[Federal Register Volume 75, Number 127 (Friday, July 2, 2010)]
[Rules and Regulations]
[Pages 38417-38422]
[FR Doc No: 2010-15751]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0801; FRL-8832-5]

Carbaryl; Order Denying Washington Toxics Coalition Petition to
Revoke Tolerances and Notice of Availability of Denial of Request to
Cancel Uses

AGENCY: Environmental Protection Agency (EPA).

ACTION: Order and Notice of Availability.

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SUMMARY: This order denies a petition requesting that EPA revoke all
pesticide tolerances for carbaryl under section 408(d) of the Federal
Food, Drug, and Cosmetic Act (FFDCA). The petition was filed on January
10, 2005 by the Washington Toxics Coalition (WTC). This order also
informs the public of the availability of a response to WTC's petition
to cancel all uses of carbaryl.

DATES: This Order is effective July 2, 2010. Objections and requests
for hearings must be received on or before August 31, 2010, and must be
filed in accordance with the instructions provided in 40 CFR part 178
(see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0801. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Jacqueline Guerry, Pesticide Re-
evaluation Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

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 Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, any person may file an objection to
any aspect of this order and may also request a hearing on those
objections. You must file your objection or request a hearing on this
order in accordance with the instructions provided in 40 CFR part 178.
To ensure proper receipt by EPA, you must identify docket ID number
EPA-HQ-OPP-2006-0801 in the subject line on the first page of your
submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before August 31, 2010.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2006-0801, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.

II. Introduction

A. What Action Is the Agency Taking?

    The WTC filed a petition dated January 10, 2005 (WTC Petition) with
EPA which, among other things, requested that EPA cancel all
registrations for the pesticide carbaryl and revoke all carbaryl
tolerances established under section 408 of the FFDCA, 21 U.S.C. 346a
(Ref. 1). It should be noted that the WTC Petition generally raises a
subset of identical issues raised by a petition submitted by the
Natural Resources Defense Council (NRDC), which is also dated January
10, 2005 (Ref. 2). Indeed, most of the WTC Petition is virtually a
verbatim recitation of the NRDC petition. The primary difference is
that the WTC Petition does not address any of the tolerance-related
issues raised in the NRDC petition; there is nothing in the WTC
Petition which supports the request to revoke tolerances. Nonetheless,
to the extent that the WTC Petition can be construed to raise
tolerance-related issues, this Order relies on EPA's response to the
NRDC petition and denies that portion of the WTC Petition that seeks
the revocation of the carbaryl tolerances. This document also announces
a notice of availability for EPA's response to WTC's Petition to cancel
all uses of carbaryl, which may be found in docket number EPA-HQ-OPP-
2006-0801.

B. What Is the Agency's Authority for Taking This Action?

    Under section 408(d)(4) of the FFDCA, EPA is authorized to respond
to a section 408(d) petition to revoke tolerances either by issuing a
final rule revoking the tolerances, issuing a proposed rule, or issuing
an order denying the petition. (21 U.S.C. 346a(d)(4)).

III. Statutory and Regulatory Background

A. FFDCA/FIFRA and Applicable Regulations

    1. In general. EPA establishes maximum residue limits, or
``tolerances,'' for pesticide residues in food and feed commodities
under section 408 of the FFDCA. (21 U.S.C. 346a). Without such a
tolerance or an exemption from the requirement of a tolerance, a food
containing a pesticide residue is ``adulterated'' under section 402 of
the FFDCA and may not be legally moved in interstate commerce. (21
U.S.C. 331, 342). Monitoring and enforcement of pesticide tolerances
are carried out by the U.S. Food and Drug Administration (FDA) and the
U.S. Department of Agriculture (USDA). Section 408 was substantially
rewritten by the Food Quality Protection Act of 1996 (FQPA), which
added the provisions discussed below establishing a detailed safety
standard for pesticides, additional protections for infants and
children, and the estrogenic substances screening program. (Public Law
104-170, 110 Stat. 1489 (1996)).
    EPA also regulates pesticides under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), (7 U.S.C. 136 et seq). While
the FFDCA authorizes the establishment of legal limits for pesticide
residues in food, FIFRA requires the approval of pesticides prior to
their sale and distribution, (7 U.S.C. 136a(a)), and establishes a
registration regime for regulating the use of pesticides. FIFRA
regulates pesticide use in conjunction with its registration scheme by
requiring EPA review and approval of pesticide labels and specifying
that use of a pesticide inconsistent with its label is a violation of
Federal law. (7 U.S.C. 136j(a)(2)(G)). In the FQPA, Congress integrated
action under the two statutes by requiring that the safety standard
under the FFDCA be used as a criterion in FIFRA registration actions as
to pesticide uses which result in dietary risk from residues in or on
food, (7 U.S.C. 136(bb)), and directing that EPA coordinate, to the
extent practicable, revocations of tolerances with pesticide
cancellations under FIFRA. (21 U.S.C. 346a(l)(1)).
    2. Safety standard for pesticide tolerances. A pesticide tolerance
may only be promulgated or left in effect by EPA if the tolerance is
``safe.'' (21 U.S.C. 346a(b)(2)(A)(i)). This standard applies both to
petitions to establish and petitions to revoke tolerances. ``Safe'' is
defined by the statute to mean that ``there is a reasonable certainty
that no harm will result from aggregate exposure to the pesticide
chemical residue, including all anticipated dietary exposures and all
other exposures for which there is reliable information.'' (21 U.S.C.
346a(b)(2)(A)(ii)). Section 408(b)(2)(D) directs EPA, in making a
safety determination, to:
    consider, among other relevant factors-- ...

    (v) available information concerning the cumulative effects of
such residues and other substances that have a common mechanism of
toxicity; and

    (vi) available information concerning the aggregate exposure
levels of consumers (and major identifiable subgroups of consumers)
to the pesticide chemical residue and to other related substances,
including dietary exposure under the tolerance and all other
tolerances in effect for the pesticide chemical residue, and
exposure from other non-occupational sources;

(21 U.S.C. 346a(b)(2)(D)(v), (vi) and (viii)).
    EPA must also consider, in evaluating the safety of tolerances,
``safety factors which . . . are generally recognized as appropriate
for the use of animal experimentation data.'' (21 U.S.C.
346a(b)(2)(D)(ix).
    Risks to infants and children are given special consideration.
Specifically, section 408(b)(2)(C) states that EPA:

    shall assess the risk of the pesticide chemical based on--

    (II) available information concerning the special susceptibility
of infants and children to the pesticide chemical residues,
including neurological differences between infants and children and
adults, and effects of in utero exposure to pesticide chemicals; and

    (III) available information concerning the cumulative effects on
infants and children of such residues and other substances that have
a common mechanism of toxicity....

(21 U.S.C. 346a(b)(2)(C)(i)(II) and (III)).
    This provision also creates a presumptive additional safety factor
for the protection of infants and children. Specifically, it directs
that ``in the case of threshold effects, ... an additional tenfold
margin of safety for the pesticide chemical residue and other sources
of exposure shall be applied for infants and children to take into
account potential pre- and post-natal toxicity and completeness of the
data with respect to exposure and toxicity to infants and children.''
(21 U.S.C. 346a(b)(2)(C)). EPA is permitted to ``use a different margin
of safety for the pesticide chemical residue only if, on the basis of
reliable data, such margin will be safe for infants and children.''
(Id.). The additional safety margin for infants and children is
referred to

throughout this Order as the ``FQPA Safety Factor.''
    3. Procedures for establishing, amending, or revoking tolerances.
Tolerances are established, amended, or revoked by rulemaking under the
unique procedural framework set forth in the FFDCA. Generally, a
tolerance rulemaking is initiated by the party seeking to establish,
amend, or revoke a tolerance by means of filing a petition with EPA.
(See 21 U.S.C. 346a(d)(1)). EPA publishes in the Federal Register a
notice of the petition filing and requests public comment. (21 U.S.C.
346a(d)(3)). After reviewing the petition, and any comments received on
it, EPA may issue a final rule establishing, amending, or revoking the
tolerance, issue a proposed rule to do the same, or deny the petition.
(21 U.S.C. 346a(d)(4)).
    Once EPA takes final action on the petition by establishing,
amending, or revoking the tolerance or denying the petition, any party
may file objections with EPA and seek an evidentiary hearing on those
objections. (21 U.S.C. 346a(g)(2)). Objections and hearing requests
must be filed within 60 days. (Id.). The statute provides that EPA
shall ``hold a public evidentiary hearing if and to the extent the
Administrator determines that such a public hearing is necessary to
receive factual evidence relevant to material issues of fact raised by
the objections.'' (21 U.S.C. 346a(g)(2)(B)). EPA regulations make clear
that hearings will only be granted where it is shown that there is ``a
genuine and substantial issue of fact,'' the requestor has identified
evidence ``which, if established, resolve one or more of such issues in
favor of the requestor,'' and the issue is ``determinative'' with
regard to the relief requested. (40 CFR 178.32(b)). EPA's final order
on the objections is subject to judicial review. (21 U.S.C.
346a(h)(1)).
    4. Tolerance reassessment and FIFRA reregistration. The FQPA
required that EPA reassess the safety of all pesticide tolerances
existing at the time of its enactment. (21 U.S.C. 346a(q)). EPA was
given 10 years to reassess the approximately 10,000 tolerances in
existence in 1996. In this reassessment, EPA was required to review
existing pesticide tolerances under the new ``reasonable certainty that
no harm will result'' standard set forth in section 408(b)(2)(A)(i).
(21 U.S.C. 346a(b)(2)(A)(i)). This reassessment was substantially
completed by the August 3, 2006 deadline. Tolerance reassessment was
generally handled in conjunction with a similar program involving
reregistration of pesticides under FIFRA. (7 U.S.C. 136a-1). Tolerance
reassessment and reregistration decisions were generally combined in a
Reregistration Eligibility Decision (``RED'') document.

B. EPA's Approach to Dietary Risk Assessment and Science Policy
Considerations

    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. In addition, EPA applies a
number of policy considerations with respect to determining the
appropriate children's safety factor, cholinesterase inhibition as a
regulatory endpoint, and the use of a bench mark dose approach. EPA has
discussed these in great detail in its response to an earlier and
virtually identical petition file by NRDC. EPA hereby incorporates and
relies upon that discussion. See Carbaryl: Order Denying NRDC's
Petition to Revoke Tolerances, dated September 30, 2008 (October 29,
2008, 73 FR 64229).

IV. Carbaryl Tolerances

A. Regulatory Background

    Carbaryl is a carbamate insecticide and molluscide that was first
registered in 1959 for use on cotton. Carbaryl has many trade names,
but is most commonly known as Sevin[reg]. In 1980, the Agency published
a position document summarizing its conclusions from a Special Review
of carbaryl, and concluded that risk concerns, particularly those
related to teratogenicity, did not warrant cancellation of the
registration for carbaryl. A Registration Standard, issued for carbaryl
in 1984 and revised in 1988, described the terms and conditions for
continued registration of carbaryl. At the time carbaryl was assessed
for purposes of reregistration, carbaryl was registered for use on over
400 agricultural and non-agricultural use sites, and there were more
than 140 tolerances for carbaryl in the Code of Federal Regulations (40
CFR 180.169). For example, carbaryl was registered for domestic outdoor
uses on lawns and gardens, and indoors in kennels and on pet sleeping
quarters. It was also registered for direct application to cats and
dogs (collar, powder, and dip) to control fleas and ticks.
    EPA completed an Interim Reregistration Eligibility Decision (IRED)
for carbaryl on June 30, 2003 (2003 IRED, Ref. 3). The Agency amended
the IRED on October 22, 2004 (2004 Amended IRED. Ref. 4), and published
a formal Notice of Availability for the document which provided for a
60-day public comment period (69 FR 62663; docket EPA-HQ-OPP-2003-
0376). EPA received numerous comments on the carbaryl IRED, including
two nearly identical petitions from the WTC and the NRDC requesting
that EPA cancel all carbaryl registrations and revoke all tolerances
(Refs. 1 and 2). The Agency published a Notice of Availability for the
WTC Petition in the Federal Register, which provided a public comment
period. See ``Petition to Revoke or Modify Tolerances Established for
Carbaryl; Notice of Availability,'' October 13, 2006 (71 FR 60511).
    The 2004 Amended IRED for carbaryl specified mitigation of risks
from residential uses including the following: Canceling liquid
broadcast applications to home lawns pending EPA review of
pharmacokinetic data to refine post-application risk estimates; home
garden/ornamental dust products must be packaged in ready-to-use shaker
can containers, with no more than 0.05 lbs. active ingredient per
container; cancellation of the following uses and application methods:
all pet uses (dusts and liquids) except collars, aerosol products for
various uses, belly grinder applications of granular and bait products
for lawns, hand applications of granular and bait products for
ornamentals and gardens.
    On March 9, 2005, EPA issued a cancellation order for the liquid
broadcast use of carbaryl on residential turf to address post-
application risk to toddlers (Ref. 5). In March 2005, EPA also issued
generic and product-specific data call-ins (DCIs) for carbaryl. The
carbaryl generic DCI required several confirmatory studies of the
active ingredient carbaryl, including additional toxicology, worker
exposure monitoring, data to support the use of carbaryl in pet
collars, and environmental fate data. The product-specific DCI required
acute toxicity and product chemistry data for all pesticide products
containing carbaryl; these data are being used for product labeling.
EPA has received numerous studies in response to these DCIs, and, where
appropriate, these studies were considered in the tolerance
reassessment.
    In response to the DCIs, many carbaryl registrants chose to
voluntarily cancel their carbaryl products, rather than revise their
labels or conduct studies to support these products. EPA published a
notice of receipt of these requests in the Federal Register on October
28, 2005 (70 FR 62112), followed by a cancellation order issued on July
3, 2006. One technical registrant, Burlington Scientific, chose to
cancel its technical product, leaving Bayer CropScience (Bayer) as the
sole

technical registrant for carbaryl. Approximately two-thirds of all of
the carbaryl products registered at the time of the 2003 IRED were
canceled through this process.
    In addition, Bayer, the sole remaining technical registrant
responsible for developing data, requested waivers of required exposure
monitoring or residue studies because the following use scenarios were
not on any Bayer technical or product labels or were to be deleted from
Bayer labels: Carbaryl use in or on pea and bean, succulent shelled
(subgroup 6B); millet; wheat; pre-plant root dip for sweet potato; pre-
plant root dip/drench for nursery stocks, vegetable transplants,
bedding plants, and foliage plants; use of granular formulations on
leafy vegetables (except Brassica); ultra low volume (ULV) application
for adult mosquito control; and dust applications in agriculture.
    Bayer subsequently requested that all of its carbaryl registrations
bearing any of the uses just mentioned be amended to delete these uses.
EPA notified all affected registrants that these uses and application
methods must be deleted from their carbaryl product labels. EPA
identified 34 product labels from 14 registrants (other than Bayer)
bearing these end uses. All of these registrants requested that their
affected carbaryl product registrations be amended to delete these
uses. EPA published Notices of receipt of these requests from Bayer and
the other 14 registrants in the Federal Register on August 20, 2008 and
October 15, 2008. On March 18, 2009, the Agency published an order
granting the requests to delete uses (74 FR 11553).
    Further, in November 2009, Bayer submitted a waiver request for the
dermal and inhalation exposure studies required for aerial application
of carbaryl bait used in the USDA Rangeland Grasshopper and Mormon
Cricket Suppression Program due to a recent reduction in the maximum
application rate, which eliminated remaining uncertainties associated
with this use scenario. The Agency accepted the waiver request in
January 2010.
    Carbaryl is a member of the N-methyl carbamate (NMC) class of
pesticides, which share a common mechanism of toxicity by affecting the
nervous system via cholinesterase inhibition. Specifically, carbaryl is
a reversible inhibitor of Acetylcholinesterase (AChE). A cumulative
risk assessment, which evaluates exposures based on a common mechanism
of toxicity, was conducted to evaluate risk from food, drinking water,
residential use, and other non-occupational exposures resulting from
registered uses of NMC pesticides, including carbaryl.
    In June 2006, EPA determined that the uses associated with 120 of
the existing carbaryl tolerances were not significant contributors to
the overall NMC cumulative risk and, as a result, these tolerances
would have no effect on the retention or revocation of other NMC
tolerances. Therefore, EPA considered these 120 tolerances for carbaryl
as reassessed on June 29, 2006, and posted this decision on the
Agency's internet site. (See http://www.epa.gov/pesticides/cumulative/carbamates_commodity.pdf).
    In late November 2006, EPA received data from a carbaryl
comparative cholinesterase study conducted to determine the comparative
sensitivity of adults and offspring to cholinesterase inhibition by
carbaryl. These data were used to revise the FQPA Safety Factor for
carbaryl for the NMC cumulative risk assessment and to select new
toxicology endpoints or points of departure (PODs) for the risk
assessment. The Agency determined that it was appropriate to use the
new FQPA Safety Factor and revised PODs in both the NMC cumulative risk
assessment and the carbaryl-specific human health risk assessment.
Because this necessitated a revision of the carbaryl human health
aggregate risk assessment, EPA also considered additional new data
generated in response to the DCI, new methodologies, and other new
information in performing its most recent assessment of carbaryl and in
responding to this Petition. EPA has thus, in effect, revised the
carbaryl single chemical assessment in response to the issues raised
during the public comment process as well as based upon more recent
data and analytical methods.
    On September 26, 2007, EPA issued the NMC cumulative risk
assessment (Ref. 6). EPA concluded that the cumulative risks associated
with the NMC pesticides meet the safety standard set forth in section
408(b)(2) of the FFDCA, provided that the mitigation specified in the
NMC cumulative risk assessment is implemented. EPA has therefore
terminated the tolerance reassessment process under 408(q) of the
FFDCA. (See 72 FR 54656). In conjunction with the NMC cumulative risk
assessment, EPA completed a Reregistration Eligibility Decision (RED)
for carbaryl on September 24, 2007 (Ref. 7) and issued this RED on
October 17, 2007 with a formal Notice of Availability in the Federal
Register (72 FR 58844). In addition to relying on the NMC cumulative
risk assessment to determine that the cumulative effects from exposure
to all NMC residues, including carbaryl, was safe, the carbaryl RED
relied upon the revised assessments and the mitigation that had already
been implemented (e.g., cancellation of pet uses except for collars).
In addition, the RED included additional mitigation with respect to
granular turf products for residential use; namely, that product labels
direct users to water the product immediately after application.
Subsequently, on August 25, 2008, EPA completed an addendum to the
Carbaryl RED, incorporating the results of a revised occupational risk
assessment and modified mitigation measures for the protection of
workers (Ref. 8).
    Subsequent to the completion of the carbaryl RED addendum, EPA
completed a revised master label table for carbaryl and a list of
carbaryl uses eligible for reregistration. These materials, which
summarized the changes necessary to implement the carbaryl RED and
addendum, were sent to all carbaryl end-use registrants on March 25,
2009. (See docket entry: EPA-HQ-OPP-2007-0941-0088.) All carbaryl end-
use registrants were required to submit revised labels to EPA by April
30, 2009. EPA has completed its review of these amended labels, and all
acceptable carbaryl products are now reregistered. Once again, some
registrants chose to cancel their carbaryl product registrations rather
than submit revised labels that incorporate the final RED mitigation.
EPA has received voluntary cancellation requests for 19 additional
carbaryl product registrations, and 7 Special Local Need registrations,
from 8 registrants, including the last remaining carbaryl products
registered for use on pets - carbaryl-treated dog and cat collars. The
Agency has published Notice of Receipt of Requests for Cancellation
and/or Cancellation Notice for all 26 carbaryl product registrations as
per sec. 6(f) of FIFRA. The two carbaryl pet collar product
registrations, specifically, will be canceled effective September 30,
2010, with a reduced existing stock provision of 3 months (74 FR
66642).
    Finally, EPA completed a response to NRDC's January 10, 2005
petition to cancel all uses of carbaryl in a letter dated September 30,
2008 (Ref. 9). The Agency's response to NRDC's petition to revoke
carbaryl tolerances is in an Order also dated September 30, 2008 (Ref.
10). This Order Denying NRDC's Petition to Revoke Tolerances was
published in the Federal Register on October 29, 2008 (73 FR 64229).

B. FFDCA Tolerance Reassessment and FIFRA Pesticide Reregistration

    As required by the Food Quality Protection Act of 1996, EPA
reassessed the safety of the carbaryl tolerances under the safety
standard established in the FQPA. In the September 2007 RED for
carbaryl, EPA evaluated the human health risks associated with all
currently registered uses of carbaryl and determined that there is a
reasonable certainty that no harm will result from aggregate, non-
occupational exposure to the pesticide chemical residue. In making this
determination, EPA considered dietary exposure from food and drinking
water and all other non-occupational sources of pesticide exposure for
which there is reliable information. (Ref. 7). The Agency has concluded
that with the adoption of the risk mitigation measures identified in
the NMC cumulative risk assessment, all of the tolerances for carbaryl
meet the safety standard as set forth in section 408(b)(2)(D) of the
FFDCA. Therefore, the tolerances established for residues of carbaryl
in or on raw agricultural commodities were considered reassessed as
safe under section 408(q) of FFDCA, as amended by FQPA, in September
2007. These findings satisfied EPA's obligation to review the carbaryl
tolerances under the FQPA safety standard.
    To implement the carbaryl tolerance reassessment, EPA commenced
with rulemaking in 2008. The Agency published a Notice of proposed
tolerance actions in the May 21, 2008 Federal Register (73 FR 29456).
This proposed rule provided for a 60-day public comment period. No
comments relevant to carbaryl tolerances were received and EPA
published a Notice of final tolerance actions in the September 10, 2008
Federal Register (73 FR 52607). This carbaryl tolerance rule is
codified in 40 CFR 180.169.

V. The Petition to Revoke Tolerances

    WTC filed a petition on January 10, 2005, requesting, among other
things, that EPA cancel all carbaryl registrations and revoke all
carbaryl tolerances. This January 10, 2005 submission is in the form of
comments on and requests for changes to the Carbaryl IRED published in
the Federal Register on October 27, 2004. (70 FR 62663) (Ref. 1).
Nevertheless, in the introduction to the comments, WTC included a
statement that it is also petitioning the Agency to revoke all carbaryl
tolerances. It should be noted that the WTC petition primarily raises a
subset of identical issues raised by a petition submitted by NRDC,
which is also dated January 10, 2005. Indeed, to the extent they
address the same issues, most of the WTC's petition is virtually a
word-for-word copy of the NRDC petition. The primary difference is that
the WTC petition does not address any of the tolerance-related issues
raised in the NRDC petition. Nonetheless, to the extent that anything
in the WTC Petition could be construed as raising a tolerance-related
issue, EPA is relying on its response to the NRDC petition to revoke
all carbaryl tolerances in denying the WTC Petition to revoke all
carbaryl tolerances.
    The issues raised by the WTC Petition center around the ecological
risk assessment that supported the 2004 IRED decision. Again, most of
these issues are identical to those raised by NRDC and have been
addressed in a response denying the NRDC petition to cancel all
carbaryl registrations, dated September 30, 2008. The ecological risk
assessment issues that are unique to the WTC Petition are addressed in
a separate response, dated June 18, 2010. EPA hereby announces the
availability of this response in the public docket EPA-HQ-OPP-2006-
0801.

VI. Public Comment

    In response to the statement that the WTC Petition sought the
revocation of the carbaryl tolerances, EPA published notice of the WTC
Petition for comment on October 13, 2006 (71 FR 60511). EPA received 28
comments in response to the notice of availability for the WTC
Petition. These comments may be found in their entirety in docket EPA-
HQ-OPP-2006-0801. A number of commenters from land grant universities
mentioned the importance of carbaryl in agriculture, especially in the
production of grapes, small fruit, and pecans. Several commenters from
the U.S. Forest Service and state departments of forestry commented on
the importance of carbaryl in controlling bark beetle. In addition, the
carbaryl registrant, Bayer CropScience, submitted comments opposing the
claim by the WTC that carbaryl poses unreasonable risks to non-target
organisms. In general, these comments focus on the importance and
benefits of carbaryl, and are not specific to carbaryl tolerances and,
therefore, are not relevant to the requested revocation of pesticide
tolerances. EPA is responding to the WTC Petition insofar as it seeks
cancellation of all carbaryl products separately, and, therefore, these
comments are not directly relevant here.
    In addition, one comment from a private citizen supported WTC's
petition, asserting that all carbaryl tolerances should be revoked (but
without, however, providing sufficient details to substantiate this
position). Another commenter, Northwest Horticultural Council,
submitted comments stating that WTC's claims are often based on
outdated information, such as carbaryl residue levels on apples and
pears reported in a 1967 monograph of the Food and Agricultural
Organization (FAO) of the United Nations World Health Organization. The
Northwest Horticultural Council states that the FAO Monograph is
superseded by 2004 residue monitoring data from USDA's Pesticide Data
Program (PDP), which shows less than 10% of samples with detection,
where carbaryl residues ranged from 0.0005 to 0.49 ppm. In any event,
the comments as a whole (including these particular comments) did not
add any new information pertaining to whether the tolerances were in
compliance with the FFDCA.

VII. Ruling on Petition

    This Order responds to the WTC Petition to revoke carbaryl
tolerances. As noted above, this request was included as part of WTC's
comments on the carbaryl IRED. The WTC Petition contains a number of
comments that do not provide a basis upon which to either cancel all
carbaryl registrations or revoke all carbaryl tolerances. Moreover, the
WTC Petition focuses solely on ecological issues. EPA is responding to
WTC's comments regarding the ecological assessment supporting the
carbaryl RED in a separate response, which is available in docket EPA-
HQ-2006-0801. However, EPA has not attempted to respond to every
comment or suggestion for improvement made in the comments provided by
the WTC.
    EPA hereby denies the WTC Petition to revoke all carbaryl
tolerances. The WTC Petition has not demonstrated that carbaryl
tolerances are unsafe. Again, the WTC Petition primarily raises a
subset of identical issues that were raised in the NRDC petition, and
does not provide any factual support for the proposition that the
carbaryl tolerances do not meet the FFDCA safety standard. To the
extent that the WTC Petition can be construed as raising any tolerance-
related issues, in denying the WTC Petition, EPA is relying on and
hereby incorporates its response to the NRDC petition. (See 73 FR
64229).

VIII. Regulatory Assessment Requirements

    As indicated previously, this action announces the Agency's order
denying a petition filed, in part, under section 408(d) of FFDCA. As
such, this action is an adjudication and not a rule. The regulatory
assessment requirements

imposed on rulemaking do not, therefore, apply to this action.

IX. Submission to Congress and the Comptroller General

    The Congressional Review Act, (5 U.S.C. 801 et seq.), as added by
the Small Business Regulatory Enforcement Fairness Act of 1996, does
not apply because this action is not a rule for purposes of 5 U.S.C.
804(3).

X. References

    1. Washington Toxics Coalition Comments to Carbaryl IRED and
petition to cancel registrations. January 10, 2005.
    2. National Resources Defense Council (NRDC) Comments to Carbaryl
IRED and petition to cancel registrations. January 10, 2005.
    3. U.S. EPA. Office of Pesticide Programs. 2003. Interim
Reregistration Eligibility Decision for Carbaryl. June 30, 2003.
    4. U.S. EPA. Office of Pesticide Programs. 2004. Amended Interim
Reregistration Eligibility Decision for Carbaryl. October 22, 2004.
    5. U.S. EPA. Office of Pesticide Programs. 2005. Letter to Peg
Cherney, Bayer CropScience, Final Cancellation Order for Carbaryl
Liquid Broadcast Application to Lawns/Turf; EPA Registration Numbers
264-324, 264-325, and 264-328. March 9, 2005.
    6. U.S. EPA Office of Pesticide Programs. 2007. Revised N-methyl
Carbamate Cumulative Risk Assessment. September 24, 2007. Docket EPA-
HQ-OPP-2007-0935-0003.
    7. U.S. EPA. Office of Pesticide Programs. Reregistration
Eligibility Decision (RED) for Carbaryl. September 24, 2007.
    8. U.S. EPA. Office of Pesticide Programs. 2008. Amended
Reregistration Eligibility Decision (RED) for Carbaryl. Revised August
24, 2008.
    9. U.S. EPA. Office of Pesticide Programs. 2008. Letter to Jennifer
Sass, Natural Resources Defense Council, Re: NRDC's comments on the
Carbaryl IRED and petition to cancel registrations dated January 10,
2005 as well as petition to cancel carbaryl registrations dated
November 26, 2007 and submitted as part of NRDC's comments to N-methyl
carbamate cumulative. September 30, 2008.
    10. U.S. EPA. Office of Pesticide Programs. Carbaryl: Order Denying
NRDC's Petition to Revoke Tolerances. September 20, 2008. Docket EPA-
HQ-OPP-2007-0941-0031.

List of Subjects in 40 CFR Part 180

    Environmental protection, Carbaryl, Pesticides and pests.

    Dated: June 18, 2010.
Steven Bradbury,
Director, Office of Pesticide Programs.
[FR Doc. 2010-15751 Filed 7-1-2010; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 80, Number 49 (Friday, March 13, 2015)]
[Rules and Regulations]
[Pages 13204-13206]
[FR Doc No: 2015-05709]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2013-1020; Airspace Docket No. 13-AWP-20]

Establishment of Class E Airspace, and Amendment of Class D and
Class E Airspace; Prescott, AZ

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action establishes Class E airspace and modifies Class D
and Class E surface area airspace at Prescott, AZ, to accommodate
aircraft departing and arriving under Instrument Flight Rules (IFR) at
Ernest A. Love Field. New Area Navigation (RNAV) Global Positioning
System (GPS) standard instrument approach procedures have made this
action necessary for the safety and management of IFR operations at the
airport. The geographic coordinates of the airport are adjusted in the
respective Class D and Class E airspace areas. This also corrects the
airport name to Ernest A. Love Field.

DATES: Effective 0901 UTC, April 30, 2015. The Director of the Federal
Register approves this incorporation by reference action under title 1,
Code of Federal Regulations, part 51, subject to the annual revision of
FAA Order

7400.9 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.9Y, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed on line at http://www.faa.gov/airtraffic/publications/. The Order is also available for
inspection at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202-
741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.9, Airspace Designations and Reporting Points, is
published yearly and effective on September 15. For further
information, you can contact the Airspace Policy and ATC Regulations
Group, Federal Aviation Administration, 800 Independence Avenue SW.,
Washington, DC 29591; telephone:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Steve Haga, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On September 2, 2014 the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) to amend the Class D and Class E
airspace areas at Ernest A. Love Field, Prescott, AZ (79 FR 51920).
Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal to the FAA. No
comments were received.
    Class D and E airspace designations are published in paragraph
5000, 6002, 6004, and 6005, respectively, of FAA Order 7400.9Y, dated
August 6, 2014, and effective September 15, 2014, which is incorporated
by reference in 14 CFR 71.1. The Class E airspace designation listed in
this document will be published subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.9Y, airspace Designations and
Reporting Points, dated August 6, 2014, and effective September 15,
2014. FAA Order 7400.9Y is publicly available as listed in the
ADDRESSES section of this final rule. FAA Order 7400.9Y lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by establishing Class E surface area airspace designated as an
extension to Class D surface area within a 6-mile radius of Ernest A.
Love Field, Prescott, Arizona, having a segment extending from the 6-
mile radius of the airport to 11 miles southwest. Class E surface area
airspace is amended by adding a segment from the 6-mile radius of the
airport to 11 miles southwest. Class E airspace extending upward from
700 feet above the surface is modified to within a 18.7-mile radius of
the airport; the Class E airspace area extending upward from 1,200 feet
above the surface is modified to within a 22-mile radius of the airport
clockwise east to west, and within a 38-mile radius of the airport to
the north. Controlled airspace is necessary to accommodate RNAV (GPS)
standard instrument approach procedures at the airport and enhances the
safety and management of IFR operations. The geographic coordinates of
the airport are updated to coincide with the FAA's aeronautical
database for the respective Class D and Class E airspace areas. This
action also corrects the airport name in the Class D and Class E
surface area airspace descriptions from Prescott, Ernest A. Love Field
to Ernest A. Love Field.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore, (1) is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a Regulatory Evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it establishes controlled airspace at Ernest A. Love Field,
Prescott, AZ.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures,'' paragraph 311a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for Part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9Y,
Airspace Designations and Reporting Points, dated August 6, 2014, and
effective September 15, 2014, is amended as follows:

Paragraph 5000 Class D airspace.

* * * * *

AWP AZ D Prescott, AZ [Modified]

Ernest A. Love Field, AZ
    (Lat. 34[deg]39'17'' N, long. 112[deg]25'09'' W)

    That airspace extending upward from the surface to and including
7,500 feet MSL within a 6-mile radius of Ernest A. Love Field. This
Class D airspace area is effective during the specific dates and
times established in advance by a Notice to Airmen. The effective
date and time will thereafter be published in the Airport/Facility
Directory.

Paragraph 6002 Class E airspace Designated as Surface Areas.

* * * * *

AWP AZ E2 Prescott, AZ [Modified]

Ernest A. Love Field, AZ
    (Lat. 34[deg]39'17'' N, long. 112[deg]25'09'' W)

    Within a 6-mile radius of Ernest A. Love Field, and within 2
miles each side of the 222[deg] bearing of the airport extending
from the 6-mile radius to 11 miles southwest of the airport. This
Class E airspace area is effective during the specific dates and
times established in advance by a Notice to Airmen. The effective
date and time will thereafter be published in the Airport/Facility
Directory.

Paragraph 6004 Class E airspace areas designated as an extension to
Class D or Class E surface area.

* * * * *

AWP AZ E4 Prescott, AZ [New]

Ernest A. Love Field, AZ
    (Lat. 34[deg]39'17'' N, long. 112[deg]25'09'' W)

    That airspace extending upward from the surface within 2 miles
each side of the Ernest A. Love Field 222[deg] bearing extending
from the 6-mile radius of the airport to 11 miles southwest of the
airport. This Class E airspace area is effective during the specific
dates and times established in advance by a Notice to Airmen. The
effective date and time will thereafter be continuously published in
the Airport/Facility Directory.

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

AWP AZ E5 Prescott, AZ [Modified]

Ernest A. Love Field, AZ
    (Lat. 34[deg]39'17''N, long. 112[deg]25'09'' W)

    That airspace extending upward from 700 feet above the surface
within a 18.7-mile radius of the Ernest A. Love Field; that airspace
extending upward from 1,200 feet above the surface within a 22-mile
radius of Ernest A. Love Field, extending clockwise from the
047[deg] bearing of the airport to the 300[deg] bearing of the
airport, and that airspace within a 38-mile radius of the airport
extending clockwise from the 300[deg] bearing of the airport to the
047[deg] bearing of the airport.

    Issued in Seattle, Washington, on February 27, 2015.
Johanna Forkner,
Acting Manager, Operations Support Group, Western Service Center, AJV-
W2.
[FR Doc. 2015-05709 Filed 3-12-15; 8:45 am]
 BILLING CODE 4910-13-P