Document ID: EPA-HQ-OPP-2005-0190-0103
Agency: epa
Document Type: Rule
Title: Orders Denying NRDC's Objections on Remand: Acetamiprid, Mepiquat
Posted Date: 2010-08-06T04:00Z

[Federal Register: August 6, 2010 (Volume 75, Number 151)]
[Rules and Regulations]               
[Page 47475-47482]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06au10-11]                         

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0190; FRL-8836-7]

 
Acetamiprid, Mepiquat; Order Denying NRDC's Objections on Remand: 
Environmental Protection Agency

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final order.

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

SUMMARY: In this order, EPA again denies objections by the Natural 
Resources Defense Council (NRDC) to actions establishing tolerance 
regulations for the pesticides acetamiprid and mepiquat under section 
408 of the Federal Food, Drug, and Cosmetic Act (FFDCA). EPA's previous 
denial of NRDC's objections, published in the Federal Register on 
August 10, 2005, was remanded to EPA by the U.S. Court of Appeals, 
Ninth Circuit, for further explanation of EPA's decision on the 
application of the FFDCA's requirement concerning an additional safety 
factor for the protection of infants and children to these pesticide 
tolerances. On remand, EPA is denying NRDC's objections because the 
objections are now either moot or not sufficient to justify the relief 
requested.

DATES: This order is effective August 6, 2010.

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2005-0190. To access the 
electronic docket, go to http://www.regulations.gov, and search for the 
docket number. Follow the instructions on the regulations.gov website 
to view the docket index or access available documents. All documents 
in the docket are listed in the docket index available in 
regulations.gov. Although listed in the index, some information is not 
publicly available, e.g., Confidential Business Information (CBI) or 
other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Meredith Laws, Registration Division 
(7510P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-7038; e-mail address: laws.meredith@epa.gov.

SUPPLEMENTARY INFORMATION:.

I. General Information

A. Does this Action Apply to Me?

    In this document EPA denies objections by the Natural Resources 
Defense Council (``NRDC'') to EPA's to establishment of certain 
pesticide tolerances. This action may also be of interest to 
agricultural producers, food manufacturers, or pesticide manufacturers. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The NAICS codes have been provided to assist you and 
others in determining whether this action might apply to certain 
entities. If you have any questions regarding the applicability of this 
action to a particular entity, consult the person listed under FOR 
FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

II. Introduction

A. What Action Is the Agency Taking?

    In this order, EPA denies objections filed by the NRDC to 
regulations establishing pesticide tolerances for acetamiprid and 
mepiquat under section 408 of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a. EPA previously denied NRDC's objections in an 
order dated August 10, 2005. (70 FR 46706 (August 10, 2005)). NRDC 
sought judicial review of the August, 2005 order, and the U.S. Court of 
Appeals, Ninth Circuit, remanded the order to EPA on the sole ground 
that EPA had not provided an adequate explanation as to one aspect of 
its decision. (NCAP v. EPA, 544 F.3d 1043, 1052 (9th Cir. 2008)). 
Specifically, the court held that EPA did not provide ``enough 
information'' on why it chose to deviate from the presumptive ten-fold 
(10X) additional safety factor for the protection of infants and 
children in FFDCA section 408(b)(2)(C). (Id.). In response to the 
remand, EPA is again denying the objections; however, EPA has not 
provided further information on its decision on the children's safety 
factor because that issue is now either moot or not outcome-
determinative with regard to the challenged tolerances.

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

    EPA's authority for issuing pesticide tolerances is contained in 
FFDCA section 408(d) and the statutory provisions governing the 
administrative review process for tolerances is in FFDCA section 
408(g)(2). (21 U.S.C. 346a(d) and (g)(2)).

[[Page 47476]]

III. Statutory and Regulatory Background

    In this unit, EPA provides background on the relevant statutes and 
regulations governing NRDC's objections as well as on pertinent Agency 
policies and practices. Unit III.A. summarizes the requirements and 
procedures in section 408 of the FFDCA and applicable regulations 
pertaining to pesticide tolerances. Unit III.B. provides an overview of 
EPA's risk assessment process. It contains an explanation of how EPA 
identifies the hazards posed by pesticides, how EPA determines the 
level of exposure to pesticides that pose a concern (``level of 
concern''), how EPA measures human exposure to pesticides, and how 
hazard, level of concern conclusions, and human exposure estimates are 
combined to evaluate risk. Further, this unit presents background 
information on the EPA's policy with regard to the statutory safety 
factor for the protection of infants and children.

A. FFDCA

    1. In general. EPA establishes maximum residue limits, or 
``tolerances,'' for pesticide residues in food under section 408 of the 
FFDCA. (21 U.S.C. 346a). Without such a tolerance or an exemption from 
the requirement of a tolerance, a food containing a pesticide residue 
is ``adulterated'' under section 402 of the FFDCA and may not be 
legally moved in interstate commerce. (21 U.S.C. 331, 342).
    2. Safety standard for pesticide tolerances.A pesticide tolerance 
may only be promulgated by EPA if the tolerance is ``safe.'' (21 U.S.C. 
346a(b)(2)(A)(i)). ``Safe'' is defined by the statute to mean that 
``there is a reasonable certainty that no harm will result from 
aggregate exposure to the pesticide chemical residue, including all 
anticipated dietary exposures and all other exposures for which there 
is reliable information.'' (21 U.S.C. 346a(b)(2)(A)(ii)). In making 
this safety determination, risks to infants and children are given 
special consideration. Specifically, this provision creates a 
presumptive additional safety factor for the protection of infants and 
children. It directs that ``[i]n the case of threshold effects, ... an 
additional tenfold margin of safety for the pesticide chemical residue 
and other sources of exposure shall be applied for infants and children 
to take into account potential pre- and post-natal toxicity and 
completeness of the data with respect to exposure and toxicity to 
infants and children.'' (21 U.S.C. 346a(b)(2)(C)). EPA is permitted to 
``use a different margin of safety for the pesticide chemical residue 
only if, on the basis of reliable data, such margin will be safe for 
infants and children.'' (Id.). The additional safety margin for infants 
and children is referred to throughout this Order as the ``children's 
safety factor.'' These provisions on pesticide safety were a part of 
major revisions to section 408 enacted by the Food Quality Protection 
Act of 1996 (FQPA). (Pub. L. 104-170, 110 Stat. 1489).
    3. Procedures for establishing, amending, or revoking tolerances. 
Tolerances are established, amended, or revoked by rulemaking under the 
unique procedural framework set forth in the FFDCA. Generally, a 
tolerance rulemaking is initiated by the party seeking to establish, 
amend, or revoke a tolerance by means of filing a petition with EPA. 
(See 21 U.S.C. 346a(d)(1)). EPA publishes in the Federal Register a 
notice of the petition filing and requests public comment. (21 U.S.C. 
346a(d)(3)). After reviewing the petition, and any comments received on 
it, EPA may issue a final rule establishing, amending, or revoking the 
tolerance, issue a proposed rule to do the same, or deny the petition. 
(21 U.S.C. 346a(d)(4)).
    Once EPA takes final action on the petition by establishing, 
amending, or revoking the tolerance or denying the petition, any person 
may file objections with EPA and seek an evidentiary hearing on those 
objections. (21 U.S.C. 346a(g)(2)). Objections and hearing requests 
must be filed within 60 days. (Id.). EPA's final order on the 
objections is subject to judicial review. (21 U.S.C. 346a(h)(1)).

B. EPA Risk Assessment for Tolerances - Policy and Practice

    1. The safety determination - risk assessment. To assess risk of a 
pesticide tolerance, EPA combines information on pesticide toxicity 
with information regarding the route, magnitude, and duration of 
exposure to the pesticide. The risk assessment process involves four 
distinct steps: Identification of the toxicological hazards posed by a 
pesticide; determination of the ``level of concern'' with respect to 
human exposure to the pesticide; estimation of human exposure to the 
pesticide; and characterization of the risk posed to humans by the 
pesticide based on comparison of human exposure to the level of 
concern.
    a. Hazard identification. In evaluating toxicity or hazard, EPA 
reviews toxicity studies, primarily in laboratory animals, to identify 
any adverse effects on the test subjects. Animal studies typically 
involve investigating a broad range of endpoints including gross and 
microscopic effects on organs and tissues, functional effects on bodily 
organs and systems, effects on blood parameters (such as red blood cell 
count, hemoglobin concentration, hematocrit, and a measure of clotting 
potential), effects on the concentrations of normal blood chemicals 
(including glucose, total cholesterol, urea nitrogen, creatinine, total 
protein, total bilirubin, albumin, hormones, and enzymes such as 
alkaline phosphatase, alanine aminotransfersase and cholinesterases), 
and behavioral or other gross effects identified through clinical 
observation and measurement. EPA examines whether adverse effects are 
caused by either short-term (e.g., ``acute'') or longer-term (e.g., 
``chronic'') pesticide exposure and the effects of pre-natal and post-
natal exposure in animals. EPA also considers whether the adverse 
effect has a threshold - a level below which exposure has no 
appreciable chance of causing the effect.
    b. Level of concern/dose-response analysis. Once a pesticide's 
potential hazards are identified, EPA determines a toxicological level 
of concern for evaluating the risk posed by human exposure to the 
pesticide. In this step of the risk assessment process, EPA essentially 
evaluates the levels of exposure to the pesticide at which effects 
might occur. An important aspect of this determination is assessing the 
relationship between exposure (dose) and response (often referred to as 
the dose-response analysis). EPA follows differing approaches to 
identifying a level of concern for threshold and non-threshold hazards. 
Because this document is only concerned with pesticide hazards that 
pose a hazard above a defined threshold, only such threshold effects 
are discussed.
    In examining the dose-response relationship for a pesticide's 
threshold effects, EPA evaluates an array of toxicity studies on the 
pesticide. In each of these studies, EPA attempts to identify the 
lowest observed adverse effect level (LOAEL) and the next lower dose at 
which there are no observed adverse affect levels (NOAEL). Generally, 
EPA will use the lowest NOAEL from the available studies as a starting 
point (called ``the Point of Departure'') in estimating the level of 
concern for humans. (Ref. 1 at 9 (The Point of Departure ``is simply 
the toxic dose that serves as the `starting point' in extrapolating a 
risk to the human population.'')). At times, however, EPA will use a 
LOAEL from a study as the Point of Departure when no NOAEL is 
identified in that study and the LOAEL is close to, or lower than, 
other relevant NOAELs. The Point of Departure is in

[[Page 47477]]

turn used in choosing a level of concern. EPA will make separate 
determinations as to the Points of Departure, and correspondingly 
levels of concern, for both short and long exposure periods as well as 
for the different routes of exposure (oral, dermal, and inhalation).
    In estimating and describing the level of concern, the Point of 
Departure is at times used differently depending on whether the risk 
assessment addresses dietary or non-dietary exposures. For dietary 
risks, EPA uses the Point of Departure to calculate an acceptable level 
of exposure or reference dose (RfD). The RfD is calculated by dividing 
the Point of Departure by applicable safety or uncertainty factors. 
Typically, EPA uses a baseline safety/uncertainty factor of 100X. That 
value includes a factor of ten (10X) where EPA is using data from 
laboratory animals to reflect potentially greater sensitivity in humans 
than animals and a factor of 10X to account for potential variations in 
sensitivity among members of the human population as well as other 
unknowns. Additional safety factors may be added to address data 
deficiencies or concerns raised by the existing data. 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. This FQPA additional safety factor largely replaces 
pre-FQPA EPA practice regarding additional safety factors. (Ref. 2 at 
4-11).
    In implementing FFDCA section 408, EPA's Office of Pesticide 
Programs, also calculates a variant of the RfD referred to as a 
Population Adjusted Dose (PAD). A PAD is the RfD divided by any portion 
of the FQPA safety factor that does not correspond to one of the 
traditional additional safety factors used in general Agency risk 
assessments. (Ref. 2 at 13-16). The reason for calculating PADs is so 
that other parts of the Agency, which are not governed by FFDCA section 
408, can, when evaluating the same or similar substances, easily 
identify which aspects of a pesticide risk assessment are a function of 
the particular statutory commands in FFDCA section 408. Today, RfDs and 
PADs are generally calculated for both acute and chronic dietary risks 
although traditionally a RfD or PAD was only calculated for chronic 
dietary risks. Throughout this document general references to EPA's 
calculated safe dose are denoted as a RfD/PAD.
    Because this order only addresses dietary risks, EPA's approach to 
non-dietary risk assessment is not further discussed.
    c. Estimating human exposure. Risk is a function of both hazard and 
exposure. Thus, equally important to the risk assessment process as 
determining the hazards posed by a pesticide and the toxicological 
level of concern for those hazards is estimating human exposure. Under 
FFDCA section 408, EPA is concerned not only with exposure to pesticide 
residues in food but also exposure resulting from pesticide 
contamination of drinking water supplies and from use of pesticides in 
the home or other non-occupational settings. (See 21 U.S.C. 
346a(b)(2)(D)(vi)).
    i. Exposure from food. There are two critical variables in 
estimating exposure in food:
     The types and amount of food that is consumed; and
     The residue level in that food.
    Consumption is estimated by EPA based on scientific surveys of 
individuals' food consumption in the United States conducted by the 
United States Department of Agriculture. (Ref. 1 at 12). Information on 
residue values comes from a range of sources including crop field 
trials, data on pesticide reduction (or concentration) due to 
processing, cooking, and other practices, information on the extent of 
usage of the pesticide, and monitoring of the food supply. (Id. at 17).
    In assessing exposure from pesticide residues in food, EPA, for 
efficiency's sake, follows a tiered approach in which it, in the first 
instance (i.e., ``Tier 1''), assesses exposure using the worst case 
assumptions that 100 percent of the crops for which tolerances exist or 
are proposed are treated with the pesticide and 100 percent of the food 
from those crops contain pesticide residues at the tolerance level. 
(Id. at 11). When such an assessment shows no risks of concern, a more 
complex risk assessment is unnecessary. By avoiding a more complex risk 
assessment, EPA's resources are conserved and regulated parties are 
spared the cost of any additional studies that may be needed. If, 
however, a Tier 1 assessment suggests there could be a risk of concern, 
EPA then attempts to refine its exposure assumptions to yield a more 
realistic picture of residue values through use of data on the percent 
of the crop actually treated with the pesticide and data on the level 
of residues that may be present on the treated crop. These latter data 
are used to estimate what has been traditionally referred to by EPA as 
``anticipated residues.'' More information on how EPA refines estimates 
of exposure from pesticides in food can be found in U.S. EPA, A User's 
Guide to Available EPA Information on Assessing Exposure to Pesticides 
in Food (June 21, 2000). (See 73 FR 42683, 42687 (July 23, 2008)).
    ii. Exposure from water. EPA may use either or both field 
monitoring data and mathematical water exposure models to generate 
pesticide exposure estimates in drinking water. Monitoring and modeling 
are both important tools for estimating pesticide concentrations in 
water and can provide different types of information. Monitoring data 
can provide estimates of pesticide concentrations in water that are 
representative of specific agricultural or residential pesticide 
practices and under environmental conditions associated with a sampling 
design. Although monitoring data can provide a direct measure of the 
concentration of a pesticide in water, it does not always provide a 
reliable estimate of exposure because sampling may not occur in areas 
with the highest pesticide use, and/or the sampling may not occur when 
the pesticides are being used.
    In estimating pesticide exposure levels in drinking water, EPA most 
frequently uses mathematical water exposure models. EPA's models are 
based on extensive monitoring data and detailed information on soil 
properties, crop characteristics, and weather patterns. (69 FR 30042, 
30058-30065 (May 26, 2004)). These models calculate estimated 
environmental concentrations of pesticides using laboratory data that 
describe how fast the pesticide breaks down to other chemicals and how 
it moves in the environment. These concentrations can be estimated 
continuously over long periods of time, and for places that are of most 
interest for any particular pesticide. Modeling is a useful tool for 
characterizing vulnerable sites, and can be used to estimate peak 
concentrations from infrequent, large storms.
    Typically EPA uses a two-tiered approach to modeling pesticide 
concentrations in surface and ground water. The first tier model uses 
high-end and worst-case assumptions as a screen to identify pesticides 
that will not result in residues in water that pose a concern. If the 
first tier model suggests that pesticide levels in water may be 
unacceptably high, a more refined model is used as a second tier 
assessment. Second tier models substitute more detailed information for 
the high-end or worst-case assumptions used in first tier models. For 
example, a second tier model may incorporate information on the maximum 
percentage of acreage surrounding a drinking water reservoir that may 
be devoted to agriculture instead of

[[Page 47478]]

assuming that 100 percent of the watershed is, in fact, farmland.
    iii. Residential exposures. Generally, in assessing residential 
exposure to pesticides EPA relies on its Residential Standard Operating 
Procedures (SOPs). (Ref. 3). The SOPs establish models for estimating 
application and post-application exposures in a residential setting 
where pesticide-specific monitoring data are not available. SOPs have 
been developed for many common exposure scenarios including pesticide 
treatment of lawns, garden plants, trees, swimming pools, pets, and 
indoor surfaces including crack and crevice treatments. The SOPs are 
based on existing monitoring and survey data including information on 
activity patterns, particularly for children. Where available, EPA 
relies on pesticide-specific data in estimating residential exposures.
    d. Risk characterization. The final step in the risk assessment is 
risk characterization. In this step, EPA combines information from the 
first three steps (hazard identification, level of concern/dose-
response analysis, and human exposure assessment) to quantitatively 
estimate the risks posed by a pesticide. Separate characterizations of 
risk are conducted for different durations of exposure. Additionally, 
separate and, where appropriate, aggregate characterizations of risk 
are conducted for the different routes of exposure (dietary and non-
dietary).
    For threshold dietary risks, EPA typically estimates risk by 
expressing human exposure as a percentage of the RfD/PAD. Exposures 
lower than 100 percent of the RfD/PAD are generally not of concern. 
Under current procedures, EPA aggregates pesticide exposure from food 
and drinking water prior to comparing exposure to the RfD/PAD.
    Prior to developing appropriate modeling techniques for combining 
pesticide exposures from food and drinking water, EPA evaluated 
aggregate dietary exposure and risk in two separate steps. (Ref. 4 at 
3-5). First, EPA would compare pesticide exposure from food to the safe 
level of exposure (i.e., the RfD/PAD). If pesticide exposure from food 
was less than 100 percent of the RfD/PAD, then EPA would calculate what 
was called a Drinking Water Level of Comparison (DWLOC) and compare the 
pesticide exposure concentration in water to the DWLOC. The DWLOC 
represented the maximum safe concentration of pesticide residue that 
could be present in drinking water taking into account the level of 
pesticide exposure from food. The DWLOC was calculated by subtracting 
pesticide exposure in food from the RfD/PAD and dividing that amount by 
the maximum water consumption level. So long as the actual pesticide 
concentration in drinking water was below the DWLOC, aggregate exposure 
to the pesticide (exposure from food and water) was generally regarded 
as safe. A numerical example may help explicate this procedure. (To 
simplify the example, units of exposure are expressed in terms of 
milligrams of pesticide per day (mg/day) instead of the more standard 
milligrams of pesticide per kilogram of human body weight per day (mg/
kg/day).) Suppose the safe level of exposure to a pesticide (i.e., the 
RfD/PAD) is 10 mg/day and consumption of food results in exposure to 
residues of this pesticide at a level of 2 mg/day. Under these facts, 
exposure to the pesticide from food represents 20 percent of the RfD/
PAD. If it is assumed that a person drinks 2 liters of water per day, 
the DWLOC can be calculated by subtracting pesticide exposure from food 
from the RfD/PAD (10 mg/day - 2 mg/day = 8 mg/day) and dividing by 2 
liters. The resulting DWLOC of 4 mg/liter is the maximum safe 
concentration of pesticide in drinking water. It follows that so long 
as actual water concentrations of the pesticide do not exceed 4 mg/
liter, EPA can conclude that aggregate dietary exposure to the 
pesticide from food and water do not exceed the RfD/PAD. If the actual 
level of the pesticide residue in drinking water were 0.1 mg/liter, 
then the pesticide concentration in drinking water would be 2.5 percent 
of the allowable amount or DWLOC ((0.1 mg/liter / 4 mg/liter) x 100 
percent) and would represent 2 percent of the RfD/PAD (((2 liters/day 
x0.1 mg/liter) / 10 mg/kg/day) x 100 percent).
    2. EPA policy on the children's safety factor. As the brief summary 
of EPA's risk assessment practice in this unit indicates, the use of 
safety factors plays a critical role in the process. This is true for 
the use of traditional 10X safety factors to account for potential 
differences between animals and humans when relying on studies in 
animals (inter-species safety factor) and potential differences among 
humans (intra-species safety factor) as well as the use of the FQPA's 
additional 10X children's safety factor.
    In applying the children's safety factor provision, EPA has 
interpreted it as imposing a presumption in favor of applying an 
additional 10X safety factor. (Ref. 2 at 4, 11). Thus, EPA generally 
refers to the additional 10X factor as a presumptive or default 10X 
factor. EPA has also made clear, however, that this presumption or 
default in favor of the additional 10X is only a presumption. The 
presumption can be overcome if reliable data demonstrate that a 
different factor is safe for children. (Id.). In determining whether a 
different factor is safe for children, EPA focuses on the three factors 
listed in section 408(b)(2)(C) - the completeness of the toxicity 
database, the completeness of the exposure database, and potential pre- 
and post-natal toxicity. In examining these factors, EPA strives to 
make sure that its choice of a safety factor, based on a weight-of-the-
evidence evaluation, does not understate the risk to children. (Id. at 
24-25, 35).

IV. Challenged Tolerance Regulations for Mepiquat and Acetamiprid

A. Mepiquat

    1. In general. 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.).
    2. Children's safety factor determination. For mepiquat, EPA 
identified increased uncertainty regarding effects on the young because 
a developmental neurotoxicity (DNT) study was outstanding. (65 FR 1790, 
1794 (January 12, 2000)). EPA concluded, however, that this uncertainty 
was offset by a number of factors and removed the additional 10X safety 
factor. First, EPA noted that no increased sensitivity in young animals 
was observed in the pre- and post-natal studies with mepiquat. (65 FR 
at 1794). In fact, in two out of the three studies involving young 
animals no effects were seen in the offspring at all (developmental 
study in rats; 2-generation reproduction study in rats). (Ref. 5 at 2). 
Further, even in the third study concerning pre- and post-natal effects 
there were reasons to accord reduced weight to the pre- or post-natal 
effects observed given that effects were seen in the offspring and the 
parents only at the highest dose tested (developmental study in 
rabbits). (Id.). Second, although neurotoxic behavioral effects in 
adult animals were found (triggering the DNT study requirement), there 
was no evidence reflecting special

[[Page 47479]]

concern for developing fetuses or the 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 at 1794). 
Finally, exposure estimates were found not to understate exposure given 
that the estimates for food were ``Tier 1'' conservative assumptions 
which would not underestimate exposure. (65 FR at 1793).

B. Acetamiprid

    1. In general. 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.).
    2. Children's safety factor determination. For acetamiprid, two 
factors increased uncertainty or raised concern about the impacts on 
children: That a DNT study was outstanding; and that increased 
sensitivity in the young was observed in the 2-generation reproduction 
study. (67 FR at 14655). EPA concluded, however, that these concerns 
were offset by other considerations. First, the DNT study had been 
required based only on neurotoxic behavioral effects seen in adults, 
and not out of a special concern for developing fetuses or the young. 
Second, the increased sensitivity observed in the 2-generation 
reproduction study was only qualitative. Sensitivity is considered to 
be qualitative only when effects occur at the same dose levels in adult 
and juvenile animals but the effects in the juvenile animals are 
qualitatively more severe than the effects in the adults. Third, the 
other two studies investigating pre- or post-natal effects in the young 
showed either no adverse effects even at levels that showed toxicity in 
parental animals, or adverse effects of the same qualitative nature at 
the same dose in parental and young animals. (Id.). Finally, exposure 
estimates were judged unlikely to underestimate exposure, especially 
because ``highly conservative'' ``Tier 1'' assumptions were used for 
exposure in food. (67 FR at 14654). Weighing all of these 
considerations EPA retained a 3X additional safety factor to address 
chronic risks and waived the factor entirely for acute risks. No 
additional factor was deemed necessary as to acute risks because 
qualitative sensitivity in the young was only observed in a study 
involving chronic dosing and as to an adverse effect related to repeat 
dosing.

V. Subsequent Tolerance Actions for Mepiquat and Acetamiprid

A. Mepiquat

    Since January, 2002, EPA has received no further tolerance 
petitions concerning mepiquat and EPA has undertaken no tolerance 
rulemakings for mepiquat.

B. Acetamiprid

    Since March, 2002, EPA has received several petitions for 
additional acetamiprid tolerances and has established tolerance 
regulations on four occasions. Because section 408 requires EPA in 
setting a pesticide tolerance to consider aggregate exposure to the 
pesticide, ``including dietary exposure under . . . all other 
tolerances for the pesticide chemical residue,'' in each of these 
subsequent actions EPA took into account exposure to acetamiprid under 
challenged tolerances established on March 27, 2002 (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). Each of the 
subsequent tolerance rulemakings is described below.
    1. 2005 - Tolerances for tuberous and corm vegetables. On April 13, 
2005, EPA established tolerances for acetamiprid on tuberous and corm 
vegetables. (70 FR 19283 (April 13, 2005)). EPA concluded that the 
additional exposure from these new tolerances, when aggregated with 
exposure under existing tolerances, was safe.
    With regard the children's safety factor, EPA relied on a revised 
analysis taking into account its Children's Safety Factor Policy, which 
had not been released at the time of the risk assessment for the NRDC-
challenged tolerances and recently-submitted data on acetamiprid and 
other similar pesticides. EPA concluded that the presumptive 10X 
children's safety factor could be removed entirely. (70 FR at 19289). 
Although increased sensitivity to the young had been observed in the 2-
generation rat study and a recently-submitted DNT study had not been 
fully evaluated, EPA determined that other factors outweighed these 
concerns. As to the increased sensitivity, EPA noted that: ``i. There 
is a clear NOAEL for [the effects seen in] the offspring, and; ii. 
These effects occurred in the presence of parental toxicity and only at 
the highest dose tested.'' (Id.). Further, EPA noted that either the 
NOAEL for the offspring in the reproduction study or some lower NOAEL 
was used in each risk assessment for acetamiprid. That meant the 
standard 10X factor to account for intra-human variability (in addition 
to the 10X factor for inter-species variability) was applied to the 
clearly-defined NOAEL for offspring effects or to some lower NOAEL. As 
to the recently-submitted DNT, EPA stated that a ``preliminary review 
of the study indicates the results are not likely to have a significant 
impact on risks for the currently proposed use, or on existing uses of 
acetamiprid . . . [and that] developmental neurotoxicity data received 
and reviewed for other compounds in this chemical class indicate that 
the results of the required DNT will not likely impact the regulatory 
doses selected for the proposed uses of acetamiprid.'' (Id.). Finally, 
EPA relied upon the fact that the exposure assessment for acetamiprid 
was conservative in that it assumed all foods with tolerances are 
treated with acetamiprid and bear tolerance-level residues (i.e., a 
Tier 1 assessment).
    2. 2007 - Tolerances for almond hulls, et al. On November 28, 2007, 
EPA established tolerances for acetamiprid on almond, hulls; fruit, 
stone, group 12, except plum, prune; nut, tree, group 14; pea and bean, 
succulent shelled, subgroup 6B; pistachio; plum, prune, dried; plum, 
prune, fresh; vegetable, cucurbit, group 9; and vegetable, legume, 
edible podded, subgroup 6A. (72 FR 67256 (November 28, 2007)). EPA 
concluded that the additional exposure from these new tolerances, when 
aggregated with exposure under existing tolerances, was safe.
    With regard to the children's safety factor, EPA relied on a 
revised analysis taking into account its now-completed review of the 
acetamiprid DNT study. EPA again concluded that the presumptive 10X 
children's safety factor could be removed entirely. Although 
qualitatively increased sensitivity to the young had been observed in 
the 2-generation rat study and the DNT study, EPA ``characterized the 
degree of concern for the effects observed in the acetamiprid DNT and 
the 2-generation

[[Page 47480]]

reproduction study as low, noting that there is a clear NOAEL for the 
offspring effects in both studies, the toxicology database is complete, 
and regulatory doses [Points of Departure] were selected to be 
protective of potential offspring effects in both the DNT and the 2-
generation study.'' (72 FR at 67260). Specifically, as to the last 
consideration, EPA cited the fact that the Points of Departure for 
calculating the RfD/PADs were at or below the clearly-defined NOAELs 
from the 2-generation reproduction and DNT studies. That means that at 
least a 100-fold margin of safety was being provided with respect to 
the clearly-defined NOAELs from these studies. Further, even though the 
exposure assessment was more refined than in prior acetamiprid 
tolerance actions, EPA still relied on conservative values from field 
trial studies and drinking water modeling.
    3. 2008 - Tolerances for bushberries, et al. On January 16, 2008, 
EPA established tolerances for acetamiprid on the bushberry subgroup 
13-07B; the caneberry subgroup 13-07A; the low growing berry subgroup 
13-07G; the onion, bulb, subgroup 3-07A; and the onion, green, subgroup 
3-07B. (73 FR 2809 (January 16, 2008)). EPA concluded that the 
additional exposure from these new tolerances, when aggregated with 
exposure under existing tolerances, was safe. EPA relied upon its 
November 28, 2007 acetamiprid rulemaking to make its safety 
determination, noting that the tolerances in this action had been 
included in the risk assessment performed to support the 2007 action. 
(73 FR at 2811).
    4. 2010 - Tolerances for small vine climbing fruit, et al. On 
February 10, 2010, EPA established tolerances for acetamiprid on the 
small vine climbing fruit, except fuzzy kiwifruit, subgroup 13-07F; and 
tea, dried. (75 FR 6576 (February 10, 2010)). EPA concluded that the 
additional exposure from these new tolerances, when aggregated with 
exposure under existing tolerances, was safe. With regard the 
children's safety factor, EPA concluded that the presumptive 10X 
children's safety factor could be removed entirely based on the 
rationale in the 2007 acetamiprid rulemaking. (75 FR at 6581).

VI. Summary of NRDC Objections, Administrative Review of the 
Objections, and Judicial Review of EPA's Order Denying the Objections

A. NRDC's Objections

    On four occasions in the first half of 2002, the NRDC and various 
other parties filed objections with EPA to final rules under FFDCA 
section establishing pesticide tolerances for various pesticides. (69 
FR 30042 (May 26, 2004)). The objections applied to 14 pesticides and 
112 separate pesticide tolerances. The challenged tolerances included 
the tolerances for mepiquat and acetamiprid addressed in today's order. 
The objections to the mepiquat tolerances were filed on March 19, 2002, 
and grouped with objections to tolerances for imidacloprid, bifenazate, 
zeta-cypermethrin, and diflubenzuron. The objections to the acetamiprid 
tolerances were filed on May 21, 2002, and grouped with objections to 
tolerances for isoxadifen-ethyl, propiconazole, fenhexamid, and 
fluazinam.
    Although NRDC's petitions raised dozens of issues, most of the 
issues related to two main claims: That EPA had not properly applied 
the additional 10X safety factor for the protection of infants and 
children in section 408(b)(2)(C); and that EPA had not accurately 
assessed the aggregate exposure of farm children to pesticide residues. 
Many of the issues were not fact-specific to the challenged tolerances 
but rather represented a generic challenge to EPA's implementation of 
the FQPA.
    Two specific issues raised by NRDC are worthy of greater 
description because they later figured in the judicial review of EPA's 
disposition of the objections. First, as to several of the pesticides, 
NRDC argued that EPA had unlawfully removed the 10X children's safety 
factor because EPA had required that a DNT study be submitted for the 
pesticides but such study had not yet been completed. NRDC framed the 
issue as follows:
     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.

(Ref. 6 at 9). Second, NRDC argued that EPA could not lawfully remove 
the children's safety factor as to all of the challenged pesticides 
because EPA relied on a drinking water exposure models to estimate 
pesticide exposure levels in water instead of ``collect[ing] pesticide-
specific data on water-based exposure.'' (Ref. 6 at 6; Ref. 7 at 5). 
According to NRDC, drinking water models, as a definitional matter, 
could not supply the ``reliable data'' needed to choose a children's 
safety factor differing from the presumptive value. (Ref. 6 at 6; Ref. 
7 at 5-6).

B. EPA's Denial of the Objections

    EPA denied NRDC's objections in two separate orders. The first was 
issued on May 26, 2004, and addressed only the tolerances for 
imidacloprid. (69 FR 30042 (May 26, 2004). The second was released on 
August 10, 2005 and addressed the tolerances for the remaining 14 
pesticides. (70 FR 46706 (August 10, 2005)). The second order relied 
heavily on the imidacloprid order because, in the process of resolving 
the claims pertaining to imidacloprid, EPA resolved many of NRDC's 
generic attacks on EPA's interpretation of the FQPA.
    As to the DNT study and the children's safety factor, EPA rejected 
``NRDC's contention that an EPA finding that a DNT study is needed in 
evaluating the risks posed by the pesticide is outcome-determinative as 
regards to retaining the children's safety factor until such time as 
the DNT study is submitted and reviewed.'' (70 FR at 46724). EPA 
carefully reviewed all of the evidence cited by NRDC regarding the DNT 
study and concluded that NRDC had not shown that the DNT was so 
critical to the protection of children that in the absence of that 
study EPA was conclusively precluded from exercising its statutory 
authority to make a case-by-case determination regarding the 
appropriate children's safety factor. EPA specifically did not address 
the factual considerations relating to its individual children's safety 
factor decisions as to mepiquat and acetamiprid (and the other 
pesticides), noting that ``NRDC has offered no pesticide-specific 
arguments as to the pesticides in this proceeding as to why the absence 
of a DNT study requires the retention of the default 10X additional 
factor.'' (Id.)
    With regard to whether reliance on drinking water models precluded 
lowering of the children's safety factor, EPA exhaustively reviewed the 
underlying factual basis for its models, the scientific peer review 
they had received, and how the models had worked in practice. EPA 
concluded that ``the models are based on reliable data and will produce 
estimates that are unlikely to underestimate exposure to pesticides in 
drinking water.'' (Id. at 46726). Accordingly, NRDC's claim that only 
actual pesticide-specific water monitoring data could provide 
``reliable data'' on the levels of pesticides in drinking water was 
rejected.

[[Page 47481]]

C. Judicial Review

    1. NRDC's Petition for Review. In August, 2005, NRDC and the 
Northwest Coalition for Alternatives to Pesticides (NCAP) filed 
petitions for review of EPA's August 10, 2005 order. No challenge had 
been filed to the May 26, 2004 order. The petitions were filed in the 
Second and Ninth Circuits and the matter was assigned to the Ninth 
Circuit. The consolidated petitions sought review as to EPA's denial of 
NRDC's objections as they pertained to the tolerances of the following 
seven pesticides: acetamiprid, fenhexamid, halosulfuron-methyl, 
isoxadifen-ethyl, mepiquat, pymetrozine, and zeta-cypermethrin.
    NRDC/NCAP's brief argued that EPA had unlawfully removed or lowered 
the children's safety factor as to these seven pesticides and that 
EPA's establishment of tolerances for the seven pesticides was 
arbitrary and capricious. (Ref. 8). As to the contentions regarding the 
children's safety factor, NRDC/NCAP made several independent claims as 
to why EPA's action was unlawful. These claims were:
     i. As to acetamiprid, halosulfuron-methyl, mepiquat, pymetrozine, 
and zeta-cypermethrin, EPA had no discretion to alter the children's 
safety factor because it had determined that a DNT study was 
specifically needed to address concerns regarding these pesticides (DNT 
studies were not required on fenhexamid and isoxadifen-ethyl);
     ii. EPA's decision on the children's safety factor could not be 
upheld because EPA provided ``no pesticide-specific response to NRDC's 
objections with respect to the missing DNT studies, and does not offer 
any explanation or justification for the agency's departure from the 
tenfold children's safety factor for these five pesticides;''
     iii. EPA lacked reliable data on pesticide exposure levels in 
drinking water for each of the pesticides and such data are necessary 
to justify altering the children's safety factor; and
     iv. EPA must retain the children's safety factor for each of the 
pesticides because data showed that they resulted in pre- or post-natal 
toxicity.

    NRDC argued EPA's decision was arbitrary and capricious because EPA 
determined that additional data were needed on the pesticides but EPA 
had not waited for submission of that data before establishing the 
pesticide tolerances and because EPA had not offered a sufficient 
explanation of its decisions on the children's safety factor.
    2. The Ninth Circuit's decision. On September 19, 2008, the Ninth 
Circuit unanimously determined that:
     i. It was not arbitrary and capricious for EPA to have established 
the tolerances for acetamiprid, mepiquat, and pymetrozine without 
waiting for DNT studies for these pesticides;
     ii. EPA had offered a reasoned explanation for why, as a general 
matter, the children's safety factor could be reduced in the absence of 
a DNT study; and
     iii. It was reasonable for EPA to rely on drinking water models in 
estimating pesticide levels in water in making children's safety factor 
determinations.

(NCAP v. EPA, 544 F.3d 1043, 1049-1051 (9th Cir. 2008)). Additionally, 
by a 2-to-1 vote, the court remanded to EPA its decision on the 
children's safety factor for acetamiprid, mepiquat, and pymetrozine. 
The majority found that EPA's order on NRDC's objections had not 
adequately explained the pesticide-specific reasons for removing or 
reducing the children's safety factor as to these pesticides in the 
absence of a required DNT study. (Id. at 1052). Without elaborating, 
the court dismissed all other issues raised by NRDC/NCAP. (Id. at 
1053).
    Although NRDC/NCAP's petition for review concerned seven 
pesticides, the court only remanded to EPA the tolerance decisions on 
acetamiprid, mepiquat, and pymetrozine. The petition for review was 
denied as to the other four pesticides because the remand only 
pertained to pesticides for which there was a question concerning EPA's 
pesticide-specific choice of a children's safety factor in the absence 
of a required DNT study. As to the fenhexamid and isoxadifen-ethyl 
tolerances, a DNT study had not been required by EPA. For halosulfuron-
methyl and zeta-cypermethrin tolerances a DNT study had been required 
and had not been submitted at the time of the tolerance action; 
however, by the time of the oral argument, the circumstances had 
changed. As to zeta-cypermethrin, the DNT study had been submitted and 
reviewed by EPA and EPA had established further tolerances in reliance 
on the DNT study. As to halosulfuron-methyl, EPA had withdrawn the 
requirement for a DNT. EPA notified the court that there was no longer 
a live controversy as to the tolerances for halosulfuron-methyl and 
zeta-cypermethrin and NRDC/NCAP and the court agreed the petition was 
moot as to these pesticides. (544 F.3d at 1048 n.4; Refs. 9, 10).

VII. Revised Order on Remand

    On remand, EPA has determined that NRDC's objections should again 
be denied. NRDC's objections to the acetamiprid tolerances are now moot 
for the same reasons that the objections to the zeta-cypermethrin and 
halosulfuron-methyl tolerances were found to be moot. The objections to 
the mepiquat tolerance are denied because all issues which could have 
affected EPA's decision on that tolerance have been resolved by the 
Ninth Circuit.

A. Acetamiprid and Mepiquat

    Like zeta-cypermethrin, EPA has received a DNT study for 
acetamiprid and relied on that study in establishing additional 
tolerances for acetamiprid. (72 FR 67256 (November 28, 2007); 73 FR 
2809 (January 16, 2008); 75 FR 6576 (February 10, 2010)). In 
establishing new tolerances for acetamiprid, EPA concluded that 
aggregate exposure under the new tolerances as well as all existing 
tolerances (including the ones challenged in NRDC's 2002 objections) is 
safe. No objections to these new acetamiprid tolerances were filed 
within the 60 day statutory timeframe for objections. Accordingly, just 
as the Ninth Circuit concluded (and NRDC agreed) that there was no live 
controversy concerning the zeta-cypermethrin tolerances and ``EPA's 
[alleged] failure to explain why it had reliable data in the absence of 
[a DNT study],'' (544 F.3d at 1408), there is no live controversy as to 
whether EPA provided an adequate explanation for its now-superseded 
tolerance decision that it had reliable data to reduce or remove the 
children's safety factor for acetamiprid in the absence of a DNT study.

B. Mepiquat

    EPA has not taken regulatory action as to mepiquat subsequent to 
the challenged tolerance action and, thus, NRDC's challenge to the 
mepiquat tolerance is not moot. Nonetheless, due to the circumstances 
of the mepiquat tolerance, EPA does not need to address the merits of 
the only remaining objection before EPA -- that EPA lacks reliable data 
justifying removal of the children's safety factor for mepiquat. As EPA 
ruled in a prior order, it may ``refuse to adjudicate the merits of 
claims where it can be shown that the claims - even if true - do not 
justify the relief requested.'' (72 FR 39318, 39323-

[[Page 47482]]

39324 (July 18, 2007)). That principle applies to the mepiquat 
objection because, as explained below, even if EPA retains the 10X 
children's safety it would not change EPA's safety determination. Thus, 
NRDC's objection to the removal of the children's safety factor, even 
if upheld, would not support the relief it requested - ``that EPA 
refrain from establishing the new tolerances for . . .mepiquat . . . 
until the pesticide tolerances have been assessed and determined to be 
safe[,] consistent with the requirements of the FQPA.'' (Ref. 6 at 22).
    An EPA decision to retain the 10X children's safety factor has the 
effect of decreasing the ``safe dose'' or RfD/PAD by a factor of 10. 
Thus, if prior to application of the 10X children's safety factor, the 
level of exposure from a particular pesticide constituted 5 percent of 
the RfD/PAD, after application of the safety factor the level of 
exposure to the pesticide would rise by a factor of 10 to 50 percent of 
the RfD/PAD. Similarly, a pesticide which had an exposure level at 50 
percent of the RfD/PAD before applying the 10X children's safety 
factor, would have an exposure level of 500 percent of the RfD/PAD 
after application of the factor. Only in the latter case, would 
retention of the children's safety factor raise a safety concern. Thus, 
for pesticides with sufficiently low risks, the decision on retention 
or removal of the children's safety factor is not outcome-determinative 
as to EPA's safety finding. (71 FR 43906, 43916-43917 (August 2, 
2006)).
    Mepiquat is one of those low risk pesticides. As EPA noted in the 
challenged tolerance document, acute exposure to mepiquat from residues 
in food equaled 1.5 percent of the acute RfD/PAD and acute exposure to 
mepiquat in water was an infinitesimal. (67 FR at 3115; 65 FR 1790, 
1793 (January 12, 2000) (acute exposure to mepiquat in drinking water 
is 0.031 percent of the allowable amount - i.e. the acute DWLOC was 
6,000 ppb and estimated acute exposure level was 1.9 ppb); see Unit 
III.B.1.d. (explaining how allowable amounts of pesticide residues in 
drinking water were calculated)). Similarly, chronic exposure to 
mepiquat from residues in food equaled 0.3 percent of the chronic RfD/
PAD and chronic exposure to mepiquat in water was also infinitesimal. 
(67 FR at 3115; 65 FR at 1794 (chronic exposure to mepiquat in drinking 
water is 0.018 percent of the allowable amount -- i.e. the chronic 
DWLOC was 6,000 ppb and the estimated chronic exposure level was 1.1 
ppb)). Retention of the 10X children's safety would raise the 
percentage exposure to approximately 15 percent of the acute RfD/PAD 
and 3 percent of the chronic RfD/PAD. Because these exposure levels 
would still be well below the applicable RfD/PADs, they would not 
change EPA's determination that the petitioned-for mepiquat tolerances 
are safe. Accordingly, because NRDC's objection to removal of the 
children's safety factor does not justify its request for EPA to 
refrain from establishing the mepiquat tolerances, it is denied.

VIII. Regulatory Assessment Requirements

    As indicated previously, this action announces the Agency's final 
order regarding objections filed under section 408 of FFDCA. The FFDCA 
specifically directs that objections be resolved by ``order,'' and thus 
this action is an adjudication and not a rule. (21 U.S.C. 
346a(g)(2)(C)). The regulatory assessment requirements imposed on 
rulemaking do not, therefore, apply to this action.

IX. Submission to Congress and the Comptroller General

    The Congressional Review Act, (5 U.S.C. 801 et seq.), as added by 
the Small Business Regulatory Enforcement Fairness Act of 1996, does 
not apply because this action is not a rule for purposes of 5 U.S.C. 
804(3).

X. References

    1. USEPA, A User's Guide to Available EPA Information on Assessing 
Exposure to Pesticides in Food (June 21, 2000).
    2. Office of Pesticide Programs, USEPA, Office of Pesticide 
Programs' Policy on the Determination of the Appropriate FQPA Safety 
Factor(s) For Use in the Tolerance Setting Process (February 28, 2002).
    3. Office of Pesticide Programs, USEPA, Standard Operating 
Procedures (SOPs) for Residential Exposure Assessments (Draft December 
19, 1997).
    4. Office of Pesticide Programs, USEPA, ``Estimating the Drinking 
Water Component of a Dietary Exposure Assessment'' (November 2, 1999).
    5. Office of Prevention, Pesticides and Toxic Substances, USEPA, 
Memorandum from Brenda Tarplee to Margarita Collantes, ``Mepiquat 
Choloride - Report of the FQPA Safety Factor Committee'' (November 1, 
1999).
    6. NRDC, Objections to the Establishment of Tolerances for 
Pesticide Chemical Residues: Imidacloprid, Mepiquat, Bifenazate, Zeta-
cypermethrin, and Diflubenzuron Tolerances (filed March 19, 2002).
    7. NRDC, Objections to the Establishment of Tolerances for 
Pesticide Chemical Residues: Isoxadifen-ethyl, Acetamiprid, 
Propiconazole, Furilazole, Fenhexamid, and Fluazinam Tolerances (filed 
May 20, 2002).
    8. Petitioners' Brief, NCAP v. EPA, Case Nos. 75255, 76807 (9th 
Cir. March 6, 2006).
    9. Letter from Kent E. Hanson, U.S. Department of Justice to Cathy 
Catterson, Clerk of the Court, United States Court of Appeals, Ninth 
Circuit, Notice of Supplemental Authority in Northwest Coalition for 
Alternatives to Pesticides v. EPA, Nos. 05-75255 & 05-76807 (May 25, 
2007).
    10. Letter from Aaron Colangelo, U.S. Department of Justice to 
Cathy Catterson, Clerk of the Court, United States Court of Appeals, 
Ninth Circuit, Response to EPA's Notice of Supplemental Authority in 
Northwest Coalition for Alternatives to Pesticides v. EPA, Nos. 05-
75255 & 05-76807 (May 29, 2007).

List of Subjects in 40 CFR Part 180

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

    Dated: July 27, 2010.
Steven Bradbury,
Director, Office of Pesticide Programs.

 [FR Doc. 2010-19431 Filed 8-5-10; 8:45 am]
BILLING CODE 6560-50-S