[Federal Register Volume 88, Number 191 (Wednesday, October 4, 2023)]
[Rules and Regulations]
[Pages 68475-68481]
[FR Doc No: 2023-21821]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2022-0508 and EPA-HQ-OPP-2022-0672; FRL-11407-01-OCSPP]

Cypermethrin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of
cypermethrin in or on multiple commodities that are identified and
discussed later in this document. The Tea Association of the U.S.A.
Inc. and the American Spice Trade Association requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 4, 2023. Objections and
requests for hearings must be received on or before December 4, 2023
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: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2022-0508 and EPA-HQ-OPP-2022-
0672, is available at https://www.regulations.gov or at the Office of
Pesticide Programs Regulatory Public Docket (OPP Docket) in the
Environmental Protection Agency Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW,
Washington, DC 20460-0001. The Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room and the OPP docket is
(202) 566-1744. For the latest status information on EPA/DC services,
docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).

     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Office of the
Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. 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-2022-0508 and EPA-HQ-OPP-2022-0672 in the
subject line on the first page of your submission. All objections and
requests for a hearing must be in writing and must be received by the
Hearing Clerk on or before December 4, 2023. Addresses for mail and
hand delivery of objections and hearing requests are provided in 40 CFR
178.25(b).
    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 (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2022-0508 and EPA-
HQ-OPP-2022-0672, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of July 20, 2022 (87 FR 43231) (FRL-9410-
03-OCSPP) EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
2E8990) by the Tea Association of the U.S.A. Inc., 362 5th Avenue,
Suite 1002, New York, NY 10001. The petition requested that 40 CFR part
180 be amended by establishing tolerances for residues of the
insecticide cypermethrin, including its metabolites and degradates, in
or on the raw agricultural commodity tea, dried at 15 parts per million
(ppm). That document referenced a summary of the petition prepared by
the Tea Association of the U.S.A. Inc., the petitioner, which is
available in the docket, https://www.regulations.gov.
    In the Federal Register of September 23, 2022 (87 FR 58047) (FRL-
9410-05-OCSPP), EPA issued a document pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
petition (PP 2E9011) by the American Spice Trade Association, 1101 17th
Street NW, Suite 700, Washington, DC 20036. The petition requested that
40 CFR part 180 be amended by establishing tolerances for residues of
the insecticide cypermethrin, including its metabolites and degradates,
in or on some raw agricultural spice commodities (Allspice; anise
pepper; Ashwagandha fruit; Batavia-cassia, fruit; Belleric myrobalan;
caper buds; cardamom, black; cardamom, Ethiopian; cardamom, green;
cardamom, Nepal; cardamom-amomum; cassia, fruit; cassia, Chinese,
fruit; Chinese hawthorn; Chinese-pepper; cinnamon, fruit; cinnamon,
Saigon, fruit; coriander, fruit; cumin, black; Dorrigo pepper, berry;
Dorrigo pepper, leaf; eucalyptus; gamboge; grains of Selim; juniper,
berry; miracle fruit; pepper, black; pepper, Indian long; pepper,
Javanese long; pepper, pink; pepper, Sichuan; pepper, white;
pepperbush, berry; pepperbush, leaf; peppercorn, green; peppertree;
peppertree, Peruvian; saunders, red; sumac, fragrant; sumac, smooth,
leaf; tamarind, seed; Tasmanian, pepper, berry; Tsaoko; Vanilla), at
0.5 ppm; and on other spice commodities (angelica, seed; Asafoetida;
calamus-root; chaste tree, Chinese, roots; coptis; coriander, seed;
fingerroot; jalap; lovage, root; lovage, seed; yellow gentian, roots)
at 0.2 ppm. That document referenced a summary of the petition prepared
by the American Spice Trade Association, the petitioner, which is
available in the docket, https://www.regulations.gov.
    No comments were received on either notice of filing.
    Based upon review of the data supporting the petition, EPA is
revising the tolerance definition and the tolerance level for tea. The
reason for these changes is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    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. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), 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 for cypermethrin including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with cypermethrin 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 cypermethrins (cypermethrin, zeta-cypermethrin, and alpha-
cypermethrin) are Type II pyrethroids that contain an alpha-cyano
moiety. The

adverse outcome pathway (AOP) shared by pyrethroids involves the
ability to interact with voltage-gated sodium channels (VGSCs) in the
central and peripheral nervous systems leading to changes in neuron
firing and, ultimately, neurotoxicity.
    While each active ingredient does not have its own complete
database, studies have been bridged across the three isomeric mixtures
and together are considered adequate for human health risk assessment.
When evaluated together, the toxicity database for cypermethrin, zeta-
cypermethrin, and alpha-cypermethrin can be used to characterize the
overall suite of effects associated with cypermethrin exposure,
including potential developmental and reproductive toxicity,
immunotoxicity, and neurotoxicity. Therefore, the toxicology database
for the cypermethrins together is considered complete with respect to
guideline toxicity studies.
    The cypermethrins affect the nervous system, and neurotoxicity is
the most sensitive effect observed throughout the toxicology database.
Clinical signs of neurotoxicity were seen for all three compounds
across species, sexes, and routes of administration. The endpoints and
points of departure (PODs) selected for risk assessment are based on
neurotoxicity and are protective of all adverse toxic effects observed
in the database. EPA determined that the acute toxicity of alpha-
cypermethrin is higher than that of cypermethrin and zeta-cypermethrin.
To account for this toxicity difference, EPA applied a 5X toxicity
factor for alpha-cypermethrin. As the current tolerance petitions are
for cypermethrin, the toxicity PODs for cypermethrin were used for risk
assessment.
    There was no evidence of increased quantitative or qualitative
susceptibility in the available rat and rabbit developmental toxicity
studies and rat 2-generation reproductive studies with the
cypermethrins. A developmental neurotoxicity (DNT) study with zeta-
cypermethrin indicated increased sensitivity in the offspring, based on
body weight changes in pups in the absence of treatment-related effects
in maternal animals at the highest dose tested. However, there is a
clear no-observed-adverse-effect-level (NOAEL) for effects seen in
pups, and the doses and endpoints selected for risk assessment are
protective of the susceptibility.
    For pyrethroid chemicals, the pharmacokinetics indicate that the
onset of neurotoxicity is rapid, with the time to peak effect for
neurobehavioral effects occurring within hours. This is followed by
rapid metabolism and elimination that does not result in
bioaccumulation. For the cypermethrins, the PODs for clinical signs
after single or repeated exposure are comparable across durations of
exposure; thus, neurotoxicity does not seem to progress with increased
exposure. Therefore, repeated dosing is essentially a series of acute
exposures. As there is no apparent increase in hazard from repeated/
chronic exposures to cypermethrins, the acute exposure assessment is
protective of chronic exposures. The totality of the information
suggests that only single day risk assessments need to be conducted for
the cypermethrins.
    Cypermethrin is classified as a Group C ``Possible human
carcinogen,'' based on an increased incidence of benign lung adenomas
and adenomas plus carcinomas combined in females in a mouse
carcinogenicity study. No tumors were seen in cypermethrin cancer
studies in rats or in a cancer study in mice with alpha-cypermethrin.
The Agency has determined that quantification of cancer risk using a
non-linear approach (i.e., reference dose or RfD) will adequately
account for all chronic toxicity, including carcinogenicity, that could
result from exposure to the cypermethrins.
    Specific information on the studies received and the nature of the
adverse effects caused by cypermethrin as well as the NOAEL and the
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies
can be found at https://www.regulations.gov in document ``Cypermethrin,
Human Health Risk Assessment for Proposed Tolerances on Tea and
Commodities of the Codex Crop Subgroups: Spices, Fruit or Berry and
Spices, Root or Rhizome. The Tolerances are Proposed Without a U.S.
Registration.'' hereinafter ``Cypermethrin Human Health Risk
Assessment'' at pages 32-39 in docket ID numbers EPA-HQ-OPP-2022-0508
and EPA-HQ-OPP-2022-0672.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for cypermethrin used for
human risk assessment can be found in the Cypermethrin Human Health
Risk Assessment on pages 18-21.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to cypermethrin, EPA considered exposure under the petitioned-
for tolerances as well as all existing tolerances for the cypermethrins
in 40 CFR 180.418. EPA assessed dietary exposures from cypermethrin in
food 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 1-day or single exposure. Such effects were identified
for cypermethrin.
    In conducting the acute dietary exposure assessment, EPA used the
2005-2010 food consumption data from the U.S. Department of
Agriculture's National Health and Nutrition Examination Survey, What We
Eat in America (NHANES/WWEIA). The acute dietary exposure assessment is
a conservative assessment that assumes tolerance level residues for
most commodities and 100 percent crop treated (PCT) for all
commodities. The highest field trial values obtained in residue studies
were used for the commodities that make the most significant
contribution to dietary risk, specifically apples, peaches, pears, and
grapes. Empirical and conservative default processing factors were used
in the assessment. EPA determined that the toxicity of alpha-
cypermethrin is higher than that of cypermethrin and zeta-cypermethrin.
To account for this

toxicity difference, HED applied a 5X toxicity factor for alpha-
cypermethrin.
    ii. Chronic exposure. A chronic dietary risk assessment is not
required for the cypermethrins because repeated exposure does not
result in a point of departure lower than that resulting from acute
exposure. Therefore, the acute dietary risk assessment is protective of
chronic dietary risk. However, HED performed a chronic dietary exposure
assessment in support of the current aggregate human health risk
assessment. There are residential exposures for the cypermethrins that
were aggregated with background exposure from dietary sources. The
chronic assessment is only being used to estimate background dietary
exposure to all cypermethrins.
    The chronic dietary exposure assessment is a refined assessment
based on Pesticide Data Program (PDP) monitoring data for most
commodities. Tolerance level residues were used for a limited number of
commodities including tea and spices. As with the acute assessment,
empirical and conservative default processing factors were used for the
processed commodities for which they were available. EPA made the
conservative assumption that 100% of all commodities would be treated.
When monitoring data were used, average residues were calculated by
incorporating one-half limit of detection (LOD) values for all non-
detects. No zeros were used to calculate the average residues. EPA
accounted for the 5X toxicity difference by multiplying the average PDP
values for commodities with alpha-cypermethrin tolerances by a factor
of 5.
    The cypermethrins have food handling establishment (FHE) uses that
need to be accounted for in the chronic dietary exposure assessment.
For chronic dietary assessment, EPA used a residue value of one-half
the FHE tolerance. EPA estimated the probability that a food item a
person consumes contains residues as a result of treatment in an FHE at
some point with any pesticide. This risk assessment paradigm is generic
for all pesticides. To date, such modelling is not specific to
cypermethrin. This estimate is 4.65%. In the chronic assessment, this
value was used for the same commodities as the ones with the FHE
residue value (0.025 ppm). For all commodities with tolerances, the
total anticipated residue from the agricultural use exceeded the total
anticipated residue from the FHE use. For this reason, the FHE residue
value was only used for commodities that don't have tolerances
associated with direct application to crops.
    iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
Cypermethrin is classified as a ``possible human carcinogen.'' The
Agency has determined that quantification of risk using a non-linear
approach (i.e., aPAD or aRfD) will adequately account for all chronic
toxicity, including carcinogenicity, that could result from exposure to
the cypermethrins.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated levels of pesticide residues in food and
the actual levels of pesticide residues that have been measured in
food. If EPA relies on such information, EPA must require pursuant to
FFDCA section 408(f)(1) 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. For the
present action, EPA will issue such data call-ins as are required by
FFDCA section 408(b)(2)(E) and authorized under FFDCA section
408(f)(1). Data will be required to be submitted no later than 5 years
from the date of issuance of these tolerances.
    EPA assumed 100% crop treated for all commodities in the acute and
chronic dietary exposure assessments. However, as discussed above, in
the chronic assessment, a percent FHE treatment value of 4.65% was
incorporated for commodities for which the FHE residue value was used.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for cypermethrin in drinking water. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment.
    In both the acute and chronic assessments, EPA used estimated
drinking water concentrations (EDWCs) generated with the Surface Water
Concentration Calculator (SWCC), and in both assessments, the EDWC was
used for both direct and indirect water. For the acute dietary risk
assessment, EPA used an (EDWC) of 3.5 ppb, and for the chronic exposure
assessment (used to determine background exposure from food and
drinking water for the purpose of aggregate risk assessment), EPA used
an EDWC 0.035 ppb. EPA also determined groundwater EDWCs with a
different model; however, the Agency used the surface water EDWCs in
the assessments because the surface water EDWCs were higher than the
groundwater EDWCs. The use of the surface water values in the dietary
exposure assessment is protective of potential exposure through
groundwater sources of drinking water.
    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 flea and tick control on pets). The cypermethrins are
registered for a variety of non-agricultural purposes including
recreational sites (i.e., golf courses, athletic fields); indoor
residential/commercial/industrial sites/structural/perimeter and lawn
uses; gardens and trees; as well as mosquito adulticide, termiticide,
and pet uses. The current action is for tolerances without a U.S.
registration for tea and spices, so no residential handler or post-
application exposures are anticipated.
    For assessing aggregate exposure to adults, the Agency used
exposures from the inhalation handler scenario from applying
cypermethrin with a sprinkler can to home gardens. For assessing
aggregate exposure to children, the Agency used exposures to children 1
to <2 years old (dermal and incidental oral) from post-application
exposure to pets treated with the pet medallion/tag formulated with
zeta-cypermethrin.
    The PODs for the oral and dermal routes are based on the same
effects: therefore, for children, the oral and dermal routes can be
combined. Since the levels of concern for incidental oral risk and
inhalation risk are different (100 and 30, respectively), the aggregate
risk index (ARI) approach was used to calculate aggregate exposure and
risk for adults. An ARI >=1 is not of concern.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of 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.''
    The Agency has determined that the pyrethroids and pyrethrins share
a

common mechanism of toxicity (https://www.regulations.gov; EPA-HQ-OPP-
2008-0489-0006). As explained in that document, the members of this
group share the ability to interact with voltage-gated sodium channels
ultimately leading to neurotoxicity. In 2011, after establishing a
common mechanism grouping for the pyrethroids and pyrethrins, the
Agency conducted a cumulative risk assessment (CRA) which is available
at https://www.regulations.gov; EPA-HQ-OPP-2011-0746. In that document,
the Agency concluded that cumulative exposures to pyrethroids (based on
pesticidal uses registered at the time the assessment was conducted)
did not present risks of concern. For information regarding EPA's
efforts to evaluate the risk of exposure to this class of chemicals,
refer to https://www.epa.gov/ingredients-used-pesticide-products/registration-review-pyrethrins-and-pyrethroids.
    Since the 2011 CRA, for each new pyrethroid and pyrethrin use, the
Agency has conducted a screen to evaluate any potential impacts on the
CRA prior to those uses being granted. A new turf use for the
pyrethroid, tau-fluvalinate, was assessed after completion of the
cumulative. The new use did impact the worst-case non-dietary risk
estimates identified in the 2011 CRA for the turf scenario. However,
the overall risk finding (i.e., pyrethroid cumulative risk is above the
Agency's level of concern (LOC) and therefore not of concern) did not
change upon registration of this new use.
    For the requested tolerances for tea and spices, the Agency has
conducted an additional screen, taking into account all previously
approved uses and these proposed tolerances. The petitioned-for
tolerances will not significantly impact the cumulative assessment
because dietary exposures make a minor contribution to total pyrethroid
exposure relative to residential exposures in the 2011 cumulative risk
assessment; furthermore, the petitioned-for tolerances are not
associated with any increase in residential or non-occupational
exposure. Therefore, the results of the 2011 CRA are still valid, and
there are no cumulative risks of concern for the pyrethroids/
pyrethrins.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal 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. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act (FQPA) Safety Factor (SF). In applying this provision,
EPA either retains the default value of 10X, or uses a different
additional safety factor when reliable data available to EPA support
the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There was no evidence of
increased quantitative or qualitative susceptibility in the available
rat and rabbit developmental toxicity studies and rat 2-generation
reproductive studies with the cypermethrins. A developmental
neurotoxicity (DNT) study with zeta-cypermethrin indicated increased
sensitivity in the offspring, based on body weight changes in pups in
the absence of treatment-related effects in maternal animals at the
highest dose tested. However, there is a clear NOAEL for effects seen
in pups, and the doses and endpoints selected for risk assessment are
protective of the susceptibility.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced from 10X to 1X. That decision is based on the
following findings:
    i. The toxicity database for the cypermethrins is considered
complete. When evaluated together, the toxicity database for
cypermethrin, zeta-cypermethrin, and alpha-cypermethrin can be used to
characterize the overall suite of effects associated with cypermethrin
exposure, including potential developmental and reproductive toxicity,
immunotoxicity, and neurotoxicity. Acceptable developmental toxicity
studies in rats and rabbits, reproduction studies in rats,
neurotoxicity studies (acute, subchronic, and developmental
neurotoxicity) in rats, and immunotoxicity studies in rats are
available.
    ii. Like other pyrethroids, the cypermethrins cause neurotoxicity
by interacting with sodium channels, leading to clinical signs of
neurotoxicity. These effects are well characterized and adequately
assessed by the available guideline and non-guideline studies. There
are no residual uncertainties with regard to evidence of neurotoxicity
for the cypermethrins.
    iii. No evidence of increased qualitative or quantitative
susceptibility was noted in the developmental toxicity or reproduction
studies for the cypermethrins. However, quantitative susceptibility was
seen in the rat DNT study with zeta-cypermethrin with an increased
sensitivity in the offspring based on body weight changes in pups in
the absence of adverse, treatment-related effects in maternal animals.
The results from the DNT study are very similar to results observed in
the reproduction studies where body weight changes (decreased body
weight gain) were seen in maternal and offspring animals at doses
similar to those in the DNT study, with no indication of increased
susceptibility. Therefore, there is no residual concern for effects
observed in the study since a clear developmental NOAEL and LOAEL were
identified for which the selected PODs for risk assessment are
protective.
    iv. There are no residual uncertainties with regard to exposure.
The dietary exposure assessments account for parent and metabolites of
concern. In addition, they are refined, but could be more highly
refined. The assessments include 100 percent crop treated assumptions,
tolerance level residues for most commodities in the acute dietary
exposure assessment, and default processing factors for many of the
processed commodities. Furthermore, conservative, upper-bound
assumptions were used to determine exposure through drinking water and
residential sources, such that these exposures have not been
underestimated.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing dietary exposure estimates to the acute
PAD (aPAD) and chronic PAD (cPAD). Short-, intermediate-, and chronic-
term aggregate risks are evaluated by comparing the estimated total
food, water, and residential exposure to the appropriate PODs to ensure
that an adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. Using the exposure assumptions described in this unit
for acute exposure, EPA has concluded that acute exposure to
cypermethrin from food and water will utilize 71% of the aPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure. Acute aggregate risk estimates are not of concern for the
general U.S. population or any population subgroup.
    2. Chronic risk. A chronic dietary risk assessment is not required
for cypermethrin because repeated

exposure does not result in a POD lower than that resulting from acute
exposure. Therefore, the acute dietary risk assessment is protective of
chronic dietary risk.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Cypermethrin
is registered for uses that could result in short-term residential
exposure, and the Agency has determined that it is appropriate to
aggregate chronic exposure through food and water with short-term
residential exposures to cypermethrin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in an aggregate MOE of 130 for
children and an ARI of 4.5 for adults. Because EPA's level of concern
for cypermethrin is an MOE below 100, or an ARI below 1, these MOEs/
ARIs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). While there is potential intermediate-term residential
exposure, because the single dose and repeat dosing cypermethrin
studies show that repeat exposures do not result in lower points of
departure, the residential assessments are conducted as a series of
acute exposures and the same endpoint is used regardless of duration.
Therefore, the short-term aggregate assessment is considered protective
of any intermediate-term exposures.
    5. Aggregate cancer risk for U.S. population. EPA has classified
cypermethrin as a ``possible human carcinogen'' and determined that a
non-linear approach relying on the acute regulatory endpoints should be
used for cancer assessment. As the acute dietary exposure estimates are
not of concern, cancer risk is not of concern.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to cypermethrin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate tolerance-enforcement methods are available in PAM
(Pesticide Analytical Manual) Volume II for determining residues of
zeta-cypermethrin in plant (Method I) and livestock (Method II)
commodities. Both methods are gas chromatographic methods with
electron-capture detection (GC/ECD) and have undergone successful
Agency petition method validations (PMVs). These methods are not
stereospecific; therefore, no distinction is made between residues of
cypermethrin (all 8 stereoisomers), zeta-cypermethrin (enriched in 4
isomers) and alpha-cypermethrin (enriched in 2 isomers).

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4).
    Codex has established an MRL of 15 ppm for residues of cypermethrin
in or on tea. The U.S. tolerance for residues of cypermethrin in or on
Tea, dried is harmonized with the Codex MRL.
    Codex has established an MRL of 0.5 ppm for residues of
cypermethrin on the crop subgroup Spices, Fruits and Berries and an MRL
of 0.2 ppm for residues on the crop subgroup Spices, Roots and
Rhizomes. The U.S. tolerances for residues of cypermethrin in or on the
individual spice commodities are harmonized with the relevant Codex
MRL.

C. Revisions to Petitioned-For Tolerances

    The Tea Association requested a tolerance of 15.0 ppm for Tea. The
United States conforms to OECD rounding classes when setting tolerances
and is establishing the tolerance level at 15 ppm rather than 15.0 ppm
for Tea, dried.

V. Conclusion

    Therefore, tolerances are established for residues of cypermethrin,
including its metabolites and degradates, in or on Allspice at 0.5 ppm;
Angelica, seed at 0.2 ppm; Anise pepper at 0.5 ppm; Asafoetida at 0.2
ppm; Ashwagandha fruit at 0.5 ppm; Batavia-cassia, fruit at 0.5 ppm;
Belleric myrobalan at 0.5 ppm; Calamus-root at 0.2 ppm; Caper buds at
0.5 ppm; Cardamom, black at 0.5 ppm; Cardamom, Ethiopian at 0.5 ppm;
Cardamom, green at 0.5 ppm; Cardamom, Nepal at 0.5 ppm; Cardamom-amomum
at 0.5 ppm; Cassia, fruit at 0.5 ppm; Cassia, Chinese, fruit at 0.5
ppm; Chaste tree, Chinese, roots at 0.2 ppm; Chinese hawthorne at 0.5
ppm; Chinese-pepper at 0.5 ppm; Cinnamon, fruit at 0.5 ppm; Cinnamon,
Saigon, fruit at 0.5 ppm; Coptis at 0.2 ppm; Coriander, fruit at 0.5
ppm; Coriander, seed at 0.2 ppm; Cumin, black at 0.5 ppm; Dorrigo
pepper, berry at 0.5 ppm; Dorrigo pepper, leaf at 0.5 ppm; Eucalyptus
at 0.5 ppm; Fingerroot at 0.2 ppm; Gamboge at 0.5 ppm; Grains of Selim
at 0.5 ppm; Jalap at 0.2 ppm; Juniper, berry at 0.5 ppm; Lovage, root
at 0.2 ppm; Lovage, seed at 0.2 ppm; Miracle fruit at 0.5 ppm; Pepper,
black at 0.5 ppm; Pepper, Indian long at 0.5 ppm; Pepper, Javanese,
long at 0.5 ppm; Pepper, pink at 0.5 ppm; Pepper, Sichuan at 0.5 ppm;
Pepper, white at 0.5 ppm; Pepperbush, berry at 0.5 ppm; Pepperbush,
leaf at 0.5 ppm; Peppercorn, green at 0.5 ppm; Peppertree at 0.5 ppm;
Peppertree, Peruvian at 0.5 ppm; Saunders, red at 0.5 ppm; Sumac,
fragrant at 0.5 ppm; Sumac, smooth, leaf at 0.5 ppm; Tamarind, seed at
0.5 ppm; Tasmanian, pepper, berry at 0.5 ppm; Tea, dried at 15 ppm;
Tsaoko at 0.5 ppm; Vanilla at 0.5 ppm; and Yellow gentian, roots at 0.2
ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) 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 action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), 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).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerances 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.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    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 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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
the rule in the Federal Register. This action 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: September 24, 2023.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

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. In Sec.  180.418, revise paragraph (a)(1) to read as follows:

Sec.  180.418  Cypermethrin and isomers alpha-cypermethrin and zeta-
cypermethrin; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the
insecticide cypermethrin ()alpha cyano-(3-
phenoxyphenyl)methyl ()cis,trans-3(2,2-dichloroethenyl-2,2-
dimethylcyclopropanecarboxylate in or on the commodities in table 1 to
paragraph (a)(1).

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Allspice \1\................................................         0.5
Angelica, seed \1\..........................................         0.2
Anise pepper \1\............................................         0.5
Asafoetida \1\..............................................         0.2
Ashwagandha fruit \1\.......................................         0.5
Batavia-cassia, fruit \1\...................................         0.5
Belleric myrobalan \1\......................................         0.5
Brassica, head and stem, subgroup 5A........................         2.0
Brassica, leafy greens, subgroup 5B.........................        14.0
Calamus-root \1\............................................         0.2
Caper buds \1\..............................................         0.5
Cardamom, black \1\.........................................         0.5
Cardamom, Ethiopian \1\.....................................         0.5
Cardamom, green \1\.........................................         0.5
Cardamom, Nepal \1\.........................................         0.5
Cardamom-amomum \1\.........................................         0.5
Cassia, fruit \1\...........................................         0.5
Cassia, Chinese, fruit \1\..................................         0.5
Cattle, fat.................................................         1.0
Cattle, meat................................................         0.2
Cattle, meat byproducts.....................................        0.05
Chaste tree, Chinese, roots \1\.............................         0.2
Chinese hawthorne \1\.......................................         0.5
Chinese-pepper \1\..........................................         0.5
Cinnamon, fruit \1\.........................................         0.5
Cinnamon, Saigon, fruit \1\.................................         0.5
Coptis \1\..................................................         0.2
Coriander, fruit \1\........................................         0.5
Coriander, seed \1\.........................................         0.2
Cotton, gin byproducts......................................        11.0
Cotton, undelinted seed.....................................         0.5
Cumin, black \1\............................................         0.5
Dorrigo pepper, berry \1\...................................         0.5
Dorrigo pepper, leaf \1\....................................         0.5
Egg.........................................................        0.05
Eucalyptus \1\..............................................         0.5
Fingerroot \1\..............................................         0.2
Gamboge \1\.................................................         0.5
Grains of Selim \1\.........................................         0.5
Goat, fat...................................................         1.0
Goat, meat..................................................         0.2
Goat, meat byproducts.......................................        0.05
Hog, fat....................................................         0.1
Hog, meat...................................................        0.05
Horse, fat..................................................         1.0
Horse, meat.................................................         0.2
Horse, meat byproducts......................................        0.05
Jalap \1\...................................................         0.2
Juniper, berry \1\..........................................         0.5
Lettuce, head...............................................         4.0
Lovage, root \1\............................................         0.2
Lovage, seed \1\............................................         0.2
Milk, fat (reflecting 0.10 in whole milk)...................         2.5
Miracle fruit \1\...........................................         0.5
Onion, bulb.................................................         0.1
Onion, green................................................         6.0
Pecan.......................................................        0.05
Pepper, black \1\...........................................         0.5
Pepper, Indian long \1\.....................................         0.5
Pepper, Javanese, long \1\..................................         0.5
Pepper, pink \1\............................................         0.5
Pepper, Sichuan \1\.........................................         0.5
Pepper, white \1\...........................................         0.5
Pepperbush, berry \1\.......................................         0.5
Pepperbush, leaf \1\........................................         0.5
Peppercorn, green \1\.......................................         0.5
Peppertree \1\..............................................         0.5
Peppertree, Peruvian \1\....................................         0.5
Poultry, fat................................................        0.05
Poultry, meat...............................................        0.05
Saunders, red \1\...........................................         0.5
Sheep, fat..................................................         1.0
Sheep, meat.................................................         0.2
Sheep, meat byproducts......................................        0.05
Sumac, fragrant \1\.........................................         0.5
Sumac, smooth, leaf \1\.....................................         0.5
Tamarind, seed \1\..........................................         0.5
Tasmanian, pepper, berry \1\................................         0.5
Tea, dried \1\..............................................          15
Tsaoko \1\..................................................         0.5
Vanilla \1\.................................................         0.5
Yellow gentian, roots \1\...................................         0.2
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of October 4, 2023.

* * * * *
[FR Doc. 2023-21821 Filed 10-3-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: February 26, 2008 (Volume 73, Number 38)]
[Notices]
[Page 10238]
[DOCID:fr26fe08-42]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP07-208-001]

Rockies Express Pipeline LLC; Notice of Amendment

February 5, 2008.
    Take notice that on January 25, 2008, Rockies Express Pipeline LLC
(Rockies Express), 370 Van Gordon Street, Lakewood, Colorado 80228,
filed an application in Docket No. CP07-208-001, pursuant to section
7(c) of the Natural Gas Act (NGA) and Part 157 of the Commission's
regulations requesting authorization to amend its application to
reflect moving the location of its proposed Hamilton Compressor Station
in Warren County, Ohio and realigning the pipeline route for 3.9 miles
in Warren and Butler Counties, Ohio to adjust for the move. Rockies
Express states that the move is for environmental reasons and will
result in de minimus change in the cost of its REX-East project, all as
more fully set forth in the application which is on file with the
Commission and open for public inspection.
    This filing is available for review at the Commission in the Public
Reference Room or may be viewed on the Commission's Web site 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, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.
    Any questions regarding this application should be directed to Skip
George, Manager of Regulatory, Rockies Express Pipeline LLC, P.O. Box
281304, Lakewood, Colorado 80228-8304, phone<PHONE_NUMBER>.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant. On or before the comment date, it is
not necessary to serve motions to intervene or protest on persons other
than the Applicant.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit the
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    Comment Date: February 26, 2008.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-3551 Filed 2-25-08; 8:45 am]

BILLING CODE 6717-01-P


IUR Petition for Consideration for Inclusion in the Specific Chemical Substances Partial Exemption Docket Cover Sheet The Environmental Protection Agency ( EPA) has received a petition dated December 30, 2003, from Dow Chemical, to exempt Napthalene, 1,2,3,4 tetrahydro 6( 1 phenylethyl) ( CAS No. 6196 98 1) and Napthalene, 1,2,3,4 tetrahydro 5( 1 phenylethyl) ( CAS No. 60466 61 7) from the reporting of processing and use elements of the EPA Inventory Update Rule ( IUR), 40 C. F. R. 710. This docket contains the petition, EPA's decision document, and other support documents.

What is the Inventory Update Rule?

The TSCA Inventory Update Rule ( IUR) requires the submission of basic production data every four years on chemical substances manufactured ( including imported) for commercial purposes in amounts of 25,000 pounds or more at a single site. Out of 80,000 chemicals on the TSCA Chemical Substance Inventory, reports are required for approximately 9,000 substances. For those substances with annual volumes of 300,000 lbs or more per site, reporters also submit chemical processing and use information. To learn more about the IUR, access http:// www. epa. gov/ opptintr/ iur/.

What is the " low current interest" partial exemption?

Certain chemicals for which the IUR processing and use information is of " low current interest" are now partially exempt from reporting and manufacturers and importers of such chemicals are not required to report processing and use information for that chemical; see 40 C. F. R § 710.46( b)( 2). EPA has determined that, at this time, the IUR downstream information associated with the listed chemicals is of low current interest. EPA may amend the list of partially exempt chemicals on its own initiative or in response to a request from the public. This petition is a request from the public for a chemical to be added to the partial exemption.

In making its determination of whether this partial exemption should apply to a particular chemical substance, EPA will consider the totality of information available for the chemical substance in question, including but not limited to, one or more of the following considerations:

( A) Whether the chemical qualifies or has qualified in past IUR collections for the reporting of the information described in § 710.52( c)( 4) ( i. e., at least one site manufactures 300,000 pounds or more of the chemical).

( B) The chemical substance's chemical and physical properties or potential for persistence, bioaccumulation, health effects, or environmental effects ( considered independently or together).

( C) The information needs of EPA, other federal agencies, tribes, states, and local governments, as well as members of the public.

( D) The availability of other complementary risk screening information.

( E) The availability of comparable processing and use information.

( F) Whether the potential risks of the chemical substance are adequately managed by EPA or another agency or authority.

How will the Agency's decision be made known? Petition status will be listed on EPA's website. Access http:// www. epa. gov/ opptintr/ iur for further information concerning this petition.


Amy_ L._ Farrell@ omb. eop. gov 08/ 26/ 2003 12: 31 AM To: Bill Harnett/ RTP/ USEPA/ US@ EPA, Bill Wehrum/ DC/ USEPA/ US@ EPA cc: Subject: this thought just came to me CONTEXT: Draft rule provision: the replacement activity shall not cause the process unit to exceed any emission limitation or operational limitation that has the effect of constraining emissions that applies to the process unit and that is legally enforceable.

From two commenters: Following support for process unit definition.

" However, we urge EPA to make clear in its final rule that this " process unit" definition should only apply for purposes of determining eligibility for the " equipment replacement" RMRR exclusion. The " process unit" definition should not be used to set " emission unit" boundaries for purposes of determining when an emissions increase at a unit triggers an NSR analysis. EPA's rules clearly provide that such an analysis can only consider increases at an individual emissions unit within a process unit. Also, if NSR should be triggered for any emissions unit within a process unit, NSR requirements such as BACT would apply ONLY at that emissions unit. The current NSR regulations clearly establish this restriction, see 40 CFR 52.21( j)( 3), and nothing in EPA's proposal indicates any intention to change it."

QUESTION: Does the rule construction in any way cloud the established boundary? Do we need premable clarification?

amy