[Federal Register Volume 87, Number 62 (Thursday, March 31, 2022)]
[Rules and Regulations]
[Pages 18717-18722]
[FR Doc No: 2022-06817]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0604; FRL-9657-01-OCSPP]

Sodium Salt of Acifluorfen; Pesticide Tolerances for Emergency
Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for
residues of sodium salt of acifluorfen in or on beet, sugar, roots and
beet, sugar, leaves. This action is in response to EPA's granting of
emergency exemptions under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) authorizing use of the pesticide on sugarbeets.
This regulation establishes a maximum permissible level for residues of
sodium salt of acifluorfen in or on these commodities. These time-
limited tolerances expire on December 31, 2024.

DATES: This regulation is effective March 31, 2022. Objections and
requests for hearings must be received on or before May 31, 2022, 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-2021-0604, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room and the OPP Docket is<PHONE_NUMBER>.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is open to visitors by
appointment only. For the latest status information on EPA/DC services
and access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting Director,
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 protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

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

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

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(g), 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-2021-0604 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 May 31,
2022. 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-2021-0604, by one of
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.

    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with FFDCA sections
408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(l)(6), is
establishing time-limited tolerances for residues of sodium salt of
acifluorfen, in or on beet, sugar, roots at 0.1 parts per million
(ppm), and beet, sugar, leaves at 0.1 ppm. These time-limited
tolerances expire on December 31, 2024.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited
tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in or on food that will result from the use
of a pesticide under an emergency exemption granted by EPA under FIFRA
section 18. Such tolerances or exemptions can be established without
providing notice or period for public comment. EPA does not intend for
its actions on FIFRA section 18-related time-limited tolerances to set
binding precedents for the application of FFDCA section 408 and the
safety standard to other tolerances and exemptions. Section 408(e) of
FFDCA allows EPA to establish a tolerance or an exemption from the
requirement of a tolerance on its own initiative, i.e., without having
received any petition from an outside party.
    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. . .
.''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' EPA has established
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemptions for Sodium Salt of Acifluorfen on Sugarbeets
and FFDCA Tolerances

    The Colorado, Michigan, Minnesota, Nebraska, and North Dakota
Departments of Agriculture requested specific emergency exemptions for
postemergence use of acifluorfen to control glyphosate-resistant
pigweed species, Palmer amaranth and waterhemp, on sugarbeets.
According to the States, glyphosate-resistant Palmer amaranth and
waterhemp have reached population levels so high that sugarbeet
production is severely impacted. They assert that without a viable
alternative tool for postemergence control, growers are unable to
contain infestations in their sugarbeet fields and are expected to
experience significant economic loss.
    After having reviewed the applications, EPA determined that an
emergency condition exists for these States, and that the criteria for
approval of these emergency exemptions are met. EPA authorized specific
exemptions under FIFRA section 18 for the use of sodium salt of
acifluorfen on sugarbeets for postemergence control of glyphosate-
resistant pigweed species in Colorado, Michigan, Minnesota, Nebraska,
and North Dakota.
    As part of its evaluation of the emergency exemption applications,
EPA assessed the potential risks presented by residues of sodium salt
of acifluorfen in or on sugarbeets. In doing so, EPA considered the
safety standard in FFDCA section 408(b)(2), and EPA decided that the
necessary tolerances under FFDCA section 408(l)(6) would be consistent
with the safety standard and with FIFRA section 18. Consistent with the
need to move quickly on the emergency exemptions in order to address
the urgent non-routine situation in these States and to ensure that the
resulting food is safe and lawful, EPA is issuing these tolerances
without notice and opportunity for public comment as provided in FFDCA
section 408(l)(6). Although these time-limited tolerances expire on
December 31, 2024, under FFDCA section 408(l)(5), residues of the
pesticide not in excess of the amounts specified in the tolerances
remaining in or on sugarbeets after that date will not be unlawful,
provided the pesticide was applied in a manner that was lawful under
FIFRA, and the residues do not exceed a level that was authorized by
these time-limited tolerances at the time of that application. EPA will
take action to revoke these time-limited tolerances earlier if any
experience with, scientific data on, or other relevant information on
this pesticide indicate that the residues are not safe.
    Because these time-limited tolerances are being approved under
emergency conditions, EPA has not made any decisions about whether
sodium salt of acifluorfen meets FIFRA's registration requirements for
use on sugarbeets or whether permanent tolerances for this use would be
appropriate. Under these circumstances, EPA does not believe that these
time-limited tolerance decisions serve as a basis for registration of
sodium salt of acifluorfen by a State for special local needs under
FIFRA section 24(c). Nor do these tolerances by themselves serve as the
authority for persons in any State other than Colorado, Michigan,
Minnesota, Nebraska, and North Dakota to use this pesticide on the
applicable crops under FIFRA section 18 absent the issuance of an
emergency exemption applicable within that State. For additional
information regarding these emergency exemptions for sodium salt of
acifluorfen, contact the Agency's Registration Division at the address
provided under FOR FURTHER INFORMATION CONTACT.

IV. 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 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 expected as a result of these emergency exemption requests

and the time-limited tolerances for residues of sodium salt of
acifluorfen on beet, sugar, roots at 0.1 parts per million (ppm), and
beet, sugar, leaves at 0.1 ppm. EPA's assessment of exposures and risks
associated with establishing time-limited tolerances follows.

A. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-
risk-pesticides.
    A summary of the toxicological endpoints for sodium salt of
acifluorfen used for human health risk assessment is shown in Table 1
of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Sodium Salt of Acifluorfen for Use in Human Health
                                                 Risk Assessment
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                                    Point of departure
        Exposure/scenario            and  uncertainty/    RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (Females 13-50       NOAEL = 20 mg/kg/day  Acute RfD = aPAD =   Rat Developmental Study: LOAEL =
 years of age).                    UFA = 10x...........   0.20 mg/kg/day.      90 mg/kg/day based on increased
                                   UFH = 10x...........                        incidence of slightly dilated
                                   FQPA SF = 1x........                        lateral ventricles of the brain.
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Acute dietary (General population  NOAEL = 293 mg/kg/    Acute RfD = aPAD =   Acute Neurotoxicity Study: LOAEL =
 including infants and children).   day.                  2.9 mg/kg/day.       440 mg/kg/day based on decreased
                                   UFA = 10x...........                        motor activity in females.
                                   UFH = 10x...........
                                   FQPA SF = 1x........
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Chronic dietary (All populations)  NOAEL = 1.25 mg/kg/   Chronic RfD = cPAD   Rat Parental Reproduction Study:
                                    day.                  = 0.013 mg/kg/day.   LOAEL = 25 mg/kg/day based on
                                   UFA = 10x...........                        dilatation of tubules in the
                                   UFH = 10x...........                        outer medulla of kidneys in
                                   FQPA SF = 1x........                        parental females of both
                                                                               generations (33/35 (P1) and 28/40
                                                                               (F1) treated parents vs 0/35-41
                                                                               controls); one occurrence of
                                                                               tubular epithelial necrosis was
                                                                               noted in the P1 females (compared
                                                                               to 0 controls).
Incidental oral short-term (1 to   NOAEL = 25 mg/kg/day  Residential LOC for  Rat Offspring Reproduction Study:
 30 days).                         UFA = 10x...........   MOE = 100.           LOAEL = 125 mg/kg/day based on
                                   UFH = 10x...........  No residential        decreased body weight (both
                                   FQPA SF = 1x........   uses. Accounts for   generations; [darr]6-26%) and
                                                          spray drift.         increased incidence of dilatation
                                                                               of the renal pelvis in the F2
                                                                               generation.
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Dermal short-term (1 to 30 days).  NOAEL = 25 mg/kg/day  Residential LOC for  Rat Offspring Reproduction Study:
                                   DAF = 18%...........   MOE = 100.           LOAEL = 125 mg/kg/day based on
                                   UFA = 10x...........  No residential        decreased body weight (both
                                   UFH = 10x...........   uses. Accounts for   generations; [darr]6-26%) and
                                   FQPA SF = 1x........   spray drift.         increased incidence of dilatation
                                                                               of the renal pelvis in the F2
                                                                               generation. Rat Developmental
                                                                               Study is supportive.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: Likely to be carcinogenic to humans at high enough doses to
                                    cause the biochemical and histopathological changes in livers of rodents,
                                    but unlikely to be carcinogenic at doses below those causing these changes.
                                    The non-linear RfD approach will be protective for chronic effects,
                                    including carcinogenicity.
----------------------------------------------------------------------------------------------------------------
DAF = dermal absorption factor. FQPA SF = FQPA Safety Factor. LOAEL = lowest observed adverse effect level. LOC
  = level of concern. NOAEL = no observed adverse effect level. PAD = population adjusted dose (a = acute, c =
  chronic). Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-
  response data and used to mark the beginning of extrapolation to determine risk associated with lower
  environmentally relevant human exposures. RfD = reference dose. MOE = margin of exposure. UF = uncertainty
  factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity
  among members of the human population (intraspecies).

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to sodium salt of acifluorfen, EPA considered exposure under
the time-limited tolerances established by this action as well as all
existing sodium salt of acifluorfen tolerances in 40 CFR 180.383. EPA
assessed dietary exposures from sodium salt of acifluorfen in food as
follows:
    i. Acute exposure. Such effects were identified for sodium salt of
acifluorfen. In estimating acute dietary exposure,

EPA used food consumption information from the Dietary Exposure
Evaluation and Model-Food Commodity Intake Database (DEEM-FCID). As to
residue levels in food, EPA assumed that sodium acifluorfen residues
were present at tolerance levels in all commodities for which
tolerances have been established or proposed and that 100% of the crops
were treated with sodium salt of acifluorfen.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the food consumption data from the Dietary
Exposure Evaluation and Model-Food Commodity Intake Database (DEEM-
FCID). As to residue levels in food, EPA assumed that acifluorfen
residues were present at tolerance levels in all commodities for which
tolerances have been identified or proposed and that 100% of the crops
were treated with sodium salt of acifluorfen.
    iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
Cancer risk is quantified using a linear or nonlinear approach. If
sufficient information on the carcinogenic mode of action is available,
a threshold or nonlinear approach is used and a cancer RfD is
calculated based on an earlier noncancer key event. If carcinogenic
mode of action data are not available, or if the mode of action data
determines a mutagenic mode of action, a default linear cancer slope
factor approach is utilized. Based on the data summarized in Unit
IV.A., EPA has concluded that a nonlinear RfD approach is appropriate
for assessing cancer risk to sodium salt of acifluorfen. Cancer risk
was assessed using the same exposure estimates as discussed in Unit
IV.B.1.ii., chronic exposure.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for sodium salt of acifluorfen. Tolerance level
residues and 100% PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for sodium salt of acifluorfen in drinking water. These
simulation models take into account data on the physical, chemical, and
fate/transport characteristics of sodium salt of acifluorfen. Further
information regarding EPA drinking water models used in pesticide
exposure assessment can be found at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-
pesticide.
    Based on the groundwater modeling results from Pesticide Root Zone
Model Ground Water (PRZM GW), the estimated drinking water
concentrations (EDWCs) of sodium salt of acifluorfen for acute
exposures are estimated to be 66.8 parts per billion (ppb) for surface
water and 146 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute and chronic (non-
cancer) dietary risk assessments, the water concentration value of 146
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).
    Sodium salt of acifluorfen is not registered for any specific use
patterns that would result in residential exposure.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at https://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.''
    At this time, there is not sufficient information to determine if
any other pesticides share a common mechanism of toxicity with sodium
salt of acifluorfen. For purposes of this time-limited tolerance
action, EPA has assumed that sodium salt of acifluorfen does not share
a common mechanism of toxicity with any 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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risks-pesticides.

C. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act (FQPA) Safety Factor (SF). In applying this provision,
EPA either retains the default value of 10X, or uses a different
additional SF when reliable data available to EPA support the choice of
a different factor.
    2. Prenatal and postnatal sensitivity. There is evidence of
increased susceptibility following in utero exposure to sodium
acifluorfen in the Sprague Dawley rat developmental toxicity study.
However, there is low concern because effects are well characterized
with clear NOAEL/LOAEL values and the chosen points of departure for
risk assessment for each scenario are protective of these effects.
    3. Conclusion. EPA has determined that reliable data show that 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 sodium salt of acifluorfen is
complete.
    ii. There is some indication that sodium salt of acifluorfen is a
neurotoxic chemical, however, the chosen points of departure for risk
assessment are protective of these effects, and there is no need for a
developmental neurotoxicity study or additional UFs to account for
neurotoxicity.
    iii. There is evidence that sodium salt of acifluorfen results in
increased susceptibility following exposure in utero rats in the
Sprague Dawley rat prenatal developmental study. However, there is low
concern because effects are well characterized with clear NOAEL/LOAEL
values and the chosen points of departure for risk assessment for each
scenario are protective of these effects.
    iv. There are no residual uncertainties identified in the exposure
database. 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 sodium salt of acifluorfen in drinking water.
These assessments will not underestimate the exposure and risks posed
by sodium salt of acifluorfen.

D. 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 population adjusted dose (aPAD) and chronic population adjusted
dose (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 sodium salt of acifluorfen will occupy 4.0% of the aPAD for females
13-49 years old, the population group receiving the greatest exposure.
There are no registered residential uses of sodium salt of acifluorfen,
and so acute aggregate risk is equivalent to acute dietary risk, which
is not of concern.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
sodium salt of acifluorfen from food and water will utilize 63% of the
cPAD for all infants <1 year old, the population group receiving the
greatest exposure. There are no registered residential uses of sodium
salt of acifluorfen, and so chronic aggregate risk is equivalent to
chronic dietary risk, which is not of concern.
    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). Sodium salt
of acifluorfen is not currently registered for a use that could result
in short-term (non-occupational) residential exposure. Because there
are no registered residential uses, short-term aggregate risk is
equivalent to chronic dietary risk, which is not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term non-dietary, non-occupational
exposure plus chronic exposure to food and water (considered to be a
background exposure level). Because there are no registered residential
uses, intermediate-term risk is equivalent to chronic dietary risk,
which is not of concern.
    5. Aggregate cancer risk for U.S. population. Sodium salt of
acifluorfen is classified as ``likely to be carcinogenic to humans at
doses high enough to cause the biochemical and histopathological
changes in livers of rodents, but unlikely to be carcinogenic at doses
below those causing these changes.'' EPA determined that non-linear
extrapolation be used in this assessment instead of a separate Q1*
based cancer aggregate assessment.'' A non-cancer dietary assessment
was completed that resulted in risk levels below the LOC of 100%. These
levels are considered protective for both non-cancer and cancer risk
because EPA regulates at doses below those where initiation of tumor
formation is expected.
    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 sodium salt of acifluorfen residues. More detailed
information on the subject action to establish time-limited tolerances
in or on beet, sugar, roots and beet, sugar, leaves can be found at
https://www.regulations.gov in the document entitled ``Sodium
Acifluorfen: Human Health Risk Assessment for Section 18 Emergency
Exemptions for the Use on Sugarbeets in Nebraska and Colorado.'' This
document can be found in docket ID number EPA-HQ-OPP-2021-0604.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, the Pesticide Analytical Manual
(PAM) Volume II gas chromatography/electron capture detector (GC/ECD)
method, 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 protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). Codex 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.
    Codex has not established a MRL for sodium salt of acifluorfen.

VI. Conclusion

    Therefore, time-limited tolerances are established for residues of
sodium salt of acifluorfen, in or on beet, sugar, roots at 0.1 parts
per million (ppm), and beet, sugar, leaves at 0.1 ppm. These tolerances
expire on December 31, 2024.

VII. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA sections 408(e) and
408(l)(6). 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 in accordance
with FFDCA sections 408(e) and 408(l)(6), 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).

VIII. 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: March 25, 2022.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

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

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

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

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

0
2. Section 180.383(b) is added to read as follows:

Sec.  180.383  Sodium salt of acifluorfen; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of the herbicide sodium salt of acifluorfen,
including its metabolites and degradates, in or on the specified
agricultural commodities in the following table, resulting from use of
the pesticide pursuant to FIFRA section 18 emergency exemptions.
Compliance with the tolerance levels specified in the following table
is to be determined by measuring only the sum of acifluorfen acid, (5-
[2-chloro-4-(trifluoromethyl) phenoxy]-2-nitrobenzoate), acifluorfen
amine methyl ester (methyl 5-[2-chloro-4(trifluoromethyl)phenoxy]-2-
aminobenzoate), calculated as the stoichiometric equivalent of
acifluorfen acid in or on the commodities. The tolerances expire on the
date specified in the table.

                        Table 2 to Paragraph (b)
------------------------------------------------------------------------
                                                     Parts
                    Commodity                         per     Expiration
                                                    million      date
------------------------------------------------------------------------
Beet, sugar, roots...............................       0.1   12/31/2024
Beet, sugar, leaves..............................       0.1   12/31/2024
------------------------------------------------------------------------

* * * * *
[FR Doc. 2022-06817 Filed 3-30-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 148 (Wednesday, August 1, 2012)]
[Notices]
[Pages 45600-45604]
[FR Doc No: 2012-18654]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2012-0437; FRL-9354-4]

Certain New Chemicals; Receipt and Status Information

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: Section 5 of the Toxic Substances Control Act (TSCA) requires

any person who intends to manufacture (defined by statute to include
import) a new chemical (i.e., a chemical not on the TSCA Chemical
Substances Inventory (TSCA Inventory)) to notify EPA and comply with
the statutory provisions pertaining to the manufacture of new
chemicals. Under TSCA sections 5(d)(2) and 5(d)(3), EPA is required to
publish in the Federal Register a notice of receipt of a premanufacture
notice (PMN) or an application for a test marketing exemption (TME),
and to publish in the Federal Register periodic status reports on the
new chemicals under review and the receipt of notices of commencement
(NOC) to manufacture those chemicals. This document, which covers the
period from May 29, 2011 to June 15, 2012, and provides the required
notice and status report, consists of the PMNs pending or expired, and
the NOC to manufacture a new chemical that the Agency has received
under TSCA section 5 during this time period.

DATES: Comments identified by the specific PMN number or TME number,
must be received on or before August 31, 2012.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2012-0437, and the specific PMN number or TME
number for the chemical related to your comment, by one of the
following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. The
DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding
legal holidays. The telephone number for the DCO is<PHONE_NUMBER>.
Such deliveries are only accepted during the DCO's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: EPA's policy is that all comments received will be
included in the docket without change and may be made available on-line
at http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or
email. The regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an email
comment directly to EPA without going through regulations.gov, your
email address will be automatically captured and included as part of
the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at http://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number of the EPA/DC Public Reading Room
is<PHONE_NUMBER>, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Bernice Mudd, Information Management Division (7407M), Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-8951; fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. As such, the
Agency has not attempted to describe the specific entities that this
action may apply to. Although others may be affected, this action
applies directly to the submitter of the PMNs addressed in this action.
If you have any questions regarding the applicability of this action to
a particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at

your estimate in sufficient detail to allow for it to be reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Why is EPA taking this action?

    EPA classifies a chemical substance as either an ``existing''
chemical or a ``new'' chemical. Any chemical substance that is not on
EPA's TSCA Inventory is classified as a ``new chemical,'' while those
that are on the TSCA Inventory are classified as an ``existing
chemical.'' For more information about the TSCA Inventory go to: http://www.epa.gov/opptintr/newchems/pubs/inventory.htm. Anyone who plans to
manufacture or import a new chemical substance for a non-exempt
commercial purpose is required by TSCA section 5 to provide EPA with a
PMN, before initiating the activity. Section 5(h)(1) of TSCA authorizes
EPA to allow persons, upon application, to manufacture (includes
import) or process a new chemical substance, or a chemical substance
subject to a significant new use rule (SNUR) issued under TSCA section
5(a), for ``test marketing'' purposes, which is referred to as a test
marketing exemption, or TME. For more information about the
requirements applicable to a new chemical go to: http://ww.epa.gov/opt/newchems.
    Under TSCA sections 5(d)(2) and 5(d)(3), EPA is required to publish
in the Federal Register a notice of receipt of a PMN or an application
for a TME and to publish in the Federal Register periodic status
reports on the new chemicals under review and the receipt of NOCs to
manufacture those chemicals. This status report, which covers the
period from May 29, 2012 to June 15, 2012, consists of the PMNs pending
or expired, and the NOCs to manufacture a new chemical that the Agency
has received under TSCA section 5 during this time period.

III. Receipt and Status Reports

    In Table I. of this unit, EPA provides the following information
(to the extent that such information is not claimed as CBI) on the PMNs
received by EPA during this period: The EPA case number assigned to the
PMN, the date the PMN was received by EPA, the projected end date for
EPA's review of the PMN, the submitting manufacturer/importer, the
potential uses identified by the manufacturer/importer in the PMN, and
the chemical identity.

                          Table I--31 PMNs Received From May 29, 2012 to June 15, 2012
----------------------------------------------------------------------------------------------------------------
                               Projected
    Case No.       Received    notice end      Manufacturer/           Use            Chemical
                     date         date           Importer
-------------------------------------------------------------------------------------------------
P-12-0373......   05/25/2012   08/22/2012  CBI.................  (G) Abrasion     (G) 1,4-
                                                                  resistant,       butanediol,
                                                                  formable dual-   polymer with
                                                                  cure laquer      substituted
                                                                  for screen       alkane and
                                                                  printing.        substituted
                                                                                methylene
                                                                                biscarbomonocy
                                                                                cle 2-
                                                                                hydroxyalkyl
                                                                                acrylate-
                                                                                blocked.
P-12-0374......   05/25/2012   08/22/2012  CBI.................  (G) A component  (G) Quaternary
                                                                  in paints/       ammonium
                                                                  coatings-        compound.
                                                                  function as a
                                                                  dispersing
                                                                  agent/
                                                                  stabilizer.
P-12-0375......   05/29/2012   08/26/2012  CBI.................  (G) Water        (G) Alkenedioic
                                                                  treatment        acid (2Z)-,
                                                                  product for      sodium salt
                                                                  cooling water.   (1:1), polymer
                                                                                with sodium
                                                                                phosphinate
                                                                                (1:1),
                                                                                hydrolyzed.
P-12-0376......   05/29/2012   08/26/2012  CBI.................  (G) Lubricant    (G) 2,5-
                                                                  additive.        furandione,
                                                                                polymer with
                                                                                ethane and 1-
                                                                                propene, and
                                                                                substituted
                                                                                aryl amines.
P-12-0377......   05/29/2012   08/26/2012  CBI.................  (G) Catalyst     (G) Mixed
                                                                  for chemical     metallic
                                                                  industry.        oxides.
P-12-0378......   05/29/2012   08/26/2012  CBI.................  (G) The new      (G) Diacrylate
                                                                  substance is     polymer with
                                                                  intended for     alkane
                                                                  use as a raw     esterdiol,
                                                                  material for     alkane diol,
                                                                  industrial       alkane acid
                                                                  waterborne       diol and
                                                                  coating          diisocyanates.
                                                                  applications.
P-12-0379......   05/29/2012   08/26/2012  CBI.................  (G) Destructive  (G) Alkyl zinc
                                                                  use.             halide.
P-12-0380......   06/01/2012   08/29/2012  CBI.................  (G) The PMN      (G) Monoazo
                                                                  substance is     compound.
                                                                  used as
                                                                  plastic
                                                                  additive. It
                                                                  is imported in
                                                                  pigment
                                                                  formulation to
                                                                  be
                                                                  incorporated
                                                                  into plastic
                                                                  parts in
                                                                  concentration
                                                                  range 0.1-2%.
P-12-0381......   05/30/2012   08/27/2012  3M Company..........  (G) Curative...  (G) Amido amine
                                                                                polyether
                                                                                polymer.
P-12-0382......   06/05/2012   09/02/2012  CBI.................  (G) Open, non-   (G) Alkenes.
                                                                  dispersive use
                                                                  in printing
                                                                  applications
                                                                  and a
                                                                  dispersive use
                                                                  in consumer
                                                                  products.
P-12-0383......   06/05/2012   09/02/2012  CBI.................  (G) Open, non-   (G) Alkanes.
                                                                  dispersive use
                                                                  in printing
                                                                  applications
                                                                  and a
                                                                  dispersive use
                                                                  in consumer
                                                                  products.

P-12-0384......   06/07/2012   09/04/2012  Royal adhesives and   (S)              (G) Secondary
                                            sealants.             Crosslinking     amine-
                                                                  agent for        terminated
                                                                  isocyanate-      polyether
                                                                  tipped resins    triol.
                                                                  used as
                                                                  adhesives and
                                                                  sealants.
P-12-0385......   06/08/2012   09/05/2012  CBI.................  (G) Coating for  (G) Lightly
                                                                  plastics.        branched
                                                                                polyester
                                                                                resin salt.
P-12-0386......   06/08/2012   09/05/2012  CBI.................  (G) Coating for  (G) Lightly
                                                                  plastics.        branched
                                                                                polyester
                                                                                resin salt.
P-12-0387......   06/11/2012   09/08/2012  CBI.................  (G) Resin for    (G) Modified
                                                                  composite        polyester.
                                                                  manufacture.
P-12-0388......   06/11/2012   09/08/2012  CBI.................  (G) Resin for    (G)
                                                                  refinish         Methacrylate,
                                                                  automotive       acrylate,
                                                                  coatings.        styrene,
                                                                                hydroxy & acid
                                                                                functional
                                                                                acrylic
                                                                                copolymer.
P-12-0389......   06/11/2012   09/08/2012  CBI.................  (G) Resin for    (G)
                                                                  refinish         Methacrylate,
                                                                  automotive       acrylate,
                                                                  coatings.        styrene,
                                                                                hydroxy & acid
                                                                                functional
                                                                                acrylic
                                                                                copolymer.
P-12-0390......   06/11/2012   09/08/2012  CBI.................  (G) Resin for    (G)
                                                                  refinish         Methacrylate,
                                                                  automotive       acrylate,
                                                                  coatings.        styrene,
                                                                                hydroxy & acid
                                                                                functional
                                                                                acrylic
                                                                                copolymer.
P-12-0391......   06/11/2012   09/08/2012  CBI.................  (G) Resin for    (G)
                                                                  refinish         Methacrylate,
                                                                  automotive       acrylate,
                                                                  coatings.        styrene,
                                                                                hydroxy & acid
                                                                                functional
                                                                                acrylic
                                                                                copolymer.
P-12-0392......   06/11/2012   09/08/2012  CBI.................  (G) Fragrance    (G) Mix of
                                                                  material for     isomers of
                                                                  highly           substituted
                                                                  dispersive use.  cyclohexyl
                                                                                carboxaldehyde
                                                                                .
P-12-0393......   06/11/2012   09/08/2012  Lubrigreen            (G) Lubricant    (S) Fatty
                                            Biosynthetics.        base oil.        acids, C8	18
                                                                                and C18-
                                                                                unsaturated.,
                                                                                reaction
                                                                                products with
                                                                                isomerized
                                                                                oleic acid
                                                                                homopolymer 2-
                                                                                propylheptyl
                                                                                ester.
P-12-0394......   06/11/2012   09/08/2012  Lubrigreen            (G) Lubricant    (S) Fatty
                                            Biosynthetics.        base oil.        acids, coco,
                                                                                reaction
                                                                                products with
                                                                                isomerized
                                                                                oleic acid
                                                                                homopolymer 2-
                                                                                propylheptyl
                                                                                ester.
P-12-0395......   06/11/2012   09/08/2012  Lubrigreen            (G) Lubricant    (S) 9-
                                            Biosynthetics.        base oil.        octadecenoic
                                                                                acid (9Z)-,
                                                                                homopolymer, 2-
                                                                                propylheptyl
                                                                                ester,
                                                                                isomerized.
P-12-0396......   06/11/2012   09/08/2012  CBI.................  (S) Polymer for  (G) Solvent-
                                                                  flexographic     based urethane
                                                                  and gravure      dispersion.
                                                                  lamination
                                                                  inks.
P-12-0397......   06/12/2012   09/09/2012  Cray Valley USA, LLC  (S) Reinforcing  (S) 3-phenyl-2-
                                                                  additive in      propenoic
                                                                  polyolefins.     acid, zinc
                                                                                salt (2:1).
P-12-0398......   06/12/2012   09/09/2012  Sasol North America.  (S) Lubricant    (S) 1,2,4-
                                                                  in special       benzenetricarb
                                                                  chain oils for   oxylic acid,
                                                                  conveyor belts.  mixed lauryl
                                                                                and octyl
                                                                                triesters.
P-12-0399......   06/12/2012   09/09/2012  CBI.................  (G) Paper        (G)
                                                                  treatment.       Perfluoroalkyl
                                                                                ethyl
                                                                                methacrylate
                                                                                copolymer,
                                                                                sodium salt.
P-12-0400......   06/12/2012   09/09/2012  CBI.................  (G) Coating for  (G) Neutralized
                                                                  beverage cans.   epoxy
                                                                                phosphate.
P-12-0401......   06/12/2012   09/09/2012  CBI.................  (G) External     (G) Water
                                                                  can coating.     reducible
                                                                                polyester
                                                                                resin.
P-12-0402......   06/13/2012   09/10/2012  CBI.................  (G) Pigment      (S) 2-
                                                                  formulation      oxepanone,
                                                                  additive.        polymer with
                                                                                aziridine,
                                                                                dodecanoate
                                                                                (ester).
P-12-0403......   05/30/2012   08/27/2012  CBI.................  (G) Coating for  (G) Aqueous
                                                                  plastics.        polyester
                                                                                polyurethane
                                                                                dispersion.
----------------------------------------------------------------------------------------------------------------

    In Table II. of this unit, EPA provides the following information
(to the extent that such information is not claimed as CBI) on the NOCs
received by EPA during this period: The EPA case number assigned to the
NOC, the date the NOC was received by EPA, the projected end date for
EPA's review of the NOC, and chemical identity.

      Table II--26 NOCs Received From May 29, 2012 to June 15, 2012
------------------------------------------------------------------------
                                   Commencement
    Case No.       Received date    notice end           Chemical
                                       date
------------------------------------------------------------------------
P-06-0726.......      06/15/2012      05/31/2012  (G) Cyclical acid,
                                                   polymer with
                                                   isocyanate, diols,
                                                   diacids,
                                                   alkanolamine, amine
                                                   salt.
P-07-0721.......      06/07/2012      05/21/2012  (S) 1,3-cyclohexadiene-
                                                   1-carboxylic acid,
                                                   4,6,6-trimethyl-,
                                                   ethyl ester.
P-08-0355.......      05/30/2012      05/25/2012  (G) Polymer of
                                                   alkanedioic acid and
                                                   alkane diamine.
P-08-0638.......      05/31/2012      05/16/2012  (G) Mixed titanate.

P-08-0639.......      05/31/2012      05/16/2012  (G) Mixed titanate.
P-09-0398.......      06/01/2012      05/14/2012  (G) Polyitaconic acid.
P-10-0135.......      05/25/2012      05/23/2012  (G) Fluoroketone.
P-10-0462.......      06/14/2012      06/07/2012  (G) Isocyanate
                                                   functional polyester
                                                   urethane polymer.
P-11-0435.......      06/14/2012      06/08/2012  (G) Alkoxylated amine
                                                   derivative.
P-11-0436.......      06/15/2012      06/11/2012  (G) Polyether sulfate
                                                   salt derivative.
P-11-0456.......      06/06/2012      05/15/2012  (G) Thermoset acrylic
                                                   polymer.
P-11-0466.......      06/15/2012      06/06/2012  (G) Alkoxylated amine
                                                   derivative.
P-11-0508.......      06/05/2012      05/07/2012  (G) Acrylic polymer.
P-11-0561.......      06/06/2012      05/18/2012  (G)
                                                   Tetrafluoroethylene
                                                   chlorotrifluoroethyle
                                                   ne copolymer.
P-11-0623.......      06/01/2012      05/31/2012  (G) Heteromonocycle,
                                                   homopolymer,
                                                   disubstituted
                                                   carbomonocycle,
                                                   substituted alkyl
                                                   ester.
P-11-0629.......      06/11/2012      04/19/2012  (G) Carbodiimide
                                                   crosslinker.
P-11-0646.......      05/30/2012      04/30/2012  (G)
                                                   Perfluoroalkylethyl
                                                   methacrylate
                                                   copolymer.
P-11-0655.......      06/13/2012      06/11/2012  (G) Aliphatic epoxy
                                                   acrylate.
P-12-0019.......      06/08/2012      06/05/2012  (S) Starch
                                                   carboxymethyl 2-
                                                   hydroxypropyl ether.
P-12-0072.......      06/12/2012      05/19/2012  (G) Quaternary
                                                   ammonium compound.
P-12-0103.......      05/25/2012      04/30/2012  (G) Alkene-substituted
                                                   fatty acid methyl
                                                   ester polymer.
P-12-0135.......      06/04/2012      05/05/2012  (G) Epoxy amine
                                                   polymer.
P-12-0151.......      06/01/2012      05/04/2012  (G) Glycol substituted
                                                   bicyclic olefin.
P-12-0157.......      06/12/2012      05/31/2012  (G) Acrylic copolymer.
P-12-0221.......      06/06/2012      06/04/2012  (G) Acrylic polymer.
P-96-0550.......      06/14/2012      06/12/2012  (G) Metallo, dihydro
                                                   hydroxy,
                                                   hydroxyethylsulfonyl,
                                                   alkylether, azo,
                                                   sulfo,
                                                   polycarbocycle,
                                                   substituted
                                                   heterocycle,
                                                   carboxylate, salt.
------------------------------------------------------------------------

    If you are interested in information that is not included in these
tables, you may contact EPA as described in Unit II. to access
additional non-CBI information that may be available.

List of Subjects

    Environmental protection, Chemicals, Hazardous substances, Imports,
Notice of commencement, Premanufacturer, Reporting and recordkeeping
requirements, Test marketing exemptions.

    Dated: July 10, 2012.
 Chandler Sirmons,
Acting Director, Information Management Division, Office of Pollution
Prevention and Toxics.
[FR Doc. 2012-18654 Filed 7-31-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 177 (Thursday, September 12, 2019)]
[Rules and Regulations]
[Pages 48062-48064]
[FR Doc No: 2019-19685]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2019-0738]
RIN 1625-AA87

Security Zone; Inner Harbor, Baltimore, MD

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary security zone
encompassing certain waters of Baltimore's Inner Harbor. This security
zone is needed to prevent waterside threats during an event held at the
Baltimore Marriott Waterfront Hotel in Baltimore, MD, September 12-14,
2019. Entry of vessels or persons into this zone is prohibited unless
specifically authorized by the Captain of the Port Maryland-National
Capital Region or his designated representative.

DATES: This rule is effective from 11:59 a.m. on September 12, 2019,
through 4 p.m. on September 14, 2019.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2019-0738 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. Ron Houck, Sector Maryland-National Capital Region
Waterways Management Division, U.S. Coast Guard; telephone 410-576-
2674, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

COTP Captain of the Port
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 Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because doing so would be impracticable and
contrary to the public interest. The Coast Guard was unable to publish
an NPRM and hold a comment period for this rulemaking due to the short
time period between event planners notifying the Coast Guard of the
event and publication of this security zone. It is necessary for the
Coast Guard to establish this security zone for this event to ensure
the appropriate level of protection for high-ranking United States
officials and the public. Delaying the rulemaking to allow for
opportunity for comment would be contrary to the security zone's
intended objectives of protecting high-ranking United States officials
and the public, as it would introduce vulnerability to their safety and
security.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable and contrary to the public interest
for the same reasons discussed above for forgoing notice and comment.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The COTP Maryland-National Capital
Region has determined that a security zone is necessary to protect
high-ranking United States officials and the public, mitigate potential
terrorist acts, and enhance public and maritime safety and security in
order to safeguard life, property, and the environment on or near the
navigable waters near the Baltimore Marriott Waterfront Hotel in
Baltimore, MD.

IV. Discussion of the Rule

    This rule establishes a security zone from 11:59 a.m. on September
12, 2019, until 4 p.m. on September 14, 2019. The security zone will
cover all navigable waters of the Inner Harbor, within the following
coordinates: from Inner Harbor Pier 6 at position latitude
39[deg]16'58.7'' N, longitude 076[deg]36'16.0'' W; thence to latitude
39[deg]16'55.3'' N, longitude 076[deg]36'14.2'' W; thence to latitude
39[deg]16'53.6'' N, longitude 076[deg]36'12.5'' W; thence to the Harbor
East Marina pier at latitude 39[deg]16'52.9'' N, longitude
076[deg]36'10.0'' W; thence northward along the pier to the shoreline
at latitude 39[deg]16'55.5'' N, longitude 076[deg]36'10.2'' W; thence
northward along the eastern shoreline of the Jones Falls canal to
latitude 39[deg]17'20.6'' N, longitude 076[deg]36'19.9'' W; thence
westward to latitude 39[deg]17'20.5'' N, longitude 076[deg]36'20.5'' W;
thence southward along the western shoreline of the Jones Falls canal
to latitude 39[deg]16'58.1'' N, longitude 076[deg]36'13.0'' W; thence
westward along Inner Harbor Pier 6 to the point of origin. The duration
of the zone is intended to protect high-ranking United States officials
and the public in these navigable waters during activities associated
with the U.S. House Republican Conference in Baltimore, MD.
    Entry into this security zone is prohibited, unless specifically
authorized by the COTP Maryland-National Capital Region or designated
representative. Except for public

vessels, this rule temporarily requires all vessels in the designated
security zone to immediately depart the security zone. Coast Guard
personnel will be present to prevent the movement of unauthorized
persons into the zone. Federal, state, and local agencies may assist
the Coast Guard in the enforcement of this rule. The Coast Guard will
issue Broadcast Notices to Mariners to further publicize the security
zone and notify the public of changes in the status of the zone. Such
notices will continue until the event is complete.

V. Regulatory Analyses

    We developed this 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 rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule 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 size,
location, and duration of the security zone. This security zone will
impact the waters affected by this rule for a 52-hour enforcement
period. Vessels will be able to safely transit around this security
zone, which would impact a small designated area of the Inner Harbor.
In addition, notifications will be made to the maritime community via
marine information broadcasts so mariners may adjust their plans
accordingly. Such notifications will be updated as necessary to keep
the maritime community informed of the status of the security 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 rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    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 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.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will 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 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 rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does 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 rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

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 rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969(42 U.S.C. 4321-4370f), and have
determined 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 rule involves a security zone lasting only 52 hours
in duration and is necessary to provide security for high-ranking
United States officials and the public. It is categorically excluded
from further review under paragraph L60(a) in Table 3-1 of U.S. Coast
Guard Environmental Planning Implementing Procedures 5090.1. A Record
of Environmental Consideration supporting this determination is
available in the docket where indicated under ADDRESSES.

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.

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 amends
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. Add Sec.  165.T05-0738 to read as follows:

Sec.  165.T05-0738  Security Zone; Inner Harbor, Baltimore, MD.

    (a) Location. The following area is a security zone: All waters of
the Inner Harbor, from surface to bottom, encompassed by a line
connecting the following points beginning at 39[deg]16'58.7'' N,
076[deg]36'16.0'' W, thence to 39[deg]16'55.3'' N, 076[deg]36'14.2'' W,
thence to 39[deg]16'53.6'' N, 076[deg]36'12.5'' W, thence to
39[deg]16'52.9'' N, 076[deg]36'10.0'' W, thence to 39[deg]16'55.5'' N,
076[deg]36'10.2'' W, thence to 39[deg]17'20.6'' N, 076[deg]36'19.9'' W;
thence to 39[deg]17'20.5'' N, 076[deg]36'20.5'' W, thence to
39[deg]16'58.1'' N, 076[deg]36'13.0'' W, thence along Inner Harbor Pier
6 back to the beginning point. These coordinates are based on datum NAD
1983.
    (b) Definitions. As used in this section--
    Captain of the Port means the Commander, U.S. Coast Guard Sector
Maryland-National Capital Region.
    Designated representative means a Coast Guard commissioned,
warrant, or petty officer designated by or assisting the Captain of the
Port Maryland-National Capital Region (COTP) in the enforcement of the
security zone.
    Public vessel means a vessel that is owned, chartered, or operated
by the Government of the United States, or by a State or political
subdivision thereof.
    (c) Regulations. (1) Under the general security zone regulations in
subpart D of this part, you may not enter the security zone described
in paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) Except for public vessels, all vessels within this security
zone at the time it is implemented are to depart the zone.
    (3) Persons desiring to transit the area of the security zone must
first obtain authorization from the COTP or the COTP's designated
representative. To seek permission to enter, contact the COTP or the
COTP's representative by telephone number<PHONE_NUMBER> or on Marine
Band Radio VHF-FM channel 16 (156.8 MHz). Those in the security zone
must comply with all lawful orders or directions given to them by the
COTP or the COTP's designated representative.
    (d) Enforcement officials. The U.S. Coast Guard may be assisted in
the patrol and enforcement of the zone by Federal, State, and local
agencies.

    Dated: September 6, 2019.
Joseph B. Loring,
Captain, U.S. Coast Guard, Captain of the Port Maryland-National
Capital Region.
[FR Doc. 2019-19685 Filed 9-11-19; 8:45 am]
BILLING CODE 9110-04-P