[Federal Register Volume 67, Number 118 (Wednesday, June 19, 2002)]
[Rules and Regulations]
[Pages 41628-41635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-15465]


=======================================================================
-----------------------------------------------------------------------

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.

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

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: 
[email protected].

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: [email protected], 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