[Federal Register Volume 75, Number 178 (Wednesday, September 15, 2010)]
[Rules and Regulations]
[Pages 55997-56013]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-22987]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2008-0347; FRL-8843-7]
40 CFR Part 180
Carbaryl; Order Denying NRDC's Objections and Requests for
Hearing
AGENCY: Environmental Protection Agency (EPA).
ACTION: Order.
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SUMMARY: In this order, the Environmental Protection Agency (EPA)
denies objections, and requests for hearing on those objections, to a
prior order denying a petition requesting that EPA revoke all pesticide
tolerances for carbaryl under section 408(d) of the Federal Food, Drug,
and Cosmetic Act. The objections and hearing requests were filed on
December 29, 2008, by the Natural Resources Defense Council (NRDC). The
original petition was also filed by NRDC.
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: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
In this document, EPA denies objections, and requests for hearing
on those objections, submitted by NRDC in response to a prior order
denying NRDC's petition requesting that EPA revoke all pesticide
tolerances for carbaryl. In addition to NRDC, and others interested in
food safety issues generally, this action may be of interest to
agricultural producers, food manufacturers, or pesticide manufacturers.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. 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?
EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008-0347. 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 Bldg.), 2777 S. Crystal Dr., 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
Facility telephone number is (703) 305-5805.
II. Introduction
A. What Action Is the Agency Taking?
In this order, EPA denies objections, and requests for a hearing on
those objections, to an earlier EPA Order, (73 FR 64229 ), denying a
petition to revoke all tolerances established for the pesticide,
carbaryl, under the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, (Refs. 1 and 2). Both the objections and hearing requests,
as well as the petition, were filed with EPA by NRDC.
NRDC's original petition, dated January 10, 2005, submitted to the
carbaryl public docket during the public comment period for the 2004
Amended Interim Reregistration Eligibility Decision (IRED) for
Carbaryl, and filed pursuant to FFDCA section 408(d)(1), asserted a
number of grounds why carbaryl tolerances allegedly fail to meet the
FFDCA's safety standard. The main arguments raised in the petition
concerned EPA's drinking water assessment and EPA's decision on the
statutory safety factor to protect infants and children that supported
the 2004 IRED decision. NRDC also petitioned the Agency to cancel all
carbaryl uses pursuant to the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) 7 U.S.C. 136(bb) and 136a, and argued
unreasonable risks on the environment. Subsequently, on November 26,
2007, NRDC petitioned EPA to cancel all carbaryl pet collar uses under
FIFRA. (Ref. 3). EPA consolidated this latter petition with the 2005
FFDCA petition because NRDC argued in it that exposure to carbaryl pet
collars make the risks presented by carbaryl unsafe within the meaning
of FFDCA section 408.
On October 29, 2008, EPA responded to both the 2005 petition to
revoke all carbaryl tolerances and the 2007 petition to cancel all pet
collar uses, denying them in their entirety. (73 FR 64229, October 29,
2008) (Ref. 4).
NRDC then filed objections to EPA's denial of NRDC's petition to
revoke all carbaryl tolerances and requested a hearing on its
objections. These objections and hearing requests were filed pursuant
to the procedures in the FFDCA, section 408(g)(2). (21 U.S.C.
346a(g)(2)). The objections narrowed NRDC's claims to two main topics -
that EPA lacks reliable data to reduce the Food Quality Protection Act
(FQPA) Children's Safety Factor and that EPA's exposure assessment for
carbaryl is flawed and underestimates the exposure to children from pet
collar uses. After carefully reviewing the objections and hearing
requests, EPA has determined that NRDC's hearing requests do not
satisfy the regulatory requirements for such requests and that its
substantive objections are without merit. Therefore, EPA, in this final
order, denies NRDC's
[[Page 55998]]
objections and its requests for a hearing on those objections.
B. What is the Agency's Authority for Taking This Action?
NRDC petitioned to revoke the carbaryl tolerances pursuant to the
petition procedures in FFDCA section 408(d)(1). (21 U.S.C. 346a(d)(1)).
Under section 408(d), EPA may respond to such a petition by either
issuing a final or proposed rule modifying or revoking the tolerances
or issuing an order denying the petition. (21 U.S.C. 346a(d)(4)). Here,
EPA responded by issuing an order under section 408(d)(4)(iii) denying
the petition. (73 FR 64229, October 29, 2008).
Orders issued under section 408(d)(4)(iii) are subject to a
statutorily-created administrative review process. (21 U.S.C.
346a(g)(2)). Any person may file objections to a section 408(d)(4)(iii)
order with EPA and request a hearing on those objections. (Id.). EPA is
required by section 408(g)(2)(C) to issue a final order resolving the
objections to the section 408(d)(4)(iii) order. (21 U.S.C.
346a(g)(2)(C)).
III. Statutory and Regulatory Background
In this Unit, EPA provides background on the relevant statutes and
regulations governing NRDC's objections and requests for hearing as
well as on pertinent Agency policies and practices. As noted, NRDC's
objections and requests for hearing raise two main claims: (1) that EPA
has unlawfully failed to retain the full tenfold FQPA safety factor for
the protection of infants and children and failed to apply an
additional threefold factor due to a deficiency in a critical study;
and (2) that EPA underestimated the exposure to children from pet
collar uses. The first claim is based on assertions that additional
safety factors are needed because of effects observed in a
developmental neurotoxicity (DNT) study with carbaryl. The pet collar
claim is primarily based upon allegations that EPA does not have
sufficient or reliable data with which to assess pet collar exposures
and that the assumptions made by EPA underestimate exposure to
children. Background information on each of these topics is included in
this Unit.
Unit III.A. summarizes the requirements and procedures in section
408 of the FFDCA and applicable regulations pertaining to pesticide
tolerances, including the procedures for petitioning for revocation of
tolerances and challenging the denial of such petitions and the
substantive standards for evaluating the safety of pesticide
tolerances. This unit also discusses the closely-related statute under
which EPA regulates the sale, distribution, and use of pesticides,
FIFRA, (7 U.S.C. 136 et seq.).
Unit III.B. provides an overview of EPA's risk assessment process.
It contains an explanation of how EPA identifies the hazards posed by
pesticides, how EPA determines the level of exposure to pesticides that
pose a concern (level of concern), how EPA measures human exposure to
pesticides, and how hazard, level of concern conclusions, and human
exposure estimates are combined to evaluate risk. Further, this unit
presents background information on Agency policies with particular
relevance to this action.
A. FFDCA/FIFRA and Applicable Regulations
1. In general. EPA establishes maximum residue limits, or
``tolerances,'' for pesticide residues in food 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 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 by EPA if the tolerance is ``safe.'' (21 U.S.C.
346a(b)(2)(A)(i)). ``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;
(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;
(viii) such information as the Administrator may require on
whether the pesticide chemical may have an effect in humans that is
similar to an effect produced by a naturally occurring estrogen or
other endocrine effects. ... 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
[[Page 55999]]
on infants and children of such residues and other substances that have
a common mechanism of toxicity. ...
This provision also creates a presumptive additional safety factor
for the protection of infants and children. Specifically, it directs
that ``[i]n 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 ``children's 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 either establishing,
amending, or revoking the tolerance or denying the petition, any person
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)). In addition, EPA
regulations prescribe the form and manner of submissions for objections
and for an evidentiary hearing. (40 CFR 178.25 and 178.27). 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).
Reassessment and reregistration decisions were generally combined in a
document labeled a Reregistration Eligibility Decision (RED).
B. EPA Risk Assessment for Tolerances--Policy and Practice
1. The safety determination - risk assessment. To assess risk of a
pesticide tolerance, EPA combines information on pesticide toxicity
with information regarding the route, magnitude, and duration of
exposure to the pesticide. The risk assessment process involves four
distinct steps:
Identification of the toxicological hazards posed by a
pesticide;
Determination of the dose-response analysis in test
animals and ``level of concern'' with respect to human exposure to the
pesticide;
Estimation of human exposure to the pesticide; and
Characterization of risk posed to humans by the pesticide
based on comparison of human exposure to the level of concern.
a. Hazard identification. In evaluating toxicity or hazard, EPA
reviews toxicity studies, primarily in laboratory animals, to identify
any adverse effects on the test subjects. Animal studies typically
involve investigating a broad range of effects including gross and
microscopic effects on organs and tissues, functional effects on bodily
organs and systems, effects on blood parameters (such as red blood cell
count, hemoglobin concentration, hematocrit, and a measure of clotting
potential), effects on the concentrations of normal blood chemicals
(including glucose, total cholesterol, urea nitrogen, creatinine, total
protein, total bilirubin, albumin, hormones, and enzymes such as
alkaline phosphatase, alanine aminotransfersase and cholinesterase),
and behavioral or other gross effects identified through clinical
observation and measurement. EPA examines whether adverse effects are
caused by different durations of exposure ranging from short-term
(e.g., acute) to longer-term (e.g., chronic) pesticide exposure, and
different routes of exposure (oral, dermal, inhalation). EPA also
evaluates potential adverse effects in different age groups. EPA
requires testing for different durations and routes of exposure and
different age groups in multiple species of laboratory animals (e.g.,
rat, mouse, dog, rabbit).
EPA also considers whether the adverse effect has a threshold - a
level below which exposure has no appreciable chance of causing the
adverse effect. For non-threshold effects, EPA assumes that any
exposure to the substance increases the risk that the adverse effect
may occur. At present, EPA only considers one adverse effect, the
chronic effect of cancer, to potentially be a non-threshold effect.
(Ref. 5 at 8-9). Because this matter involves a pesticide with
threshold effects, assessment of non-threshold effects is not further
discussed. Moreover, the toxic effects of carbaryl are short in
duration (1 day or less) and, as such, long-term, chronic threshold
effects are not discussed further here.
b. Level of concern/dose-response analysis. Once a pesticide's
potential hazards are identified, EPA determines a toxicological level
of concern for evaluating the risk posed by human exposure to the
pesticide. In this step of the risk assessment process, EPA essentially
evaluates the levels of exposure to the pesticide at which effects
might occur. An important aspect of this determination is assessing the
relationship between exposure (dose) and response (often referred to as
the dose-response analysis).
In examining the dose-response relationship for a pesticide's
threshold effects, EPA evaluates an array of toxicity studies on the
pesticide. In each of these studies, EPA attempts to identify the
lowest observed adverse effect level (LOAEL) and the next lower dose at
which there are no observed adverse affect levels (NOAEL). Often, EPA
will use the lowest NOAEL from the relevant available studies -- for
the duration and route for which risk is being assessed, as a starting
point (called the Point of Departure (POD)) in estimating the level of
concern for
[[Page 56000]]
humans. (Ref. 5 at 9 (The POD is simply the ``dose that serves as the
starting point in extrapolating a risk to the human population.'')). At
times, however, EPA will use a LOAEL from a study on the most sensitive
endpoint as the POD when no NOAEL is identified in that study.
Alternatively, in the absence of a NOAEL for the most sensitive adverse
effect, EPA will use the LOAEL as the risk assessment POD, and
determine an extrapolated NOAEL by dividing the LOAEL by an uncertainty
factor.
EPA is increasingly using modeling to ascertain what is referred to
as a Benchmark Dose (BMD) as a substitute for a NOAEL in selecting a
POD. In its revised assessment of carbaryl, EPA used a BMD approach for
deriving the POD from the available rat toxicity studies. (Ref. 8). A
benchmark dose, or BMD, is a point estimate along a dose-response curve
that corresponds to a specific response level. For example, a
BMD10 represents a 10% change from the background level (the
background level is typically derived from the control group).
Generically, the direction of change from background can be an increase
or a decrease depending on the biological parameter and the chemical of
interest. In the case of carbaryl, a reduction in acetylcholinesterase
(AChE) activity (referred to as ``inhibition'' of AChE) is the toxic
effect of concern. In addition to a BMD, a ``confidence limit'' may
also be calculated. Confidence limits express the uncertainty in a BMD
that may be due to sampling and/or experimental error. The lower
confidence limit on the dose used as the BMD is termed the BMDL, which
the Agency uses as the POD. Use of the BMDL for deriving the POD
rewards better experimental design and procedures that provide more
precise estimates of the BMD, resulting in tighter confidence
intervals. Use of the BMDL also helps ensure with high confidence
(e.g., 95% confidence) that the selected percentage of AChE inhibition
is not exceeded.
Numerous scientific peer review panels over the last decade have
supported the Agency's application of the BMD approach as a
scientifically supportable method for deriving PODs in human health
risk assessment, and as an improvement over the historically applied
approach of using NOAELs or LOAELs. The NOAEL/LOAEL approach does not
account for the variability and uncertainty in the experimental
results, which are due to characteristics of the study design, such as
dose selection, dose spacing, and sample size. With the BMD approach,
all the dose response data are used to derive a POD. Moreover, the
response level used for setting regulatory limits can vary based on the
chemical and/or type of toxic effect (Refs. 6, 7 and 8).
The POD is, in turn, used in choosing a level of concern. EPA will
make separate determinations as to the Points of Departure, and
correspondingly levels of concern, for both short and long exposure
periods as well as for the different routes of exposure (oral, dermal,
and inhalation). In estimating and describing the level of concern, the
POD is at times used differently depending on whether the risk
assessment addresses dietary or non-dietary exposures. For dietary
risks, EPA uses the POD to calculate an acceptable level of exposure or
safe dose. This safe dose has been traditionally referred to as the
reference dose (RfD). The RfD is defined as the risk assessment POD
divided by all uncertainty/safety factors (UF/SFs) except those
specific to FQPA. The Population Adjusted Dose (PAD), on the other
hand, is defined as the POD divided by all UF/SFs, including those
specific to FQPA. In cases where there are no UF/SFs specific to FQPA,
the RfD and PAD are numerically identical. Typically, EPA uses a
baseline safety/uncertainty factor equal to 100. These factors include
a factor of 10 (10X) where EPA is using data from laboratory animals
(inter-species factor) to reflect potentially greater sensitivity in
humans than laboratory animals and a factor of 10X to account for
potential variations in sensitivity among members of the human
population (intra-species factor) as well as other unknowns. Additional
uncertainty factors may be added to address data deficiencies or
concerns raised by the existing data. Under the FQPA, a safety factor
of 10X is presumptively applied to protect infants and children, unless
reliable data support selection of a different factor. This FQPA safety
factor largely replaces pre-FQPA EPA practice regarding additional
safety factors. (Ref. 9 at 4-11).
c. Estimating human exposure. Risk is a function of both hazard and
exposure. Thus, equally important to the risk assessment process as
determining the hazards posed by a pesticide and the toxicological
level of concern for those hazards is estimating human exposure. Under
FFDCA section 408, EPA is concerned not only with exposure to pesticide
residues in food but also exposure resulting from pesticide
contamination of drinking water supplies and from use of pesticides in
the home or other non-occupational settings. (See 21 U.S.C.
346a(b)(2)(D)(vi)). EPA considers multiple routes of exposure (oral,
dermal, and inhalation) and aggregates these exposures where
scientifically appropriate. Because EPA exposure estimates are not
involved in EPA's determination of this matter, no further description
of EPA exposure assessment practices is included.
d. Risk characterization. The final step in the risk assessment is
risk characterization. In this step, EPA combines information from the
first three steps (hazard identification, level of concern/dose-
response analysis, and human exposure assessment) to quantitatively
estimate the risks posed by a pesticide. Separate characterizations of
risk are conducted for different durations of exposure. Additionally,
where appropriate, EPA aggregates exposures across different routes in
characterizing risk.
In estimating and describing the level of concern, the POD is at
times used differently depending on whether the risk assessment
addresses dietary or non-dietary exposures. For threshold risks, EPA
estimates risk in one of two ways. Where EPA has calculated a RfD/PAD,
risk is estimated by expressing human exposure as a percentage of the
RfD/PAD. Exposures lower than 100 percent of the RfD/PAD are generally
not of concern. Alternatively, EPA may express risk by comparing the
Margin of Exposure (MOE) between estimated human exposure and the POD
with the acceptable or target MOE. The acceptable or target MOE is the
product of all applicable safety factors. To calculate the actual MOE
for a pesticide, estimated human exposure to the pesticide is divided
into the POD. In contrast to the RfD/PAD approach, the higher the MOE,
the less risk posed by the pesticide. Accordingly, if the target MOE
for a pesticide is 100, MOEs equal to or exceeding 100 would generally
not be of concern.
As a conceptual matter, the RfD/PAD and MOE approaches are
fundamentally equivalent. For a given risk and given exposure of a
pesticide, if exposure to a pesticide were found to be acceptable under
an RfD/PAD analysis it would also pass under the MOE approach, and
vice-versa. However, for any specific pesticide, risk assessments for
different exposure durations or routes may yield different results.
This is a function not of the choice of the RfD/PAD or MOE approach but
of the fact that the levels of concern and the levels of exposure may
differ depending on the duration and route of exposure.
2. EPA policy on the children's safety factor. As the above brief
summary of EPA's risk assessment practice indicates, the use of safety
factors plays
[[Page 56001]]
a critical role in the process. This is true for traditional 10X safety
factors to account for potential differences between animals and humans
when relying on studies in animals (inter-species safety factor) and
potential differences among humans (intra-species safety factor) as
well as the FQPA 10X children's safety factor.
In applying the children's safety factor provision, EPA has
interpreted it as imposing a presumption in favor of applying a 10X
safety factor to the 10X inter-species and 10X intra-species safety
factors. (Ref. 9 at 4, 11). Thus, EPA generally refers to the 10X
children's safety factor as a presumptive or default 10X factor. EPA
has also made clear, however, that this presumption or default in favor
of the 10X children' safety is only a presumption. The presumption can
be overcome if reliable data demonstrate that a different factor is
safe for children. (Id.). In determining whether a different factor is
safe for children, EPA focuses on the three factors listed in section
408(b)(2)(C) - the completeness of the toxicity database, the
completeness of the exposure database, and potential pre- and post-
natal toxicity. In examining these factors, EPA strives to make sure
that its choice of a safety factor, based on a weight-of-the-evidence
evaluation, does not understate the risk to children. (Id. at 24-25,
35).
3. EPA policy on cholinesterase inhibition. Carbaryl is a member of
the N-methyl carbamate class of pesticides. Each member of this class
shares the ability to inhibit the enzyme, acetylcholinesterase, leading
to neurotoxicity. N-methyl carbamate neurotoxicity is characterized by
the rapid onset (often 15-30 minutes) and rapid recovery (within
hours). Cholinesterase inhibition is a disruption of the normal process
in the body by which the nervous system chemically communicates with
muscles and glands. Communication between nerve cells and a target cell
(i.e., another nerve cell, a muscle fiber, or a gland) is facilitated
by the chemical, acetylcholine. When a nerve cell is stimulated it
releases acetylcholine into the synapse (or space) between the nerve
cell and the target cell. The released acetylcholine binds to receptors
in the target cell, stimulating the target cell in turn. As EPA has
explained, ``the end result of the stimulation of cholinergic
pathway(s) includes, for example, the contraction of smooth (e.g., in
the gastrointestinal tract) or skeletal muscle, changes in heart rate
or glandular secretion (e.g., sweat glands) or communication between
nerve cells in the brain or in the autonomic ganglia of the peripheral
nervous system.'' (Ref. 10 at 10).
Acetylcholinesterase (AChE) is an enzyme that breaks down
acetylcholine and terminates its stimulating action in the synapse
between nerve cells and target cells. When AChE is inhibited,
acetylcholine builds up, prolonging the stimulation of the target cell.
This excessive stimulation potentially results in a broad range of
adverse effects on many bodily functions including muscle cramping or
paralysis, excessive glandular secretions, or effects on learning,
memory, or other behavioral parameters. Depending on the degree of
inhibition these effects can be serious, even fatal.
EPA's cholinesterase inhibition policy statement explains EPA's
approach to evaluating the risks posed by cholinesterase-inhibiting
pesticides such as carbaryl. (Ref. 10). The policy focuses on three
types of effects associated with cholinesterase-inhibiting pesticides
that may be assessed in animal and human toxicological studies: (1)
physiological and behavioral/functional effects; (2) cholinesterase
inhibition in the central and peripheral nervous system; and (3)
cholinesterase inhibition in red blood cells and blood plasma. The
policy discusses how such data should be integrated in deriving a POD
for a cholinesterase-inhibiting pesticide.
EPA uses a weight-of-the-evidence approach to determine the toxic
effect that will serve as the appropriate POD for a risk assessment for
AChE inhibiting pesticides, such as carbaryl (Id). The neurotoxicity
that is associated with these pesticides can occur in both the central
(brain) and the peripheral nervous system. In its weight-of-the-
evidence analysis, EPA reviews data, such as AChE inhibition data from
the brain, peripheral tissues and blood (e.g., red blood cell (RBC) or
plasma), in addition to data on clinical signs and other functional
effects related to AChE inhibition. Based on these data, EPA selects
the most appropriate effect on which to regulate; such effects can
include clinical signs of AChE inhibition, central or peripheral
nervous tissue measurements of AChE inhibition, or RBC AChE measures
(Id). Although RBC AChE inhibition is not adverse in itself, it is a
surrogate for inhibition in peripheral tissues when peripheral data are
not available. As such, RBC AChE inhibition provides an indirect
indication of adverse effects on the nervous system (Id.). Measures of
AChE inhibition in the peripheral nervous system are very rare for N-
methyl carbamate pesticides and no such peripheral data exists for
carbaryl. For these reasons, other state and national agencies such as
California, Washington, Canada, the European Union, as well as the
World Health Organization (WHO), all use blood measures in human health
risk assessment and/or worker safety monitoring programs.
4. EPA policy on assessing risk from cumulative effects from
pesticides with a common mechanism of toxicity. Section 408(b)(2)(D) of
the FFDCA directs EPA to consider available information on the
cumulative effects on human health resulting from exposure to multiple
pesticide chemicals that have a common mechanism of toxicity. EPA
begins a cumulative risk assessment by identifying a group of
pesticides, called a common mechanism group, that bring about the same
toxic effect by a common mechanism of toxicity. Pesticides share a
common mechanism of toxicity if they act the same way in the body; that
is, if the same toxic effect occurs in the same organ or tissue by
essentially the same sequence of major biochemical events.
There are many steps involved in quantitatively assessing the
potential human health risk associated with exposure to the N-methyl
carbamate pesticides. The complex series of evaluations involve hazard
and dose-response analyses; assessments of food, drinking water,
residential/non-occupational exposures; combining exposures to produce
a cumulative risk estimate; and risk characterization. Given the
complexity of the analyses, EPA's policy is to only conduct a
cumulative assessment if each of the individual chemicals in the
assessment has been determined to be ``safe,'' based on aggregate
exposures only to that individual chemical.
IV. Regulatory History of Carbaryl
A. In General
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]. 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). The primary risk of concern from exposure
to carbaryl is acute neurotoxic effects. Carbaryl is a member of the N-
methyl carbamate class of pesticides. This group shares a common
mechanism of toxicity; namely, the ability to inhibit
[[Page 56002]]
the enzyme acetylcholinesterase (AChE) through carbamylation of the
active site. Pesticides included is this group, other than carbaryl,
are aldicarb, carbofuran, formetanate hydrochloride, methiocarb,
methomyl, oxamyl, pirimicarb, propoxur, and thiodicarb.
B. FFDCA Tolerance Reassessment and FIFRA Pesticide Reregistration
1. Interim reregistration eligibility decision. EPA completed an
interim reregistration eligibility decision (IRED) for carbaryl on June
30, 2003 (2003 IRED). The decision on reregistration was treated as
interim because of carbaryl's membership in the N-methyl carbamate
cumulative group. When EPA determines that a pesticide shares a common
mechanism of toxicity with other substances, EPA cannot complete either
the assessment or reassessment of a tolerance or a registration or
reregistration determination until it has assessed available
information regarding exposures to the other substances. For these
pesticides, EPA's practice is to issue an IRED pending completion of
the tolerance reassessment activities. An IRED memorializes EPA's
determination on a narrowly defined issue: Whether a given active
ingredient alone is eligible for reregistration under FIFRA and
tolerance reassessment under the FFDCA, pending a cumulative assessment
for pesticides sharing a common mechanism of toxicity.
Although EPA found in the 2003 IRED that carbaryl dietary exposures
from food and water were below the relevant safe doses (i.e., the acute
PAD (aPAD) and chronic PAD (cPAD)), EPA concluded that numerous
residential uses posed a risk of concern. Accordingly, the 2003 IRED
specified various changes to the carbaryl registration to address these
risks, including: Canceling liquid broadcast applications to home lawns
pending EPA review of pharmacokinetic data to refine post-application
risk estimates; repackaging home garden/ornamental dust products in
ready-to-use shaker can containers, with no more than 0.05 lbs. active
ingredient (ai) per container; canceling 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.
2. Amended interim reregistration eligibility decision. The Agency
amended the 2003 IRED on October 22, 2004 (2004 Amended IRED), and
published a formal Notice of Availability for the document, which
provided for a 60-day public comment period. EPA received numerous
comments on the carbaryl 2004 Amended IRED, including the NRDC petition
requesting that EPA cancel all carbaryl registrations and revoke all
tolerances. The mitigation detailed in the 2004 Amended IRED for
residential uses included limiting applications of liquid formulations
to residential turf areas to spot treatment only; requiring dust
formulations to be packaged in a ready-to-use container containing no
more than 0.05 lbs ai/container; and cancelation of all pet uses,
except for carbaryl treated pet collars. 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.
11). In March 2005, EPA also issued generic and product-specific data
call-ins (DCIs) for carbaryl. The carbaryl generic DCI required several
studies of the active ingredient carbaryl, including additional
toxicology, worker exposure monitoring, 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 their 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
have been canceled through this process.
Bayer subsequently requested that all of their carbaryl
registrations be amended to delete the following uses: 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. 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 all 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). Most recently, in a letter dated September 30,
2009, Wellmark International submitted a request to voluntarily cancel
its pet collar registrations pursuant to section 6(f) of FIFRA (74 FR
54045, October 21, 2009). These are the only carbaryl pet collar
registrations and the last remaining pet product registrations for
carbaryl. EPA issued its final order cancelling carbaryl registrations
for pet collar uses on December 16, 2009. (74 FR 66642, December 16,
2009).
3. Reregistration eligibility decision. As noted, the
reregistration eligibility decision had to remain interim in nature
until the N-methyl carbamate cumulative risk assessment was completed.
That assessment was issued on September 26, 2007, and EPA concluded
that the cumulative risks associated with the N-methyl carbamate
pesticides meet the safety standard set forth in section 408(b)(2) of
the FFDCA, provided that the mitigation specified in the N-methyl
carbamate cumulative risk assessment is implemented, such as
cancellation of all uses of carbofuran, termination of methomyl use on
grapes, etc. EPA has therefore terminated the tolerance reassessment
process under 408(q) of the FFDCA. (See Ref. 12 for additional
information).
In conjunction with the N-methyl carbamate cumulative risk
assessment, EPA completed a RED for carbaryl on September 24, 2007 (the
RED was issued on October 17, 2007 with a formal Notice of Availability
in the Federal Register (72 FR 58844)). (Ref. 12). In addition to
relying on the N-methyl carbamate cumulative risk assessment to
determine that the cumulative effects from exposure to all N-methyl
carbamate 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).
Additionally, the RED included additional mitigation with respect to
granular turf products for residential use; namely, that product labels
direct users to water the product in immediately after application. EPA
[[Page 56003]]
subsequently completed an addendum to the carbaryl RED, dated August
25, 2008, which incorporated the results of a revised occupational risk
assessment and modified mitigation measures for the protection of
workers. The Agency issued a Notice of Availability for the RED
addendum in the October 29, 2008 Federal Register (73 FR 64317).
4. Risk assessment issues with the IRED and RED relevant to NRDC
petition--a. selection of POD. When deriving Points of Departure and
assigning uncertainty/safety factors in risk assessment, EPA looks at
all the appropriate data available at a given time. In cases when new
data become available improving the quality of the overall
toxicological database, it is typical practice to re-consider previous
decisions of the most appropriate Point(s) of Departure and uncertainty
factors. Specific to carbaryl, Points of Departures and uncertainty/
safety factors have changed over time as new data have become available
to fill data gaps, provide additional information on existing data, and
describe the effects in juvenile animals.
For the 2003 IRED and 2004 Amended IRED, the POD for acute exposure
was from a developmental neurotoxicity (DNT) study. The POD used for
risk assessment was 1 milligrams/kilogram/day (mg/kg/day) based upon
the results of the DNT study. In the DNT study the LOAEL was 10 mg/kg/
day based upon functional observational changes (pinpoint pupils,
tremors, and gait abnormalities). Also occurring in this study were
morphometric changes in the brain with a LOAEL of 10 mg/kg/day:
bilateral decrease in the size of the forebrain in adult males; a
bilateral decrease in the length of the cerebella in female pups; and a
bilateral increase in the length of the cerebella in female adults. A
NOAEL for these effects was not identified in the study because a
morphometric analysis was conducted in only the control and high-dose
groups (10 mg/kg/day), but not in low-dose (0.1 mg/kg/day) or mid-dose
(1.0 mg/kg/day) groups. Initially, upon review of the data, EPA had
requested that morphometric analysis of the low-dose and mid-dose
groups be conducted, but this was not possible because the brain
tissues had dried during the preservation process. Nonetheless, EPA
determined that the developmental NOAEL was likely 1 mg/kg/day. This
conclusion was based on the finding that the morphometric changes,
although statistically significant, were minimal in nature and,
therefore, judged not likely to be present at the mid-dose of 1 mg/kg/
day. (Refs. 13, 14, and 15).
Subsequently, in November of 2006, OPP received data from a
carbaryl comparative cholinesterase assay study (CCA study) performed
by EPA's Office of Research and Development. CCA studies are specially
designed toxicity studies that evaluate comparative sensitivity in
adult and juvenile rats with respect to inhibition of cholinesterase
activity. In the case of the carbaryl CCA study, the juvenile rats were
aged post-natal day 11 and 17 (PND11 and PND17).
In the carbaryl CCA, a time course study was first conducted to
determine the time to peak ChE effects followed by a dose-response
study where rats were dosed by oral gavage with corn oil or 3, 7.5, 15,
or 30 mg carbaryl/kg body weight. All ages received the same dose so as
to better compare the effects across ages. The dose was given at 2 ml/
kg. Therefore, the dosing solutions were 0, 1.5, 3.75, 7.5, or 15 mg/
ml. In 2007, EPA conducted a BMD analysis for the carbaryl CCA study,
using the same modeling methodology used in the N-methyl carbamate
cumulative risk assessment. This BMD analysis demonstrated sensitivity
of PND11 and PND17 pups compared to adult ORD ChE data. Previously, in
2005 and in support of the N-methyl carbamate cumulative risk
assessment, the Agency also conducted a BMD analysis of brain and RBC
cholinesterase inhibition in rat oral toxicity studies for adults.
(Ref. 16, see also Refs. 17 and 18). The BMD10 is the
estimated benchmark doses that results in 10% cholinesterase inhibition
(a level generally regarded as not an adverse effect), and the
BMDL10 is the lower 95% confidence interval on the
BMD10, for the data evaluated. Generally, the
BMD10 is used to compare across compartments and across ages
but the BMDL10 is used as the POD. The results of the study
are presented in the following table in terms of the BMD10
and BMDL10:
----------------------------------------------------------------------------------------------------------------
Brain (mg/kg) RBC (mg/kg )
Age ---------------------------------------------------------------
BMD10 BMDL10 BMD BMDL10
----------------------------------------------------------------------------------------------------------------
PND11 1.46 1.14 1.11 0.78
----------------------------------------------------------------------------------------------------------------
PND17 3.00 2.37 1.41 1.05
----------------------------------------------------------------------------------------------------------------
Adults 2.63 2.03 0.96 0.73
----------------------------------------------------------------------------------------------------------------
As the table shows, juvenile 11-day old (PND11) pups were 1.8 times
more sensitive to inhibition of brain cholinesterase than adult rats in
terms of BMDs. The BMD analyses show that the brain BMD for pups is
protective of adults since the pup BMD values are lower than adult
values. For the red blood cell cholinesterase (RBC ChE) compartment,
the RBC BMD10 in PND11 pups is similar to that in adults.
Although the RBC BMDL10 for PND11 pups is numerically lower
(0.8 mg/kg) than the BMDL10 for PND11 brain AChE inhibition
(1.1 mg/kg), the magnitude of this difference is not biologically
meaningful, particularly in light of the similarity in
BMD10s, and considering the higher variability typically
seen in RBC measurements relative to brain. Brain represents the target
tissue for the N-methyl carbamates as opposed to using a surrogate
measure (RBC) and the brain BMDL10 of 1.1 mg/kg would be
protective of both central nervous system and peripheral nervous system
effects. (Refs. 17 and 18).
For the carbaryl risk assessment, the BMDL10 for
inhibition of brain cholinesterase in PND11 juveniles from the CCA
study was chosen as the most sensitive and appropriate POD for
calculating a safe dose instead of using an extrapolated NOAEL from the
DNT study. Several factors were critical to that determination. First,
the CCA study is considered a sentinel study for the N-methyl
carbamates as it evaluates the most sensitive endpoint (cholinesterase
inhibition) in the most sensitive age group (PND11) at the time of peak
effect. For each N-methyl carbamate with a valid CCA study, this study
is being used in the risk assessment to inform the children's safety
factor or the POD. EPA has high confidence in the quality of the data
from the carbaryl study because it used a broad range of doses and used
the radiometric method of measuring AChE inhibition. (Ref. 19). The
radiometric method for assaying
[[Page 56004]]
ACHe inhibition provides the most appropriate method for measuring
cholinesterase inhibition due to N-methyl carbamate exposure because
factors (i.e., assay temperature, dilution, and incubation time) which
promote reversibility are minimized.
Second, gavage studies, such as the CCA study, are the preferred
and most sensitive studies for carbaryl. The toxicity profile of
carbaryl and other N-methyl carbamates is characterized by a rapid
onset of toxicity with a peak time of effect around 15 to 60 minutes
and rapid recovery (typical half-lives in adult rats are 1 to 2 hours).
This pattern of toxicity is shown in Figure 1 for carbaryl.
[GRAPHIC] [TIFF OMITTED] TR15SE10.020
With N-methyl carbamates, due to rapid recovery, toxicity does not
accumulate in juveniles or adults with repeated exposures. As such, EPA
is most concerned about acute effects, particularly those which occur
at the peak time of effect. The Agency has found for these pesticides
that acute studies, particularly via gavage administration, provide the
most sensitive effects (i.e., more health protective) for risk
assessment. Specifically, acute gavage studies provide more sensitive
effects than studies administered in the diet, even studies of much
longer durations. For example, the NOAEL and LOAEL for RBC AChE
inhibition in the carbaryl dietary 2-year rat chronic/carcinogenicity
study are 10/12\1\ mg/kg/day and 60.2/78.6 mg/kg/day in adult rats,
whereas the BMD10/BMDL10 for RBC AChE inhibition
in adult rats in acute gavage studies are 0.96 and 0.73 mg/kg. Based on
this comparison, the acute gavage study provides toxicity values almost
tenfold more sensitive than in the 2-year feeding study.
---------------------------------------------------------------------------
\1\ Two values are provided for males/females.
---------------------------------------------------------------------------
This pattern of toxicity is somewhat unique to this class of
pesticides and can be attributed to the pharmacokinetic and
pharmacodynamic properties of N-methyl carbamates, like carbaryl. The
parent active ingredient, carbaryl, is the toxicologically active
compound. As such, no metabolic activation is required; instead,
metabolism results in detoxification of carbaryl. As evidenced by the
rapid onset of toxicity, these pesticides are rapidly absorbed,
distributed, and cleared from the body.
For this class of pesticides, neurotoxicity is correlated to peak
concentrations of carbaryl. Specifically, brain tissue levels and
inhibition of brain AChE at the time of peak effect are highly
correlated. In dietary administration studies like the 2-year study and
the DNT study, rats are exposed to carbaryl over several hours of
feeding. This is in contrast to a bolus dose in gavage studies where
the entire dose is given at one time. In the dietary studies, the total
administered dose of carbaryl consumed may be equal or even higher than
the gavage dose. However, it is the internal dose of carbaryl at the
target tissues which is related to the magnitude to toxicity. In the
dietary studies, due to the rapid metabolism and clearance, carbaryl
does not reach a peak level like that in gavage studies at the target
tissues and thus the degree of toxicity in dietary studies is far less
than that for gavage studies. As a result, acute gavage studies tend to
be far more sensitive than dietary studies for N-methyl carbamates.
This is the case for carbaryl as shown by the high quality and
sensitive data from the CCA study.
Finally, the changes in brain morphometrics (10 mg/kg) from the DNT
study originally used in the POD derivation were determined to be a
marginal effect not consistently seen in carbarmate pesticides. (See
Unit IV.B.4.b. for a full discussion of EPA's review of the DNT study.)
Although a 10X uncertainty factor was originally applied to the
marginal brain morphometric endpoint, the real NOAEL is likely greater
than 1 mg/kg and less than 10 mg/kg.
In any event, the extrapolated NOAEL from the DNT study is
essentially
[[Page 56005]]
equivalent to the BMDL10 for PND11 juveniles in the CCA
study (i.e., 1 mg/kg/day as compared to 1.1 mg/kg/day). As explained
below, if the LOAEL from the DNT was used in calculating a safe dose,
EPA would retain a children's safety factor of no greater than 10X due
to the lack of a NOAEL in that study. Retention of a children's safety
factor of 10X would make the extrapolated NOAEL for the DNT study
essentially equivalent to the BMDL10 for PND11 juveniles in
the CCA study (i.e., 1 mg/kg/day as compared to 1.1 mg/kg/day).
b. Children's safety factor. With respect to the children's safety
factor, in preliminary reviews undertaken in 1999 and 2001, EPA
initially retained the full 10X safety factor for carbaryl. The reasons
for retaining the 10X children's safety factor were that EPA was
missing a two-generation reproduction study for carbaryl and the DNT
study showed changes in brain morphometric measurements of the
offspring which raised concerns. The data from the DNT study showed
that for the first generation pups, there were no treatment-related
effects on pup weight, pup survival indices, developmental landmarks
(tooth eruption and eye opening), Functional Observational Battery
(FOB) measurements or motor activity assessments. There were also no
treatment related effects on brain weight and gross or microscopic
pathology. There were, however, changes noted in brain morphometric
measurements at the high dose (10 mg/kg/day): Bilateral decrease in the
size of the forebrain in adult males; a bilateral decrease in the
length of the cerebella in female pups; and a bilateral increase in the
length of the cerebella in female adults. EPA requested that a
morphometric analysis of the low-dose and mid-dose groups be conducted,
but this was not possible because brain samples had not been prepared
for measurement and the tissues had dried during the preservation
process. At the time, EPA found these changes at the high dose to be
significant. (See generally Refs. 20, 21, 22, 23, 24, 25 and 26).
When new information became available in 2002, EPA removed the 10X
safety factor for acute dietary and short-and intermediate-term
exposures. (Refs. 13, 14 and 15). Not only did EPA receive a new two-
generation reproduction study (and therefore no longer had any data
gaps) but EPA also obtained new brain morphometric measurements from
the DNT study for the control and high-dose groups. The new
measurements demonstrated that even at the high dose, the morphometric
changes, although statistically significant, were minimal in nature.
This is consistent with the DNT study results for other N-methyl
carbamates (aldicarb and carbofuran), which did not show any changes in
morphometrics. In addition, the DNTs available for all three N-methyl
carbamates have not shown any long-term effects, including effects on
behavior. The Agency is also not aware of any literature studies that
have shown any changes in brain histopathology following N-methyl
carbamate exposure to animals of any age. Based on this information,
EPA concluded that the brain morphometic effects were not likely to be
present at the mid-dose. (Refs. 13, 14 and 15). Because the
developmental effects in the DNT were now well-characterized and the
evidence strongly indicated that no brain morphometric changes would
have been present at the mid-dose (1 mg/kg/day), EPA determined that
the children's safety factor was not needed. In addition, there were no
concerns or residual uncertainties for pre- and/or postnatal toxicity
from other carbaryl development studies.
After EPA received the CCA study in 2006, it modified its decision
on the children's safety factor slightly. As explained above, the
BMDL10 for PND11 juveniles from the CCA study was chosen for
the POD in calculating a safe dose. Because (1) EPA had a complete data
set for carbaryl including high quality data comparing the relative
sensitivity of adults and the young, (2) the effects in the young had
been well-characterized, and (3) the most sensitive effect in the young
(the BMDL10 from the CCA study) was being used to calculate
the safe dose (i.e., the BMDL10 was divided by inter- and
intra-species safety factors), EPA determined that a children's safety
factor was not needed for risk assessments based on the CCA study.
Where carbaryl assessments relied on other data not involving the
testing of juveniles, EPA retained a children's safety factor of 1.8X
reflecting the degree of sensitivity of the young observed in the CCA
study.
c. Calculation of safe dose/aPAD for carbaryl. For dietary risks,
EPA calculated the aPAD by dividing the dietary POD (the
BMDL10 for PND11 juveniles in the CCA study) by the inter-
species and intra-species safety factors (100X) to yield a value of
0.01 mg/kg. For dermal risks, instead of calculating an aPAD, EPA
assessed risk under a MOE approach. The acceptable or target MOE was
calculated using a POD of 86 mg/kg. The POD was obtained by multiplying
the BMDL10 of 30.56 mg/kg from the dermal toxicity study by
2.8, because in an in vitro dermal absorption study, rat skin was 2.8
times more permeable than human skin to carbaryl. The target MOE for
risk assessment is 100 for adults because the inter-species and intra-
species safety factors total 100X. The target MOE for risk assessment
for infants and children is 180 because, in addition to the 100X, the
children's safety factor is 1.8X.
V. NRDC Petitions Regarding Carbaryl
In the underlying petition, NRDC requested, among other things,
that EPA cancel all carbaryl registrations and revoke all carbaryl
tolerances. (Ref. 2). NRDC's January 10, 2005 petition was submitted in
the form of comments on and requests for changes to the Carbaryl
Interim Reregistration Eligibility Decision published in the Federal
Register on October 27, 2004, 70 FR 62663. Nonetheless, in the
introduction to the comments, NRDC included a statement that NRDC was
also petitioning the Agency to revoke all carbaryl tolerances. Among
other things, NRDC raised issues with the dietary assessment, and in
particular, EPA's drinking water assessment that supported the 2004
IRED decision. NRDC also raised concerns about the data surrounding
EPA's selection of a children's safety factor. NRDC raised other safety
factor issues, particularly as they relate to EPA use of the DNT study.
NRDC's petition also included generic disagreements with how EPA
conducts its assessments.
Subsequently, as part of its comments on the N-methyl carbamate
cumulative assessment dated November 26, 2007, NRDC requested that EPA
cancel all carbaryl pet collar registrations. (Ref. 3). The basis for
NRDC's petition to cancel all pet collar registrations rested on issues
related to EPA's assessment of cumulative effects under the FFDCA. In
addition, NRDC incorporated by reference its earlier petition to revoke
all carbaryl tolerances. Accordingly, EPA addressed the exposure issues
raised in the subsequent pet collar petition as part of its response to
the earlier petition to revoke all carbaryl tolerances.
VI. EPA's Response to the Petitions to Revoke Carbaryl Tolerances
On October 29, 2008, EPA denied NRDC's petition to revoke all
pesticide tolerances for carbaryl under section 408(d) of the FFDCA.
(73 FR 64229). EPA's Order also constituted a response to NRDC's
petition dated November 26, 2007, to cancel carbaryl pet collar
registrations submitted as part of NRDC's comments on the N-methyl
carbamate cumulative assessment. Again, EPA's response to NRDC's
petition to cancel pet collar registrations was addressed in that Order
because the
[[Page 56006]]
basis for the petition to cancel pet collars rested on issues related
to EPA's assessment of cumulative effects under the FFDCA.
VII. NRDC's Objections and Requests for Hearing
On December 28, 2008, NRDC filed, pursuant to FFDCA section
408(g)(2), objections to EPA's denial of its tolerance revocation
petition and requested a hearing on those objections. As indicated
above, NRDC's objections and requests for hearing raise two main
claims: (1) that EPA lacks reliable data to reduce the default tenfold
safety factor and (2) that EPA's exposure assessment for carbaryl is
flawed and underestimates the exposure to children from pet collar
uses.
NRDC asserts that EPA failed to consider the available
developmental neurotoxicity data and, therefore, unlawfully lowered the
10X children's safety factor. Specifically, NRDC argues that the DNT
study showed adverse developmental abnormalities in juvenile test
animals at doses that had no effect on adult test animals. According to
NRDC, this finding alone supports a full 10X children's safety factor.
In addition, NRDC asserts that the DNT study did not identify a no-
effect level in juvenile animals, supporting a further 3X safety
factor. Thus, NRDC argues that EPA should have applied a 30X safety
factor (10X for age sensitivity and 3X for failure to identify a no-
effect level) to the end-point from the DNT to establish a final POD.
According to NRDC, to do otherwise is ``arbitrary and capricious, and
contrary to the law.'' (Ref. 1 at 8.)
NRDC also asserts that EPA's exposure assessment underestimates
exposure to children from pet collar uses. NRDC further asserts that
EPA relied on flawed studies and data, and, therefore, the Agency's
determination that tolerances are safe is improper. Among other things,
NRDC argues that at the time of EPA's determination, data on exposure
from use of carbaryl in pet collars required by a 2005 DCI had not been
submitted and that without the data EPA's decision is ``arbitrary and
capricious and contrary to law.'' (Ref. 1 at 9).
EPA regulations make clear that to be considered by the
Administrator, a request for an evidentiary hearing must meet certain
criteria. (40 CFR 178.27). One such criteria is that the request must
include a copy of any report, article, survey, or other written
document (or the pertinent pages thereof) upon which the objector
relies to justify an evidentiary hearing, unless the document is an EPA
document that is routinely available to any member of the public.
In support of its request for a hearing, NRDC submitted the
following documents as evidence that a hearing is appropriate: (1)
Poisons on Pets Health Hazards from Flea and Tick Products, David
Wallinga, MD., MPA and Linda Greer, Ph.D (NRDC, November 2000); and (2)
Opportunities to Improve Data Quality and Children's Health through the
Food Quality Protection Act (EPA- OIG Evaluation Report; Report
2006-P-00009) (January 10, 2006).
In addition, NRDC cited to the following EPA documents: (1) Amended
Carbaryl Reregistration Eligibility Decision (RED) (August, 2008); (2)
Carbaryl RED (September, 2007); (3) Carbaryl Interim RED (IRED) (June,
2003); Organophosphate Cumulative Risk Assessment (2006); and, Revised
N-Methyl Carbamate Cumulative Risk Assessment [DRAFT] (2007).
VIII. Response to Objections and Requests for Hearing
A. Overview
EPA denies NRDC's objections as well as its hearing requests.
NRDC's hearing requests fail to meet the statutory and regulatory
requirements for holding a hearing. NRDC has failed to proffer evidence
on its hearing requests which would, if established, resolve one or
more issues in its favor. Most significant, however, is that NRDC's
claims do not present genuine and substantial issues of fact. On the
merits, NRDC's objections with respect to the use of particular studies
to establish an appropriate POD as well as appropriate safety factors
are denied on scientific, policy, and legal grounds. Finally, NRDC's
objection with respect to EPA exposure assessment of pet collars is
denied as moot because EPA has already issued a cancellation order
under section 6(f) of FIFRA for the last remaining carbaryl pet collar
product registration.
The remainder of this Unit is organized in the following manner.
Unit VIII.B. describes in greater detail the requirements pertaining to
when it is appropriate to grant a hearing request. Unit VIII.C.
examines the evidence proffered by NRDC in support of its hearing
requests. Unit VIII.D. provides EPA's response to the NRDC's objections
and hearing requests.
B. The Standard for Granting an Evidentiary Hearing
EPA has established regulations governing objections to tolerance
rulemakings and tolerance petition denials and requests for hearings on
those objections. (40 CFR part 178; 55 FR 50291, December 5, 1990).
Those regulations prescribe both the form and content of hearing
requests and the standard under which EPA is to evaluate requests for
an evidentiary hearing.
As a threshold matter, EPA's regulations limit the issues that can
be raised in any hearing as well as in objections. In general, the
provisions of FFDCA section 408(g) establish an informal rulemaking
process that is governed by section 553 of the Administrative Procedure
Act (APA) and the case law interpreting these requirements, except to
the extent that section 408 provides otherwise. For example, section
408(d) allows the Agency to proceed to a final rule after publication
of a submitted petition, rather than requiring publication of a
proposal. In this regard, it is well established that the failure to
raise factual or legal issues during the comment period of a rulemaking
constitutes waiver of the issues in further proceedings. See generally,
74 FR 59608, 59624-59629, November 18, 2009.
The fact that FFDCA section 408 in certain limited circumstances
supplements the informal rulemaking with a hearing does not
fundamentally alter the requirements applicable to informal
rulemakings. Nor does it convert this into a formal rulemaking, subject
to the exception in section 553 of the APA. Section 408 of the FFDCA
establishes a unique statutory structure with multiple procedural
stages, and delegates to EPA the discretion to determine the
implementation that best achieves the statutory objectives.
Accordingly, EPA interprets the notice and comment rulemaking portion
of the FFDCA section 408 process as an integral part of the FFDCA
process, inextricably linked to the administrative hearing. The point
of the rulemaking is to resolve the issues that can be resolved, and to
identify and narrow any remaining issues for adjudication.
Consequently, the administrative hearing does not represent an
unlimited opportunity to supplement the record, particularly with
information that was available during the comment period, but that
commenters have chosen to withhold.
EPA has consistently interpreted FFDCA section 408 in this fashion
since the 1996 amendments. For example, EPA previously ruled that a
petitioner could not raise new issues in filing objections to EPA's
denial of its original petition. (See 72 FR 39318, 39324, July 18,
2007.) (EPA's tolerance revocation procedures ``are not some sort of
`game,'
[[Page 56007]]
whereby a party may petition to revoke a tolerance on one ground, and
then, after the petition is denied, file objections to the denial based
on an entirely new ground not relied upon by EPA in denying the
petition.''). EPA reasoned that new issues were not cognizable because
they are ``not an objection to the `provisions of the ... order
[denying the petition]' '' (Id.). Similarly, EPA denied a request for a
hearing because the requestor had failed in their original petition to
raise the claim asserted in their objection. (73 FR 42683, 42696, July
23, 2008). EPA noted that although requestor did argue in its petition
that EPA cannot make a safety finding without completing the endocrine
screening program under FFDCA section 408(p), it did not assert claims
regarding the endocrine data and the children's safety factor. Citing
its previous decision, EPA denied the objections and hearing requests
as to the children's safety factor. (Id.). In that same decision, EPA
also denied a number of hearing requests on the ground that the
requestor failed to proffer supporting evidence; EPA opined that a
failure to offer evidence at an earlier stage of the administrative
proceeding could not be cured by suddenly submitting such evidence with
a hearing request. See 73 FR 42710 (``Presumably Congress created a
multi-stage administrative process for resolution of tolerance
petitions to give EPA the opportunity in the first stage of the
proceedings to resolve factual issues, where possible, through a
notice-and-comment process, prior to requiring EPA to hold a full
evidentiary hearing, which can involve a substantial investment of
resources by all parties taking part .... Accordingly, if a party were
to withhold evidence from the first stage of a tolerance petition
proceeding and only produce it as part of a request for a hearing on an
objection, EPA might very likely determine that such an untimely
submission of supporting evidence constituted an amendment to the
original petition requiring a return to the first stage of the
administrative proceeding (if, consideration of information that was
previously available is appropriate at all'')). Finally, in a recent
decision, the United States Court of Appeals for the District of
Columbia Circuit upheld this interpretation of section 408. See Nat'l
Corn Growers Assn. v. EPA, No 09-1284, slip op. at 9-10 (C.A.D.C. July
23, 2010)(``We agree with EPA....[T]he comment period would be
redundant and superfluous is the same concerns could be raised at the
objections stage.'')
Nonetheless, EPA does not interpret the statute and regulations to
preclude the submission of any new information as part of the
objections phase. Such a position would in fact be inconsistent with
EPA's own regulations and past practice, which require that in order to
support a hearing request, a party submit more than ``mere allegations
or denials.'' (40 CFR 178.32(b)(2)). Rather, EPA's interpretation in
this regard is analogous to the determination of whether a final rule
is the logical outgrowth of the proposal and the comments. Ultimately,
EPA's policy is merely that the objections phase does not present an
opportunity for parties to begin the process entirely anew, by raising
issues or information that could have been fairly presented as comments
on the proposed rule or Notice of Filing of the pesticide petition. Nor
is the statute's additional procedural step an excuse to withhold
information that was clearly available at the time of the rulemaking.
As to the form and content of a hearing request, the regulations
specify that a hearing request must include: (1) a statement of the
factual issues on which a hearing is requested and the requestor's
contentions on those issues; (2) a copy of any report, article, or
other written document ``upon which the objector relies to justify an
evidentiary hearing;'' and (3) a summary of any other evidence relied
upon to justify a hearing. (40 CFR 178.27).
The standard for granting a hearing request is set forth in 40 CFR
178.32. That section provides that a hearing will be granted if EPA
determines that the ``material submitted'' shows all of the following:
(1) There is a genuine and substantial issue of fact for
resolution at a hearing. An evidentiary hearing will not be granted on
issues of policy or law.
(2) There is a reasonable possibility that available evidence
identified by the requestor would, if established, resolve one or more
of such issues in favor of the requestor, taking into account
uncontested claims or facts to the contrary. An evidentiary hearing
will not be granted on the basis of mere allegations, denials, or
general descriptions of positions and contentions, nor if the
Administrator concludes that the data and information submitted, even
if accurate, would be insufficient to justify the factual determination
urged.
(3) Resolution of the factual issue(s) in the manner sought by the
person requesting the hearing would be adequate to justify the action
requested. An evidentiary hearing will not be granted on factual issues
that are not determinative with respect to the action requested. For
example, a hearing will not be granted if the Administrator concludes
that the action would be the same even if the factual issue were
resolved in the manner sought.
(40 CFR 178.32(b)).
This provision essentially imposes four requirements upon a hearing
requestor. First, the requestor must show it is raising a question of
fact, not one of law or policy. Hearings are for resolving factual
issues not for debating law or policy questions. Second, the requestor
must demonstrate that there is a genuine dispute as to the issue of
fact. If the facts are undisputed or the record is clear that no
genuine dispute exists, there is no need for a hearing. Third, the
requestor must show that the disputed factual question is material,
i.e., that it is outcome determinative with regard to the relief
requested in the objections. Finally, the requestor must make a
sufficient evidentiary proffer to demonstrate that there is a
reasonable possibility that the issue could be resolved in favor of the
requestor. Hearings are for the purpose of providing objectors with an
opportunity to present evidence supporting their objections; as the
regulation states, hearings will not be granted on the basis of ``mere
allegations, denials, or general descriptions of positions or
contentions.'' (40 CFR 178.32(b)(2)).
EPA's hearing request requirements are based heavily on FDA
regulations establishing similar requirements for hearing requests
filed under other provisions of the FFDCA. (53 FR 41126, 41129, October
19, 1988). FDA pioneered the use of summary judgment-type procedures to
limit hearings to disputed material factual issues and thereby conserve
agency resources. FDA's use of such procedures was upheld by the
Supreme Court in 1972, (Weinberger v. Hynson, Westcott & Dunning, Inc.,
412 U.S. 609 (1973)), and, in 1975, FDA promulgated generic regulations
establishing the standard for evaluating hearing requests. (40 FR
22950, May 27, 1975). It is these regulations upon which EPA relied in
promulgating its hearing regulations in 1990.
Unlike EPA, FDA has had numerous occasions to apply its regulations
on hearing requests. FDA's summary of the thrust of its regulations,
which has been repeatedly published in the Federal Register in orders
ruling on hearing requests over the last 26 years, is
[[Page 56008]]
instructive on the proper interpretation of the regulatory
requirements. That summary states:
A party seeking a hearing is required to meet a `threshold burden
of tendering evidence suggesting the need for a hearing.' [] An
allegation that a hearing is necessary to sharpen the issues' or fully
develop the facts' does not meet this test. If a hearing request fails
to identify any evidence that would be the subject of a hearing, there
is no point in holding one.
A hearing request must not only contain evidence, but that
evidence should raise a material issue of fact concerning which a
meaningful hearing might be held. [] FDA need not grant a hearing in
each case where an objection submits additional information or posits a
novel interpretation of existing information. [] Stated another way, a
hearing is justified only if the objections are made in good faith and
if they ``draw in question in a material way the underpinnings of the
regulation at issue.'' Finally, courts have uniformly recognized that a
hearing need not be held to resolve questions of law or policy.
(49 FR 6672, 6673, February 22, 1984; 72 FR 39557, 39558, July 19,
2007) (citations omitted)). EPA has been guided by FDA's application of
its regulations in this proceeding. Congress confirmed EPA's authority
to use summary judgment-type procedures with hearing requests when it
amended FFDCA section 408 in 1996. Although the statute had been silent
on this issue previously, the FQPA added language specifying that when
a hearing is requested, 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)). This language explicitly grants EPA broad discretion to
deny a hearing. Specifically, the language in section 408 provides that
EPA is to determine whether a hearing is ``necessary to receive factual
evidence'' as well as whether the issues raised in objections are
``material'' issues of fact. Thus, even where evidence relevant to an
issue of material fact is proffered (essentially the standard set forth
in 40 CFR 178.32), EPA construes the statutory language as requiring it
to hold a hearing only where EPA determines a hearing is necessary to
receive proffered evidence. In other words, the statute grants EPA the
discretion to determine that the issues could be resolved entirely on
the basis of the existing written record. See 74 FR at 59627.
C. Evidentiary Proffer by NRDC
As noted above, the purpose for holding hearings is ``to receive
factual evidence.'' (21 U.S.C. 346a(g)(2)(B); 53 FR 41126, 41129,
October 19, 1988 (``Hearings are for the purpose of gathering evidence
on disputed factual issues . . . .'')). A requestor must identify
evidence relied upon to justify a hearing and either submit copies of
that evidence or summarize it. (40 CFR 178.27). After reviewing the
proffer, EPA must find that there is a reasonable possibility that the
proffered evidence, if established, would resolve one or more
genuinely-disputed, material factual issues in a requestor's favor. (40
CFR 178.32(b)). Because a substantial portion of NRDC's evidentiary
proffer is deficient on its face, EPA finds it most efficient to
preliminarily review the proffer before turning to the individual
issues raised by NRDC.
NRDC identifies the following as ``relevant documentation'': Order
denying NRDC's petition to revoke tolerances (October 29, 2008);
Amended Carbaryl Registration Eligibility Decision (RED) (August 2008);
Carbaryl RED (September 2007); and Carbaryl Interim RED (2003 IRED)
(June 2003). NRDC also includes a reference to information on EPA's
reregistration of carbaryl, available online at http:/www.epa.gov/
pesticides/reregistration/carbaryl/. EPA assumes that these are the
documents NRDC intends to proffer as evidence in support of its request
for a hearing.
In addition, throughout it objections and request for a hearing,
NRDC includes footnotes with citations to additional documents. As a
general matter, EPA assumes NRDC is doing so in the context of it
supporting its objections, rather than as a proffer of evidence to
justify a hearing. Indeed, merely citing to a document in a footnote
does not constitute a proffer of evidence. Nevertheless, in an effort
to address NRDC's hearing request as comprehensibly as possible, EPA
will address these footnote citations as well. In the future, however,
NRDC would be well advised to make clear exactly what evidence it is
proffering as a justification for its hearing request.
The documents cited in footnotes generally fall into three
categories. The first are EPA documents that can be grouped in the same
category as the documents NRDC identified as ``relevant documents.''
These documents are: EPA Fact Sheet for Carbaryl (revised on 10/22/04);
EPA's Organophospate Cumulative Risk Assessment (USEPA 2006); EPA's
Revised N-Methyl Carbamate Cumulative Risk Assessment [DRAFT] (USEPA
2007).
This group of EPA documents, combined with the other EPA documents
identified by NRDC as ``relevant documents'' (including ``[i]nformation
on EPA's reregistration of carbaryl [] available online at http://
www.epa.gov/pesticides/reregistration/carbaryl/'') do not present
evidence of a genuinely-disputed, material issue of fact. (73 FR 42694-
95, July 23, 2008) (citing to EPA decision-making record is vague and
fails to identify new evidence which, if established, would resolve an
issue in petitioner's favor)). First, given that the purpose of a
hearing is to gather or receive evidence, proffering evidence already
considered and relied upon by EPA is not sufficient justification for
holding a hearing. Second, as a matter of law, EPA does not understand
how it can be argued that a proffer consisting of a general reference
to the decision-making record--which EPA has found supports one result,
could constitute evidence that if established would justify the
opposite conclusion. Third, EPA concludes that the non-specific
citation to numerous documents related to the multi-year process of
conducting FIFRA reregistration and FFDCA tolerance reassessment is so
vague a proffer as to not constitute a proffer at all. (Id.)
It should be noted, however, that in two cases, NRDC does offer a
specific citation in the 2008 Amended Carbaryl RED. First, NRDC cites
to a specific page as a reference for the largest uses of carbaryl
(based upon pounds of active ingredient used per year): apples,
asparagus, cherries, corn, grapefruit, grapes, hay, oranges, peaches,
pecans, soybeans, and turf. While use information is relevant to EPA's
overall reregistration decision, it is not material to NRDC's
objections or its request for a hearing. As such it does not identify
evidence that would justify holding a hearing.
Similarly, NRDC cites to a specific page in the 2008 Amended
Carbaryl RED for the proposition that EPA issued a data call-in for
data on exposure from the use of carbaryl in pet collars but that those
results had not been submitted. NRDC objects to EPA's assessment of
carbaryl tolerances in part because EPA did not have these data.
However, EPA has since received the data. Moreover, while this issue
may be relevant to NRDC's objection, arguing that EPA did not have
sufficient data upon which to make a decision (without offering into
evidence data EPA should have but did not consider) is not a basis upon
which to grant a hearing. Again, a hearing is for
[[Page 56009]]
the purpose of gathering or receiving evidence and to resolve material
factual disputes. It is undisputed that at the time, EPA had not
received the data. It is also undisputed that the data has since been
submitted. Thus, there is no issue in dispute over the submission of
the data or evidence to suggest otherwise. In sum, EPA does not
consider NRDC's citations to EPA's decision-making record a sufficient
proffer of evidence to justify a hearing.
The second category of documents cited in footnotes consists of the
following documents, loosely described as articles and reports:
``Poisons on Pets. Health Hazards from Flea and Tick Products'' NRDC
November, 2000; NRDC's 2008 Green Paws report available at http://www.greenpaws.org/better.php; Opportunities to Improve Data Quality and
Children's Health through the Food Quality Protection Act (FQPA) (EPA
Inspector General Report No. 2006-P-00009 (January 10, 2006)); 2007/
2008 American Pet Products Manufacturing Association (APPA) National
Pet Owners Survey; and Kansas State University Press Release. ``K-State
Expert Says Fleas Can Be An Itchy Situation'' (November 16, 1999). None
of these documents proffer evidence of a genuinely-disputed, material
issue of fact. EPA will address each in turn.
The NRDC publication ``Poison on Pets'' focuses on seven
organophosphate insecticides used in flea and tick control products;
namely, chlorpyrifos, dichlorvos, phosmet, naled, tetrachlorvinpos,
diazinon, and malathion. As a preliminary matter, EPA need not
determine whether the information in this publication raises a material
issue of fact about which a meaningful hearing might be held because,
as explained in Unit VIII.D.2, the cancellation of all carbaryl pet
collar product registrations renders NRDC's hearing request moot. In
addition, factually, the document's relevance to carbaryl is at most
tangential. While the report does mention carbaryl, it does so
primarily in the context of arguing against the use of carbamates.
Specifically, on page 49 of 67, the report notes that carbaryl and
propoxur are the two major carbamates used for flea control, combining
for approximately 8% of all active ingredients used to treat pets and
kennels. The report states that NRDC scientists believes that carbaryl
is one of the most significant pesticide disrupters of the endocrine
system, interfering with sperm structure and function as well as
increasing the risk of miscarriage. The report concludes its paragraph
on carbamates by noting that ``[f]ortunately, use of pet products with
carbaryl already has decreased.'' (Poisons on Pets at 50). In its
objections, NRDC relies on the report to reiterate generally applicable
arguments that NRDC made regarding organophosphate pesticides to argue
why NRDC also believes EPA's exposure assessment of carbaryl is flawed.
This document, however, adds no justification for a hearing not
otherwise included in NRDC's objections. In short, the report does not
proffer evidence of a genuinely-disputed, material issue of fact
related specifically to carbaryl.
As best EPA can determine, NRDC's Green Paws report is a website
page devoted to alternative, non-toxic methods of flea and tick
control, such as using a flea comb and regular bathing. Again, EPA need
not determine whether the information in this ``report'' raises a
material issue of fact about which a meaningful hearing might be held
because, as explained in Unit VIII.D.2, the cancellation of all
carbaryl pet collar product registrations renders NRDC's hearing
request moot. In addition, this ``report'' does not contain carbaryl-
specific information and does not provide any evidence of a genuinely-
disputed, material issue of fact related to NRDC's objections or
request for a hearing. As such, it does not provide factual evidence
justifying a hearing.
Similarly, NRDC generally relies on the EPA Inspector General
Report to emphasize the importance of DNT test data. This report,
however, does not contain carbaryl-specific information and does not
provide any evidence of a genuinely-disputed, material issue of fact
related to NRDC's objections or request for a hearing. At best, the
report implies that registration decisions should not be made in the
absence of a DNT study. However, EPA's assessment of carbaryl included
the submission and review of a DNT study. In sum, the report does not
identify factual evidence that would, if established, resolve an issue
in NRDC's favor.
NRDC also cites to the 2007/2008 American Pet Product Association
(APPA) National Pet Owners Survey for the proposition that ``nearly two
out of every three households owns a pet, which equates to 88.3 million
cats and 74.8 million dogs.'' First, although NRDC asserts the survey
is available at the APPA website on-line, as far as EPA is able to
determine this is proprietary information. For non-members, the 2009/
2010 survey (at the time of this writing) was available at a cost of
$1,695. EPA did not purchase a copy for purposes of responding to
NRDC's hearing request and, therefore, was unable to independently
verify the survey results. Second, EPA need not determine whether the
information in this survey raises a material issue of fact about which
a meaningful hearing might be held because, as explained in Unit
VIII.D.2, the cancellation of all carbaryl pet collar product
registrations renders NRDC's hearing request moot. Third, a statement--
even a factual one, as to the number of households that own a pet does
not present evidence of a genuinely-disputed, material issue of fact
related to NRDC's objections or request for a hearing. At best, this
information implies that because there are so many pet owners, the
probability that some owners use carbaryl pet collars and would be
exposed is not insignificant. However, EPA's assessment of carbaryl pet
collars assumes exposure, including exposure to children. Accordingly,
even if the evidence here were established, it would not resolve the
issue identified by NRDC in its favor; namely, that EPA underestimated
the exposure of children that come into contact with pets wearing
carbaryl pet collars. In sum, a survey on the number of households that
have pets does not present evidence to justify a hearing regarding the
assumptions EPA made regarding children's exposure to pets wearing
carbaryl pet collars.
Finally, NRDC cites to a 1999 press release for the proposition
that ``[e]very year Americans spend over one billion dollars on
products designed to kill fleas and ticks on our pets.'' First, EPA was
unable to access a copy of the press release through the web link
provided by NRDC. Thus, it is unclear that this document could even be
introduced as evidence. Second, EPA need not determine whether the
information in this press release raises a material issue of fact about
which a meaningful hearing might be held because, as explained in Unit
VIII.D.2, the cancellation of all carbaryl pet collar product
registrations renders NRDC's hearing request moot. Third, a statement
as to the sales of flea and tick control products generally does not
present any factual evidence specific to carbaryl or information
related to NRDC's objections or request for a hearing. Fourth, the
reference is more than a decade old. Thus, even if it were relevant to
a current genuinely-disputed, material issue of fact, this information
is simply out-of-date. In sum, there can be no serious contention that
the proffer of an outdated press release that generally refers to the
amount Americans spend on pesticides to control fleas and ticks
presents evidence to justify a hearing.
The third category consists of one document: Xue J, Zartarian V,
Moya J,
[[Page 56010]]
Freeman N, Beamer P, Black K, Tulve N, Shalat S: A meta-analysis of
children's hand-to-mouth frequency data for estimating nondietary
ingestion exposure (Risk Anal. 2007 Apr.; 27(2): 411-20). The Xue, et
al. 2007 paper collected hand-to-mouth frequency data from 9 available
studies representing 429 subjects and more than 2,000 hours of behavior
observation. A meta-analysis was conducted on these data to study
differences in hand-to-mouth frequency based on study, age group,
gender, and location (indoor vs. outdoor), to fit variability and
uncertainty distributions that can be used in probabilistic exposure
assessments, and to identify any data gaps. Results of this analysis
indicate that age and location are important for hand-to-mouth
frequency, but study and gender are not. This paper represents the
first comprehensive effort to fit hand-to-mouth frequency variability
and uncertainty distributions by indoor/outdoor location and by age
groups, using the new standard set of age groups recommended by the
U.S. Environmental Protection Agency for assessing childhood exposures.
This document is ``proffered'' in connection with NRDC's objections
and request for a hearing on issues related to EPA exposure assessment
of carbaryl pet collar products. EPA need not determine whether the
information in this meta-analysis raises a material issue of fact about
which a meaningful hearing might be held because, as explained in Unit
VIII.D.2, the cancellation of all carbaryl pet collar product
registrations renders NRDC's hearing request moot. Nonetheless, EPA
notes that NRDC's proffer is improper. NRDC's original Petition did not
address this information because it pre-dated the Xue paper. However,
NRDC's subsequent petition, dated November 26, 2007, regarding pet
collars, which in essence amended its previous petition, also did not
reference or rely in any manner on this information. To the contrary,
in its pet collar petition, NRDC generally takes issue with
modifications EPA made to the assumptions underlying the carbaryl pet
collar residential exposure component of the probabilistic risk
assessment of the N-methyl carbamate cumulative assessment (as compared
to the carbaryl, single chemical, determinative assessment). In so
doing, NRDC generally asserted that the net result of these changes is
that EPA underestimated the exposure of children to carbaryl from pet
collars. It is only in its request for a hearing and objections that
NRDC raises for the first time a host of specific issues based upon the
analysis in the Xue paper related to the carbaryl pet collar
residential exposure component of the N-methyl carbamate cumulative
assessment. Thus, even if the issues concerning pet collars were not
moot, it would be inappropriate to allow NRDC to now cure a poorly
drafted petition by recasting its arguments or raising issues for the
first time--and proffering evidence that was previously available in
support of such arguments had they been raised earlier--at the hearing
and objections stage of the process. See Nat'l Corn Growers Assc. v.
EPA, No. 09-1284, slip op. at 8-9 (C.A.D.C. July 23, 2010) (upholding
EPA's refusal to consider at the objections stage evidence and
arguments that could have been but were not submitted during the
comment period); see also 72 FR at 39324 (tolerance revocation
procedures are not ``game,'' whereby a party may file objections to
denial based on entirely new ground(s) not relied upon in denying the
petition.); 73 FR at 42710 (inappropriate to cure failure to offer
evidence at an earlier stage of administrative proceeding by submitting
such evidence with a hearing request).
In sum, NRDC has failed to identify factual evidence sufficient to
justify a hearing. Specifically, NRDC has failed to proffer evidence
that, if established, would resolve one or more genuinely-disputed,
material factual issues in its favor. Accordingly, in addition to the
reasons discussed below, NRDC's hearing request is denied.
D. Response to Specific Issues Raised in Objections and Hearing
Requests
1. Failure to apply a 10X children's safety factor and another 3X
additional safety factor to the DNT study LOAEL in calculating a safe
dose for carbaryl or to otherwise rely on the DNT study in assessing
the risk of carbaryl. In its objection to EPA's calculation of a safe
dose for carbaryl, NRDC makes three, separate but related arguments:
(1) it was unlawful for EPA to calculate the safe dose for carbaryl
without applying a 10X children's safety factor (in addition to the
inter- and intra-species safety factors) to the LOAEL from the DNT
study; (2) it was unlawful for EPA to calculate the safe dose for
carbaryl without applying an additional 3X safety factor (in addition
to the inter- and intra-species and children's safety factors) to the
LOAEL from the DNT study to account for the lack of a NOAEL in this
study; and (3) ``[e]ven if the DNT data were not used to derive a [safe
dose], EPA's failure to incorporate the important information on age-
sensitivity that is provided by the DNT is arbitrary and capricious,
and contrary to law.'' (Ref. 1 at 8).
NRDC's arguments concerning the application of additional safety
factors of 10X and 3X to the DNT study LOAEL is material to its request
for the revocation of the carbaryl tolerances only if both arguments
are accepted - i.e., it is determined that both additional safety
factors should be used in assessing the safety of carbaryl. This is
because there is already essentially a tenfold difference between the
DNT study LOAEL (10 mg/kg/day) and the POD used in calculating the safe
dose for carbaryl. That POD is the BMDL10 of 1.1 mg/kg/day
for brain cholinesterase inhibition in PND11 juveniles in the CCA
study. Use of either the 10X safety factor or the 3X factor alone
applied to the DNT study LOAEL would not produce a value lower than the
existing POD, only a combined 30X would do that. For this reason, for
NRDC to sustain on materiality grounds its objection and hearing
request as to its first two arguments it must either show (1) it is
entitled to a hearing on both arguments; (2) it is entitled to a
hearing on one argument and, as to the other, even if it is not
entitled to a hearing, its substantive argument is meritorious, or (3)
if it is not entitled to a hearing on either argument, that both of its
substantive arguments are meritorious. As explained below, NRDC has not
made such a showing.
a. Application of a 10X children's safety factor and a 3X safety
factor for lack of a NOAEL to the DNT study. NRDC states that it
``provides a scientific and legal argument that EPA must apply a 30X
adjustment factor, based on a 10X FQPA factor to account for evidence
for permanent structural brain damage in juvenile animals in the DNT
study ..., and a 3X factor for the failure of the DNT study to identify
with confidence an observable no-effect level for juvenile animals
exposed to carbaryl.'' (Obj. at 7). Its legal argument appears to be
that the children's safety factor provision in FFDCA section
408(b)(2)(C) compels EPA to apply a 10X safety factor when a study
reveals juveniles are more sensitive than adults. EPA bases this
conclusion on three considerations: (1) the children's safety factor is
a statutory requirement; (2) NRDC has phrased its argument regarding
juvenile sensitivity and the 10X children's safety factor in mandatory
terms (Ref. 2 at 4 (``Based on the reports available in the EPA
documents demonstrating increased susceptibility in fetuses and newborn
animals, the EPA is obligated to retain the FQPA 10X factor, in
accordance with the law.'')); and (3) there are not specific legal
requirements in FFDCA
[[Page 56011]]
section 408 regarding a safety factor to address the lack of a NOAEL in
a toxicity study.
Hearings are not granted on legal questions. (40 CFR 178.32(b)(1)).
EPA has repeatedly concluded, and NRDC appears to have admitted, that
its argument regarding retention of the children's safety factor to
address juvenile sensitivity is a question of law. (73 FR 5439, 5445,
January 30, 2008; 72 FR 52108, 52115-52117, September 12, 2007; 71 FR
43906, 43919, August 2, 2006). Accordingly, NRDC's hearing request on
this issue is denied.
Turning to the merits of the objection--at least insofar as EPA is
able to discern the basis for the objection, NRDC's objection, as well
as its corresponding hearing request, is initially denied for a lack of
particularity in the objection. EPA should not have to guess at the
substance or basis for an objection. NRDC's objection is also being
denied on the following separate grounds. EPA finds no basis for NRDC's
interpretation of FFDCA section 408(b)(2)(C). EPA has on a number of
occasions rejected the interpretation that the children's safety factor
provision mandates that the absence of a particular study or a finding
of pre- or post-natal toxicity or increased sensitivity in the young
removes EPA's discretion to choose a different safety factor. (73 FR
5439, 5444, January 30, 2008; 72 FR 52108, 52115-52117, September 12,
2007; 71 FR 43906, 43919, August 2, 2006). EPA explained its rationale
recently in responding to NRDC objections that made the same argument
as in this case:
The statute does direct EPA to consider ``susceptibility of
infants and children'' to pesticides. (21 U.S.C. 346a(b)(2)(C)(i)(II)).
It also states that an additional safety factor to protect infants and
children shall be applied ``to take into account potential pre- and
post-natal toxicity . . . .'' (21 U.S.C. 346a(b)(2)(C)). Nonetheless,
in clear and unmistakable language, Congress decreed that,
``[n]otwithstanding such requirement for an additional margin of
safety'' to take into account potential pre- and post-natal toxicity,
EPA is authorized to choose a different safety factor if EPA has
reliable data showing a different factor is safe. (Id.). Interpreting
the statute as creating a rigid, per se rule that the identification of
sensitivity in the young removes EPA's discretion to choose a different
safety factor is inconsistent with this language and the flexibility
granted to the Agency.
(72 FR at 52117; see also 73 FR at 5444). NRDC has raised no arguments
in its current objections that convince EPA to vary from its long-held
interpretation. Accordingly, EPA denies NRDC's objection with respect
to retaining a 10X children's safety factor.
Even giving NRDC every benefit of the doubt, and assuming it did
not intend its argument on the 10X children's safety factor to be only
a legal question, NRDC is still not entitled to a hearing or relief on
the merits. Perhaps NRDC was suggesting that (1) its assertion that the
brain effects in the DNT were ``severe and permanent'' and (2) its
claim that the DNT is a particularly important study due to its focus
on cognitive effects, were sufficient factual reasons, when combined
with the sensitivity finding, to compel EPA to retain the 10X
children's safety factor even if EPA was not legally required to do so
solely based on a finding of sensitivity in the young.
There are several reasons no hearing is required on this re-
articulation of NRDC's claim. First, NRDC has proffered no evidence in
support of its assertion on sensitivity and nature of the effects in
the young. EPA reached quite different conclusions on the significance
of the effects seen in the pups at the LOAEL in the DNT study.
Nonetheless, NRDC has merely recycled its prior comments without
acknowledging EPA's findings or attempting to assert that there is a
disputed question of fact regarding how EPA has characterized the
effects in the study. Critically, NRDC proffers no evidence (or even
arguments) in support of its assertions. As such, NRDC's claims about
sensitivity and the nature of the effects in pups in the DNT study are
nothing more than ``mere allegations'' and hardly qualify as a relevant
objection. Indeed, EPA's regulations specifically state that ``[a]n
evidentiary hearing will not be granted on the basis of mere
allegations, denials, or general descriptions of positions and
contentions . . . .'' (40 CFR 178.32(b)(2)).
Second, NRDC's argument that, as between the carbaryl CCA and the
DNT study, EPA failed to give proper consideration and weight to the
DNT study does not present a genuine issue of material fact to be
resolved at a hearing. Nat'l Corn Growers Assc. v. EPA, No. 09-1284,
slip op. at 13 (C.A.D.C. July 23, 2010) (``there is no material issue
of fact based upon `[m]ere differences in the weight or credence given
to particular scientific studies.'''); (47 FR at 55474) (``[Objectors]
assertion about this evidence is, at best, an argument that a different
inference (i.e., that the pieces are not `reasonably uniform' and `cube
shaped') should be drawn from established fact (the dimensions of the
pieces) than the agency has drawn. No hearing is required in such
circumstances.''); C.f. Norvich, 773 F.2d 1363 (``differences in the
weight or credence given to particular scientific studies ... are
insufficient [to show a material issue of fact for a hearing]''). Here,
all NRDC has done is point to a study already in the record that EPA
has reviewed and considered numerous times. Thus, NRDC has failed to
proffer any evidence to suggest that there is a factual, rather than an
interpretive, matter to be resolved at a hearing. See Nat'l Corn
Growers Assc. v. EPA, No. 09-1284, slip op. at 13 (a ``dispute between
experts'' as to the weight or credence given a particular scientific
study does not present a material issue of fact for a hearing).
Third, NRDC's claims regarding the unique endpoints examined in the
DNT study and its importance in evaluating the safety of pesticides are
not disputed facts. EPA does not contest these points. A hearing will
only be granted if there is a ``genuine and substantial issue of fact
for resolution at a hearing.'' (40 CFR 178.32(b)(1)).
Finally, a hearing is also denied on this re-articulated claim
because at bottom it calls for a policy determination. NRDC is claiming
that based on certain facts an additional safety factor is needed. This
is a policy judgment for EPA not a factual determination on which
evidence could be submitted for adjudication. ``An evidentiary hearing
will not be granted on issues of policy or law.'' (Id.)
On the merits, this re-articulated claim fails as well. First, it
is denied because it has not been made with the particularity required.
The statute requires that objections ``specif[y] with particularity the
provisions of the regulation or order deemed objectionable and stating
reasonable grounds therefore,'' and EPA's regulations make clear that
for an objection to be properly presented it must explain ``with
particularity . . . [its] basis . . . .'' (40 CFR 178.25(a)(2)); see
Nat'l Corn Growers Assc. v. EPA, No. 09-1284, slip op. at 11. Second,
EPA's conclusions on sensitivity and the nature of the effects on the
pups in the DNT study differ significantly from NRDC's assertions and
are well supported in the record. On the nature of the effects, EPA
concluded that the changes in brain morphometrics for pups seen in the
DNT were minimal. (See Unit IV.B.4.b). In addition, the data from the
DNT study showed that for the
[[Page 56012]]
first generation pups, there were no treatment-related effects on pup
weight, pup survival indices, developmental landmarks, FOB
measurements, or motor activity assessments. These conclusions are
found on a careful analysis of the DNT study. On the other hand, NRDC
merely restates its previous comments and neither offers an explanation
for its characterization of the DNT study results nor proffers any
evidence in support of its allegation. (Id.) (``by simply resubmitting
their Comments, without addressing the responses the EPA had made to
them ... [petitioners] `failed to lodge a relevant objection'''). On
the sensitivity of the young, EPA concluded that the brain morphometric
effects in the juvenile rats in the DNT study would not be present at 1
mg/kg/day. Thus, EPA has determined that the LOAELs and NOAELs for
adults and juveniles in the DNT study were the same. NRDC has offered
no reasons as to why EPA's findings on these points was in error. (Id.)
Indeed, there is nothing to suggest that EPA's conclusion that these
findings on sensitivity and the nature of the effects in the young did
not require retention of a 10X factor was unreasonable. To the
contrary, this conclusion is consistent with both EPA policy and
practice. While on occasion EPA has applied an additional children's
safety factor based solely on the nature of the effects seen in the
young, such additional safety factors have only been utilized in
situations involving significantly different factual circumstances.
(See 74 FR 39545, 39549-39550, August 7, 2009) (for pesticide that
showed sensitivity in the young, 3X children's safety factor retained
due to very narrow dose range (3X) from NOAEL to fatal dose level).
Third, as to the NRDC's assertions regarding the importance of the DNT
study, EPA would note that there is a DNT study for carbaryl and it has
been fully considered in assessing the risk of carbaryl. Importantly,
in evaluating that study, EPA determined based on the effects seen in
that study at what level a NOAEL for pup effects was likely to have
been seen and that level is nearly identical to the level used as the
POD for assessing carbaryl risks. For all of these reasons, this
objection is denied.
Having denied NRDC's objection that a 10X children's safety factor
is required due to the alleged identification of age sensitivity,
NRDC's claim regarding a 3X factor due to the lack of a NOAEL in the
DNT study becomes immaterial. As noted above, additional factors of 10X
or below applied to the DNT study LOAEL for pups (along with the
standard inter- and intra-species safety factors) will not result in a
lower aPAD for carbaryl and thus granting NRDC's objection would not
change EPA's safety determination. Because NRDC's objection on this
issue is not outcome-determinative, it is denied on the basis of
immateriality. See Nat'l Corn Growers Assc. v. EPA, No. 09-1284, slip
op. at 13; 72 FR 39318, 39323-39324, July 18, 2007. In addition, there
are no disputed facts with regard to the question of whether an
additional safety factor is needed to address the lack of a NOAEL in
the DNT study. NRDC asserts that an additional 3X safety factor should
be applied to the DNT study LOAEL for pups because no NOAEL was
identified for that test group. EPA agrees that if it were using the
pup LOAEL from the DNT study as a POD, at least a 3X factor is needed
to account for the lack of a NOAEL in that study. In fact, in its risk
assessment, EPA essentially applied a safety factor of 10X to the DNT
study's LOAEL (10 mg/kg/day) by its determination that no brain
morphometric effects would be expected at the mid-dose (1 mg/kg/day).
Thus, EPA does not disagree with NRDC's assertion that an additional
safety factor is needed to address the lack of a NOAEL in the DNT
study. In sum, because this objection is immaterial and there are no
disputed material facts, NRDC's hearing request and objection on this
issue are denied. (40 CFR 178.32(b)).
b. Arbitrary and capricious. NRDC argues that even if EPA uses the
BMDL10 for PND11 juveniles from the CCA study for the POD
for calculating the carbaryl safe dose, it must ``incorporate the
important information on age-sensitivity that is provided by the DNT
[study]'' into its risk assessment and that EPA's failure to do so was
arbitrary and capricious. (Ref. 1 at 8). The only hint that NRDC
provides as to what it means by this vague allegation is a table
appearing on page eight of its objections in which NRDC suggests that
the additional 10X and 3X safety factors it argues are needed for the
DNT study should be applied to the BMDL10 for PND11
juveniles in the CCA study in computing the safe dose. NRDC advances no
specific argument as to why this approach should be taken and proffers
no evidence in support of it. As an initial matter, therefore, this
objection and its corresponding hearing request is denied for a lack of
particularity in the objection. EPA should not have to guess at the
substance of an objection.
Even assuming the objection passes the particularity requirement,
it is without merit. The predicate to this argument is that additional
safety factors are needed as to the pup LOAEL in the DNT study. Thus,
this objection and hearing request stand in the shoes of the objections
and hearing requests regarding the alleged need for additional 10X and
3X safety factors on the pup LOAEL in the DNT study. As to the
additional 10X children's safety factor, NRDC's objection and hearing
request is denied for the identical reasons that EPA denied NRDC's
direct claims regarding an additional 10X children's safety factor. As
to the 3X safety factor, NRDC's assertion that a lack of a NOAEL in the
DNT study necessitates the application of an additional safety factor
to the POD in the CCA study does not warrant a hearing and is
substantively meritless because it is nothing more than a mere
allegation without any supporting basis. (40 CFR 178.32(b)(2)). NRDC
offers no evidence as to why a LOAEL-to-NOAEL safety factor should be
transferred from a study where it is needed (the DNT study) to a study
where a clear NOAEL or its equivalent (a BMDL10) is
identified (the CCA study). Further, to the extent that NRDC intended
to make some other point by its vague claim that it was arbitrary and
capricious for EPA not to take the DNT study results into account in
its carbaryl safety determination, its hearing request is denied as
being no more than a ``general description of [a] position[],'' 40 CFR
178.32(b)(2), and the objection is denied on the ground that the
record, on its face, shows that EPA carefully considered the results of
the DNT study in making its safety determination on carbaryl. (See Unit
IV.B.4.b).
2. Improper reliance on flawed data for exposure assessment
resulting in underestimation of exposure to children from pet collars.
NRDC makes several arguments as to why EPA's exposure assessment is
flawed and, therefore, EPA cannot make its tolerance safety finding for
carbaryl. NRDC first argues that EPA cannot make its safety finding
because required transferable residue studies have not yet been
submitted. NRDC further argues that the exposure studies that EPA did
rely on are highly variable and unreliable and, therefore, EPA cannot
be reasonably certain that children in the highly exposed tails of the
exposure curve will be protected. NRDC also argues that EPA made
several unfounded or faulty assumptions in it exposure assessment such
that EPA cannot show that there is an unreasonable certainty of no harm
from the aggregate exposures to carbaryl.
EPA denies both the hearing request and the objections as moot
because all carbaryl pet collar registrations have
[[Page 56013]]
been cancelled. In a letter dated September 30, 2009, Wellmark
International submitted a request to voluntarily cancel its pet collar
registrations pursuant to section 6(f) of FIFRA. (74 FR 54045, October
21, 2009). These are the only carbaryl pet collar registrations and the
last remaining pet product registration for carbaryl. EPA issued its
final order cancelling carbaryl registrations for pet collar uses on
December 16, 2009. (74 FR 66642).
E. Conclusion on Objections and Request for a Hearing
For the reasons stated above, all of the NRDC's objections as well
as its request for a hearing are denied.
IX. Regulatory Assessment Requirements
As indicated previously, this action announces the Agency's final
order regarding objections filed under section 408 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.
X. 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).
XI. References
1. Natural Resources Defense Council, ``Objections to the Order
Denying NRDC's Petition to Revoke All Tolerances for Carbaryl, and
Request for Public Evidentiary Hearing'' (December 29, 2008).
2. Natural Resources Defense Council, Petition to Revoke All
Carbaryl Tolerances and Cancel All Carbaryl Registrations, (January
10, 2005).
3. Natural Resources Defense Council, Petition to Cancel
Carbaryl and Propoxur for Pet Collar Uses, (November 26, 2007).
4. US EPA, Carbaryl; Order Denying NRDC's Petition to Revoke
Tolerances, 73 FR 64229, October 29, 2008.
5. US EPA, ``A User's Guide to Available EPA Information on
Assessing Exposure to Pesticides in Food'' (June 21, 2000).
6. FIFRA Science Advisory Panel. 2002. Methods Used to Conduct a
Preliminary Cumulative Risk Assessment for Organophosphate
Pesticides. Final Report from the FIFRA Scientific Advisory Panel
Meeting of February 5-7, 2002 (Report dated March 19, 2002). FIFRA
Scientific Advisory Panel, Office of Science Coordination and
Policy, Office of Prevention, Pesticides and Toxic Substances, U.S.
Environmental Protection Agency. Washington, DC. SAP Report 2002-01.
7. FIFRA Science Advisory Panel. 2005a. Final report on N-Methyl
Carbamate Cumulative Risk Assessment: Pilot Cumulative Analysis.
Final Report from the FIFRA Scientific Advisory Panel Meeting of
February 2005 (Report dated September 2, 1998). Available at: http://www.epa.gov/scipoly/sap/2005/february/minutes.pdf.
8. FIFRA Science Advisory Panel. 2005b. Final report on
Preliminary N-Methyl Carbamate Cumulative Risk Assessment. Final
Report from the FIFRA Scientific Advisory Panel Meeting of July 29-
30, 2005 (Report dated September -, 2005). Available at: http://www.epa.gov/scipoly/sap/2005/august/minutes.pdf.
9. Office of Pesticide Programs, US EPA, ``Office of Pesticide
Programs' Policy on the Determination of the Appropriate FQPA Safety
Factor(s) For Use in the Tolerance Setting Process'' (February 28,
2002).
10. US EPA Office of Pesticide Programs, ``The Use of Data on
Cholinesterase Inhibition for Risk Assessments of Organophosphorous
and Carbamate Pesticides'' (August 18, 2000).
11. US EPA Office of Pesticide Programs. March 9, 2005 letter to
Peg Cherney, Bayer Crop Science, Final Cancellation Order for
Carbaryl Liquid Broadcast Application to Lawns/Turf; EPA
Registration Numbers 264-324, 264-325, and 264-328.
12. US EPA Office of Pesticide Programs. 2007. Office of
Prevention, Pesticides and Toxic Substances, EPA, Reregistration
Eligibility Decision for Carbaryl (September 24, 2007).
13. US EPA Office of Pesticide Programs. 2002. Hazard
Identification Assessment Review Committee (HIARC) report (March 5,
2002).
14. US EPA Office of Pesticide Programs. 2002. FQPA SF Committee
report (April 3, 2002).
15. US EPA Office of Pesticide Programs. 2002. HIARC report (May
9, 2002).
16. Moser, G. (2007) Report of Cholinesterase Comparative
Sensitivity Study of Carbaryl. Unpublished study prepared by US EPA,
ORD, NHEERL. (MRID 47143001).
17. US EPA Office of Pesticide Programs. 2007. Carbaryl: Updated
Endpoint Selection for Single Chemical Risk Assessment (June 29,
2007).
18. US EPA Office of Pesticide Programs. 2007b. Carbaryl. HED
Chapter of the Reregistration Eligibility Decision Document (RED).
EPA-HQ-OPP-2007-0941-0003. PC Code: 056801, DP Barcode: D334770.
(June 28, 2007).
19. Johnson, C.D. and Russell, R.L. (1975) A rapid, simple
radiometric assay for cholinesterase, suitable for multiple
determinations. Analytical Biochemistry. 64:229-238.
20. US EPA Office of Pesticide Programs. 1998. Hazard
Identification Assessment Review Committee (HIARC) report (July 7,
1998).
21. US EPA Office of Pesticide Programs. 1998. FQPA SF Committee
report (August 27, 1998).
22. US EPA Office of Pesticide Programs. 1999. HIARC report
(April 27, 1999).
23. US EPA Office of Pesticide Programs. 1999. HIARC report
(November 15, 1999).
24. US EPA Office of Pesticide Programs. 1999. FQPA SF Committee
report (December 13, 1999).
25. US EPA Office of Pesticide Programs. 2001. HIARC report
(April 5, 2001).
26. US EPA Office of Pesticide Programs. 2001. FQPA SF Committee
report (April 30, 2001).
List of Subjects in 40 CFR Part 180
Environmental protection, Carbaryl, Pesticides and pests.
Dated: September 8, 2010.
Steven Bradbury,
Director, Office of Pesticide Programs
[FR Doc. 2010-22987 Filed 9-14-10; 8:45 am]
BILLING CODE 6560-50-S