[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Rules and Regulations]
[Pages 57336-57341]
[FR Doc No: 2019-23382]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0619; FRL-10000-06]

Pendimethalin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
pendimethalin in or on the leaf petiole vegetable subgroup 22B, monarda
oil, monarda fresh leaves, rosemary oil, and rosemary fresh leaves.
Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 25, 2019. Objections and
requests for hearings must be received on or before December 24, 2019,
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-2018-0619, is available at http://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 is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email 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.
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 Government Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2018-0619 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 24, 2019. 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-2018-0619, by one of
the following methods:
     Federal eRulemaking Portal: http://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 http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of December 21, 2018 (83 FR 65660) (FRL-
9985-67), 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
8E8694) by IR-4, IR-4 Project Headquarters, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201 W,
Princeton, NJ 08540. The petition requested that 40 CFR part 180 be
amended by establishing tolerances for residues of the herbicide
pendimethalin, including its metabolites and degradates, in or on the
following raw agricultural commodities: Leaf petiole vegetables,
subgroup 22B at 0.15 ppm; monarda, oil at 1.0 ppm; monarda, fresh
leaves at 0.20 ppm; rosemary, oil at 1.0 ppm; and rosemary, fresh
leaves at 0.20 ppm. That document referenced a summary of the petition
prepared by BASF, the registrant, which is available in the docket,
http://www.regulations.gov. There were no comments received in response
to the notice of filing.
    Based upon review of the data supporting the petition, EPA has
modified the levels at which some of the tolerances are being set. 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 pendimethalin including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with pendimethalin
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 target organ for pendimethalin is the thyroid. Thyroid toxicity
in chronic and subchronic rat and mouse studies was manifested as
alterations in thyroid hormones (decreased total T4 and T3, increased
percent of free T4 and T3), increased thyroid weight, and microscopic
thyroid lesions (including increased thyroid follicular cell height,
follicular cell hyperplasia, as well as follicular cell adenomas). Due
to these effects, the Agency required that a developmental thyroid
assay be conducted to evaluate the impact of pendimethalin on thyroid
hormones, structure, and/or thyroid hormone homeostasis during
development. A developmental thyroid study was submitted and
demonstrated that there is no potential thyroid toxicity following pre-
and/or post-natal exposure to pendimethalin.
    There is no evidence that pendimethalin is a developmental,
reproductive, neurotoxic, or immunotoxic chemical. There is no evidence
of increased qualitative or quantitative susceptibility in the young.
EPA classified pendimethalin as a ``Group C'' possible human carcinogen
based on a statistically significant increased trend and pair-wise
comparison between the high-dose group and controls for thyroid
follicular cell adenomas in male and female rats. A non-quantitative
approach (i.e., non-linear, reference dose (RfD) approach) was used to
assess cancer risk since mode-of-action studies are available to
demonstrate that the thyroid tumors are due to a thyroid-pituitary
imbalance, and also since pendimethalin was shown to be non-mutagenic
in mammalian somatic cells and germ cells.
    Specific information on the studies received and the nature of the
adverse effects caused by pendimethalin 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 at http://www.regulations.gov in the document titled ``Pendimethalin--Human
Health Risk Assessment to Support the Proposed New Uses on Leaf Petiole
Vegetable Subgroup 22B, Monarda and

Rosemary'' on pages 37-41 in docket ID number EPA-HQ-OPP-2018-0619.

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 http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for pendimethalin used for
human risk assessment is discussed in Unit III.B of the final rule
published in the Federal Register of February 16, 2018 (83 FR 6975)
(FRL-9973-03).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to pendimethalin, EPA considered exposure under the
petitioned-for tolerances as well as all existing pendimethalin
tolerances in 40 CFR 180.361. EPA assessed dietary exposures from
pendimethalin 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 pendimethalin. In estimating acute
dietary exposure, EPA used Dietary Exposure Evaluation Model software
with the Food Commodity Intake Database (DEEM-FCID) Version 3.16. This
software uses 2003-2008 food consumption data from the U.S. Department
of Agriculture's (USDA's) National Health and Nutrition Examination
Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in
food, EPA used tolerance-level residues and 100 percent crop treated
(PCT) for all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the DEEM-FCID, Version 3.16 software with 2003-2008
food consumption data from the USDA's NHANES/WWEIA. As to residue
levels in food, EPA used tolerance-level residues and 100 PCT for all
commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that a nonlinear RfD approach is appropriate for assessing
cancer risk to pendimethalin. Cancer risk was assessed using the same
exposure estimates as discussed in Unit III.C.1.ii., chronic exposure.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue or PCT information in the dietary assessment for
pendimethalin. Tolerance level residues and 100 PCT were assumed for
all food commodities.
    2. Dietary exposure from drinking water. In drinking water, the
residue of concern is pendimethalin, parent only. The Agency used
screening-level water exposure models in the dietary exposure analysis
and risk assessment for pendimethalin in drinking water. These
simulation models take into account data on the physical, chemical, and
fate/transport characteristics of pendimethalin. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Root Zone Model Ground Water (PRZM GW) and
Surface Water Concentration Calculator (SWCC) models, the estimated
drinking water concentrations (EDWCs) of pendimethalin for acute
exposures are estimated to be 96.4 parts per billion (ppb) for surface
water and 4.38 x 10\-9\ ppb for ground water. For chronic exposures
they are estimated to be 9.73 ppb for surface water. For chronic
exposures, pendimethalin did not reach groundwater even after running
the model with an extended 100-year weather file.
    For the acute dietary risk assessment, the water concentration
value of 96.4 ppb was used to assess the contribution to drinking
water. For the chronic dietary risk assessment, the water concentration
of value 9.73 ppb was used to assess the contribution to 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).
    Pendimethalin is currently registered for the following uses that
could result in residential exposures: Turf, home gardens, and
ornamentals. EPA assessed residential exposure using the following
assumptions. First, for handlers, it is assumed that residential use
will result in short-term (1 to 30 days) duration dermal and inhalation
exposures. Second, residential post-application exposure is also
assumed to be short-term (1 to 30 days) in duration, resulting from the
following exposure scenarios: (1) Gardening: Adults (dermal) and
children 6 < 11 years old (dermal); (2) physical activities on turf:
Adults (dermal) and children 1-2 years old (dermal and incidental
oral); (3) mowing turf: Adults (dermal) and children 11 < 16 years old
(dermal); and (4) exposure to golf courses during golfing: Adults
(dermal), children 11 < 16 years old (dermal), and children 6 < 11
years old (dermal).
    EPA did not combine exposure resulting from adult handler and post-
application exposure resulting from treated gardens, lawns, and/or
golfing because the conservative assumptions and inputs within each
estimated exposure scenario would result in an overestimate of adult
exposure. EPA selected the most conservative adult residential scenario
(adult dermal post-application exposure from gardening) as the
contributing source of residential exposure to be combined with the
dietary exposure for the aggregate assessment. The children's oral
exposure is based on post-application hand-to-mouth exposures. To
include exposure from object-to-mouth and soil ingestion in addition to
hand-to-mouth would overestimate the potential for oral exposure.
However, there is the potential for co-occurrence of dermal and oral
exposure, since the toxicological effects from the dermal and oral
routes of exposure are the same. As a result, the children's aggregate
assessment combines post-application dermal and oral exposure along
with dietary exposure from food and water. Further information
regarding EPA standard assumptions and generic inputs for residential

exposures may be found at http://www2.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.''
    EPA has not found pendimethalin to share a common mechanism of
toxicity with any other substances, and pendimethalin does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
pendimethalin does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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 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 indication of
pre- or post-natal qualitative or quantitative increased susceptibility
in the developmental studies in rats and rabbits or the 2-generation
reproduction studies in rats. A developmental thyroid toxicity study
demonstrated that there is no potential thyroid toxicity following pre-
and/or post-natal exposure to pendimethalin.
    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 to 1X. That decision is based on the following
findings:
    i. The toxicity database for pendimethalin is complete. Although a
subchronic inhalation study was not available in the database, EPA
determined that one is not needed at this time based on a weight-of-
evidence analysis, considering the following: (1) All relevant hazard
and exposure information, which indicates its low acute inhalation
toxicity; (2) its physical/chemical properties, which indicate its low
volatility; and (3) the use of an oral POD that results in a
residential inhalation margin of exposure (MOE) more than 10X the level
of concern (in the case of pendimethalin MOE = 30 based on thyroid
POD).
    ii. There is no indication that pendimethalin is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that pendimethalin results in increased
susceptibility in utero rats or rabbits in the prenatal developmental
studies or in young rats in the 2-generation reproduction study. In
addition, a developmental thyroid toxicity study demonstrated that
there is no potential thyroid toxicity following pre- or post-natal
exposure to pendimethalin.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to pendimethalin in drinking water. EPA used
similarly conservative assumptions to assess post-application exposure
of children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
pendimethalin.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to pendimethalin will occupy 2.1% of the aPAD for all infants less than
1 year old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
pendimethalin from food and water will utilize 2.4% of the cPAD for
children one to two years old, the population group receiving the
greatest exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
pendimethalin is not expected.
    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). Pendimethalin
is currently 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 pendimethalin.
    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 aggregate MOEs of 130 for adults
and 92 for children 1 to 2 years old, the two population subgroups
receiving the greatest combined dietary and non-dietary exposure.
Because EPA's level of concern for pendimethalin is a MOE of 30 or
below, these MOEs 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).
    An intermediate-term adverse effect was identified; however,
pendimethalin is not registered for any use patterns that would result
in intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for

evaluating intermediate-term risk for pendimethalin.
    5. Aggregate cancer risk for U.S. population. As discussed in Unit
III.A., EPA has determined that an RfD approach based on the chronic
point of departure is appropriate for evaluating cancer risk. As there
are not chronic aggregate risks of concern, there are no cancer
aggregate risk concerns.
    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 pendimethalin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, gas chromatography with electron
capture detection (GC/ECD), is available to enforce the tolerance
expression.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
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). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established any MRLs for pendimethalin for the
crops covered by this action.

C. Revisions to Petitioned-For Tolerances

    The Agency is establishing tolerances for monarda, fresh leaves;
rosemary, fresh leaves; monarda, oil; and rosemary, oil to be
consistent with the Organization for Economic Co-operation and
Development (OECD) rounding class practice (at 0.2 ppm and 1 ppm
instead of at 0.20 ppm and 1.0 ppm). For the joint review of the
pendimethalin on celery data, the U.S. EPA and Canada PMRA have used
the OECD calculation procedures to determine the recommended maximum
residue level (MRL). Although the Agency-calculated level using the
OECD procedure is the same as the petitioned-for level of 0.15 ppm,
PMRA is proposing to recommend a MRL of 0.2 ppm for pendimethalin in
celery. The different levels are a result of different proposed use
rates in the U.S. and Canada. EPA is therefore establishing a U.S.
tolerance of 0.2 ppm for the leaf petiole vegetable subgroup 22B for
harmonization purposes with Canada.

V. Conclusion

    Therefore, tolerances are established for residues of
pendimethalin, including its metabolites and degradates, in or on the
leaf petiole vegetable subgroup 22B at 0.2 ppm; monarda, fresh leaves
at 0.2 ppm; monarda, oil at 1 ppm; rosemary, fresh leaves at 0.2 ppm;
and rosemary, oil at 1 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), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). 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 18, 2019.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    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. In Sec.  180.361, add alphabetically the entries ``Leaf petiole
vegetable subgroup 22B''; ``Monarda, fresh leaves''; ``Monarda, oil'';
``Rosemary, fresh leaves''; and ``Rosemary, oil'' to the table in
paragraph (a)(1) to read as follows:

Sec.  180.361  Pendimethalin; tolerances for residues.

    (a)(1) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Leaf petiole vegetable subgroup 22B.....................             0.2

                                * * * * *
Monarda, fresh leaves...................................             0.2
Monarda, oil............................................               1

                                * * * * *
Rosemary, fresh leaves..................................             0.2
Rosemary, oil...........................................               1

                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 2019-23382 Filed 10-24-19; 8:45 am]
 BILLING CODE 6560-50-P


Farm ID # _______________

Methyl Bromide Critical Use Exemption Enterprise Budget Work Sheets Alternatives Pepper  Double Crop Yield Cartons Per Acre  Pepper Cartons Per Acre  Cucurbits IFAS Average 900 564 Farm Information Cost Information IFAS Farm Information Acre Carton Acre Carton Pre Harvest Production Costs:

Fertilizer 575.11 Fumigant 847.00 Crop Protection Materials 1,087.64 Transplants/ Seeds 826.30 Stakes 64.00 Plastic String 27.50 Plastic Mulch/ Irrigation Tubing 337.67 Frost Protection Machinery: Irrigation 350.98 Non irrigation 499.88 Plastic Mulch/ Drip Tape Disposal 140.96 Scounting 27.50 Labor Costs: Tractor Drivers 300.38 Direct Labor 330.28 Miscellaneous 200.00 Interest 219.28 Fixed Costs: Land Cost 350.00 Supervision 1,114.17 Overhead 1,392.71 Total Pre Harvest Production Costs: 8,691.36 $ 5.94 $  $ # DIV/ 0!

Harvesting 2,248.20 $ 1.54 $ # DIV/ 0!

Packing, Selling & Related Overhead 4,043.04 $ 2.76 $ # DIV/ 0! Farming Costs:

DCTM_ ARP. xls August 3, 2003 Farm ID # _______________

TOTAL COST: 14,982.60 $ 10.23 $  $ # DIV/ 0!

DCTM_ ARP. xls August 3, 2003


[Federal Register Volume 79, Number 187 (Friday, September 26, 2014)]
[Notices]
[Pages 57929-57930]
[FR Doc No: 2014-23014]

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

ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9017-2]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or http://www.epa.gov/compliance/nepa/.

Weekly Receipt of Environmental Impact Statements

Filed 09/15/2014 Through 09/19/2014
Pursuant to 40 CFR 1506.9.

 Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: http://www.epa.gov/compliance/nepa/eisdata.html.

EIS No. 20140272, Final Supplement, USFS, MT, Beaverhead-Deerlodge
National Forest Land and Resource Management Plan to to Comply with a
District of Montana Court Order (Temporary Roads), Review Period Ends:
10/27/2014, Contact: Jan Bowey<PHONE_NUMBER>.
EIS No. 20140273, Draft EIS, USFS, MT, Como Forest Health Project
(FHP), Comment Period Ends: 11/10/2014, Contact: Sara Grove 406-821-
1251.
EIS No. 20140274, Second Final EIS (Tiering), FHWA, IL, Illiana
Corridor Tier Two, Review Period Ends: 10/27/2014, Contact: Catherine
A. Batey<PHONE_NUMBER>.
EIS No. 20140275, Final EIS, FHWA, AZ, South Mountain Freeway (Loop
202), Review Period Ends: 11/25/2014, Contact: Alan Hansen 602-382-
8964.
EIS No. 20140276, Draft EIS, BR, WA, Cle Elum Pool Raise Project--A
Component of the Yakima River Basin Integrated Water Resource
Management Plan, Comment Period Ends: 11/25/2014, Contact: Candace
McKinley<PHONE_NUMBER>, ext. 613.
EIS No. 20140277, Final EIS, USFS, MT, Greater Red Lodge Vegetation and
Habitat Management Project, Review Period Ends: 11/10/2014, Contact:
Amy Waring<PHONE_NUMBER>.

EIS No. 20140278, Draft EIS, BLM, CA, Desert Renewable Energy
Conservation Plan (DRECP), Comment Period Ends: 01/09/2015, Contact:
Vicki Campbell<PHONE_NUMBER>.
EIS No. 20140279, Final EIS, BR, CA, Contra Loma Reservoir and
Recreation Area Final Resource Management Plan, Review Period Ends: 10/
27/2014, Contact: David Woolley<PHONE_NUMBER>.
EIS No. 20140280, Draft EIS, FRA, FL, All Aboard Florida Intercity
Passenger Rail Project, Comment Period Ends: 12/03/2014, Contact: John
Winkle<PHONE_NUMBER>.
EIS No. 20140281, Draft Supplement, FHWA, AK, Juneau Access
Improvements Project, Comment Period Ends: 11/10/2014, Contact: Tim
Haugh<PHONE_NUMBER>.

Amended Notices

EIS No. 20140236, Final EIS, USACE, WA, Lower Snake River Programmatic
Sediment Management Plan, Review Period Ends: 09/29/2014, Contact:
Sandra Shelin<PHONE_NUMBER>. Revision to FR Notice Published 08/22/2014;
Extending Review Period from 09/22/2014 to 09/29/2014.
EIS No. 20140240, Draft Supplement, USACE, WA, Mount St. Helens Long-
Term Sediment Management Plan, Comment Period Ends: 10/06/2014,
Contact: Tina Teed<PHONE_NUMBER>. Revision to FR Notice Published 08/22/
2014; Extending Comment Period from 09/29/2014 to 10/06/2014.
EIS No. 20140266, Draft EIS, FRA, IL, Chicago--Detroit/Pontiac
Passenger Rail Corridor Program, Comment Period Ends: 12/19/2014,
Contact: Andrea Martin<PHONE_NUMBER>. Revision to FR Notice Published
09/19/2014; Correction to Comment Period from 11/03/2014 to 12/19/2014.
EIS No. 20140271, Final EIS, FHWA, WI, West Waukesha Bypass, Review
Period Ends: 10/20/2014, Contact: George Poirier<PHONE_NUMBER>. Revision
to FR Notice Published 09/19/2014; Correction to the Review Period
should be 10/20/2014.

    Dated: September 23, 2014.
Dawn Roberts,
Management Analyst, NEPA Compliance Division, Office of Federal
Activities.
[FR Doc. 2014-23014 Filed 9-25-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 217 (Wednesday, November 9, 2016)]
[Notices]
[Pages 78809-78810]
[FR Doc No: 2016-27075]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2016-0632; FRL--9955-05-ORD]

Proposed Information Collection Request; Comment Request;
Willingness To Pay Survey To Evaluate Recreational Benefits of Nutrient
Reductions in Coastal New England Waters

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) is planning to
submit an information collection request (ICR), ``Willingness to Pay
Survey to Evaluate Recreational Benefits of Nutrient Reductions in
Coastal New England Waters'' (EPA ICR No. 2558.01, OMB Control No.
2080-NEW) to the Office of Management and Budget (OMB) for review and
approval in accordance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.). Before doing so, EPA is soliciting public
comments on specific aspects of the proposed information collection as
described below. This is a request for approval of a new collection. An
Agency may not conduct or sponsor and a person is not required to
respond to a collection of information unless it displays a currently
valid OMB control number.

DATES: Comments must be submitted on or before January 9, 2017.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-ORD-
2016-0632, online using www.regulations.gov (our preferred method), by
email to<EMAIL_ADDRESS>or by mail to: EPA Docket Center,
Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania
Ave. NW., Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Marisa Mazzotta, U.S. Environmental
Protection Agency, Office of Research and Development, Atlantic Ecology
Division, 27 Tarzwell Drive, Narragansett, Rhode Island 02882;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (i) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: Researchers at the EPA's Office of Research and
Development (ORD), Atlantic Ecology Division (AED) are piloting an
effort to better understand how reduced water quality due to nutrient
enrichment affects the economic prosperity, social capacity, and
ecological integrity of coastal New England communities. This project
proposes a survey to collect data for a case study of changes in
recreation demand and values due to changes in nutrients in
northeastern coastal waters. This includes the development of methods
and tools for estimating recreational values that can be applied in
other locations, either by EPA researchers, EPA's regional offices or
state partners. Our initial geographic focus for these efforts will be
Cape Cod, Massachusetts (``the Cape''; Barnstable County), and New
England residents within 100 miles of the Cape. We focus on Cape Cod
and its surrounding coastal areas both in order to limit the scope of
the work to remain feasible within our research budget and to
coordinate this socio-economic analysis with extensive ecological
research being conducted on the Cape by ORD researchers, researchers at
EPA's Region 1 office, and other external research groups. Cape Cod is
also in the midst of an extensive regional planning effort related to
its coastal waters, and this research can provide helpful socio-
economic information to decision makers about the use of those waters.
Because the 100-mile radius from Cape Cod includes a large area of
southern New England and the largest population centers in New England,
the results will be more broadly applicable to residents of southern
New England.
    One of the key water quality concerns on Cape Cod, and throughout
New England, is nonpoint sources of nitrogen, which lead to ecological
impairments in estuaries, with resultant socio-economic impacts. The
decisions needed to meet water quality standards are highly complex and
involve significant cross-disciplinary challenges in identifying,
implementing, and monitoring social and ecological management needs. We
will focus on understanding recreational uses as valued economic goods
in coastal New England (including beachgoing, swimming, fishing,
shellfishing, and boating).

    As a part of these efforts, EPA's ORD/AED is seeking approval to
conduct a revealed preference survey to collect data on: People's
saltwater recreational activities; how recreational values are related
to water quality; how perceptions of water quality relate to objective
measures; the connections between perceptions of water quality,
recreational choices and values, and sense of place; and demographic
information. If approved, the survey will be administered using a
mixed-mode approach that includes a mailed invitation to a web survey
with an optional paper survey for people who are unable or unwilling to
answer the web survey. The survey will be sent to a total of 8,400
residents living in counties where more than 25% of the county's
geographic boundaries falls within 100 miles of the Cape as measured
from Bourne, Massachusetts, which is the first town on Cape Cod heading
east. This area includes coastal counties of New Hampshire, the eastern
half of Massachusetts, all of Rhode Island, and the eastern part of
Connecticut. In addition, we will oversample two populations: residents
of Cape Cod and people who shellfish recreationally. We will send 750
surveys to each of these groups.
    ORD will use the survey responses to estimate willingness to pay
for changes related to reductions in nutrient and pathogen loadings to
coastal New England waters. The analysis relies on state of the art
theoretical and statistical tools for non-market welfare analysis. A
non-response bias analysis will also be conducted to inform the
interpretation and validation of survey responses.
    All responses to the survey will be kept confidential to the extent
provided by law. To ensure that the final survey sample includes a
representative and diverse population of individuals, the survey
questionnaire will elicit basic demographic information, such as age,
race and ethnicity, number of children under 18, type of employment,
and income. However, the survey questionnaire will not ask respondents
for personal identifying information, such as names or phone numbers.
Instead, each survey response will receive a unique identification
number. Prior to taking the survey, respondents will be informed that
their responses will be kept confidential to the extent provided by
law. The name and address of the respondent will not appear in the
resulting database, preserving the respondents' identities. The survey
data will be made public only after it has been thoroughly vetted to
ensure that all other potentially identifying information has been
removed. After data entry is complete, the surveys themselves will be
destroyed and only respondent codes will remain.
    Form Numbers: None.
    Respondents/affected entities: Eligible respondents for the survey
are individuals 18 years of age or older who reside in counties where
at least 25% of county's geographic area falls within a 100-mile radius
of Cape Cod. This includes coastal counties of New Hampshire, the
eastern half of Massachusetts, all of Rhode Island, and the eastern
part of Connecticut. The sample will be stratified by geography, with
Barnstable County, Massachusetts sampled at a rate 3.06 times higher
than the rest of the population in the study area. Additionally, the
sample will be a dual-frame sample, where the main frame is the general
population address-based frame of the U.S. Postal Service Delivery
Sequence File, and a supplementary frame is the frame of shellfish
license holder records. Households will be selected randomly from the
DSF, which covers over 97% of residences in the U.S. EPA will request
participation from a random stratified sample of 10,270 households in
two phases. The first phase, a pretest, will be sent to 370 addresses.
The second phase, encompassing full survey administration, will be
administered to an additional 9,900 addresses. In each phase, we
anticipate a response rate of 27 percent, resulting in 90 and 2,365
completed surveys, respectively, after accounting for expected
undeliverable surveys.
    Respondent's obligation to respond: voluntary.
    Estimated number of respondents: 2,455 (total).
    Frequency of response: The survey is a one-time data collection
activity.
    Total estimated burden: 614 hours (total). Burden is defined at 5
CFR 1320.03(b).
    Total estimated cost: Assuming 15 minutes are needed to complete
the survey, the total respondent cost comes to $21,386 for the pre-test
and main survey combined, using an average wage rate for New England of
$34.83 from the United States Department of Labor. This would be a one-
time expenditure of their time.
    Changes in Estimates: This is the first notice; there is no change
in estimates at this time.

    Dated: October 31, 2016.
Wayne Munns,
Division Director, Atlantic Ecology Division.
[FR Doc. 2016-27075 Filed 11-8-16; 8:45 am]
 BILLING CODE 6560-50-P