[Federal Register Volume 75, Number 127 (Friday, July 2, 2010)]
[Rules and Regulations]
[Pages 38417-38422]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-15751]



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.


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 (703) 305-5805.

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: (215) 814-2184; e-mail 
address: guerry.jacqueline@epa.gov.


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 

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

[[Page 38418]]

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 (703) 305-5805.

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-

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. 
    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

[[Page 38419]]

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. 
    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 

    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 
    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 

[[Page 38420]]

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 
    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).

[[Page 38421]]

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-

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 

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

[[Page 38422]]

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. 

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-
    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-

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]