Order Denying Objections to Issuance of Tolerances, 46706-46740 [05-15840]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 70, Number 153 (Wednesday, August 10, 2005)]
[Rules and Regulations]
[Pages 46706-46740]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-15840]



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Part IV





Environmental Protection Agency





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40 CFR Part 180



Order Denying Objections to Issuance of Tolerances; Final Rule

Federal Register / Vol. 70, No. 153 / Wednesday, August 10, 2005 / 
Rules and Regulations

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0190; FRL-7727-4]


Order Denying Objections to Issuance of Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final Order.

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SUMMARY: On four occasions in the first half of 2002, the Natural 
Resources Defense Council (NRDC) and various other parties filed 
objections with EPA to final rules under section 408 of the Federal 
Food, Drug, and Cosmetic Act (FFDCA), (21 U.S.C. 346a), establishing 
pesticide tolerances for various pesticides. The objections apply to 14 
pesticides and 112 separate pesticide tolerances. Although the 
objections raise numerous pesticide-specific issues, they all focus on 
the potential risks that the pesticides pose to farm children. This 
Order responds to NRDC's objections as to all of the challenged 
tolerances with the exception of the objections pertaining to the 
imidacloprid tolerance on blueberries which were previously denied. The 
objections to the other tolerances are denied for the reasons stated 
herein.

FOR FURTHER INFORMATION CONTACT: Nicole Williams, Registration 
Division, (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-5551; fax number: (703) 308-6920; e-
mail address: williams.nicole@epa.gov.

SUPPLEMENTARY INFORMATION: This order is outlined as follows:

I. General Information
 A. Does This Action Apply to Me?
 B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?
 1. Docket
 2. Electronic access
II. Introduction
 A. What Action Is the Agency Taking?
 B. What Is the Agency's Authority for Taking This Action?
III. Statutory and Regulatory Background
 A. Statutory Background
 B. Assessing Risk Under the FFDCA
 C. Science Policies
 1. Children's Safety Factor Policy
 2. Aggregate Exposure Policies
 D. NRDC Farmworker Children Petition
IV. The Challenged Tolerance Decisions
 1. Halosulfuron-methyl
 2. Pymetrozine
 3. Mepiquat
 4. Bifenazate
 5. Zeta-cypermethrin
 6. Diflubenzuron
 7. 2,4-D
 8. Isoxadifen-ethyl
 9. Acetamiprid
 10. Propiconazole
 11. Furilazole
 12. Fenhexamid
 13. Fluazinam
V. NRDC Objections
 A. In General
 B. Generic Issues
 1. Children's safety factor issue
 2. Aggregate exposure issues.
 3. Reliance on LOAELs and NOAELs
 C. Pesticide-specific Issues
VI. Public Comment
 A. In General
 B. Individual Comments
 1. The FQPA Implementation Working Group
 2. Inter-Regional Research Project Number 4 (IR-4)
 3. ISK Biosciences - Fluazinam
 4. Bayer CropScience - Isoxadifen-ethyl
 5. Aventis CropScience - Acetamiprid
 6. FMC Corporation - Zeta-cypermethrin
 7. Crompton Corporation - Diflubenzuron and Bifenazate
 a. Diflubenzuron
 b. Bifenazate
 8. Syngenta Crop Protection - Propiconazole and Pymetrozine
 a. Propiconazole
 b. Pymetrozine
 9. BASF Corporation - Mepiquat
 10. Industry Task Force II on 2,4-D Research Data
VII. Response to Objections
 A Expired Tolerances
 B. Children's Exposure to Pesticides in Agricultural Areas
 1. Studies Focusing on Exposure to Children in Agricultural Areas
 2. Information Bearing on Exposure Levels as a Result of Spray 
Drift and Post-Application Drift of Volatilized Residues
 a. Pesticide Spray Drift During Application
 (1) Comparison of AgDrift Model estimates with exposurefrom 
residential lawn use generally.
 (2)Evaluation of MOE's based on AgDrift Model for the pesticides in 
the Objections
 b. Volatilization of Applied Pesticides
 (1) Analysis of CFPR Report and Ranking Study
 (2) Vapor Pressure
 c. Conclusion
 C. Failed to Retain Children's 10X Safety Factor
 1. Introduction
 2. Lack of DNT Study Generally
 a. Pesticides may cause neurological developmental effects
 b. 1998 Retrospective Study on Submitted DNT Studies
 c. 10X Task Force Report
 d. EPA's 10X Policy
 e. Conclusion
 3. Other Pesticide-specific Missing Toxicity Data
 a. Diflubenzuron
 b. Fluazinam
 c. Furilazole
 d. 2,4-D
 4. Missing Exposure Data - General
 a. Farm Children Exposure
 b. Lack of comprehensive drinking water (DW) monitoring data
 5. Missing Exposure Data - Specific
 a. Mepiquat
 b. Bifenazate
 c. Zeta-cypermethrin
 d. Diflubenzuron
 e. Acetamiprid
 6. Missing Risk Assessments
 a. Halosulfuron-methyl
 b. Bifenazate
 c. Isoxadifen-ethyl
 d. Propiconazole
 e. Fenhexamid
 f. Fluazinam
 g. 2,4-D
 7. Conclusion on Children's Safety Factor Objections
 C. LOAEL/NOAEL
 1. Generic Legal Argument
 2. Objections Pertaining to Specific Pesticides
 a. Pymetrozine
 b. Mepiquat
 c. Zeta-cypermethrin
 d. Fluazinam
 e. Isoxadifen-ethyl, Acetamiprid, Propiconazole, Furilazole, and 
Fenhexamid
 D. Aggregate Exposure
 1. Worker Exposure
 2. Classification of Farm Children as a Major Identifiable 
Population Subgroup
 3. Adequacy of EPA's Assessment of the Aggregate Exposure of 
Children, Including Children in Agricultural Areas
 4. Residential Exposure as a Result of Use Requiring a Tolerance
 5. Anticipated Residues/Exposures Due to Purchase of Food at 
Farmstands
 6. Population Percentile Used in Aggregate Exposure Estimates
 a. In General
 b. Choice of Population Percentile
 7. Alleged Inadequacies Pertaining to Specific Pesticides
 a. Pymetrozine
 b. Bifenazate
 c. Zeta-cypermethrin
 d. Diflubenzuron
 e. 2,4-D
 f. Isoxadifen-ethyl, acetamiprid, fluazinam
E. Human Testing
F. Conclusion on Objections
VIII. Response to Comments on NRDC's Objections
IX. Regulatory Assessment Requirements
X. Submission to Congress and the Comptroller General
XI. Time and Date of Issuance of This Order
XII. References

I. General Information

A. Does This Action Apply to Me?

    In this document EPA denies objections to a tolerance actions filed 
by the Natural Resources Defense Council (NRDC) and the following 
additional parties: Boston Women's Health Book Collective, Breast 
Cancer Action, Californians for Pesticide Reform, Commonweal, Lymphoma 
Foundation of America, Natural Resources Defense

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Council, Northwest Coalition for Alternatives to Pesticides, Pesticide 
Action Network, North America, Pineros y Campesinos Unidos del 
Noroeste, SF-Bay Area Chapter of Physicians for Social Responsibility, 
and Women's Cancer Resource Center. This action may also be of interest 
to agricultural producers, food manufacturers, or other pesticide 
manufacturers. Potentially affected categories and entities may 
include, but are not limited to:
     Industry, e.g., NAICS 111, 112, 311, 32532, Crop 
production, Animal production, Food manufacturing, Pesticide 
manufacturing.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities who may be interested in today's 
action.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2005-0190. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1801 S. Bell St., Arlington, VA. This docket facility is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
docket telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at https://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at https://www.epa.gov/edocket/ to view public comments, 
access the index listing of the contents of the official public docket, 
and to access those documents in the public docket that are available 
electronically. Although not all docket materials may be available 
electronically, you may still access any of the publicly available 
docket materials through the docket facility identified in Unit I.B.1. 
Once in the system, select ``search,'' then key in the appropriate 
docket ID number.

II. Introduction

A. What Action Is the Agency Taking?

    On four occasions in the first half of 2002, the NRDC and various 
other parties filed objections with EPA to final rules under section 
408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), (21 U.S.C. 
346a), establishing pesticide tolerances for various pesticides. [The 
objectors are hereinafter collectively referred to as ``NRDC.'']. The 
objections apply to 14 pesticides and 112 separate pesticide 
tolerances. This Order responds to objections as to all of the 
tolerances other than the objections as to the imidacloprid tolerance 
on blueberries. Those objections were denied previously. (69 FR 30042, 
May 26, 2004).
    Although the objections raise numerous pesticide-specific issues, 
they all primarily focus on the potential risks that the pesticides 
pose to farm children. Further, each of the objections makes two main 
assertions with regard to the pesticide tolerances in question: (1) 
That EPA has not properly applied the additional 10X safety factor for 
the protection of infants and children in section 408(b)(2)(C); and (2) 
that EPA has not accurately assessed the aggregate exposure of farm 
children to pesticide residues. NRDC did not exercise the option 
provided in section 408(g)(2) to request a hearing on its objections, 
but instead asked that the Agency rule on its objections on the basis 
of its written objections and attached submissions.
    Because the objections raised questions of broad interest, EPA 
published a representative copy of the objections in the Federal 
Register for comment, (67 FR 41628, June 19, 2002), and made all of the 
objections available for public review on its website. On May 26, 2004, 
EPA denied the objections as to one of the challenged tolerances 
(imidacloprid on blueberries) because that tolerance had expired. (69 
FR 30042, May 26, 2004). At the same time EPA denied the objections to 
the imidacloprid tolerance on mootness grounds, EPA also established a 
new imidacloprid blueberry tolerance and as part of that action 
addressed the issues raised by the NRDC objections. (69 FR 30076, May 
26, 2004). In the course of addressing these issues, EPA responded to a 
petition concerning farm children filed in 1998 by NRDC and various 
other parties. (69 FR at 30069-70, May 26, 2004). This Order relies 
heavily on much of the reasoning set forth in connection with the 
establishment of the new imidacloprid blueberry tolerance.
    The body of this document contains the following sections. First, 
there is a background section which explains the applicable statutory 
and regulatory provisions, the relevant EPA science policy documents, 
and prior NRDC actions with regard to farm children. Second, EPA 
describes the objected-to tolerance actions. Third, there is a section 
setting forth in greater detail the substance of the objections. 
Fourth, a summary of the public comment is presented. Finally, EPA 
announces its response to the objections and responds to public 
comments.

B. What Is the Agency's Authority for Taking This Action?

    The procedure for filing objections to tolerance actions and EPA's 
authority for acting on such objections is contained in section 408(g) 
of the FFDCA and regulations at 40 CFR part 178. (21 U.S.C. 346a(g)).

III. Statutory and Regulatory Background

A. Statutory Background

    EPA establishes maximum residue limits, or ``tolerances,'' for 
pesticide residues in food under section 408 of the FFDCA. (21 U.S.C. 
346a). Without such a tolerance or an exemption from the requirement of 
a tolerance, a food containing a pesticide residue is ``adulterated'' 
under section 402 of the FFDCA and may not be legally moved in 
interstate commerce. (21 U.S.C. 331, 342). Monitoring and enforcement 
of pesticide tolerances are carried out by the U.S. Food and Drug 
Administration (FDA) and the U. S. Department of Agriculture (USDA).
    A pesticide tolerance may only be promulgated by EPA if the 
tolerance is ``safe.'' (21 U.S.C. 346a(b)(2)(A)(i)). ``Safe'' is 
defined by the statute to mean that ``there is a reasonable certainty 
that no harm will result from aggregate exposure to the pesticide 
chemical residue, including all anticipated dietary exposures and all 
other exposures for which there is reliable information.'' (21 U.S.C. 
346a(b)(2)(A)(ii)). Section 408 directs EPA, in making a safety 
determination, to ``consider, among other relevant factors- . . . 
.available information concerning the aggregate exposure levels of 
consumers (and major identifiable subgroups of consumers) to the 
pesticide chemical residue and to other related substances, including 
dietary exposure under the tolerance and all other tolerances in effect 
for the pesticide chemical residue, and

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exposure from other non-occupational sources.'' (21 U.S.C. 
346a(b)(2)(D)(vi)). Other provisions address in greater detail exposure 
considerations involving ``anticipated and actual residue levels'' and 
``percent of crop actually treated.'' (See 21 U.S.C. 346a(b)(2)(E) and 
(F)). Section 408(b)(2)(C) requires EPA to give special consideration 
to risks posed to infants and children. This provision directs that 
``an additional tenfold margin of safety for the pesticide chemical 
residue and other sources of exposure shall be applied for infants and 
children to take into account potential pre- and post-natal toxicity 
and completeness of the data with respect to exposure and toxicity to 
infants and children.'' (21 U.S.C. 346a(b)(2)(C)). EPA is permitted to 
``use a different margin of safety for the pesticide chemical residue 
only if, on the basis of reliable data, such margin will be safe for 
infants and children.'' (Id.). [The additional safety margin for 
infants and children is referred to throughout this notice as the 
``children's safety factor.''] These provisions establishing the 
detailed safety standard for pesticides were added to section 408 by 
the Food Quality Protection Act of 1996 (FQPA), an act that 
substantially rewrote this section of the statute.
    Tolerances are established by rulemaking under the unique 
procedural framework set forth in the FFDCA. Generally, the rulemaking 
is initiated by the party seeking the tolerance by means of filing a 
petition with EPA. (See 21 U.S.C. 346a(d)(1)). EPA publishes in the 
Federal Register a notice of the petition filing along with a summary 
of the petition, prepared by the petitioner. (21 U.S.C. 346a(d)(3)). 
After reviewing the petition, and any comments received on it, EPA may 
issue a final rule establishing the tolerance, issue a proposed rule, 
or deny the petition. (21 U.S.C. 346a(d)(4)). Once EPA takes final 
action on the petition by either establishing the tolerance or denying 
the petition, any affected party has 60 days to file objections with 
EPA and seek an evidentiary hearing on those objections. (21 U.S.C. 
346a(g)(2)). EPA's final order on the objections is subject to judicial 
review. (21 U.S.C. 346a(h)(1)).
    EPA also regulates pesticides under the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA), (7 U.S.C. 136 et seq). While 
the FFDCA authorizes the establishment of legal limits for pesticide 
residues in food, FIFRA requires the approval of pesticides prior to 
their sale and distribution, (7 U.S.C. 136a(a)), and establishes a 
registration regime for regulating the use of pesticides. FIFRA 
regulates pesticide use in conjunction with its registration scheme by 
requiring EPA review and approval of pesticide labels and specifying 
that use of a pesticide inconsistent with its label is a violation of 
Federal law. (7 U.S.C. 136j(a)(2)(G)). In the FQPA, Congress integrated 
action under the two statutes by requiring that the safety standard 
under the FFDCA be used as a criterion in FIFRA registration actions as 
to pesticide uses which result in dietary risk from residues in or on 
food, (7 U.S.C. 136(bb)), and directing that EPA coordinate, to the 
extent practicable, revocations of tolerances with pesticide 
cancellations under FIFRA. (21 U.S.C. 346a(l)(1)).

B. Assessing Risk Under the FFDCA

    In assessing and quantifying non-cancer risks posed by pesticides 
under the FFDCA as amended by the FQPA, EPA first determines the 
toxicological level of concern and then compares estimated human 
exposure to this level of concern. This comparison is done through 
either calculating a safe dose in humans (incorporating all appropriate 
safety factors) and expressing exposure as a percentage of this safe 
dose (the reference dose (RfD) approach) or dividing estimated human 
exposure into the lowest dose at which no adverse effects from the 
pesticide are seen in relevant studies (the margin of exposure (MOE) 
approach). How EPA determines the level of concern, chooses safety 
factors, and assesses risk under these two approaches is explained in 
more detail below. EPA's general approach to estimating exposure is 
also briefly discussed.
    For dietary risk assessment (for risks other than cancer), the dose 
at which no adverse effects are observed (the ``NOAEL'') from the 
toxicology study identified as appropriate for use in risk assessment 
is used to estimate the toxicological level of concern. However, the 
lowest dose at which adverse effects of concern are identified (the 
``LOAEL'') is sometimes used for risk assessment if no NOAEL was 
achieved in the toxicology study selected. A safety or uncertainty 
factor is then applied to this toxicological level of concern to 
calculate a safe dose for humans, usually referred to by EPA as an 
acute or chronic reference dose (RfD). The RfD is equal to the NOAEL 
divided by all applicable safety or uncertainty factors. Typically, a 
safety or uncertainty factor of 100X is used, 10X to account for 
uncertainties inherent in the extrapolation from laboratory animal data 
to humans and 10X for variations in sensitivity among members of the 
human population as well as other unknowns. Further, under the FQPA, an 
additional safety factor of 10X is presumptively applied to protect 
infants and children, unless reliable data support selection of a 
different factor. To quantitatively describe risk using the RfD 
approach, estimated exposure is expressed as a percentage of the RfD. 
Dietary exposures lower than 100 percent of the RfD are generally not 
of concern.
    For non-dietary, and combined dietary and non-dietary, risk 
assessments (other than cancer risk assessments) the same safety 
factors are used to determine the toxicological level of concern. For 
example, when 1,000X is the appropriate safety factor (10X to account 
for interspecies differences, 10X for intraspecies differences, and 10X 
for FQPA), the level of concern is that there be a 1,000-fold margin 
between the NOAEL from the toxicology study identified as appropriate 
for use in risk assessment and human exposure. To estimate risk, a 
ratio of the NOAEL to aggregate exposures (margin of exposure (MOE) = 
NOAEL/exposure) is calculated and compared to the level of concern. In 
contrast to the RfD approach, the higher the MOE, the safer the 
pesticide. Accordingly, if the level of concern for a pesticide is 
1,000, MOE's exceeding 1,000 would generally not be of concern.
    For cancer risk assessments, EPA generally assumes that any amount 
of exposure will lead to some degree of cancer risk. Using a model 
based on the slope of the cancer dose-response curve in relevant 
studies, EPA estimates risk in terms of the probability of occurrence 
of additional cancer cases as a result of exposure to the pesticide. An 
example of how such a probability risk is expressed would be to 
describe the risk as one in one hundred thousand (1 X 10-5), 
one in a million (1 X 10-6), or one in ten million (1 X 
10-7). Under certain specific circumstances, MOE 
calculations will be used for the carcinogenic risk assessment. No 
further discussion of cancer risk assessment is included here because 
NRDC's objections do not relate to cancer risks.
    Equally important to the risk assessment process as determining the 
toxicological level of concern is estimating human exposure. As 
explained in more detail in Unit VII.D.5. of this document, EPA uses a 
tiering system to estimate exposure which attempts to minimize 
resources expended in exposure estimates. The first tier is generally a 
worst case assessment that is relatively easy to conduct because it 
relies on conservative (health-protective) assumptions. Only if that 
tier suggests

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that the pesticide may pose a risk of concern are more resource-
intensive tiers triggered where the focus is on obtaining more 
realistic exposure values. (Ref. 1).

C. Science Policies

    As part of implementation of the major changes to FFDCA section 408 
included in the FQPA, EPA has issued a number of policy guidance 
documents addressing critical science issues. Of particular interest to 
the NRDC objections are the science policies covering the children's 
safety factor, aggregate pesticide exposure, and the population 
percentile of exposure used in estimating aggregate exposure.
    1. Children's safety factor policy. On January 31, 2002, EPA 
released its science policy guidance on the children's safety factor. 
(Ref. 2) [This policy is hereinafter referred to as the ``Children's 
Safety Factor Policy'']. That policy had undergone an intensive and 
extended process of public comment as well as internal and external 
science peer review. An EPA-wide task force was established to consider 
the children's safety factor in March 1998. Taking into account reports 
issued by the task force on both toxicity and exposure issues, EPA's 
Office of Pesticide Programs (OPP) released a draft children's safety 
policy document in May 1999. That document was subject to an extended 
public comment period as well as review by the FIFRA Scientific 
Advisory Panel. (Id. at 5). Although the January 31, 2002 policy 
differed in some respects from prior Agency practice, for the most part 
the policy statement reflected EPA's experience in implementing the 
children's safety factor provision since the passage of the FQPA.
    The Children's Safety Factor Policy emphasizes throughout that EPA 
interprets the children's safety factor provision as establishing a 
presumption in favor of application of an additional 10X safety factor 
for the protection of infants and children. (Id. at 4, 11, 47, A-6). 
Further, EPA notes that the children's safety factor provision permits 
a different safety factor to be substituted for this default 10X factor 
only if reliable data are available to show that the different factor 
will protect the safety of infants and children. (Id.). Given the 
wealth of data available on pesticides, however, EPA indicates a 
preference for making an individualized determination of a protective 
safety factor if possible. (Id. at 11). EPA states that use of the 
default factor could under- or over-protect infants and children due to 
the wide variety of issues addressed by the children's safety factor. 
(Id.). EPA notes that ``[i]ndividual assessments may result in the use 
of additional factors greater or less than, or equal to 10X, or no 
additional factor at all.'' (Id.). Concluding that individualized 
assessments would be able to be made in most cases, EPA indicates that 
``this guidance document focuses primarily on the considerations 
relevant to determining a safety factor `different' from the default 
10X that protects infants and children. Discussions in this document of 
the appropriateness, adequacy, need for, or size of an additional 
safety factor are premised on the fact that reliable data exist for 
choosing a `different' factor than the 10X default value.'' (Id. at 
12).
    In making such individual assessments regarding the magnitude of 
the safety factor, EPA stresses the importance of focusing on the 
statutory language that ties the children's safety factor to concerns 
regarding potential pre- and post-natal toxicity and the completeness 
of the toxicity and exposure databases. (Id. at 11-12). As to the 
completeness of the toxicity database, EPA recommends use of a weight-
of-the-evidence approach which considers not only the presence or 
absence of data generally required under EPA regulations and guidelines 
but also the availability of ``any other data needed to evaluate 
potential risks to children.'' (Id. at 20). EPA indicates that the 
principal inquiry concerning missing data would center on whether the 
missing data would significantly affect calculation of a safe exposure 
level (commonly referred to as the RfD). (Id. at 22; accord 67 FR 
60950, 60955, September 27, 2002) (finding no additional safety factor 
necessary for triticonazole despite lack of developmental neurotoxicity 
(DNT) study because the ``DNT [study] is unlikely to affect the manner 
in which triticonazole is regulated.'')). When the missing data are 
data above and beyond general regulatory requirements, EPA indicates 
that the weight of evidence would generally only support the need for 
an additional safety factor where the data ``is being required for 
`cause,' that is, if a significant concern is raised based upon a 
review of existing information, not simply because a data requirement 
has been levied to expand OPP's general knowledge.'' (Ref. 2 at 23). 
Finally, with regard to the DNT study, EPA lists several important 
factors addressing the weight of evidence bearing on the degree of 
concern when such a study has been required but has not yet been 
completed. (Id. at 24). Moreover, EPA reiterates that, like any other 
missing study, the absence of the DNT study does not trigger a 
mandatory requirement to retain the default 10X value, but rather 
requires an individualized assessment centering on the question of 
whether ``a DNT 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 risk assessment . . . .'' (Id.). The extent to which the 
policy stresses the need for EPA's evaluation of the completeness of 
the database to focus directly on whether missing data might possibly 
lower an existing RfD was a change in emphasis from past actions.
    As to potential pre- and post-natal toxicity, the Children's Safety 
Factor Policy lists a variety of factors that should be considered in 
evaluating the degree of concern regarding any identified pre- or post-
natal toxicity. (Id. at 27-31). As with the completeness of the 
toxicity database, EPA emphasizes that the analysis should focus on 
whether any identified pre- or post-natal toxicity raises uncertainty 
as to whether the RfD is protective of infants and children. (Id. at 
31). Once again, the presence of pre- or post-natal toxicity, by 
itself, is not regarded as determinative as to the children's safety 
factor. Rather, EPA stresses the importance of evaluating all of the 
data under a weight-of-evidence approach focusing on the safety of 
infants and children. (Id.). This attention on the overall database 
also indicated a shift in emphasis for EPA's implementation of the 
children's safety factor provision as previous decisions had often 
treated a finding of increased sensitivity in the young as almost 
necessitating some additional safety factor.
    In evaluating the completeness of the exposure database, EPA 
explains that a weight-of-the-evidence approach should be used to 
determine the confidence level EPA has as to whether the exposure 
assessment ``is either highly accurate or based upon sufficiently 
conservative input that it does not underestimate those exposures that 
are critical for assessing the risks to infants and children.'' (Id. at 
32). EPA describes why its methods for calculating exposure through 
various routes and aggregating exposure over those routes generally 
produce conservative exposure estimates - i.e. health-protective 
estimates due to overestimation of exposure. (Id. at 40-43). 
Nonetheless, EPA emphasizes the importance of verifying that the 
tendency for its methods to overestimate exposure in fact were 
adequately

[[Page 46710]]

protective in each individual assessment. (Id. at 44).
    Given that this policy was released at roughly the same time the 
challenged tolerance actions were issued and that the toxicological, 
exposure, and risk assessments leading up to such actions can take 
several months or even years, the challenged tolerance actions were not 
evaluated prior to being finalized under this new restatement of EPA's 
policy on the children's safety factor. EPA's experience in making 
decisions under the 2002 policy is that while for many pesticides the 
safety factor determination remains unchanged, for others the safety 
factors may go up or down. To generalize, in situations where the 
database is incomplete, EPA's heightened emphasis on whether the 
missing data may affect the assessment of risk has tended to make it 
more likely that EPA will retain the full 10X children's safety factor. 
(See, e.g., 70 FR 7876, 7882, February 16, 2005) (avermectin - 10X 
factor retained due to lack of DNT study and acute and subchronic 
neuorotoxicity studies and residual toxicological concerns as to safety 
of young); 70 FR 7886, 7891, February 16, 2005) (clothianidim - 10X 
factor retained due to lack of developmental immunotoxicity study); 69 
FR 58058, 58062-58063, September 29, 2004) (fenamidone - 10X factor 
retained due to lack of DNT study); but see 69 FR 52182, 52187, August 
25, 2004) (folpet - 10X removed despite lack of DNT study because the 
DNT study is unlikely to change RfD)). On the other hand, in instances 
where a study shows increased sensitivity in the young, the focus on 
whether in the context of the overall database such sensitivity 
indicates that EPA's risk assessment is not protective of infants and 
children, has frequently resulted in the removal of the factor. (See, 
e.g., 69 FR 63083, 63092-63093, October 29, 2004) (pyraclostrobin - 10X 
factor removed because additional sensitivity well-characterized); 69 
FR 58290, 58295, September 30, 2004) (cyazofamid - 10X factor removed 
because additional sensitivity well-characterized); but see 69 FR 
62602, 62610, October 27, 2004) (deltamethrin - 10X factor lowered but 
not removed taking into consideration level at which additional 
sensitivity was observed)). As these decisions evidence, the 
determination on the children's safety factor is heavily dependent on 
the results from the studies specific to the pesticide in question. 
(See, e.g., 70 FR 14535, 14541-14542, March 23, 2005) (dinotefuran - 
10X factor retained as to some risk assessments due to the lack of a 
developmental immunotoxicity study; no additional factor on any risk 
assessment found necessary to address lack of a DNT study)).
    2. Aggregate exposure policies. As mentioned above, the FQPA-added 
safety standard directs that the safety of pesticide residues in food 
be based on ``aggregate exposure'' to the pesticide. (21 U.S.C. 
346a(b)(2)(A)(ii)). Aggregate exposure to a pesticide includes all 
``anticipated dietary exposure and all other exposures for which there 
is reliable information.'' (Id.). The statute makes clear that in 
assessing aggregate exposure pertaining to a pesticide EPA must 
consider not only exposure to the pesticide in the food covered by the 
tolerance in question but exposure to the pesticide as a result of 
other tolerances and from ``other non-occupational sources.'' (Id. 
346a(b)(2)(D)(vi)). Further, the statute directs EPA to consider 
aggregate exposure to other substances related to the pesticide so long 
as that exposure results from a non-occupational source. (Id. 
346a(b)(2)(D)(vi)). In November 2001, EPA released a science guidance 
document entitled ``General Principles for Performing Aggregate 
Exposure and Risk Assessments.'' This document deals primarily with the 
complex subject of integrating distributional and probabilistic 
techniques into aggregate exposure analyses. (Ref. 3).
    More relevant to the current objections is the science guidance 
document issued in March 2000 addressing the population percentile of 
exposure used in making acute exposure estimates for applying the 
safety standard under section 408. (Ref. 4) [hereinafter referred to as 
``Percentile Policy'']. Traditionally, EPA had used the 95th percentile 
of human exposure in acute dietary exposure assessments as representing 
a reasonable worst case scenario. (Id. at 15). Due to the very 
conservative (health-protective) assumptions used for acute exposure 
assessments, the 95th percentile was viewed as a reasonable 
approximation of an exposure level not likely to be exceeded by any 
individuals. (Id. at 15-17). For these assessments EPA generally 
assumed that all crops for which there is a tolerance are treated with 
the pesticide and all treated crops have residues at the highest level 
legally permitted.
    More recently, because of the availability of better data on 
residue values and new risk assessment techniques, EPA has restructured 
its approach to the use of population exposure percentiles in making 
safety determinations for acute risks under section 408. EPA has 
retained the 95th percentile as the starting point of analysis for 
worst case (tolerance level) assessments. EPA, however, generally uses 
higher percentiles of exposure when less conservative assumptions are 
made concerning residue values. (Id.). For example, beginning in the 
late 1990's, EPA has increasingly relied upon probabilistic assessment 
techniques for assessing acute dietary exposure and risk. Because EPA 
generally uses much more realistic exposure values (e.g., monitoring 
data on pesticide levels in food) in conducting probabilistic 
assessments, a higher population exposure percentile was generally 
found to be necessary to ensure that exposure for the overall 
population was not understated. The Percentile Policy explains and 
defends EPA's choice of the 99.9th percentile as a starting point for 
evaluating exposure and acute risk with probabilistic assessments.
    EPA confirms in the Percentile Policy document that it will 
generally continue to use the 95th percentile of exposure for non-
probabilistic, or what has been referred to as ``deterministic'' acute 
risk assessments that use worst case exposure assumptions.'' (Id. at 
17, 29). The conservative (health-protective) nature of this approach 
is confirmed by data EPA cites showing that deterministic assessments 
of exposure at the 95th percentile assuming residues at tolerance 
levels regularly result in exposure predictions significantly higher 
than probabilistic exposure estimates of the 99.9th percentile using 
monitoring data. (Id. at 16-17).
    Importantly, EPA's Percentile Policy makes clear that in choosing a 
population percentile to estimate exposure, EPA is not intending to 
define the portion of the population that is to be protected. The 
policy explicitly states that: ``OPP's goal is to regulate pesticides 
in such a manner that everyone is reasonably certain to experience no 
harm as a result of dietary and other non-occupational exposures to 
pesticides.'' (Id. at 28).

D. NRDC Farmworker Children Petition

    On October 22, 1998, NRDC and 58 other public interest 
organizations and individuals submitted a petition to EPA asking that 
EPA ``find that farm children are a major identifiable subgroup and 
must be protected under FQPA when setting allowable levels of pesticide 
residue in food.'' (Ref. 5) [hereinafter referred to as the ``Farm 
Children Petition'']. The Farm Children Petition claims that ``[a]n 
increasing body of scientific evidence, including biomonitoring data 
and residential exposure studies, indicates that farm children face 
particularly significant

[[Page 46711]]

exposures and health risks from pesticides.'' (Id. at 3). In addition 
to requesting the ``major identifiable subgroup'' designation, the 
Petition also asked that EPA use the children's safety factor to 
protect farm children, require additional exposure data on farm 
children exposure and not issue any new tolerances until such data are 
available, deny registration for any pesticide without a validated 
method for detecting residues in food, increase research into issues 
concerning farm children exposure to pesticides, and honor the 
President's Executive Order on Environmental Justice.
    EPA responded to the Farm Children Petition in the Imidacloprid 
Order. EPA declined to name farm children as a separate major, 
identifiable subgroup pointing out that any pesticide exposures to 
children as a result of proximity to agricultural fields can be fully 
taken into account as part of the consideration of EPA's already 
existing major identifiable subgroups of children. (69 FR 30069, May 
26, 2004). EPA agreed with most of the other aspects of NRDC's 
petition. (69 FR 30076-30077, May 26, 2004).

IV. The Challenged Tolerance Decisions

    Table 1 lists the tolerance actions challenged by NRDC. The 
tolerance actions are grouped as they were by NRDC in NRDC's four sets 
of objections.

                 Table 1.--Challenged Tolerance Actions
------------------------------------------------------------------------
         Pesticides Involved              FR Citations (respectively)
------------------------------------------------------------------------
halosulfuron-methyl, pymetrozine      66 FR 66333, December 26, 2001; 66
                                       FR 66778, December 27, 2002; 66
                                       FR 66786, December 27, 2001
-------------------------------------
imidacloprid, mepiquat, bifenazate,   67 FR 2580, January 18, 2002; 67
 zeta-cypermethrin, diflubenzuron      FR 3113, January, 23, 2002; 67 FR
                                       4913, February 1, 2002; 67 FR
                                       6422, February 12, 2002; 67 FR
                                       7085, February 15, 2002
-------------------------------------
2,4-D                                 67 FR 10622, March 8, 2002
-------------------------------------
isoxadifen-ethyl, acetamiprid,        67 FR 12875, March 20, 2002; 67 FR
 propiconazole, furilazole,            14649, March 27, 2002; 67 FR
 fenhexamid, fluazinam                 14866, March 28, 2002; 67 FR
                                       15727, April 3, 2002; 67 FR
                                       19114, April 18, 2002; 67 FR
                                       19120, April 18, 2002
------------------------------------------------------------------------

    Each of these tolerance actions, except imidacloprid, is summarized 
briefly below.
    1. Halosulfuron-methyl. NRDC challenged two separate tolerance 
actions on halosulfuron-methyl: (1) A December 26, 2001 action 
establishing tolerances on the melon subgroup; (66 FR 66333, December 
26, 2001), and (2) a December 27, 2001 action establishing time-limited 
tolerances in connection with an emergency exemption under FIFRA on 
asparagus, (66 FR 66778, December 27, 2002). The risk assessments for 
both actions yielded similar results. Given halosulfuron-methyl's 
exposure pattern and toxicological characteristics, EPA determined that 
halosulfuron-methyl potentially presented acute, chronic, short-term, 
and intermediate-term risks and EPA quantitatively assessed these risks 
in making its safety determination. (66 FR 66336-66339; 66 FR 66783-
66784). All of these risks were found to be below the Agency's level of 
concern. (Id.). Although a DNT study was outstanding, EPA determined 
that the additional 10X children's safety factor was not needed to 
protect infants and children because the toxicological data showed no 
evidence of greater sensitivity to the young and indicated that the DNT 
study was unlikely to affect the risk assessment. EPA explained the 
latter conclusion by noting that:
    (a) The alterations in the fetal nervous system occurred in only 
one species (in rats and not in rabbits); (b) the fetal effects 
which will be investigated in the required developmental 
neurotoxicity study were seen only at a dose of 750 mg/kg/day which 
is close to the Limit-Dose (1,000 mg/kg/day); (c) there was no 
evidence of clinical signs of neurotoxicity, brain weight changes, 
or neuropathology in the subchronic or chronic studies in rats; (d) 
the developmental neurotoxicity study is required only as 
confirmatory data to understand what the effect is at a high 
exposure (dose) level.
(66 FR at 66782).
    2. Pymetrozine. NRDC challenged a December 27, 2001 action 
establishing tolerances for pymetrozine on cotton seed, cotton gin 
byproducts, the fruiting vegetables crop group, the cucurbit vegetables 
crop group, the leafy vegetables crop group (except Brassica), head and 
stem Brassica, leafy Brassica, turnip greens, dried hops, and pecans. 
(66 FR 66786, December 27, 2001). Given pymetrozine's exposure pattern 
and toxicological characteristics, EPA determined that pymetrozine 
potentially presented acute, chronic, short-term, and cancer risks and 
EPA quantitatively assessed these risks in making its safety 
determination. (66 FR at 66791-66792). All of these risks were found to 
be below the Agency's level of concern. (Id.). Although a DNT study was 
outstanding, EPA determined that the additional 10X children's safety 
factor could generally be reduced to 3X because the toxicological data 
showed no evidence of greater sensitivity to the young and there was no 
evidence of abnormalities in the development of the fetal nervous 
system. (64 FR 52438, 52444, September 29, 1999). Because the endpoint 
used for assessing acute dietary and short-term risk for the general 
population, including infants and children, was based on a LOAEL a 
second 3X safety factor was used for these risk assessments. (Id.).
    3. Mepiquat. NRDC challenged a January 23, 2002 action establishing 
tolerances for mepiquat on cotton gin byproducts and meat byproducts of 
cattle, goats, hogs, horses and sheep. (67 FR 3113, January, 23, 2002). 
Given mepiquat's exposure pattern and toxicological characteristics, 
EPA determined that mepiquat potentially presented acute and chronic 
risks and EPA quantitatively assessed these risks in making its safety 
determination. (67 FR at 3116). All of these risks were found to be 
below the Agency's level of concern. (Id.). Although a DNT study was 
outstanding, EPA determined that the additional 10X children's safety 
factor was not needed to protect infants and children because the 
toxicological data showed no evidence of greater sensitivity to the 
young and the evidence signaling a need for a DNT study did not show 
``some special concern for the developing fetuses or young'' such as 
``neuropathy in adult animals; [central nervous system] malformations 
following prenatal exposure; brain weight or sexual maturation changes 
in offspring; and/or functional changes in offspring.`` (65 FR 1790, 
1794, January 12, 2000)).

[[Page 46712]]

    4. Bifenazate. NRDC challenged a February 1, 2002 action 
establishing tolerances for bifenazate on wet apple pomace, undelinted 
cotton seed, cotton gin byproducts, the pome fruit crop group, grapes, 
raisins, dried hops, nectarines, peaches, plums, strawberries and the 
fat of cattle, goats, hogs, horses, and sheep. (67 FR 4913, February 1, 
2002). Given bifenazate's exposure pattern and toxicological 
characteristics, EPA determined that bifenazate potentially presented a 
chronic risk and EPA quantitatively assessed this risk in making its 
safety determination. (67 FR at 4919). As assessed, chronic risk was 
below the Agency's level of concern. (Id.). Because there was no 
outstanding toxicity data, the existing toxicity data showed no 
evidence of increased sensitivity of the young, and exposure data were 
deemed unlikely to understate exposure, EPA determined that it was safe 
for infants and children to remove the children's safety factor. (67 FR 
at 4918-4919).
    5. Zeta-cypermethrin. NRDC challenged a February 12, 2002 action 
establishing tolerances for zeta-cypermethrin on the podded legume 
vegetable crop group; the succulent, shelled peas and beans crop group; 
dried shelled peas and beans crop group; soybeans; the fruiting 
vegetables crop group; grain sorghum; sorghum stover; sorghum forage; 
wheat grain; wheat forage; wheat hay; wheat straw; aspirated grain 
fractions; and meat of cattle, goats, hogs, horses and sheep. (67 FR 
6422, February 12, 2002). Given zeta-cypermethrin's exposure pattern 
(including the exposure pattern of a toxicologically similar pesticide, 
cypermethrin) and toxicological characteristics, EPA determined that 
zeta-cypermethrin potentially presented acute, chronic, short-term, 
intermediate-term, and cancer risks and EPA quantitatively assessed 
these risks in making its safety determination. (67 FR at 6426-6429). 
All of these risks were found to be below the Agency's level of 
concern. (Id.). Although a DNT study was outstanding, EPA determined 
that the additional 10X children's safety factor was not needed to 
protect infants and children because the toxicological data showed no 
evidence of greater sensitivity to the young and the evidence signaling 
a need for a DNT study did not show ``some special concern for the 
developing fetuses or young'' such as ``neuropathy in adult animals; 
[central nervous system] malformations following prenatal exposure; 
brain weight or sexual maturation changes in offspring; and/or 
functional changes in offspring.'' (Id. at 6426).
    6. Diflubenzuron. NRDC challenged a February 15, 2002 action 
establishing a tolerance for diflubenzuron on pears. (67 FR 7085, 
February 15, 2002). Given diflubenzuron's exposure pattern and 
toxicological characteristics, EPA determined that diflubenzuron 
potentially presented a chronic risk and EPA quantitatively assessed 
this risk in making its safety determination. (Id. at 7089-7090). As 
assessed, chronic risk was below the Agency's level of concern. (Id.). 
EPA determined that the additional 10X children's safety factor was not 
needed to protect infants and children because the toxicological data 
showed no evidence of greater sensitivity to the young, there was no 
missing toxicological data, and the exposure assessments were unlikely 
to understate exposure. (Id. at 7089).
    7. 2,4-D. NRDC challenged a March 8, 2002, action establishing a 
time-limited tolerance for 2,4-D on soybeans. (67 FR 10622, March 8, 
2002). Given 2,4-D's exposure pattern and toxicological 
characteristics, EPA determined that 2,4-D potentially presented acute, 
chronic, and short-term risks and EPA quantitatively assessed these 
risks in making its safety determination. (Id. at 10628-10629). All of 
these risks were found to be below the Agency's level of concern. 
(Id.). Although a DNT study was outstanding, EPA determined that the 
additional 10X children's safety factor could be reduced because the 
toxicological data showed no evidence of greater sensitivity to the 
young and all other required toxicological data was complete. (Id. at 
10627-10628). A factor of 3X was retained because the DNT study was 
triggered based on a finding of neuropathology (retinal degeneration) 
and was applied to all population subgroups for all durations of 
exposure.
    8. Isoxadifen-ethyl. NRDC challenged a March 20, 2002, action 
establishing tolerances for isoxadifen-ethyl on corn commodities. (67 
FR 12875, March 20, 2002). Given isoxadifen-ethyl's exposure pattern 
and toxicological characteristics, EPA determined that isoxadifen-ethyl 
potentially presented acute and chronic risks and EPA quantitatively 
assessed these risks in making its safety determination. (Id. at 12876-
12877; 66 FR 33179, 33184-33185, June 21, 2001). All of these risks 
were found to be below the Agency's level of concern. (Id.). Although 
the data showed evidence of increased pre-natal sensitivity, EPA 
determined that the additional 10X children's safety factor could be 
reduced to 3X because the toxicological data were complete (i.e., there 
were no outstanding studies such as a DNT study). (Id. at 33184). This 
additional factor was applied to the acute dietary risk assessment for 
females aged 13-50 because the increased sensitivity resulted from in 
utero exposure. (Id.).
    9. Acetamiprid. NRDC challenged a March 27, 2002, action 
establishing tolerances for acetamiprid on dried citrus pulp, the 
citrus fruit crop group, cotton gin byproducts, cotton undelinted seed, 
grapes, the fruiting vegetable crop group, the leafy brassica vegetable 
crop group, the leafy vegetable crop group, the pome fruit group, 
tomato paste, as well as various animal products. (67 FR 14649, March 
27, 2002). Given acetamiprid 's exposure pattern and toxicological 
characteristics, EPA determined that acetamiprid potentially presented 
acute, chronic, short-term, and intermediate-term risks and EPA 
quantitatively assessed these risks in making its safety determination. 
(Id. at 14656-14657). All of these risks were found to be below the 
Agency's level of concern. (Id.). Although the data showed qualitative 
evidence of increased pre-natal sensitivity and a DNT study was 
outstanding, EPA determined that the additional 10X children's safety 
factor could be reduced to 3X because two of the three toxicological 
studies bearing on effects on the young showed no increased sensitivity 
in the young, the evidence of increased sensitivity was only 
qualitative and not quantitative, and the DNT study was not requested 
based on evidence indicating a special concern for developing fetuses 
or the young. (Id. at 14656). This additional factor was applied for 
all population subgroups for all exposures other than acute dietary 
exposure because the increased sensitivity resulted from chronic 
exposure. (Id.).
    10. Propiconazole. NRDC challenged a March 28, 2002, action re-
establishing a time-limited tolerance for propiconazole on blueberries 
in connection with an emergency exemption under FIFRA. (67 FR 14866, 
March 28, 2002). Given propiconazole's exposure pattern and 
toxicological characteristics, EPA determined that propiconazole 
potentially presented acute, chronic, short-term, intermediate-term, 
and cancer risks and EPA quantitatively assessed these risks in making 
its safety determination. (64 FR 2995, 2999-3001, January 20, 1999). 
All of these risks were found to be below the Agency's level of 
concern. (Id.). Based on the completeness of the toxicity database and 
the lack of any evidence showing increased pre- or post-natal 
sensitivity, EPA determined that removing the additional 10X children's 
safety factor

[[Page 46713]]

would be protective of infants and children. (Id. at 3000).
    11. Furilazole. NRDC challenged an April 3, 2002, action 
establishing tolerances for furilazole on corn commodities. (67 FR 
15727, April 3, 2002). Given furilazole's exposure pattern and 
toxicological characteristics, EPA determined that furilazole 
potentially presented acute, chronic, and cancer risks and EPA 
quantitatively assessed these risks in making its safety determination. 
(Id. at 15732-15733). All of these risks were found to be below the 
Agency's level of concern. (Id.). Although EPA was lacking a chronic 
toxicity study in dogs for furilazole, EPA determined that the 
additional 10X children's safety factor could be removed and that a 3X 
additional factor would be protective of infants and children because 
otherwise the database was complete, there was no evidence of pre- or 
post-natal sensitivity, and the subchronic toxicity studies in rats and 
dogs show that the toxicity of furilazole is similar, both 
qualitatively and quantitatively, in both species. The 3X factor was 
applied to the chronic risk assessment because the missing study was a 
chronic study. (Id. at 15730).
    12. Fenhexamid. NRDC challenged an April 18, 2002, action 
establishing tolerances for fenhexamid on the caneberry crop subgroup, 
the bushberry crop subgroup, juneberry, lingonberry, salal, and 
pistachio. (67 FR 19114, April 18, 2002). Given fenhexamid's exposure 
pattern and toxicological characteristics, EPA determined that 
fenhexamid potentially presented a chronic risk and EPA quantitatively 
assessed this risk in making its safety determination. (Id. at 19118). 
As assessed, chronic risk was found to be below the Agency's level of 
concern. (Id.). Although the data showed qualitative evidence of 
increased pre-natal sensitivity, EPA determined that the additional 10X 
children's safety factor could be reduced to 3X because the 
toxicological data were complete, two of the three toxicological 
studies bearing on effects on the young showed no increased sensitivity 
in the young, and the evidence of increased sensitivity was only 
qualitative and not quantitative. (Id. at 19117).
    13. Fluazinam. NRDC challenged an April 18, 2002, action 
establishing a tolerance for fluazinam on the wine grapes. (67 FR 
19120, April 18, 2002). Given fluazinam's exposure pattern and 
toxicological characteristics, EPA determined that fluazinam 
potentially presented acute and chronic risks and EPA quantitatively 
assessed these risks in making its safety determination. (Id. at 19127-
19128). All of these risks were found to be below the Agency's level of 
concern. (Id.). Because the data showed qualitative evidence of 
increased pre-natal sensitivity and a DNT study had been required (but 
not yet submitted) based on evidence of neurotoxic lesions, EPA 
retained the additional 10X safety factor for acute dietary exposure to 
the population subgroup females aged 13-50. For other populations and 
exposures the additional 10X factor was reduced to 3X because the 
increased sensitivity had only been seen with in utero exposure. (Id. 
at 19126-19127).

V. NRDC Objections

A. In General

    As mentioned above, NRDC submitted four separate sets of objections 
on various pesticide tolerances during the first half of 2002. The 
objections were received on February 25, 2002; March 19, 2002; May 7, 
2002; and May 20, 2002. (Refs. 6, 7, 8, and 9). NRDC was joined in the 
objections concerning 2,4-D by the following public interest and/or 
advocacy organizations: Boston Women's Health Book Collective, Breast 
Cancer Action, Californians for Pesticide Reform, Commonweal, Lymphoma 
Foundation of America, Northwest Coalition for Alternatives to 
Pesticides, Pesticide Action Network North America, Pineros y 
Campesinos Unidos del Noroeste, SF-Bay Area Chapter of Physicians for 
Social Responsibility, and Women's Cancer Resource Center.

B. Generic Issues

    NRDC raises a myriad of claims in its objections. Most of the 
claims fall fairly neatly into three categories: (1) Children's safety 
factor issues; (2) aggregate exposure issues; and (3) issues regarding 
use of findings from hazard studies in calculating safe exposure levels 
- the``no observed effect level'' (NOEL) versus ``no observed adverse 
effect level'' (NOAEL) and the ``lowest observed adverse effect level'' 
(LOAEL) questions.
    1. Children's safety factor issues. For each of the pesticides 
included in the objections, NRDC asserts that EPA used an additional 
safety factor for the protection of infants and children that is 
different from the default 10x value. NRDC claims that EPA erred in 
doing so due to the ``significant toxicity and exposure data gaps'' 
corresponding to the tolerances established. (See, e.g., Ref. 7 at 3). 
Three types of data gaps are cited by NRDC. First, NRDC notes that as 
to certain of the pesticides EPA has required a developmental 
neurotoxicity study but such study has not yet been submitted. Pointing 
to various EPA documents recommending that this study be widely 
required and EPA's specific finding that this study is required as to 
the pesticides in question, NRDC argues that use of a factor different 
than the default 10X is precluded. Second, NRDC claims EPA lacks 
``pesticide-specific data on water-based exposure'' to the pesticides. 
(Id. at 6). NRDC argues that exposure estimates EPA calculated through 
the use of models cannot qualify as the ``reliable data'' needed to 
vary from the default 10X value. (Id.). Third, NRDC claims that ``EPA 
failed 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 [], and exposure from spray 
drift.'' (Ref. 9 at 5).
    2. Aggregate exposure issues. NRDC raises several issues relating 
to whether EPA properly estimated ``aggregate exposure'' for the 
pesticides in question. First, NRDC argues that farm children are a 
``major identifiable subgroup'' and that EPA has failed to consider 
information concerning the sensitivities and exposures of farm children 
as a major identifiable subgroup'' in conducting its aggregate exposure 
assessment. According to NRDC, farm children have unique exposures to 
pesticides ``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 breast milk.'' (Ref. 7 at 12). Further, NRDC asserts farm 
children's exposure is increased because they ``often accompany their 
parents to work in the fields . . . .'' (Id.). NRDC cites various 
studies collected in its ``Farm Children Petition'' as well as more 
recent studies in support of these claims. (Ref. 7 at 12-13). Second, 
NRDC argues that EPA's aggregate exposure assessment is flawed for 
these pesticides because EPA did not consider the added exposure to 
pesticides that farmworkers receive as a result of their occupation. 
(Id. at 14). NRDC states that EPA's interpretation of the statute as 
excluding occupational exposure is incorrect. (Id.). Third, NRDC claims 
that EPA has underestimated aggregate exposure for several of the 
pesticides because EPA used ``anticipated residues'' for estimating 
exposure rather than assuming residues would be at the tolerance level. 
NRDC argues that ``EPA must ensure that the legal level of pesticide 
chemical residue - the established tolerance levels - are themselves 
safe.'' (Ref. 9 at 20). Additionally, NRDC asserts that using

[[Page 46714]]

``anticipated residues'' does not take into account the ``significant 
number of consumers who purchase produce at farmers markets, farm 
stands, and `pick-your-own' farming operations.'' (Id. at 19). These 
``potentially millions of consumers,'' NRDC contends, are exposed ``to 
residues of these pesticides at the tolerance level.'' (Id. at 20). 
Fourth, NRDC argues that for several of the pesticides EPA has, in 
effect, underestimated aggregate exposure by using the 95th population 
percentile of exposure instead of the 99.9th percentile in determining 
whether exposure to the pesticide meets the safety standard. (Ref. 7 at 
19). NRDC claims that this is inconsistent with existing Agency policy. 
(Id.).
    3. Reliance on LOAELs and NOAELs. NRDC asserts that, in the absence 
of identifying a NOEL in relevant animal studies, EPA cannot make a 
safety finding under section 408(b)(2). In support of this argument, 
NRDC cites to legislative history using the term NOEL. NRDC calls 
particular attention to the instances where EPA determined safety 
relying on a LOAEL: Use of acute neurotoxicity LOAEL to evaluate oral 
exposure for pymetrozine; (Ref. 6 at 9), use of reproductive toxicity 
LOAEL for mepiquat; (Id.), use of developmental toxicity LOAEL for 
zeta-cypermethrin; (Ref. 7 at 19), use of LOAEL for dermal toxicity for 
fluazinam; (Ref. 9 at 18), and reliance on rat and mouse dietary 
studies for fluazinam that identified only a LOAEL. (Id.). NRDC, 
however, also objects to several pesticide tolerances for use of a 
NOAEL in making the safety determination. (Ref. 9 at 17-18).

C. Pesticide-specific Issues

    NRDC's pesticide-specific objections to some extent build upon the 
more general objections described immediately above. As to each of the 
pesticides, NRDC identifies allegedly missing toxicity or exposure data 
and argues that these missing data necessitate retention of the default 
10X children's safety factor. Additionally, for several of the 
pesticides, NRDC raises specific issues regarding the aggregate 
exposure estimate. One aggregate exposure issue raised repeatedly is 
EPA's reliance on allegedly arbitrary processing factors for estimating 
residues in processed food. These objections are addressed in detail in 
Unit VIID.7.b. and f. below, respectively.
    Finally, NRDC objects to the 2,4-D tolerance on soybeans arguing 
that EPA relied upon a human exposure study ``in an arbitrary departure 
from the Agency's stated policy on considering human tests and a 
violation of international and federal law.'' (Ref. 8 at 22). Also with 
regard to 2,4-D, NRDC discusses various toxicological studies that 
according to NRDC show that 2,4-D is a carcinogen, an endocrine 
disruptor, and a neurotoxicant. (Id. at 4-7). NRDC did not link these 
toxicological claims to its specific objections.

VI. Public Comment

A. In General

    On June 19, 2002, EPA published a notice in the Federal Register 
calling attention to and requesting comments on the NRDC Objections. 
(67 FR 41628, June 19, 2002). As part of that notice, EPA published the 
full text of one set of objections in the Federal Register. A period of 
60 days was initially allowed for comment but that period was extended 
twice and was closed on October 16, 2002. (See 67 FR 58536, September 
17, 2003; 67 FR 53505, August 16, 2002). In addition to a large number 
of form letters (principally supporting the objections) and the NRDC's 
comments mentioned above, EPA received roughly 20 sets of substantive 
comments. These comments were for the most part from pesticide 
manufacturers and each requested denial of the objections. The most 
significant of these comments are summarized below. EPA has not 
repeated comments in instances where they were made by more than one 
commenter.

B. Individual Comments

    1. The FQPA Implementation Working Group. Extensive comments were 
filed by the FQPA Implementation Working Group (IWG), an organization 
comprised of associations representing pesticide manufacturers, 
growers, and food processors. (Ref. 10) [hereinafter cited as ``IWG 
comments'']. The IWG comments provided two alternative approaches as to 
why the NRDC's objections should be denied. First, the IWG asserted 
that EPA has misinterpreted the concept of ``aggregate exposure'' ever 
since passage of the FQPA, and once this interpretation is corrected, 
it becomes clear that the objections, for the most part, are flawed. 
These comments by IWG were thoroughly described and responded to in the 
Imidacloprid Order. (69 FR at 30072-30073, May 26, 2004).
    Second, in the alternative, the IWG, assuming the EPA's aggregate 
exposure interpretation is retained, explained that the NRDC objections 
are factually flawed. IWG's comments concerning pesticide exposure to 
farm children and exposure to pesticides in drinking water were 
discussed in the Imidacloprid Order. (69 FR at 30049, 30069). One issue 
not addressed was IWG's comments on pesticide exposure from food 
purchased at farm stands. The IWG challenges the NRDC's assertion that 
levels of pesticide residues in foods purchased at farm stands are 
higher than residue levels in food purchased at other retail outlets. 
The IWG notes that ``NRDC does not p