[Federal Register: July 18, 2007 (Volume 72, Number 137)]
[Rules and Regulations]
[Page 39318-39331]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18jy07-8]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0050; FRL-8135-3]
Alachlor, Chlorothalonil, Metribuzin; Denial of Objections
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final order.
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SUMMARY: In this order, EPA denies objections to an order denying a
petition requesting the modification or revocation of the pesticide
tolerances for alachlor, chlorothalonil, and metribuzin, established
under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA).
The petition was filed on December 17, 2004, by the States of New York,
California, Connecticut, and Massachusetts. The petitioners claimed
that EPA had improperly removed an additional safety factor for the
protection of infants and children from the risk assessments for these
pesticide tolerances and that inclusion of this safety factor rendered
the tolerances unsafe. EPA issued an order denying that petition, in
part, on August 2, 2006. On October 2, 2006, New York, Connecticut, and
Massachusetts filed objections to EPA's denial order.
DATES: This final order is effective July 18, 2007. Supplemental
objections, as described in Unit VII.C., may be submitted on or before
September 17, 2007, and must be filed in accordance with the
instructions provided in 40 CFR part 178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2005-0050. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov web site to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
[[Page 39319]]
available either in the electronic docket at http://
www.regulations.gov, or, if only available in hard copy, at the OPP
Public Docket, in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Terria Northern, Special Review and
Reregistration Division, (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: 703-305-7093; e-mail
address: northern.terria@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities that are potentially affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://
www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
EPA is permitting supplemental objections to be filed under section
408(g) of the FFDCA concerning one issue described in Unit VII.C. The
EPA procedural regulations which govern the submission of objections
and requests for hearings appear in 40 CFR part 178. You must file your
objection or request a hearing in accordance with the instructions
provided in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number EPA-HQ-OPP-2005-0050 in the subject line on
the first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before September
17, 2007.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2005-0050, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 204607-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
II. Introduction
A. What Action Is the Agency Taking?
In this order, EPA denies objections to an order denying a petition
requesting the modification or revocation of the pesticide tolerances
for alachlor, chlorothalonil, and metribuzin, among other pesticides,
established under section 408 of the FFDCA. The petition was filed on
December 17, 2004, by the States of New York, California, Connecticut,
and Massachusetts (``the States'') (Ref. 1). The States contended that
EPA is lacking data for each of the challenged pesticides on
developmental neurotoxicity, endocrine effects, and/or cumulative
effects of exposure to pesticides with a common mechanism of toxicity.
This lack of data, the States argued, mandates that EPA must retain the
statutory additional tenfold (10X) safety factor for the protection of
infants and children. The States further alleged that once the 10X
safety factor is retained, the challenged tolerances no longer meet the
safety standard under FFDCA section 408 and must be modified or
revoked.
On August 2, 2006, EPA denied the petition with regard to alachlor,
chlorothalonil, and metribuzin. (71 FR 43906, August 2, 2006). As to
alachlor and metribuzin, EPA denied the petition because the tolerances
for these pesticides would continue to meet the safety standard even if
the additional 10X safety factor sought by the States is applied. For
chlorothalonil, EPA denied the petition on the ground that there is
reliable data on chlorothalonil showing that the additional 10X safety
factor is not needed to protect the safety of infants and children. The
petition is still pending before EPA as to two other pesticides,
methomyl and thiodicarb.
On October 2, 2006, objections were filed to EPA's denial order by
the States of New York, Connecticut, and Massachusetts (although
California did not join the objections, for simplicity, the objectors
are still referred to as the ``States'' in this order). (Ref. 2) The
objections renew the States' claim that EPA has unlawfully removed the
children's 10X safety factor and also argue that EPA has
``manipulated'' exposure assessments in making its safety
determination. It is these objections that are addressed in today's
order.
B. What Is the Agency's Authority for taking this Action?
The procedure for filing objections to tolerance actions and EPA's
authority for acting on such objections is contained in section 408(g)
of the FFDCA and regulations at 40 CFR part 178. (21 U.S.C. 346a(g)).
[[Page 39320]]
III. Statutory and Regulatory Background
A. Statutory Background
1. In general. EPA establishes maximum residue limits, or
``tolerances,'' for pesticide residues in food under section 408 of the
FFDCA. (21 U.S.C. 346a). Without such a tolerance or an exemption from
the requirement of a tolerance, a food containing a pesticide residue
is ``adulterated'' under section 402 of the FFDCA and may not be
legally moved in interstate commerce. (21 U.S.C. 331, 342). Monitoring
and enforcement of pesticide tolerances are carried out by the U.S.
Food and Drug Administration and the U.S. Department of Agriculture.
Section 408 was substantially rewritten by the Food Quality Protection
Act of 1996 (``FQPA''), which added the provisions discussed below
establishing a detailed safety standard for pesticides, additional
protections for infants and children, tolerance reassessment
requirements, and the estrogenic substances screening program.
EPA also regulates pesticides under the Federal Insecticide,
Fungicide, and Rodenticide Act (``FIFRA''), (7 U.S.C. 136 et seq.).
While the FFDCA authorizes the establishment of legal limits for
pesticide residues in food, FIFRA requires the approval of pesticides
prior to their sale and distribution, (7 U.S.C. 136a(a)), and
establishes a registration regime for regulating the use of pesticides.
FIFRA regulates pesticide use in conjunction with its registration
scheme by requiring EPA review and approval of pesticide labels and
specifying that use of a pesticide inconsistent with its label is a
violation of Federal law. (7 U.S.C. 136j(a)(2)(G)). In the FQPA,
Congress integrated action under the two statutes by requiring that the
safety standard under the FFDCA be used as a criterion in FIFRA
registration actions as to pesticide uses which result in dietary risk
from residues in or on food, (7 U.S.C. 136(bb)), and directing that EPA
coordinate, to the extent practicable, revocations of tolerances with
pesticide cancellations under FIFRA. (21 U.S.C. 346a(l)(1)).
2. Safety standard for pesticide tolerances. A pesticide tolerance
may only be promulgated by EPA if the tolerance is ``safe.'' (21 U.S.C.
346a(b)(2)(A)(i)). ``Safe'' is defined by the statute to mean that
``there is a reasonable certainty that no harm will result from
aggregate exposure to the pesticide chemical residue, including all
anticipated dietary exposures and all other exposures for which there
is reliable information.'' (21 U.S.C. 346a(b)(2)(A)(ii)). Section
408(b)(2)(D) directs EPA, in making a safety determination, to:
consider, among other relevant factors- . . . .
(v) Available information concerning the cumulative effects of
such residues and other substances that have a common mechanism of
toxicity; . . .
(vi) Available information concerning the aggregate exposure
levels of consumers (and major identifiable subgroups of consumers)
to the pesticide chemical residue and to other related substances,
including dietary exposure under the tolerance and all other
tolerances in effect for the pesticide chemical residue, and
exposure from other non-occupational sources.. . . .
(viii) Such information as the Administrator may require on
whether the pesticide chemical may have an effect in humans that is
similar to an effect produced by a naturally occurring estrogen or
other endocrine effects. . . .
(21 U.S.C. 346a(b)(2)(D)(v), (vi) and (viii)). In its first denial
order, EPA explained in detail the risk assessment process it follows
in making safety determinations under these statutory provisions. (71
FR at 43908-43910).
Section 408(b)(2)(C) requires EPA to give special consideration to
risks posed to infants and children. Specifically, this provision
states that EPA:
shall assess the risk of the pesticide chemical based on- . . .
(II) available information concerning the special susceptibility
of infants and children to the pesticide chemical residues,
including neurological differences between infants and children and
adults, and effects of in utero exposure to pesticide chemicals; and
(III) available information concerning the cumulative effects on
infants and children of such residues and other substances that have
a common mechanism of toxicity. . . .
(21 U.S.C. 346a(b)(2)(C)(i)(II) and (III)).
This provision further directs that ``[i]n the case of threshold
effects, . . . an additional tenfold margin of safety for the pesticide
chemical residue and other sources of exposure shall be applied for
infants and children to take into account potential pre- and post-natal
toxicity and completeness of the data with respect to exposure and
toxicity to infants and children.'' (21 U.S.C. 346a(b)(2)(C)). EPA is
permitted to ``use a different margin of safety for the pesticide
chemical residue only if, on the basis of reliable data, such margin
will be safe for infants and children.'' (Id.). [The additional safety
margin for infants and children is referred to throughout this order as
the ``children's safety factor.''] EPA's policy regarding
implementation of the children's safety factor provision is described
in the first denial order. (71 FR at 43910, 43918-43919).
3. Procedures for establishing, amending, or revoking tolerances.
Tolerances are established, amended, or revoked by rulemaking under the
unique procedural framework set forth in the FFDCA. Generally, the
rulemaking is initiated by the party seeking to establish, amend, or
revoke a tolerance by means of filing a petition with EPA. (See 21
U.S.C. 346a(d)(1)). EPA publishes in the Federal Register a notice of
the petition filing and requests public comment. (21 U.S.C.
346a(d)(3)). After reviewing the petition, and any comments received on
it, EPA may issue a final rule establishing, amending, or revoking the
tolerance, issue a proposed rule to do the same, or deny the petition.
(21 U.S.C. 346a(d)(4)). Once EPA takes final action on the petition by
either establishing, amending, or revoking the tolerance or denying the
petition, any affected party has 60 days to file objections with EPA
and seek an evidentiary hearing on those objections. (21 U.S.C.
346a(g)(2)). EPA's final order on the objections is subject to judicial
review. (21 U.S.C. 346a(h)(1)).
4. Tolerance reassessment and FIFRA reregistration. The FQPA
requires, among other things, that EPA reassess the safety of all
pesticide tolerances existing at the time of its enactment. (21 U.S.C.
346a(q)). In this reassessment, EPA is required to review existing
pesticide tolerances under the new ``reasonable certainty that no harm
will result'' standard set forth in section 408(b)(2)(A)(i). (21 U.S.C.
346a(b)(2)(A)(i)). This reassessment was substantially completed by the
August, 2006 deadline. Tolerance reassessment is generally handled in
conjunction with a similar program involving reregistration of
pesticides under FIFRA. (7 U.S.C. 136a-1). Reassessment and
reregistration decisions are generally combined in a document labeled a
Reregistration Eligibility Decision (``RED'').
5. Estrogenic substances screening program. Section 408(p) of the
FFDCA creates the estrogenic substances screening program. (21 U.S.C.
346a(p)). This provision gives EPA 2 years from enactment of the FQPA
to ``develop a screening program . . . to determine whether certain
substances may have an effect in humans that is similar to an effect
produced by a naturally occurring estrogen, or such other endocrine
effect as the Administrator may designate.'' (21 U.S.C. 346a(p)(1)).
This screening program must use ``appropriate validated test systems
and scientifically relevant information.'' (Id.). Once the program is
developed, EPA is required to take public comment and seek independent
scientific review of it. Following the period for public comment and
scientific review, and not
[[Page 39321]]
later than 3 years following enactment of the FQPA, EPA is directed to
``implement the program.'' (21 U.S.C. 346a(p)(2)).
The scope of the estrogenic screening program was expanded by an
amendment to the Safe Drinking Water Act (SDWA) passed
contemporaneously with the FQPA. That amendment gave EPA the authority
to provide for the testing, under the FQPA estrogenic screening
program, ``of any other substance that may be found in sources of
drinking water if the Administrator determines that a substantial
population may be exposed to such substance.'' (42 U.S.C. 300j-17).
The steps taken by EPA in implementing the endocrine screening
program are described in the first denial order. (71 FR at 43910-43911,
43920-43921).
B. Evaluating the Safety of Tolerances through the Use of Risk
Assessment Including the Use of Safety Factors
In the order denying the petition, EPA explained its risk
assessment process for assessing the safety of tolerances in great
detail. (71 FR at 43908-43910). That level of detail is not repeated
here; however, a brief summary of the risk assessment process with an
emphasis on how safety factors are incorporated into the process is
included below for the convenience of the reader.
Evaluation of the safety of a pesticide tolerance includes both
examination of the pesticide's toxicity and the amount of exposure to
the pesticide. EPA principally evaluates a pesticide's toxicity by
attempting to establish safe levels of exposure for humans with regard
to the adverse effects seen in animal studies conducted with the
pesticide. Safe levels of exposure are established by first identifying
the doses in animal studies at which no adverse effects were seen, and
then dividing these dose levels with safety factors to provide an extra
measure of protection for humans. Traditionally, EPA has used 2 safety
factors of 10 when establishing a safe human dose level based on animal
studies. One factor of 10 is applied to account for potentially
increased sensitivity of humans vis-a-vis the test animals and a second
factor of 10 is used to account for variable sensitivity in humans. (71
FR at 43909). The FQPA imposed a presumptive additional ten-fold factor
to provide extra protection for infants and children.
Having derived a safe dose level for humans, EPA then compares this
dose level to aggregate human exposure to the pesticide. EPA follows a
tiered approach in assessing exposure to pesticide residues. EPA
initially uses the very conservative (health-protective) assumption
that all food that legally may contain residues of a pesticide actually
does contain such residues at the maximum legal level (Tier 1). Only if
this analysis suggests that exposure may be a concern does EPA
undertake the more resource-intensive effort of refining its exposure
assessment to produce a more realistic estimate of exposure. In the
first level of refinement of its worst case assessment, EPA
incorporates data on the percentage of a crop treated with a pesticide
and/or data on anticipated residues in food from crop field trials
(Tier 2). Further refinements rely heavily on pesticide residue
monitoring data of food in commerce and may include information from
residue decline and degradation studies and studies evaluating the
effect of commercial and consumer practices such as washing, cooking,
and peeling on pesticide residues (Tiers 3-4). (Ref. 3; 71 FR at 43909-
43910).
IV. The Challenged Tolerances
In its first denial order, EPA presented detailed information on
the pesticides whose tolerances are at issue. (71 FR at 43911-43912).
This information is briefly summarized below.
Alachlor. Alachlor is a selective herbicide used in agriculture for
the control of broadleaf weeds and grasses. Alachlor is registered
under FIFRA for use on corn, soybeans, sorghum, peanuts, and beans and
37 FFDCA tolerances are currently associated with those uses. (40 CFR
180.249). In December 1998, EPA released a RED for alachlor finding it
eligible for reregistration. (Ref. 4). The RED also reassessed
alachlor's tolerances concluding that 22 met the requirements of
section 408 but that 16 would have to be revised or revoked. (Id. at
184-187; Ref. 5 at 13-14). (The current number of tolerances for
alachlor and the other two pesticides may not match the number of
reassessed tolerances due to subsequent actions to establish or revoke
tolerances as well as to a generic administrative action amending
tolerance nomenclature. (68 FR 39428, July 1, 2003)). In making its
safety determination as to alachlor, EPA removed the 10X children's
safety factor based on its determination that (1) the toxicology
database was complete; (2) the toxicology data showed no evidence of
neurotoxicity and thus there was no need for a developmental
neurotoxicity study for alachlor; (3) the toxicology data showed no
evidence of increased susceptibility in the young; and (4) the exposure
estimate was unlikely to understate exposure to infants and children.
(Ref. 4 at 50).
Chlorothalonil. Chlorothalonil is a broad spectrum, non-systemic
protectant pesticide mainly used as a fungicide to control fungal
foliar diseases of vegetable, field, and ornamental crops. In
connection with these uses there are 66 FFDCA tolerances currently
established for chlorothalonil. (40 CFR 180.275). In April 1999, EPA
released a RED for chlorothalonil finding it eligible for
reregistration so long as various uses were prohibited and numerous
risk mitigation steps were taken. (Ref. 6 at v-vi). The RED also
reassessed chlorothalonil's tolerances concluding that all met the
requirements of section 408 except one that would have to be raised.
Further, an additional tolerance was found to be necessary in
connection with one use site. (Id. at 171-174; Ref. 5 at 58-59). Except
as to acute risks, EPA removed the 10X children's safety factor for
chlorothalonil based on its determination that (1) the toxicology
database was complete; (2) the toxicology data showed no evidence of
increased susceptibility in the young; and (3) the exposure estimate
was unlikely to understate exposure to infants and children. (Ref. 6 at
170; 66 FR 56233, 56242, November 7, 2001). Because a chlorothalonil
acute study did not identify a dose with no adverse effects, EPA
retained an additional FQPA safety factor of 3X in assessing acute
risks. (Ref. 6 at 23).
Metribuzin. Metribuzin is a herbicide used on a wide range of
sites, including vegetable and field crops, turf grasses (recreational
areas), and non-crop areas, to selectively control certain broadleaf
weeds and grassy weed species. In connection with these uses there are
61 FFDCA tolerances currently established for metribuzin (40 CFR
180.332).
In February 1999, EPA released a RED for metribuzin finding it
eligible for reregistration based on various risk mitigation steps
proposed by the registrant. (Ref. 7 at iv). The RED also reassessed
metribuzin's tolerances concluding that 22 met the requirements of
section 408 but that 38 would have to be revised or revoked. (Id. at
101-107; Ref. 5 at 187-188). EPA removed the 10X children's safety
factor for metribuzin based on its determination that the toxicology
database was complete and it showed no evidence of increased
susceptibility in the young. (Ref. 7 at 51).
[[Page 39322]]
V. Prior Proceedings
A. The Petition to Modify or Revoke
The States' petition requested that EPA modify or revoke all of the
tolerances for alachlor, chlorothalonil, methomyl, metribuzin, and
thiodicarb. (Ref. 1 at 1). These tolerances must be modified or
revoked, the States asserted, because they do not meet the safety
standard in section 408 of the FFDCA. (Id. at 2). The States argued
that the tolerances are unsafe because EPA's latest safety conclusion
for these tolerances did not include the full 10X children's safety
factor and, if that full 10X safety factor is included, EPA cannot make
the required reasonable certainty of no harm determination.
The States claimed that ``as a matter of law'' the full 10X
children's safety factor must be retained for each of these pesticides
because of missing data concerning developmental neurotoxicity,
endocrine effects, and/or cumulative effects of pesticides having a
common mechanism of toxicity. It is ``legally impermissible,'' the
States asserted, if any of these data are absent for EPA to conclude
that there are ``reliable data'' to choose an additional safety factor
other than 10X. (Id. at 2, 5, 9, 11).
As statutory support for this allegation, the States cited several
provisions in section 408. First, as to developmental neurotoxicity,
the States pointed to section 408(b)(2)(C)'s requirement that EPA
assess the risk to children based on ``available information concerning
the special susceptibility of infants and children to the pesticide
chemical residues, including neurological differences between infants
and children and adults . . . .'' The States noted that EPA has
announced that it plans to require developmental neurotoxicity
(``DNT'') studies on all pesticides that are neurotoxic. (Ref. 1 at 10
citing 64 FR 42945, August 6, 1999). Second, as to endocrine effects,
the States cited both the provision in section 408(b)(2)(D)(vii)
requiring consideration of ``such information as the Administrator may
require on whether the pesticide chemical may have an effect in humans
that is similar to an effect produced by a naturally occurring estrogen
or other endocrine effects'' and the requirement in section 408(p) for
EPA to develop and implement an endocrine screening program. Finally,
with regard to cumulative effects, the States referenced the provision
in section 408(b)(2)(D)(v) requiring consideration of ``available data
on the cumulative effects of such residues and other substances that
have a common mechanism of toxicity,'' and the requirement in section
408(b)(2)(C) mandating that EPA assess the risk to children based on
similar considerations.
B. EPA's Denial of the Petition
Following consideration of the petition and comments received on
the petition, EPA issued an order on August 2, 2006, denying the
requested revocation as to alachlor, chlorothalonil, and metribuzin.
(71 FR 43906, August 2, 2006). EPA did not address the requested
revocation of methomyl and thiodicarb tolerances because those
tolerances are still being evaluated as part of the tolerance
reassessment program. The reasons for denying the petition are
described below.
1. Alachlor and metribuzin. The States' petition was denied as to
alachlor and metribuzin because EPA found that, even if it accepted as
accurate the States' claim that it should have retained the 10X
children's safety factor for these pesticides, the States had not shown
that the tolerances were unsafe. (71 FR at 43916). As to alachlor, the
States had based their conclusion that alachlor would be unsafe if an
additional 10X factor was applied relying on an unrefined risk estimate
in the alachlor RED. EPA pointed out, however, that ``the RED also
contained a revised risk assessment for alachlor that showed the
highest aggregate risk estimate to be that exposure of children aged 1-
6 is 4 percent of the [maximum safe dose],'' and that ``incorporating
an additional 10X safety factor into such a risk estimate would
increase the risk estimate to no greater than 40 percent of the
[maximum safe dose], or still well within the safe level.'' (Id.).
A similar conclusion was reached as to metribuzin. (Id.). Again,
the States had relied upon a risk estimate based on an unrefined
exposure assessment to argue that application of the additional 10X
safety factor would show that the metribuzin tolerances are unsafe. EPA
showed that a slight refinement of the exposure and risk assessment
made the requested retention of the additional 10X safety factor
irrelevant to the safety determination. EPA made clear that, in moving
from an unrefined, worst case exposure assessment to a more refined
assessment, it had still taken a very conservative, health-protective
approach to estimating exposure. An example is the manner in which EPA
incorporated monitoring data on the level of metribuzin residues in
potatoes into the exposure assessment. Data from the U.S. Department of
Agriculture had shown that only 1 out of 1,472 samplings of potatoes
revealed any detectable residue of metribuzin. ``Nonetheless, in its
risk assessment, EPA assumed that all potatoes contained metribuzin at
the level found in that one sample (0.05 parts per million).'' (Id. at
43917).
Therefore, EPA did not evaluate the merits of the States' claim
that the 10X children's safety factor should have been retained for
alachlor and metribuzin. Instead it denied the petition as to these two
pesticides because the petition, even if its claims were accepted as
true, did not demonstrate that the pesticide tolerances were unsafe.
2. Chlorothalonil. Based on its conclusion that application of an
additional 10X safety factor to the chlorothalonil risk assessment may
have raised a safety issue, EPA evaluated the merits of the States'
claims that EPA should have retained the 10X children's safety factor
for chlorothalonil. The States had argued that the children's safety
factor must be retained for chlorothalonil due to the lack of data on
cumulative effects and potential endocrine disruption. Further,
although the States did not specifically claim that EPA should retain
the children's safety factor due to a lack of developmental
neurotoxicity data on chlorothalonil, its general allegations could be
read as suggesting as much.
As to developmental neurotoxicity data, EPA pointed out that it
only required such data for pesticides that were neurotoxins. The
States, EPA found, had made no plausible argument that developmental
neurotoxicity data were needed for non-neurotoxic pesticides nor had
they alleged that chlorothalonil was neurotoxic. Further, EPA confirmed
that its review of the chlorothalonil database did not show
chlorothalonil to be neurotoxic. Accordingly, EPA rejected the States'
claim that data bearing on developmental neurotoxicity were needed for
chlorothalonil. (Id. at 43919).
The States contended that data was lacking on cumulative effects
due to EPA's finding that chlorothalonil was a member of a related
group of chemicals. In response, EPA reviewed the data on
chlorothalonil and these chemicals and concluded that chlorothalonil
did not share a common mechanism of toxicity with these chemicals, and
thus combined exposure to chlorothalonil and these chemicals would not
produce cumulative effects. Therefore, EPA found that no additional
data was needed on potential cumulative effects from exposure to
chlorothalonil and these chemicals. (Id. at 43922).
On endocrine effects data, the States' entire argument was that
because EPA had not obtained data under the
[[Page 39323]]
endocrine screening program on chlorothalonil it was legally obligated
to retain the 10X children's safety factor. EPA responded that the
States had misread the statute and not considered the factual
information bearing on chlorothalonil. The children's safety provision,
EPA noted, does not impose rigid rules regarding retaining the
children's safety factor if particular pieces of data are missing.
Rather, EPA pointed out that the safety provision gives EPA the
discretion to evaluate the completeness of the database and determine
if reliable data are available to choose an additional safety factor
different than 10X that is protective of the safety of children.
Nothing in the endocrine screening provision or its legislative
history, EPA concluded, overturned this discretion granted EPA under
the children's safety provision. (Id. at 43920). Further, EPA took into
account that its existing data requirements for pesticides included
testing very similar to that which had been proposed for use in the
endocrine screening program. A review of the relevant test data for
chlorothalonil showed that chlorothalonil is not an endocrine
disruptor. EPA concluded that it had adequate reliable data on
chlorothalonil's potential to cause endocrine effects to determine that
it was safe to remove the children's safety factor. (Id. at 43921).
Given its conclusion - based on interpretation of the statute as
well as a thorough review of all of the extensive test data on
chlorothalonil - that adequate, reliable data were available on
developmental toxicity, cumulative effects, and endocrine effects, EPA
rejected the States' claim that EPA was required to retain the 10X
children's safety factor for chlorothalonil. Because the States'
argument that the chlorothalonil tolerances are unsafe and must be
revoked was based entirely on retention of the 10X children's safety
factor, EPA denied its petition to revoke these tolerances.
VI. The States' Objections
On October 2, 2006, three of the four petitioning States (New York,
Connecticut, and Massachusetts) filed objections to EPA's denial of
their petition. (Ref. 2). EPA finds the objections to be somewhat
unclear. To the best of its understanding, EPA believes the objecting
States are making four separate, but related, objections.
First, the States take issue with EPA's denial of the petition as
to alachlor and metribuzin based on the conclusion that application of
the children's safety factor for these pesticides would not change the
determination on these pesticides' safety. The States claim that EPA
made its determination on the need for the children's safety factor
based on the size of the risk posed by these pesticides as opposed to
the ``merits.'' (Id. at 7).
Second, the States claim that EPA ``manipulated'' exposure data
using ``statistical sleight-of-hand techniques'' to make pesticide
exposure levels appear to be lower. (Id. at 2, 5). The objected-to
techniques are reliance on data showing the percent of a crop treated
with a pesticide and data showing the effect of food processing on
residue amounts. The States argue that ``EPA's use of such techniques
are [sic] counter to the intent of the FQPA to protect infants and
children from unsafe exposure to pesticides.'' (Id. at 5).
Third, the States renew their claim that EPA lacks data on
endocrine disruption. The States allege that ``[e]ndocrine disruption
was not considered in the FQPA assessment because EPA does not yet have
in place the endocrine disruption screening program that was required
by the FQPA to have been completed by 1999.'' (Id. at 3). Additionally,
the States argue that EPA has ignored ``the growing body of evidence
that the effects of endocrine disrupting chemicals can be associated
with very low doses, especially if exposure occurs in vulnerable stages
such as fetal development.'' (Id. at 4).
Finally, the States argue that EPA removed the children's safety
factor for these pesticides despite lingering uncertainty concerning
their safety. As support for the assertion of uncertainty, the
objecting States cite to EPA's description of the adverse effects seen
in animal studies with several of the pesticides. (Id. at 7-8).
The States do not include in their objections any of the claims in
their petition regarding lack of data on developmental neurotoxicity or
cumulative effects.
VII. EPA's Response to the Objections
For the reasons stated below, EPA denies each of the four
objections lodged by the States. EPA's response to objections is
necessarily circumscribed by the scope of the objections. Section 408
contains a mandatory exhaustion provision which requires that issues be
presented and resolved by EPA in administrative proceedings prior to
judicial review. (21 U.S.C. 346a(g) and (h)). This exhaustion
requirement is designed to ``bring the agency's experience to bear on a
contested question'' and make a full record on the dispute to aid in
any judicial review of EPA's action. Nader v. US EPA, 859 F.2d 747,
753-54 (9th Cir. 1988). EPA cannot bring its experience to bear or make
a record on challenges that have not been made. To ensure that EPA can
evaluate the challenges that are made, the statute requires that
objections ``specif[y] with particularity the provisions of the
regulation or order deemed objectionable and stating reasonable grounds
therefor,'' and EPA's regulations make clear that for an objection to
be properly presented it must explain ``with particularity . . . [its]
basis . . . .'' (40 CFR 178.25(a)(2)). For EPA to go beyond the
specific arguments raised in objections, or to treat vague allegations
as a general challenge to an EPA decision, and address matters not
raised with particularity would undermine the purpose for exhaustion
and merely invite objectors to improperly raise issues on judicial
review which had not been exhausted before the Agency.
A. Addressing the ``Merits'' of the Children's Safety Factor
Determination for Alachlor and Metribuzin
For alachlor and metribuzin, EPA denied the States' petition
because grounds for the petition (failure to retain the children's
safety factor) did not support the relief requested (revocation of the
tolerances). The States object to this determination arguing that EPA
should not decide whether to apply the children's safety factor based
on the risks posed by a pesticide but instead based on the ``merits.''
Although EPA does not disagree with the general thrust of this
proposition, EPA does not believe it has any relevance to EPA's
decision on the petition as to alachlor and metribuzin. In responding
to the States' petition, EPA did not decide whether the children's
safety factor should be retained for alachlor and chlorothalonil. To
the contrary, EPA simply assumed that the State's contention on the
children's safety factor was correct for the purpose of determining
whether it affected the safety determination. When it became clear the
State's contention (that the children's safety factor should be
retained) did not support their claim that the tolerances were unsafe,
EPA denied the petition for failing to show the tolerances were unsafe.
EPA believes it is appropriate for it to refuse to adjudicate the
merits of claims where it can be shown that the claims - even if true -
- do not justify the relief requested. In related circumstances, the
Supreme Court has refused to require agencies to undertake such an
``exercise in futility.'' (Weinberger v. Hynson, Westcott & Dunning,
Inc., 412 U.S. 609, 621 (1973) (upholding FDA's authority to deny an
administrative hearing on a
[[Page 39324]]
new drug application when the hearing requestor had not offered any
evidence showing the statutory standard for approval could be met)).
EPA has enshrined this principle in its regulations governing
objections and requests for hearings by providing that hearings will
not be granted as to ``factual issues that are not determinative with
respect to the action requested. For example, a hearing will not be
granted if the Administrator concludes that the action would be the
same even if the factual issue were resolved in the manner sought.''
(40 CFR 178.32(b)(3)).
Accordingly, EPA denies the objection that it was required to
determine whether the children's safety factor should be applied for
alachlor and metribuzin on the ``merits.'' EPA is not required to
adjudicate issues that, even if substantiated, would not support the
relief requested in the petition.
B. Use of Data on Percent Crop Treated and Residue Reduction from
Processing
1. Overview/failure to raise issue in petition. The States object
to the lawfulness of EPA's reliance on percent crop treated information
and food processing factors in assessing the risk to the three
pesticides. According to the States, reliance on percent crop treated
data runs ``counter to the intent of the FQPA to protect infants and
children from unsafe exposure to pesticides . . . because EPA's methods
have resulted in a failure to address individual exposures.'' (Ref. 2
at 5, 6). Individuals are not protected, the States contend, when EPA,
in estimating pesticide exposure, takes percent crop treated data into
account by assuming that consumers eat a mixture of pesticide-treated
and untreated food and thus are exposed to an average of the residues
on the treated and untreated commodities. This approach, the States
argue, spreads a pesticide's exposure - by a ``statistical sleight-of-
hand'' -- over the entire population instead of focusing on the
individuals who eat the treated commodities. The States assert that if
EPA's approach was applied to the enforcement of drunk driving laws,
highway patrol officers could not make drunk driving arrests based on
an individual driver's blood alcohol level but instead would have to
examine the average blood alcohol levels of all drivers. As to the
effect of food processing on residue levels, the States allege that EPA
assumes that reductions in pesticide residues that occur as a result of
food processing will also occur in unprocessed raw foods. Finally, they
also assert that EPA has limited data on food processing's effect on
residue levels.
As an intial matter, EPA believes that such an objection is
improper, for the most part, as beyond the scope of the denial order.
The objection is appropriate, if at all, only as to EPA's decision as
to metribuzin, and even then, only as to reliance on percent crop
treated data. Objections must be made with ``particularity [as to] the
provisions of the . . . order deemed objectionable . . . .'' (21 U.S.C.
346a(g)(2)). The FFDCA's tolerance revocation procedures are not some
sort of ``game,'' whereby a party may petition to revoke a tolerance on
one ground, and then, after the petition is denied, file objections to
the denial based on an entirely new ground not relied upon by EPA in
denying the petition. (See Vermont Yankee Nuclear Power Corp. v. NRDC,
435 U.S. 519, 553 (1978)).
Although it is clear on the face of the alachlor and chlorothalonil
REDs that EPA relied on percent crop treated and processing data and
factors in assessing the chronic risk these pesticides posed, (Ref. 4
at 56, 83-83; Ref. 6 at 28-31), the States did not once mention a
concern with the lawfulness of this practice in their petition to
revoke tolerances. Understandably, given the States' silence regarding
reliance on percent crop treated data and processing factors, EPA did
not address this issue in its denial order as to alachlor and
chlorothalonil. To the contrary, EPA's denial order for these
pesticides was based on other grounds. For chlorothalonil, EPA denied
the States' claim that EPA must retain the 10X children's safety factor
by rejecting the States' arguments that the safety factor must be
retained because of missing data on neurotoxicity, endocrine effects,
and cumulative effects. As to alachlor, the denial order was based on
an even more narrow ground - that the States had failed to show that
retention of the 10X children's safety factor would render the alachlor
tolerances unsafe. The States' error, EPA pointed out, was in
misreading the RED's explicit conclusions on the size of the alachlor
risk. The only issue, therefore, that the order resolved was what the
RED stated with regard to the risk of alachlor. Accordingly, because
the denial order as it pertains to alachlor and chlorothalonil did not
address reliance on percent crop treated data and processing factors,
the States' objection to use of percent crop treated data and
processing factors is not an objection to the ``provisions of the . . .
order.'' (21 U.S.C. 346a(g)(2)).
Arguably, the States' objection to the use of percent crop treated
data is timely and appropriate as to reliance on percent crop treated
data for metribuzin because EPA relied on percent crop treated data for
the first time in denying the petition as to that pesticide. However,
as with alachlor and chlorothalonil, there does not appear to be any
basis for the processing factor objection as to metribuzin. Not only
does the metribuzin RED discuss processing data that was relied upon,
but also the only processing factors used in the revised risk
assessment cited in the petition denial were factors used to increase
estimated exposure values in processed food. (Ref. 7 at 26, 102; Ref. 8
at 5). Notably, the only specific processing factor cited in the
objections as problematic is a processing factor that pertains to a
different pesticide (chlorothalonil) and was used to show residues were
reduced upon food processing. (Ref. 2 at 6).
Turning to the merits, for the reasons explained below, EPA finds
the States' objection to the use of percent crop treated data and
processing factors to be without basis. In brief, EPA concludes that:
i. It has ample legal authority to consider percent crop treated
data and food processing factors in making a safety determination under
section 408 of FFDCA;
ii. Reliance on percent crop treated data in risk assessment is not
inconsistent with protection of individuals and was used in a
conservative fashion in estimating metribuzin exposure; and
iii. Processing factors are only applied to processed foods.
2. Legal authority. It is not clear from the States' objections as
to whether they are arguing that EPA may never use percent crop treated
and food processing data in estimating pesticide exposure or whether
EPA has used it in an impermissible fashion with regard to the
challenged pesticide tolerances. To the extent that the States are
contending that the ``intent of the FQPA'' bars EPA as a legal matter
from relying on percent crop treated information and processing data
factors in estimating pesticide exposure and risk, they are mistaken.
Such an interpretation is contrary to the plain language of the
statute.
Section 408(b)(2)(D)(vi) directs that EPA ``shall consider, among
other relevant factors -- . . . available information concerning the
aggregate exposure levels of consumers . . . to the pesticide chemical
residue . . . .'' (21 U.S.C. 346a(b)(2)(D)). The extent of use of a
pesticide and the degree to which a pesticide residue degrades or
concentrates during processing are clearly relevant information
[[Page 39325]]
``concerning aggregate exposure levels of consumers.'' Further,
Congress expressly recognized in the FQPA that this type of information
is relevant and appropriate to a FQPA safety analysis. The statute, as
amended by the FQPA, contains special provisions placing certain
requirements upon EPA when it relies upon percent crop treated data in
chronic risk assessments or anticipated residue data. (21 U.S.C.
346a(b)(2)(E) and (F)). Anticipated residue data is a term of art
encompassing, among other things, data on the effect food processing
has on pesticide residue levels. (70 FR at 46731-46732; Ref. 9) This
term was in use by EPA well before such language was adopted in the
FQPA. (Ref. 10; see, e.g., 54 FR 33044, 33045, August 11, 1989).
Given this clear legal authority, the States' vague allegations
that the use of percent crop treated data or processing factors runs
counter to the intent of the FQPA are meritless.
3. Use of percent crop treated data and individual exposure. The
States' claim that EPA's use of percent crop treated data is not
protective of individuals appears to be based on a lack of
understanding of (1) the differences between acute and chronic risks
and (2) the different techniques EPA uses for incorporating percent
crop treated information into risk assessments. At times, EPA uses
percent crop treated data in estimating exposure for both chronic and
acute risk assessments. Such data, however, is used in a different
manner in these assessments due to the differences in how acute and
chronic exposures may result in harm. Moreover, as to both acute and
chronic risk, EPA is concerned with the risk to an individual within
major, identifiable population subgroups and incorporates percent crop
treated data in a manner consistent with that concern. Further
explanation of this approach is provided below.
With a chronic risk, EPA is concerned with adverse effects that
occur from the cumulative effect of repeated exposures over an extended
time period (i.e., generally a period of 1 year or more for dietary
exposure). The focus for a chronic exposure assessment is not on the
level of any one exposure or even the variation in exposure from day-
to-day so much as the general level of the continuing exposure. Thus,
in estimating chronic pesticide exposure, EPA uses average daily
pesticide exposure over the appropriate time period. In estimating
average daily pesticide exposure, EPA takes into account that, given
the national distribution of food in the United States, over a chronic
timeframe a person will consume food from a mixture of sources--
regional, national, and international--as well as food grown at
different times of the growing season. It is likely, therefore, that to
the extent a food commodity is not uniformly treated with a given
pesticide, the consumer will over time be exposed to a fairly
representative sample of treated and untreated commodities.
Accordingly, in refined exposure estimates for chronic pesticide
exposures, EPA generally averages dietary pesticide exposure from a
food based on the percentage of that food that has been treated with
the pesticide. For example, if the estimated residue value for a
pesticide on treated blueberries is 1 part per million (ppm) and half
of the blueberry crop is treated, EPA would estimate the chronic
pesticide exposure level from blueberries using the assumption that all
blueberries contain 0.5 ppm of the pesticide (i.e., treated blueberries
bear 1 ppm pesticide residues and over time a person gets an equal
mixture of treated and untreated blueberries). EPA has long used
percent crop treated data in this manner in chronic risk assessments
and Congress explicitly recognized the appropriateness of this method
of estimating pesticide exposure in the FQPA. (21 U.S.C.
346a(b)(2)(F)).
With acute hazards, EPA is concerned with an adverse effect that
can result from a single pesticide exposure or pesticide exposure over
a single day to an individual. Thus, acute pesticide exposure
assessments are designed to measure or estimate the maximum amount of
residue that may be present in a single commodity serving or meal.
EPA's traditional method of using percent crop treated data in chronic
risk assessments is problematic for acute risk assessments because it
masks the highest levels of pesticide residues expected in food by
averaging residue values from treated and untreated commodities in
estimating pesticide exposure. For this reason, EPA, up until the mid-
1990's, did not use percent crop treated data in acute risk
assessments. Instead, for acute risk assessments, EPA assumed that all
commodities for which a pesticide had a tolerance contain residues at
the tolerance level. That changed, however, with the introduction in
the last decade of probabilistic risk assessment analysis.
Probabilistic analysis, when used in pesticide exposure/risk
assessment, is ``a statistical method where the range of exposures to
pesticide residues and the probability of exposure to any particular
level is quantified.'' (Ref. 3 at 22). Probabilistic exposure
assessments are particularly helpful in realistically estimating
pesticide exposure levels from short-term exposures (e.g., a single
meal) where there are multiple variables affecting pesticide exposure
levels. For pesticide exposures from food these variables can include:
i. Several different foods may be consumed in differing amounts;
ii. The consumed foods may or may not have been treated with the
pesticide in question; and
iii. Foods that are treated may have a wide range of residue
levels.
Integral to probabilistic analysis of pesticide exposure is information
on differing consumption patterns among individuals, the range of the
levels of pesticide residue in treated food, and the percent of food
that has been treated with a pesticide. Importantly, information on
percent crop treated is not used in a probabilistic analysis to average
residue levels between treated and untreated crops but rather solely to
determine ``the probability of [an individual] encountering a treated
commodity.'' (Ref. 11 at 14). Thus, percent crop treated information is
used in a fundamentally different fashion in probabilistic acute risk
assessments than in non-probabilistic chronic risk assessments. (The
Agency currently does not use probabilistic techniques for chronic risk
assessment due to limitations in its food consumption database.)
The States' challenge to EPA's use of percent crop treated data for
metribuzin is flawed because the States attack the appropriateness of
the exposure estimate for a chronic risk assessment based on concerns
more applicable to acute risk. The States argue that the adjustment of
residue values by the percentage of the treated crop understates
exposure of individual children because ``if a child is eating treated
carrots, he or she is consuming carrots that all contain pesticide
residues . . . .'' (Ref. 2 at 5). EPA generally agrees that if the
concern is acute risk, it would be inappropriate to estimate acute
exposure for non-blended commodities by multiplying the expected
residue value in a food (e.g., carrots) by an estimate of the percent
of carrots treated with the pesticide. Acute exposure assessments
should be designed to identify actual exposures that can occur to an
individual at a single meal or in a single day. For metribuzin (and
alachlor and chlorothalonil as well), however, EPA used percent crop
treated data only for estimating chronic pesticide exposure and risk.
For chronic dietary risk, it is generally exposure over a period of at
least 1 year that matters and over such a time period a person is
likely to
[[Page 39326]]
consume a mixture of treated and untreated commodities.
For the same reason, the States' drunk driving hypothetical is not
persuasive. Their hypothetical is somewhat analogous to the situation
EPA faces in assessing acute pesticide risk - both the highway patrol
officer investigating a suspected drunk driver and EPA in evaluating
acute risk from pesticide exposures are interested in ascertaining an
individual's actual level of exposure (to alcohol or pesticides,
respectively) at a certain point in time. However, the hypothetical has
no relevance to chronic pesticide risk assessment - the type of risk
assessment involved in the State's objections -- because with chronic
pesticide risk it is appropriate for EPA to focus on a person's general
pesticide exposure level over an extended period rather than one
particular exposure at a single point in time.
The States additionally argue that because ``families purchase food
from the same place each week, a family could virtually always eat
treated carrots . . . .'' (Ref. 2 at 5). What the States fail to take
into account, however, is that, although a family may do its food
shopping at the same store week-to-week and even may purchase a bag of
carrots every week, from week-to-week the bag of carrots is likely to
come not just from a different farm but a different region of the
United States due to the national distribution of food commodities.
Perishable foods are available on a nearly year-round basis in the
United States only because the country's national food distribution
network ships foods nationwide from different parts of the country or
world as dictated by the differing growing seasons in these areas. For
foods such as grains, root crops, or other commodities which have
significantly greater storage times, a broad mixing of commodities
occurs due to centralization of storage facilities prior to the
commodities entering the food distribution network.
The States also fail to take into account the conservative manner
that EPA uses percent crop treated data to estimate chronic exposure
both generally and with regard to how these data were used for the
metribuzin risk assessment. As discussed earlier, EPA uses a tiered
approach to assess pesticide exposure in food, starting with a worst
case assessment which assumes that all foods with tolerances contain
the pesticide at the tolerance level (Tier 1) and then refining those
assumptions through a series of tiers that increasingly incorporate
data designed to measure residues at the time of consumption. Higher
tiers (Tiers 3 and 4) rely heavily on monitoring data of pesticide
residues in food sampled either at central food distribution points or
in retail locations. Percent crop treated data is commonly introduced
in Tier 2 as an initial refinement of worst case assumptions, and that
is how it was used in the metribuzin risk assessment. There, EPA
conducted primarily a Tier 2 assessment assuming that foods with
metribuzin tolerances contained residues at the tolerance level reduced
only by the percentage of these foods treated with metribuzin. EPA's
experience has been that Tier 2 assessments significantly overstate
exposure levels compared to higher tier assessments relying on
monitoring data. This is well illustrated by the metribuzin risk
assessment. For one crop commodity in that assessment, potatoes, EPA
used monitoring data to estimate exposure levels rather than a
combination of assuming tolerance level residues diminished only by the
percent of the crop treated. The monitoring data showed that only 1 out
of 1,472 potato samples had metribuzin residues. In that sample,
metribuzin was detected at a level of 0.05 ppm. Conservatively, EPA
assumed in its risk assessment that all potatoes contain 0.05 ppm of
metribuzin. Despite this conservative approach to the monitoring data,
a Tier 2 assessment relying on percent crop treated data and tolerance
level residues in potatotes would have produced a much higher exposure
estimate than the assessment relying on monitoring data. The tolerance
for metribuzin in potatoes is 0.6 ppm. Decreasing that value by the
percent crop treated value for metribuzin use on potatotes (70 percent)
yields an estimated residue value in potatoes of 0.42 ppm, or almost an
order of magnitude higher than the value derived from monitoring data
which was used in the metribuzin risk assessment. (Ref. 8). There would
have been an even bigger gap between a Tier 2 exposure assessment for
potatoes and an assessment relying on monitoring data if EPA had made
the reasonable, but still conservative assumption, that all potato
samples in which no metribuzin was detected contained metribuzin at
half the level of detection for the analytical method (levels of
detection ranged from 0.016 to 0.030 ppm). (Ref. 12).
The conservativeness of EPA's metribuzin exposure assessment is
further demonstrated by the most recent pesticide monitoring data (for
the years 2002 - 2005) on foods for which EPA relied on percent crop
treated information (asparagus, barley, carrots, corn (field, sweet,
and pop), peas (dried and succulent), sugarcane, tomatoes, and wheat).
Over these 4 years, USDA, through its Pesticide Data Program has
collected pesticide monitoring data on asparagus, barley, carrots, corn
(sweet), peas (succulent), tomatoes, and wheat. Out of 10,313 samples,
only 11 showed metribuzin residues. (Ref. 13). These data demonstrate
that, for all practical purposes, meaningful levels of metribuzin are
nonexistent in food. Thus, EPA's use of percent crop treated data to
refine the worst case assumption of all food bearing tolerance level
residues in estimating chronic human exposure to metribuzin is very
unlikely to have resulted in an understatement of such exposure. The
States, for their part, offer no evidence to support their contention
that EPA's use of percent crop treated data in the metribuzin risk
assessment has led to an underestimate of metribuzin exposure.
Accordingly, the States' objection to the use of percent crop
treated information is denied. First, as discussed in Unit VII.B.1.,
EPA denies this objection as to alachlor and chlorothalonil because it
exceeds the scope of denial order and the petition underlying it.
Second, as is explained in Unit VII.B.1., to the extent the States are
making a legal argument that EPA may never consider percent crop
treated data, that argument is defeated by the plain language of the
statute. Third, to the extent they are arguing that the manner in which
EPA uses percent crop treated data in chronic risk assessments
understates pesticide exposures to individuals, their argument is not
well-taken because they confuse chronic and acute exposure and risk;
they do not take into account that the food distribution system in this
country is national in scope; and they do not recognize the
conservative fashion in which percent crop treated data was used in the
metribuzin risk assessment to estimate exposure. Moreover, the States
have offered no evidence to support their speculations about EPA
underestimating exposure. Finally, the States have made no challenge to
the accuracy of EPA's factual findings with regard to the percent crop
treated data on metribuzin.
4. Use of processing data. The States object to the use of food
processing factors claiming that such factors ``are generally based on
limited test data from certain crops and extrapolated to other crops or
conditions using a variety of statistical techniques.'' (Ref. 2 at 5).
Further, citing to the chlorothalonil RED, the States claim that EPA
wrongfully used a processing factor for carrots showing that
chlorothalonil residues declined significantly in cooked carrots in
estimating exposure to chlorothalonil from raw carrots.
[[Page 39327]]
According to the States, EPA erred because ``if a child is eating
freshly treated raw carrots, the processing factor should not apply.''
(Ref. 2 at 6). The States imply that it is common practice for EPA to
apply processing factors to raw food.
A bit of background might be helpful here. In estimating exposure
to pesticide residues in food, EPA uses residue data from commercial
food processing studies as well as, on occasion, data from in-home food
preparation studies. (Ref. 3). These studies reveal whether commercial
or home processing concentrates or reduces pesticide residues. Based on
the degree of reduction or concentration of residues in food
processing, EPA computes processing factors which when applied to level
of residues found in raw foods will calculate the level of residue
expected in the food following processing.
Data on the commercial processing of food (e.g., processing apples
into apple juice; separating wheat into grain and bran) is routinely
required as a part of pesticide registration under FIFRA and the
tolerance petition process under the FFDCA. (40 CFR 158.240; Ref. 14).
EPA has extensive guidance on the use of such data in pesticide
exposure assessments including the appropriateness of extrapolating
between data on different commodities. (Refs. 9 and 14). In the absence
of commercial processing data, EPA relies on default processing factors
in estimating exposure in processed foods. These default processing
factors are extremely conservative in that they assume that:
i. Residues are concentrated to the maximum extent physically
possible in processed foods, and
ii. When a raw commodity is processed into two separate processed
commodities, all of the pesticide in the raw commodity is translocated
to both processed commodities.
For example, in estimating residues in processed commodities resulting
from the juicing of apples, EPA uses default processing factors that
assume that all pesticide residues from the apple concentrate in both
the juice and the remaining dry matter, apple pomace, which is fed to
animals. (70 FR at 46733-46734). Data on pesticide residue levels
following in-home food preparation is not routinely required and
reliance on this information is used in risk assessments relatively
rarely. Generally, these data are produced by pesticide manufacturers
in an attempt to demonstrate that EPA has overstated residues in food
as consumed.
The States' objection as to the use of processing factors is
replete with problems. First, as noted above, if the States were
concerned about the use of processing data in calculating processing
factors, those concerns should have been raised in its petition. The
REDs for all three pesticides extensively discussed processing data.
Second, the States' claim that processing data are ``limited'' is too
general and vague to satisfy the regulatory requirement that the basis
for objections be stated with ``particularity.'' (40 CFR 178.25(a)(2)).
The States neither point to specific data missing on these pesticides
nor address the extensive EPA guidance and test guidelines concerning
the collection and use of processing data. Third, the States' claim
that EPA applies processing factors to raw foods in estimating residue
levels in raw foods is specious. In support, the States assert that, in
the chlorothalonil RED, EPA used a processing factor that showed a
marked reduction of residues during the cooking of carrots to estimate
the residues in raw carrots. The States are wrong. As the RED clearly
states, the processing factor of 0.005 is for ``all cooked or processed
food forms'' of carrots. (Ref. 6 at Table 6). Further, although the
printouts from the computer risk assessment runs used to compile the
1998 chlorothalonil RED do not contain a high level of detail, later
chlorothalonil risk assessments plainly show that the cooking factor
for carrots is only applied to ``cooked'' carrots and not to
``uncooked'' carrots. (Ref. 15). The States, again, cite no basis for
their claim to the contrary. The States' objection here is based on
nothing more than speculation and incorrect assumptions and is,
therefore, denied.
C. Data on Endocrine Effects
The States object to EPA's removal of the children's safety factor
for chlorothalonil arguing that ``[e]ndocrine disruption was not
considered in the FQPA assessment because EPA does not yet have in
place the endocrine disruption screening program that was required by
the FQPA . . . .'' (Ref. 2 at 3). The States further allege that ``EPA
failed to consider other published information on endocrine disruption,
and instead has made a unilateral decision to wait for the endocrine
disruption program to be established before it can make any
determination about endocrine disruption potential.'' (Id.).
These claims have no factual basis. In its order denying the
States' petition, EPA described the multiple chlorothalonil studies it
had addressing potential endocrine effects and found that
chlorothalonil was not an endocrine disruptor. (71 FR at 43921). The
States have made no credible challenge to EPA's scientific
determination based on this extensive database. Further, the States are
simply wrong in claiming that potential endocrine disruption was not
considered by EPA.
In reviewing EPA's disposition of the endocrine disruptor issue in
its petition denial, EPA has discovered one error in that document.
There, EPA stated that the chlorothalonil two-generation reproduction
study in rats was conducted ``under the most recent testing
guidelines.'' (71 FR at 43921). Although this chlorothalonil study is
largely consistent with these testing guidelines it was performed and
reviewed by EPA prior to the finalization of the revised guidelines. In
light of this misstatement, EPA has once again carefully reviewed the
evidence on whether chlorothalonil is an endocrine disruptor. EPA
reaffirms its earlier conclusion that chlorothalonil is not an
endocrine disruptor for the reasons below.
EPA has extensive data bearing on chlorothalonil's potential to
disrupt endocrine systems. For all pesticides that result in residues
in foods, EPA reviews numerous studies that bear on a pesticide's
potential endocrine effects. (71 FR at 43921). For chlorothalonil, EPA
reviewed two complete sets of data on developmental toxicity,
reproductive toxicity, subchronic toxicity, chronic toxicity, and
cancer. (Ref. 16). Developmental studies evaluate several endpoints
susceptible to endocrine influence including effects on maternal animal
fertility and pregnancy rates and on pup viability and sex ratios in
pups. (71 FR at 43921). The chlorothalonil studies showed no treatment-
related effects on any of these endpoints. (Refs. 17, 18, 19, and 20).
Subchronic, chronic, and cancer studies must include examination of
organs that play a critical role in the endocrine system (e.g., testes,
epididymides, uterus, ovaries, mammary glands, and thyroid with
parathyroid). These organs are removed, weighed and subjected
microscopically to examination for evidence of any pathology. (71 FR at
43921). For chlorothalonil, no effects were seen in these organs in
sub-chronic, chronic, and cancer studies involving rats, dogs, and
mice. Rather, these studies consistently showed non-endocrine mediated
effects on the stomach and kidneys, or on body weight. (Refs. 19, 21,
22, 23, 24, 25, 26, 27, 28, 29, 30, 31, and 32).
[[Page 39328]]
The most important study for evaluating endocrine effects is the
two-generation reproduction study in rats. (71 FR 43921). This study
has been proposed by the Endocrine Disruptor Screening Program as the
critical study for resolving whether chemicals are endocrine disruptors
in mammals. The two-generation reproduction study examines numerous
endpoints potentially influenced by the endocrine system including the
endocrine-related organs noted above, as well as various reproduction
endpoints both with regard to adults and pups. The most recent
amendment to the guidelines for the reproduction study recommended
expansion of the study to include consideration of the time of vaginal
patency and balanopreputial separation in pups and determination of
estrous cycle length and sperm enumeration, morphology, and motility in
adults. (Ref. 33). Although the most recent chlorothalonil reproduction
study was conducted prior to finalization of these amendments to the
guideline, it nonetheless addressed all of these endpoints other than
examination of adult sperm. Consistent with the other chlorothalonil
toxicity studies, the reproduction study reported similar effects on
the stomach and kidneys and no effects on the endocrine-related organs.
A delay in vaginal patency and balanopreputial separation was noted at
the high dose in pups; however, this effect was determined to have been
a consequence of body weight decrements during lactation and not an
endocrine effect, based on the fact that no differences were seen in
mating and reproductive performance between treated and control
animals. (Ref. 34). The findings in this study were similar to those in
an earlier reproduction study with chlorothalonil. (Ref. 35).
What each of these studies show is that chlorothalonil's toxicity
is not endocrine-mediated but rather operates by quite different
mechanisms. Chlorothalonil causes a thickening and roughening,
including hyperplasia and hyperkeratosis, of the lining (epithelium) of
the non-glandular portion of the stomach and adverse effects on the
kidney including increased weight and tumors. Chlorothalonil's effects
on the stomach are due to irritation of the stomach lining followed by
cytotoxicity, necrosis, increased cell proliferation, and restorative
hyperplasia. The kidney effects are caused by chlorothalonil's
disruption of enzymatic processes in the kidney leading to vacuolar
degeneration, rapid cellular regeneration and proliferation, and
eventually tumor formation. These effects are not related to the
endocrine system. (Ref. 16). In fact, repeated examinations of the
primary organs in the endocrine system in chlorothalonil studies have
shown no adverse effects. Similarly, chlorothalonil's effect on body
weight is a non-specific response not targeting any of the body's
organs and thus not endocrine-related. Although data on effects on
adult sperm were not collected in the reproduction study, repeated
examinations of the testes in that and other studies showed no concern
with this organ. Accordingly, EPA reaffirms its prior conclusion that
it has sufficient data on the potential of chlorothalonil to cause
endocrine effects in the young to remove the additional children's
safety factor with regard to this endpoint.
For the first time in this proceeding, the States claim in their
objections that EPA ignored ``published data [on endocrine disruption]
that suggests that the full 10X factor should be applied . . ..'' (Ref.
2 at 4). Specifically, the States cite to two scientific articles which
they claim document ``the growing body of evidence that the effects of
endocrine disrupting chemicals can be associated with very low doses,
especially if exposure occurs in vulnerable stages such as during fetal
development.'' (Id.). EPA has several difficulties with this claim.
First, for the reasons cited in Units VII.B., EPA questions the
appropriateness of raising new factual claims at this stage of the
proceedings. Second, the two articles cited are, for the most part,
general overview discussions of endocrine disrupting chemicals, and do
not show - and the States do not claim they show - that chlorothalonil
is an endocrine disruptor.\1\ Third, EPA does not understand the
relevance the level at which endocrine disruptors cause effects has
with regard to a pesticide such as chlorothalonil which has been found
not to be an endocrine disruptor.
---------------------------------------------------------------------------
\1\ One of the articles, contains an EPA list of endocrine
disruptors which includes chlorothalonil. That list is dated October
24, 1996 and provides no reason for chlorothalonil's inclusion. The
article notes that there is ``no doubt this list will change rapidly
in the near future. Some of the chemicals on this list will probably
be dropped from future consideration and other new ones are expected
to be added.'' (Keith, Lawrence H., Environmental Endocrine
Disruptors, Pure & Applied Chemistry., Vol. 70,No 12 pp. 2319-2326,
at 2321 (1998)). As EPA has detailed in its order on the petition
and this order, it has extensive data on chlorothalonil that shows
that chlorothalonil is not an endocrine disruptor. As mentioned
above, the objectors have provided no factual grounds challenging
that determination.
---------------------------------------------------------------------------
Accordingly, EPA denies the States' objection concerning endocrine
disruptor data. To recap, EPA denied the States' petition which sought
the revocation of the chlorothalonil tolerances based on the States'
claim that EPA had unlawfully removed the children's safety factor
given the alleged absence of data on, among other things, endocrine
disruption. EPA explained that:
i. It was not legally compelled to retain the children's safety
factor because data on chlorothalonil had not been collected under the
endocrine disruptor screening program;
ii. It had adequate data on whether chlorothalonil was an endocrine
disruptor; and
iii. Those data showed that chlorothalonil was not an endocrine
disruptor. (71 FR at 43919-43921).
In its objections the States make no specific challenge to EPA's
factual determination as to the second and third points; rather, they
do little other than repeat the assertion presented in their petition
that EPA cannot remove the children's safety factor until data is
gathered under the endocrine disruptor screening program. EPA,
therefore, denies the objections based on the legal and unchallenged
factual grounds asserted in its order denying the petition. (See 71 FR
at 43906). To the extent the States believe that the misstatement
concerning conformance of the chlorothalonil reproduction study to the
most recent testing guidelines caused it not to dispute EPA's factual
findings, EPA will entertain supplemental objections addressing this
factual issue so long as such supplemental objections are filed within
60 days of the date of publication of this order and otherwise meet the
requirements governing objections in section 408(g) of FFDCA and 40 CFR
part 178.
D. Alleged Uncertainty with Regard to Safety
The States object that there is uncertainty with regard to the
safety of each of the pesticides and, for that reason, EPA should have
retained the 10X children's safety factor. To demonstrate the alleged
uncertainty, the States do nothing more than quote language from EPA's
denial order that summarized the toxicological effect findings for
chlorothalonil, alachlor, and methomyl. Presumably, the States are
contending that the mere fact that at some dose a pesticide can cause
an adverse effect in an animal study is sufficient to show a level of
uncertainty that bars EPA from exercising its discretion to vary from
the tenfold children's safety factor. As explained below, this argument
is without a basis. The mere presence of an adverse effect
[[Page 39329]]
in a toxicology study is insufficient without more factual context to
show uncertainty. Because the States do not provide that context, their
argument collapses at its inception.
Before addressing the merits of the States' objection, as a
preliminary matter, EPA notes that this objection only applies to
chlorothalonil and not to methomyl, alachlor, or metribuzin since EPA
declined to retain the children's safety factor only as to
chlorothalonil. As discussed above, the methomyl petition is still
pending before EPA, and as to alachlor and metribuzin EPA did not
address the issue of whether the children's safety factor should be
retained given that, even if the factor is retained (due to uncertainty
or some other reason), the tolerances would still meet the safety
standard. Finally, even as to chlorothalonil, EPA questions the
appropriateness of this objection given that it is based on arguments
not included in the States' petition.
Turning to the merits of the objection-assuming it is properly
filed as to chlorothalonil -- the objection can be quickly dismissed.
The States are correct to note that the issue of whether there is
uncertainty regarding the safety of children is a key consideration in
a determination as to whether to retain or modify the children's safety
factor. However, the States fail to make a significant argument that
there is uncertainty regarding the safety of chlorothalonil. Certainly,
the mere repetition of EPA's findings for chlorothalonil on the adverse
effects seen in animal studies does not demonstrate uncertainty as to
the safety of infants and children.
Adverse effects found in toxicological animal studies with a
pesticide comprise just one piece of the complex puzzle informing the
evaluation of uncertainty that is critical to the children's safety
factor determination. Standing alone, they show little regarding the
certainty or uncertainty regarding risks to infants and children.
Rather, this certainty or uncertainty, which drives the determination
of the children's safety factor, is informed by a weight-of-the-
evidence evaluation of many issues including: what effects are seen in
animals; what dose levels the effects occurred at; how strong the
effects were; whether there was a good dose-response relationship with
regard to the effects; how clearly a threshold for the effects have
been identified; whether similar or related effects were seen in the
same or other species in other studies; whether these effects are seen
in adult and young animals, and, if so, at the same or differing
levels; and what level of protection against the effects is provided by
traditional safety factors. Reliance on a single fact (such as the type
of adverse effect seen in an animal study), in isolation, without
explanation of how it bears on the ultimate safety factor determination
and certainty/uncertainty regarding that determination, is insufficient
to state a meaningful challenge to EPA's conclusion on the children's
safety factor.
For example, the first adverse effect cited by the States is that
``increased kidney weights and hyperplasia'' were seen in a
chlorothalonil chronic rat study and that these effects were used in
calculation of a safe dose for that pesticide. That is all the States
say with regard to the increased kidney weights and hyperplasia. They
do not discuss what dose level the effects occurred at, how significant
the effects were, whether a clear no-effect level was identified for
the effects, what safety factors were used to protect against the
effect in humans, or any of the other issues identified above bearing
on EPA's certainty/uncertainty regarding these effects. By itself, the
fact that an adverse effect occurred shows little, and the failure of
the States to offer any argument as to why such an effect evidences
uncertainty renders their objection deficient on its face.
Accordingly, the States' objection that the children's safety
factor is required for chlorothalonil due to uncertainty raised by
adverse effects is denied. This argument is entirely absent from its
petition and is thus not properly raised as an objection. In any event,
the objection is denied on the merits for a failure to cite relevant
factors or to make a meaningful factual showing on uncertainty.
E. Summary of Findings on the Objections
EPA denies each of the States' four objections for the reasons
summarized below:
Objection #1: EPA was required to determine whether the children's
safety factor should be applied for alachlor and metribuzin on the
``merits.''
In ruling on a petition to revoke tolerances as unsafe, EPA is not
required to resolve substantive issues concerning the children's safety
factor if resolution of those issues in the manner sought by the
petitioner would not alter the safety determination for the challenged
tolerances.
Objection #2: EPA unlawfully relied on percent crop treated data
and processing factors to decrease the estimated risks of the
challenged pesticide tolerances.
First, this objection is improper as to alachlor and chlorothalonil
because the denial order did not rely on percent crop treated data or
processing factors in resolving the objections as to these pesticide
tolerances. The objection as to use of processing factors is improper
as to metribuzin because EPA did not rely on processing factors to
decrease metribuzin exposure estimates in the denial order.
Second, as to the objection with regard to the use of percent crop
treated data in the metribuzin risk assessment, the plain language of
the statute makes clear that EPA may rely on such information and the
States' claims that reliance on such data is not protective of
individual risk were not substantiated. Additionally, EPA's
conservative use of percent crop treated data in the metribuzin risk
assessment is unlikely to have underestimated metribuzin exposure and
the States have presented no evidence to the contrary.
Third, alternate grounds for denying the States' objection to the
use of processing factors include: (1) the States have failed to
particularize their criticism of the use of such information and
instead rely on vague and unsubstantiated allegations; and (2) the
States' claim that EPA uses processing factors to estimate residue
levels in raw, unprocessed food is in contravention of clear record
evidence, and without any substantiation.
Objection #3: EPA has failed to consider endocrine effects for
challenged pesticides because EPA has not obtained data for these
pesticides under the endocrine-screening program and because EPA has
not considered outside literature bearing on endocrine effects.
First, this objection is improper as to alachlor and metribuzin
because the denial order did not resolve any issue regarding endocrine
effects as to these two pesticides. This objection is only properly
filed as to chlorothalonil.
Second, EPA has considered substantial data on the potential
endocrine effects of chlorothalonil and concluded that it is not an
endocrine disruptor. The States' objection does not challenge this
factual determination. The statute does not require that EPA retain the
children's safety factor until the endocrine-screening program is
completed.
Third, the States' claim that EPA has not properly considered
outside literature on endocrine disruption is denied as going beyond
the provisions of the denial order. An alternate ground for denying
this argument is that literature cited by the States is general
[[Page 39330]]
in nature and does not provide information on chlorothalonil.
Objection #4: Where a pesticide causes adverse effects in animal
toxicological studies EPA may not remove the children's safety factor
due to lingering uncertainty concerning its safety.
First, this objection is improperly submitted in that the question
of whether the mere presence of adverse effects in animal toxicological
studies is determinative under the children's safety factor provision
was not addressed in the petition denial order.
Second, an alternate ground for denying this objection is that the
mere citation of adverse effects is inadequate standing alone to
demonstrate uncertainty regarding the safety of a pesticide.
VIII. Judicial Review
This is a final order under FFDCA section 408(g)(2)(C) and is
reviewable in the United States Courts of Appeals pursuant to FFDCA
section 408(h)(1). (21 U.S.C. 346a(g)(2)(C) and 346a(h)(1)). To the
extent supplemental objections are timely filed, as discussed in Unit
VII.C., EPA will issue a separate, reviewable order under FFDCA section
408(g)(2)(C) pertaining solely to any such supplemental objections.
IX. Regulatory Assessment Requirements
As indicated previously, this action announces the Agency's final
order regarding objections filed under section 408 of FFDCA. As such,
this action is an adjudication and not a rule. The regulatory
assessment requirements imposed on rulemaking do not, therefore, apply
to this action.
X. Submission to Congress and the Comptroller General
The Congressional Review Act, (5 U.S.C. 801 et seq.), as added by
the Small Business Regulatory Enforcement Fairness Act of 1996, does
not apply because this action is not a rule for purposes of 5 U.S.C.
804(3).
XI. References
1. Petition of New York, California, Connecticut and Massachusetts
for Modification of Tolerances for Pesticide Chemical Residues
Established in Reregistration Eligibility Determinations for the
Following Chemicals: Alachlor; Chlorothalonil; Methomyl; Metribuzin;
Thiodicarb (December 17, 2004) (petition addressed to Michael O.
Leavitt, Administrator, United States Environmental Protection Agency).
2. Objection of New York, Connecticut, and Massachusetts to Order
Denying Petition to Revoke or Modify Tolerances for Alachlor,
Chlorothalonil and Metribuzin (October 2, 2006).
3. Office of Pesticide Programs, U.S. EPA, ``Available Information
on Assessing Pesticide Exposure From Food: A User's Guide'' (June 21,
2000).
4. Office of Prevention, Pesticides, and Toxic Substances, U.S.
EPA, Reregistration Eligibility Decision: Alachlor (December 1998).
5. U.S. EPA, Permanent Tolerances by Pesticide: Aug. 1996 TIS
(August 2002) (available at http://www.epa.gov/oppsrrd1/tolerance/pdf-
files/TolUniv8-05-2002.PDF).
6. Office of Prevention, Pesticides, and Toxic Substances, U.S.
EPA, Reregistration Eligibility Decision: Chlorothalonil (April 1999).
7. Office of Prevention, Pesticides, and Toxic Substances, U.S.
EPA, Reregistration Eligibility Decision: Metribuzin (February 1998).
8. Office of Prevention, Pesticides, and Toxic Substances, U.S.
EPA, Memorandum from Douglas Dotson to Paula Deschamp, ``Metribuzin
Acute and Chronic Dietary Exposure Assessments'' (April 17, 2006).
9. Office of Pesticide Programs, U.S. EPA, ``Guidance For Refining
Anticipated Residue Estimates For Use In Acute Dietary Probabilistic
Risk Assessment'' (June 15, 2000).
10. U.S. EPA, ``Guidelines for the Use of Anticipated Residues in
Dietary Exposure Assessment'' (March 25, 1991).
11. Office of Pesticide Programs, U.S. EPA, ``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).]
12. Office of Pesticide Programs, U.S. EPA, ``Assigning Values To
Nondetected/Non-Quantified Pesticide Residues In Human Health Food
Exposure Assessments.'' (March 23, 2000).
13. U.S. Department of Agriculture, Pesticide Data Program (2002 -
2005) (available at http://www.ams.usda.gov/science/pdp/download.htm
and in the docket).
14. Office of Prevention, Pesticide, and Toxic Substances, U.S.
EPA, OPPTS Harmonized Test Guidelines: Series 860 Residue Chemistry
Test Guidelines, OPPTS 860.1520 - Processed Food/Feed (August 1996).
15. Office of Prevention, Pesticides, and Toxic Substances, U.S.
EPA, Memorandum from J.R. Tomerlein to Dennis McNeilly/Rosemary Kearns,
``Chlorothalonil: Acute and Chronic Dietary Exposure Assessments for a
Tolerance on Edible Podded Peas Without a U.S. Registration'' (December
15, 2004).
16. Office of Prevention, Pesticides, and Toxic Substances, U.S.
EPA, Memorandum from P.V. Shah to Pete Caulkins, ``HED Response to
Questions Raised by SRRD Regarding Chlorothalonil'' (June 22, 2006).
17. Health Effects Division, Office of Pesticide Programs, U.S.
EPA, Data Evaluation Record (TXR No: 0052493): Prenatal Developmental
Toxicity Study - Rabbit; Chlorothalonil (1994).
18. Health Effects Division, Office of Pesticide Programs, U.S.
EPA, Data Evaluation Record (TXR No: 0052493): Prenatal Developmental
Toxicity Study - Rat; Chlorothalonil (1994).
19. Office of Pesticide and Toxic Substances, U.S. EPA, Memorandum
from Alan C. Levy to Cynthia Giles-Parker, ``Chlorothalonil - Reviews
of the Following Toxicity Studies: Rat Oncogenicity, Rabbit
Teratogenicity, One-Generation Rat Reproduction (rangefinding), Rat
Pilot Metabolism With AT-125, Comparison of Dog and Rat Metabolism, and
Rat Dermal Metabolism'' (1991).
20. Office of Pesticide and Toxic Substances, U.S. EPA, Memorandum
from David L. Ritter to Henry Jacoby, ``EPA Reg. No 677-313 - Review of
miscellaneous Toxicity Data'' (1984).
21. Health Effects Division, Office of Pesticide Programs, U.S.
EPA, Data Evaluation Record (TXR No: 0052493): Subchronic Oral Toxicity
in Dogs (diet); Chlorothalonil (1994).
22. Health Effects Division, Office of Pesticide Programs, U.S.
EPA, Data Evaluation Record (TXR No: 0052493): 90-Day Oral Toxicity
[diet] - rats; Chlorothalonil (1994).
23. Health Effects Division, Office of Pesticide Programs, U.S.
EPA, Data Evaluation Record (TXR No: 0052493): Subchronic Feeding
Neurotoxicity in Rat; Chlorothalonil (2004).
24. Health Effects Division, Office of Pesticide Programs, U.S.
EPA, Data Evaluation Record (TXR No: 0052493): Combined chronic
toxicity/carcinogenicity (diet)- rats; Chlorothalonil (1996).
25. Health Effects Division, Office of Pesticide Programs, U.S.
EPA, Data Evaluation Record (TXR No: 0052493): Chronic Toxicity in Dogs
(diet); Chlorothalonil (1995).
26. Health Effects Division, Office of Pesticide Programs, U.S.
EPA, Data Evaluation Record (TXR No: 0052493): Carcinogenicity study in
mice [feeding]; Chlorothalonil (1995).
27. Office of Pesticides and Toxic Substances, U.S. EPA, Memorandum
to Diane Beavers, ``Chlorothalonil (CTN)
[[Page 39331]]
and its 4-OH metabolite in almonds, rice, wheat and meat, milk, poultry
and eggs. Petition for tolerances'' (1984).
28. Office of Pesticides and Toxic Substances, Memorandum from
David Ritter to H. Jacoby, ``EPA Reg.No 50534-7 Data Call in
Submission. Chlorothalonil Registration Standard; review of data''
(1986).
29. Office of Prevention, Pesticides, and Toxic Substances,
Memorandum from Alan C. Levy to Walter Waldrop/Andrew W. Ertman,
``Chlorothalonil - Review of 30-Day, 90-Day and One-Year Dog Studies
(Oral Administration, Gelatin Capsules)'' (1996).
30. Health Effects Division, U.S. EPA, Data Evaluation Report;
Ninety Day Mouse Feeding Study; Technical Chlorothalonil (DS-2787)
(1983).
31. Office of Prevention, Pesticides, and Toxic Substances, U.S.
EPA, Memorandum from Alan C. Levy to Karen Whitby, ``Chlorothalonil -
Rereview of a Chronic Dog Study and a Developmental Rat Study; Review
of a Dermal Absorption Rat Study'' (1995).
32. Office of Pesticides and Toxic Substances, U.S. EPA, Memorandum
from D. Ritter to Lois Rossi, ``EPA No 50534-7 - CX, Submission of
additional toxicity data'' (1988).
33. Office of Prevention, Pesticides, and Toxic Substances, U.S.
EPA, Health Effects Test Guidelines; OPPTS 870.3800; Reproduction and
Fertility Effects (August 1998).
34. Health Effects Division, Office of Pesticide Programs, U.S.
EPA, Data Evaluation Record (TXR No: 0052493): Reproduction and
Fertility Effects Study - [rat]; Chlorothalonil (1995).
35. Office of Pesticide and Toxic Substances, U.S. EPA, Memorandum
from Alan C. Levy to Walter Waldrop/Andrew W. Ertman, ``Chlorothalonil
- Two-Generation Reproduction Study in Rats'' (1993).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 1, 2007.
Debra Edwards,
Director, Office of Pesticide Programs.
[FR Doc. E7-13830 Filed 7-17-07; 8:45 am]
BILLING CODE 6560-50-S