[Federal Register: December 29, 2006 (Volume 71, Number 250)]
[Rules and Regulations]
[Page 78374-78382]
[DOCID:fr29de06-11]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0769; FRL-8093-6]

Zeta-Cypermethrin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of the
insecticide zeta-cypermethrin, in or on almond, hulls; animal feed,
nongrass, group 18, forage; animal feed, nongrass, group 18, hay;
berry, group 13; cilantro, leaves; food/feed items (other than those
covered by a higher tolerance as a result of use on growing crops) in
food/feed handling establishments; fruit, pome, group 11; fruit, stone,
group 12; grape; grass, forage, group 17; grass, hay, group 17; nut,
tree, group 14; peanut; rapeseed; sunflower; sunflower, refined oil;
turnip, greens; vegetable, cucurbit, group 9; and vegetable, root and
tuber, group 1, except sugar beet. FMC Corporation and Interregional
Research Project Number 4 (IR-4) requested this tolerance under the
Federal Food, Drug and Cosmetic Act (FFDCA), as amended by the Food
Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective December 29, 2006. Objections and
requests for hearings must be received on or before February 27, 2007,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0769. All documents in the
docket are listed in the index for the docket. 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
Room S-4400, One Potomac Yard (South Building), 2777 South Crystal
Drive, Arlington, VA 22202-3553. The Docket Facility is open from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
Docket telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Linda DeLuise, Registration Division,
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Avenue, NW., Washington, DC 20460-0001; telephone number:
(703) 305-5428; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers
andfarmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

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

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2006-0769 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before February 27, 2007.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0769, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Avenue, NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Room S-4400, One Potomac Yard (South
Building), 2777 South Crystal Drive, Arlington, VA 22202-3553.
Deliveries are only accepted during the Docket's normal hours of
operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays). Special arrangements should be made for deliveries of boxed
information. The Docket telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of November 8, 2000 (65 FR 67003) (FRL-
6750-2); August 2, 2002 (67 FR 50430) (FRL-7185-9); July 16, 2003 (68
FR 42030) (FRL-7314-7); March 16, 2005 (70 FR 12874) (FRL-7705-2); May
10, 2006 (71 FR 27243) (FRL-8067-8); and August 25, 2006 (71 FR 50414)
(FRL-8088-9), EPA issued notices pursuant to section 408(d)(3) of
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide
petitions (PP 1F3994; PP 2F6444; PP 3E6677; PP 3F6577; PP 4F6893; and
PP 5F6896) by FMC Corporation, 1735 Market Street, Philadelphia, PA
19103-7597 and Interregional Research Project Number 4 (IR-4), 681 U.S.
Highway 1 South, North Brunswick, NJ 08902-3390. These
petitions requested that 40 CFR 180.418 be amended by establishing a
tolerance for residues of the insecticide zeta-cypermethrin, (S)-
cyano(3-phenoxyphenyl)methyl ()-cis-trans-3-(2,2-
dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate), in or on barley,
grain at 0.5 parts per million (ppm) (5F6896); barley, hay at 2 ppm
(5F6896); barley, straw at 4 ppm (5F6896); berries group at 0.5 ppm
(5F6896); canola, meal at 0.05 ppm (5F6896); canola, oil at 0.6 ppm
(5F6896); canola, seed at 0.05 ppm (5F6896); cilantro at 10 ppm
(3E6677); cucurbit vegetables at 0.1 ppm (2F6444); food/feed items
(other than those covered by a higher tolerance as a result of use on
growing crops) in food/feed handling establishments at 0.05 ppm
(4F6893); fruit, pome, group 11 at 0.6 ppm (3F6577); fruit, stone,
group 12 at 0.9 ppm (3F6577); grapes at 1 ppm (5F6896); grass, forage
at 7 ppm (5F6896); grass, hay at 22 ppm (5F6896); grass, straw at 8 ppm
(5F6896); grass, screenings at 12 ppm (5F6896); juice, grape at 0.05
ppm (5F6896); nongrass animal feed, forage at 10 ppm (5F6896); nongrass
animal feed, hay at 33 ppm (5F6896); peanuts at 0.05 ppm (2F6444);
raisins at 0.2 ppm (5F6896); root and tuber vegetables, roots at 0.1
ppm (2F6444); sunflower at 0.2 ppm (1F3994); sunflower oil at 0.2 ppm
(1F3994); tree nut group, nutmeat at 0.05 ppm (5F6896); tree nut group,
hulls at 3 ppm (5F6896); and turnip greens at 14 ppm (3E6677). These
notices included a summary of the petition prepared by FMC Corporation,
the registrant, and IR-4. There were no comments received in response
to these notices of filing.
    The proposed tolerances were later amended as follows: almond,
hulls at 6 ppm (5F6896); animal feed, nongrass, group 18, forage at 8
ppm (5F6896); animal feed, nongrass, group 18, hay at 40 ppm (5F6896);
berry, group 13 at 0.8 ppm (5F6896); cilantro, leaves at 10 ppm
(3E6677); food/feed items (other than those covered by a higher
tolerance as a result of use on growing crops) in food/feed handling
establishments at 0.05 ppm (4F6893); fruit, pome, group 11 at 2 ppm
(3F6577); fruit, stone, group 12 at 1 ppm (3F6577); grape at 2 ppm
(5F6896); grass, forage, group 17 at 10 ppm (5F6896); grass, hay, group
17 at 35 ppm (5F6896); nut, tree, group 14 at 0.05 ppm (5F6896); peanut
at 0.05 ppm (2F6444); rapeseed at 0.2 ppm (5F6896); sunflower at 0.2
ppm (1F3994); sunflower, refined oil at 0.5 ppm (1F3994); turnip,
greens at 14 ppm (3E6677); vegetable, cucurbit, group 9 at 0.2 ppm
(2F6444); and vegetable, root and tuber, group 1, except sugar beet at
0.1 ppm (2F6444).
    For various reasons, EPA has decided not to establish several of
the proposed tolerances. The proposed tolerances for canola meal,
canola oil, grape juice and raisins oil are not being established
because grape and canola processing studies indicate that residues in
these processed commodities do not concentrate above the tolerance
level in raw commodity. The proposed tolerances in barley grain, hay
and straw are not being established because there was an inadequate
number of residue field trials submitted in support of these
tolerances. The proposed tolerances for grass screenings and grass
straw are not being established because these commodities are not
significant livestock feed items.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' 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.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete

http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for a tolerance for residues of zeta-cypermethrin,
in or on almond, hulls at 6 ppm; animal feed, nongrass, group 18,
forage at 8 ppm; animal feed, nongrass, group 18, hay at 40 ppm; berry,
group 13 at 0.8 ppm; cilantro, leaves at 10 ppm; food/feed items (other
than those covered by a higher tolerance as a result of use on growing
crops) in food/feed handling establishments at 0.05 ppm; fruit, pome,
group 11 at 2 ppm; fruit, stone, group 12 at 1 ppm; grape at 2 ppm;
grass, forage, group 17 at 10 ppm; grass, hay, group 17 at 35 ppm; nut,
tree, group 14 at 0.05 ppm; peanut at 0.05 ppm; rapeseed at 0.2 ppm;
sunflower at 0.2 ppm; sunflower, refined oil at 0.5 ppm; turnip, greens
at 14 ppm; vegetable, cucurbit, group 9 at 0.2 ppm; and vegetable, root
and tuber, group 1, except sugar beet at 0.1 ppm. EPA's assessment of
exposures and risks associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The toxicology database for zeta-cypermethrin/cypermethrin is
complete, and there are no data gaps. The specific quality is
relatively high and the toxicity profile of zeta-cypermethrin can be
characterized for all effects, including potential developmental,
reproductive, neurotoxic, carcinogenic and mutagenic effects.
    More detailed information on the studies received and the nature of
the toxic effects caused by zeta-cypermethrin as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found in the
document entitled, zeta-cypermethrin: Revised Human Health Risk
Assessment for Proposed Uses on Numerous Raw Agricultural Commodities.
Petitions: 3F6577, 3E6677, 2F6444, 4F6893 and 5F6896 for the
Establishment of Tolerances on Various Raw Agricultural, Processed
Commodities and Food Items in Food Handling Establishments. PC Code:
109702, D334263. Regulatory Action: Section 3. Risk Assessment Type:
Zeta-Cypermethrin/Cypermethrin Aggregate,'' dated November 29, 2006, by
going to http://www.regulations.gov, and searching for docket ID number

EPA-HQ-OPP-2006-0769. Locate and click on the hyperlink for EPA
document ID number EPA-HQ-OPP-2006-0769-0031. Double-click on the
document to view the referenced information on pages 16-20.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, 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 (LOC). 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.
An uncertainty factor (UF) is applied to reflect uncertainties inherent
in the extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk and estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at http://www.epa.gov/pesticides/health/human.htm.

    A summary of the toxicological endpoints for zeta-cypermethrin used
for human risk assessment is shown below in Table 1 of this unit:

             Table 1.--Summary of Toxicological Dose and Endpoints for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                  FQPA SF and Level of
          Exposure/Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                           Assessment, UF*             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (U.S. general            NOAEL = 10 mg/kg/day     FQPA SF = 1x             Acute neurotoxicity
 population including infants and      UF = 100x..............  aPAD = acute RfD / FQPA   study - rat (zeta-
 children)                             Acute RfD = 0.1 mg/kg/    SF = 0.1 mg/kg/day.      cypermethrin);
                                        day.                                             LOAEL = 50 mg/kg/day
                                                                                based on clinical
                                                                                signs of neurotoxicity
                                                                                and changes in the
                                                                                FOB.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations)      NOAEL = 6 mg/kg/day      FQPA SF = 1x             Chronic feeding study -
                                       UF = 100x..............   cPAD = chronic RfD /     dog;
                                       Chronic RfD = 0.06 mg/    FQPA SF = 0.06 mg/kg/   LOAEL = 20.4/18.1 mg/kg/
                                        kg/day.                  day.                     day based on clinical
                                                                                signs of neurotoxicity
                                                                                and mortality in
                                                                                males, and decreased
                                                                                body weight and body
                                                                                weight gain in
                                                                                females.
----------------------------------------------------------------------------------------------------------------
Short- and Intermediate-Term           NOAEL = 7.4 mg/kg/day    Residential LOC for MOE  Developmental
 Incidental Oral (1 day to 6 months)                             = 100                    neurotoxicity study -
                                                                Occupational LOC for      rat (zeta-
                                                                 MOE = N/A.               cypermethrin);
                                                                                LOAEL = 17 mg/kg/day
                                                                                based on decreased
                                                                                body weight in the
                                                                                offspring.
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Short- and Intermediate-Term Dermal    NOAEL = 7.4 mg/kg/day    Residential LOC for MOE  Developmental
 (Infants and Children Only; 1 day to   (dermal absorption       = 100                    neurotoxicity study -
 6 months)                              rate = 2.5%)                                      rat (zeta-
                                                                                cypermethrin);
                                                                                LOAEL = 17 mg/kg/day
                                                                                based on decreased
                                                                                body weight in the
                                                                                offspring.
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Short- and Intermediate-Term Dermal    None.                    Occupational LOC for     No systemic effects
 (Adults, Workers; 1 day to 6 months)                            MOE = N/A                were observed in a 21-
                                                                                day dermal study (zeta-
                                                                                cypermethrin) up to
                                                                                1,000 mg/kg/day and
                                                                                there is no
                                                                                developmental concern.
                                                                                No hazard identified
                                                                                to support
                                                                                quantification of
                                                                                risk.
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Long-Term Dermal (>6 months)           NOAEL = 6 mg/kg/day      Residential LOC for MOE  Chronic feeding study -
                                        (dermal absorption       = 100                    dog;
                                        rate = 2.5%)            Occupational LOC for     LOAEL = 20.4/18.1 mg/kg/
                                                                 MOE = 100.               day based on clinical
                                                                                signs of neurotoxicity
                                                                                and mortality in
                                                                                males, and decreased
                                                                                body weight and body
                                                                                weight gain in
                                                                                females.
----------------------------------------------------------------------------------------------------------------
Short- and Intermediate-Term           NOAEL = 2.7 mg/kg/day    Residential LOC for MOE  21-day inhalation study
 Inhalation (1 to 6 months)             (inhalation absorption   = 100                    - rat;
                                        rate = 100% oral        Occupational LOC for     LOAEL = 0.05 mg/kg/day
                                        equivalent)              MOE = 100.               based on decreases in
                                                                                body weight and
                                                                                salivation.
----------------------------------------------------------------------------------------------------------------
Long-Term Inhalation (>6 months)       NOAEL = 2.7 mg/kg/day    Residential LOC for MOE  21-day inhalation study
                                        (inhalation absorption   = 300                    - rat;
                                        rate = 100% oral        Occupational LOC for      LOAEL = 0.05 mg/kg/day
                                        equivalent)              MOE = 300 (For the       based on decreases in
                                                                 lack of an alternative   body weight and
                                                                 study. Route-to-route    salivation.
                                                                 estimation would
                                                                 result in a less
                                                                 protective endpoint.).
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)        Zeta-Cypermethrin has been classified as a Category C (possible human
                                         carcinogen); therefore, no quantification is required. The chronic RfD/
                                         PAD will adequately account for all chronic toxicity effects, including
                                           carcinogenicity, likely to result from exposure to this pesticide.
----------------------------------------------------------------------------------------------------------------
\*\UF = uncertainty factor; FQPA SF = any additional safety factor retained to account for data deficiencies or
  residual concerns unique to the FQPA; NOAEL = no observed adverse effect level; LOAEL = lowest observed
  adverse effect level; PAD = population adjusted dose (a = acute, c = chronic); RfD = reference dose; MOE =
  margin of exposure; LOC = level of concern; and N/A = not applicable.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.418) for the residues of zeta-cypermethrin,
(S)-cyano(3-phenoxyphenyl)methyl ()-cis-trans-3-(2,2-
dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate), in or on a
variety of raw agricultural commodities. Risk assessments were
conducted by EPA to assess dietary exposures from zeta-cypermethrin in
food. Modeled drinking water estimates were included in both the acute
and chronic dietary exposure analyses as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a one-day or single exposure.
    The Agency conducted an unrefined acute dietary exposure assessment
using the Dietary Exposure Evaluation Model software with the Food
Commodity Intake Database (DEEM-FCID\TM\, Version 2.03). This analysis
evaluated the individual food consumption as reported by respondents in
the USDA 1994-1996 and 1998 nationwide Continuing Surveys of Food
Intake by Individuals (CSFII) and accumulated exposure to the chemical
for each commodity. The acute analysis is based on Tier 1 assumptions
of tolerance-level residues for existing uses and Agency-recommended
tolerance levels for the numerous proposed new uses and 100% crop
treated (CT) for all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, the DEEM-FCID\TM\ analysis evaluated the individual food
consumption data as reported by respondents in the USDA 1994-1996 and
1998 nationwide CSFII and accumulated exposure to the chemical for each
commodity.Anticipated residues (averages for crop field trials) were
calculated for the numerous proposed new uses from field trial data.
100% CT was assumed for all proposed new uses except for non-grass
animal feed; and grass fodder, forage and hay. For existing uses,
anticipated residues are based on USDA PDP monitoring data, crop field
trial data and empirical processing factors and may be considered
refined.
    iii. Cancer. Zeta-cypermethrin was classified as a group ``C''
(possible human carcinogen), based on an increased incidence of lung
adenonas and adenomas plus carcinomas combined in female mice. The
evidence was not considered strong enough to warrant a quantitative
estimation of human cancer risk. Risk assessments based on endpoint
selected for the chronic population adjusted dose (cPAD) will be
protective of any potential carcinogenic risk from exposure to zeta-
cypermethrin for the U.S. general population and all population
subgroups, including infants and children. Additionally, EPA relied

on the chronic exposure assessment in assessing cancer risk.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data
and information on the anticipated residue levels of pesticide residues
in food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must, pursuant
to section 408(f)(1), require that data be provided 5 years after the
tolerance is established, modified or left in effect, demonstrating
that the levels in food are not above the levels anticipated. Following
the initial data submission, EPA is authorized to require similar data
on a time frame it deems appropriate. For the present action, EPA will
issue such data call-ins for information relating to anticipated
residues as are required by FFDCA section 408(b)(2)(E) and authorized
under FFDCA section 408(f)(1). Such data call-ins will be required to
be submitted no later than 5 years from the date of issuance of this
tolerance.
    Section 408(b)(2)(F) of the FFDCA states that the Agency may use
data on the actual percent of food treated for assessing chronic
dietary risk only if the Agency can make the following findings:
Condition 1, that the data used are reliable and provide a valid basis
to show what percentage of the food derived from such crop is likely to
contain such pesticide residue; Condition 2, that the exposure estimate
does not underestimate exposure for any significant subpopulation
group; and Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by section 408(b)(2)(F) of the FFDCA, EPA may require registrants to
submit data on PCT.
    The Agency used PCT information as follows:
    For cypermethrin: broccoli, 6%; bulb crops, 16%; cabbage, 3%;
cauliflower, 13%; celery, 1%; cole crops, 3%; collards, 9%; cotton, 5%;
garlic, 13%; greens, mustard, 8%; greens, turnips, 4%; kale, 13%;
lettuce, 26%; onions, 15%; pecans, 5%; and spinach, 2%.
    For zeta-cypermethrin: bulb crops, 4%; cabbage, 1%; carrots, 1%;
cole crops, 1%; corn, field, < 1%; cotton, 4%; lettuce, 17%; onions,
13%; peanuts, < 1%; pecans, 9%; sorghum, < 1%; soybeans, < 1%; sweet corn,
< 1%; and wheat, winter, < 1%.
    The Agency believes that the three conditions, listed in Unit
III.C.1.iv., have been met with regard to the PCT estimates. With
respect to Condition 1, PCT estimates for existing uses are derived
from Federal and private market survey data, which are reliable and
have a valid basis. The Agency is reasonably certain that the
percentage of the food treated is not likely to be an underestimation.
EPA estimates projected percent crop treated (PPCT) for a new pesticide
use by assuming that the PCT during the pesticide's initial 5 years of
use on a specific use site will not exceed the average PCT of the
market leader (i.e., the one with the greatest PCT) on that site over
the three most recent surveys. Comparisons are only made among
pesticides of the same pesticide types (i.e., the dominant insecticide
on the use site is selected for comparison with the new insecticide).
The PCTs included in the average may be each for the same pesticide or
for different pesticides since the same or different pesticides may
dominate for each year selected. Typically, EPA uses data from the U.S.
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS) as the source for the PCT data because they are publicly
available. When a specific use site is not surveyed by USDA/NASS, EPA
uses proprietary data and calculates the estimated PCT.
    The estimated PPCT, based on the average PCT of the market leader,
is appropriate for use in the chronic dietary risk assessment. This
method of estimating a PPCT for a new use of a registered pesticide or
a new pesticide produces a high-end estimate that is unlikely, in most
cases, to be exceeded during the initial 5 years of actual use.
Predominant factors that bear on whether the estimated PPCT could be
exceeded include pest pressure concerns, relative efficacies, pest
prevalence and other factors. Although PPCT data (estimates) for crop
group 18: nongrass animal feeds (forage and hay) and crop group 17:
grass forage, fodder and hay are limited, estimates are provided (PPCT)
for alfalfa hay, other hay and pasture/rangeland. The estimate for
pasture/rangeland may understate the PPCT for grasses since the
rangeland component probably receives less treatment than the pasture
component (the latter which contains more grass than does rangeland).
It is unlikely that actual PCT for zeta-cypermethrin will exceed the
estimated PPCT for this chemical on each of these 3 crops during the
next 5 years.
    As to Conditions 2 and 3, regional consumption information and
consumption information for significant subpopulations is taken into
account through EPA's computer-based model for evaluating the exposure
of significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which zeta-
cypermethrin may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for zeta-cypermethrin in drinking
water. Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of zeta-cypermethrin. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/[fxsp0]oppefed1/models/[fxsp0]water/

index.htm.
    Based on the PRZM/EXAMS (surface water) and SCI-GROW (ground water)
models, the estimated environmental concentrations (EECs) of zeta-
cypermethrin for acute exposures are estimated to be 1.04 parts per
billion (ppb) for surface water and 0.0036 ppb for ground water. The
EECs for chronic exposures are estimated to be 0.013 ppb for surface
water and 0.0036 ppb for ground water.
    The estimated drinking water concentrations (EDWCs) for zeta-
cypermethrin were calculated based on 6 aerial applications of
cypermethrin at a maximum application rate of 0.10 lbs. a.i./acre/
season to Brassica leafy vegetables with a 7-day re-treatment interval
(RTI). Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model (DEEM-FCID\TM\, Version 2.03).
For acute dietary risk assessment, the peak water concentration value
of 1.04 ppb was used to assess the contribution to drinking water. For
chronic dietary risk assessment, the annual average concentration of
0.013 ppb was used to assess the contribution to drinking water.

    The ground water screening concentration is 0.0036 ppb. These
values generally represent upper-bound estimates of the concentrations
that might be found in surface water and ground water due to the use of
cypermethrin on Brassica leafy vegetables, which has the highest
application rate among both cypermethrin and zeta-cypermethrin on all
crops over which the chemicals are applied.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides and/or flea and tick control on pets).
    For zeta-cypermethrin/cypermethrin, there is a potential for
exposure in residential settings during application by homeowners who
use products containing zeta-cypermethrin/cypermethrin. There is a
potential for exposure in residential settings from entering areas
treated with zeta-cypermethrin/cypermethrin, such as residential lawns,
indoor surfaces and spaces, outdoor surfaces, and animal premises that
could lead to non-occupational exposure to adults and children. As a
result, risk assessments have been completed for residential handler
scenarios and for post-application scenarios.
    Short- and intermediate-term dermal exposure risk assessments were
not conducted for adults, due to the lack of an appropriate toxicity
endpoint of concern for this population subgroup. Short- and
intermediate-term dermal exposure risk assessments were not conducted
for infants and children because no potential exposure to infants and
children is anticipated under the residential handler scenarios.
    A long-term dermal exposure assessment was not conducted, since
there is no potential for long-term exposures via the proposed uses of
zeta-cypermethrin. There is potential for short- and intermediate-term
inhalation exposure in residential handler settings during the
application process for adult homeowners who use products containing
zeta-cypermethrin.
    Short- and intermediate-term inhalation exposure assessments were
not conducted for infants and children because no potential exposure to
infants and children is anticipated under the residential handler
scenarios. A long-term inhalation exposure assessment was not
conducted, since there are no potential long-term exposures via the
proposed uses of zeta-cypermethrin.
    These residential risk assessments assumed the maximum application
rates allowed by product labels and that residents would wear shorts
and short-sleeved shirts with no gloves when applying zeta-
cypermethrin. It was also assumed that the size of a lawn or garden
treated by a homeowner is 0.5 acres.There is also a potential for
exposure in residential settings from entering areas treated with zeta-
cypermethrin, such as residential lawns, indoor surfaces and spaces and
outdoor surfaces that could lead to non-occupational exposures to
adults and children.
    The post-application risk assessment included high-end assumptions
for factors such as exposure duration and skin surface area. The 0.15
lb. a.i./acre application rate for turf was used in the model to
estimate post-application residential exposure of toddlers. Since this
rate is equal to or higher than many of the agricultural application
rates, this scenario is protective of any exposure of farm children via
spray drift from agricultural zeta-cypermethrin/cypermethrin
applications. Such use of the Agency's Standard Operating Procedures
for Residential Assessment results in reasonable worst case estimates
of risks.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.'' Cypermethrin is a member of
the pyrethroid class of pesticides. Although all pyrethroids alter
nerve function by modifying the normal biochemistry and physiology of
nerve membrane sodium channels, EPA is not currently following a
cumulative risk approach based on a common mechanism of toxicity for
the pyrethroids. Although all pyrethroids interact with sodium
channels, there are multiple types of sodium channels and it is
currently unknown whether the pyrethroids have similar effects on all
channels.
    EPA does not have a clear understanding at this time of effects on
key downstream neuronal function (e.g., nerve excitability). Further,
EPA has not determined how these key events interact to produce their
compound-specific patterns of neurotoxicity. There is ongoing research
by the Agency's Office of Research and Development and pyrethroid
registrants to evaluate the differential biochemical and physiological
actions of pyrethroids in mammals. This research is expected to be
completed by 2007. When available, the Agency will consider this
research and make a determination of common mechanism as a basis for
assessing cumulative risk. Information regarding EPA's procedures for
cumulating effects from substances found to have a common mechanism can
be found on EPA's website at http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional ten-fold margin of safety for infants and children in the
case of threshold effects to account for pre- and/or post-natal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10x
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
    2. Pre-natal and post-natal sensitivity. In the last tolerance
rulemaking for zeta-cypermethrin, February 12, 2002 (67 FR 6422), EPA
removed the FQPA 10x safety factor based on its conclusion that the
data showed no concern for increased sensitivity due to pre- and/or
post-natal exposure and that the lack of a required developmental
neurotoxicity (DNT) study in the rat did not raise residual concerns
regarding the safety of children, because the DNT study had not been
required based on special concern for the developing fetuses or young.
After release of its revised policy statement on the FQPA children's
safety factor, EPA revisited its FQPA safety factor decision and
determined that, given the lack of certainty regarding the results of
the then absent DNT study, it was necessary to retain the full 10x FQPA
safety factor as a database uncertainty factor. In 2005, that
additional safety factor was incorporated into the preliminary risk
assessment for cypermethrin and zeta-cypermethrin in connection with
the reregistration and tolerance reassessment decision for these
pesticides.With the subsequent receipt and evaluation of the DNT study
for

zeta-cypermethrin (2005, MRID 46670402), the toxicology database for
FQPA assessment is now complete.
    In the acute and subchronic neurotoxicity studies, clinical signs
of neurotoxicity typical of pyrethroids were observed (i.e., gait
abnormalities, decreased motor activity, notable changes in the
functional observational battery (FOB) and tremors); however, no
neuropathology was observed. In the other guideline studies, tremors
and gait abnormalities were observed in both dogs and rats following
oral exposure, and similar clinical signs were seen in the rat
inhalation study. There is no evidence of increased susceptibility of
fetuses following in utero exposure in the developmental toxicity
studies in rats or rabbits or in the offspring following pre- and/or
post-natal exposure in the 2-generation rat reproduction study.
    In the DNT study, there was limited evidence of increased
susceptibility of the offspring. No toxicity was observed in the
maternal animals at the highest dose tested, while decreased body
weight, decreased subsession motor activity and changes in brain
morphometry were seen in the offspring at this same dose. An in-depth
analysis of the effects seen in the pups revealed that these effects
were of low concern because: Body weight decreases were seen only
during late lactation (post-natal days 13-21) when the pups are
potentially exposed to higher levels of the chemical via both milk and
feed; the decreases in motor activity are not considered biologically
significant since they were seen only in the subsession data (not in
total or ambulatory counts), only in one sex (females), only on post-
natal day 21 (not in measurements taken at three other time periods)
and the differences did not reach statistical significance; and the
sole brain morphometric change (statistically significant increase in
the mean vertical thickness of the cortex) was determined to occur in
isolation, only in female pups on day 21, and was not considered
biologically significant because when the values of individual treated
animals were compared with individual control animals, the incidence
and magnitude of the change suggested a low concern.No statistically or
biologically significant changes were seen in any other brain areas in
male or female pups at any time period. Thus, the only biologically
significant effect observed in the DNT study was the change in
offspring body weights.
    Based on these factors, the limited susceptibility seen in the DNT
was determined to be of low concern. Therefore, there are no residual
uncertainties for pre- and/or postnatal toxicity. There are no residual
uncertainties identified in the exposure databases. The chronic and
cancer dietary food exposure assessments utilize anticipated residues
calculated from field trial data and PCT data for all commodities.
Although refined, the assessments are based on reliable data and will
not underestimate exposure/risk. The drinking water exposure is based
on conservative modeling estimates. The residential exposure assessment
utilizes residential SOPs for the adult handler and post-application
scenarios and to assess post-application exposure to children, as well
as incidental oral ingestion by toddlers. The residential SOPs are
based on reasonable worst-case assumptions and will not likely
underestimate exposure/risk. These assessments are unlikely to
underestimate the potential exposure to infants and children resulting
from the use of zeta-cypermethrin/cypermethrin.
    3. Conclusion. Based on the data discussed above, the FQPA safety
factor can be removed (i.e., reduced to 1x) due to the completeness of
the toxicology database, the lack of residual concerns regarding pre-
and/or post-natal toxicity and the reliance on exposure data unlikely
to underestimate exposure to the pesticide. Thus, a FQPA safety factor
of 1x is appropriate for zeta-cypermethrin.

E. Aggregate Risks and Determination of Safety

    The Agency currently has two ways to estimate total aggregate
exposure to a pesticide from food, drinking water and residential uses.
First, a screening assessment can be used, in which the Agency
calculates drinking water levels of comparison (DWLOCs) which are used
as a point of comparison against EDWCs. The DWLOC values are not
regulatory standards for drinking water, but are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
More information on the use of DWLOCs in dietary risk assessments can
be found at http://www.epa.gov/oppfead1/trac/science/screeningsop.pdf.

    More recently, the Agency has used another approach to estimate
aggregate exposure through food, drinking water and residential
pathways. In this approach, modeled surface and ground water EDWCs are
directly incorporated into the dietary exposure analysis, along with
food. This provides a more realistic estimate of exposure because
actually body weights and water consumption from the CSFII are used.
The combined food and water exposures are then added to estimated
exposure from residential uses to calculate aggregate risks. The
resulting exposure and risk estimates are still considered to be high
end, due to the assumptions used in developing drinking water modeling
inputs.
    1. Acute risk. Using the exposure assumptions discussed in Unit
III.C.1.i., the acute dietary exposure from food and drinking water to
zeta-cypermethrin will occupy 30% of the aPAD for the U.S. general
population and 54% of the aPAD for children (1-2 years old), the most
highly exposed population subgroup.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to zeta-
cypermethrin from food and drinking water will utilize 1% of the cPAD
for the U.S. general population and 3% of the cPAD for children (1-2
years old), the most highly exposed population subgroup.
    3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus average (chronic) exposure levels to
food and water (considered to be a background exposure level).Zeta-
cypermethrin is currently registered for use that could result in
short-term residential exposure and the Agency has determined that it
is appropriate to aggregate chronic food and water and short-term
exposures for zeta-cypermethrin. Short-term risks were estimated for
toddlers' incidental oral exposures outdoors on turf and indoors on
treated surfaces. The latter were based on uses of cypermethrin, due to
its higher application rate compared to zeta-cypermethrin. Short-term
risks for adult dermal exposure were not evaluated because no short-
term dermal endpoint applicable to the adult population was identified.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, water and residential
exposures aggregated result in aggregate MOEs of 8,600 for the U.S.
general population; 8,500 for all infants (< 1 year old); and 780 for
children (1-2 years old), the population subgroup at greatest exposure.
These aggregated MOEs do not exceed the Agency's LOC for aggregate
exposure to food, water and residential uses.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Intermediate-
term exposure is not expected from residential uses of zeta-
cypermethrin.

    5. Aggregate cancer risk for U.S. population. The Agency considers
the chronic aggregate risk assessment, making use of the cPAD, to be
protective of any aggregate cancer risk. See Unit III.E.2. for more
detail.
    6. Determination of safety. Based on these risk assessments,
estimates of acute aggregate, chronic aggregate and short-term
aggregate (food, water and residential uses) risk do not exceed EPA's
level of concern. As a result, EPA concludes that there is a reasonable
certainty that no harm will result to the U.S. general population and
all population subgroups, including infants and children from aggregate
exposure to zeta-cypermethrin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement analytical methodology for cypermethrin and;
therefore, zeta-cypermethrin residues is available in PAM Volume II.
PAM Volume II lists Methods I and II for the determination of residues
of cypermethrin per se in/on plant and livestock commodities,
respectively. Both are gas chromatography (GC) methods with electron
capture detection and have undergone successful Agency method tryout.
Method I has a detection limit of 0.01 ppm and Method II has detection
limits of 0.005 ppm for milk and 0.01 ppm for livestock tissues.These
methods are not stereo specific; thus no distinction is made between
residues of cypermethrin (all 8 stereoisomers) and zeta-cypermethrin
(an enriched isomer form of cypermethrin). Agency reviews of recent
zeta-cypermethrin petitions (PP 8F4970, PP 4F3012, PP 9F6040, PP 9F6037
and PP 0F6207) required the petitioner to submit a revised section F to
add the phrase ``and its inactive R-isomers'' after the chemical name
zeta-cypermethrin in the tolerance expression, since the PAM Volume II
method is not stereospecific.

B. International Residue Limits

    No specific CODEX, Canadian or Mexican maximum residue limits
(MRLs) or tolerances have been established for zeta-cypermethrin. There
are CODEX MRLs for cypermethrin residues in/on various plant and
livestock commodities and the CODEX and U.S. tolerances are in harmony
with respect to MRL/tolerance expression in that both regulate the
parent compound, cypermethrin, since enforcement methods do not
distinguish between cypermethrin and zeta-cypermethrin. During review
of residue data associated with the current pesticide petitions (zeta-
cypermethrin), attempts were made to harmonize residue levels whenever
possible.

V. Conclusion

    Therefore, the tolerance is established for residues of zeta-
cypermethrin, (S)-cyano(3-phenoxyphenyl)methyl ()-cis-
trans-3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate), in
or on almond, hulls at 6 ppm; animal feed, nongrass, group 18, forage
at 8 ppm; animal feed, nongrass, group 18, hay at 40 ppm; berry, group
13 at 0.8 ppm; cilantro, leaves at 10 ppm; food/feed items (other than
those covered by a higher tolerance as a result of use on growing
crops) in food/feed handling establishments at 0.05 ppm; fruit, pome,
group 11 at 2 ppm; fruit, stone, group 12 at 1 ppm; grape at 2 ppm;
grass, forage, group 17 at 10 ppm; grass, hay, group 17 at 35 ppm; nut,
tree, group 14 at 0.05 ppm; peanut at 0.05 ppm; rapeseed at 0.2 ppm;
sunflower at 0.2 ppm; sunflower, refined oil at 0.5 ppm; turnip, greens
at 14 ppm; vegetable, cucurbit, group 9 at 0.2 ppm; and vegetable, root
and tuber, group 1, except sugar beet at 0.1 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled
Federalism(64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' is defined in the Executive order
to include regulations that have ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' This final rule directly regulates
growers, food processors, food handlers and food retailers, not States.
This action does not alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of section 408(n)(4) of FFDCA. For these same reasons, the
Agency has determined that this rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175 requires EPA to develop
an accountable process to ensure ``meaningful and timely input by
tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive order to include regulations that have
``substantial direct effects on one or more Indian tribes on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This

rule will not have substantial direct effects on tribal governments, on
the relationship between the Federal Government and Indian tribes or on
the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: December 21, 2006.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.418 is amended by alphabetically adding commodities to
the table in paragraph (a)(2) to read as follows:

Sec.  180.418  Cypermethrin and an isomer zeta-cypermethrin; tolerances
for residues.

    (a)* * *
    (2) * * *

------------------------------------------------------------------------
                                                                  Parts
                           Commodity                               per
                                                                 million
------------------------------------------------------------------------
                                * * * * *
Almond, hulls..................................................        6
Animal feed, nongrass, group 18, forage........................        8
Animal feed, nongrass, group 18, hay...........................       40
                                * * * * *
Berry, group 13................................................      0.8
                                * * * * *
Cilantro, leaves...............................................       10
                                * * * * *
Food/feed items (other than those covered by a higher tolerance     0.05
 as a result of use on growing crops) in food/feed handling
 establishments................................................
Fruit, pome, group 11..........................................        2
Fruit, stone, group 12.........................................        1
                                * * * * *
Grape..........................................................        2
Grass, forage, group 17........................................       10
Grass, hay, group 17...........................................       35
                                * * * * *
Nut, tree, group 14............................................     0.05
                                * * * * *
Peanut.........................................................     0.05
                                * * * * *
Rapeseed.......................................................      0.2
                                * * * * *
Sunflower......................................................      0.2
Sunflower, refined oil.........................................      0.5
                                * * * * *
Turnip, greens.................................................       14
                                * * * * *
Vegetable, cucurbit, group 9...................................      0.2
                                * * * * *
Vegetable, root and tuber, group 1, except sugar beet..........      0.1
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E6-22288 Filed 12-28-06; 8:45 am]

BILLING CODE 6560-50-S


                 	     Product Ingredient Review Program

Agenda

Request for Waiver of Requirement for DNT Study

Meeting Between Pyrethrins Joint Venture and USEPA

EPA Headquarters

Crystal City, VA

July 24, 2008

12:30 – 1:30 PM

Introduction – 5’

Background – 5’

Basis for EPA Requirement as outlined in the RED – 10’

Review of PJV Re-read of Slides from Neurotoxicity Study – 15’

Basis for the Waiver -15’

Next Steps – 10’

Serving Makers of Formulated Products for Home and Commercial Use Since 1914.

900 17th Street, NW • Washington, DC 20006 • T:202.872.8110 • F: 202.872.8114  •   HYPERLINK "http://www.cspa.org"  www.cspa.org


[Federal Register Volume 84, Number 116 (Monday, June 17, 2019)]
[Notices]
[Pages 28031-28032]
[FR Doc No: 2019-12738]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14633-001]

Notice of Application Ready for Environmental Analysis and
Soliciting Comments, Recommendations, and Terms and Conditions: New
England Hydropower Company, LLC

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Exemption From Licensing.
    b. Project No.: 14633-001.
    c. Date filed: October 1, 2018.
    d. Applicant: New England Hydropower Company, LLC (NEHC).
    e. Name of Project: Albion Dam Hydroelectric Project.
    f. Location: On the Blackstone River, near the Towns of Cumberland
and Lincoln, Providence County, Rhode Island. No federal or tribal
lands would be occupied by project works or located within the project
boundary.
    g. Filed Pursuant to: Public Utility Regulatory Policies Act of
1978, 16 U.S.C. 2705, 2708 (2012), amended by the Hydropower Regulatory
Efficiency Act of 2013, Public Law 113-23, 127 Stat. 493 (2013).
    h. Applicant Contact: Michael C. Kerr, 100 Cummings Center, Suite
451C, Beverly, MA 01915; phone at<PHONE_NUMBER> or email at
<EMAIL_ADDRESS>    i. FERC Contact: Patrick Crile,<PHONE_NUMBER>, or email at
<EMAIL_ADDRESS>    j. Deadline for filing comments, recommendations, and terms and
conditions: 60 days from the issuance date of this notice; reply
comments are due 105 days from the issuance date of this notice.
    The Commission strongly encourages electronic filing. Please file
comments, recommendations, and terms and conditions using the
Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000
characters, without prior registration, using the eComment system at
http://www.ferc.gov/docs-filing/ecomment.asp. You must include your
name and contact information at the end of your comments. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. The first page of any filing should include
docket number P-14633-001.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    k. This application has been accepted and is now ready for
environmental analysis.
    l. The proposed Albion Dam Hydroelectric Project would consist of:
(1) An approximately 266-foot-long existing concrete gravity dam with
an ogee spillway; (2) an existing 20.4-acre impoundment with a normal
storage capacity of 235 acre-feet at an operating elevation of
approximately 87.0 feet North American Vertical Datum of 1988; (3) a
new 51-foot-long, 45.75-foot-wide intake canal; (4) two new 14-foot-
wide, 10.4-foot-high hydraulically-powered sluice gates, each equipped
with a 15-foot-wide, 9.7-foot-high steel trashrack with 9-inch clear-
bar spacing; (5) two new 30-foot-long, 15-foot-wide, 9.7-foot-high
concrete penstocks; (6) a new 50-foot-long, 24-foot-wide, 18-foot-high
concrete powerhouse containing two 210-kilowatt (kW) Archimedes Screw
turbine-generator units, for a total installed capacity of 420 kW; (7)
a new 50-foot-long concrete tailrace; (8) a new step-up transformer and
500-foot-long, above-ground transmission line connecting the project to
the distribution system owned by the Narragansett Electric Company; (9)
a new access road; and (10) appurtenant facilities. The existing Albion
Dam and appurtenant works are owned by the State of Rhode Island.
    NEHC proposes to operate the project in a run-of-river mode with an
estimated annual energy production of approximately 2,034 megawatt-
hours.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's website at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support. A copy is also available for inspection and
reproduction at the Cumberland Town Hall, 45 Broad Street, Cumberland,
RI 02864.
    All filings must (1) bear in all capital letters the title
``COMMENTS'', ``REPLY COMMENTS'', ``RECOMMENDATIONS,'' or ``TERMS AND
CONDITIONS,'' (2) set forth in the heading the name of the applicant
and the project number of the application to which the filing responds;
(3) furnish the name, address, and telephone number of the person
submitting the filing; and (4) otherwise comply with the requirements
of 18 CFR 385.2001 through 385.2005. All comments, recommendations, or
terms and conditions must set forth their evidentiary basis and
otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may
obtain copies of the application directly from the applicant. Each
filing must be accompanied by proof of service on all persons listed on
the service list prepared by the Commission in this proceeding, in
accordance with 18 CFR 4.34(b) and 385.2010.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects.

For assistance, contact FERC Online Support.
    n. Public notice of the filing of the initial development
application, which has already been given, established the due date for
filing competing applications or notices of intent. Under the
Commission's regulations, any competing development application must be
filed in response to and in compliance with public notice of the
initial development application. No competing applications or notices
of intent may be filed in response to this notice.
    o. With this notice, we are initiating informal consultation with
the U.S. Fish and Wildlife Service and NOAA Fisheries under section 7
of the Endangered Species Act and the joint agency regulations
thereunder at 50 CFR part 402; and NOAA Fisheries under section 305(b)
of the Magnuson-Stevens Fishery Conservation and Management Act and
implementing regulations at 50 CFR 600.920. We are also initiating
consultation with the Rhode Island State Historic Preservation Officer,
as required by section 106 of the National Historic Preservation Act,
and the implementing regulations of the Advisory Council on Historic
Preservation at 36 CFR 800.2.
    p. Based on the presence of an existing dam, the applicant's
coordination with federal and state agencies during the preparation of
the application, and studies completed during pre-filing consultation,
we accept the consultation that has occurred on this project during the
pre-filing period as satisfying National Environmental Policy Act
scoping. Based on a review of the application, resource agency
consultation letters, and comments filed to date, Commission staff
intends to prepare a single environmental assessment (EA) for the
proposed project. Commission staff determined that the issues that need
to be addressed in its EA have been adequately identified during the
pre-filing period, which included a public meeting, and no new issues
are likely to be identified through additional scoping. The EA will
consider assessing the potential effects of project construction and
operation on geology and soils, aquatic, terrestrial, threatened and
endangered species, recreation and land use, and cultural and historic
resources.
    q. Procedural Schedule and Final Amendments: The application will
be processed according to the following preliminary schedule. Revisions
to the schedule will be made as appropriate.

------------------------------------------------------------------------
              Milestone                           Target date
------------------------------------------------------------------------
Filing of comments, recommendations,   August 2019.
 and terms and conditions.
Commission issues Environmental        December 2019.
 Assessment.
------------------------------------------------------------------------

    r. Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of this notice.

    Dated: June 11, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-12738 Filed 6-14-19; 8:45 am]
BILLING CODE 6717-01-P