reduce or eliminate the likelihood that a reasonable person would
question the employee's impartiality. After considering these factors,
the Agency decided the prudent course was be to recuse Drs. Brimijoin
and Chambers from the HSRB carbofuran discussion but to authorize
limited, as needed, participation.
    As documented in Dr. William Farland's May 1, 2006 memorandum
entitled, ``Ethics Determination for Participation at the May 2-3, 2006
EPA Human Studies Review Board Meeting'' (Ref. 39), EPA authorized the
HSRB to ask Drs. Brimijoin and Chambers clarifying questions regarding
their 1997 review, in the event that the HSRB deemed it necessary as
part of their deliberations. At no point during the meeting did any of
the HSRB's members indicate in any way that they wanted to consult with
their recused colleagues. Nor did any of the members state that they
wanted clarification on any point associated with the study.
    For all of the above reasons, Petitioners' objection on this point
is denied.

I. Objections to Revocation of Import Tolerances

    Petitioners object to EPA's revocation of the tolerances for
imported foods along with the tolerances associated with domestic uses.
Petitioners allege that the revocation of the import tolerances is not
supported by the available data because EPA's own risk assessments
conclude that, when considered separately from the domestic uses, the
residues from imported foods covered by these tolerances are ``safe.''
Petitioners further argue that EPA ``has not asserted any claim or
rationale in the Final Order justifying its conclusions that the import
tolerances are unsafe'' and therefore the revocation is unjustified.
    1. Background. In the proposed rule, EPA explained that its finding
that aggregate exposure from all of the existing uses of carbofuran is
not safe does not necessarily mean that no individual tolerance or
group of tolerances could meet the FFDCA 408(b)(2) safety standard and
be maintained (73 FR 44865 (July 31, 2008)). Rather, to the extent
parties wanted to retain a particular subset of existing tolerances,
the onus was on commenters to identify those uses and to submit
information to demonstrate that the tolerance(s) meet the statutory
standard. Indeed, EPA specifically identified the import tolerances as
a subset that might meet the safety standard (Id.).
    No one submitted any comments alleging the need to retain
individual tolerances for purposes of imports, or indicated an
intention to seek to maintain those tolerances. The only subset of
tolerances that commenters suggested was safe was the subset identified
by the Petitioners, which included the import tolerances along with
four domestic food uses.
    In the final rule, EPA analyzed the aggregate exposures from the
subset of tolerances the Petitioners sought to retain, and concluded
that the aggregate residues from food covered by those tolerances and
from residues in drinking water are unsafe (74 FR 23084-23088).
    2. Denial of hearing request. A hearing is denied on this subissue
because there is no disputed factual matter for resolution at a
hearing. As the objection notes, EPA and Petitioners' risk assessment
both concluded that the residues from imported food alone fell within
the risk cup (Obj. at 52-54). The only issue this objection raises is
whether EPA should have independently determined to retain a subset of
the tolerances that Petitioners sought to maintain. This is a legal
issue, and hearings are not appropriate on such issues (40 CFR
178.32(b)(1)). (See 73 FR 42696-42697 (July 23, 2008) (denying NRDC's
request for a hearing on objection that children's safety factor could
not be reduced in absence of endocrine screening data). FDA also has
repeatedly confirmed that the application of a legal standard to
undisputed facts is a question of law for which a hearing is not
required. (See, e.g., 68 FR 46403, 46406 n.18, 46408, 46409 (August 5,
2003) (whether facts in the record show there is a reasonable certainty
of no harm is a question of law; whether a particular effect is a
``harm'' is a question of law)).
    In addition, Petitioners failed to raise this issue as part of
their comments on the proposed rule, and never requested retention of
only the import tolerances. Accordingly, as discussed in Unit VI.D, EPA
considers this issue to have been untimely raised, and therefore
waived. (See, 73 FR 42,696 (July 23, 2008) (denying NRDC's hearing
request on claims not presented in their original petition); 72 FR
39318, 39324 (July 18, 2007) (ruling that parties may not raise new
issues in filing objections to EPA's denial of original petition)).
    3. Denial of Objection. Petitioners incorrectly allege that EPA
provided no rationale for the revocations of the import tolerances. In
the final rule, EPA clearly found that the aggregate exposures to
carbofuran residues from all remaining uses, when combined with
residues found in drinking water, were unsafe (74 FR 23084-23088 (May
15, 2009).
    EPA can only maintain tolerances that it can determine will be
``safe'' within the meaning of section 408(b)(2)(A)(ii). In making this
determination, EPA must consider aggregate exposures from ``dietary
exposure under the tolerance and all other tolerances in effect for the
pesticide chemical residue, and exposure from other non-occupational
sources'' (21 U.S.C. 346a(b)(2)(D)(vi)). At the time of the final rule,
EPA evaluated the safety to the public from all dietary exposures to
residues of carbofuran, which included not only the import tolerances,
but also from residues on foods associated with domestic registrations
and from residues in drinking water contaminated by the domestic uses.
Indeed, until domestic use ceases--or at least until EPA has a
reasonable basis to believe that it will cease--the Agency has no
discretion to ignore the exposures from those uses. And revocation of
the tolerances themselves does not necessarily resolve the issue, given
the circumstances here. Until the registrations are cancelled, residues
from contaminated drinking water, which is the primary contributor to
the risks, must be included in EPA's risk assessment (Id).
    The consequence of this requirement is that, when one tolerance is
unsafe, all tolerances are equally unsafe until aggregate exposures
have been reduced to acceptable levels. Accordingly, in circumstances
where aggregate exposures exceed the risk cup, there are potentially
multiple variations of the potential subset of tolerances that might
meet the safety standard. FFDCA section 408 does not compel EPA to
determine the appropriate subset that would meet the safety standard.
EPA is compelled ``to revoke or modify a tolerance if [EPA] determines
it is not safe,'' but the statute grants EPA the discretion to
determine how to proceed where more than one tolerance is unsafe. EPA's
general policy in such situations is not to independently select the
subset that meets the standard, but to rely on the pesticide registrant
and the public to determine which of the various subsets of tolerances
are of sufficient importance to warrant retention. There are a number
of reasons EPA adopted this policy; it would be an unreasonable burden
for the Agency to evaluate every possible combination of tolerances
that might fit within the risk cup. In addition, if there were multiple
different combinations that might within the risk cup, it is not clear
that any party would

agree that EPA had selected the appropriate combination of tolerances.
This is particularly relevant, since EPA relies on individual entities
to maintain the tolerance, by continuing to submit necessary data to
demonstrate the continuing safety of the covered residues.

J. Summary of Reasons for Denial of Petitioners' Objections and Hearing
Requests

    1. General Denial. All of Petitioners' objections and hearing
requests are denied because they are irrelevant, and thus immaterial,
to EPA's final regulation revoking carbofuran tolerances. The lack of
relevance stems from Petitioners' decision to object not to the safety
decision EPA made in its final revocation regulation but to instead
argue that EPA should reach a different decision based on FMC's
proposed changes to the carbofuran registration that were submitted to
EPA 44 days after the regulation published in the Federal Register.
These proposed registration changes are central to and inextricably
intertwined with the contention that underlies all of Petitioners'
objections--that the carbofuran tolerances are safe, because in order
to retain the contested tolerances, Petitioners must succeed on all of
their objections. There exist statutory and regulatory procedures under
FIFRA for FMC to pursue an amended carbofuran registration. As part of
seeking an amended registration, FMC may petition to reestablish the
revoked carbofuran tolerances. However, it is not proper to object to a
final FFDCA tolerance revocation regulation based on the assertion that
subsequently-filed, and as of yet unapproved FIFRA registration
amendments, may change the risk picture under the FFDCA.
    FMC has had ample opportunity prior to issuance of the final
tolerance revocation regulation to amend its FIFRA registration,
whether during the comment period on the proposed rule, the extended
reregistration process, or the public process initiated as part of the
NOIC for carbofuran. And FMC has requested a number of modifications to
its registrations during that time period. Yet, FMC has waited until
EPA issued a final revocation regulation finding that carbofuran
tolerances are unsafe, particularly as to infants and children, before
filing its latest series of proposed FIFRA registration amendments. For
this FFDCA proceeding, that is too late. The FFDCA commands that EPA
``shall modify or revoke a tolerance if the Administrator determines it
is not safe'' (21 U.S.C. 346a(b)(2)(A)(i)). The statute also places EPA
under a special injunction to protect infants and children from the
risks of pesticides (21 U.S.C. 346a(b)(2)(C)). EPA has made a final
determination that carbofuran tolerances are unsafe and further
determined that that lack of safety falls hardest on infants and
children. Petitioners had the statutory right under FFDCA to challenge
the accuracy of EPA's safety finding on carbofuran tolerances. FMC also
has the statutory right under FIFRA to request amendment of its
registration. What Petitioners may not do is prolong the FFDCA
tolerance revocation process by challenging EPA's safety determination
based on proposed FIFRA registration changes that were not before EPA
at the time of its final revocation decision.
    2. Alternate Grounds for Denial. Despite the fact that Petitioners'
objections and hearing requests are facially defective for reliance on
newly-proposed FIFRA registration amendments, EPA has carefully
examined each of Petitioners' objections and hearing requests and found
that, in every instance, there are alternate grounds for denial. Those
grounds are summarized below.
    There are multiple problems with Petitioners' hearing requests.
Many of these problems stem from the Petitioners' decision to withhold
analyses and information from the notice-and-comment rulemaking portion
of this proceeding. Thus, despite EPA's clear warning that issues not
raised in comments on the proposed rule, and information not submitted
in that same timeframe, would be considered waived, Petitioners
included several new issues, and numerous documents and analyses for
the first time with their objections although they were clearly
available earlier. Petitioners also have, for the most part, ignored
how EPA responded to the comments they did submit in the notice-and-
comment rulemaking, and instead have often merely recycled their
earlier comments as objections without addressing the reasons why EPA
found them lacking in the first instance. This strategy, unfortunately
for Petitioners, is fatal to many of their hearing requests and
objections. EPA will not grant hearings on issues that have been
waived, on issues where supporting documents were untimely submitted,
or on claims that have become stale in that EPA addressed them in the
final rule and Petitioners have not responded by clarifying where
disputed issues still remain.
    It is not as if Petitioners lacked warning that EPA would take such
an approach. Not only did EPA clearly state in the proposed rule that
comments and information must be submitted in the comment period to be
preserved but in 2007 EPA denied a hearing to a party who treated the
notice-and-comment rulemaking process in a similarly cavalier fashion.
In that instance, the party in question, like Petitioners, filed
objections that largely mirrored its earlier submissions to the Agency
without taking into account how EPA's final action had altered the
nature of issues in dispute (See, e.g., 73 FR 42693 (``NRDC's
objections largely restate the claims in its petition. Significantly,
NRDC does not acknowledge or respond to the DDVP dietary and
residential risk assessments made in response to the NRDC
petition.'')). Such objections and hearing requests were denied for a
lack of materiality (73 FR 42698-42699 (``When an objector does not
challenge EPA conclusions in the section 408(d)(4)(iii) order but
rather challenges some prior conclusion that was superseded by the
section 408(d)(4)(iii) order, the objector has not raised a live
controversy as to an issue material to the section 408(d)(4)(iii)
order.'').
    a. Children's Safety Factor Objection. In support of their
objection on the children's safety factor, Petitioners put forward
several arguments; EPA summarizes below the various reasons for
rejecting Petitioners' hearing requests and objections on each
argument. Given the voluminous number of arguments asserted by
petitioners in support of this objection, it is easy to lose track of
the fact that all of the arguments relate to a single decision by EPA--
the decision to reduce the presumptive 10X children's safety factor to
4X, rather than to 1X or 2X as the Petitioners desire.
    (i) Subissue: Are brain AChE measures in juveniles adequately
protective of CNS effects in juveniles? EPA based its determination to
reduce the children's safety factor to 4X on the ratio of sensitivity
shown between carbofuran's effects on RBC AChE and brain AChE in
juvenile rats. It is EPA's general policy to rely on RBC AChE as a
surrogate for effects on the PNS but Petitioners failed to provide
adequate RBC AChE data in juveniles to fully characterize the dose
level of concern for PNS effects in infants and children. Petitioners
claim EPA was wrong from the start. They claim that once EPA determined
it had adequate data on brain AChE, the RBC data was irrelevant because
brain AChE is an adequately-protective surrogate for PNS effects.
    Petitioners' hearing requests and objections on this issue are
denied for identical reasons: the available evidence

identified by petitioners is ``insufficient to justify the factual
determination urged'' (40 CFR 178.32(b)(2)). The critical issue with
regard to EPA's children's safety factor decision is whether EPA has
reliable data to ensure that residues of carbofuran in food will not
cause adverse effects on infants and children's PNS. Petitioners claim
that carbofuran data on brain AChE in juveniles is such reliable data.
However, the evidence they proffer to support such an assertion is
facially insufficient. Primarily, Petitioners cite data involving
comparisons of brain AChE and PNS effects in adult animals. But
evidence from adult animals is beside the point; the question is
whether brain AChE in juveniles is protective of the PNS in juveniles.
For at least 25 years, EPA has required toxicity tests be performed
with pre- and post-natal animals as well as adult animals because young
animals can be more sensitive and affected in a different manner than
adults. Further, the only studies Petitioners cite that compared brain
AChE in juveniles with PNS effects in juveniles, were conducted using
other pesticides. For good reason, EPA requires that pesticides be
individually tested in toxicity studies. Moreover, the majority of the
data cited by Petitioners in other chemicals actually fails to
demonstrate that the brain is more sensitive than the PNS, and the
remainder of the evidence is, at best, merely equivocal on this point.
    To reiterate, if EPA chooses to select a children's safety factor
different than 10X, it bears the statutory burden of showing that
reliable data support its determination that the selected factor is
safe for infants and children. Thus, Petitioners, in seeking to
establish that EPA erred by not selecting an even lower children's
safety factor for carbofuran (in fact, no such factor at all),
similarly bear the burden of showing that there are reliable data for
the proposition that juvenile brain AChE data for carbofuran are
protective of PNS effects in children. Petitioners' equivocal and
largely irrelevant proffer cannot meet that standard, particularly
where EPA is lacking data it has traditionally-required on
cholinesterase-inhibiting pesticides to protect against PNS effects,
and the data EPA does have on measures of PNS effects indicate that
effects on the juvenile PNS occur at lower doses than effects on brain
AChE.
    (ii) Subissue: Are RBC AChE measures adequately reliable evidence
of CNS effects? As a corollary to their claim that brain AChE measures
are adequately protective of PNS effects, Petitioners also argue that
RBC is not an appropriate surrogate for CNS effects in most
circumstances. A hearing is not warranted on this subissue because
Petitioners' evidentiary proffers either concern matters of undisputed
fact (e.g., RBC AChE inhibition is not an adverse effect, RBC AChE can
be variable at low doses) or inadequate and irrelevant data on other
pesticides. Further, Petitioners' claim basically reduces to an
argument over which is the ``preferred'' surrogate for PNS effects in
the absence of data directly measuring such effects. Thus, this
subissue is an argument about science policy and EPA's regulations are
clear that hearings will not be held on policy matters. Even more
problematic to Petitioners' hearing request on this subissue is its
lack of materiality. Having failed in the previous subissue to proffer
sufficient evidence to show carbofuran brain AChE data in juveniles is
protective of carbofuran's effect on the PNS in juveniles, Petitioners'
attempt to attack EPA's basis for addressing carbofuran's effects on
the PNS in juveniles can only undercut Petitioners' ability to
demonstrate the safety of the carbofuran tolerances. With the demise of
Petitioners' brain AChE argument, EPA's analysis of the RBC AChE data
is the only remaining basis for reducing the children's safety factor.
If Petitioners are successful in showing that RBC AChE data are not a
reliable measure of PNS effects in juveniles, EPA would have no
reliable data on such impacts and would be required to retain the full
children's safety factor. As such, Petitioners' claim is immaterial;
even if the claim were upheld, it would not justify the ultimate relief
sought by Petitioners.
    As to Petitioners' objection to EPA's science policy decision to
use RBC cholinesterase as a surrogate for PNS effects, EPA explains in
detail in Unit VI.E, the biological basis for its policy decision, the
multitude of data supporting its approach, and the frequent
consultations with the SAP concerning the wisdom of using such an
approach. The equivocal data submitted by Petitioners does not raise a
serious question regarding EPA's policy. In any event, as noted with
regard to the hearing request, this subissue lacks materiality in that
success on this subissue by Petitioners would retard rather than
advance their challenge to EPA's action.
    (iii) Subissue: Is ``lip-smacking'' a CNS or PNS effect?
Petitioners object that EPA's evidence of ``lip smacking'' in a
carbofuran adult developmental rat study does not support concern for
potential PNS effects because lip smacking is more properly correlated
to CNS, rather than PNS inhibition. A hearing is denied on this issue
because Petitioners did not raise this issue in its comments on the
proposed tolerance revocation. A hearing on this issue is also
inappropriate because the issue is immaterial. EPA's decision that a 4X
children's safety factor is appropriate did not rest exclusively--or
even significantly--on the effects observed in this developmental
study. Rather, EPA retained the children's safety factor based on the
lack of data in the PNS and/or a surrogate at the low end of the
response curve, and the fact that the available pup RBC data at higher
doses affirmatively indicate that the PNS appears to be significantly
more sensitive than the CNS.
    Petitioners' objection on this subissue is denied because both
parties agree that muscle fasiculations, which are the movements EPA
described at the SAP meeting and in the proposed and final rules, are
PNS-mediated effects. Further, it is unclear that the effects described
in the studies Petitioners submitted are actually the same effects seen
in the carbofuran study; other factors in the studies suggest that the
movements being studied are not purely cholinergic, which calls into
question whether the effects are the same. For the same reason, this
calls into question the contention that the effects are exclusively
CNS-related. Finally, the cited studies fail to support Petitioners'
remaining contentions. Since it is unclear that the studies actually
describe the same effects, and Petitioners have failed to demonstrate
that the effects are exclusively CNS-related, the evidence does not,
therefore, rebut EPA's conclusions regarding the movements described in
the carbofuran study.
    (iv) Subissue: Did EPA err by relying on studies not conducted
pursuant to EPA's GLP regulations? Petitioners claim that EPA's
reliance on the ORD data is problematic because the data were not
conducted in accordance with EPA's GLP regulations at 40 CFR part 160.
Petitioners have not cited any evidence suggesting there is a
substantive problem with the ORD data or made any arguments to such
effect. Thus, this subissue presents only a legal question and legal
questions are not appropriate grounds for a hearing. EPA denies
Petitioners' objection on this point because EPA regulations make clear
its GLP regulations only apply to studies in support of a pesticide
registration or tolerance (40 CFR 160.1(a), 160.3). In any event, non-
compliance with the GLP regulations does not automatically disqualify a
study from EPA consideration but rather goes to reliability (40 CFR
160.17(a)).

(As noted, Petitioners have made no claim that the ORD data is not
reliable.).
    (v) Subissue: Was EPA's selection of a 4X children's safety factor
consistent with EPA's approach to other carbamate pesticides?
Petitioners object that EPA was inconsistent in retaining a 4X
children's safety factor for carbofuran given that EPA removed the
children's safety factor for other carbamates. A hearing is not
appropriate on this subissue because it presents a purely legal
question. There is no dispute regarding the facts of EPA's decision in
each case, the only question is whether EPA acted appropriately on
carbofuran given its decision on the children's safety factor for other
carbamate pesticides, such as carbaryl. The objection is denied because
EPA's decisions in each case were consistent; EPA applied a different
children's safety factor to carbofuran than to the other carbamate
pesticides based on the different facts in each case. For example, the
data showed that carbaryl differed significantly from carbofuran in
terms of each chemical's relative sensitivity in juveniles with regard
to brain and RBC AChE inhibition. For carbofuran, EPA concluded that
RBC AChE inhibition in juveniles was more sensitive than brain AChE
inhibition in juveniles by a factor of 4X. For carbaryl, the AChE
inhibition in brain and RBC of juveniles was essentially equal.
    (vi) Subissue: Did EPA err in not using within-animal brain to RBC
AChE inhibition comparisons to derive the children's safety factor? EPA
derived an alternate to the default 10X children's safety factor based
on the ratio of RBC and brain AChE inhibition. In their comments on the
proposed rule, Petitioners criticized this approach, arguing that EPA
should have compared the RBC and brain AChE inhibition levels at the
same time in the same rat when these rats are exposed to carbofuran.
Petitioners claimed to have done such an analysis and that the analysis
showed that within rat inhibition levels in brain and RBC AChE were
roughly equivalent. Although the results of the statistical analyses
were summarized in the comments, the underlying analysis was not
submitted. In the final tolerance revocation regulation, EPA
extensively reviewed the ``within animal'' approach and rejected it as
fundamentally flawed in several regards. Additionally, EPA noted that
EPA's review of the Petitioners' suggested approach showed that it
produced results, which are in fact consistent with EPA's conclusions.
In their objections, Petitioners do not respond to EPA's rejection of
the within animal approach in the final tolerance revocation rule
either by explaining their disagreement with EPA's critique or
proffering evidence to counter EPA's conclusion. Rather, Petitioners
simply resubmitted essentially the same comments they provided on the
proposed rule. Petitioners also again failed to submit the underlying
analysis supporting their within animal calculations.
    A hearing on this subissue is not appropriate for two reasons.
First, Petitioners' repeated failure to submit the analysis supporting
their claim reduces this objection to a mere allegation. Under EPA's
regulations, hearings will not be granted on the basis of mere
allegations. More importantly, Petitioners' objection on this subissue
is irrelevant, and therefore immaterial, with regard to EPA's final
tolerance revocation regulation because Petitioners ignored EPA's
extensive analysis of this subissue in the final rule and refiled their
comments on the proposal as if EPA's determination in the final rule
did not exist. The statute, however, requires that objections be filed
on the final rule, not on the proposal. By ignoring the EPA's final
rule on this subissue, Petitioners have failed to lodge a relevant
objection. Both EPA and FDA precedent make clear that when the agency
substantively responds to comments on the proposal, the commenter may
only keep that issue alive in its objections by addressing the agency's
substantive response. In other words, the final rule is the focal point
for determining whether issues remain that must be resolved by the
objection and hearing process. Any other approach relegates the notice-
and-comment rulemaking stage of the revocation process to a meaningless
exercise.
    Petitioners' objections on this subissue are denied as irrelevant
to the conclusions reached in the final rule. The final rule explains
why Petitioners' arguments are without a basis, and Petitioners have
failed to address that explanation. For essentially the same reasons,
EPA denies the objection.
    For essentially the same reasons, EPA denies the hearing request
and objection designated above as Objection/hearing request sub issue:
Technical Flaws in EPA's statistical comparisons. Petitioners'
objection and hearing request on this subissue consist of mere
reiteration of the comments submitted in response to the proposed
tolerance revocation. The final rule explained the reasons that
Petitioners' arguments are flawed, and the objections are denied for
the same reasons.
    (vii) Subissue: Is EPA's approach to comparing brain and RBC AChE
inhibition in juveniles due to carbofuran exposure scientifically
valid? Petitioners allege that EPA's approach to calculating the
relative sensitivity between AChE inhibition in brain and RBC in
juveniles is not scientifically valid. EPA derived the ratio of RBC and
brain AChE inhibition using the data on administered dose (measured in
terms of BMD50) for PND11 animals. In addition, the
Petitioners criticize EPA for incorrectly assuming that the
relationship of the dose response curve between BMD50s and
BMD10s is linear, which they claim overstates the potential
differences. In support of the claim that EPA's approach overstates the
differences, Petitioners argue that data suggests that
BMD50s for brain and RBC AChE inhibition for the carbamates
tend to diverge more than the dose levels that cause the low levels of
AChE inhibition used to select the PoD (i.e., the BMD10s),
which demonstrates that at levels causing lower levels of inhibition,
no safety factor is necessary. Petitioners' argument is that the 4X
ratio EPA calculated based on the BMD50 is unnecessarily
protective, because the difference between brain and RBC at the doses
causing lower levels of inhibition (i.e., 10%), which are the levels at
which EPA is regulating, would not be significant.
    Petitioners' hearing request on this subissue is denied for two
reasons. First, Petitioners proffered no evidence on any carbamate,
much less carbofuran, in support of their claim that BMD50s
for the carbamates tend to diverge more than the BMD10s or
that the response curve between BMD50s and BMD10s
is not linear. A hearing will not be granted on the basis of mere
allegations. Second, Petitioners' claims are immaterial because unless
Petitioners can show what the relationship is between the response
curves for BMD50s and BMD10s (an assertion they
have not even made), a showing that EPA's assumption of linearity is
incorrect can only force EPA to abandon the 4X children's safety factor
in favor of the default 10X value.
    The objection that EPA's modeling is scientifically invalid is
denied. EPA's modeling has been repeatedly reviewed and approved by the
SAP, including most recently with respect to the modeling of
carbofuran's dose-response curves. There is no indication in the
modeling that EPA's assumption of parallel dose-response curves
overstates the difference, and given the absence of data supplied by
Petitioners in support of this objection, the objection is denied.
    (viii) Subissue: Did EPA err by combining data from different
toxicological studies in calculating the estimates of BMD50s
that serves as

quantitative support for derivation of the 4X childrens' safety factor?
In its risk assessment, EPA relied on all of the valid data from the
available studies to calculate the estimates that served as the PoD,
and to calculate BMD50s used in choosing the children's
safety factor. In their comments on the proposed rule, Petitioners
claimed that EPA's decision to combine data for different strains of
rats, sexes, experiments, laboratories, dates, dose preparations, rat
ages, and times between dosing and AChE measurement, is problematic,
claiming that these differences in study design severely limit the
validity of EPA's comparisons and caused EPA to overestimate the
difference between brain and RBC AChE inhibition. EPA responded to
these comments in full during the rulemaking (74 FR 23052-23053; Ref.
85). Petitioners referenced their earlier comments in their objections,
but presented no further evidence on any of these points. Nor in their
objections and request for hearing did Petitioners address EPA's
explanation set forth in the final rule.
    A hearing is not appropriate on this subissue because Petitioners
have not challenged the basis EPA asserted in the final rule for
rejecting their concerns nor have they proffered any evidence that
calls the substance of EPA's conclusions into question. A hearing is
not warranted on the basis of mere denials or contentions, nor when the
commenter simply reiterates comments raised in response to the proposed
rule (40 CFR 178.32(b)(1) and (2)). Additionally, this hearing request
is rejected for lack of materiality. If EPA abandoned its sophisticated
analysis of multiple studies and datasets and simply followed the
general approach laid out in its BMD policy, EPA would have chosen a
significantly lower BMD dramatically raising EPA's risk estimates.
    Petitioners' objection on this subissue is denied because
Petitioners have not responded to the explanation EPA provided in the
final rule supporting its meta-analysis of multiple studies. Consistent
with Agency guidance, EPA believes that consideration of all available
data is the scientifically more defensible approach, rather than the
selective exclusion of reliable data. Petitioners' objection on this
point is particularly weak given that their analysis also combines
various data sets and only arrives at a higher estimate of the BMD by
selectively excluding, without explanation, the data most pertinent to
assessing carbofuran's acute affects.
    b. Drinking Water Exposure Objection--In large part, Petitioners'
objections to EPA's assessment of carbofuran levels in drinking water
are inextricably intertwined with their recently-proposed registration
amendments which attempt to create a scheme whereby carbofuran use
would be limited in individual watersheds. As explained above (see Unit
VI.F.2.a), objections based on these recently-proposed registration
amendments are irrelevant to EPA's determination in the final tolerance
revocation rule. Nonetheless, in Unit VI.F, EPA exhaustively evaluated
all of the arguments put forward in Petitioners' drinking water
objection and explained why a hearing was not appropriate on any of
these arguments and why, on the merits, the arguments were without
basis. Below EPA has summarized its reasoning.
    The first four subissues below pertain to EPA's assessment of the
carbofuran groundwater exposure assessment and the last eight address
the surface water assessment. In this regard, it is important to note
that, in order to determine that a tolerance for a particular use will
be safe, EPA must be able to determine that anticipated concentrations
in both surface water and ground water resulting from that use will be
safe.
    (i) Subissue: Did EPA err in relying on the results of the
prospective ground water study (PGW) and historical monitoring to
validate groundwater exposure estimate? The Petitioners object that EPA
should not have relied for validation on their PGW study or historical
monitoring data. They argue that these data no longer reflect current
use patterns and that all areas like those seen in the PGW have now
been removed from the carbofuran label.
    A hearing is not appropriate on this subissue because the
Petitioners have failed to proffer evidence, which would, if
established, resolve a material issue in their favor. First,
Petitioners fail to take into account the clear record evidence that
EPA scaled the PGW modeling to reflect the lower current use rates.
Second, Petitioners are simply incorrect to claim that EPA
``validated'' its quantitative groundwater assessment based on historic
monitoring data that are not reflective of current application rates.
The targeted monitoring data used for validation were based on
application rates that are identical or lower than the current use
rates. Third, the majority of Petitioners' evidence is untimely, and to
the extent Petitioners' are claiming that the PGW and other targeted
monitoring data are not reflective of FMC's June 29, 2009 proposed
registration amendments, that claim is irrelevant to the current
proceeding. Finally, Petitioners' evidentiary proffer on the PGW is
internally contradictory given that Petitioners' own experts relied on
the PGW to validate the modeling submitted in support of this
objection.
    The objection on this subissue is denied because timely evidence
and reasoning submitted by Petitioners is contradictory, non-probative,
or flatly contradicted by the record.
    (ii) Subissue: Does EPA's assessment of carbofuran levels in ground
water account for all of FMC's label mitigation measures and ``rely on
unrealistic and overly conservative assumptions about potential
concentrations''? In this objection, the Petitioners allege that
maximum concentrations of carbofuran in groundwater are expected to be
below 1.1 ppb, based on their proposed geographic restrictions and well
setbacks. EPA believes Petitioners' objection and hearing request on
this subissue is inextricably intertwined with FMC's recently-submitted
FIFRA registration amendments and thus the objection is denied as
irrelevant on that account.
    Nonetheless, to the extent possible EPA has attempted to evaluate
this objection based on the label mitigation measures submitted and
adopted prior to issuance of the final tolerance revocation rule and
ruled on it on that basis. EPA denies the objection and its associated
hearing request because Petitioners have again failed to object to
EPA's final rule. It is clear from the record that EPA's final rule and
risk assessment did account for all of the risk mitigation measures
submitted as part of the September 2008 comments. Petitioners have not
raised any substantive challenge to the manner in which EPA's modeling
addressed those measures. In addition, Petitioners' objections provide
no further clarification as to what is meant by their claim that EPA's
assessment relied on ``unrealistic and overly conservative
assumptions.'' Therefore, this objection, and the attendant hearing
request, is denied based on Petitioners' failure to state with
``particularity * * * the basis for the objection * * *.''(40 CFR
178.25(a)(2)). As Petitioners raised similar allegations in their
comments, EPA has assumed that they intended to incorporate all of the
issues raised in the comments on the proposed rule. However, EPA
addressed these assertions in the final rule. Because Petitioners have
once again ignored the explanations provided in the final rule, this
objection and hearing request are denied as immaterial.
    (iii) Subissue: Is EPA's assessment of the levels of carbofuran in
groundwater appropriate given the manner in which

EPA assessed groundwater exposures in the NMC CRA? Petitioners object
that EPA's estimates in the final rule are inconsistent with the
groundwater concentration estimates EPA developed for the NMC CRA.
However, they do not identify any specific inconsistency, they simply
make the general allegation. They allege that, by contrast, their
assessment, which estimated maximum concentrations of 1.1 ppb, is
consistent with the NMC CRA.
    EPA denies the request for a hearing on this sub-issue because
there is no disputed factual matter for resolution (i.e., the manner in
which EPA assessed groundwater exposure for carbofuran and for the NMCs
is a matter of record); rather, the objection poses the legal question
of whether it was appropriate for EPA to assess groundwater exposure
for carbofuran and the NMCs in a different manner. Further, because
Petitioners have not identified any specific inconsistency between the
two groundwater exposure assessments, it constitutes nothing more than
a mere allegation or denial. As EPA's regulations make clear, a mere
``denial'' of an EPA position is not sufficient to satisfy the standard
for granting a hearing (40 CFR 178.32(b)(2)). Finally, the claim that
their modeling is consistent with the NMC CRA does not justify a
hearing on this question. As EPA explained in the final rule, the
values estimated in the modeling conducted for the NMC CRA are greater
than the 1.1 ppb level that FMC claims is the maximum expected 1-in-10-
year peak concentration. A hearing is not warranted where the claim is
clearly contradicted by the record (40 CFR 178.32(b)(2)).
    On the merits, Petitioners' objection is denied because the results
of Petitioners' groundwater assessment are not consistent with the
estimates developed for the NMC CRA. The NMC CRA examined carbofuran at
two sites, northeast Florida and the Delmarva Peninsula. In Florida,
concentrations were found to be below levels of concern because of high
pH, but in Delmarva, both in corn and in melon scenarios EPA estimated
that 90% of daily concentrations could be as high as 20.5 and 25.6 ppb,
respectively. These values are far greater than the 1.1 ppb that
Petitioners claim is the maximum expected 1-in-10-year peak
concentration.
    (iv) Did EPA err in not using PCT data in assessing surface water
exposure? The Petitioners object to the assumption in the surface water
assessments in the final rule that 100% of the crops in a watershed
will be treated with carbofuran. The Petitioners argue that actual
carbofuran sales data on a county basis from 2002-present demonstrate
that the current carbofuran PCT is less than 4.25%. Using this PCT, and
taking into account the recently submitted ``no application buffers,''
the Petitioners allege that the modeling in Exhibit 15 demonstrates
that carbofuran concentrations in surface water will not exceed 1.1
ppb, ``which is below the level of concern.'' In support of this
objection, the Petitioners reference county level sales data that were
submitted to the Agency after the close of the comment period. They
also reference the use tracking system proposed in their recent
registration amendments (Exhibit 2) and the modeling contained in
Exhibit 15. Because this subissue is inextricably intertwined with
Petitioners' recently-proposed FIFRA registration amendments, it is
denied as irrelevant.
    To the extent Petitioners' objection on this subissue is limited to
EPA's refusal to use a 4% PCT in estimating drinking water
concentrations in individual watersheds based on the information
provided as part of their comments on the proposed rule, this objection
and hearing request are also denied as immaterial. The Petitioners have
failed to respond to EPA's explanation in the final rule that the
information and methodology on which they relied to estimate a 4% PCT
was fundamentally flawed, and to submit any evidence calling the basis
of EPA's response into question (40 CFR 178.32(b)(3)). Additionally,
the proffered evidence here is untimely. The sales data and methodology
used to generate use estimates, as well as the modeling in Exhibit 15,
were not submitted during the comment period on the proposed rule even
though the information was clearly available to Petitioners (40 CFR
178.32(b)(2)).
    Petitioners' objection on this subissue is denied because the
proffered evidence is untimely and, even if considered, insufficient.
Although EPA does use reliable data on pesticide usage in estimating
exposure levels in food, this approach has limited applicability in
drinking water assessments due to the differences in the sources of
food and water for consumers. The food market in the United States is
national in scope but the sources of drinking water are primarily
local. Thus, while differences in the usage of pesticides across the
country will average out in estimating pesticide exposure from food,
such averaging is not applicable to estimating pesticide exposure in
drinking water--i.e., a person's drinking water exposure is generally
always from the same watershed. Moreover, the information that
Petitioners submitted on PCT was not usage data--the type of
information normally used in estimating PCT for food--but sales data.
The link between sales data and the location of use is tenuous. Given
that EPA lacks the information to allow EPA to generally use PCT
information in estimating drinking water exposure, and the poor quality
of information Petitioners submitted on usage (i.e. county-level sales
data), EPA concludes it could not make an exposure estimate on
carbofuran in drinking water with sufficient confidence to meet the
FFDCA's reasonable certainty of no harm standard.
    (v) Subissue: Do the results of FMC surface water modeling
establish that carbofuran levels will not exceed 1.1 ppb? The
Petitioners claim that the prior surface water assessments submitted to
the Agency and a new assessment incorporating FMC's newly-proposed
FIFRA registration amendments demonstrate that carbofuran
concentrations in surface water are not expected to exceed 1.1 ppb.
Because this subissue is inextricably intertwined with Petitioners'
recently-proposed FIFRA registration amendments, it is denied as
irrelevant. Nonetheless, EPA has carefully evaluated all of
Petitioners' allegation to determine if any of their claims meet the
standard for a hearing or are otherwise meritorious.
    A hearing is also denied on this sub-issue because Petitioners'
objection on this subissue is irrelevant, and therefore immaterial,
with regard to EPA's final tolerance revocation regulation. Petitioners
have not responded to EPA's extensive analysis of these studies, which
included an explanation for the Agency's conclusion that they were
significantly flawed, presented in the final rule. The statute,
however, requires that objections be filed on the final rule not the
proposal. By ignoring EPA's final rule on this subissue, Petitioners
have failed to lodge a relevant objection. Both EPA and FDA precedent
make clear that when the agency substantively responds to comments on
the proposal, the commenter may only keep that issue alive in its
objections by addressing the agency's substantive response (40 CFR
178.32(b)(3)). Similarly, the Petitioners' new assessment directly
relies on FMC's newly-proposed FIFRA registration amendments and is
thus irrelevant to this proceeding. Their new assessment is also
untimely in that it primarily appears to be a fuller description of
Petitioners' National CWS Assessment, which was described, but not
provided as part of their comments on the proposed rule (40 CFR
178.32(b)(2)).

    EPA has outlined the substantial flaws in the previously-submitted
assessments in the final tolerance revocation rule and in Unit VI.F,
above. For the all the reasons cited therein, this objection is denied.
    (vi) Did EPA inappropriately rely on NAWQA monitoring data in
assessing carbofuran levels in surface water? The Petitioners object to
EPA's discussion in the final rule of the high concentrations detected
in Zollner Creek in Oregon and claim that EPA inappropriately relied on
NAWQA monitoring data in estimating surface water exposure levels of
carbofuran. A hearing on this issue is denied because there are no
material factual issues in dispute. The extent to which EPA discussed
the Zollner Creek data as part of its discussion of monitoring results
from all other NAWQA sites, SDWA post-treatment monitoring, and the
results of field studies is clear on the record. The record is also
clear regarding the degree of reliance EPA placed on monitoring data in
estimating carbofuran levels in surface water. The objection on this
subissue is denied because it was reasonable for EPA to consider NAWQA
data in assessing the likelihood that carbofuran residues may be
present in surface water. Moreover, the record is clear that, even
though EPA considered the NAWQA data, it placed primary emphasis on the
carbofuran levels detected in post-treatment SDWA monitoring.
    (vii) Should EPA consider FMC's newly-proposed terms of
registration for carbofuran? The objection is denied because it is
based on FMC's newly proposed revisions to its carbofuran registration
that were submitted after publication of the final tolerance revocation
rule and is thus irrelevant to this proceeding. An additional ground
for denial of this objection and hearing request is that Petitioners
proferred no evidence to support their allegation that these proposed
requirements would be effective in limiting carbofuran exposure to the
extent claimed
    (viii) Should EPA have used the NMC CRA surface water estimates in
assessing exposure to carbofuran in surface water? Petitioners object
to EPA's surface water exposure estimates on the ground that they are
inconsistent with the estimates EPA developed for purposes of the NMC
CRA. This hearing request is denied because there are no factual
matters in dispute; rather, the only question is a legal one of whether
it was inappropriate for EPA to use different approaches to assessing
surface water exposure for the carbofuran surface water assessment and
the cumulative assessment of surface water exposure for NMCs (40 CFR
178.32(b)(1)). In addition, this issue was raised in Petitioners'
comments on the proposed revocation. In the final revocation, EPA
explained how the substantial differences between a cumulative risk
assessment for a class of pesticides and a risk assessment for a single
pesticide necessitate different approaches. Petitioners have not
challenged the substance of EPA's response to their comments or
submitted evidence that calls the substance of EPA's final rule
conclusions into question, and the objection and associated hearing
request is therefore immaterial (40 CFR 178.32(b)(3)). Finally, on
multiple grounds, Petitioners' evidentiary proffer is insufficient to
support a conclusion that there is a reasonable possibility that the
issue could be resolved in their favor. Petitioners' objection on this
subissue is denied for essentially the same reasons explained in the
final tolerance revocation.
    (ix) Has EPA taken natural surface water pH conditions into
account? The Petitioners contend that the PCT levels guaranteed by the
recently proposed use tracking system, along with natural surface water
pH conditions in the areas included under the revised label will ensure
that potential exposures are de minimis. Because this objection is
inextricably intertwined with FMC's newly-proposed FIFRA registration
amendments, it is denied as irrelevant to this proceeding.
    Even assuming Petitioners' allegation concerning soil pH can be
separated from the proposed registration amendments, Petitioners'
claims are insufficient to justify the action urged (40 CFR
178.32(b)(3)). Petitioners admit that their pH analyses explicitly only
capture 95% of surface waters. Because EPA cannot ignore the other 5%
of surface water, this information, even if established, would provide
an insufficient basis on which EPA could reasonably conclude that the
drinking water exposures would be ``safe.'' Additionally, the proffered
evidence for this objection is untimely because although the effects of
pH were clearly discussed in the proposed rule, Petitioners' claim and
the analyses supporting it were not submitted during the comment
period.
    For the same reasons, the Petitioners' objection is denied.
    (x) Has EPA taken the effect of existing drinking water treatment
systems into account? The Petitioners contend that, in the areas where
carbofuran use is allowed under revised labels, the majority of the
total population is protected from carbofuran by water treatment
systems and that the rest of the population is protected by
Petitioners' newly-proposed FIFRA registration amendments. Because this
objection is inextricably intertwined with FMC's newly-proposed FIFRA
registration amendments, it is denied as irrelevant to this proceeding.
    Separating out the allegations that are independent from the new
registration amendments, EPA denies this hearing request on the grounds
that Petitioners' claims are insufficient to justify the action urged
(40 CFR 178.32(b)(3)) in that they would fail to justify a conclusion
that the carbofuran tolerances are safe. The fact that the majority of
people are protected is irrelevant if major identifiable subpopulations
are not. Further, both the objection and the proffered evidence are
untimely because Petitioners' claims and analyses supporting them were
not submitted during the comment period. For the same reasons, this
objection is denied.
    c. Recovery Time Objection--(i) Subissue: Has EPA overstated risk
through its approach to considering recovery time to the effects of
carbofuran? For carbofuran, EPA estimated acute dietary exposure for
the acute risk assessment by summing exposure over a 24-hour period.
Because humans are likely to recover in a relatively short time period
from any single carbofuran exposure, EPA also undertook a more
sophisticated exposure assessment that took recovery time into effect.
This more sophisticated analysis was not substituted for the 24-hour
assessment approach but rather was used to evaluate whether the 24-hour
approach substantially overstated risk. The reason for not simply
adopting the assessment incorporating recovery time was based on
concerns that other aspects of its exposure model tend to understate
exposure. If the assessment using recovery time had suggested that
carbofuran risks may be acceptable, EPA would have further examined how
exposure should be assessed. However, because both the assessment based
on 24-hour exposure and the one incorporating recovery time showed
carbofuran exposures significantly exceed the safe level, EPA concluded
that its exposure assessment was reasonable. Further supporting this
conclusion was the fact that various other analyses showed that a
single eating occasion could result in excessive risk to infants.
Petitioners have objected to this approach claiming that recovery time
should be included in EPA's ``primary'' risk assessment.
    EPA is denying this hearing request on two grounds. First, the
objection fails

to present a disputed issue of material fact because EPA did
incorporate recovery time into its analysis. Rather, Petitioners' only
challenge is to whether EPA should have only presented risk estimates
that accounted for recovery. This is a policy issue, and hearings are
not appropriate on such (40 CFR 178.32(b)(1)).
    Second, the fact that EPA relied on 24-hour aggregate exposures in
addition to analyses that accounted for recovery is not material,
because even though accounting for recovery resulted in a 2-3X
reduction in exposure estimates, many of EPA's estimates for aggregate
exposures ranged between 2700% aPAD and 9400% aPAD for infants.
Accounting for recovery does not, therefore, demonstrate that aggregate
exposures will be safe for infants. Of greater significance in this
regard is EPA's finding that infants are at risk from a single
exposure. Recovery is only relevant, by definition, where the risk is
derived from multiple exposures over time.
    Petitioners' objection to EPA's policy decision to present acute
risks in terms of 24 hours of exposure is denied because EPA's policy
approach here is reasonable. For the reasons explained in Unit VI.G,
there are several factors that may cause EPA's exposure/risk model to
either understate or overstate exposure/risk. It is unreasonable to
present risks only incorporating factors that tend to reduce exposure/
risk estimates (e.g., recovery time), as Petitioners suggest. EPA's
approach of evaluating the impact that these factors may have on the
risk assessment is an appropriate method of taking all relevant factors
into account.
    (ii) Subissue: Did EPA err in calculating carbofuran half-lives? In
the proposed rule, EPA used half-lives of 150 minutes and 300 minutes,
based on calculations derived for the NMC CRA. In the final rule, EPA
calculated half-lives specific to carbofuran to ensure that its
analyses accurately reflected carbofuran's risk. Petitioners contend
that EPA's calculation of carbofuran half-lives of 186 minutes and 426
minutes were flawed, and that the data instead support the use of a
150-minute half-life.
    Petitioners' hearing requests on this subissue are denied for two
reasons. First, Petitioners have not provided the underlying analyses
conducted in support of their claims that the appropriate half-life for
carbofuran is 150 minutes, rather than the 186 or 426 minutes that EPA
calculated. Petitioners' evidentiary proffer thus consists of no more
than mere allegations and denials. Hearings will not be granted on this
basis (40 CFR 178.32(b)(2)).
    Further, the issue of the appropriate half-lives for carbofuran is
not material. Petitioners have proffered no evidence to show that
reliance on a 150-minute half-life rather than a 186-minute half-life
would make a significant difference to their estimates. By contrast, in
the risk assessment supporting the final rule, EPA's estimates show
that the use of a 150-minute or 186-minute half-life makes little or no
difference. In addition, EPA's final risk assessment found that infants
are at risk from a single exposure. Recovery is only relevant, by
definition, where the risk is derived from multiple exposures over
time.
    EPA denies Petitioners' objection on this subissue because the
evidence submitted fails to establish their allegations, or to rebut
the data and analyses discussed in the final rule.
    d. Human Study Objection--Issue: Did EPA reasonably conclude that a
human toxicity study with carbofuran was barred from EPA consideration
by the Human Research Rule? In conducting its dietary risk assessment
for carbofuran, EPA relied on toxicity data conducted with rats, and
applied the default 10X interspecies factor to account for the
potential uncertainty in extrapolating from animal data to humans.
Petitioners object to the decision to use a 10X interspecies factor
claiming that data from a human toxicity study (Arnold) provides a
basis for reducing this factor to 3X. However, EPA has previously
determined that the Arnold study lacks scientific validity and thus may
not be considered by the Agency under EPA's Human Research rule. That
decision was based on the advice of the HSRB, which found the Arnold
study to constitute ``poor science'' (Ref. 38 at 11).
    Although Petitioners have made a number of arguments in support of
adopting a 3X interspecies factor, all of the arguments rely on
consideration of the Arnold study. Thus, as a preliminary matter,
Petitioners must show that a hearing is appropriate based exclusively
on whether EPA erred in determining that the Arnold study cannot be
considered under the Human Research rule or, that even if a hearing is
not warranted, that EPA's decision under the Human Research rule was
incorrect.
    Petitioners have proffered no evidence that merits a hearing on
EPA's application of the Human Research rule to the Arnold study. As an
evidentiary proffer, Petitioners claim (1) that review of the Arnold
study under the Human Research rule was too narrow in that it did not
consider the Arnold study in light of the animal data; (2) that
insufficient weight was given prior independent reports on the value of
the Arnold study; (3) that the ``technical'' concerns raised by the
HSRB are addressed by ``the data within the study'' and that these
``technical'' deficiencies do not render the Arnold study unreliable.
The first proffer is not material because the availability of animal
data does not address the validity of the Arnold human study. At
bottom, this issue involves a challenge to the policy underlying the
Human Research rule that allows only limited consideration of human
toxicity studies. A hearing is not appropriate on such a policy issue,
nor on the Human Research rule itself. Petitioners' second proffer is a
legal/policy question regarding the weight to be accorded to existing
peer review reports. No hearing is required on such issues. To the
extent the third proffer even constitutes a proffer of ``evidence,'' it
fails because it is nothing more than a mere allegation. Petitioners
have supplied no information as to how the HSRB's ``technical''
concerns are resolved by the study itself.
    Viewed on their merits, these claims do not convince EPA that it
erred in determining that the Arnold study did not meet the Human
Research rule because it lacked scientific validity. EPA concluded,
based on the advice of the HSRB, that, because the Arnold study had an
extremely small sample size (2 persons per dose) and highly variable
measurement of RBC and plasma AChE, it had no scientific value. The
claim by Petitioners that somehow the Arnold study could be
rehabilitated by considering it in the context of carbofuran animal
data misunderstands the issue. The question under the Human Research
rule is whether the human study at issue is scientifically valid. Here,
EPA found the Arnold study to be flawed at its core. Animal data on
carbofuran are simply irrelevant to the problems with sample size and
AChE measurement in the Arnold study. As to the earlier reports on the
Arnold study, Petitioners have provided no reason as to why these
should outweigh the HSRB's conclusion concerning whether the Arnold
study met the Human Research rule standard. The earlier reports were
completed well before the Human Research rule was promulgated and thus
could not have addressed the rule's requirements. Further, the earlier
reports identified the same defects, but concluded that the Arnold's
study's flaws could be addressed by the use of additional safety

factors--an option not available under the Human Research rule. In such
circumstances, it was reasonable for EPA to give primary weight to the
HSRB findings. Petitioners' claim that the HSRB only identified
``technical'' problems with the Arnold study and that the study itself
addresses the HSRB's concerns is without basis. The flaws in the Arnold
study are not technical but fundamental, and cannot be explained away.
Finally, Petitioners' allegations that EPA hampered the HSRB's
consideration of the prior peer review reports and that EPA's recusal
decision was somehow improper are contradicted by the record.
Accordingly, the objection is denied.
    e. Import Tolerance Objection--Issue: Did EPA err by failing to
retain the carbofuran tolerances that apply solely to imported food.
Whether EPA had some type of independent duty to retain carbofuran
tolerances for the imported foods bananas, rice, coffee, and sugarcane
despite its finding that aggregate exposure to carbofuran is unsafe, is
a legal question. Hearings are not held on legal issues. Having found
that aggregate exposure to carbofuran is unsafe, EPA was clearly
warranted, if not required, to revoke all tolerances. For the policy
reasons identified above, (see Unit VI.I), when aggregate risk to a
pesticide is unsafe, EPA defers to interested parties to decide in the
first instance what tolerances, if any, they wish to retain. Although
explicitly invited to do so, no person submitted a comment on the
proposed revocation that identified the import tolerances as a subset
of tolerances that were asserted to be safe, and that the commenter
wished to retain. Accordingly, this objection is denied.

K. Conclusion

    For all of the reasons set forth above, EPA denies the Petitioners'
objections and their requests for a hearing on those objections.

VII. 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.

VIII. 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).

IX. References

    EPA has established an official record for this rulemaking. The
official record includes all information considered by EPA in
developing this proposed rule including documents specifically
referenced in this action and listed below, any public comments
received during an applicable comment period, and any other information
related to this action, including any information claimed as CBI. This
official record includes all information physically located in docket
ID number EPA-HQ-OPP-2005-0162, as well as any documents that are
referenced in the documents listed below or in the docket. The public
version of the official record does not include any information claimed
as CBI.
    Objections to the Final Order Revoking Tolerances for Carbofuran,
and Request for Public Evidentiary Hearing, submitted by National
Potato Council, National Corn Growers Association, National Cotton
Council, National Sunflower Association, and FMC Corporation. June 30,
2009. EPA-HQ-OPP-2005-0162-0578.

Exhibit 1

     FMC's letter of 9-29-08 and accompanying label amendments.

Exhibit 2

     FMC's letter of 12-24-08 and accompanying label
amendments.

Exhibit 3

     FMC's letter of 6-30-09 and accompanying label amendments.

Exhibit 4

     Expert Report: Carbofuran's FQPA Safety Factor and
Interspecies Uncertainty Factor by K. Wallace (6 p.)
     13 published articles on pesticide effect on
cholinesterase activity.

Exhibit 5

     Central Nervous System as the Primary Target for
Carbofuran's Effects on Lip Smacking by Neal, Williams, & Lamb (3 p.)
     10 published articles on effects of cholinergic
stimulation.

Exhibit 6

     Expert Report: Carbofuran FQPA Safety Factor by K. Wallace
(8 p.)
     9 published articles on HBC versus brain cholinesterase
inhibition.

Exhibit 7

     Dose Response Modeling Issue in Carbofuran by Sielken:
AChE and BMD Ratios

Exhibit 8

     Dose Response Modeling Issue in Carbofuran by Sielken:
Statistical Comparison of AChE Inhibition in RBC and Brain in Rats
Exposed to Carbofuran.

Exhibit 9

     Dose Response Modeling Issue in Carbofuran by Sielken:
OPP's Estimates of the Half-Life of AChE Recovery.

Exhibit 10

     Reiner, 1971. Spontaneous Reactivation of Phosphorylated
and Carbamylated Cholinesterases Bulletin WHO 44, 109-112.

Exhibit 11

     Carbofuran Dietary Risk Assessment. 2009. (Exponent Inc.,
for FMC)

Exhibit 12

     Williams, Cheplick, Engle, Fawcett and Hoogeweg. 2009.
National Carbofuran Leaching Assessment. Vol 1. Waterborne
Environmental Inc., Engel Consulting, and Fawcett Consulting for FMC.

Exhibit 13

     Williams, Cheplick, Engle, Fawcett and Hoogeweg. 2009.
National Carbofuran Leaching Assessment. Vol 2. Setback Analysis.
Waterborne Environmental Inc., Engel Consulting, and Fawcett Consulting
for FMC.

Exhibit 14

     Memorandum. From: Hoogeweg and Williams, Waterborne, Inc.,
To: Fuge, Latham and Watkins, LLP. June 30, 2009. Subject: Groundwater
pH in selected states.

Exhibit 15

     Williams, Fawcett and Engle. 2009. The Development and
Evaluation of a Carbofuran Management Plan to Protect Drinking Water
Derived from Surface Water Sources. Waterborne Environmental Inc., for
FMC.

Exhibit 16

     Memorandum. From: Hoogeweg and Williams, Waterborne, Inc.,
To: Fuge, Latham and Watkins, LLP. June 30, 2009. Subject: Surface
water pH in selected states.

Exhibit 17

     Memorandum. From: Williams, Waterborne, Inc., To: Fuge,
Latham and Watkins, LLP. June 30, 2009. Subject: Water Treatment
Assessment in Carbofuran Use States.

Exhibit 18

     Petition of the National Corn Grower's Association, the
National Sunflower Association, the National Potato Council, and FMC
Corporation to Defer the Effective Date of Certain Tolerance
Revocations for Carbofuran.

References

    1. Acute oral (gavage) dose range-finding study of
cholinesterase depression from carbofuran technical in juvenile (day
11) rats. Hoberman, 2007. MRID 47143703 (unpublished FMC study) EPA-
HQ-OPP-2007-1088-0062.
    2. Acute oral (gavage) time course study and final report of
cholinesterase depression from carbofuran technical in adult and
juvenile (day 11 postpartum) rats. Hoberman, 2007. MRID 47143704, 05
(unpublished FMC studies) EPA-HQ-OPP-2007-1088-0063 and -0066.
    3. Acute time-course study of carbofuran technical administered
by gavage to adult and postnatal day 11 male and female CD (Sprague-
Dawley) rats: Tyl, Marr, and Myers. 2005. (Unpublished study
received Nov. 14, 2005; prepared by RTI International, RTP, NC;
submitted by FMC Corp., Philadelphia, Pa.; FMC Study No: A2005-5982.
MRID 46688913. EPA-HQ-OPP-2005-0162-0058.
    4. Acute dose-response study of carbofuran technical
administered by gavage to adult and postnatal day 11 male and female
CD (Sprague-Dawley) rats: Tyl and Myers. 2005. MRID 46688914. EPA-
HQ-OPP-2005-0162-0078.
    5. Anderson, S. A. (2002). The Toxicokinetics of Peripheral
Cholinesterase Inhibition from Orally Administered Carbofuran in
Adult Male and Female CD Rats. (Unpublished study received May 15,
2002; prepared by Toxicokinetics Laboratory, RTP, NC; submitted by
FMC Corp., Philadelphia, Pa.; FMC Study No: A2001-5379. MRID 456757-
01.
    6. An Investigation into the Potential for Carbofuran Leaching
to Ground Water Based on Historical and Current Use Practices.
Submitted by FMC Corporation, Philadelphia, PA.: Report No. PC-0363.
MRID 47221602. EPA-HQ-OPP-2007-1088-0022.
    7. Arnold, J.D. (1976) Evaluation of the Safe Exposure Levels to
Carbamate, Administered Orally to Healthy Adult Normal Male
Volunteers. (Unpublished study received Oct. 24, 1979 under 279-
2712; prepared by Quincy Research Center, submitted by FMC Corp.,
Philadelphia, Pa.; CDL:241303-B) Accession no. 241303. MRID
00092826. EPA-HQ-ORD-2006-0310-0020.
    8. Arnold, J.D. (1977) Carbamate (Carbofuran) Human Dermal
Study. Final rept. (Unpublished study received Oct. 24, 1979 under
279-2712; prepared by Quincy Research Center, submitted by FMC
Corp., Philadelphia, Pa.; CDL:241303-C), Accession no. 241303. MRID
00092827. EPA-HQ-ORD-2006-0310-0020.
    9. Arnold, J.D. (1978) Comparison of Cholinesterase Inhibition
and Effects of Furadan 4F and FMC 35001 4 EC (ACT 152.03). Rev.
final rept. (Unpublished study received Oct. 24, 1979 under 279-
2712; prepared by Quincy Research Center, submitted by FMC Corp.,
Philadelphia, Pa.; CDL:241305-A) Accession no. 241305, MRID no.
00092829. EPA-HQ-ORD-2006-0310-0020.
    10. Benjamins, J.A. and McKhann, G.M. (1981) Development,
regeneration, and aging of the brain. In: Basic Neurochemistry, 3rd
edition. Edited by Siegel, G.J., Albers, R.W., Agranoff, B.W., and
Katzman, R. Little, Brown and Co., Boston. pp 445-469.
    11. Bretaud S, Toutant JP, Saglio P. 2000. Effects of
carbofuran, diuron, and nicosulfuron on acetylcholinesterase
activity in goldfish (Carassius auratus). Ecotoxicol Environ Saf.
2000 Oct.; 47(2):117-24.
    12. Carbofuran Acute Aggregate Dietary (Food and Drinking Water)
Exposure and Risk Assessments for the Reregistration Eligibility
Decision (T. Morton, 7/22/08, D351371). EPA-HQ-OPP-2005-0162-0508.
    13. Carbofuran Environmental Risk Assessment and Human Drinking
Water Exposure Assessment for IRED. March 2006. EPA-HQ-OPP-2005-
0162-0080.
    14. Carbofuran. HED Revised Risk Assessment for the
Reregistration Eligibility Decision (RED) Document (Phase 6). (PC
090601) D 330541, July 26, 2006. EPA-HQ-OPP-2005-0162-0307.
    15. Carbofuran. HED Revised Risk Assessment for the Notice of
Intent to Cancel. (PC 090601) D 347038, January 2007. EPA-HQ-OPP-
2007-1088-0034.
    16. Carr, Chambers, Guarisco, Richardson, Tang, and Chambers.
2001. Effects of repeated oral postnatal exposures to chlorpyrifos
on open-field behavior in juvenile rats. Toxicol. Sci. 59: 260-267.
    17. Chen, W.L., Sheets, Nolan and Mattson. 1999. Human red blood
cell acetylcholinesterase inhibition as the appropriate and
conservative surrogate endpoint for establishing chlorpyrifos
refernce dose. Regul. Toxicol. 'Pharmacol. 29, 15-22.
    18. Comments in Opposition to Proposed Tolerance Revocations for
Carbofuran. (September 29, 2008). Submitted by the National Potato
Council, National Corn Growers Association, National Cotton Coucil,
National Sunflower Association, and FMC Corporation. EPA-HQ-OPP-
2005-0162-0547.1.
    19. Costa, Hand, Schwab, and Murphy. 1981a. Reduced [3H]
quinuclidinyl benzilate binding to muscarinic receptors in
disulfoton-tolerant mice. Toxicol. Appl. Pharmacol. 60: 441-450.
    20. Costa, Hand, Schwab, and Murphy. 1981b. Tolerance to the
carbamate insecticide propoxur. Toxicology. 21: 267-278.
    21. Costa and Murphy. 1983. Unidirectional cross-tolerance
between the carbamate insecticide propoxur and the organophosphate
disulfoton in mice. Fund. Appl. Toxicol. 3: 483-488.
    22. Davison, A.N. and Dobbing, J. (1966) Myelination as a
vulnerable period in brain development. Br. Med. Bull. 22: 40-44.
    23. Dobbing, J. and Smart, J.L. (1974) Vulnerability of
developing brain and behaviour. Br. Med. Bull. 30: 164-168;
    24. Dose-Time Response Modeling of Rat Brain AChE Activity:
Carbofuran Gavage Dosing: BMD50s for PND11
animals, January 14, 2009. EPA-HQ-OPP-2005-0162-0571.
    25. Dose-Time Response Modeling of Rat RBC AChE Activity:
Carbofuran Gavage Dosing: BMD50s for PND11
Animals, January 14, 2009. EPA-HQ-OPP-2005-0162-0570.
    26. El-Naggar AEl-R, Abdalla MS, El-Sebaey AS, Badawy SM. (2009)
Clinical findings and cholinesterase levels in children of
organophosphates and carbamates poisoning. Eur. J. Pediatrics 168:
951-956.
    27. Engel, Bernard, Richard S. Fawcett, and W. Martin Williams.
2008. Comments to the FIFRA Scientific Advisory Panel--Volume V.:
The Water Risk Assessment for Carbofuran. From Carbofuran Scientific
Advisory Panel Meeting, Feb. 5-8, 2008, Docket ID Number: EPA-HQ-
OPP-2007-1088 FMC Corporation, Agricultural Products Group Written
Comments.
    28. EPA Response to the Transmittal of Meeting Minutes of the
FIFRA Scientific Advisory Panel Meeting Held February 5-8 2008 on
the Agency's Proposed Action under FIFRA 6(b) Notice of Intent to
Cancel Carbofuran (E. Reaves, A. Lowit, J. Liccione 7/2008 D352315).
EPA-HQ-OPP-2005-0162-0505.
    29. Fawcett, R., B. Engel, W. Williams. 2007. An Investigation
into the Potential for Carbofuran Leaching to Ground Water Based on
Historical and Current Product Uses. (MRID 47221602) Project Number
PC/0363. 32 p. EPA-HQ-OPP-2005-0162-0454.1
    30. FIFRA SAP (1998) ``A set of Scientific Issues Being
Considered by the Agency in Connection with Proposed Methods for
Basin-scale Estimation of Pesticide Concentrations in Flowing Water
and Reservoirs for Tolerance Reassessment.'' Final Report from the
FIFRA Scientific Advisory Panel Meeting of July 29-30, 1998 (Report
dated September 2, 1998). Available at: http://www.epa.gov/scipoly/
sap/meetings/1998/july/final1.pdf.
    31. FIFRA SAP (1999) ``Sets of Scientific Issues Being
Considered by the Environmental Protection Agency Regarding Use of
Watershed-derived Percent Crop Areas as a Refinement Tool in FQPA
Drinking Water Exposure Assessments for Tolerance Reassessment.''
Final Report from the FIFRA Scientific Advisory Panel Meeting of
February 5-7, 2002 (Report dated May 25, 1999). SAP Report 99-03C.
Available at: http://www.epa.gov/scipoly/sap/meetings/1999/may/
final.pdf.
    32. SAP. 2001a. REPORT: FIFRA Scientific Advisory Panel Meeting,
September 29, 2000, held at the Sheraton Crystal City Hotel,
Arlington, Virginia. Session VI-A Set of Scientific Issues Being
Considered by the Environmental Protection Agency Regarding:
Progress Report on Estimating Pesticide Concentrations in Drinking
Water and Assessing Water Treatment Effects on Pesticide Removal and
Transformation: A Consultation. SAP Report No 2002-2.
    33. FIFRA SAP. (2002a). ``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.
    34. FIFRA Science Advisory Panel (SAP). 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.
    35. FIFRA Science Advisory Panel (SAP). 2005b. ``Final report on
Preliminary N-Methyl Carbamate Cumulative Risk Assessment.'' Final
Report from the FIFRA Scientific Advisory Panel Meeting of July 29-
30, 1998 (Report dated September 2, 1998). Available at: http://
www.epa.gov/scipoly/sap/2005/august/minutes.pdf.
    36. FIFRA Science Advisory Panel (SAP). 2008. ``Final report on
the Agency's Proposed Action under FIFRA 6(b) Notice of Intent to
Cancel Carbofuran.'' Report from the FIFRA Scientific Advisory Panel
Meeting of February, 5-8 2008 (Report dated September 2, 1998).
Available at: http://www.epa.govscipoly/sap/meetings/2008/february/
carbofuransapfinal.pdf.
    37. Hoberman, A. M. (1998). Developmental Neurotoxicity Study of
Chlorpyrifos Administered Orally via Gavage to Crl:CDBR VAF/Plus
Presumed Pregnant Rats. EPA--MRID No. 44556901. Dow Chemical Co.,
Midland, MI.
    38. HSRB Meeting Minutes. June 1, 2006. Minutes of the United
States Environmental Protection Agency (EPA) Human Studies Review
Board (HSRB) May 2-3, 2006 Public Meeting Docket Number: EPA-HQ-ORD-
2006-0310. http://www.epa.gov/osa/hsrb/files/meeting-materials/may-
2-3-2006-public-meeting/mayminutesfinal.pdf.
    39. HSRB Memorandum: Farland to HSRB Board. May 1, 2006 ``Ethics
Determination for Participation at the May 2-3, 2006 EPA Human
Studies Review Board Meeting.''
    40. HSRB Report. July 7, 2006. Memorandum from Fisher to Gray.
Subject: May 2-3, 2006 EPA Human Studies Review Board Meeting
Report. http://www.epa.gov/osa/hsrb/files/meeting-materials/may-2-3-
2006-public-meeting/final7706.pdf.
    41. Hunter, D. L., Lassiter, T. L., and Padilla, S. 1999.
Gestational exposure to chlorpyrifos: comparative distribution of
trichloropyridinol in the fetus and dam. Toxicol. Appl. Pharmacol.
158, 16-23.
    42. Issue Paper for the FIFRA SAP Meeting on Carbofuran: Human
Health Risk Assessment Reregistration Eligibility Science Chapter
for Carbofuran, Environmental Fate and Effects Chapter. March 2006.
EPA-HQ-OPP-2007-1088-0031.
    43. Jones, R. David, Sidney Abel, William Effland, Robert
Matzner, and Ronald Parker. 1998. Proposed Methods for Basin-scale
Estimation of Pesticide Concentrations in Flowing Water and
Reservoirs for Tolerance Reassessment: Chapter IV., An Index
Reservoir for Use in Assessing Drinking Water Exposure. Presentation
to the FIFRA Science Advisory Panel, July 29-30, 1998.
    44. Jones, R. David. 2007a. Additional chemographs for potatoes
and cucurbits for drinking water exposure assessment in support of
the reregistration of carbofuran. Internal EPA Memorandum to Jude
Andreasen and Danette Drew dated October 23, 2007. EPA-HQ-OPP-2005-
0162-0486.
    45. Jones, R. David. 2007b. Summary Evaluation of Recently
Submitted FMC Water Exposure Studies. (DP 347901) Internal EPA
Memorandum to Jude Andreasen dated December 26, 2007. Available in
the federal docket at www.regulations.gov at EPA-HQ-OPP-2007-1088-
0016.
    46. Jones, R. David (2008a) (5/1/2008). Additional refinements
for estimations of drinking water exposure from carbofuran use on
corn. (DP 351653). EPA-HQ-OPP-2005-0162-0569.
    47. Jones, R. David. 2008b. Additional Refinements of the
Drinking Water Exposure Assessment for the Use of Carbofuran on Corn
and Melons. (DP 353714) Internal EPA Memorandum to Jude Andreasen
and Thurston Morton, dated June 23, 2008. EPA-HQ-OPP-2005-0162-0510.
    48. Jones, R. David. (2008c) Updated Refinements of the Drinking
Water Exposure Assessment for the Use of Carbofuran on Corn and
Melons, 8/18/2008. (DP 355584) Internal EPA Memorandum to Jude
Andreasen and Thurston Morton, dated August 18, 2008. EPA-HQ-OPP-
2005-0162-0516.
    49. Lauzon, John D., Ivan P. O'Halloran, David J. Fallow, A.
Peter von Bertoldi, and Doug Aspinall. 2005. Spatial Variability of
Soil Test Phosphorus, Potassium, and pH of Ontario Soils. Agronomy
Journal 97:524-532.
    50. Lifshitz, Shahak, Bolotin, and Sofer. 1997. Carbamate
Poisoning in Early Childhood and in Adults. Clinical Toxicology. 35:
25-27.
    51. Marable BR, Maurissen JP, Mattsson JL, Billington R. 2007.
Differential sensitivity of blood, peripheral, and central
cholinesterases in beagle dogs following dietary exposure to
chlorpyrifos. Regul Toxicol Pharmacol. 2007 Apr;47(3):240-8.
    52. Mattsson, J. L., Maurissen, J. P., Nolan, R. J., and Brzak,
K. A. 2000. Lack of differential sensitivity to cholinesterase
inhibition in fetuses and neonates compared to dams treated
perinatally with chlorpyrifos. Toxicol Sci 53, 438-46.
    53. McDaniel K.L. and Moser V.C. (2004) Differential profiles of
cholinesterase inhibition and neurobehavioral effects in rats
exposed to fenamiphos or profenofos. Neurotoxical Teratol. 26:407-
415.
    54. McDaniel K.L., Padilla S., Marshall R.S., Phillips P.M.,
Podhorniak L., Qian Y., Moser V.C. (2007) Comparison of acute
neurobehavioral and cholinesterase inhibitory effects of N-methyl
carbamates in rats. Toxicol. Sci. 98, 552-560.
    55. Morton, T., 4/29/09, D358037, Carbofuran Acute Aggregate
Dietary (Food and Drinking Water) Exposure and Risk Assessments for
the Reregistration Eligibility Decision.
    56. Moser V.C. (1995) Comparisons of the acute effects of
cholinesterase inhibitors using a neurobehavioral screening battery
in rats. Neurotoxical Teratol 17: 617-625.
    57. National Assessment of the Relative Vulnerability of
Community Water Supply Reservoirs in Carbofuran Use Areas. Performed
by Waterborne Environmental Inc., Leesburg, VA and Engel Consulting,
West Lafayette, IN. Submitted by FMC Corporation, Philadelphia, PA.
WEI Report No. 528.01-B, FMC Report No. PC-0387. MRID 47272301. EPA-
HQ-OPP-2007-1088-0024.
    58. National Resources Inventory 1992, cited in USGS 2002,
``Herbicide Concentrations in the Mississippi River Basin--the
importance of chloracetanilide degradates.'' R.A. Rebich, R.H.
Coupe, E.M.Thurman.
    59. Nostrandt, A.C., Padilla, S., and Moser, V.C. (1997). The
relationship of oral chlorpyrifos effects on behavior,
cholinesterase inhibition, and muscarinic receptor density in rat.
Pharmacol. Biochem. Behav. 58, 15-23.
    60. Ott, Wayne R. 1995. Environmental Statistics and Data
Analysis. CRC Press. Boca Raton, Florida.
    61. Padilla S, Marshall RS, Hunter DL, Oxendine S, Moser VC,
Southerland SB, Mailman RB. 2005. Neurochemical effects of chronic
dietary and repeated high-level acute exposure to chlorpyrifos in
rats. Toxicol Sci. 2005 Nov;88(1):161-71.
    62. Padilla S., Marshall R.S., Hunter D.L., and Lowit A. 2007.
Time course of cholinesterase inhibition in adult rats treated
acutely with carbaryl, carbofuran, formetanate, methomyl,
methiocarb, oxamyl, or propoxur. Toxicology and Applied
Pharmacology, 219; 202-209.
    63. PND17 BMDs and BMDLs and recovery half-lives for the effects
of carbofuran on brain and blood AChE (PND17--DR.pdf). EPA-HQ-OPP-
2007-1088-0047.
    64. Richardson, J., and Chambers, J. (2003). Effects of
gestational exposure to chlorpyrifos on postnatal central and
peripheral cholinergic neurochemistry. J Toxicol Environ Health A
66, 275-89.
    65. Richardson, J., and Chambers, J. 2005. Effects if repeated
oral postnatal exposure to chlorpyrifos on cholinergic
neurochemistry in developing rats. Toxicol Sci 84, 352-59.
    66. Report on cholinesterase sensitivity study of carbofuran:
Adult and PND11 MRID 47289001 (ORD study). EPA-HQ-OPP-2007-1088-
0065.
    67. Revised Drinking Water Assessment in Support of the
Reregistration of Carbofuran (PC Code 090601) (R. David Jones, 9/5/
07 D3424057). EPA-HQ-OPP-2005-0162-0485.
    68. Rupniak, NM, Jenner, P and Marsden, CD. 1983. Cholinergic
manipulation of perioral behaviour induced by chronic neuroleptic
administration to rats. Psychopharmacology 79 (2-3): 226-230.
    69. Screening Level analysis of the small business impacts of
revoking carbofuran tolerances. (Wyatt, T.J. July 2008) 28 pgs. EPA-
HQ-OPP-2005-0162-0506.
    70. Setzer W. October 5, 2007. Dose-time response modeling of
rat brain AChE activity: Carbofuran gavage dosing. 64 pgs. EPA-HQ-
OPP-2007-1088-0053.
    71. Schwab, Hand, Costa and Murphy. 1981. Reduced Muscarinic
Receptor Binding in Tissues of Rats Tolerant to the Insecticide
Disulfoton. Neurotoxicology. 2: 635-647.
    72. Somani, S. M. and Dube, S. N. 1989. In vivo dose response
relationship between physostigmine and cholinesterase activity in
RBC and tissues of rat. Life Science 44, 1907-1915.
    73. Thelin, Gail P., and Leonard P. Gianessi. 2000. Method for
Estimating

Pesticide Use for County Areas of the Conterminous United States.
U.S. Geological Survey Open-File Report 00-250. Sacramento,
California, 2000. Available at: http://water.usgs.gov/nawqa/pnsp/
pubs/ofr00250.
    74. Trask, Jennifer R., and Joshua Amos. 2005. Watershed
Regressions for Pesticides (WARP) for Carbofuran in Illinois
Watersheds. Prepared by Waterborne Environmental Inc., Leesburg, VA.
WEI 362.07. (MRID 46688915) Submitted by FMC Corporation,
Philadephia, PA FMC Study P3786. EPA-HQ-OPP-2005-0162-0061.
    75. USEPA (2000a) ``Assigning Values to Nondetected/
Nonquantified Pesticide Residues in Human Health Dietary Exposure
Assessments.'' March 23, 2000. Available at: http://www.epa.gov/
pesticides/trac/science/trac3b012.pdf.
    76. USEPA. (2000b). ``Benchmark Dose Technical Guidance
Document.'' Draft report. Risk Assessment Forum, Office of Research
and Development, U.S. Environmental Protection Agency. Washington,
DC. EPA/630/R-00/001.
    77. USEPA. (2000c) ``Choosing a Percentile of Acute Dietary
Exposure as a Threshold of Regulatory Concern.'' March 16, 2000.
Available at: http://www.epa.gov/pesticides/trac/science/
trac2b054.pdf.
    78. USEPA. (2000d). ``The Use of Data on Cholinesterase
Inhibition for Risk Assessments of Organophosphorous and Carbamate
Pesticides.'' August 18, 2000. Available at: http://www.epa.gov/
pesticides/trac/science/cholin.pdf.
    79. USEPA. (2002). ``Office of Pesticide Programs' Policy on the
Determination of the Appropriate FQPA Safety Factor(s) For Use in
Tolerance Assessment.'' Available at: http://www.epa.gov/oppfead1/
trac/science/determ.pdf.
    80. USEPA Peer Review Handbook 3rd Edition. 2006. Prepared for
the U.S. Environmental Protection Agency by Members of the Peer
Review Advisory Group, for EPA's Science Policy Council http://
www.epa.gov/peerreview/.
    81. USEPA (2007a). ``Revised N-Methyl Carbamate Cumulative Risk
Assessment U.S. Environmental Protection Agency, Office of Pesticide
Programs,'' September 24, 2007. Available at: http://www.epa.gov/
oppsrrd1/REDs/nmc_revised_cra.pdf.
    82. USEPA (2007b). Carbaryl. HED Chapter of the Reregistration
Eligibility Decision Document (RED). PC Code: 056801, DP Barcode:
D334770. 28 June 2007. EPA-HQ-OPP-2007-0941-0003.
    83. U.S. Environmental Protection Agency. 2008a. EPA response to
the transmittal of meeting minutes of the FIFRA Scientific Advisory
Panel Meeting held February 5-8 on the Agency's proposed action
under FIFRA 6(b) Notice of Intent to Cancel Carbofuran (3-26-08). E.
Reaves et al., July 22, 2008, DP 352315. EPA-HQ-OPP-2005-0162-0505.
    84. USEPA (2009a) Jones, R. David, Reuben Baris, and Marietta
Echeverria. 2009. Response to comments on EPA's proposed tolerance
revocations for carbofuran specifically related to drinking water
exposure assessment. Internal EPA memorandum to Jude Andreasen dated
April 29, 2009. D362182. EPA-HQ-OPP-2005-0162-0565.
    85. USEPA (2009b) Response to Comments in Opposition to Proposed
Tolerance Revocations for Carbofuran Docket EPA-HQ-OPP-2005-0162''
submitted by the National Potato Council, National Corn Growers
Association, National Cotton Council, National Sunflower
Association, and FMC Corporation (September 29, 2008). April 29,
2009. EPA-HQ-OPP-2005-0162-0567.
    86. Watershed Regressions for Pesticides (WARP) Model Estimates
for Carbofuran in Illinois Watershed. Performed by Waterborne
Environmental, Inc., Leesburg, VA. WEI 362.07. Submitted by FMC
Corporation, Philadelphia, PA. Report No. P-3786. MRID 46688915.
EPA-HQ-OPP-2007-1088-0021.
    87. WHO JMPR, 1999. FAO/WHO Joint Meeting on Pesticide Residues.
Report of the 1998 FAO/WHO Joint Meeting on Pesticide Residues. Food
and Agriculture Organization-United Nations. Rome, Italy. http://
www.fao.org.
    88. Whyatt, R., Barr, D., Camann, D., Kinney, P., Barr, J.,
Andrews, H., et al. (2003). Contemporary-use pesticides in personal
air samples during pregnancy and blood samples at delivery among
urban minority mothers and newborns. Environmental Health
Perspectives, vol. 111, num. 5, pp. 749-756.
    89. Williams, W. M., (2007a) B. Engel, S. Dasgupta, and C. G.
Hoogeweg. An In-Depth Investigation to Estimate Surface Water
Concentrations of Carbofuran within Indiana Community Water
Supplies. (MRID 47221603) Performed by Waterborne Environmental,
Inc., Leesburg, VA, Engel Consulting, and Fawcett Consulting.
Submitted by FMC Corporation, Philadelphia, PA. WEI No 528.01, FMC
Report No. PC-0378. EPA-HQ-OPP-2005-0162-0453.
    90. Williams, W. M. (2007b) B. Engel, J. Amos, and C. G.
Hoogeweg. National Assessment of the Relative Vulnerability of
Community Water Supply Reservoirs in Carbofuran Use Areas. (MRID
47272301) Performed by Waterborne Environmental, Inc.and Engel
Consulting. Submitted by FMC Corporation, Philadelphia, PA. EPA-HQ-
OPP-2005-0162-0463.
    91. Zwiener RJ, Ginsburg CM. (1988) Organophosphate and
carbamate poisoning in infants and children. Pediatrics 81:121-126.
    92. Vecchia, A.V. and Crawford, C. G. (2006). Simulation of
Daily Pesticide Concentrations From Watershed Characteristics and
Monthly Climatic Data USGS Scientific Investigations. USGS Report
2006-5181. 60 pgs.

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: October 30, 2009.
Debra Edwards,
Director, Office of Pesticide Programs.
[FR Doc. E9-27261 Filed 11-17-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: November 13, 2009 (Volume 74, Number 218)]
[Notices]
[Page 58640]
[DOCID:fr13no09-67]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0488]

Medical Devices: Ophthalmic Devices; Laser-Assisted In Situ
Keratomileusis (LASIK) Devices; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
reopening until November 15, 2010 of a public docket to receive
information and comments on laser-assisted in situ keratomileusis
(LASIK) devices.

DATES: The agency encourages interested parties to submit information
and comments by November 15, 2010.

ADDRESSES: Submit electronic comments or information to http://
www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Domini Bean, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., WO66 Rm. 4422, Silver Spring, MD 20993,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 12, 2008 (73 FR 53028), FDA
published a notice announcing the opening of a public docket to receive
information and comments on the post market experience associated with
the use of laser-assisted in situ keratomileusis (LASIK) devices, as
well as information regarding potential barriers that may exist in
providing the agency with feedback regarding LASIK procedures.
Interested persons were invited to submit comments by September 14,
2009. At this time, the agency is reopening the docket to continue to
receive public comments. Information and comments submitted to the
docket will assist us in identifying ways in which we can improve our
public outreach efforts regarding the safety and effectiveness of LASIK
devices.

II. Submission of Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy. All
comments submitted to the public docket are public information and may
be posted to the FDA's Web site at http://www.fda.gov for public
viewing. Comments are to be identified with the docket number found in
brackets in the heading of this document. Received comments may be seen
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

    Dated: October 30, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and Radiological Health.
[FR Doc. E9-27222 Filed 11-12-09; 8:45 am]

BILLING CODE 4160-01-S