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June 19, 2002.
NRDC's
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Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/2002/June/Day-19/p15465.htm
[Federal Register: June 19, 2002 (Volume 67, Number 118)]
[Rules and Regulations]
[Page 41628-41635]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19jn02-6]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0057; FRL-7167-7]
Objections to Tolerances Established for Certain Pesticide
Chemicals
AGENCY: Environmental Protection Agency (EPA).
ACTION: Availability of final rule objections; request for comments.
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SUMMARY: On February 25, 2002, March 19, 2002, and May 7, 2002, the
Natural Resources Defense Council (NRDC) filed objections with EPA
regarding final rules establishing tolerances under section 408 of the
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, for the
following pesticides on the crops noted: 2,4-D (soybeans), halosulfuron
methyl (melons, asparagus), pymetrozine (cotton, undelinted seed;
cotton gin byproducts; fruiting vegetables; head and stem Brassica
vegetables; cucurbit vegetables; leafy vegetables; leafy Brassica and
turnip greens; hops, dried; and pecans), imidacloprid (blueberries),
mepiquat (cottonseed; cotton, gin byproducts; meat byproducts of
cattle, goats, hogs, horses, and sheep), bifenazate (apple, wet pomace;
cotton, undelineted seed; cotton, gin byproducts, pome fruit group;
grapes; grapes, raisins; hops, dried cones; nectarines; peaches; plums;
strawberries; and milk, fat, meat, and meat byproducts of cattle,
goats, horses, hogs, and sheep), zeta-cypermethrin (succulent, shelled
peas and beans; dried, shelled peas and beans, except soybeans;
soybean, seed; fruiting vegetables, except cucurbits; sorghum, grain,
forage, stover; wheat, grain, forage, hay, straw; aspirated grain
fractions; meat of cattle, goats, hogs, horses, sheep), diflubenzuron
(pears). NRDC's objections concern a number of issues under section 408
of the FFDCA including the additional 10X safety factor for the
protection of infants and children and aggregate exposure to pesticide
chemical residues. This document seeks comment on the NRDC objections.
DATES: Comments, identified by docket ID number OPP-2002-0057, must be
received on or before August 19, 2002.
ADDRESSES: Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper
receipt by EPA, it is imperative that you identify docket ID number
OPP-2002-0057 in the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: Peter Caulkins, Registration Division
(MC7505C), Office of Pesticide Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone
number: (703) 305-6550; fax number: (703) 305-6920; e-mail address:
caulkins.peter@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Do These Objections Affect Me?
This action is directed to the public in general. This action may,
however, be of interest to agricultural producers, food manufacters, or
pesticide manufacturers. Potentially affected categories and entities
may include, but are not limited to:
------------------------------------------------------------------------
Examples of Potentially
Categories NAICS Affected Entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities who may be affected by these
objections. Other types of entities not listed in the table could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
[[Page 41629]]
determining whether or not these objections might apply to certain
entities. If you have questions regarding the applicability of this
action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT.
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the Federal Register--Environmental
Documents. You can also go directly to the Federal Register listings at
http://www.epa.gov/fedrgstr/.
2. In person. The Agency has established an official record for
this action under docket ID number OPP-2002-0057. The official record
consists of the documents specifically referenced in this action, any
public comments received during an applicable comment period, and other
information related to this action, including any information claimed
as Confidential Business Information (CBI). This official record
includes the documents that are physically located in the docket, as
well as the documents that are referenced in those documents. The
public version of the official record does not include any information
claimed as CBI. The public version of the official record, which
includes printed, paper versions of any electronic comments submitted
during an applicable comment period, is available for inspection in the
Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
PIRIB telephone number is (703) 305-5805.
C. How and to Whom Do I Submit Comments?
You may submit comments through the mail, in person, or
electronically. To ensure proper receipt by EPA, it is imperative that
you identify docket ID number OPP-2002-0057 in the subject line on the
first page of your response.
1. By mail. Submit your comments to: Public Information and Records
Integrity Branch (PIRIB), Information Resources and Services Division
(7502C), Office of Pesticide Programs (OPP), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
2. In person or by courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Information Resources
and Services Division (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB
telephone number is (703) 305-5805.
3. Electronically. You may submit your comments electronically by
e-mail to: opp-docket@epa.gov, or you can submit a computer disk as
described above. Do not submit any information electronically that you
consider to be CBI. Avoid the use of special characters and any form of
encryption. Electronic submissions will be accepted in WordPerfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be
identified by docket ID number OPP-2002-0057. Electronic comments may
also be filed online at many Federal Depository Libraries.
D. How Should I Handle CBI that I Want to Submit to the Agency?
Do not submit any information electronically that you consider to
be CBI. You may claim information that you submit to EPA in response to
this document as CBI by marking any part or all of that information as
CBI. Information so marked will not be disclosed except in accordance
with procedures set forth in 40 CFR part 2. In addition to one complete
version of the comment that includes any information claimed as CBI, a
copy of the comment that does not contain the information claimed as
CBI must be submitted for inclusion in the public version of the
official record. Information not marked confidential will be included
in the public version of the official record without prior notice. If
you have any questions about CBI or the procedures for claiming CBI,
please consult the person listed under FOR FURTHER INFORMATION CONTACT.
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used
that support your views.
4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Offer alternative ways to improve the notice or collection
activity.
7. Make sure to submit your comments by the deadline in this final
rule.
8. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.
II. Background
A. What Action is the Agency Taking?
EPA is publishing for comment objections received from NRDC
concerning final rules establishing tolerances under FFDCA, 21 U.S.C.
346a, for five pesticide chemicals: Imidacloprid (blueberries), 67 FR
2580 (January 18, 2002) (FRL-6817-6); mepiquat (cottonseed; cotton, gin
byproducts; meat byproducts of cattle, goats, hogs, horses, and sheep),
67 FR 3113 (January 23, 2002) (FRL-6818-7); bifenazate (apple, wet
pomace; cotton, undelinted seed; cotton, gin byproducts, pome fruit
group; grapes; grapes, raisins; hops, dried cones; nectarines; peaches;
plums; strawberries; and milk, fat, meat, and meat byproducts of
cattle, goats, horses, hogs, and sheep), 67 FR 4913 (February 1, 2002)
(FRL-6818-3); zeta-cypermethrin (succulent, shelled peas and beans;
dried, shelled peas and beans, except soybeans; soybean, seed; fruiting
vegtables, except cucurbits; sorghum, grain, forage, stover; wheat,
grain, forage, hay, straw; aspirated grain fractions; meat of cattle,
goats, hogs, horses, sheep), 67 FR 6422 (February 12, 2002) (FRL-6818-
8); diflubenzuron (pears), 67 FR 7085 (February 15, 2002) (FRL-6821-7).
These objections were filed with the Agency on March 19, 2002. On
February 25, 2002, NRDC had filed similar objections with EPA
concerning final rules establishing tolerances for two pesticide
chemicals: Halosulfuron methyl (melons, asparagus), 66 FR 66333
(December 26, 2001) (FRL-6816-8); 66 FR 66778 (December 27, 2001) (FRL-
6816-1); and pymetrozine (cotton, undelinted seed; cotton gin
byproducts; fruiting vegetables; head and stem Brassica vegetables;
cucurbit vegetables; leafy vegetables; leafy Brassica and turnip
greens; hops, dried; and pecans), 66 FR 66786 (December 27, 2001) (FRL-
6804-
[[Page 41630]]
1). On May 7, 2002, NRDC filed objections with EPA concerning final
rules establishing tolerances for the pesticide 2,4-D (soybeans), 67 FR
10622 (March 8, 2002) (FRL-6827-1). EPA is also requesting comment on
these objections. The text of all sets of objections will be available
on EPA's website at http://www.epa.gov/pesticides/tolerance/.
B. What Issues Are Raised by the Objections?
NRDC's objections raise a host of issues under FFDCA section 408,
including:
1. Whether EPA correctly applied the provision addressing an
additional 10X safety factor for the protection of children;
2. Whether farm children are a major identifiable population
subgroup;
3. Whether EPA should consider occupational exposure in evaluating
the safety of tolerances;
4. Whether EPA has included all residential exposures in
calculating aggregate exposure to pesticide chemical residues;
5. Whether safety findings under section 408 can be made on the
basis of a lowest-observed-adverse-effect-level (LOAEL) rather than a
no-observed-adverse-affect-level (NOAEL);
6. Whether safety findings under section 408 can be made when risk
is assessed using exposure estimates based on population percentiles
lower than 99.9%; and
7. Whether EPA has adequately considered exposure levels in foods
purchased at farm stands. The objections also raise various pesticide-
specific issues as to some of the tolerances.
C. Why is EPA Seeking Public Comment on These Objections?
Because several of the issues raised by NRDC concern matters of
great interest not just to NRDC but to growers, food distributors and
processors, and pesticide manufacturers as well as members of the
public, EPA believes it decision-making will be enhanced by obtaining
the views of all affected parties. For that reason, EPA has established
a 60-day comment period.
D. Why is EPA Only Publishing One Set of NRDC's Objections?
Although NRDC has filed three separate sets of objections, EPA is
only publishing the second set of those objections in the Federal
Register. EPA, however, is seeking comment on all three sets of
objections. The first and third sets of objections are not being
published in the Federal Register simply because much of them duplicate
arguments made more fully in the second set of objections. All three
sets of objections are available on EPA's website at http://
www.epa.gov/pesticides/tolerance/. Additional tolerance objections
received will also be posted.
E. What Process Will EPA Follow in Ruling on the Objections?
Under section 408(g)(2)(A) of the FFDCA, any person may file
objections with EPA within 60 days of issuance of a final tolerance
regulation. 21 U.S.C. 346a(g)(2). Such person may also request a public
evidentiary hearing on the objections; however, NRDC has not requested
such a hearing. Under EPA regulations, EPA must publish an order
setting forth its determination on each of NRDC's objections. 40 CFR
178.37(a). Such order must contain EPA's reasons for its determination.
40 CFR 178.37(b). If based on the objections EPA determines that the
tolerance regulation should be modified or revoked, EPA will publish by
order any revisions to the regulation. 21 U.S.C. 346a(g)(2)(C); 40 CFR
178.35.
III. Objections to the Establishment of Tolerances for Pesticide
Chemical Residues
The text of this objection is published with minor editorial
changes.
OPP-301204 (Imidacloprid)
OPP-301209 (Mepiquat)
OPP-301206 (Bifenazate)
OPP-301207 (Zeta-cypermethrin)
OPP-301213 (Diflubenzuron)
Pursuant to 21 U.S.C. 346a(g) and 40 CFR part 180, NRDC makes
the following objections:
1. NRDC objects to the regulation issued under 21 U.S.C.
346a(l)(6), establishing a time-limited tolerance for pesticide
chemical residues of imidacloprid until December 31, 2003. Federal
Register (67 FR 2580, January 18, 2002) (FRL-6817-6).
2. NRDC objects to the regulation issued under 21 U.S.C.
346a(d)(4), establishing a tolerance for pesticide chemical residues
of mepiquat. Federal Register (67 FR 3113, January 23, 2002) (FRL-
6818-7).
3. NRDC objects to the regulation issued under 21 U.S.C.
346a(d)(4), establishing a tolerance for pesticide chemical residues
of bifenazate. Federal Register (67 FR 4913, February 1, 2002) (FRL-
6818-3).
4. NRDC objects to the regulation issued under 21 U.S.C.
346a(d)(4), establishing a tolerance for pesticide chemical residues
of zeta-cypermethrin. Federal Register (67 FR 6422, February 12,
2002) (FRL-6818-8).
5. NRDC objects to the regulation issued under 21 U.S.C.
346a(d)(4), establishing a tolerance for pesticide chemical residues
of diflubenzuron. Federal Register (67 FR 7085, February 15, 2002)
(FRL-6821-7).
As discussed below in section III, of these objections, NRDC
requests a waiver of the tolerance objection fees pursuant to 40 CFR
180.33(m).
I. Introduction
Under FFDCA, as amended by the Food Quality Protection Act
(FQPA), EPA may only establish a tolerance for pesticide chemical
residues in or on a food if EPA determines that the tolerance ``is
safe.'' 21 U.S.C. 346a(b)(2)(A)(i). A tolerance will meet this
requirement only if ``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.'' Id. Section
346a(b)(2)(A)(ii). The health-protective standard of the FQPA
requires EPA to give special consideration to the health of infants
and children, and EPA must ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue.'' Id. Section
346a(b)(2)(C)(ii)(i).
EPA has violated the requirements of the FQPA in establishing
new tolerances for imidacloprid, mepiquat, bifenazate, zeta-
cypermethrin, and diflubenzuron--published at 67 FR 2580 (Jan. 18,
2002) (imidacloprid), 67 FR 3113 (Jan. 23, 2002) (mepiquat), 67 FR
4913 (Feb. 1, 2002) (bifenazate), 67 FR 6422 (Feb. 12, 2002) (zeta-
cypermethrin), and 67 FR 7085 (Feb. 15, 2002) (diflubenzuron). With
respect to all five pesticides, EPA failed to apply the children's
10X safety factor, acknowledge and consider farm children as a major
identifiable subgroup, take into consideration reliable data
concerning occupational exposure, or fully assess aggregate
exposures. For imidacloprid, mepiquat, and zeta-cypermethrin, EPA
failed to regulate on the basis of a no-observed-effect-level
(NOEL). With respect to imidacloprid and mepiquat, EPA additionally
failed to protect all infants and children and not just those within
a certain percentile, and as a result left potentially more than a
million children unprotected. With respect to diflubenzuron, EPA
failed to guarantee that legal food will be safe food based on
exposure to pesticide chemical residues at the tolerance level.
Finally, for imidacloprid, EPA also violated the FQPA by improperly
relying on percent of crop treated in assessing dietary exposure.
II. Grounds for the Objections
A. In Establishing These Tolerances, EPA Improperly Failed to Apply the
Children's 10X Safety Factor
In establishing tolerances for imidacloprid, mepiquat,
bifenazate, zeta-cypermethrin, and diflubenzuron, EPA failed to
include an additional 10X safety factor for infants and children as
required by the FQPA. Under the FQPA's precautionary approach to
protecting children, EPA must maintain an additional 10-fold margin
of safety in its risk assessments for individual pesticides to
``take into account potential pre-natal and post-natal developmental
toxicity and completeness of the data with respect to exposure and
toxicity to infants and
[[Page 41631]]
children.'' 21 U.S.C. 346a(b)(2)(C). EPA can use a different margin
of safety ``only if, on the basis of reliable data, such margin will
be safe for infants and children.'' Id. Yet there are significant
toxicity and exposure data gaps for each of these new tolerances
established by EPA. In addition, EPA has acknowledged that it lacks
necessary and required data to assess toxicity to the developing
brain and nervous system for imidacloprid, mepiquat, and zeta-
cypermethrin in particular, and therefore lacks the ``reliable
data'' necessary under the FQPA to authorize a different margin of
safety.
The regulations establishing new tolerances for imidacloprid,
mepiquat, bifenazate, zeta-cypermethrin, and diflubenzuron reveal
toxicity and exposure data gaps for each pesticide:
1. Imidacloprid. EPA is establishing time-limited tolerances for
imidacloprid residues on blueberries in two States--New Jersey and
Michigan. (67 FR 2581, January 18, 2002) (FRL-6817-6). But in
measuring dietary exposure to imidacloprid as a result of these
tolerances, EPA relied on estimated national consumption data and
not regional or State-specific data. Federal Register 64 FR 39045
(July 21, 1999) (FRL-6485-4). EPA acknowledged that it ``does not
have available information on the regional consumption of food to
which imidacloprid may be applied in a particular area.'' Id. This
data gap is of particular importance because of the nature of the
food at issue--fresh blueberries are likely to be most heavily
consumed locally, near where they are picked. In other words,
consumers in New Jersey and Michigan are most likely to eat
blueberries grown in New Jersey and Michigan (and therefore treated
with imidacloprid). Many ``U-Pick'' farms are located in New Jersey
and Michigan, leading to likely elevated exposures due to immediate
consumption and due to the presence of consumers in the fields. Use
of national data to assess the dietary exposure of consumers in
particular regions is especially inappropriate where the tolerance
is approved only for specific regions. By using national data, EPA
will underestimate the dietary exposure of consumers in New Jersey
and Michigan, who are the most exposed to imidacloprid residues on
blueberries.
This is the case because consumers in New Jersey and Michigan
are likely to eat more blueberries than the national average because
of their ready availability, cost, proximity to market, and
freshness, and they are more likely to eat locally grown blueberries
containing imidacloprid residues than the average U.S. consumer. A
child eating blueberries in one of these two high-imidacloprid-use
States will certainly stand a greater chance of consuming a greater
amount of imidacloprid--when local blueberries are ripe and
plentiful--than national consumption data (which is not seasonal,
but is averaged throughout the year) would suggest. Additional
outstanding data requirements include prospective groundwater
monitoring studies, a residential short-term risk assessment, and a
developmental neurotoxicity study that is 2 1/2 years overdue
(discussed further below). (64 FR 39045, 39046).
2. Mepiquat. There are several outstanding data requirements for
mepiquat, including side-by-side residue field trials and a
developmental neurotoxicity study that is over 2 years overdue. (67
FR 3116, January 23, 2002) (FRL-6818-7); (65 FR 1790, 1794, Jan. 12,
2000).
3. Bifenazate. Data gaps for bifenazate include a developmental
toxicity assessment, short-, medium-, and long-term inhalation
exposure studies, and an assessment of drinking water exposure to
bifenazate degradates. (67 FR 4915, 4917, 4918, Feb. 1, 2002).
4. Zeta-cypermethrin. The toxicity and exposure assessments of
zeta-cypermethrin are incomplete because EPA explicitly failed to
address drinking water exposure to zeta-cypermethrin degradates, and
a required developmental neurotoxicity study has not been completed.
67 FR 6425, 6426 (Feb. 12, 2002).
5. Diflubenzuron. Data gaps include missing residue chemistry
and toxicology data for two diflubenzuron metabolites, deemed
necessary by EPA to justify an unconditional registration. 67 FR
7090 (Feb. 15, 2002).
In addition to the above data gaps, for all five pesticides EPA
has failed to collect pesticide-specific data on water-based
exposure, rendering it impossible to find that ``reliable data''
exist to reduce the tenfold safety factor. 64 FR 39045 (July 21,
2002) (imidacloprid); 67 FR 3115 (Jan. 23, 2002) (mepiquat); 67 FR
4918 (Feb. 1, 2002) (bifenazate); 67 FR 6425 (Feb. 12, 2002) (zeta-
cypermethrin); 67 FR 7088 (Feb. 15, 2002) (diflubenzuron). The use
of predictive models to estimate drinking water exposure to these
pesticides serves as a stop-gap measure, but cannot take the place
of actual ``reliable data'' that justify removing the statutory
tenfold safety factor. Because EPA has used modeling scenarios to
approximate drinking water exposure to these pesticides, it has not
relied on any data at all--only predictions that are, in NRDC's
view, not conservative. Relying only on modeling results, in the
absence of any reliable and confirmatory monitoring data, results in
an additional data gap that prevents EPA from overturning the
presumptive 10X safety factor. In addition, for all five pesticides
EPA failed adequately to consider important exposure routes for
millions of infants and children, including exposure to children
living on farms and who accompany their parents into farm fields
(see discussion of farm children below), and exposure from spray
drift. All of these deficiencies in toxicity and exposure data
preclude EPA's removal of the presumptive 10X safety factor. 21
U.S.C. 346a(b)(2)(C). Furthermore, the absence of required
developmental neurotoxicity (DNT) tests for imidacloprid, mepiquat,
and zeta-cypermethrin is a crucial data gap that by itself should
prohibit EPA from overturning the default 10X safety factor. In its
1993 report, Pesticides in the Diets of Infants and Children, the
National Academy of Sciences/National Research Council cited strong
evidence that pesticide exposures may disrupt the normal development
of a child's brain and nervous system. More conclusive evidence has
since been published supporting this finding1. Studies by EPA staff
scientist Dr. Makris show that DNT testing is more sensitive than
other studies in measuring the effects of exposure on proper
development of the brain and nervous system, and therefore DNT
testing is more appropriate for protecting children's health. DNT
testing is essential for pesticides, not only as a measure of
toxicity to the developing brain and nervous system, but also as an
often more sensitive measure of developmental and reproductive
effects generally8. EPA's 10X Task Force has recommended that
developmental neurotoxicity testing be included as part of the
minimum core toxicology data set for all chemical food-use
pesticides for which a tolerance would be set. See 10X Task Force,
EPA, Toxicology Data Requirements for Assessing Risks of Pesticide
Exposure to Children's Health (draft), Nov. 30, 1998, at 11.
Although DNT testing has not yet been incorporated in the minimum
core toxicology data set for all pesticides, EPA has required DNT
studies on a case-by-case basis for particular pesticides, including
imidacloprid, mepiquat, and zeta-cypermethrin. 64 FR 39046
(imidacloprid); 67 FR 3116 (Jan. 23, 2002) (mepiquat); 67 FR 6426
(Feb. 12, 2002) (zeta-cypermethrin). In spite of this, in
establishing new tolerances, the Agency failed to retain the
presumptive FQPA 10X safety factor for any of these pesticides. EPA
has expressly acknowledged that DNT testing is necessary and
required to assess the risks of imidacloprid, mepiquat, and zeta-
cypermethrin, and these studies are still missing. 64 FR 39046; 67
FR 3116 (Jan. 23, 2002); 67 FR 6426 (Feb. 12, 2002). These critical
data gaps make it impossible to assess the neurotoxic effects of
these pesticides to fetuses, infants, and children. The FQPA neither
requires nor justifies regulatory delay in order to collect this
additional data. The potential future submission of DNT studies for
these pesticides does not justify removing 10X in anticipation of
those studies; EPA must use the 10-fold safety factor to protect
children's health while the data is missing. 21 U.S.C.
346a(b)(2)(C). Even though these conditions have been unfulfilled,
and DNT results are required and overdue, EPA has established new
tolerances for imidacloprid, mepiquat, and zeta-cypermethrin. In
doing so, EPA failed to apply the required 10X safety factor for
children that is intended to compensate for just such data gaps. Id.
(Interestingly, EPA justified removing 10X for diflubenzuron because
a DNT test was not required for that pesticide, 67 FR 7089, yet EPA
did not deem the requirement of DNT tests for the other pesticides
sufficient justification to maintain 10X.)
EPA's recently released 10X policy paper attempts to justify the
Agency's decision to ignore 10X even in the absence of required DNT
studies. See OPP, EPA, Determination of the Appropriate FQPA Safety
Factor(s) in Tolerance Assessment, Feb. 28, 2002, at 23-25. EPA
states: [S]imply because OPP has required a DNT for a particular
pesticide does not necessarily mean that a database uncertainty
factor is needed. However, if the available information indicates
that a DNT
[[Page 41632]]
study is likely to identify a new hazard or effects at lower dose
levels of the pesticide that could significantly change the outcome
of its overall risk assessment, the database uncertainty factor
should be considered. Id. at 24. This position is untenable. The
FQPA requires that an additional 10X safety factor must be applied;
this burden can be overcome ``only if, on the basis of reliable
data, such margin will be safe for infants and children.'' 21 U.S.C.
346a(b)(2)(C). EPA's approach to required DNT studies completely
reverses this presumption and declares that, even in the absence of
required data on neurotoxicity for developing fetuses, infants, and
children, the default 10X safety factor can be removed if the
missing data is not ``expected'' to ``significantly change the
outcome'' of the overall risk assessment. Under this approach, the
removal of the safety factor is based not upon the statutorily
demanded ``reliable data,'' but upon the risk assessor's
expectation-his or her intuition or professional judgment. The FQPA
cannot accommodate this counterintuitive and underprotective
approach. EPA has required DNT tests for imidacloprid, mepiquat, and
zeta-cypermethrin, and these studies have not been conducted. EPA
therefore cannot argue that ``reliable data'' justifies removing the
statutory presumptive 10X FQPA safety factor.
Had EPA not removed 10X, many of these pesticide tolerances
would have been acknowledged to be unsafe. Even ignoring all of the
other flaws in EPA's tolerance regulations for these pesticides
(addressed below), this single decision to overturn 10X resulted in
unsafe tolerances improperly being declared ``safe.''
For imidacloprid, EPA calculated that the margin of exposure
(MOE) for chronic dietary and residential exposure for children aged
one to six was 302. 64 FR 39047. Relying on an FQPA safety factor of
3X instead of 10X, EPA established a ``safe'' MOE of 300, and
therefore the actual MOE was just barely outside the Agency's level
of concern for chronic exposure. Id. But if EPA had applied 10X, as
it was obligated to do under the FQPA, the safe MOE would have been
1000 and the tolerance as proposed would have been found unsafe. (As
it is, the actual MOE of 302 for children aged one to six is
shockingly close to the EPA-declared ``safe'' MOE of 300.).
For zeta-cypermethrin, EPA calculated the following actual MOEs:
MOE for combined aggregate exposure for children is 830; MOE for
short-term aggregate exposure for children is 600; MOE for short-
term aggregate exposure for infants is 1000; MOE for intermediate-
term aggregate exposure for adult males is 640; MOE for
intermediate-term aggregate exposure for adult females is 740; MOE
for intermediate-term aggregate exposure for children is 300; and
the MOE for intermediate-term aggregate exposure for infants is 530.
67 FR 6428 (Feb. 12, 2002). At the same time, EPA relied on an FQPA
safety factor of only 1X (in other words, no FQPA safety factor at
all), to establish a ``safe'' MOE of 100, and thus declared that all
of these actual MOEs were safe. Id. Yet if EPA has properly applied
the presumptive 10X FQPA safety factor, the safe MOE would have been
set at 1000 instead of 100, all of the above actual MOEs would have
been acknowledged as unsafe, and the new tolerances for zeta-
cypermethrin could not have been established.
In light of the incomplete data and potential pre-natal and
post-natal developmental toxicity for imidacloprid, mepiquat,
bifenazate, zeta-cypermethrin, and diflubenzuron, EPA's failure to
apply the 10X children's safety factor violates the FQPA and EPA's
own stated policy on proper application of the 10X safety factor.
See OPP, EPA, Determination of the Appropriate FQPA Safety Factor(s)
in Tolerance Assessment, Feb. 28, 2002, at 11 (``Risk assessors . .
. should presume that the default 10X safety factor applies and
should only recommend a different factor, based on an individualized
assessment, when reliable data show that such a different factor is
safe for infants and children.''). The absence of required DNT
studies for imidacloprid, mepiquat, and zeta-cypermethrin make EPA's
failure to apply 10X for these pesticides especially egregious. EPA
lacks reliable data to overturn the presumption of a 10X FQPA safety
factor for any of the five pesticides addressed in these objections:
Imidacloprid, mepiquat, bifenazate, zeta-cypermethrin, and
diflubenzuron. Where there are no data or where there are gaps in
data--either for particular toxic effects, for specific patterns of
food consumption, or for particular routes of exposure--there cannot
be the ``reliable data'' required by the FQPA to remove 10X.
B. Farm Children Are Especially Vulnerable To Pesticide Exposure, And
Are Not Adequately Considered In These Tolerances
Farm children should be deemed to comprise an especially
vulnerable population, and their exposure to imidacloprid, mepiquat,
bifenazate, zeta-cypermethrin, and diflubenzuron must be considered
in establishing tolerances where data is available. The FQPA
requires that EPA consider exposure not just to consumers as a
whole, but also to major identifiable subgroups of consumers. 21
U.S.C. 346a(b)(2)(D). In establishing tolerances, EPA must consider,
among other relevant factors, available information concerning the
dietary consumption patterns of consumers (and major identifiable
subgroups of consumers); . . . available information concerning the
aggregate exposure levels of consumers (and major identifiable
subgroups of consumers); and available information concerning the
variability of the sensitivities of major identifiable subgroups of
consumers. 21 U.S.C. 346a(b)(2)(D)(iv); (vi); (vii). Farm children
are a major identifiable subgroup under these statutory provisions,
and their unique dietary consumption patterns, aggregate exposure
levels, and sensitivities to exposure should have been assessed by
EPA in establishing new tolerances for imidacloprid, mepiquat,
bifenazate, zeta- cypermethrin, and diflubenzuron.
More than 320,000 children under the age of six live on farms in
the United States. In addition, many hundreds of thousands of
children play or attend schools on or near agricultural land, and
others have family members who work on farms or handle pesticides as
part of their jobs. The nation's 2.5 million farm workers have
approximately one million children living in the United States. See
NRDC et al., Petition for a Directive that the Agency Designate Farm
Children As a Major Identifiable Subgroup and Population at Special
Risk to be Protected under the Food Quality Protection Act, Oct. 22,
1998, at 1 (hereafter NRDC, Farm Kids Petition).
Children living in agricultural communities are heavily exposed
to pesticides, whether or not they work in the fields 9-11. Farm
children come in contact with pesticides through residues from their
parents' clothing, dust tracked into their homes, contaminated soil
in areas where they play, food eaten directly from the fields, drift
from aerial spraying, contaminated well water, and breastmilk.
Furthermore, farm children often accompany their parents to work in
the fields, raising their pesticide exposures even higher. See NRDC,
Farm Kids Petition, at 2-3. Citing data from the Department of
Labor, the U.S. General Accounting Office has reported that seven
percent of farmworkers with children 5 years old or younger took
their children with them when they worked in the fields. See U.S.
General Accounting Office, Pesticides: Improvements Needed to Ensure
the Safety of Farmworkers and Their Children, (RCED-00-40), March
14, 2000, at 6 (hereafter ``GAO, Safety of Farmworkers and Their
Children''). Children age nine or older may and do work on large
farms. Farm children are likely to have the highest exposure to
pesticides of any group of people in the country. Many of the
children with the greatest pesticide exposures are from migrant
farmworker families, who are poor and usually people of color or
recent immigrants. See NRDC, Farm Kids Petition, at 2-3.
Children have unique exposure patterns and sensitivities to
pesticides. Per pound of body weight, children eat, drink, and
breathe more than adults. Children also engage in more frequent
hand-to-mouth contact, and therefore have higher rates of oral
exposure from objects, dust, or soil. See NRDC, Farm Kids Petition,
at 3; GAO, Safety of Farmworkers and Their Children, at 17. The GAO
found that crawling, sitting, and lying on contaminated surfaces may
also increase exposure rates of farm children to pesticides. See
GAO, Safety of Farmworkers and Their Children, at 17. Furthermore,
as the GAO concluded, ``[b]ecause young children's internal organs
and bodily processes are still developing and maturing, their
enzymatic, metabolic, and immune systems may provide less natural
protection than those of an adult.'' Id.
EPA's regulations establishing tolerances for imidacloprid,
mepiquat, bifenazate, zeta-cypermethrin, and diflubenzuron fail to
consider information concerning the sensitivities and exposures of
farm children as a major identifiable subgroup. 64 FR 39041
(imidacloprid); 67 FR 3113 (Jan. 23, 2002) (mepiquat); 67 FR 4913
(Feb. 1, 2002) (bifenazate); 67 FR 6422 (Feb. 12, 2002) (zeta-
cypermethrin); 67 FR 7085 (Feb. 15, 2002) (diflubenzuron). Under 21
U.S.C. 346a(b)(2)(D), EPA must consider data regarding farm
children's dietary consumption patterns, aggregate exposure
[[Page 41633]]
levels, and sensitivities to exposure. If reliable data are lacking,
EPA must require the pesticide chemical registrants to secure the
necessary data and should not issue new tolerances until such data
are available.
C. EPA Failed To Consider Worker Risk In Establishing These Tolerances
The FQPA requires consideration of worker risk in establishing
final tolerances. A tolerance is not considered safe under the
statute unless 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) (emphasis added). Worker exposure is clearly
included in this catch-all category of ``all other exposures'' to be
considered in setting a tolerance. In establishing tolerances for
imidacloprid, mepiquat, bifenazate, zeta-cypermethrin, and
diflubenzuron, EPA cites no provision of the statute or any other
authority to support its repeated incantation that aggregate
exposure does not include occupational exposure. 64 FR 39042
(imidacloprid); 67 FR 3114 (Jan. 23, 2002) (mepiquat); 67 FR 4914
(Feb. 1, 2002) (bifenazate); 67 FR 6423 (Feb. 12, 2002) (zeta-
cypermethrin); 67 FR 7086 (Feb. 15, 2002) (diflubenzuron). The
statute's provision stating that EPA ``shall consider, among other
relevant factors... available information concerning the aggregate
exposure from other non-occupational sources'' does not justify
ignoring farmworkers' exposure in setting tolerances. 21 U.S.C.
408(b)(2)(D) (emphasis added). This provision explicitly requires
EPA to consider ``relevant factors'' other than those enumerated,
and is plainly illustrative rather than exhaustive. Moreover, much
of farmworkers' elevated exposure comes not only from their
occupational activities, but also because of the high exposures in
the homes in which they live, the air they breathe, the water they
drink. Clearly farmworkers are a high risk population deserving of
careful consideration and protection 12-23. EPA's failure to
consider worker risks in establishing these tolerances violates the
FQPA's mandate that aggregate exposure assessments include
allexposures for which there is reliable information. 21 U.S.C.
346a(b)(2)(A)(ii).
D. The Aggregate Risk Assessment Is Inadequate
The FQPA, 21 U.S.C. 346a(b)(2)(A)(ii) requires that, to
establish a pesticide tolerance, there must be a reasonable
certainty that no harm will result from aggregate exposure to
pesticide chemical residue, including all anticipated dietary
exposures and other exposures for which there are reliable
information. Aggregate exposure is the total exposure to a single
chemical or its residues that may occur from dietary (i.e., food and
drinking water), residential, and all known or plausible exposure
routes (including oral, dermal and inhalation). See id. Therefore,
in addition to food and water exposures, the aggregate assessment
must take into account exposures due to air drift and migration of
contaminated soil, residential exposures from registered uses, and
residential ``take-home'' exposures to families of those directly
exposed to the pesticides through its agricultural uses.
Furthermore, the aggregate assessment must consider exposures from
uses that do not conform with the label, if there is an indication
that such uses occur.
EPA failed to conduct an adequate aggregate assessment in
establishing tolerances for imidacloprid, mepiquat, bifenazate,
zeta-cypermethrin, and diflubenzuron. First, all of the exposure
data gaps outlined in Unit V.A. constitute missing information that
properly should have been incorporated into EPA's aggregate exposure
assessment. Also, none of the regulations establishing tolerances
for these five pesticides consider exposure through air drift,
migration of contaminated soil, or residential take-home exposures.
The bifenazate aggregate assessment suffers from an additional
defect: EPA relied on unsupported and apparently arbitrary
processing factors to reduce estimates of dietary exposure to
bifenazate on apples and grapes. 67 FR 4917 (Feb. 1, 2002).
For all five pesticides, EPA incorrectly concluded that the new
tolerances would not result in any increased residential exposure
because the tolerances themselves were not for residential uses. 64
FR 39044 (imidacloprid); 67 FR 3116 (Jan. 23, 2002) (mepiquat); 67
FR 4918 (Feb. 1, 2002) (bifenazate); 67 FR 6425 (Feb. 12, 2002)
(zeta-cypermethrin); 67 FR 7087 (Feb. 15, 2002) (diflubenzuron).
This ignores reliable data concerning take-home exposure resulting
from agricultural uses 9, 24. NRDC's 1998 report, Trouble on the
Farm, documents the scientific evidence supporting the potential for
take-home exposures from pesticides, even when not registered for
residential use. See NRDC, Trouble on the Farm: Growing up with
Pesticides in Agricultural Communities, 1998. As many as a dozen
different pesticide residues have been found in household dust in
some homes, including agricultural insecticides and herbicides not
registered for use in the home. See NRDC, Farm Kids Petition at 3.
In addition, EPA deliberately ignores known residential uses in
establishing new tolerances for these pesticides. The Agency
completely fails to assess and incorporate those residential uses as
a source of aggregate exposure, in violation of the FQPA.
Imidacloprid has significant residential uses, including uses on
flowering plants, ground covers, turf, lawns, golf courses,
walkways, recreation areas, household dwellings, and cats and dogs.
64 FR 39045 (July 21, 1999). However, based on predictions of low
toxicity, EPA concludes that a number of missing residential
exposure assessments are not required, including both acute and
chronic short-term dermal, intermediate-term dermal, long-term
dermal, and inhalation. Id. The one residential exposure assessment
that EPA does require--short-term risk assessment of oral exposure--
has not yet been completed, but EPA wrongly proceeded with an
aggregate risk assessment of exposure to imidacloprid anyway. Id.
Bifenazate is registered for use on landscape ornamentals at
residential and recreational sites. 67 FR 4918 (Feb. 1, 2002).
Nevertheless, EPA makes the unsupported conclusion that no
residential post-application assessment is warranted, and therefore
this potential source of exposure is disregarded. 67 FR 4918 (Feb.
1, 2002).
In establishing new tolerances for zeta-cypermethrin, EPA
wrongly ignores indoor and outdoor residential uses of cypermethrin
(which the agency states is toxicologically identical to zeta-
cypermethrin for purposes of these tolerances). 67 FR 6427 (Feb. 12,
2002).
Diflubenzuron is registered for use on outdoor residential and
recreational areas. 67 FR 7089 (Feb.15, 2002). But EPA wrongly chose
not to evaluate exposure through these uses because diflubenzuron
``is only applied to the tree canopy.'' Id. The above deficiencies
reveal that EPA improperly underestimated aggregate exposure to
these pesticides and their residues that may occur from dietary,
residential, and all other known or plausible exposure routes. The
assumptions and missing data in EPA's analysis of aggregate exposure
for these five pesticides systematically serve to underestimate
exposure and therefore underestimate risk, contrary to the
requirements of the FQPA.
E. EPA Improperly Failed To Rely On A NOEL For Dietary Risk Estimates
EPA cannot lawfully establish tolerances in the absence of a
NOEL. The report of the House Committee on Commerce clearly states
its intent for all safety factors to be applied to the NOEL. See
H.R. Rep. No. 104-669, Part 2, at 43, presented to the House on July
23, 1996. By using a NOEL, the risk assessor is assured that
regulatory decisions are based on a dose at which no effect is
elicited. The use of a LOAEL carries no such assurances. ``Adverse''
effects are often crude toxicological endpoints, such as death, or
dramatic loss of body or organ weight, and are not designed to
coordinate to the vulnerable points in embryonic development. A
LOAEL may represent a dose high enough to elicit significant
unpleasant and harmful effects, and can not be considered as
protective as a true NOEL.
For imidacloprid, mepiquat, and zeta-cypermethrin, EPA failed to
regulate on the basis of a NOEL, and instead relied on a LOAEL in
conducting particular assessments.
For imidacloprid, EPA relied only on a LOAEL for acute toxicity,
and was unable to discern a NOAEL for the acute toxic effects of the
pesticide. 64 FR 39044 (July 21, 1999). EPA also assessed only a
LOAEL for chronic toxicity (a level that produced an increased
number of thyroid lesions). Id.
To establish the new tolerances for mepiquat, EPA measured
reproductive toxicity only on the basis of a LOAEL; the reproductive
toxicity study did not establish a reproductive NOAEL. 65 FR 1792
(Jan. 12, 2000).
For zeta-cypermethrin, a developmental toxicity study yielded
only a LOAEL. 67 FR 6426 (Feb. 12, 2002).
Lacking a NOEL for these endpoints, EPA has no scientific basis
upon which to conclude that there is a fully safe level at which
infants and children will not suffer developmental harm because of
imidacloprid, mepiquat, or zeta-cypermethrin exposure. Therefore,
EPA
[[Page 41634]]
cannot make a legal finding that any specific level of imidacloprid,
mepiquat, or zeta-cypermethrin on food is ``safe'' for infants and
children, or that there is a ``reasonable certainty of no harm'' to
infants and children, at any specific level. 21 U.S.C. 346a(b)(2).
As a matter of law, under 21 U.S.C. 346a(b)(2), EPA may not
establish these new tolerances for imidacloprid, mepiquat, or zeta-
cypermethrin.
F. EPA Failed To Ensure A Reasonable Certainty Of No Harm For All
Infants And Children In Establishing These Tolerances
Under the FQPA, EPA must ensure that there is a reasonable
certainty that no children will be harmed through exposure to
pesticide chemical residues. 21 U.S.C. 346a(b)(2)(C). If the best
evidence suggests that thousands of children will exceed the
reference dose for a pesticide, EPA is barred by statute from
finding a reasonable certainty of no harm to these particular
infants and children, and the Agency may not issue a tolerance at
that level. However, in establishing tolerances for imidacloprid and
mepiquat, EPA regulates dietary residues at only the 95th
percentile. 64 FR 39044 (acute dietary exposure to imidacloprid at
the 95th percentile); 65 FR 1793 (acute dietary exposure to mepiquat
at the 95th percentile). This runs contrary to EPA's previous policy
of using the 99.9th percentile child (which itself is inadequate to
fully protect children). Regulation at the 95th percentile means
that five percent of all American children under age six (around 1.2
million children in all) could exceed the chronic reference dose
every day, based on the best information available to the agency.
Both imidacloprid and mepiquat are used on common children's foods--
imidacloprid on blueberries, and mepiquat on grapes. No reading of
the FQPA will support any approach that allows millions of children
to exceed the reference dose. Regulating dietary residues of
imidacloprid and mepiquat at the 95th percentile violates the FQPA's
requirement that EPA ``ensure that there is a reasonable certainty
that no harm will result to infants and children from aggregate
exposure to the pesticide chemical residue.'' 21 U.S.C.
346a(b)(2)(C)(ii)(I).
G. EPA Failed To Guarantee That Legal Food Will Be Safe Food Based On
Exposure To Pesticide Chemical Residues Of Diflubenzuron At The
Tolerance Level
To assess chronic dietary exposure, EPA relied on estimates of
``anticipated residues'' for diflubenzuron. 67 FR 7087-7088 (Feb.
15, 2002). In doing so, EPA failed to account for the dietary
exposure of a significant number of consumers who purchase produce
at farmers markets, farm stands, and ``U-Pick'' farming operations.
Over 1.9 million people buy vegetables and fruits from nearly 13,000
farmers, at more than 2,000 community-based farmers markets and farm
stands in the United States. See National Association of Farmers'
Market Nutrition Programs (http://www.nafmnp.org/) 
. These consumers
include pregnant women, infants, and children, and must be
protected. By ignoring this significant community of consumers, EPA
vastly underestimates dietary exposure and cannot ensure that
exposure to residues of diflubenzuron at the tolerance level will be
safe. Reliance on 21 U.S.C. 346a(b)(2)(E) to factor in anticipated
residues of diflubenzuron does not justify ignoring the known
dietary exposure of potentially millions of consumers to residues of
these pesticides at the tolerance level. EPA must ensure that the
legal level of pesticide chemical residue--the established tolerance
levels--are themselves safe. 21 U.S.C. 346a(b)(2)(A).
H. EPA Violated the FQPA by Relying on Percent of Crop Treated in
Assessing Dietary Exposure to Imidacloprid
In establishing time-limited tolerances for imidacloprid on
blueberries in New Jersey and Michigan, EPA relied on estimates of
the percent of crop treated to measure chronic dietary risk. 64 FR
39044-39045 (July 21, 1999). The FQPA, however, authorizes EPA's use
of data on the percent of crop treated to assess chronic dietary
risk only if EPA can make certain findings. In particular, EPA must
find that: 1. ``The data are reliable and provide a valid basis to
show what percentage of the food derived from such crop is likely to
contain such pesticide chemical residue; 2. the exposure estimate
does not understate exposure for any significant subpopulation
group; and 3. if data are available on pesticide use and consumption
of food in a particular area, the population in such area is not
dietarily exposed to residues above those estimated.'' 21 U.S.C.
346a(b)(2)(F)(i); (ii); (iii).
These statutory criteria are not satisfied in this instance.
EPA's new time-limited tolerance for imidacloprid on blueberries is
geographically restricted to two States, yet EPA relies on national
percent crop treated data. 67 FR 2580 (Jan. 18, 2002); 64 FR 39044-
39045 (July 21, 1999). National data cannot provide a valid basis
for measuring the percent of the blueberry crop treated with
imidacloprid in New Jersey and Michigan, given that the new
tolerance restricts the use of imidacloprid to those two States.
Furthermore, relying on national data will plainly understate
exposure for significant subpopulation groups--blueberry consumers
in New Jersey and Michigan, who will be exposed to higher levels of
imidacloprid residues than consumers in the rest of the nation. EPA
therefore failed to meet the requirements of the FQPA to justify
using percent of crop treated data to assess chronic risk. 21 U.S.C.
408(b)(2)(F).
III. Relief Requested
In light of the above outlined statutory violations, NRDC
respectfully requests that EPA refrain from establishing the new
tolerances for imidacloprid, mepiquat, bifenazate, zeta-
cypermethrin, and diflubenzuron until the pesticide tolerances have
been assessed and determined to be safe consistent with the
requirements of the FQPA.
IV. Supporting Material
NRDC incorporates by reference the following attachments in
support of these objections:
Attachment A: NRDC, et al., Petition for a Directive that the
Agency Consistently Fulfill Its Duty to Retain the Child-Protective
Tenfold Safety Factor Mandated by the Food Quality Protection Act,
April 23, 1998.
Attachment B: NRDC, et al., Petition for a Directive that the
Agency Designate Farm Children As a Major Identifiable Subgroup and
Population at Special Risk to be Protected under the Food Quality
Protection Act, Oct. 22, 1998.
Attachment C: NRDC, Putting Children First: Making Pesticide
Levels in Food Safer for Infants and Children, April 1998.
Attachment D: NRDC, Trouble on the Farm: Growing up with
Pesticides in Agricultural Communities, 1998.
Attachment E: U.S. General Accounting Office, Pesticides:
Improvements Needed to Ensure the Safety of Farmworkers and Their
Children, (RCED-00-40), March 14, 2000. NRDC reserves the right to
submit additional supplemental information in further support of
these objections.
V. Request for a Fee Waiver
Pursuant to 40 CFR 180.33(m), NRDC hereby requests a waiver of
all tolerance objection fees imposed by 40 CFR 180.33(i). A waiver
of fees will promote the public interest. NRDC is a national non-
profit, tax-exempt public policy research and environmental
organization. NRDC makes information available to thousands of
citizens by means of its numerous and varied publications,
educational programs, seminars, and public-interest litigation.
These objections to the tolerances established for imidacloprid,
mepiquat, bifenazate, zeta-cypermethrin, and diflubenzuron are
intended to benefit primarily the public as opposed to NRDC. As
outlined above, these objections challenge EPA regulations that fail
to properly implement the FQPA and, as a result, pose threats to the
public health, especially children's health. Furthermore, NRDC has
no financial interest in the sale, manufacture, or use of
imidacloprid, mepiquat, bifenazate, zeta-cypermethrin, or
diflubenzuron. Requiring NRDC to pay the fees would work an
unreasonable hardship.
Respectfully submitted,
Erik D. Olson
Jon P. Devine, Jr.
Aaron Colangelo
Natural Resources Defense Council
1200 New York Avenue, NW., Suite 400, Washington, DC 20005
Phone: (202) 289-6868
Fax: (202) 289-1060
Dated: March 19, 2002.
IV. References
1. Crumpton, T.L., Seidler, F.J., and Slotkin, T.A. Developmental
neurotoxicity of chlorpyrifos in vivo and in vitro: Effects on nuclear
transcription factors involved in cell replication and differentiation.
Brain Research 2000; 857:87-98.
2. Dam, K., Seidler, F.J., and Slotkin, T.A. Developmental
neurotoxicity of chlorpyrifos: Delayed targeting of DNA synthesis after
repeated administration. Brain Research: Developmental Brain Research
1998; 108:39-45.
[[Page 41635]]
3. Dam, K., Seidler, F.J., and Slotkin, T.A. Chlorpyrifos releases
norepinephrine from adult and neonatal rat brain synaptosomes. Brain
Research: Developmental Brain Research 1999; 118:129-33.
4. Dam, K., Garcia, S.J., and Seidler, F.J., and Slotkin, T.A.
Neonatal chlorpyrifos exposure alters synaptic development and neuronal
activity in cholinergic and catecholaminergic pathways. Brain Research:
Developmental Brain Research 1999; 116:9-20.
5. Dam, K., Seidler, F.J., and Slotkin, T.A. Chlorpyrifos exposure
during a critical neonatal period elicits gender-selective deficits in
the development of coordination skills and locomotor activity. Brain
Research: Developmental Brain Research 2000; 121:179-87.
6. Levin, E.D., Addy, N., Nakajima, A., Christopher, N.C., Seidler,
F.J., and Slotkin, T.A. Persistent behavioral consequences of neonatal
chlorpyrifos exposure in rats. Brain Research: Developmental Brain
Research 2001; 130:83-9.
7. Raines, K.W., Seidler, F.J., and Slotkin, T.A. Alterations in
serotonin transporter expression in brain regions of rats exposed
neonatally to chlorpyrifos. Brain Research: Developmental Brain
Research 2001; 130:65-72.
8. Kimmel C.A., and Makris, S.L. Recent developments in regulatory
requirements for developmental toxicology. Toxicology Letters 2001;
120:73-82.
9. Lu, C., Fenske, R.A., Simcox, N.J., and Kalman, D. Pesticide
exposure of children in an agricultural community: Evidence of
household proximity to farmland and take home exposure pathways.
Environmental Research 2000; 84:290-302.
10. Loewenherz, C., Fenske, R.A., Simcox, N.J., Bellamy, G., and
Kalman, D. Biological monitoring of organophosphorus pesticide exposure
among children of agricultural workers in central Washington State.
Environmental Health Perspectives 19970; 105:1344-53.
11. Fenske, R.A. Pesticide exposure assessment of workers and their
families. Occupational Medicine 1997; 12:221-37.
12. Fiedler, N., Kipen, H., Kelly-McNeil, K., and Fenske, R. Long-
term use of organophosphates and neuropsychological performance.
American Journal of Industrial Medicine 1997; 32:487-96.
13. Blair, A., Grauman, D.J., Lubin, J.H., and Fraumeni, J.F., Jr.
Lung cancer and other causes of death among licensed pesticide
applicators. Journal of the National Cancer Institute 1983; 71:31-7.
14. Blair, A., and White, D.W. Leukemia cell types and agricultural
practices in Nebraska. Archives of Environmental Health 1985; 40:211-4.
15. Blair, A. Herbicides and non-Hodgkin's lymphoma: new evidence
from a study of Saskatchewan farmers. Journal of the National Cancer
Institute 1990; 82:544-5.
16. Ji, B.T., Silverman, D.T., and Stewart, P.A., et al.
Occupational exposure to pesticides and pancreatic cancer. American
Journal of Industrial Medicine 2001; 39:92-9.
17. Cantor, K.P., Blair, A., and Everett, G., et al. Pesticides and
other agricultural risk factors for non-Hodgkin's lymphoma among men in
Iowa and Minnesota. Cancer Research 1992; 52:2447-55.
18. Hoar, S.K., Blair, A., Holmes, F.F., Boysen, C., and Robel,
R.J. Herbicides and colon cancer. The Lancet 1985; 1:1277-8.
19. Hoar, S.K., Blair, A., and Holmes, F.F., et al. Agricultural
herbicide use and risk of lymphoma and soft-tissue sarcoma. Journal of
the American Medical Association 1986; 256:1141-7.
20. Zahm, S.H., Weisenburger, D.D., Saal, R.C., Vaught, J.B.,
Babbitt, P.A., and Blair, A. The role of agricultural pesticide use in
the development of non-Hodgkin's lymphoma in women. Archives of
Environmental Health 1993; 48:353-8.
21. Zahm, S.H., and Blair, A. Pesticides and non-Hodgkin's
lymphoma. Cancer Research 1992; 52:5485s-5488s.
22. Zahm, S.H., Blair, A. Cancer among migrant and seasonal
farmworkers: an epidemiologic review and research agenda. American
Journal of Industrial Medicine 1993; 24:753-66.
23. Zheng, T., Zahm, S.H., Cantor, K.P., Weisenburger, D.D., Zhang,
Y., and Blair, A. Agricultural exposure to carbamate pesticides and
risk of non-Hodgkin lymphoma. Journal of Occupational and Environmental
Medicine 2001; 43:641-9.
24. Lu, C., Knutson, D.E., Fisker-Andersen, J., Fenske, R.A.
Biological monitoring survey of organophosphorus pesticide exposure
among pre-school children in the Seattle metropolitan area.
Environmental Health Perspectives 2001; 109:299-303.
List of Subjects
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Tolerances.
Authority: 21 U.S.C. 346(a).
Dated: June 7, 2002.
Marcia E. Mulkey,
Director, Office of Pesticide Programs.
[FR Doc. 02-15465 Filed 6-18-02; 8:45 am]
BILLING CODE 6560-50-S