[Federal Register: August 4, 2010 (Volume 75, Number 149)]
[Rules and Regulations]
[Page 46847-46854]
[DOCID:fr04au10-7]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0797; FRL-8835-8]

Halosulfuron-methyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
halosulfuron-methyl in or on multiple commodities which are identified
and discussed later in this document. Additionally, this regulation
removes the existing tolerance on bean, snap, succulent at 0.05 parts
per million (ppm) in that it is superseded by this action establishing
a tolerance at 0.05 ppm on pea and bean, succulent shelled, subgroup
6B. The Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 4, 2010. Objections and
requests for hearings must be received on or before October 4, 2010,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0797. 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., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are

not limited to those engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. How Can I 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.gpoaccess.gov/ecfr.

C. How Can I File an Objection or Hearing Request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2009-0797 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
October 4, 2010. 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 that does not contain any 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 a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2009-0797, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of Wednesday, January 6, 2010 (75 FR 864)
(FRL-8801-5), EPA issued a notice pursuant to section 408(d)(3) of
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
petition (PP 9E7577) by IR-4 Project Headquarters, 500 College Road
East, Suite 201 W, Princeton, NJ 08549. The petition requested that 40
CFR 180.479 be amended by establishing tolerances for residues of the
herbicide halosulfuron-methyl, methyl 3-chloro-5-[[[[(4,6-dimethoxy-2-
pyrimidinyl)amino]carbonyl]amino]sulfonyl]-1-methyl-1 H-pyrazole-4-
carboxylate, and its metabolites and degradates (compliance with the
tolerance level specified is to be determined by measuring only those
halosulfuron-methyl residues convertible to 3-chloro-1-methyl-5-
sulfamoylpyrazole-4-carboxylic acid, expressed as the stoichiometric
equivalent of halosulfuron-methyl) in or on pea and bean, succulent
shelled, subgroup 6B; pea and bean, dried shelled, except soybean,
subgroup 6C; vegetables, tuberous and corm, subgroup 1C; bushberry,
subgroup 13-07B; apple; rhubarb; and okra at 0.05 ppm That notice
referenced a summary of the petition prepared by Gowan Company, the
registrant, which is available in the docket, http://
www.regulations.gov. There were no comments received in response to the
notice of filing.
    Based upon review of the data supporting the petition, EPA is not
taking action at this time on the petitioned-for tolerance for pea and
bean, dried shelled, except soybean, subgroup 6C due to insufficient
field trial data to support this use. Additionally, the Agency is
revoking the existing tolerance on bean, snap, succulent at 0.05 ppm in
order to eliminate redundancy with the 0.05 ppm tolerance on pea and
bean, succulent shelled, subgroup 6B established by this action. EPA is
also revising the tolerance expressions for halosurfuron-methyl for new
uses in this regulation and for existing plant and livestock
commodities to clarify the chemical moieties that are covered by the
tolerances and specify how compliance with the tolerances is to be
measured. The reasons for these changes are explained in Unit IV.D.

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 section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for halosulfuron-methyl
including exposure resulting from the tolerances established by this
action. EPA's assessment of exposures and risks associated with
halosulfuron-methyl follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
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.

    Halosulfuron-methyl has low acute toxicity by oral, dermal, and
inhalation routes of exposure. It is not a dermal sensitizer nor is it
an eye or skin irritant. The toxicity mode of action in mammals is
undetermined. However, available data show that the dog is the most
sensitive animal species. In the dog, decreased body weight was seen in
the chronic oral toxicity study and decreased body weight gain was
observed in females in the subchronic oral toxicity study. In the rat
and mouse, there was a decrease in body weight gains at high dose
levels in short-term and long-term oral and dermal studies. Both acute
and subchronic neurotoxicity studies showed no neurotoxic effects.
There was no quantitative evidence for increased susceptibility
following pre- and/or post-natal exposure. However, there was
qualitative evidence for increased susceptibility. In the rat
developmental toxicity study, increases in resorptions, soft tissue
(dilation of the lateral ventricles) and skeletal variations, and
decreases in body weights were seen in the fetuses compared to clinical
signs and decreases in body weights and food consumption in the
maternal animals. In the rabbit study, increases in resorptions and
post-implantation losses and a decrease in mean litter size were seen
in the presence of decreases in body weight and food consumption in
maternal animals. Thus, in both species, the developmental effect was
considered to be qualitatively more severe than maternal effects.
    Halosulfuron-methyl is classified as ``not likely to be
carcinogenic to humans'' based on a lack of evidence for
carcinogenicity in mice and rats following long-term dietary
administration. Halosulfuron-methyl is negative for mutagenicity in a
battery of genotoxicity studies. There is no evidence of immunotoxicity
in the available studies for halosulfuron-methyl. Acute and subchronic
neurotoxicity studies showed no evidence of neurotoxicity.
    Specific information on the studies received and the nature of the
adverse effects caused by halosulfuron-methyl as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at http://
www.regulations.gov in document: ``Halosulfuron-Methyl: Human Health
Risk Assessment for IR-4 Proposed Uses on Crop Group 6B Succulent
Shelled Pea and Bean Subgroup, Crop Group 1C Tuberous and Corm
Vegetables Subgroup, Crop Group 6C Dried Shelled Pea and Bean (Except
Soybean), Subgroup 13-07B Bushberry, Okra, Apples, and Rhubarb, dated
April 5, 2010,'' p. 13 in docket ID number EPA-HQ-OPP-2009-0797-0005.

B. Toxicological Points of Departure/Levels of Concern

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

         Table--Summary of Toxicological Doses and Endpoints for for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of Departure and
          Exposure/Scenario            Uncertainty/FQPA Safety   RfD, PAD, LOC for Risk  Study and Toxicological
                                               Factors                 Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary                          NOAEL = 50 milligrams/   Acute RfD = 0.5 mg/kg/   Developmental Toxicity
 (Females 13-49 years of age)........   kilograms/day (mg/kg/    day                       Rabbit
                                        day)                    aPAD = 0.5 mg/kg/day...  LOAEL = 150 mg/kg/day
                                       UFA = 10x..............                            based on decreased
                                       UFH = 10x..............                            mean litter size,
                                       FQPA SF = 1x...........                            increased number of
                                                                                resorptions and
                                                                                increased post-
                                                                                implantations loss.
----------------------------------------------------------------------------------------------------------------
Acute dietary                          N/A                      N/A                      No adverse effect
(General population including infants                                                     attributable to a
 and children).                                                                           single dose was
                                                                                identified and no dose/
                                                                                endpoint was selected.
----------------------------------------------------------------------------------------------------------------
Chronic dietary                        NOAEL= 10 mg/kg/day UFA  Chronic RfD = 0.1 mg/kg/ Chronic Toxicity - Dog
(All populations)....................   = 10x                    day                      LOAEL = 40 mg/kg/day
                                       UFH = 10x..............  cPAD = 0.1 mg/kg/day...   based on decreased
                                       FQPA SF = 1x...........                            body weight gains in
                                                                                females.
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term             NOAEL= 50 mg/kg/day UFA  Residential LOC for MOE  Developmental Toxicity
(1 to 30 days).......................   = 10x                    = 100.                    Rabbit
                                       UFH = 10x..............                           LOAEL = 150 mg/kg/day
                                       FQPA SF = 1x...........                            based on decreased
                                                                                body weight gain, food
                                                                                consumption, and food
                                                                                efficiency (maternal
                                                                                toxicity).
----------------------------------------------------------------------------------------------------------------
Incidental oral intermediate-term      NOAEL= 10 mg/kg/day      Residential LOC for MOE  13 week Subchronic
(1 to 6 months)......................   UFA= 10x                 = 100                    toxicity - Dog
                                       UFH= 10x...............                            LOAEL = 40 mg/kg/day
                                       FQPA SF = 1x...........                            based on on decreased
                                                                                body weight gains and
                                                                                food efficiency along
                                                                                with hematological and
                                                                                clinical chemistry
                                                                                changes.
----------------------------------------------------------------------------------------------------------------

Dermal short-term                      Dermal study NOAEL =     Residential LOC for MOE  21-Day Dermal Toxicity
(1 to 30 days).......................   100mg/kg/day             = 100                    Study - Rat
                                       UFA = 10x..............                           LOAEL = 1,000 mg/kg/day
                                       UFH = 10x..............                            based on decreased
                                       FQPA SF = 1x...........                            body weight gain in
                                                                                males.
----------------------------------------------------------------------------------------------------------------
Dermal intermediate-term               Dermal study NOAEL= 10   Residential LOC for MOE  13 Week Subchronic
(1 to 6 months)......................   mg/kg/day (dermal        = 100                    Toxicity - Dog
                                        absorption rate = 75%)                           LOAEL = 40 mg/kg/day
                                       UFA = 10x..............                            based on decreased
                                       UFH = 10x..............                            body weight gains and
                                       FQPA SF = 1x...........                            food efficiency along
                                                                                with hematological and
                                                                                clinical chemistry
                                                                                changes.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term                  Inhalation study NOAEL   Residential LOC for MOE  Developmental Toxicity
(1 to 30 days).......................   = 50 mg/kg/day           = 100                     Rabbit
                                        (inhalation absorption                           LOAEL = 150 mg/kg/day
                                        rate = 100%)                                      based on decreased
                                       UFA = 10x..............                            body weight gain, food
                                       UFH = 10x..............                            consumption, and food
                                       FQPA SF = 1x...........                            efficiency (maternal
                                                                                toxicity).
----------------------------------------------------------------------------------------------------------------
Inhalation Intermediate-term           Inhalation (or oral)     Residential LOC for MOE  13 week Subchronic
(1 to 6 months)......................   study NOAEL = 10 mg/kg/  = 100                    Toxicity - Dog
                                        day (inhalation                                  LOAEL = 40 mg/kg/day
                                        absorption rate =                                 based on based on
                                        100%)                                             decreased body weight
                                       UFA = 10x..............                            gains and food
                                       UFH = 10x..............                            efficiency along with
                                       FQPA SF = 1x...........                            hematological and
                                                                                clinical chemistry
                                                                                changes.
----------------------------------------------------------------------------------------------------------------
Cancer                                 Classification: not likely to be carcinogenic to humans by the oral route, based on no evidence of carcinogenicity from
                                                               studies in rats and mice.
----------------------------------------------------------------------------------------------------------------
A 75% dermal absorption factor should be used in route-to-route extrapolation for the intermediate term dermal
  exposure risk. Absorption via the inhalation route is presumed to be equivalent to oral absorption.NOAEL = no
  observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA =
  extrapolation from animal to human (inter-species). UFH = potential variation in sensitivity among members of
  the human population (intra-species). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute,
  c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. N/A = not applicable.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to halosulfuron-methyl, EPA considered exposure under the
petitioned-for tolerances as well as all existing halosulfuron-methyl
tolerances in 40 CFR 180.479. EPA assessed dietary exposures from
halosulfuron-methyl 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 halosulfuron-methyl including
decreased mean litter size, increased number of resorptions (total and
per dam) and increased post-implantation loss (developmental toxicity)
were identified for the population subgroup females 13 to 49 years old
(the only population subgroup with a toxicological endpoint
attributable to a single dose of halosulfuron-methyl). In estimating
acute dietary exposure, EPA used food consumption information from the
United States Department of Agriculture (USDA) 1994-1996 and 1998
Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As
to residue levels in food, EPA assumed tolerance-level residues and 100
percent crop treated (PCT) for all existing and recommended new uses of
halosulfuron-methyl.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assumed tolerance-
level residues and 100 PCT for all existing and recommended new uses of
halosulfuron-methyl
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that halosulfuron-methyl does not pose a cancer risk to
humans. Therefore, a dietary exposure assessment for the purpose of
assessing cancer risk is unnecessary.
    iv. Anticipated residue and PCT information EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for halosulfuron-methyl. 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 halosulfuron-methyl in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of halosulfuron-methyl. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at http://www.epa.gov/oppefed1/models/water/
index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST),
Pesticide Root Zone Model /Exposure Analysis Modeling System (PRZM/
EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models,
the estimated drinking water concentrations

(EDWCs) of halosulfuron-methyl are Tier I EDWCs based on a maximum
annual application rate of 0.125 lb active ingredient (ai)/acre(A) for
rice.
    Acute exposures and chronic exposures for non-cancer assessments
are estimated to be 59.2 parts per billion (ppb) based on FIRST model
for surface water and 0.065 ppb bases on SCI-GROW model results for
ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model.
    For acute and chronic dietary risk assessment, the water
concentration value of 59.2 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).
    Halosulfuron-methyl is currently registered for the following uses
that could result in residential exposures: Ornamentals, and commercial
and residential turfgrass. EPA assessed residential exposure using the
following assumptions: Residential handlers may receive short-term
dermal and inhalation exposures to halosulfuron-methyl when mixing,
loading and applying halosulfuron-methyl products. Adults and children
may be exposed to halosulfuron-methyl residues through dermal contact
with turf during postapplication activities. In addition, toddlers may
receive short- and intermediate-term oral exposure from incidental
ingestion during postapplication activities.
    Halosulfuron-methyl exposure data for handler activities were not
submitted to EPA in support of registered lawn uses. EPA's Draft
Standard Operating Procedures (SOPs) for Residential Exposure
Assessments, and Recommended Revisions were used as the basis for the
residential handler exposure calculations. The handler exposure data
used in this assessment are from the Outdoor Residential Exposure Task
Force (ORETF).
    For residential exposure from lawn use, the Agency evaluated the
combined exposure and risk estimates to adults from halsulfuron-methyl
under scenarios including:
    i. Mix/load and broadcast application of liquid formulation (garden
hose-end sprayer) for both dermal and inhalation routes, and
    ii. Post-application exposure by dermal route.
    For residential postapplication exposure, the following scenarios
resulting from lawn treatment were assessed:
    a. Adult and children 3 to <6 years old post-application dermal
exposure,
    b. Child 3 to <6 years old incidental ingestion of pesticide
residues on lawns from hand-to-mouth transfer,
    c. Toddlers' object-to-mouth transfer from mouthing of pesticide-
treated turf grass, and
    d. Children 3 to <6 years old incidental ingestion of soil from
pesticide-treated residential areas. Post-application exposures from
various activities following lawn treatment are considered to be the
most common and significant in residential settings.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/
pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found halosulfuron-methyl to share a common mechanism
of toxicity with any other substances, and halosulfuron-methyl does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
halosulfuron-methyl does not have a common mechanism of toxicity with
other substances. For information regarding EPA's efforts to determine
which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://
www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicity database for halosulfuron-methyl includes rat and rabbit
developmental toxicity studies and a 2-generation reproduction toxicity
study in rats. As discussed in Unit III.A., there was no quantitative
evidence for increased susceptibility following pre-natal and/or post-
natal exposure. However, there was qualitative evidence for increased
susceptibility of fetuses in the rat and rabbit developmental studies.
In the rat study, increases in resorptions, soft tissue (dilation of
the lateral ventricles) and skeletal variations, and decreases in body
weights were seen in the fetuses compared to clinical signs and
decreases in body weights and food consumption in the maternal animals.
In the rabbit study, increases in resorptions and post-implantation
losses and decrease in mean litter size was seen in the presence of
decreases in body weight and food consumption in maternal animals.
Thus, in both species, the developmental effect was considered to be
qualitatively more severe than maternal effects (i.e., qualitative
evidence for susceptibility). In both studies, there are clear NOAELs/
LOAELs for developmental and maternal toxicities, developmental effects
were seen in the presence of maternal toxicity, and the effects were
only seen at the high dose. Additionally, in rats, developmental
effects were seen at a dose which is approaching the limit-dose. The
degree of concern is low and there are no residual uncertainties for
prenatal toxicity in both rats and rabbits.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for halosulfuron-methyl is complete except
for an immunotoxicity study as required by the latest amendment to 40
CFR part 158. After analysis of the database, an additional factor
(UFDB) for database uncertainty is not needed to account for
the lack of this study because the available data do not suggest that
this chemical affects the immune system.
    ii. There is no indication that halosulfuron-methyl is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. Although there is qualitative evidence of increased
susceptibility in the prenatal developmental studies in

rats and rabbits, as discussed in this unit, there are no residual
uncertainties after establishing toxicity endpoints and the degree of
concern for pre-and/or post-natal toxicity is low.
    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, and conservative (protective)
assumptions in the ground water and surface water modeling were used to
assess exposure to halosulfuron-methyl in drinking water. Similarly
conservative assumptions were also used 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 halosulfuron-methyl.

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 halosulfuron-methyl will occupy less than 1% of the aPAD for the
population subgroup of concern, females 13-49 years old, the only
population group where there are acute toxicology concerns.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
halosulfuron-methyl from food and water will utilize 5% 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
halosulfuron-methyl 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). Halosulfuron-
methyl 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 halosulfuron-methyl.
    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 short-term aggregate MOEs ranging
from 2,800 to 4,800. The MOE for the U.S. population is 4,700. The most
highly exposed subgroup is all infants (< 1 year old), with a MOE of
2,800. Because these estimates of short-term aggregate risk for
halosulfuron-methyl are above a MOE of 100, these MOEs are not of
concern to EPA.
    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). Halosulfuron-methyl is currently registered for uses that could
result in intermediate-term residential exposure, and the Agency has
determined that it is appropriate to aggregate chronic exposure through
food and water with intermediate-term residential exposures to
halosulfuron-methyl.
    Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures result in
aggregate MOEs ranging from 500 to 680. The MOE for the U.S. population
is 500. The most highly exposed children's subgroup was all infants (<
1 year old), with a MOE of 680. These estimates of aggregate risk do
not exceed the Agency's level of concern.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, halosulfuron-methyl is not expected to pose a cancer risk to
humans.
    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 halosulfuron-methyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate analytical method is available for the enforcement of
tolerances for residues of halosulfuron-methyl in plants. Monsanto
Analytical Method RES-109-97-4 (gas chromatography, using thermionic-
specific detection, TSD, nitrogen specific) has been validated by EPA.
The method's limit of quantitation (LOQ) determined across a variety of
tested crops is 0.05 ppm. 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>; e-mail
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 U.N. 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.
     There are no Codex, Canadian or Mexican maximum residue limits
(MRLs) established for residues of halosulfuron-methyl in crop or
livestock commodities.

C. Revisions to Petitioned-For Tolerances

    EPA is not taking action on the petitioned-for tolerance for pea
and bean, dried shelled (except soybean) due to inadequate data
available to support these uses. Generally, EPA recommends that five
field trials be submitted for peas but none have been submitted with
this petition.
    EPA is revising the tolerance expressions for halosurfuron-methyl
for new uses in this regulation and for existing plant and livestock
commodities to clarify the chemical moieties that are covered by the
tolerances and specify how compliance with the tolerances is to be
measured.
    The revised tolerance expression for livestock commodities makes
clear that the tolerances cover residues of halosulfuron-methyl and its
metabolites and degradates and that compliance with the tolerance
levels will be determined by measuring only those halosulfuron-methyl
residues containing the 3-chlorosulfonamide (3CSA) moiety, expressed as
the stoichiometric equivalent of halosulfuron-methyl.

    EPA believes that it is reasonable to make these changes in the
tolerance expressions final without prior proposal and opportunity for
comment, because public comment is not necessary, in that the changes
have no substantive effect on the tolerance, but rather are merely
intended to clarify the tolerance expression compliance component(s)
measurement.

V. Conclusion

    Therefore, tolerances are established for residues of the herbicide
halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2-
pyrimidiny)amino]carbonylaminosulfonyl]-3-chloro-1-methyl-1H-pyrazole-
4-carboxylate, including its metabolites and degradates, in or on pea
and bean, succulent shelled, subgroup 6B; vegetable, tuberous and corm,
subgroup 1C; bushberry, subgroup 13-07B; apple; rhubarb; and okra at
0.05 ppm. Compliance with the tolerance level specified below is to be
determined by measuring only halosulfuron-methyl.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule 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 final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., 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 section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule 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 section 408(n)(4) of FFDCA. 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 final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: July 26, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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

0
2. Section 180.479 is amended as follows:
0
i. Revise the introductory text in paragraphs (a)(1) and (a)(2);
0
ii. In paragraph (a)(2), in the table, revise the commodity Bean, snap,
succulent to read Pea and bean, succulent shelled, subgroup 6; and
0
iii. Alphabetically add the following commodities to the table in
paragraph (a)(2) to read as follows:

Sec.  180.479  Halosulfuron-methyl; tolerances for residues.

     (a) * * * (1) Tolerances are established for residues of the
herbicide halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2-
pyrimidiny)amino] carbonylaminosulfonyl]-3-chloro-1-methyl-1H-pyrazole-
4-carboxylate, including its metabolites and degradates, in or on the
commodities in the following table. Compliance with the tolerance
levels specified in the following table is to be determined by
measuring only those halosulfuron-methyl residues containing the 3-
chlorosulfonamide (3-CSA) moiety, expressed as the stoichiometric
equivalent of halosulfuron-methyl, in or on the commodity.
* * * * *
     (2) Tolerances are established for residues of the herbicide
halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2-
pyrimidiny)amino]carbonylaminosulfonyl]-3-chloro-1-methyl-1H-pyrazole-
4-carboxylate, including its metabolites and degradates, in or on the
commodities in the following table. Compliance with the tolerance
levels specified in the following table is to be determined by
measuring only halosulfuron-methyl.

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Apple................................................               0.05
                                * * * * *
Bushberry, subgroup 13-07B...........................               0.05
                                * * * * *
Okra.................................................               0.05

                                * * * * *
Pea and bean, succulent shelled, subgroup 6B.........               0.05
                                * * * * *
Rhubarb..............................................               0.05
                                * * * * *
Vegetable, tuberous and corm, subgroup 1C............               0.05
------------------------------------------------------------------------

* * * * *

[FR Doc. 2010-19053 Filed 8-3-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register: March 3, 2009 (Volume 74, Number 40)]
[Notices]
[Page 9236-9238]
[DOCID:fr03mr09-44]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

February 23, 2009.
    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER07-521-008.
    Applicants: New York Independent System Operator, Inc.

    Description: New York Independent System Operator, Inc. Submits
Compliance Filing.
    Filed Date: 02/18/2009.
    Accession Number: 20090219-0291.
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 11, 2009.

    Docket Numbers: ER07-1332-003.
    Applicants: Smoky Hills Wind Farm, LLC.
    Description: Supplemental Information to April 2008 Change in
Status Filing and Request for Shortened Notice Period of Smoky Hills
Wind Farm, LLC.
    Filed Date: 02/20/2009.
    Accession Number: 20090220-5146.
    Comment Date: 5 p.m. Eastern Time on Monday, March 02, 2009.

    Docket Numbers: ER08-1377-001.
    Applicants: Xcel Energy Services Inc.
    Description: Northern States Power Co--MN & Northern States Power
Co--WI Submits Revised Versions of Certain Service Agreements to Rate
Schedule Transmission Service Tm-1 Relating to Implementation of the
Midwest ISO Ancillary Services Market etc.
    Filed Date: 02/19/2009.
    Accession Number: 20090220-0179.
    Comment Date: 5 p.m. Eastern Time on Thursday, March 12, 2009.

    Docket Numbers: ER08-1574-002.
    Applicants: ORNI 18, LLC.
    Description: ORNI 18, LLC submits Notice of Non-Material Change in
Status.
    Filed Date: 02/19/2009.
    Accession Number: 20090219-5044.
    Comment Date: 5 p.m. Eastern Time on Thursday, March 12, 2009.

    Docket Numbers: ER08-1591-001.
    Applicants: California Independent System Operator Corporation.
    Description: California Independent System Operator Corporation
Submits Instant Filing in Compliance with FERC's 12/30/08 Letter.
    Filed Date: 01/29/2009.
    Accession Number: 20090202-0542.
    Comment Date: 5 p.m. Eastern Time on Monday, March 02, 2009.

    Docket Numbers: ER09-169-001.
    Applicants: California Independent System Operator Corporation.
    Description: California Independent System Operator Corp Submits
Substitute Second Revised Sheet 20.00 et al. to FERC Electric Tariff,
Third Replacement Volume 1 in Compliance with the Commission's 12/30/08
Order.
    Filed Date: 01/28/2009.
    Accession Number: 20090129-0224.
    Comment Date: 5 p.m. Eastern Time on Monday, March 02, 2009.

    Docket Numbers: ER09-507-001.
    Applicants: PSEG Power Connecticut LLC.
    Description: PSEG Power Connecticut LLC Submits Revised Reliability
Must-run Agreements with ISO New England Inc for Power Connecticut's et
al.
    Filed Date: 02/18/2009.
    Accession Number: 20090219-0286.
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 11, 2009.

    Docket Numbers: ER09-552-001.
    Applicants: Goldfinch Capital Management, LP.
    Description: Goldfinch Capital Management, LP Submits Petition for
Acceptance of Initial Tariff and Waivers.
    Filed Date: 02/19/2009.
    Accession Number: 20090220-0297.
    Comment Date: 5 p.m. Eastern Time on Thursday, March 12, 2009.

    Docket Numbers: ER09-564-001.
    Applicants: PJM Interconnection, LLC.
    Description: PJM Interconnection, LLC submits Sub. Original Service
Agreement 2085 that Supersedes Original Service Agreement 2085,
Substituting the Name DPL Energy, LLC for DP&L in the Agreement.
    Filed Date: 02/18/2009.
    Accession Number: 20090219-0290.
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 11, 2009.

    Docket Numbers: ER09-594-001.
    Applicants: Coaltrain Energy LP.
    Description: Coaltrain Energy LP Submits Substitute Original Sheets
1 and 2 and Revised Attachment A.
    Filed Date: 02/19/2009.
    Accession Number: 20090220-0296.
    Comment Date: 5 p.m. Eastern Time on Thursday, March 12, 2009.

    Docket Numbers: ER09-595-001.
    Applicants: Gotham Energy Marketing, LP.
    Description: Gotham Energy Marketing LP Submits Substitute Tariff
Sheets and Revised Attachment A.
    Filed Date: 02/19/2009.
    Accession Number: 20090220-0294.
    Comment Date: 5 p.m. Eastern Time on Thursday, March 12, 2009.

    Docket Numbers: ER09-596-001.
    Applicants: Silverado Energy LP.
    Description: Silverado Energy LP Submits Substitute Original Sheets
1 and 2 and Revised Attachment A.
    Filed Date: 02/19/2009.
    Accession Number: 20090220-0292.
    Comment Date: 5 p.m. Eastern Time on Thursday, March 12, 2009.

    Docket Numbers: ER09-597-001.
    Applicants: Rockpile Energy LP.
    Description: Rockpile Energy LP Submits Substitute Tariff Sheets
and Revised Attachment A.
    Filed Date: 02/19/2009.
    Accession Number: 20090220-0293.
    Comment Date: 5 p.m. Eastern Time on Thursday, March 12, 2009.

    Docket Numbers: ER09-598-001.
    Applicants: Big Bog Energy, LP.
    Description: Big Bog Energy LP Submits Substitute Original Sheets 1
and 2 and Revised Attachment A.
    Filed Date: 02/19/2009.
    Accession Number: 20090220-0295.
    Comment Date: 5 p.m. Eastern Time on Thursday, March 12, 2009.

    Docket Numbers: ER09-626-001.
    Applicants: Participating Transmission Owners Administrative
Committee.
    Description: SSP Administrative Committee Request Waiver of Certain
Business Practice Standards of the NAESB, etc.
    Filed Date: 02/18/2009.
    Accession Number: 20090219-0287.
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 11, 2009.

    Docket Numbers: ER09-712-000.
    Applicants: High Lonesome Mesa, LLC.
    Description: Petition of High Lonesome Mesa, LLC for Order
Accepting Market-Based Rate Tariff for Filing and Granting Waivers and
Blanket Approvals.
    Filed Date: 02/18/2009.
    Accession Number: 20090219-0292.
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 11, 2009.

    Docket Numbers: ER09-727-000.
    Applicants: Central Illinois Light Company.
    Description: Central Illinois Light Company Submits Boundary Line
Agreement between AmerenCILCO and the City of Springfield, IL et al.
requesting an effective date of 4/19/09 for the Boundary Line
Agreement.
    Filed Date: 02/18/2009.
    Accession Number: 20090219-0288.
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 11, 2009.

    Docket Numbers: ER09-728-000.
    Applicants: Twin Cities Energy, LLC.
    Description: Twin Cities Energy, LLC Submits Notice of Succession
to the Tariff of Alberta Power, LLC.
    Filed Date: 02/18/2009.
    Accession Number: 20090219-0289.
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 11, 2009.

    Docket Numbers: ER09-729-000.
    Applicants: Avista Corporation.
    Description: Avista Corp Submits Revisions to its Electric Tariff
Volume 11 for the Sale, Assignments, or Transfer of Transmission
Rights, etc.
    Filed Date: 02/19/2009.
    Accession Number: 20090220-0291.
    Comment Date: 5 p.m. Eastern Time on Thursday, March 12, 2009.

    Docket Numbers: ER09-730-000.
    Applicants: PJM Interconnection LLC.

    Description: PJM Interconnection Submits Revised Tariff Sheets of
their Open Access Transmission Tariff.
    Filed Date: 02/19/2009.
    Accession Number: 20090220-0290.
    Comment Date: 5 p.m. Eastern Time on Thursday, March 12, 2009.

    Docket Numbers: ER09-731-000.
    Applicants: Illinois Power Company.
    Description: Ameren Services Company Submits Construction Agreement
between AmerenIP and the Exelon Generation Company, LLC.
    Filed Date: 02/19/2009.
    Accession Number: 20090220-0298.
    Comment Date: 5 p.m. Eastern Time on Thursday, March 12, 2009.
    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E9-4383 Filed 3-2-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 27 (Friday, February 8, 2019)]
[Rules and Regulations]
[Pages 2707-2709]
[FR Doc No: 2019-00858]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0635; Product Identifier 2017-NM-183-AD; Amendment
39-19490; AD 2018-23-04]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc., Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Bombardier, Inc., Model DHC-8-102, -103, and -106 airplanes; Model DHC-
8-200 series airplanes; and Model DHC-8-300 series airplanes. This AD
was prompted by a report that a certain modification to the auto
relight system is incompatible with a certain beta lockout system
modification and could result in de-activation of the auto ignition
feature of the No. 2 engine. This AD requires an inspection of the auto
ignition system and applicable rectification. We are issuing this AD to
address the unsafe condition on these products.

DATES: This AD is effective March 15, 2019.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of March 15,
2019.

ADDRESSES: For service information identified in this final rule,
contact Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt
Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>internet
http://www.bombardier.com. You may view this service information at the
FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA.
For information on the availability of this material at the FAA, call
206-231-3195. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0635.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0635; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the regulatory evaluation, any comments received, and
other information. The address for Docket Operations (phone: 800-647-
5527) is U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Joe Catanzaro, Aerospace Engineer,
Airframe and Propulsion Section, FAA, New York ACO Branch, 1600 Stewart
Avenue, Suite 410, Westbury, NY 11590; telephone<PHONE_NUMBER>; fax 516-
794-5531; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain Bombardier, Inc.,
Model DHC-8-102, -103, and -106 airplanes; Model DHC-8-200 series
airplanes; and Model DHC-8-300 series airplanes. The NPRM published in
the Federal Register on July 23, 2018 (83 FR 34800). The NPRM was
prompted by a report that a certain modification to the auto relight
system is incompatible with a certain beta lockout system modification
and could result in de-activation of the auto ignition feature of the
No. 2 engine. The NPRM proposed to require an inspection of the auto
ignition system and applicable rectification. We are issuing this AD to
address unintentional de-activation of the auto ignition feature of the
No. 2 engine when the beta lockout system is activated, which could
result in an uncommanded in-flight shutdown of the No. 2 engine.
    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian AD CF-2017-21R1, dated June
28, 2017 (referred to after this as the Mandatory Continuing
Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for certain Bombardier, Inc., Model DHC-8-102, -103, and -106
airplanes; Model DHC-8-200 series airplanes; and Model DHC-8-300 series
airplanes. The MCAI states:

    During the incorporation of the Auto Relight modification per
Bombardier SB [Service Bulletin] 8-74-02 on an aeroplane with a Beta
Lockout System (BLS) installed, it was noticed that if SB 8-74-02 is
incorporated in conjunction with, or after the incorporation of BLS
SB 8-76-35 ([Canadian] AD CF-2013-15) or SB 8-76-24 (FAA AD 2000-02-
13 [Amendment 39-11531 (65 FR 4095, January 26, 2000)]), the #2
engine auto ignition function of the beta lockout system will not be
available when the beta lockout system is activated. This condition,
if not corrected, may result in a #2 engine uncommanded in-flight
shut down.
    To preclude any future occurrence of the noted deficiency,
Bombardier has issued SB 8-74-02 Revision B to highlight its
incompatibility with post SB 8-76-35 or 8-76-24 BLS compliant
aeroplanes. In addition, Bombardier issued a new SB, 8-74-06 for
Auto Relight System modification that can be incorporated in
conjunction with or on those aeroplanes that were previously
modified per SB 8-76-35 or 8-76-24.
    To address this potentially unsafe condition, Bombardier has
also issued SB 8-74-07 to inspect and rectify the system wiring on
affected aeroplanes.
    The original version of this [Canadian] AD was issued to mandate
compliance with the SB 8-74-07 requirements.
    Revision 1 of this [Canadian] AD is issued to clarify the
Applicability section and correct a typographic error in the SB
number referenced in the Corrective Action section of the original
[Canadian] AD.

    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0635.

Comments

    We gave the public the opportunity to participate in developing
this final rule. We have considered the comment received. The Air Line
Pilots Association, International (ALPA) indicated its support for the
NPRM.

Conclusion

    We reviewed the relevant data, considered the comment received, and
determined that air safety and the public interest require adopting
this final rule as proposed, except for minor

editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    Bombardier has issued Service Bulletin 8-74-07, dated April 13,
2016. This service information describes procedures for an inspection
to determine correct operation of the auto ignition system for
airplanes on which a beta lockout system was installed, and
rectification to re-activate a previously disabled auto ignition system
that will address inadvertent de-activation of the auto ignition
feature. This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 185 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Inspection............................  1 work-hour x $85 per                 $0             $85         $15,725
                                         hour = $85.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary on-condition
actions that would be required based on the results of the inspection.
We have no way of determining the number of aircraft that might need
this action:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Rectification.................................  3 work-hours x $85 per hour =                 $6            $261
                                                 $255.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes and
associated appliances to the Director of the System Oversight Division.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have 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.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2018-23-04 Bombardier, Inc.: Amendment 39-19490; Docket No. FAA-
2018-0635; Product Identifier 2017-NM-183-AD.

(a) Effective Date

    This AD is effective March 15, 2019.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bombardier, Inc., Model DHC-8-102, -103, -
106, -201, -202, -301, -311, and -315 airplanes, certificated in any
category, serial numbers 003 through 540 inclusive, on which
Bombardier Service Bulletin 8-74-02, dated March 3, 2000; or
Revision A, dated January 27, 2014; has been accomplished
concurrently with or after accomplishment of Bombardier Service
Bulletin 8-76-35 or 8-76-24.

(d) Subject

    Air Transport Association (ATA) of America Code 74, Ignition;
76, Engine Controls.

(e) Reason

    This AD was prompted by a report that a certain modification to
the auto relight system is incompatible with a certain beta lockout
system modification and could result in de-activation of the auto
ignition feature of the No. 2 engine. We are issuing this AD to
address unintentional de-activation of the auto ignition feature of
the No. 2 engine when the beta lockout system is activated, which
could result in an uncommanded in-flight shutdown of the No. 2
engine.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Inspection and Corrective Action

    Within 6,000 flight hours or 36 months, whichever occurs first,
after the effective date of this AD, inspect and, as applicable,
rectify the auto ignition system in accordance with the
Accomplishment Instructions of Bombardier Service Bulletin 8-74-07,
dated April 13, 2016.

(h) Credit for Previous Actions

    This paragraph provides credit for rectification required by
paragraph (g) of this AD, if those actions were performed before the
effective date of this AD using Bombardier In-Service Modification
Summary Package IS8Q7400001, Revision C, dated November 27, 2015.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO Branch, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your request to your principal
inspector or local Flight Standards District Office, as appropriate.
If sending information directly to the manager of the certification
office, send it to ATTN: Program Manager, Continuing Operational
Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Before
using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, New York ACO
Branch, FAA; or Transport Canada Civil Aviation (TCCA); or
Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If
approved by the DAO, the approval must include the DAO-authorized
signature.

(j) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) Canadian AD CF-2017-21R1, dated June 28, 2017, for related
information. This MCAI may be found in the AD docket on the internet
at http://www.regulations.gov by searching for and locating Docket
No. FAA-2018-0635.
    (2) For more information about this AD, contact Joe Catanzaro,
Aerospace Engineer, Airframe and Propulsion Section, FAA, New York
ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (3) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (k)(3) and (k)(4) of this AD.

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Bombardier Service Bulletin 8-74-07, dated April 13, 2016.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact
Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt
Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>internet
http://www.bombardier.com.
    (4) You may view this service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Des Moines, Washington, on October 26, 2018.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.

    Editorial Note: This document was received for publication by
the Office of the Federal Register on January 30, 2019.
[FR Doc. 2019-00858 Filed 2-7-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 184 (Friday, September 21, 2018)]
[Notices]
[Page 47949]
[FR Doc No: 2018-20742]

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

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

FEDERAL REGISTER CITATION OF PREVIOUS ANNOUNCEMENT: 83 FR 47215,
September 18, 2018.

PREVIOUSLY ANNOUNCED TIME AND DATE OF THE MEETING: Thursday, September
20, 2018 at 2:00 p.m.

CHANGES IN THE MEETING: The Closed Meeting scheduled for Thursday,
September 20, 2018 at 2:00 p.m. has been changed to Thursday, September
20, 2018 at 1:30 p.m.

CONTACT PERSON FOR MORE INFORMATION: For further information and to
ascertain what, if any, matters have been added, deleted or postponed,
please contact the Office of the Secretary at<PHONE_NUMBER>.

    Dated: September 19, 2018.
Brent J. Fields,
Secretary.
[FR Doc. 2018-20742 Filed 9-19-18; 4:15 pm]
 BILLING CODE 8011-01-P


[Federal Register: October 10, 2006 (Volume 71, Number 195)]
[Notices]
[Page 59545]
[DOCID:fr10oc06-92]

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

SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

In the Matter of Pretory USA, Inc. (n/k/a Sunrise Petroleum
Resources, Inc.); Order of Suspension of Trading

October 5, 2006.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Pretory USA, Inc. (n/k/a Sunrise Petroleum Resources, Inc.) because it
has not filed any periodic reports since it filed an amended Form 10-SB
on February 18, 2000.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed company.
    Therefore, it is ordered, pursuant to section 12(k) of the
Securities Exchange Act of 1934, that trading in the above-listed
company is suspended for the period from 9:30 a.m. EDT on October 5,
2006, through 11:59 p.m. EDT on October 18, 2006.

    By the Commission.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 06-8597 Filed 10-5-06; 11:50 am]

BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 126 (Tuesday, July 6, 2021)]
[Rules and Regulations]
[Pages 35389-35391]
[FR Doc No: 2021-14367]

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

DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 744

[Docket No.<PHONE_NUMBER>]
RIN 0694-AI52

Addition of Certain Entities to the Entity List; Correction of
Existing Entry on the Entity List

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule.

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

SUMMARY: This final rule amends the Export Administration Regulations
(EAR) by adding four entities to the Entity List. These four entities
have been determined by the U.S. Government to be acting contrary to
the foreign policy and national security interests of the United States
and will be listed on the Entity List under the destination of Burma.
This rule also amends the EAR by correcting the address of one entity,
listed under Burma, on the Entity List.

DATES: This rule is effective July 6, 2021.

FOR FURTHER INFORMATION CONTACT: Chair, End-User Review Committee,
Office of the Assistant Secretary for Export Administration, Bureau of
Industry and Security, Department of Commerce, Phone:<PHONE_NUMBER>,
Email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

Entity List

    The Entity List (supplement no. 4 to part 744 of the EAR)
identifies entities for which there is reasonable cause to believe,
based on specific and articulable facts, that the entities have been
involved, are involved, or pose a significant risk of being or becoming
involved in activities contrary to the national security or foreign
policy interests of the United States. The EAR (15 CFR parts 730-774)
impose additional license requirements on, and limit the availability
of most license exceptions for, exports, reexports, and transfers (in-
country) to listed entities. The license review policy for each listed
entity is identified in the ``License Review Policy'' column on the
Entity List, and the impact on the availability of license exceptions
is described in the relevant Federal Register document adding entities
to the Entity List. BIS places entities on the Entity List pursuant to
part 744 (Control Policy: End-User and End-Use Based) and part 746
(Embargoes and Other Special Controls) of the EAR.
    The End-User Review Committee (ERC), composed of representatives of
the Departments of Commerce (Chair), State, Defense, Energy and, where
appropriate, the Treasury, makes all decisions regarding additions to,
removals from, or other modifications to the Entity List. The ERC makes
all decisions to add an entry to the Entity List by majority vote and
makes all decisions to remove or modify an entry by unanimous vote.

Burma

    This rule is part of an ongoing effort by the United States
Government to impose restrictions on Burmese entities that support the
Burmese military as part of a broader response to the February 1, 2021
coup by the military, which overthrew Burma's democratically-elected
government. On February 10, 2021, President Biden signed Executive
Order (E.O.) 14014, ``Blocking Property With Respect to the Situation
in Burma'' (E.O. 14104), in which he declared a national emergency to
address the threat posed to the United States by the situation in, and
in relation to, Burma following the coup. See 86 FR 9429 (Feb. 12,
2021).
    Since February 2021, BIS has taken several actions under the EAR to
strengthen export controls on Burma. These include the publication of
``Burma: Implementation of Sanctions'' (86 FR 10011) on February 18,
2021; ``Burma: Implementation of Sanctions'' (86 FR 13173) on March 8,
2021; ``Addition of Entities to the Entity List'' (86 FR 13179) on
March 8, 2021; and ``Expansion of Certain End-Use and End-User Controls
and Controls on Specific Activities of U.S. Persons; Corrections; and
Burma Sanctions'' (86 FR 18433) on April 9, 2021.

ERC Entity List Decisions

Additions to the Entity List

    This rule implements the decision of the ERC to add four entities
to the Entity

List. The four entities are added based on Sec.  744.11 (License
requirements that apply to entities acting contrary to the national
security or foreign policy interests of the United States) of the EAR.
The four entities are located in Burma.
    By making these Entity List additions, this final rule further
strengthens export controls on Burma and addresses the foreign policy
and national security concerns that formed the basis for the issuance
of E.O. 14104. This rule also supports the United States Government's
efforts to promote an immediate return to democracy in Burma.
Specifically, BIS is adding the following four entities to the Entity
List under the destination of Burma: Wanbao Mining, Ltd. and its two
subsidiaries, Myanmar Wanbao Mining Copper, Ltd. and Myanmar Yang Tse
Copper, Ltd.; and King Royal Technologies Co., Ltd. In particular, by
adding Wanbao Mining, Ltd., Myanmar Wanbao Mining Copper, Ltd., and
Myanmar Yang Tse Copper, Ltd. to the Entity List, this rule enhances
the U.S. Government's efforts to ensure that items subject to the EAR
are not available for copper mining operations by these three entities,
which have revenue-sharing agreements with Myanmar Economic Holdings
Limited (MEHL). MEHL provides revenue for Burma's Ministry of Defence,
an entity responsible for the February 1, 2021 military coup. On March
8, 2021, BIS added MEHL and the Ministry of Defence to the Entity List.
See 86 FR 13179 (March 8, 2021). Additionally, BIS is adding King Royal
Technologies Co., Ltd., a telecommunications company, to the Entity
List for providing satellite communication services in support of the
Burmese military.
    Pursuant to Sec.  744.11(b) of the EAR, the ERC determined that the
conduct of the above-described four entities raises sufficient concerns
that prior review, via the imposition of a license requirement for
exports, reexports, or transfers (in-country) of all items subject to
the EAR involving these four entities and the possible issuance of
license denials or the possible imposition of license conditions on
shipments to these entities, will enhance BIS's ability to prevent
violations of the EAR or otherwise protect U.S. national security or
foreign policy interests.
    For the four entities added to the Entity List in this final rule,
BIS imposes a license requirement that applies to all items subject to
the EAR. In addition, no license exceptions are available for exports,
reexports, or transfers (in-country) to the persons being added to the
Entity List in this rule. BIS imposes a license review policy of a
presumption of denial for these four entities. The acronym ``a.k.a.,''
which is an abbreviation of `also known as,' is used in entries on the
Entity List to identify aliases, thereby assisting exporters,
reexporters and transferors in identifying entities on the Entity List.
    For the reasons described above, this final rule adds the following
four entities to the Entity List and includes, where appropriate,
aliases:

Burma

     King Royal Technologies Co., Ltd.;
     Myanmar Wanbao Mining Copper, Ltd.;
     Myanmar Yang Tse Copper, Ltd.; and
     Wanbao Mining, Ltd.

Correction to the Entity List

    This final rule implements a correction to one existing entry on
the Entity List for an entity that was added to the Entity List under
the destination of Burma on March 8, 2021 (86 FR 13180, March 8, 2021).
Specifically, BIS is correcting the entry for Myanmar Economic
Corporation by changing the address to refer to ``Burma.''

Savings Clause

    Shipments of items removed from eligibility for a License Exception
or export, reexport, or transfer (in-country) without a license (NLR)
as a result of this regulatory action that were en route aboard a
carrier to a port of export, reexport, or transfer (in-country), on
July 6, 2021, pursuant to actual orders for export, reexport, or
transfer (in-country) to or within a foreign destination, may proceed
to that destination under the previous eligibility for a License
Exception or export, reexport, or transfer (in-country) without a
license (NLR).

Export Control Reform Act of 2018

    On August 13, 2018, the President signed into law the John S.
McCain National Defense Authorization Act for Fiscal Year 2019, which
included the Export Control Reform Act of 2018 (ECRA) (50 U.S.C. 4801-
4852). ECRA provides the legal basis for BIS's principal authorities
and serves as the authority under which BIS issues this rule.

Rulemaking Requirements

    1. Executive Orders 13563 and 12866 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This rule has been determined to be not significant for
purposes of Executive Order 12866.
    2. Notwithstanding any other provision of law, no person is
required to respond to or be subject to a penalty for failure to comply
with a collection of information, subject to the requirements of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA), unless
that collection of information displays a currently valid Office of
Management and Budget (OMB) Control Number. This regulation involves
collections previously approved by OMB under control number 0694-0088,
Simplified Network Application Processing System, which includes, among
other things, license applications and commodity classification, and
carries a burden estimate of 29.6 minutes for a manual or electronic
submission for a total burden estimate of 31,835 hours. Total burden
hours associated with the PRA and OMB control number 0694-0088 are not
expected to increase as a result of this rule.
    3. This rule does not contain policies with Federalism implications
as that term is defined in Executive Order 13132.
    4. Pursuant to section 1762 of the Export Control Reform Act of
2018, this action is exempt from the Administrative Procedure Act (5
U.S.C. 553) requirements for notice of proposed rulemaking, opportunity
for public participation, and delay in effective date.
    5. Because a notice of proposed rulemaking and an opportunity for
public comment are not required to be given for this rule by 5 U.S.C.
553, or by any other law, the analytical requirements of the Regulatory
Flexibility Act, 5 U.S.C. 601, et seq., are not applicable.
Accordingly, no regulatory flexibility analysis is required and none
has been prepared.

List of Subjects in 15 CFR Part 744

    Exports, Reporting and recordkeeping requirements, Terrorism.
    Accordingly, part 744 of the Export Administration Regulations (15
CFR parts 730-774) is amended as follows:

PART 744--[AMENDED]

0
1. The authority citation for 15 CFR part 744 continues to read as
follows:

    Authority:  50 U.S.C. 4801-4852; 50 U.S.C. 4601 et seq.; 50
U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22
U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 12058, 43 FR 20947, 3 CFR,
1978 Comp., p. 179; E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p.
608; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 13026,
61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13099, 63 FR 45167, 3
CFR, 1998 Comp., p. 208; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp.,
p. 783; E.O. 13224, 66 FR 49079, 3 CFR, 2001 Comp., p. 786; Notice
of September 18, 2020, 85 FR 59641 (September 22, 2020); Notice of
November 12, 2020, 85 FR 72897 (November 13, 2020).

0
2. Supplement No. 4 to part 744 is amended under BURMA by:
0
a. Adding in alphabetical order an entry for ``King Royal Technologies
Co., Ltd.'';
0
b. Revising the listing for ``Myanmar Economic Corporation''; and
0
c. Adding in alphabetical order entries for ``Myanmar Wanbao Mining
Copper, Ltd.,'' ``Myanmar Yang Tse Copper, Ltd.,'' and ``Wanbao Mining,
Ltd.''.
    The additions and revision read as follows:

Supplement No. 4 to Part 744--Entity List

* * * * *

----------------------------------------------------------------------------------------------------------------
                                                                              License review    Federal Register
        Country                     Entity             License requirement        policy            citation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
BURMA..................                                         * * * * * *
                         King Royal Technologies Co.,  All items subject    Presumption of     86 FR [INSERT FR
                          Ltd., a.k.a., the following   to the EAR. (See     denial.            PAGE NUMBER AND
                          one alias:                    Sec.   744.11 of                        July 6, 2021].
                         --KRT.                         the EAR).
                         4, Min Dhama Rd., Shwe Gabar
                          6th St, Shwe Gabar Housing,
                          Mayangone, Yangon , Burma;
                          and
                         Room 4 Shwe Gabar 6th
                          Yangon, Burma.
                                                                * * * * * *
                         Myanmar Economic              For all items        Presumption of     86 FR 13180, 3/8/
                          Corporation, a.k.a., the      subject to the       denial.            2021. 86 FR
                          following one alias:          EAR. (See Sec.                          [INSERT FR PAGE
                         --MEC.                         744.11 of the                           NUMBER AND July
                                                        EAR).                                   6, 2021].
                         Corner of Ahlone Road and
                          Strand Road, Ahlone
                          Township, Yangon, Burma.
                                                                * * * * * *
                         Myanmar Wanbao Mining         All items subject    Presumption of     86 FR [INSERT FR
                          Copper, Ltd., Yangon Office   to the EAR. (See     denial.            PAGE NUMBER AND
                          70 (I)Bo Chein Street Pyay    Sec.   744.11 of                        July 6, 2021].
                          Road, Hlaing Township,        the EAR).
                          Yangon, Burma.
                         Myanmar Yang Tse Copper,      All items subject    Presumption of     86 FR [INSERT FR
                          Ltd., 70/I, Bo Chein St.,     to the EAR. (See     denial.            PAGE NUMBER AND
                          Ward (11), Hlaing, Yangon,    Sec.   744.11 of                        July 6, 2021].
                          Burma.                        the EAR).
                         Wanbao Mining, Ltd., 70 Bo    All items subject    Presumption of     86 FR [INSERT FR
                          Chain Ln, Yangon, Burma.      to the EAR. (See     denial.            PAGE NUMBER AND
                                                        Sec.   744.11 of                        July 6, 2021].
                                                        the EAR).

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

* * * * *

Matthew S. Borman,
Deputy Assistant Secretary for Export Administration.
[FR Doc. 2021-14367 Filed 7-2-21; 8:45 am]
BILLING CODE 3510-33-P