[Federal Register Volume 81, Number 37 (Thursday, February 25, 2016)]
[Rules and Regulations]
[Pages 9353-9360]
[FR Doc No: 2016-03910]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0314 and EPA-HQ-OPP-2014-0489; FRL-9941-87]

Triclopyr; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends the tolerances for residues of
triclopyr in milk and livestock commodities which are identified and
discussed later in this document, and amends the tolerance expressions
to include triclopyr choline salt. Dow AgroSciences, LLC requested
these tolerance changes under the Federal Food, Drug, and Cosmetic Act
(FFDCA).

DATES: This regulation is effective February 25, 2016. Objections and
requests for hearings must be received on or before April 25, 2016, 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 dockets for this action, identified by docket
identification (ID) numbers EPA-HQ-OPP-2014-0314 and EPA-HQ-OPP-2014-
0489, are 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: Susan Lewis, 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
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP
test guidelines referenced in this document electronically, please go
to http://www.epa.gov/test-guidelines-pesticides-and-toxic-substances.

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
by docket ID numbers EPA-HQ-OPP-2014-0314 and EPA-HQ-OPP-2014-0489 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 April 25, 2016. 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 numbers EPA-HQ-OPP-2014-0314 and EPA-
HQ-OPP-2014-0489, 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 Wednesday, November 25, 2015 (80 FR
73695) (FRL-9937-14), EPA issued a document pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a revised
pesticide petition (PP 4F8249) by Dow AgroSciences, LLC, 9330
Zionsville Rd., Indianapolis, IN 46268-1054. The revised petition
requested that 40 CFR part 180.417(a)(1) be amended by establishing a
tolerance for residues of the herbicide triclopyr, [(3,5,6-trichloro-2-
pyridinyl)oxy] acetic acid, in or on the raw agricultural commodity
milk, fat at 0.7 parts per million (ppm); and increasing the tolerance
in or on milk from 0.01 ppm to 0.6 ppm. The petition also requested
that 40 CFR part 180.417(a)(2) be amended by establishing tolerances
for residues of triclopyr, [(3,5,6-trichloro-2-pyridinyl)oxy] acetic
acid and its metabolite 3,5,6-trichloro-2-pyridinol (TCP), calculated
as the stoichiometric equivalent of triclopyr, in or on the raw
agricultural commodities of cattle, goat, hog, horse, and sheep meat
byproducts at 0.7 ppm; by increasing tolerances in cattle, goat, hog,
horse, and sheep fat from 0.05 ppm to 0.09 ppm; and increasing
tolerances in cattle, goat, hog, horse, and sheep meat from 0.05 ppm to
0.08 ppm.
    In the Federal Register of Friday, September 5, 2014 (79 FR 53009)
(FRL-9914-98), 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 4F8279) by Dow AgroSciences, LLC, 9330 Zionsville Rd.,
Indianapolis, IN 46268-1054. The petition requested that 40 CFR part
180.417(a)(1) and 180.417(a)(2) be amended to include residues of the
herbicide triclopyr choline salt as triclopyr, [(3,5,6-trichloro-2-
pyridinyl)oxy] acetic acid, including its metabolites and degradates,
in or on the raw agricultural commodities listed.
    The documents referenced summaries of the petitions prepared by Dow
AgroSciences, LLC, the registrant, which are available in the dockets
at http://www.regulations.gov. The petition summary for PP 4F8249 is
located in docket number EPA-HQ-OPP-2014-0314, and the petition summary
for PP 4F8279 is located in docket number EPA-HQ-OPP-2014-0489. Several
comments were received on the notices of filing. EPA's response to
those comments are discussed in Unit IV.D.
    Based upon review of the data supporting the petitions, EPA has (1)
determined that a tolerance for milk fat is not required; (2) increased
the proposed tolerances for the fat and meat of cattle, goat, hog,
horse, and sheep; (3) decreased the proposed tolerances for the meat
byproducts of cattle, goat, hog, horse, and sheep; and (4) determined
that the current tolerances for kidney, liver, and meat byproducts
except kidney and liver of cattle, goat, hog, horse, and sheep are not
required.
    EPA is also revising the tolerance expressions to correct the
nomenclature of the chemical name, clarify the chemical moieties that
are covered by the tolerances, and specify how compliance will be
measured. The reasons for these changes are 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 triclopyr including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with triclopyr 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 bioequivalence of the three chemical forms of triclopyr (acid,
triethylamine salt, and butoxyethyl ester) has been addressed through a
variety of special studies with the salt and ester forms, including
data on comparative disposition, plasma half-life, tissue distribution,
and hydrolytic cleavage. Those studies were found to adequately address
the issue of bioequivalence amongst these forms of triclopyr.
Additionally, the currently available information supports the
bioequivalence of triclopyr and triclopyr choline salt. Therefore,
studies conducted with any one form of triclopyr have been used to
support the toxicology database for triclopyr as a whole.
    Triclopyr has been classified as having low acute toxicity via the
oral, dermal, and inhalation routes. It is minimally-irritating
(butoxyethyl ester) to corrosive (triethylamine salt) to the eye. It is
a dermal sensitizer but not a dermal irritant.
    Overall, effects in the triclopyr database were indicative of
kidney and liver toxicity in rats and dogs, respectively. The primary
effect observed in rats was degeneration of the proximal tubule of the
kidney, which was seen at approximately the same dose in the subchronic
oral and 2-generation reproduction toxicity studies. Body-weight
decreases in rats were observed in the subchronic neurotoxicity and
immunotoxicity studies at doses approximately ten times higher than
doses resulting in kidney effects. In dogs, liver toxicity was
evidenced by increased liver enzymes, increased liver weights, and
liver histopathology at a similar dose as kidney effects in the rat.
Changes in hematological parameters (decreased packed-cell volume,
decreased hemoglobin, and decreased red blood cell count) were also
observed in dogs at the same dose.
    There is evidence of increased qualitative susceptibility to
offspring from triclopyr exposure in the rat 2-generation reproduction
study, based on increased incidence of rare pup malformations observed
in the presence of parental toxicity. There is also potential
qualitative susceptibility in the rat developmental toxicity study;
however, the evidence was not as conclusive as the reproduction
toxicity study. Concern is low since effects are well-characterized
with clearly established no-observed adverse-effect level/lowest-
observed adverse-effect level (NOAEL/LOAEL) values, effects were seen
in the presence of parental toxicity, and selected endpoints are
protective of the observed effects.
    Triclopyr has been classified as a ``Group D Chemical--unable to be
classified as to human carcinogenicity.'' Although there was marginal
evidence of carcinogenicity in animal studies (adrenal tumors in male
rats and mammary gland tumors in female rats and mice), EPA has
determined that the chronic reference dose (cRfD) will adequately
account for all chronic effects, including carcinogenicity, likely to
result from exposure to triclopyr. The Agency reached this conclusion
employing a weight-of-evidence (WOE) approach after considering the
following factors: (1) A lack of statistical significance at the high
dose in pair-wise tests for all the tumors of concern; (2) for the
adrenal tumors, there was a lack of dose-response and any pre-
neoplastic lesions in the adrenal glands, along with evidence that the
tumors were mainly benign; (3) for the mammary gland tumors, incidence
in the concurrent control mice was at the low end of the historical
control range; and (4) the chronic RfD is approximately 700-fold lower
than the dose that induced the mammary gland tumors in female rats.
    Acceptable subchronic neurotoxicity and immunotoxicity studies have
been submitted and show no evidence of neurotoxicity or immunotoxicity.
    Specific information on the studies received and the nature of the
adverse effects caused by triclopyr as well as the NOAEL and the LOAEL
from the toxicity studies can be found at http://www.regulations.gov in
document, ``Triclopyr. Human Health Risk Assessment for Petition to
Amend Tolerance Expressions to Include Triclopyr Choline Salt; and
Petition to Remove Grazing Restrictions for Dairy Cattle'' on pp. 13-15
in docket ID numbers EPA-HQ-OPP-2014-0314 and EPA-HQ-OPP-2014-0489.

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 the NOAEL and the LOAEL are identified.
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://www.epa.gov/pesticides-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for triclopyr used for
human health risk assessment is shown in Table 1 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for Triclopyr for Use in Human Health Risk Assessment
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                                        Point of departure and
          Exposure/Scenario               uncertainty/safety     RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49 years of  NOAEL = 5 mg/kg/day....  Acute RfD = 0.05 mg/kg/  2-Generation Rat
 age).                                 UFA = 10x..............   day.                     Reproduction Study
                                       UFH = 10x..............  aPAD = 0.05 mg/kg/day..   with Triclopyr Acid
                                       FQPA SF = 1x...........                           LOAEL = 25 mg/kg/day
                                                                                based on increased
                                                                                incidence of rare
                                                                                malformations
                                                                                (exencephaly and
                                                                                ablepharia).
Acute dietary (General population      NOAEL = 100 mg/kg/day..  Acute RfD = 1.0 mg/kg/   Developmental Rat
 including infants and children).      UFA = 10x..............   day.                     Toxicity Study with
                                       UFH = 10x..............  aPAD = 1.0 mg/kg/day...   Triclopyr BEE
                                       FQPA SF = 1x...........                           LOAEL = 300 mg/kg/day
                                                                                based on maternal
                                                                                mortality. Additional
                                                                                effects seen at this
                                                                                dose included clinical
                                                                                signs, necropsy
                                                                                findings, decreased
                                                                                food and water
                                                                                consumption, and
                                                                                increased kidney and
                                                                                liver weights.
Chronic dietary (All populations)....  NOAEL= 5 mg/kg/day.....  Chronic RfD = 0.05 mg/   2-Generation Rat
                                       UFA = 10x..............   kg/day.                  Reproduction Study
                                       UFH = 10x..............  cPAD = 0.05 mg/kg/day..   with Triclopyr Acid
                                       FQPA SF = 1x...........                           LOAEL = 25 mg/kg/day
                                                                                based on degeneration
                                                                                of the proximal renal
                                                                                tubules.
Incidental oral short-term (1 to 30    NOAEL= 5 mg/kg/day.....  LOC for MOE = 100......  Subchronic Oral Rat
 days) and intermediate-term (1 to 6   UFA = 10x..............                            Toxicity Study with
 months).                              UFH = 10x..............                            Triclopyr Acid
                                       FQPA SF = 1x...........                           LOAEL = 20 mg/kg/day
                                                                                based on degeneration
                                                                                of the proximal renal
                                                                                tubules.
Inhalation short-term (1 to 30 days)   Inhalation (or oral)     LOC for MOE = 1000.....  Subchronic Oral Rat
 and intermediate-term (1 to 6          study.                                            Toxicity Study with
 months).                              NOAEL= 5 mg/kg/day                                 Triclopyr Acid
                                        (inhalation absorption                           LOAEL = 20 mg/kg/day
                                        rate = 100%).                                     based on degeneration
                                       UFA = 10x..............                            of the proximal renal
                                       UFH = 10x..............                            tubules.
                                       FQPA SF/UFDB = 10x.....
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other
  data deficiency. UFH = potential variation in sensitivity among members of the human population
  (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to triclopyr, EPA considered exposure under the petitioned-for
tolerances as well as all existing triclopyr tolerances in 40 CFR
180.417. EPA assessed dietary exposures from triclopyr 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 triclopyr. In estimating acute dietary exposure, EPA used food
consumption information from the United States Department of
Agriculture (USDA) 2003-2008 National Health and Nutrition Examination
Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in
food, EPA assumed that triclopyr residues were present at tolerance
levels in all commodities for which tolerances have been established or
proposed, and that 100% of those crops were treated with triclopyr.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 2003-2008
NHANES/WWEIA. As to residue levels in food, EPA assumed that triclopyr
residues were present at tolerance levels in all commodities for which
tolerances have been established or proposed except milk, and that 100%
of those crops were treated with triclopyr. An average anticipated
residue (AR) calculated from a livestock feeding study was used for all
milk commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
determined that the chronic RfD will adequately account for all chronic
effects, including carcinogenicity, that are likely to result from
triclopyr exposure. Therefore, a dietary exposure assessment for the
purpose of assessing cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use PCT information in the dietary assessment for
triclopyr. However, EPA did use anticipated residue information for
milk commodities in the chronic dietary assessment. Tolerance-level
residues and 100 PCT were assumed for all other food commodities.
    Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data
and information on the anticipated residue levels of pesticide residues
in food and the actual levels of pesticide 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.
    2. Dietary exposure from drinking water. EPA calculated and
required setback distances from the application site to the functional
potable water intake in order to maintain average drinking water
concentration levels below 400 parts per billion (ppb). Since potable
water intakes are required to be turned off until triclopyr
concentration levels are below 400 ppb, EPA has determined that for
acute and chronic dietary risk assessments, the water concentration
value of 400 ppb is appropriate to use 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).
    Triclopyr is currently registered for the following uses that could
result in residential exposures: Aquatic and turf areas. EPA assessed
residential exposure using the following assumptions: Handler
inhalation exposure from spot applications to turf for adults, post-
application inhalation and ingestion exposures of water from swimming
for children 3 to <6 years old, and post-application incidental oral
exposure to turf for children 1 to <2 years old. The dermal route of
exposure is not quantitatively assessed because there is no dermal
hazard. Short-term residential handler exposure, and short- and
intermediate-term residential post-application exposures are expected.
Chronic exposures are not expected. Further information regarding EPA
standard assumptions and generic inputs for residential exposures may
be found at http://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.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to triclopyr and any other
substances.
    3,5,6-trichloro-2-pyridinol, commonly known as TCP, is a metabolite
of triclopyr, chlorpyrifos, and chlorpyrifos-methyl. Risk assessment of
TCP was conducted in 2002, and the previous conclusions that the acute
and chronic dietary aggregate exposure estimates are below EPA's level
of concern (LOC) are still valid since the tolerances changes will not
have a noticeable effect on dietary exposures to TCP. 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 Web site at http://www.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 Food Quality
Protection Act Safety Factor (FQPA 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. As summarized in Unit
III.A., there is evidence of increased qualitative susceptibility to
offspring from triclopyr exposure in the 2-generation reproduction
toxicity study and potential qualitative susceptibility in the rat
developmental toxicity study. However, the concern is low since effects
are well-characterized with clearly established NOAEL/LOAEL values,
effects were seen in the presence of parental toxicity, and selected
endpoints, which are protective of the effects in adult animals, are
protective of the observed effects.
    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, with the exception for inhalation exposures
where the FQPA SF is retained at 10X. These decisions are based on the
following findings:
    i. The toxicity database for triclopyr is adequate for
characterizing triclopyr toxicity and quantification of hazard
exposures. For assessing risks associated with inhalation exposures,
the FQPA SF is retained at 10X to incorporate the database uncertainty
factor (UFDB) to account for the lack of a subchronic
inhalation toxicity study.
    ii. There is no indication that triclopyr is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
    iii. There is evidence of increased qualitative susceptibility to
offspring from triclopyr exposure. However, the concern is low since
effects are well-characterized with clearly established NOAEL/LOAEL
values, effects were seen in the presence of parental toxicity, and
selected endpoints, which are protective of the effects in adult
animals, are protective of the observed effects.
    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 for all crops except milk
commodities and drinking water in which anticipated residues were used.
EPA used 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
triclopyr.

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 triclopyr will occupy 53% of the aPAD for females 13-49 years old,
and 8% 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
triclopyr from food and water will utilize 46% of the cPAD for all
infants less than 1 year 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
triclopyr 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). Triclopyr 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 triclopyr.
    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 120 for
children 1 to <2 years old (dietary exposure with post-application
incidental oral exposure from turf use). Because EPA's level of concern
for triclopyr is a MOE of 100 or below, this MOE is not of concern.
    For adults and children 3 to <6 years old, an aggregate risk index
(ARI) is used since the POD for the oral and inhalation routes of
exposure are the same, but the LOC values for oral (MOE<100) and
inhalation (MOE<1000) exposures are different. The ARIs are 3.6 for
children 3 to <6 years old (dietary exposure with post-application
inhalation and ingestion from aquatic use), and 1.4 for adults (dietary
exposure with handler inhalation exposure from turf use). Since EPA's
level of concern is an ARI below 1, these 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). Although triclopyr is currently registered for uses that could
result in intermediate-term residential exposure, EPA determined that a
quantified intermediate-term aggregate assessment is unnecessary since
the short- and intermediate-term PODs are the same and the short-term
aggregate provides a worst-case estimate of residential exposure and is
therefore protective of the longer-term exposures.
    5. Aggregate cancer risk for U.S. population. As summarized in Unit
III.A., EPA has determined that an aggregate exposure risk assessment
for cancer risk is not required based on WOE conclusions on the
marginal evidence of carcinogenicity in two adequate rodent
carcinogenicity studies and the use of the chronic RfD which will
adequately account for any potential carcinogenic effects.
    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 triclopyr residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies (Methods ACR 77.2 and ACR 77.4,
using gas chromatography with electron-capture detection (GC/ECD);
Method GRM 97.02 using gas chromatography with mass-spectrometry
detection (GC/MS)) are available to enforce the tolerance expression.
The Food and Drug Administration (FDA) PESTDATA database dated 1/94
(Pesticide Analytical Manual (PAM) Vol. I, Appendix I) indicates that
triclopyr is completely recovered (>80%) using multi-residue method PAM
Vol. I Section 402. Data pertaining to multi-residue methods testing of
triclopyr and its metabolites through Protocols B, C, D, and E have
been submitted and forwarded to FDA.
    The methods 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 MRL for triclopyr.

C. Revisions to Petitioned-for Tolerances

    Based on the available residue chemistry data, EPA has determined
that a tolerance for milk fat is not required. Also, EPA is increasing
the proposed tolerances for fat (0.09 ppm) and meat (0.08 ppm) of
cattle, goat, hog, horse, and sheep to 0.10 ppm, and decreasing the
proposed tolerances for meat byproducts of cattle, goat, hog, horse,
and sheep from 0.7 ppm to 0.50 ppm in order to harmonize with
established Canadian MRLs. The current tolerances for kidney (0.5 ppm),
liver (0.5 ppm), and meat byproducts except kidney and liver (0.05 ppm)
of cattle, goat, hog, horse, and sheep are being removed and replaced
by establishing tolerances for meat byproducts of cattle, goat, hog,
horse, and sheep at 0.50 ppm.
    EPA is also revising the chemical name of triclopyr in the
tolerance expressions to reflect the preferred Chemical Abstract
Service (CAS) nomenclature. Lastly, in accordance with Agency guidance
on tolerance expressions, the tolerance expressions for triclopyr are
revised by clarifying that the tolerances cover ``residues of the
herbicide triclopyr, including its metabolites and degradates as well
as how residues of triclopyr are to be measured.''

D. Response to Comments

    Several comments were received in both dockets, EPA-HQ-OPP-2014-
0314 and EPA-HQ-OPP-2014-0489, containing general comments disapproving
of the use and EPA's approval of pesticides, and two similar comments
stating that triclopyr should be banned due to its toxic effects on
aquatic animals and its soil half-life. EPA understands these
commenters' concerns and recognizes that some individuals believe that
pesticides should be banned on agricultural crops. However, the
existing legal framework provided by Section 408 of the FFDCA states
that tolerances may be set when persons seeking such tolerances or
exemptions have demonstrated that the pesticide meets the safety
standard imposed by that statute. These comments appear to be directed
at the underlying statute and not EPA's implementation of it; the
commenters have made no contention that EPA has acted in violation of
the statutory framework. In addition, some of the

comments stated that triclopyr's negative effects are detrimental to
human health. EPA has concluded that there is a reasonable certainty of
no harm to humans after considering the toxicological studies and the
exposure levels of humans to triclopyr.

 V. Conclusion

    Therefore, tolerances are established for residues of triclopyr, 2-
[(3,5,6-trichloro-2-pyridinyl)oxy]acetic acid, in or on cattle, meat
byproducts at 0.50 ppm; goat, meat byproducts at 0.50 ppm; hog, meat
byproducts at 0.50 ppm; horse, meat byproducts at 0.50 ppm; sheep, meat
byproducts at 0.50 ppm; amended for milk at 0.60 ppm; cattle, fat at
0.10 ppm; cattle, meat at 0.10 ppm; goat, fat at 0.10 ppm; goat, meat
at 0.10 ppm; hog, fat at 0.10 ppm; hog, meat at 0.10 ppm; horse, fat at
0.10 ppm; horse, meat at 0.10 ppm; sheep, fat at 0.10 ppm; and sheep,
meat at 0.10 ppm.
    The following livestock tolerances for ``kidney,'' ``liver,'' and
``meat byproducts, except kidney and liver'' are removed since these
commodities will be combined under the ``meat byproducts'' tolerances:
Cattle, kidney at 0.5 ppm; cattle, liver at 0.5 ppm; cattle, meat
byproducts, except kidney and liver at 0.05 ppm; goat, kidney at 0.5
ppm; goat, liver at 0.5 ppm; goat, meat byproducts, except kidney and
liver at 0.05 ppm; hog, kidney at 0.5 ppm; hog, liver at 0.5 ppm; hog,
meat byproducts, except kidney and liver at 0.05 ppm; horse, kidney at
0.5 ppm; horse, liver at 0.5 ppm; horse, meat byproducts, except kidney
and liver at 0.05 ppm; sheep, kidney at 0.5 ppm; sheep, liver at 0.5
ppm; and sheep, meat byproducts, except kidney and liver at 0.05 ppm.

VI. Statutory and Executive Order Reviews

    This action amends and establishes tolerances under FFDCA section
408(d) in response to petitions 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: February 11, 2016.
Susan Lewis,
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.  180.417, revise paragraph (a)(1) introductory text, the
commodity ``Milk,'' in the table in paragraph (a)(1) and paragraph (a)
(2) to read as follows:

Sec.  180.417  Triclopyr; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the
herbicide triclopyr, including its metabolites and degradates, in or on
the commodities in the table below resulting from the application of
the butoxyethyl ester of triclopyr, triethylamine salt of triclopyr, or
choline salt of triclopyr. Compliance with the tolerance levels
specified below is to be determined by measuring only triclopyr, 2-
[(3,5,6-trichloro-2-pyridinyl)oxy]acetic acid.

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

                                * * * * *
Milk.......................................................         0.60

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

    (2) Tolerances are established for residues of the herbicide
triclopyr, including its metabolites and degradates, in or on the
commodities in the table below resulting from the application of the
butoxyethyl ester of triclopyr, triethylamine salt of triclopyr, or
choline salt of triclopyr. Compliance with the tolerance levels
specified below is to be determined by measuring the combined residues
of triclopyr, 2-[(3,5,6-trichloro-2-pyridinyl)oxy]acetic acid, and its
metabolite 3,5,6-trichloro-2-pyridinol (TCP), calculated as the
stoichiometric equivalent of triclopyr.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat................................................         0.10
Cattle, meat...............................................         0.10
Cattle, meat byproducts....................................         0.50

Goat, fat..................................................         0.10
Goat, meat.................................................         0.10
Goat, meat byproducts......................................         0.50
Hog, fat...................................................         0.10
Hog, meat..................................................         0.10
Hog, meat byproducts.......................................         0.50
Horse, fat.................................................         0.10
Horse, meat................................................         0.10
Horse, meat byproducts.....................................         0.50
Sheep, fat.................................................         0.10
Sheep, meat................................................         0.10
Sheep, meat byproducts.....................................         0.50
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-03910 Filed 2-24-16; 8:45 am]
 BILLING CODE 6560-50-P


                                  Fact Sheet
                  Hot Work on Hollow or Enclosed Structures
                              in Marine Terminals

Hot work being performed on hollow structures located within a marine terminal can present a hazard to both the worker and facility.  OSHA defines hot work to mean riveting, welding, flame cutting, or other fire or spark producing operations (29 CFR 1917.152(a)).

Hollow or enclosed structures include, but are not limited to; drums, inaccessible voids,  hatches, coamings, pipe stanchions, booms, lamp posts, crane pedestals, crane portal beams, doubler-plates, railings, mooring bitts, bollards, vents, container frames and bulkheads, sponsons, pontoons, floats, and buoys. Additional requirements for work on or in tanks or confined spaces, including the testing of confined spaces, can be found in 29 CFR 1917.152.  As a reminder any hot work being done in conjunction with ship repair falls under regulations found in 29 CFR 1915.

Hazards of hollow or enclosed structures:

  * May contain flammable or toxic gases, liquids, or residue;
  * Commonly filled with combustible preservatives;
  * Often contaminated with saltwater, fuel oils, solvents, degreasers, or cleaning chemicals;
  * May contain high pressure or vacuum effects due to fluctuations in temperatures; and
  * Some hollow structures may contain polyurethane foam insulation and extreme caution must be taken when performing hot work against this material.

Recommended control measures prior to hot work on hollow or enclosed structures:

  * Always wear proper PPE, clothing, gloves, and eye protection during drilling, cutting and hot work operations (29 CFR 1917 Subpart E and 29 CFR 1918 Subpart J).
  * Inspect any adjacent areas which may be affected by the hot work to ensure all combustible materials are removed, covered or isolated.
  * Open all sampling ports to drain residual products and have a designated person test for the presence of flammable or combustible gases or liquids.
  * When a sampling port is not available, drill a small hole into the structure to facilitate air sampling and testing.  Use sharp bits and blades, and always lubricate the drilling bits and metal blades with cutting oil or soapy water to minimize the generation of heat and sparks.
  * Hollow structures that have contained flammable or combustible substances shall be made safe prior to hot work.  A designated person should be contacted to ensure that an appropriate method is used, (e.g. filled with water, cleaned, pressure-washed, degreased, steamed, and ventilated or inerted).
  * Before heat is applied to a hollow structure, an opening to release built-up pressure during heat application shall be provided (29 CFR 1917.152(c)(8)(ii)).
This is one in a series of informational fact sheets highlighting OSHA programs, policies or standards.  It does not impose any new compliance requirements.  For a comprehensive list of compliance requirements of OSHA standards or regulation, refer to Title 29 of the Code of Federal Regulations.  This information will be made available to sensory-impaired individuals upon request.  The voice phone is<PHONE_NUMBER>; teletypewriter (TTY) number:<PHONE_NUMBER>.
This is one in a series of informational fact sheets highlighting OSHA programs, policies or standards.  It does not impose any new compliance requirements.  For a comprehensive list of compliance requirements of OSHA standards or regulation, refer to Title 29 of the Code of Federal Regulations.  This information will be made available to sensory-impaired individuals upon request.  The voice phone is<PHONE_NUMBER>; teletypewriter (TTY) number:<PHONE_NUMBER>.


[Federal Register Volume 83, Number 99 (Tuesday, May 22, 2018)]
[Proposed Rules]
[Pages 23619-23621]
[FR Doc No: 2018-10899]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2017-1081]
RIN 1625-AA87

Security Zones; Dignitary Arrival/Departure and United Nations
Meetings, New York, NY

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes to modify the Marine Air Terminal,
LaGuardia Airport Security Zone. The modification of the security zone
would expand the existing security zone boundary north along the Rikers
Island Bridge to the intersecting point on the southern tip of Rikers
Island then east to the western end of LaGuardia Airport. This expanded
security zone is necessary to protect the port, waterfront facilities,
and waters of the United States from terrorism, sabotage, or other
subversive acts and incidents of a similar nature during visits to New
York City by various dignitaries. We invite your comments on this
proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before July 23, 2018.

ADDRESSES: You may submit comments identified by docket number USCG-
2017-1081 using the Federal eRulemaking Portal at http://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email MST1 Kristina Pundt, Sector New York
Waterways Division, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    On September 29, 2014, the Coast Guard published a Notice of
Proposed Rulemaking (NPRM) with a request for comments entitled,
``Security Zones; Dignitary Arrival/Departure and United Nations
Meetings, New York, NY'' in the Federal Register (79 FR 58298). This
NPRM proposed to disestablish three regulated navigation areas (RNAs)
and replace each with a security zone. No comments nor requests for a
public meeting were received. On December 30, 2014 the Coast Guard
published a Final Rule titled, ``Security Zones; Dignitary Arrival/
Departure and United Nations Meetings, New York, NY'' in the Federal
Register (79 FR 78308). This final rule disestablished the RNAs and
replaced each with a security zone. One of the security zones
established was the Marine Air Terminal, LaGuardia Airport security
zone.
    The purpose of this rulemaking is to modify the existing Marine Air
Terminal, LaGuardia Airport security zone. Due to location adjustments
of security staging areas, the Coast Guard has determined that
modification of the existing security zone is necessary to safeguard
the port, waterfront facilities, and waters of the United States from
terrorism, sabotage, or other subversive acts and incidents of a
similar nature during visits by various dignitaries to New York City.
    The Coast Guard proposes this rulemaking under the authority in 33
U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; and
Department of Homeland Security Delegation No. 0170.1.

III. Discussion of Proposed Rule

    The Coast Guard proposes to amend 33 CFR 165.164 by modifying the

existing Marine Air Terminal, LaGuardia Airport security zone. The
modification of the security zone would expand the existing security
zone boundary north along the Rikers Island Bridge to the intersecting
point on the southern tip of Rikers Island then east to the western end
of LaGuardia Airport. Due to location adjustments of security staging
areas, the Coast Guard has determined that the existing security zone
does not provide an adequate level of security. The proposed
modification will allow enforcement of a security zone that will
minimize threat exposure. The regulatory text we are proposing appears
at the end of this document.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes and Executive orders and
we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This NPRM has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, the NPRM has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the limited size
and enforcement of the proposed security zone. Although expanding upon
the current security zone, the proposed modification only encompasses a
small designated area of Bowery Bay. Additionally, the proposed
security zone will only be enforced during the infrequent visits of
domestic and foreign dignitaries for as limited duration as necessary
to safeguard against destruction, loss, or injury from sabotage or
other subversive acts, accidents, or other causes of a similar nature.
Moreover, the Coast Guard will issue a Broadcast Notice to Mariners via
VHF-FM marine channel 16 prior to periods of enforcement. Lastly, the
rule would continue to allow vessels to seek permission to transit the
zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
security zone may be small entities, for the reasons stated in section
IV.A above, this proposed rule would not have a significant economic
impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section. The Coast Guard will not retaliate against small entities that
question or complain about this proposed rule or any policy or action
of the Coast Guard.

C. Collection of Information

    This proposed rule would not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Directive 023-01, which guides the Coast Guard in complying
with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-
4370f), and have made a preliminary determination that this action is
one of a category of actions that do not individually or cumulatively
have a significant effect on the human environment. This proposed rule
involves the modification of a security zone that would prohibit entry
into Bowery Bay for a limited duration and for a limited number of
instances each year. Normally such actions are categorically excluded
from further review under paragraph L60(a) of Appendix A, Table 1 of
DHS Instruction Manual 023-01-001-01, Rev. 01. A draft Record of
Environmental Consideration supporting this determination is available
in the docket where indicated under ADDRESSES. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this proposed rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.

Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places, or vessels.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, visit http://www.regulations.gov/privacyNotice.
    Documents mentioned in this NPRM as being available in the docket,
and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that website's
instructions. Additionally, if you go to the online docket and sign up
for email alerts, you will be notified when comments are posted or a
final rule is published.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. In Sec.  165.164, revise paragraph (a)(3) to read as follows:
    (a) * * *
    (3) Marine Air Terminal, LaGuardia Airport Security Zone: All
waters of Bowery Bay, Queens, New York, inside of a line drawn from the
start of the Rikers Island Bridge in Queens at approximate position
40[deg]46'37'' N, 073[deg]53'30'' W to the intersecting point on the
southern side of Rikers Island at approximate position 40[deg]47'12''
N, 073[deg]53'06'' W, then a line drawn east to the western end of
LaGuardia Airport at approximate position 40[deg]47'00'' N,
073[deg]52'44'' W, then a line drawn south following the shoreline back
to the point of origin at 40[deg]46'37'' N, 073[deg]53'30'' W (NAD
1983).

    Dated: May 7, 2018.
M.H. Day,
Captain, U.S. Coast Guard, Captain of the Port New York.
[FR Doc. 2018-10899 Filed 5-21-18; 8:45 am]
 BILLING CODE 9110-04-P


Table 5: Annual Burden And Cost For The Federal Government Activity ( A) EPA Hours Per Occurrence ( B) Occurrences Per Year ( C) Technical Personhours Per Year ( C= AxB) ( D) Management Person hours Per Year ( D= Cx0.05) ( E) Clerical Person hours Per Year ( E= Cx0.1) ( F) Total Cost Per Yearb Report Activity 1. Batch Vapor and in line Cleaning Machine A. Initial Notification Report 1.00 393.00 c 393.00 19.65 39.30 $ 17,753.96 B. Initial Compliance Report 2.00 393.00 c 786.00 39.30 78.60 $ 35,508.72  Performance Test Results 8.00 39.00 d 312.00 15.60 31.20 $ 14,095.06 C. Annual Compliance Report 2.00 1,180.00 e 2,360.00 118.00 236.00 $ 106,616.54 D. Exceedance Report 1.00 118.00 f 118.00 5.90 11.80 $ 5,330.82 2. Batch Cold Cleaning Machines A. Initial Notification / Compliance Report 0.25 251.00 g 62.75 3.14 6.28 $ 2,833.51 Totalh 4,031.75 201.59 403.18 $ 182,138.61 a Total number of facilities estimated as: 3,069 batch vapor and in line cleaning machines/ 2.6 cleaning machines per facility = 1180 facilities.

b Costs were calculated using the following hourly rates: technical at $ 18.94 + 110% overhead = $ 39.77/ hr; manager at $ 26.97 + 110% overhead  $ 56.63/ hr; and clerical at $ 12.25/ hr + 110% overhead = $ 25.74..

c On time costs were estimated based on 1180 facilities averaged over 3 years; 1180 facilities/ 3years = 3931 facilities/ year.

d Assumed that 50% of the facilities will choose the equipment standard; 20% of those will conduct one time idling test; and one time cost is averaged over 3 years:

50% x 1180 facilities x 20% / 3 years = 39 facilities.

e All facilities must submit annual compliance reports summarizing either solvent consumption data or monitoring results for each cleaning machine.

f Assumed that 10% of the facilities exceed the solvent emission or monitoring limits one time per year: 10% x 1180 facilities = 118 facilities).

g Costs were based on 752 with batch cold cleaning machines averaged over 3 years: 752 facilities/ 3 years = 251 facilities.

h Total hours = ( C) + ( D) + ( E) = hours.