[Federal Register Volume 77, Number 148 (Wednesday, August 1, 2012)]
[Rules and Regulations]
[Pages 45498-45503]
[FR Doc No: 2012-18388]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0477; FRL-9354-7]

Pyrimethanil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
pyrimethanil in or on multiple commodities which are identified and
discussed later in this document. 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 1, 2012. Objections and
requests for hearings must be received on or before October 1, 2012,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION.)

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2011-0477, is available at http://www.regulations.gov or at the OPP Docket in the Environmental
Protection Agency Docket Center (EPA/DC), located in EPA West, Rm.
3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division
(7509P) Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
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://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2011-0477 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 1, 2012. 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-2011-0477, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.

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

II. Summary of Petitioned-For Tolerance

    In the Federal Register of July 20, 2011 (76 FR 43231) (FRL-8880-
1), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 1E7861)
by IR-4,500 College Road East, Suite 201W, Princeton, NJ 08540. The
petition requested that 40 CFR 180.518 be amended by establishing
tolerances for residues of the fungicide pyrimethanil (4,6-dimethyl-N-
phenyl-2-pyrimidinamine) in or on the raw agricultural commodities
onion, bulb, subgroup 03-07A at 0.1 parts per million (ppm), onion,
green, subgroup 03-07B at 2.0 ppm, berry and small fruit, small fruit
vine climbing subgroup, except fuzzy kiwifruit 13-07F at 5.0 ppm, berry
and small fruit, low growing berry subgroup 13-07G at 3.0 ppm and
ginseng at 2.5 ppm. That notice referenced a summary of the petition
prepared by Bayer CropScience, the registrant, which is available in
the docket, http://www.regulations.gov. There were no comments received
in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has
modified the levels at which tolerances are being established for some
of the commodities. The reason for this change is explained in Unit
IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. * *
*''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for pyrimethanil including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with pyrimethanil follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Pyrimethanil is of low acute lethality by the oral, dermal, and
inhalation routes. It is a slight eye irritant, is not irritating to
the skin, and it is not a dermal sensitizer. A single oral dose of
1,000 milligrams/kilogram (mg/kg) produced a number of acute signs of
neurotoxicity, including ataxia, dilated pupils, and decreases in motor
activity, hind limb grip strength, and body temperature. However, there
was no evidence of neurotoxicity with repeated dosing in a subchronic
neurotoxicity study in rats. Exposure to pyrimethanil in oral toxicity
studies primarily resulted in decreased body weights and body-weight
gain, often accompanied by decreases in food consumption. The major
target organs of repeated oral exposure were the liver and the thyroid.
No reproductive toxicity was observed, and developmental effects (e.g.,
decreased fetal weight, retarded ossification, extra ribs) were
observed only at maternally toxic doses. Special short-term exposure
studies demonstrated increased liver uridine diphosphate glucuronosyl
transferase (UDPGT) activity leading to decreases in thyroid hormones
(T3, T4) and compensatory increases in thyroid stimulating hormone
(TSH) in adult rats. Thyroid adenomas were seen in rats following long-
term exposure, and it was concluded that they were mediated via
disruption of the thyroid/pituitary axis. There were no concerns for
mutagenicity.
    The EPA has classified pyrimethanil as ``Not Likely To Be
Carcinogenic To Humans At Doses That Do Not Alter Rat Thyroid Hormone
Homeostasis.'' This decision was based on the following:
    1. There were treatment-related increases in thyroid follicular
cell tumors in male and female Sprague-Dawley rats at doses which were
considered adequate to assess carcinogenicity.
    2. There were no treatment-related tumors were seen in male or
female CD-1 mice at doses which were considered adequate to assess
carcinogenicity.
    3. There is no mutagenicity concern and there is no evidence for
thyroid carcinogenesis mediated through a mutagenic mode of action.
    4. The non-neoplastic toxicological evidence (i.e., thyroid growth,
thyroid hormonal changes) indicated that pyrimethanil was inducing a
disruption in the thyroid-pituitary hormonal status. The overall
weight-of-evidence was considered sufficient to indicate that
Pyrimethanil induced thyroid follicular tumors through an antithyroid
mode of action.
    5. Rats are substantially more sensitive than humans to the
development of thyroid follicular cell tumors in response to thyroid
hormone imbalance. EPA determined that quantification of carcinogenic
risk is not required since the thyroid tumors arise through a non-
linear mode of action and the no observed adverse effect level (NOAEL)
(17 mg/kg/day) established for deriving the chronic reference dose
(cRfD) is not expected to alter thyroid hormone homeostasis nor result
in thyroid tumor formation.
    Specific information on the studies received and the nature of the
adverse effects caused by pyrimethanil as well as the NOAEL and the
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies
can be found at http://www.regulations.gov in the document titled
``Pyrimethanil Human-Health Risk Assessment for Proposed Uses on

Ginseng, Bulb Onion Subgroups 3-07A and B, and Small Berry Subgroups
13-07F and G,'' pp. 32-34 in docket ID number EPA-HQ-OPP-2011-0477.

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 pyrimethanil used for
human risk assessment is shown in the Table of this unit.

 Table 1.--Summary of Toxicological Doses and Endpoints for Pyrimethanil for Use in Human Health Risk Assessment
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                                     Point of departure and
         Exposure/scenario              uncertainty/safety   RfD, PAD, LOC for risk    Study and toxicological
                                             factors                assessment                 effects
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Acute dietary (Females 13-49 years   NOAEL = 45 mg/kg/day..  Acute RfD = 0.45 mg/kg/ Developmental Toxicity--
 of age).                            UFA = 10X.............   day.                    Rabbit:
                                     UFH = 10X.............  aPAD = 0.45 mg/kg/day.  LOAEL = 300 mg/kg/day based
                                     FQPA SF = 1X..........                           on increases in fetuses
                                                                                with 13 thoracic vertebrae
                                                                                and 13 pairs of ribs.
Acute dietary (General population    NOAEL = 100 mg/kg/day.  Acute RfD = 1 mg/kg/    Acute Neurotoxicity--Rat:
 including infants and children).    UFA = 10X.............   day.                   LOAEL = 1,000 mg/kg/day
                                     UFH = 10X.............  aPAD = 1 mg/kg/day....   based on decreased motor
                                     FQPA SF = 1X..........                           activity, ataxia,
                                                                                decreased body
                                                                                temperature, hind limb
                                                                                grip strength, and dilated
                                                                                pupils.
Chronic dietar (All populations)...  NOAEL= 17 mg/kg/day...  Chronic RfD = 0.17 mg/  Chronic Toxicity--Rat:
                                     UFA = 10X.............   kg/day.                LOAEL = 221 mg/kg/day based
                                     UFH = 10X.............  cPAD = 0.17 mg/kg/day.   on decreased body-weight
                                     FQPA SF = 1X..........                           gains; increased serum
                                                                                cholesterol and GGT,
                                                                                increased relative liver/
                                                                                body weight ratios,
                                                                                necropsy and
                                                                                histopathological findings
                                                                                in the liver and thyroid.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population-adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to pyrimethanil, EPA considered exposure under the petitioned-
for tolerances as well as all existing pyrimethanil tolerances in 40
CFR 180.518. EPA assessed dietary exposures from pyrimethanil 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 pyrimethanil. 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 default processing factors (as necessary),
empirical processing factors for orange and apple juice, tolerance
level residues and 100 percent crop treated (PCT) for all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assumed default
processing factors (as necessary), empirical processing factors for
orange and apple juice, tolerance level residues and 100 PCT for all
commodities.
    iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
Cancer risk is quantified using a linear or nonlinear approach. If
sufficient information on the carcinogenic mode of action is available,
a threshold or nonlinear approach is used and a cancer RfD is
calculated based on an earlier noncancer key event. If carcinogenic
mode of action data are not available, or if the mode of action data
determines a mutagenic mode of action, a default linear cancer slope
factor approach is utilized. Based on the data summarized in Unit
III.A., EPA has concluded that a nonlinear RfD approach is appropriate
for assessing cancer risk to pyrimethanil. Cancer risk was assessed
using the same exposure estimates as discussed in Unit III.C.1.ii.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for pyrimethanil. 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 pyrimethanil in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of pyrimethanil. 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 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
pyrimethanil for acute exposures are estimated to be 86.5 parts per
billion (ppb) for surface water and 4.8 ppb for ground water. For
chronic exposures for non-cancer assessments, they are estimated to be
29.4 ppb for surface water and 4.8 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model.
    For acute dietary risk assessment, the water concentration value of
86.5 ppb was used to assess the contribution to drinking water.
    For chronic dietary risk assessment, the water concentration of
value 29.4 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).
    Pyrimethanil is not registered for any specific use patterns that
would result in residential exposure.
    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 pyrimethanil to share a common mechanism of
toxicity with any other substances, and pyrimethanil does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
pyrimethanil 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 Web site 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
toxicology database for pyrimethanil 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 evidence of
increased quantitative or qualitative susceptibility of fetuses or
offspring following exposure to pyrimethanil in these studies.
    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 toxicology database for pyrimethanil is complete.
    ii A guideline immunotoxicity study has been submitted, and there
is no evidence for immunotoxicity due to pyrimethanil treatment.
Evidence of neurotoxicity was observed at a very high dose (the limit
dose) in the acute neurotoxicity study in rats. However, the study has
a clear NOAEL, which is being utilized as the POD for the acute dietary
exposure scenario, and there was no evidence of neurotoxicity observed
in the subchronic neurotoxicity study in rats up to the highest dose
tested in that study (430 mg/k/day). A developmental neurotoxicity
(DNT) study is not required.
    iii. There is no evidence that pyrimethanil results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. Thyroid has been shown to be one of the target organs in adult
animals for pyrimethanil-induced toxicity thus raising a potential
concern for thyroid toxicity in the young. EPA, however, concluded that
there is no concern for thyroid toxicity in the young based on the
following weight of evidence considerations: the effects seen on the
thyroid and the liver in the database, while treatment-related, are not
severe in nature; and in each of the studies that show an effect on
thyroid hormone levels, as well as in all studies chosen for PODs
selection, there is a wide dose spread (~10-fold difference between
NOAELs and LOAELs) which provides a measure of protection for any
potential effects linked to decreased thyroid hormone levels in
offspring.
    v. There are no residual uncertainties with respect to exposure
data. The dietary food exposure assessment utilizes tolerance-level
residues (established or recommended) and 100 PCT for all proposed/
established commodities. By using these assumptions, the acute and
chronic exposures/risks will not be underestimated. The dietary
drinking water assessment utilizes water concentration values generated
by models and associated modeling parameters that are designed to
provide conservative, health-protective, high-end estimates of water
concentrations that will not likely be exceeded. These assessments will
not underestimate the exposure and risks posed by pyrimethanil.

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 population adjusted dose (aPAD) and chronic population adjusted
dose (cPAD). For linear cancer risks, EPA calculates the lifetime
probability of acquiring cancer given the estimated aggregate exposure.
Short-, intermediate-, and chronic-term risks are evaluated by
comparing the estimated aggregate food, water, and residential exposure
to the appropriate PODs to ensure that an adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to pyrimethanil will occupy 35% of the aPAD for all infants <1 year
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
pyrimethanil from food and water will utilize 64% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. There are no residential uses for pyrimethanil.
    3. Short-and intermediate-term risk. Short-term and intermediate-
term aggregate exposure takes into account short-and intermediate-term
residential exposure plus chronic exposure to food

and water (considered to be a background exposure level). A short-and
intermediate-term adverse effect was identified; however, pyrimethanil
is not registered for any use patterns that would result in short- and/
or intermediate-term residential exposure. Short-and intermediate-term
risk is assessed based on short-and intermediate-term residential
exposure plus chronic dietary exposure. Because there is no short-and
intermediate-term residential exposure and chronic dietary exposure has
already been assessed under the appropriately protective cPAD (which is
at least as protective as the POD used to assess short-and
intermediate-term risk), no further assessment of short-and
intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating short-and intermediate-term risk
for pyrimethanil.
    4. Aggregate cancer risk for U.S. population. The Agency determined
that the thyroid tumors seen in rat studies arise through a non-linear
mode of action and the NOAEL (17 mg/kg/day) established for deriving
the cRfD is not expected to alter thyroid hormone homeostasis nor
result in thyroid tumor formation. Thus, the chronic risk assessment
addresses any cancer risk.
    5. 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 pyrimethanil residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology high-performance liquid
chromatography (HPLC) is available to enforce the tolerance expression.
The method may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has established MRLs for pyrimethanil in or on strawberry
at 3 ppm, bulb onions at 0.2 ppm, and spring onion at 3 ppm. These MRLs
are the same as the tolerances established by this rule for
pyrimethanil on the low growing berry subgroup 13-07G, the bulb onion
subgroup 3-07A, and the green onion subgroup 3-07B in the United
States.
    The Codex has established an MRL for pyrimethanil in or on grapes
at 4 ppm which is less than tolerance of 5.0 ppm set on the small vine
climbing fruit subgroup 13-07F of which grape is a member. The reason
for this is due to the fact that the European PHI is 21 days and the
U.S. PHI is 7 days. Residues are thus higher in U.S. residue trials,
necessitating a higher tolerance.

C. Revisions to Petitioned-For Tolerances

    Using the Organization for Economic Co-operation and Development
(OECD) tolerance calculation procedures for the residue data set
indicates that the requested tolerance of 2.5 ppm for residues of
pyrimethanil in/on ginseng is too high and that a tolerance of 1.5 ppm
is appropriate. Also, the tolerance levels for the bulb onion subgroup
3-07A and green onion subgroup 3-07B were modified to harmonize with
existing Codex Maximum Residue Levels (MRLs). Lastly, EPA has revised
the tolerance expressions to clarify:
    1. That, as provided in FFDCA section 408(a)(3), the tolerance
covers metabolites and degradates of pyrimethanil not specifically
mentioned; and
    2. That compliance with the specified tolerance levels is to be
determined by measuring only the specific compounds mentioned in the
tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of pyrimethanil
(4,6-dimethyl-N-phenyl-2-pyrimidinamine) in or on onion, bulb, subgroup
03-07A at 0.20 ppm; onion, green, subgroup 03-07B at 3.0 ppm; fruit,
small, vine climbing subgroup 13-07F, except fuzzy kiwifruit 13-07F at
5.0 ppm; berry, low growing, subgroup 13-07G at 3.0 ppm and ginseng at
1.5 ppm.
    Also, due to the tolerances established in this unit by this
document, the following existing tolerances are removed as unnecessary;
strawberry; grape; onion, bulb; and onion, green.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this 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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination

with Indian Tribal Governments'' (65 FR 67249, November 9, 2000) do not
apply to this 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) (Pub. L.
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 18, 2012.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Section 180.518 is amended as follows:
0
a. Revising the introductory text to paragraph (a)(1);
0
b. Removing the entries for ``Grape''; ``Onion, bulb''; and ``Onion,
green; and ``Strawberry'' from the table in paragraph (a)(1);
0
c. Alphabetically adding the following commodities to the table in
paragraph (a)(1); and
0
d. Revising the introductory text for paragraphs (a)(2) and (3).
    The amendments read as follows:

Sec.  180.518  Pyrimethanil; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the
fungicide pyrimethanil, 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 pyrimethanil (4,6-dimethyl-N-phenyl-2-pyrimidinamine).

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

                                * * * * *
Berry, low growing, subgroup 13-07G.........................         3.0

                                * * * * *
Fruit, small, vine climbing, subgroup 13-07F, except fuzzy           5.0
 kiwifruit..................................................

                                * * * * *
Ginseng.....................................................         1.5

                                * * * * *
Onion, bulb, subgroup 3-07A.................................         2.0
Onion, green, subgroup 3-07B................................         3.0

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

     (2) Tolerances are established for residues of the fungicide
pyrimethanil, 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 the sum of pyrimethanil and its metabolite 4-[4,6-
dimethyl-2-pyrimidinyl)amino]phenol, calculated as the stoichiometric
equivalent of pyrimethanil.
* * * * *
    (3) Tolerances are established for residues of the fungicide
pyrimethanil, 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 the sum of pyrimethanil and its metabolite 4,6-dimethyl-
2-(phenylamino)-5-pyrimidinol, calculated as the stoichiometric
equivalent of pyrimethanil.
* * * * *
[FR Doc. 2012-18388 Filed 7-31-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)]
[Notices]
[Pages 49128-49130]
[FR Doc No: 2018-21158]

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

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2009-0025]

Underwriters Laboratories, Inc.: Grant of Expansion of
Recognition and Modification to the Nationally Recognized Testing
Laboratory (NRTL) Program's List of Appropriate Test Standards

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice.

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

SUMMARY: In this notice, OSHA announces the final decision to expand
the scope of recognition for Underwriters Laboratories, Inc., (UL) as a
NRTL to include 26 additional test standards. In addition, OSHA
announces the addition of 22 test standards to the NRTL Program's List
of Appropriate Test Standards.

DATES: The expansion of the scope of recognition becomes applicable on
September 28, 2018.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, U.S. Department of Labor, telephone:<PHONE_NUMBER>;
email: [email protected].
    General and technical information: Contact Mr. Kevin Robinson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration, U.S. Department of Labor, phone:
(202) 693-2110 or email: [email protected]. OSHA's web page
includes information about the NRTL Program (see http://www.osha.gov/dts/otpca/nrtl/index.html).

SUPPLEMENTARY INFORMATION:

I. Notice of Final Decision

    OSHA hereby gives notice of the expansion of the scope of
recognition of Underwriters Laboratories, Inc., as a NRTL. UL's
expansion covers the addition of 26 test standards to its scope of
recognition.
    OSHA recognition of a NRTL signifies that the organization meets
the requirements specified by 29 CFR 1910.7. Recognition is an
acknowledgment that the organization can perform independent safety
testing and certification of the specific products covered within the
scope of recognition and is not a delegation or grant of government
authority. As a result of recognition, employers may use products
properly approved by the NRTL to meet OSHA standards that require
testing and certification of the products.
    The agency processes applications by a NRTL for initial
recognition, or for expansion or renewal of this recognition, following
requirements in Appendix A to 29 CFR 1910.7. This appendix requires the
Agency publish two notices in the Federal Register in processing an
application. In the first notice, OSHA announces the application and
provides a preliminary finding and, in the second notice, the Agency
provides the final decision on the application. These notices set forth
the NRTL's scope of recognition or modifications of that scope. OSHA
maintains an informational web page for each NRTL that details its
scope of recognition. These pages are available from the agency's
website at http://www.osha.gov/dts/otpca/nrtl/index.html.
    UL submitted an application, dated May 31, 2017, (OSHA-2009-0025-
0020) to expand its recognition to include 26 additional test
standards. This application was updated on November 1, 2017, (OSHA-
2009-0025-0021) to include an additional standard, for a total of 27
standards. OSHA determined that one of the standards requested in UL's
application, UL 2703, ``Standard for Mounting System, Mounting Devices,
Clamping/Retention Devices, and Ground Lugs for Use with Flat-Plate
Photovoltaic Modules and Panels,'' does not meet the requirements for
an appropriate test standard in 29 CFR 1910.7; indeed, this standard is
not included on the NRTL Program's List of Appropriate Test Standards.
The types of products covered by UL 2703 do not fit into any of the
categories covered by OSHA's NRTL Program. Specifically, the standard
covers mechanical products, while OSHA's NRTL Program addresses mainly
electrical end products. Accordingly, OSHA declines to add UL 2703 to
the NRTL Program's List of Appropriate Test Standards and rejects UL's
application to add the standard to its scope of recognition. OSHA staff
performed a detailed analysis of the application packet and reviewed
other pertinent information. OSHA did not perform any on-site reviews
in relation to this application.
    OSHA published the preliminary notice announcing UL's expansion
application in the Federal Register on April 20, 2018, (83 FR 17568).
The agency requested comments by May 7, 2018, but it received no timely
comments in response to this notice. OSHA is now proceeding with this
final notice to grant expansion of UL's scope of recognition.
    To obtain or review copies of all public documents pertaining to
UL's application, go to http://www.regulations.gov or contact the
Docket Office, Occupational Safety and Health Administration, U.S.
Department of Labor, 200 Constitution Avenue NW, Room N-3653,
Washington, DC 20210. Docket No. OSHA-2009-0025 contains all materials
in the record concerning UL's recognition.

II. Final Decision and Order

    OSHA staff examined UL's expansion application, capability to meet
the requirements of the test standards, and other pertinent
information. Based on a review of this evidence, OSHA finds that UL
meets the requirements of 29 CFR 1910.7 for expansion of its
recognition, subject to the specified limitation and conditions listed
below. OSHA, therefore, is proceeding with this final notice to grant
UL's scope of recognition. OSHA limits the expansion of UL's
recognition to testing and certification of products for demonstration
of conformance to the test standards listed, below in Table 1.

 Table 1--List of Appropriate Test Standards for Inclusion in UL's NRTL
                          Scope of Recognition
------------------------------------------------------------------------
          Test standard                     Test standard title
------------------------------------------------------------------------
TIA 4950 *......................  Requirements for Battery-Powered,
                                   Portable Land Mobile Radio
                                   Applications in Class I, II, and III,
                                   Division 1, Hazardous (Classified)
                                   Locations.
UL 25A *........................  Standard for Meters for Gasoline and
                                   Gasoline/Ethanol Blends with Nominal
                                   Ethanol Concentrations up to 85
                                   Percent (E0-E85).

UL 25B *........................  Meters for Diesel Fuel, Biodiesel
                                   Fuel, Diesel/Biodiesel Blends with
                                   Nominal Biodiesel Concentrations up
                                   to 20 Percent (B20), Kerosene, and
                                   Fuel Oil.
UL 79A *........................  Standard for Power-Operated Pumps for
                                   Gasoline and Gasoline/Ethanol Blends
                                   with Nominal Ethanol Concentrations
                                   up to 85 Percent (E0-E85).
UL 79B *........................  Standard for Power-Operated Pumps for
                                   Diesel Fuel, Biodiesel Fuel, Diesel/
                                   Biodiesel Blends with Nominal
                                   Biodiesel Concentrations up to 20
                                   Percent (B20), Kerosene, and Fuel
                                   Oil.
UL 87A *........................  Standard for Power-Operated Dispensing
                                   Devices for Gasoline and Gasoline/
                                   Ethanol Blends with Nominal Ethanol
                                   Concentrations up to 85 Percent (E0-
                                   E85).
UL 87B *........................  Power-Operated Dispensing Devices for
                                   Diesel Fuel, Biodiesel Fuel, Diesel/
                                   Biodiesel Blends with Nominal
                                   Biodiesel Concentrations up to 20
                                   Percent (B20), Kerosene, and Fuel
                                   Oil.
UL 486F *.......................  Bare and Covered Ferrules.
UL 567A *.......................  Standard for Emergency Breakaway
                                   Fittings, Swivel Connectors and Pipe-
                                   Connection Fittings for Gasoline and
                                   Gasoline/Ethanol Blends with Nominal
                                   Ethanol Concentrations up to 85
                                   Percent (E0-E85).
UL 567B *.......................  Standard for Emergency Breakaway
                                   Fittings, Swivel Connectors and Pipe-
                                   Connection Fittings for Diesel Fuel,
                                   Biodiesel Fuel, Diesel/Biodiesel
                                   Blends with Nominal Biodiesel
                                   Concentrations up to 20 Percent
                                   (B20), Kerosene, and Fuel Oil.
UL 842A *.......................  Standard for Valves for Gasoline and
                                   Gasoline/Ethanol Blends with Nominal
                                   Ethanol Concentrations up to 85
                                   Percent (E0-E85).
UL 842B *.......................  Standard for Valves for Diesel Fuel,
                                   Biodiesel Fuel, Diesel/Biodiesel
                                   Blends with Nominal Biodiesel
                                   Concentrations up to 20 Percent
                                   (B20), Kerosene, and Fuel Oil.
UL 962..........................  Standard for Household and Commercial
                                   Furnishings.
UL 1973 *.......................  Standard for Batteries for Use in
                                   Stationary, Vehicle Auxiliary Power
                                   and Light Electric Rail (LER)
                                   Applications.
UL 2054 *.......................  Standard for Household and Commercial
                                   Batteries.
UL 2271 *.......................  Standard for Batteries for Use in
                                   Light Electric Vehicle (LEV)
                                   Applications.
UL 2586A *......................  Standard for Hose Nozzle Valves for
                                   Gasoline and Gasoline/Ethanol Blends
                                   with Nominal Ethanol Concentrations
                                   up to 85 Percent (E0-E85).
UL 2586B *......................  Standard for Hose Nozzle Valves for
                                   Diesel Fuel, Biodiesel Fuel, Diesel/
                                   Biodiesel Blends with Nominal
                                   Biodiesel Concentrations up to 20
                                   Percent (B20), Kerosene, and Fuel
                                   Oil.
UL 2594.........................  Standard for Electric Vehicle Supply
                                   Equipment.
UL 2775 *.......................  Standard for Fixed Condensed Aerosol
                                   Extinguishing System Units.
UL 4703 *.......................  Standard for Photovoltaic Wire.
UL 8753 *.......................  Standard for Field-Replaceable Light
                                   Emitting Diode (LED) Light Engines.
UL 60335-2-24...................  Household and Similar Electric
                                   Appliances--Safety--Part 2-24:
                                   Particular Requirements for
                                   Refrigerating Appliances, Ice-Cream
                                   Appliances and Ice-Makers.
UL 60730-2-5 *..................  Automatic Electrical Controls for
                                   Household and Similar Use, Part 2-5:
                                   Particular Requirements for Automatic
                                   Electrical Burner Control Systems.
UL 60947-5-1 *..................  Low-Voltage Switchgear and
                                   Controlgear--Part 5-1: Control
                                   Circuit Devices and Switching
                                   Elements--Electromechanical Control
                                   Circuit Devices.
UL 62109-1......................  Standard for Safety of Power
                                   Converters for Use in Photovoltaic
                                   Power Systems--Part 1: General
                                   Requirements.
------------------------------------------------------------------------
* Represents the standards that OSHA will add to the NRTL Program's List
  of Appropriate Test Standards

    In this notice, OSHA also announces the addition of 22 new test
standards to the NRTL Program's List of Appropriate Test Standards.
Table 2, below, lists the test standards that are new to the NRTL
Program. OSHA has determined that these test standards are appropriate
test standards and will include them in the NRTL Program's List of
Appropriate Test Standards.

  Table 2--Test Standards OSHA Is Adding to the NRTL Program's List of
                       Appropriate Test Standards
------------------------------------------------------------------------
          Test standard                     Test standard title
------------------------------------------------------------------------
TIA 4950........................  Requirements for Battery-Powered,
                                   Portable Land Mobile Radio
                                   Applications in Class I, II, and III,
                                   Division 1, Hazardous (Classified)
                                   Locations.
UL 25A..........................  Standard for Meters for Gasoline and
                                   Gasoline/Ethanol Blends with Nominal
                                   Ethanol Concentrations up to 85
                                   Percent (E0-E85).
UL 25B..........................  Meters for Diesel Fuel, Biodiesel
                                   Fuel, Diesel/Biodiesel Blends with
                                   Nominal Biodiesel Concentrations up
                                   to 20 Percent (B20), Kerosene, and
                                   Fuel Oil.
UL 79A..........................  Standard for Power-Operated Pumps for
                                   Gasoline and Gasoline/Ethanol Blends
                                   with Nominal Ethanol Concentrations
                                   up to 85 Percent (E0-E85).
UL 79B..........................  Standard for Power-Operated Pumps for
                                   Diesel Fuel, Biodiesel Fuel, Diesel/
                                   Biodiesel Blends with Nominal
                                   Biodiesel Concentrations up to 20
                                   Percent (B20), Kerosene, and Fuel
                                   Oil.
UL 87A..........................  Standard for Power-Operated Dispensing
                                   Devices for Gasoline and Gasoline/
                                   Ethanol Blends with Nominal Ethanol
                                   Concentrations up to 85 Percent (E0-
                                   E85).
UL 87B..........................  Power-Operated Dispensing Devices for
                                   Diesel Fuel, Biodiesel Fuel, Diesel/
                                   Biodiesel Blends with Nominal
                                   Biodiesel Concentrations up to 20
                                   Percent (B20), Kerosene, and Fuel
                                   Oil.
UL 486F.........................  Bare and Covered Ferrules.
UL 567A.........................  Standard for Emergency Breakaway
                                   Fittings, Swivel Connectors and Pipe-
                                   Connection Fittings for Gasoline and
                                   Gasoline/Ethanol Blends with Nominal
                                   Ethanol Concentrations up to 85
                                   Percent (E0-E85).
UL 567B.........................  Standard for Emergency Breakaway
                                   Fittings, Swivel Connectors and Pipe-
                                   Connection Fittings for Diesel Fuel,
                                   Biodiesel Fuel, Diesel/Biodiesel
                                   Blends with Nominal Biodiesel
                                   Concentrations up to 20 Percent
                                   (B20), Kerosene, and Fuel Oil.

UL 842A.........................  Standard for Valves for Gasoline and
                                   Gasoline/Ethanol Blends with Nominal
                                   Ethanol Concentrations up to 85
                                   Percent (E0-E85).
UL 842B.........................  Standard for Valves for Diesel Fuel,
                                   Biodiesel Fuel, Diesel/Biodiesel
                                   Blends with Nominal Biodiesel
                                   Concentrations up to 20 Percent
                                   (B20), Kerosene, and Fuel Oil.
UL 1973.........................  Standard for Batters for Use in Light
                                   Electric Rail (LER) Applications and
                                   Stationary Applications.
UL 2054.........................  Standard for Household and Commercial
                                   Batteries.
UL 2271.........................  Standard for Batteries for Use in
                                   Light Electric Vehicle (LEV)
                                   Applications.
UL 2586A........................  Standard for Hose Nozzle Valves for
                                   Gasoline and Gasoline/Ethanol Blends
                                   with Nominal Ethanol Concentrations
                                   up to 85 Percent (E0-E85).
UL 2586B........................  Standard for Hose Nozzle Valves for
                                   Diesel Fuel, Biodiesel Fuel, Diesel/
                                   Biodiesel Blends with Nominal
                                   Biodiesel Concentrations up to 20
                                   Percent (B20), Kerosene, and Fuel
                                   Oil.
UL 2775.........................  Standard for Fixed Condensed Aerosol
                                   Extinguishing System Units.
UL 4703.........................  Standard for Photovoltaic Wire.
UL 8753.........................  Standard for Field-Replaceable Light
                                   Emitting Diode (LED) Light Engines.
UL 60730-2-5....................  Automatic Electrical Controls for
                                   Household and Similar Use, Part 2-5:
                                   Particular Requirements for Automatic
                                   Electrical Burner Control Systems.
UL 60947-5-1....................  Low-Voltage Switchgear and
                                   Controlgear--Part 5-1: Control
                                   Circuit Devices and Switching
                                   Elements--Electromechanical Control
                                   Circuit Devices.
------------------------------------------------------------------------

    OSHA's recognition of any NRTL for a particular test standard is
limited to equipment or materials for which OSHA standards require
third-party testing and certification before use in the workplace.
Consequently, if a test standard also covers any products for which
OSHA does not require such testing and certification, a NRTL's scope of
recognition does not include these products.
    The American National Standards Institute (ANSI) may approve the
test standards listed above as American National Standards. However,
for convenience, the use of the designation of the standards-developing
organization for the standard as opposed to the ANSI designation may
occur. Under the NRTL Program's policy (see OSHA Instruction CPL 1-0.3,
Appendix C, paragraph XIV), any NRTL recognized for a particular test
standard may use either the proprietary version of the test standard or
the ANSI version of that standard. Contact ANSI to determine whether a
test standard is currently ANSI-approved.

A. Conditions

    In addition to those conditions already required by 29 CFR 1910.7,
UL must abide by the following conditions of the recognition:
    1. UL must inform OSHA as soon as possible, in writing, of any
change of ownership, facilities, or key personnel, and of any major
change in its operations as a NRTL, and provide details of the
change(s);
    2. UL must meet all the terms of its recognition and comply with
all OSHA policies pertaining to this recognition; and
    3. UL must continue to meet the requirements for recognition,
including all previously published conditions on UL's scope of
recognition, in all areas for which it has recognition.
    Pursuant to the authority in 29 CFR 1910.7, OSHA hereby expands the
scope of recognition of UL, subject to the limitation and conditions
specified above.

Authority and Signature

    Loren Sweatt, Deputy Assistant Secretary of Labor for Occupational
Safety and Health, authorized the preparation of this notice.
Accordingly, the Agency is issuing this notice pursuant to 29 U.S.C.
657(g)(2), Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25,
2012), and 29 CFR 1910.7.

    Signed at Washington, DC, on September 24, 2018.
Loren Sweatt,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2018-21158 Filed 9-27-18; 8:45 am]
 BILLING CODE 4510-26-P


[Federal Register: December 1, 2010 (Volume 75, Number 230)]
[Proposed Rules]
[Page 74670-74673]
[DOCID:fr01de10-26]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-1161; Directorate Identifier 2010-NM-152-AD]
RIN 2120-AA64

Airworthiness Directives; Empresa Brasileira de Aeronautica S.A.
(EMBRAER) Model ERJ 170 and ERJ 190 Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as:

    It has been found occurrence of screw units manufactured with
metallographic non-conformity that may increase their susceptibility
to brittle fracture. The screw failure may result in loss of the
related balance washer causing a possible ram air turbine (RAT)
imbalance event, which may result in RAT structural failure, which
associated with an electrical emergency situation, could result in
loss of power to airplane flight controls hydraulic back-up system.
* * * * *
Loss of power to the hydraulic back-up system for airplane flight
controls could reduce the ability of the flightcrew to maintain the
safe flight and landing of the airplane. The proposed AD would require
actions that are intended to address the unsafe condition described in
the MCAI.

DATES: We must receive comments on this proposed AD by January 18,
2011.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Empresa Brasileira de Aeronautica S.A. (EMBRAER), Technical
Publications Section (PC 060), Av. Brigadeiro Faria Lima, 2170-Putim-
12227-901 S[atilde]o Jose dos Campos-SP-BRASIL; telephone: +55 12 3927-
5852 or +55 12 3309-0732; fax: +55 12 3927-7546; e-mail:
<EMAIL_ADDRESS>Internet: http://www.flyembraer.com. You may
review copies of the referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday,

except Federal holidays. The AD docket contains this proposed AD, the
regulatory evaluation, any comments received, and other information.
The street address for the Docket Operations office (telephone (800)
647-5527) is in the ADDRESSES section. Comments will be available in
the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Cindy Ashforth, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-2768; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2010-1161;
Directorate Identifier 2010-NM-152-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The Ag[ecirc]ncia Nacional de Avia[ccedil][atilde]o Civil (ANAC),
which is the aviation authority for Brazil, has issued Brazilian
Airworthiness Directives 2010-06-04 and 2010-06-05, both dated July 26,
2010 (referred to after this as ``the MCAI''), to correct an unsafe
condition for the specified products. The MCAI state:

    It has been found occurrence of screw units manufactured with
metallographic non-conformity that may increase their susceptibility
to brittle fracture. The screw failure may result in loss of the
related balance washer causing a possible ram air turbine (RAT)
imbalance event, which may result in RAT structural failure, which
associated with an electrical emergency situation, could result in
loss of power to airplane flight controls hydraulic back-up system.
* * * * *
Loss of power to the hydraulic back-up system for airplane flight
controls could reduce the ability of the flightcrew to maintain the
safe flight and landing of the airplane. Required actions include doing
a general visual inspection to determine the model, part number, and
serial number of the RAT, and to determine if a certain symbol is
marked on affected RATs. Corrective actions include replacing the RAT
balance screw and marking the RAT identification plate. You may obtain
further information by examining the MCAI in the AD docket.

Relevant Service Information

    EMBRAER has issued Service Bulletins 170-24-0048, Revision 01,
dated May 12, 2010 (for Model ERJ 170 airplanes); and 190-24-0019,
Revision 01, dated May 11, 2010 (for Model ERJ 190 airplanes). The
actions described in this service information are intended to correct
the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a Note within the proposed AD.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 241 products of U.S. registry. We also estimate that
it would take about 9 work-hours per product to comply with the basic
requirements of this proposed AD. The average labor rate is $85 per
work-hour. Required parts would cost about $0 per product. Where the
service information lists required parts costs that are covered under
warranty, we have assumed that there will be no charge for these costs.
As we do not control warranty coverage for affected parties, some
parties may incur costs higher than estimated here. Based on these
figures, we estimate the cost of the proposed AD on U.S. operators to
be $184,365, or $765 per product.

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.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 this proposed
regulation:
    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); and
    3. 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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

    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]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Empresa Brasileira de Aeronautica S.A. (EMBRAER): Docket No. FAA-
2010-1161; Directorate Identifier 2010-NM-152-AD.

Comments Due Date

    (a) We must receive comments by January 18, 2011.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to all Empresa Brasileira de Aeronautica
S.A. (EMBRAER) Model ERJ 170-100 LR, -100 STD, -100 SE, and -100 SU
airplanes; and Model ERJ 170-200 LR, -200 SU, and -200 STD
airplanes; and Model ERJ 190-100 STD, -100 LR, -100 ECJ, and -100
IGW airplanes; and Model ERJ 190-200 STD, -200 LR, and -200 IGW
airplanes; certificated in any category.

Subject

    (d) Air Transport Association (ATA) of America Code 24:
Electrical power.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    It has been found occurrence of screw units manufactured with
metallographic non-conformity that may increase their susceptibility
to brittle fracture. The screw failure may result in loss of the
related balance washer causing a possible ram air turbine (RAT)
imbalance event, which may result in RAT structural failure, which
associated with an electrical emergency situation, could result in
loss of power to airplane flight controls hydraulic back-up system.
* * * * *
Loss of power to the hydraulic back-up system for airplane flight
controls could reduce the ability of the flightcrew to maintain the
safe flight and landing of the airplane.

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Actions

    (g) Within 1,200 flight hours or 6 months after the effective
date of this AD, whichever occurs first: Do a general visual
inspection to determine the RAT model, part number, and serial
number, in accordance with Part 1 of the Accomplishment Instructions
of EMBRAER Service Bulletin 170-24-0048, Revision 01, dated May 12,
2010; or EMBRAER Service Bulletin 190-24-0019, Revision 01, dated
May 11, 2010; as applicable. A review of airplane maintenance
records is acceptable in lieu of this inspection if the model, part
number, and serial number of the RAT can be conclusively determined
from that review.

    Note 1:  For the purpose of this AD, a general visual inspection
(GVI) is: ``A visual examination of an interior or exterior area,
installation or assembly to detect obvious damage, failure or
irregularity. This level of inspection is made from within touching
distance, unless otherwise specified. A mirror may be necessary to
enhance visual access to all exposed surfaces in the inspection
area. This level of inspection is made under normally available
lighting conditions such as daylight, hangar lighting, flashlight or
drop-light, and may require removal or opening of access panels or
doors. Stands, ladders or platforms may be required to gain
proximity to the area being checked.''

    (1) For any RAT not having a serial number identified in EMBRAER
Service Bulletin 170-24-0048, Revision 01, dated May 12, 2010; or
EMBRAER Service Bulletin 190-24-0019, Revision 01, dated May 11,
2010: No further action is required by this paragraph.
    (2) For any RAT having a serial number identified in EMBRAER
Service Bulletin 170-24-0048, Revision 01, dated May 12, 2010; or
EMBRAER Service Bulletin 190-24-0019, Revision 01, dated May 11,
2010: Within 1,200 flight hours or 6 months after the effective date
of this AD, whichever occurs first, inspect to determine if the
symbol ``24-5'' is marked on the RAT identification plate. A review
of airplane maintenance records is acceptable in lieu of this
inspection if the RAT identification plate can be conclusively
determined to be marked with ``24-5'' from that review.
    (i) If the symbol ``24-5'' is marked on the RAT identification
plate: No further action is required by this paragraph.
    (ii) If the symbol ``24-5'' is not marked on the RAT
identification plate: Within 1,200 flight hours or 6 months after
the effective date of this AD, whichever occurs first, replace the
RAT balance screw with a new balance screw, and mark the RAT
identification plate with the symbol ``24-5,'' in accordance with
Part 2 of the Accomplishment Instructions of EMBRAER Service
Bulletin 170-24-0048, Revision 01, dated May 12, 2010; or EMBRAER
Service Bulletin 190-24-0019, Revision 01, dated May 11, 2010; as
applicable.
    (h) As of the effective date of this AD, no person may install a
RAT identified in Part 1 of the Accomplishment Instructions of
EMBRAER Service Bulletin 170-24-0048, Revision 01, dated May 12,
2010; or EMBRAER Service Bulletin 190-24-0019, Revision 01, dated
May 11, 2010; as applicable; on any airplane, unless that RAT is
identified with the symbol ``24-5'' on the identification plate.

Credit for Actions Accomplished in Accordance With Previous Service
Information

    (i) Actions accomplished before the effective date of this AD in
accordance with EMBRAER Service Bulletins 170-24-0048 or 190-24-
0019, both dated March 31, 2010, as applicable, are considered
acceptable for compliance with the corresponding actions specified
in this AD.

FAA AD Differences

    Note 2:  This AD differs from the MCAI and/or service
information as follows:
    (1) The Brazilian ADs apply to ``airplanes equipped with
Hamilton Sundstrand ram air turbine (RAT), Model ERPS37T, Part
Number (P/N) 1703781 Series; with the serial numbers (S/N) contained
in Embraer Service Bulletin[s 170-24-0048 or 190-24-0019],'' and
their first action is an inspection to determine if affected
equipment is installed. This AD applies to all of the airplanes,
with the first action in the AD being an inspection to determine if
affected equipment is installed, because the affected part could be
rotated onto any of the airplanes listed in the applicability.
    (2) Although the MCAI states not to install the part identified
in paragraph (h) of this AD after accomplishing the actions
specified in paragraph (g)(2) of this AD, this AD prohibits
installation of the part as of the effective date of this AD.

Other FAA AD Provisions

    (j) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. Send information to ATTN:
Cindy Ashforth, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your principal maintenance inspector (PMI) or
principal avionics inspector (PAI), as appropriate, or lacking a
principal inspector, your local Flight Standards District Office.
The AMOC approval letter must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (k) Refer to MCAI Brazilian Airworthiness Directives 2010-06-04
and 2010-06-05, both dated July 26, 2010; EMBRAER Service Bulletin
170-24-0048, Revision 01, dated May 12, 2010; and EMBRAER Service
Bulletin 190-24-0019, Revision 01, dated May 11, 2010; for related
information.

    Issued in Renton, Washington, on November 18, 2010.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2010-30140 Filed 11-30-10; 8:45 am]
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[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Notices]
[Pages 10313-10314]
[FR Doc No: 2023-03424]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP23-430-000.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Non-Conforming--Columbia Gas
Virginia--50473-12 to be effective 2/1/2023.
    Filed Date: 2/6/23.
    Accession Number: 20230206-5119.
    Comment Date: 5 p.m. ET 2/21/23.

    Docket Numbers: RP23-437-000.
    Applicants: Gulf South Pipeline Company, LLC.
    Description: Sec.  4(d) Rate Filing: Amendment to Neg Rate Agmt
(Chevron 41610) to be effective 2/13/2023.
    Filed Date: 2/13/23.
    Accession Number: 20230213-5046.
    Comment Date: 5 p.m. ET 2/27/23.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.

    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at:http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: February 13, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-03424 Filed 2-16-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: July 8, 2009 (Volume 74, Number 129)]
[Notices]
[Page 32620-32621]
[DOCID:fr08jy09-86]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Advisory Committee for Pharmaceutical Science and Clinical
Pharmacology; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.

    Name of Committee: Advisory Committee for Pharmaceutical Science
and Clinical Pharmacology.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held August 5, 2009, from 8 a.m.
to 5 p.m.
    Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD. The hotel telephone number is 301-
589-5200.
    Contact Person: Paul Tran, Center for Drug Evaluation and Research
(HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express
delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301-827-
7001, FAX:<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER>) in the
Washington, DC area), code<PHONE_NUMBER>. Please call the Information Line
for up-to-date information on this meeting. A notice in the Federal
Register about last minute modifications that impact a previously
announced advisory committee meeting cannot always be published quickly
enough to provide timely notice. Therefore, you should always check the
agency's Web site and call the appropriate advisory committee hot line/
phone line to learn about possible modifications before coming to the
meeting.
    Agenda: The committee will: (1) Receive a status update from the
Office of Generic Drugs (OGD) on bioequivalence for highly variable
drugs (highly variable means that the rate and amount of the drug
entering blood varies significantly from one administration to
another); (2) receive presentations from the Office of Pharmaceutical
Science (OPS) on the scientific and regulatory challenges of
Transdermal Drug Delivery Systems (TDDS); (3) receive presentations
from OPS and discuss current thinking on ``Classifying Pre-Surgical
Preparations as Sterile Products'' in consideration of how these
products are used; and (4) be updated by OPS on the current status of
the International Conference on Harmonization (ICH) Quality Topics
[i.e., those relating to chemical and pharmaceutical quality assurance
(stability testing, impurity testing, etc.)], and outline the role of
the ICH Implementation Work Group (Q IWG), its future activities, and
any remaining gaps and challenges.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/
default.htm, click on the year 2009 and scroll down to the appropriate
advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before July
21, 2009. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Those desiring to make formal oral
presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before July 13, 2009. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by July 14,
2009.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Paul Tran at least 7
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/
AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: June 29, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-16136 Filed 7-7-09; 8:45 am]

BILLING CODE 4160-01-S