 7 11.2 14 < 0.02 < 0.01
--------------------------------------------------------------------------------------------------------------------------------------------------------
ID 1.6 7 11.2 14 < 0.02 < 0.01
--------------------------------------------------------------------------------------------------------------------------------------------------------
ID 1.6 7 11.2 14 < 0.02 < 0.01
--------------------------------------------------------------------------------------------------------------------------------------------------------
CA 1.6 + 2.4 5 11.2 15 < 0.05 0.03
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CA 1.6 + 2.4 5 11.2 15 < 0.05 0.02
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2. Maneb. In response to EPA's requests for data in the late 1980s
and early 1990s, one registrant, Elf Atochem North America, Inc.
submitted data in 1994 pertaining to the magnitude of maneb residues in
or on potatoes. The data were determined to be insufficient to fulfill
the total field trial requirement, because ``field trials were not
conducted in states where a 3-day PHI is allowed.'' However, they did
indicate that residues of maneb and ETU from maneb will not exceed the
established tolerance of 0.1 ppm in or on potatoes harvested 1 day
following the last of eight foliar applications of the dry flowable
formulation for a total seasonal rate of 12.8 lb active ingredient/Acre
(ai/A) because the combined residues of maneb and its metabolite ETU were
nondetectable (< 0.06 to < 0.08 ppm) in or on potatoes (Refs. 13, 14 and 5).
Available field trial data for maneb and ETU in or on potatoes were
among the data used in conjunction with MBS from 1989-1990 to assess
acute and chronic dietary (food) risk in the 2005 maneb RED. In the
2005 RED, EPA determined that the overall aggregate risk from residues
of maneb and ETU on food was determined to be below the Agency's
levels-of-concern. The reduction in PHI to 3 days will not change this
determination.
3. Metiram. The Task Force did not provide new evidence to support
a 3-day PHI for use of metiram on potatoes because such data had
previously been submitted to the Agency in 1988. This earlier data
involved field trials performed in 1987 in seven states to measure the
magnitude of metiram and ETU residues on potatoes. The review of these
studies shows that ``(t)he 80% WP metiram formulation was foliarly
applied 10 times (with a 5- to 21-day retreatment interval), to potato
plants at 1.6 lb ai/A/application (1x) using
[[Page 37777]]
ground equipment. Individual residues of metiram and ETU were < 0.10 ppm
(nondetectable) and < 0.01(nondetectable) to 0.02 ppm, respectively, in
or on treated potato tuber samples harvested immediately (0-day)
following the last of the above treatment schedule. The maximum
residues of metiram in or on potato tubers following treatments at 1x
were < 0.10 ppm which is below the established tolerance of 0.5 ppm''
(Ref. 10). The tolerance was later reassessed and set at 0.2 ppm, which
met the FFDCA safety finding as well allowing the Agency to harmonize
the tolerance with the Codex maximum residue limit (MRL) for EBDCs in
or on potatoes.
Since residues of metiram measured in or on potatoes were below the
tolerance level for potatoes harvested immediately after the final
treatment, potatoes harvested 3 days after treatment should have
residues that are lower and also below the tolerance level. As was
stated in the maneb discussion, overall risk from residues of metiram
and ETU on food was determined to be below the Agency's levels of
concern, and would be expected to remain so if a 3-day PHI for potatoes
were established nationwide (Ref. 10).
C. Revision of the Cancer Endpoint for ETU
The Task Force notes in its 2003 petition that the Q1*\11\ for ETU
has changed since the 1992 NOIC. If there is evidence, such as tumor
formation, and the pesticide is classified as a carcinogen, a
quantitative assessment is conducted using a Q1* (non-threshold) or a
Margin of Exposure (threshold) approach. The Agency evaluated the risk
from ETU in the NOIC using a Q1* of 0.11 milligrams/kilogram/day (mg/
kg/day)-1. The Agency subsequently recalculated the ETU Q1*
in 1995, resulting in a Q1* of 0.06 mg/kg/day-1. As a result
of this new assessment endpoint, the Task Force suggests that the
reduction in the PHI for use of EBDCs on potatoes would be even less
likely to result in exceedances of the Agency's levels of concern. In
its reregistration decisions for the EBDCs, using the lower Q1*, EPA
found that the level of concern for cancer risk was not exceeded.
---------------------------------------------------------------------------
\11\ The Q1*, or cancer slope factor, is an upper bound estimate
of the increased cancer risk from a lifetime exposure to an agent. Upper
bound in this context is a plausible upper limit to the true probability.
---------------------------------------------------------------------------
The reduction of the Q1* for ETU was significant new evidence that
allowed the Agency to make a safety finding for the reregistration of
EBDC fungicides. It is important to note that the field trial data
alone indicate that residues of ETU on potatoes from application of
EBDCs would not be significantly different for PHIs of 3 and 14 days.
Therefore, the reduction of the Q1* for ETU is a less compelling
argument for reducing the PHI to 3 days as exposure levels show that
there are no risks of concern.
VI. Risk-Benefit Assessment
A. Significance of Substantial New Evidence
When the Agency issued the cancellation order for EBDC fungicides
in 1992, it allowed a shorter, 3-day PHI for EBDCs on potatoes in nine
states in which late blight disease occurred. The Agency was made aware
soon thereafter that late blight disease was also present in four
states not identified in the cancellation order, and the 3-day PHI was
extended to those states to afford the same protection against late
season onset of late blight disease through amendments to the
cancellation order. The evidence presented by the Task Force that late
blight has since spread to almost all potato-growing states, when
combined with the scientific finding that the resulting exposures would
still meet the ``reasonable certainty of no harm'' standard set forth
in section 408 of the FFDCA, is a compelling justification for extending
the 3-day PHI to all states in which EBDCs could be applied to potatoes.
It is important to keep in mind that there are also residue data
for mancozeb and maneb on potatoes submitted since the cancellation
order that support the nationwide adoption of the 3-day PHI. As shown
above, the mancozeb field trial data indicate that mancozeb and ETU
residues from the use of mancozeb on potatoes were insignificant, and
that the concentrations of mancozeb and ETU residues reflecting a 3-day
PHI were not significantly different than those reflecting a 14-day
PHI. Similarly, maneb field trial data submitted since the cancellation
order indicate that ETU residues were undetectable for treated potatoes
after both 1-day and 7-day PHIs. These data, in conjunction with
previously submitted metiram data showing no ETU residues on potatoes
harvested the day of treatment, indicate that adoption of a 3-day PHI
nationwide will not meaningfully increase exposure to ETU in or on potatoes.
Although the requirements for additional field trials for use of
maneb on potatoes are still outstanding because geographic
representation was inadequate, the Agency believes it unlikely that the
residues resulting from a 3-day PHI in other regions would be
sufficiently different to be of concern, based on similar data for
mancozeb on potatoes. In modifying the Cancellation Order to change the
14-day PHI from the use of EBDCs on potatoes to 3 days nationwide, the
Agency would condition the registration with a requirement that the
registrants provide the confirmatory data to fulfill the field trial
data requirement (OPP guideline 171-4(k); OPPTS guideline 860.1500).
As described above, the reduction of the Q1* for ETU was also
``substantial new evidence'' but a less compelling argument for
modifying the cancellation order because the exposure levels to ETU
were not of concern.
B. Alternative Control Measures
As stated earlier, EBDCs are needed to control the nationwide
spread of late blight, because the alternative products that are
registered to address late blight are not adequate (Ref. 2).
VII. Subpart D Determination
Under 40 CFR 164.131(a), the Administrator is to provide a hearing
to modify a prior final cancellation decision only if it is determined
that certain criteria have been met. Having concluded that the EBDC
Task Force has presented substantial new evidence concerning the
request to provide for a 3-day PHI nationwide which was not available
when the final cancellation order went into effect, the Administrator
must now determine whether that evidence ``may materially affect'' that
order. The Administrator has concluded that the new information
materially affects whether the cancellation order should be modified
because this information allows the Agency to find that a nationwide 3-
day PHI meets the FIFRA standard for registration. Thus, the first
criterion in 40 CFR 164.131(a) has been met.
Information provided by the Task Force on the late blight spread
nationwide could not have ``through the exercise of due diligence''
been obtained before the 14-day restriction was in place as late blight
had not yet spread nationwide. When information existed concerning the
spread of late blight nationwide and the need for additional tools to
combat it, the Task Force submitted the newly obtained information.
Therefore, the second criterion in 40 CFR 164.131(a) has also been met.
Based on the above analysis and because the Agency believes it is
appropriate under this circumstance to modify the cancellation order to
allow a 3-day PHI, the Administrator has decided to issue this notice under
[[Page 37778]]
subpart D to provide an opportunity for a hearing.
Since EPA issued its NOIC in 1992, substantial new evidence has
been presented to the Agency that supports amendment of the
cancellation order to allow all states to have a 3-day PHI for
potatoes. The new information focuses on the need for the EBDCs to
combat the late blight problem in the United States. For example,
metalaxyl-resistant strains of late blight were reported in at least 32
states, which means that resistant strains are currently present in
virtually all potato producing states. Additionally, since the pest
problem can spread long distances via airborne spores and virtually all
states that produce planting stock (seed-potatoes) have documented the
presence of metalaxyl-resistant strains; all production states have a
high probability of encountering metalaxyl-resistant late blight
strains in any given year. Based on the information reviewed, a 3-day
PHI is likely to reduce the number of tubers that become infected just
prior to harvest and will therefore increase the number of tubers that
can be stored.
Pursuant to 40 CFR 164.131(c), the Administrator is specifying
those issues of fact and law to be adjudicated in the hearing convened
pursuant to this notice. Because the purpose of such a hearing is only
to consider whether to modify certain aspects of the Administrator's
prior cancellation decision and because a prompt conclusion to the
hearing is a requisite of meaningful relief for the applicant, the
evidentiary presentation in the hearing shall be strictly confined to
the issues of fact and law which the Administrator has determined are
presented by the Task Force submission.
1. Issues of fact. The issues of fact to be adjudicated are:
i. What is the current status (nationwide) of late blight on potatoes?
ii. Has the occurrence of late blight changed since the initial
cancellation order issued in 1992?
iii. Are EBDCs necessary to respond to late blight?
iv. What are the dietary risks associated with EBDC use on potatoes?
2. Issues of law. The issues of law to be adjudicated are:
i. Has substantial new evidence been presented pertaining to the
request to reduce the nationwide PHI on potatoes to 3 days?
ii. If it is substantial new evidence, could the applicant, through
due diligence, have discovered this information prior to issuance of
the cancellation order?
iii. Does the 3-day PHI meet the FIFRA 2(bb) standard?
The sole objective of this hearing is to determine whether or not
the order canceling all sale, distribution, and use of pesticide
products containing EBDCs that do not comply with the current label
restriction on the PHI for potatoes should be modified to permit a
nationwide 3-day PHI.
B. Hearing Requests
The applicant and the Agency shall automatically be parties in the
hearing. Any other person or party who seeks to participate in the
hearing must submit a written hearing request describing the interest
of that person or party in the proceeding and the nature and purpose of
the participation sought. All requests for a hearing must be received
by the Office of the Hearing Clerk within 30 calendar days from the
date of publication of this Notice in the Federal Register. Such
requests must include an identification of the requestor's interest in
the proceeding, the hearing issues the requestor wishes to participate
in, and the requestor's position with respect to such issue(s).
Requests for a hearing must be submitted to: Office of Hearing Clerk,
U.S. EPA, 1200 Pennsylvania Ave, N.W., Washington, D.C. 20460. Requests
may be hand delivered to the Office of the Hearing Clerk at: 1099 14th
St., NW., Suite 350, Washington, DC.
C. Scheduling
As required by 40 CFR 164.131(c), the Administrator is specifying a
schedule for this hearing. In recognition of the narrow scope of the
proceeding, the Administrator is establishing the following schedule.
However, if no other interested party requests a hearing, the Agency
intends to file a motion pursuant to 40 CFR 164.60 requesting that the
Administrative Law Judge issue an accelerated decision pursuant to 40
CFR 164.91(a)(8) in favor of modifying the cancellation order as requested.
The Chief Administrative Law Judge shall appoint an Administrative
Law Judge to preside at this proceeding within 20 calendar days from
date of publication of this Notice in the Federal Register. The hearing
shall commence in Washington, DC as soon thereafter as practicable but
in no event later than 40 calendar days from the date of publication of
this Notice in the Federal Register. The presiding Administrative Law
Judge shall transmit recommended findings of fact and conclusions of
law and the hearing record to the Administrator within 70 calendar days
from the date of publication of this Notice in the Federal Register.
The parties shall submit any objections to the recommended findings of
fact and conclusions of law to the Administrator within 10 business
days after issuance, and the Administrator will enter a final order as
soon thereafter as practicable.
D. Separation of Functions
EPA's Rules of Practice forbid anyone who may take part in deciding
this case at any stage of the proceeding, from discussing the merits of
the proceeding ex parte with any party or with any person who has been
connected with the preparation or presentation of the proceeding as an
advocate or in any investigative or expert capacity, or with any of his
or her representatives (40 CFR 164.7).
Accordingly, the following EPA offices, and the staffs thereof, are
designated as the judicial staff of EPA in any administrative hearing
on this issue: the Office of Administrative Law Judges, the
Environmental Appeals Board, the Deputy Administrator, and the members
of the staff in the immediate office of the Deputy Administrator, and
the Administrator and the members of staff in the immediate office of
the Administrator. The following offices are designated as the trial
staff in any proceeding which may arise under this Notice: The Office
of General Counsel, the Assistant Administrator for the Office of
Prevention, Pesticides, and Toxic Substances and immediate staff, the
Office of Pesticide Programs, and the Office of Compliance Monitoring.
None of the persons designated as the judicial staff may have any ex
parte communications with the trial staff or any other interested
person not employed by EPA on the merits of any of the issues involved in
this proceeding, without fully complying with the applicable regulations.
IX. References
1. USEPA, 1992. Ethylene Bisdithiocarbamate (EBDCs); Notice of
Intent to Cancel and Conclusion of Special Review [57 FR 7484].
2. USEPA, 2005e. Reregistration Eligibility Decision (RED) for Mancozeb.
3. USEPA, 2005d. Reregistration Eligibility Decision (RED) for Maneb.
4. USEPA, 2005c. Reregistration Eligibility Decision (RED) for Metiram.
5. USEPA, 1998. Maneb (014505) and Mancozeb (014504) on Onions and
Potatoes: Reregistration. Memo from Susan Hummel to R. B. Perfetti,
January 6, 1998.
6. USEPA, 2003. Reregistration of Mancozeb: Request to Reduce Pre-
Harvest Interval for Potatoes and Waive Processing Study. Memo from C.
[[Page 37779]]
Olinger to Tawanda Spears, September 7, 2003.
7. USEPA, 2005a. Assessment of the EBDC/ETU Task Forces Request to
Reduce the EBDC Fungicides PHI on Potatoes from 14 to 3 Days. Memo from
R. Michell and T. Kiely to Tawanda Spears, April 7, 2005.
8. USEPA, 1995. New York State Department of Environmental
Conservation Emergency Exemption Requests For The Use of Dimethomorph
and Cymoxanil Package Mixtures With Mancozeb (Acrobat M2, Curzate M-8)
For Control of Potato Late Blight (95-NY-06, 95-N&Y-07). Memo from J.
Hogue and R. Michell to L. Pemberton.
9. EBDC/ETU Task Force, 2003. Re: Amendments to the Registrations
of Products Containing Ethylene Bidisthiocarbamates (``EBDCs'') as an
Active Ingredient to Change the Preharvest Interval (``PHI'') for
Potatoes. Memo from Edward Ruckert to James Jones, August 25, 2003.
10. USEPA, 2005b. Metiram (Chemical ID No. 014601, Case No. 0644)
Revised Residue Chemistry Chapter for the Reregistration Eligibility
Decision (RED) Document. Memo from C. Olinger to Tawanda Spears, June
23, 2005.
11. Bookbinder, M. (1988) Metiram and Ethylene Thiourea: Magnitude
of the Residue in Potatoes Treated by Ground Equipment in Colarado,
Idaho, Maine, Michigan, North Dakota, Oregon, and Wisconsin, 1987.
Unpublished study prepared by Enviro-Bio-Tech, Ltd. 223 p.
12. USEPA, 2001. Reregistration of Mancozeb: Potato Crop Field
Trial and Corn Processing Studies. Memo from C. Olinger to Anne
Overstreet, March 15, 2001.
13. USEPA, 1988. Reregistration Standard for Maneb. November 10, 1988.
14. USEPA, 1996. Maneb (014505) and Mancozeb (014504) on Onions and
Potatoes: Reregistration. Memo from S. Hummel to K. Boyle, September 6,
1996.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: July 2, 2007.
Peter Caulkins,
Acting Director, Special Review and Reregistration Division, Office of
Pesticide Programs
[FR Doc. E7-13471 Filed 7-10-07; 8:45 am]
BILLING CODE 6560-50-S
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