[Federal Register: July 11, 2007 (Volume 72, Number 132)]
[Notices]
[Page 37771-37779]
[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.

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:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>or
Michele Knorr, Office of General Counsel, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001;
telephone number:<PHONE_NUMBER>; fax number: e-mail address:
<EMAIL_ADDRESS>

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<PHONE_NUMBER>.
    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

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

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.

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.

                            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
--------------------------------------------------------------------------------------------------------------------------------------------------------
CA                                                         1.6 + 2.4             5               11.2           15              < 0.05               0.02
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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

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

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.

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


[Federal Register Volume 86, Number 42 (Friday, March 5, 2021)]
[Proposed Rules]
[Pages 12895-12898]
[FR Doc No: 2021-04586]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 271

[EPA-R09-RCRA-2019-0491; FRL-10019-33-Region 9]

California: Authorization of State Hazardous Waste Management
Program Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; correction.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) approved revisions
to California's federally authorized hazardous waste program by
publishing proposed and final rules in the Federal Register on October
18, 2019 and January 14, 2020, respectively. The notice for the
proposed rule inadvertently and unintentionally left out citations for
approving the State's authority to adopt additional waste streams as
universal wastes in the State Analogues to the Federal Program table.
In addition, the scope of the State program that is considered
``broader in scope'' than the federal program was mis-designated. We
are proposing to correct these and related errors. EPA seeks public
comment prior to taking final action.

DATES: Comments on this proposed correction must be received by April
5, 2021.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
RCRA-2019-0491, at https://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. EPA may publish any comment
received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Laurie Amaro, EPA Region 9, 75
Hawthorne St., San Francisco, CA 94105. By phone:<PHONE_NUMBER> or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

A. Why are corrections to the revised state program authorization
necessary?

    States that have received final authorization from EPA under the
Resource Conservation and Recovery Act (RCRA) Sec.  3006(b), 42 U.S.C.
6926(b), must maintain a hazardous waste program that is equivalent to,
consistent with, and no less stringent than the federal program. As the
federal program changes, states must change their programs and ask EPA
to authorize the changes. EPA's Federal Register notices regarding
proposed and final authorization of revisions to state hazardous waste
management programs provide the public with an opportunity to comment
and also offer details with respect to the scope of the revised program
authorizations on which both the general public and the regulated
community may rely. Where these notices omit critical information or
fail to clearly delineate the scope of authorized program revisions,
corrections may be necessary and/or appropriate.

B. What corrections is EPA making to this rule?

    After proposing updates to California's authorized hazardous waste
program on October 18, 2019 (80 FR 55871), EPA authorized changes to
California's hazardous waste program on January 14, 2020 (85 FR 2038).
EPA is now proposing to correct the updated authorization by clarifying
that: (1) California is authorized to add federally-regulated hazardous
waste streams to its universal waste program and the requirements that
California establishes to manage such added waste streams are federally
enforceable, whether they are added to California's universal waste
program prior to or after EPA's authorization of the State's universal
waste program; (2) State universal waste requirements that apply to
non-RCRA wastes designated by California as ``hazardous waste,'' also
known as ``non-RCRA hazardous waste,'' are beyond the scope of the
federal program and are not being authorized; and, similarly, (3) other
wastes that are sometimes federally-regulated hazardous waste and
sometimes non-RCRA hazardous waste under California law, are part of
the federally authorized program, but only insofar as these materials
constitute federally-regulated hazardous waste. If these corrections
are

finalized, these changes to the scope of California's authorized
universal hazardous waste program would become effective.

C. What happens if EPA receives comments that oppose this proposed
action?

    EPA will consider all comments received during the comment period
and address them in a final rule. You may not have another opportunity
to comment. If you want to comment on the corrections proposed here,
you must do so at this time.

D. What has California previously been authorized for?

    California initially received final authorization for the state
hazardous waste management program on July 23, 1992 (57 FR 32726),
effective August 1, 1992. EPA granted final authorization for changes
to California's program on the following dates: September 26, 2001 (66
FR 49118), effective September 26, 2001 and October 7, 2011 (76 FR
62303), effective October 7, 2011 and January 14, 2020 (85 FR 2038),
effective January 14, 2020.

E. What changes is EPA proposing to authorize with this action?

    EPA proposes to correct and clarify the terms of the January 14,
2020 authorization of California's hazardous waste program with respect
to universal waste.

1. Proposed Changes to the State Analogues to the Federal Program Table

    EPA is recreating in this proposal the State Analogues to the
Federal Program table that was published in the proposed authorization
update Federal Register notice at 84 FR 55872 (October 18, 2019). This
table is a helpful tool in tracking the elements of the authorized
State hazardous waste program.
    As an initial matter, EPA is adding citations in the table to
reflect the Agency's proposed authorization of California's authority
to add waste streams to the State's universal waste program at Title 22
of the California Code of Regulations (CCR) 66260.22 and 66260.23, the
federal analogues of which are 40 CFR 260.20(a) and 260.23(a) through
(d), respectively. Authorization of these provisions--which were
inadvertently omitted from the proposed and final rules authorizing
California universal waste program--is critical to EPA's ability to
enforce State universal waste program requirements for federally-
regulated hazardous wastes that have already been or are added to
California's universal waste program in the future. If these proposed
corrections to authorize 22 CCR 66260.22 and 66260.23 are finalized,
EPA will be empowered to enforce California's universal waste
requirements for federally regulated hazardous waste that California
has already added or adds to its universal waste program pursuant to
these requirements in the future.
    Similarly, EPA is adding a footnote to the updated State Analogues
to the Federal Program table to clarify the implications of the
authorization of the State's universal waste program on a waste stream
that the State already identified as a universal waste before the
universal waste authorization update was effective, i.e., aerosol cans.
This footnote clarifies that, while EPA has more recently taken action
to identify aerosol cans as universal waste (citing 84 FR 67202,
December 9, 2019, effective February 7, 2020), California's previous
reliance on 22 CCR 66260.22 and 66260.23 to add such wastes, which are
proposed to be authorized in accordance with this correction, would be
considered retroactive. Thus, if these corrections are approved,
California's universal waste requirements for aerosol cans would be
federally enforceable. The Agency believes that these State
requirements would have been included in California's universal waste
authorization update application, but for the fact that the federal
aerosol can universal waste rule was not in effect at the time of the
State's July 10, 2019 submittal of its application. Because the Agency
is correcting the recent authorization update and is now proposing
approval of California's analogous provisions for adding new universal
waste streams under 40 CFR 260.20 and 260.23, and because aerosol cans
were previously added to California's universal waste program in
accordance with its analogues to these provisions, the Agency maintains
that the clarifying footnote in this proposal is both helpful and
appropriate.
    The corrections proposed in this rule, and described above, would
require modifications to the State Analogues to the Federal Program
table published on October 18, 2019 (80 FR 55871), as follows:

                 State Analogues to the Federal Program
------------------------------------------------------------------------
                                                        Analogous State
                                                           Authority
     Description of Federal                           California Code of
   requirement (checklist, if      Federal Register    Regulations (CCR)
           applicable)               date and page    Title 22, Division
                                                      4.5 and Health and
                                                          Safety Code
------------------------------------------------------------------------
40 Code of Federal Regulations    60 FR 25492, May    22 CCR 66260.22,
 (CFR) 260.20(a) and 260.23(a)     11, 1995.           adopted 2003,
 through (d) (Checklist 142 E).                        amended March 15,
                                                       2003.
                                                      22 CCR 66260.23,
                                                       adopted 2003,
                                                       amended February
                                                       4, 2009.
40 (CFR) part 273, subparts A     60 FR 25492, May    22 CCR 66273,
 through G--Standards for          11, 1995.           October 22, 2018.
 Universal Waste \a\.             63 FR 71225,        Health & Safety
Excluding 273.33(a)(3)(iii) and    December 24, 1998.  Code 25201.16,
 273.33 (b)(1) through (4)        64 FR 36466, July    October 3, 2001.
 (Checklists 142 A, B, D, E,       6, 1999.
 176, 181, 209, 215) \b\.         70 FR 45508, Aug.
                                   5, 2005.
                                  71 FR 40254, July
                                   14, 2006 \c\.
------------------------------------------------------------------------
\a\ Because several definitions in the state universal waste regulations
  do not have federal counterparts, the state cited additional federal
  regulations at 40 CFR 260.1, 260.10, 261.4, 262.81, 264.142 and 270.2
  in support of its application for authorization of the State's
  universal waste program.
\b\ Although Checklist 214 is mentioned in the State Attorney General's
  Statement, EPA is not including it here because the typographical and
  spelling corrections made in this checklist are not relevant to the
  State's regulatory language.
\c\ Adding Aerosol Cans to Universal Waste (84 FR 67202, December 9,
  2019, effective February 7, 2020) is not included here because it was
  not in effect at the time of the State's application. In addition, we
  are approving the State's analogous provisions for adding waste
  streams under 40 CFR 260.20 and 260.23, thus the state may add
  additional waste streams that meet the conditions outlined in 40 CFR
  273.81. As a result, California's inclusion of aerosol cans in its
  universal waste program is also proposed to be authorized. Unlike the
  authorization of most of RCRA hazardous waste management requirements,
  the authorization of 22 CCR 66260.22(a) and 66260.23(a) through (d)
  means that any federally regulated hazardous waste added to
  California's universal waste program pursuant to these requirements
  are automatically authorized, regardless of when California adds them.

2. Proposed Changes to the List of State Provisions Deemed ``Broader in
Scope''

    This notice also proposes to correct that part of EPA's California
universal waste authorization update that mistakenly identified
California's regulation of aerosol cans and other California-listed
universal wastes as broader in scope than the federal program. EPA
proposes to revise the list of California requirements beyond the scope
of the federal program by deleting the following paragraph from the
list of State requirements that are broader in scope than the federal
program (section G from the October 18, 2019 proposal):

    California-only universal wastes. California has added the
following non-RCRA waste streams to its universal waste program:
Aerosol cans, cathode ray tubes (CRTs), CRT glass and electronic
devices.

    The inclusion of this language in this section of the 2019 proposal
was an inadvertent error. These materials were all previously
identified by California as universal hazardous waste in accordance
with 22 CCR 66260.22 and 66260.23 and, except for aerosol cans, were
all included in California's authorization update application. As a
result, similar to aerosol cans, California's regulation of CRTs, CRT
glass and electronic devices should be considered within the scope of
the authorized California universal waste program.
    The Agency is also proposing to correct the list of requirements
that are beyond the scope of the federal program to clarify that non-
RCRA wastes included in the California universal waste program are
broader in scope than the federal program. Thus, where wastes may
sometimes be federally regulated (when, for example, they exhibit a
characteristic for hazardous waste) but at other times are not
federally regulated (where they do not exhibit a characteristic),
California is authorized for that part of its universal waste program
that covers the federally-regulated portion of the waste stream, but
not for that portion of the State program that covers ``non-RCRA
hazardous waste'' (i.e., non-federally regulated hazardous waste that
California regulates as hazardous waste). For example, electronic waste
(e-waste) may sometimes constitute a RCRA hazardous waste, but is
always considered a ``non-RCRA hazardous waste'' under California law.
EPA is proposing to correct its authorization of California's universal
waste program by identifying the non-federally regulated portion of
such a universal waste stream as broader in scope than the federal
program.
    Thus, EPA proposes to add the following language to its analysis of
the parts of the California universal waste program that are broader in
scope than the federal program:

    Non-RCRA wastes. California regulates as hazardous waste some
wastes not regulated by EPA under RCRA. These are referred to as
``non-RCRA hazardous waste.'' Any non-RCRA hazardous wastes that a
state regulates as a hazardous waste are generally considered beyond
the scope of the federal program (broader-in-scope). To the extent
that California has included non-RCRA hazardous wastes in the
State's universal waste program, regulation of those non-RCRA
hazardous wastes as universal waste would be broader in scope than
the federal program.

I. How does this action affect Indian country (18 U.S.C. 1151) in
California?

    California is not authorized to carry out its hazardous waste
program in Indian country within the state. Therefore, this action has
no effect on Indian country. EPA retains jurisdiction over Indian
country and will continue to implement and administer the federal RCRA
program on these lands.

K. Statutory and Executive Order Reviews

    The Office of Management and Budget (OMB) has exempted this action
(RCRA state authorization) from the requirements of Executive Order
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011). Therefore, this action is not subject to review by OMB. This
action proposes corrections to the authorization of state requirements
for the purpose of RCRA 3006 and imposes no additional requirements
beyond those imposed by state law. Accordingly, this action will not
have a significant economic impact on a substantial number of small
entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.).
Because this action proposes correction of the authorization of pre-
existing requirements under state law and does not impose any
additional enforceable duty beyond that required by state law, it does
not contain any unfunded mandate or significantly or uniquely affect
small governments, as described in the Unfunded Mandates Reform Act of
1995 (Pub. L. 104-4). As explained above, this proposed action also
does not significantly or uniquely affect the communities of Tribal
governments, as specified by Executive Order 13175 (65 FR 67249,
November 9, 2000). This proposed action will not have substantial
direct effects on the states, on the relationship between the national
government and the states, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132 (64 FR 43255, August 10, 1999), because it
merely corrects the Federal Register notice in which EPA authorized
state requirements as part of the state RCRA hazardous waste program
without altering the relationship or the distribution of power and
responsibilities established by RCRA. This proposed action also is not
subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because
it is not economically significant, and it does not concern
environmental health or safety risks that EPA has reason to believe may
disproportionally affect children. This proposed correction is not
subject to Executive Order 13211, ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355
May 22, 2001), because it is not a significant regulatory action under
Executive Order 12866.
    Under RCRA 3006(b), the EPA grants a state's application for
authorization, as long as the state meets the criteria required by
RCRA. It would thus be inconsistent with applicable law for the EPA,
when it reviews a state authorization application, to require the use
of any particular voluntary consensus standard in place of another
standard that otherwise satisfies the requirements of RCRA. Thus, the
requirements of section 12(d) of the National Technology Transfer and
Advancement Act of 1995 do not apply. See 15 U.S.C. 272 note, sec.
12(d)(3), Public Law 104-113, 110 Stat. 783 (Mar. 7, 1996) (exempting
compliance with the NTTAA's requirement to use VCS if compliance is
``inconsistent with applicable law''). As required by section 3 of
Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this
proposed correction to its rule, the EPA has taken the necessary steps
to eliminate drafting errors and ambiguity, minimize potential
litigation, and provide a clear legal standard for affected conduct.
The EPA has complied with Executive Order 12630 (53 FR 8859, March 15,
1988) by examining the takings implications of the proposed correction
to the rule in accordance with the ``Attorney General's Supplemental
Guidelines for the Evaluation of Risk and Avoidance of Unanticipated
Takings'' issued under the Executive Order. This proposed correction to
the rule authorizing California's universal waste program does not
impose an information collection burden under the provisions of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Executive
Order 12898 (59 FR 7629, February 16, 1994)

establishes federal executive policy on environmental justice. Its main
provision directs federal agencies, to the greatest extent practicable
and permitted by law, to make environmental justice part of their
mission by identifying and addressing, as appropriate,
disproportionately high and adverse human health or environmental
effects of their programs, policies, and activities on minority
populations and low-income populations in the United States. Because
this proposed correction to the California universal waste
authorization rule authorizes pre-existing state rules which are at
least equivalent to, and no less stringent than existing federal
requirements, and impose no additional requirements beyond those
imposed by state law, and there are no anticipated significant adverse
human health or environmental effects, the rule is not subject to
Executive Order 12898. The Congressional Review Act, 5 U.S.C. 801 et
seq., as added by the Small Business Regulatory Enforcement Fairness
Act of 1996, generally provides that before a rule may take effect, the
agency promulgating the rule must submit a rule report, which includes
a copy of the rule, to each House of the Congress and to the
Comptroller General of the United States. The EPA will submit a report
containing this document and other required information to the U.S.
Senate, the U.S. House of Representatives, and the Comptroller General
of the United States prior to publication of the final rule correction
in the Federal Register. A major rule cannot take effect until 60 days
after it is published in the Federal Register. This proposed correction
is not a ``major rule'' as defined by 5 U.S.C. 804(2).

    Authority: This action is issued under the authority of sections
2002(a), 3006, and 7004(b) of the Solid Waste Disposal Act as
amended, 42 U.S.C. 6912(a), 6926, and 6974(b).

    Dated: February 26, 2021.
Deborah Jordan,
Acting Regional Administrator, Region IX.
[FR Doc. 2021-04586 Filed 3-4-21; 8:45 am]
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[Federal Register Volume 82, Number 101 (Friday, May 26, 2017)]
[Notices]
[Page 24411]
[FR Doc No: 2017-10890]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736.

Extension:
    Form 10, SEC File No. 270-51, OMB Control No. 3235-0064.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget this request for extension of the previously approved
collection of information discussed below.
    Form 10 (17 CFR 249.210) is used by issuers to register a class of
securities pursuant to Section 12(b) or Section 12(g) (15 U.S.C. 78l(b)
and 78l(g)) of the Exchange Act of 1934. Form 10 requires financial and
other information about such matters as the issuer's business,
properties, identity and remuneration of management, outstanding
securities and securities to be registered and financial condition. The
information provided by Form 10 is intended to ensure the adequacy of
information available to investors about a company. Form 10 takes
approximately 215.21 hours per response to prepare and is filed by
approximately 216 respondents. We estimate that 25% of the 215.21 hours
per response (53.803 hours) is prepared by the company for an annual
reporting burden of 11,621 hours (53.803 hours per response x 216
responses).
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    The public may view the background documentation for this
information collection at the following Web site, www.reginfo.gov.
Comments should be directed to: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503, or by sending an email to:
<EMAIL_ADDRESS>and (ii) Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549 or send an email
to<EMAIL_ADDRESS>Comments must be submitted to OMB within 30
days of this notice.

    Dated: May 23, 2017.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-10890 Filed 5-25-17; 8:45 am]
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[Federal Register Volume 78, Number 73 (Tuesday, April 16, 2013)]
[Notices]
[Page 22540]
[FR Doc No: 2013-08818]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP13-787-000]

El Paso Natural Gas Company, L.L.C.; Notice of Petition for
Declaratory Order

    Take notice that on April 5, 2013, pursuant to Rule 207(a)(2) of
the Commission's Rules of Practice and Procedure, 18 CFR
385.207(a)(2)(2012), El Paso Natural Gas Company, L.L.C. (EPNG) submits
this Petition for a Declaratory Order seeking guidance on an issue
concerning the application and interpretation of EPNG's tariff and
contracts, as more fully described in their petition. Specifically,
EPNG seeks Commission guidance concerning whether UNS Gas Inc. and
Texas Gas Service Company, a Division of ONEOK, Inc., will be entitled
to the rate provided by Article 11.2(a) of EPNG's 1996 Settlement
(``Article 11.2(a) rate'') after the term of their existing Article
11.2(a) contracts expires on August 31, 2013.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern time on Friday, May 3, 2013.

    Dated: April 9, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-08818 Filed 4-15-13; 8:45 am]
BILLING CODE 6717-01-P