[Federal Register: July 28, 2009 (Volume 74, Number 143)]
[Notices]
[Page 37287-37288]
[DOCID:fr28jy09-92]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2009-0170]

Agency Information Collection Activities; Revision of a Currently
Approved Information Collection Request: Annual and Quarterly Report of
Class I Motor Carriers of Passengers (OMB 2139-0003)

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FMCSA
announces its plan to submit to the Office of Management and Budget
(OMB) for approval its request to revise a currently approved
information collection request (ICR) entitled, ``Annual and Quarterly
Report of Class I Motor Carriers of Passengers.'' This information
collection is necessary to ensure that motor carriers comply with
financial and operating statistics requirements at chapter III of title
49 CFR part 369 entitled, ``Reports of Motor Carriers.'' On March 24,
2009, FMCSA published a Federal Register notice (at 74 FR 12436)
allowing for a 60-day comment period on the revision of this ICR. The
comment received in response to the notice expressed support for this
ICR.

DATES: Please send your comments by August 27, 2009. OMB must receive
your comments by this date in order to act quickly on the ICR.

ADDRESSES: All comments should reference Federal Docket Management
System (FDMS) Docket Number FMCSA-2009-0170. Interested persons are
invited to submit written comments on the proposed information
collection to the Office of Information and Regulatory Affairs, Office
of Management and Budget. Comments should be addressed to the attention
of the Desk Officer, Department of Transportation/Office of the
Secretary, and sent via electronic mail to oira_
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to the
Office of Information and Regulatory Affairs, Office of Management and
Budget, Docket Library, Room 10102, 725 17th Street, NW., Washington,
DC 20503.

FOR FURTHER INFORMATION CONTACT: Ms. Vivian Oliver, Office of Research
and Information Technology, Department of Transportation, Federal Motor
Carrier Safety Administration, West Building 6th Floor, 1200 New Jersey
Avenue, SE., Washington, DC 20590. Telephone:<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Title: Annual and Quarterly Report of Class I Motor Carriers of
Passengers (formerly OMB Control Number 2139-0003).
    OMB Control Number: 2126-0031.
    Type of Request: Revision of a currently-approved information
collection request.
    Respondents: Class I Motor Carriers of Passengers.
    Estimated Number of Respondents: 6.
    Estimated Time per Response: 18 minutes per response.
    Expiration Date: 09/30/2009.
    Frequency of Response: Quarterly and annually.
    Estimated Total Annual Burden: 9 hours [30 responses x 18 minutes
per response/60 minutes = 9].
    Background: For-hire Class I motor carriers of passengers
(including interstate and intrastate) \1\ are required to file Motor
Carrier Annual and Quarterly Reports (Form MP-1) that provide financial
and operating data (see 49 U.S.C. 14123; and implementing FMCSA
regulations at 49 CFR part 369). The agency uses this information to
assess the health of the industry and identify industry changes that
may affect national transportation policy. The data also show company
financial stability and traffic patterns. Motor carriers of passengers
required to comply with the regulations are classified on the basis of
their annual gross carrier operating revenues. Under the Financial &
Operating Statistics (F&OS) program, the FMCSA collects balance sheet
and income statement data along with information on tonnage, mileage,
employees, transportation equipment, and other related data.
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    \1\ For purposes of the Financial & Operating Statistics (F&OS)
program, passenger carriers are classified into the following two
groups; (1) Class I carriers are those having average annual gross
transportation operating revenues (including interstate and
intrastate) of $5 million or more from passenger motor carrier
operations after applying the revenue deflator formula as shown in
the Note at 49 CFR 369.3; and (2) Class II passenger carriers are
those having average annual gross transportation operating revenues
(including interstate and intrastate) of less than $5 million from
passenger motor carrier operations after applying the revenue
deflator formula as shown in the Note at 49 CFR 369.3. Only Class I
carriers of passengers are required to file the Annual and Quarterly
Report Form MP-1. Class II passenger carriers, however, must notify
the agency when there is a change in their classification or their
revenues exceed the Class II limit.
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    The data and information collected is made publicly available as
prescribed in 49 CFR part 369. Class I motor carriers are required by
49 U.S.C. 14123 to file annual financial reports with the Secretary.
The Secretary has exercised his discretion under section 14123 to also
require Class I property carriers (including dual-property carriers),
Class I household goods carriers and Class I passengers carriers to
file quarterly reports.
    Over the years, the regulations were formerly administered by the
Interstate Commerce Commission (ICC), but the ICC Termination Act of
1995 (ICCTA) (Pub. L. 104-88, 109 Stat. 803 (Dec. 29, 1995); now
codified at 49 U.S.C. 14123) abolished the ICC and transferred the
responsibility for collecting and disseminating motor carrier financial
information to the Secretary of Transportation (Secretary). On
September 30, 1998, the Secretary delegated and transferred the
authority

to administer the F&OS program to the former Bureau of Transportation
Statistics (BTS), now a part of the Research and Innovative Technology
Administration (RITA), to former Chapter XI, subchapter 13 of 49 CFR
part 1420 (63 FR 52192).
    On September 29, 2004, the Secretary transferred the responsibility
for the F&OS program from BTS to FMCSA in the belief that the program
was more aligned with FMCSA's safety mission and its other motor
carrier responsibilities (69 FR 51009). On August 10, 2006 (71 FR
45740), the Secretary published a final rule that transferred and
redesignated the motor carrier financial and statistical reporting
regulations of BTS that were formerly located at chapter XI of title 49
CFR to FMCSA in 49 chapter III of title 49 CFR part 369.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including: (1) Whether the proposed
collection is necessary for the performance of FMCSA's functions; (2)
the accuracy of the estimated burden; (3) ways for the FMCSA to enhance
the quality, usefulness, and clarity of the collected information; and
(4) ways that the burden could be minimized without reducing the
quality of the collected information. The Agency will summarize and/or
include your comments in the request for OMB's clearance of this
information collection request.

    Issued on July 16, 2009.
David Anewalt,
Acting Associate Administrator, Research and Information Technology.
[FR Doc. E9-17956 Filed 7-27-09; 8:45 am]

BILLING CODE 4910-EX-P


[Federal Register Volume 84, Number 218 (Tuesday, November 12, 2019)]
[Rules and Regulations]
[Pages 60937-60943]
[FR Doc No: 2019-24295]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0283; FRL-10000-50]

Propyzamide; Pesticide Tolerance for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for
residues of propyzamide in or on cranberry. This action is in response
to EPA's granting of an emergency exemption under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of
the pesticide on cranberry. This regulation establishes a maximum
permissible level for residues of propyzamide in or on this commodity.
The time-limited tolerance expires on December 31, 2022.

DATES: This regulation is effective November 12, 2019. Objections and
requests for hearings must be received on or before January 13, 2020
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-2019-0283, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

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

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Publishing Office's e-CFR site at
http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 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-
2019-0283 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 January 13, 2020. Addresses
for mail and hand delivery of objections and hearing requests are
provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2019-0283, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with FFDCA sections
408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is
establishing a time-limited tolerance for residues of the herbicide
propyzamide, including its metabolites and degradates in or on
cranberry. Compliance with the tolerance level in or on cranberry at 1
part per million (ppm) is to be determined by measuring only those
propyzamide residues convertible to methyl 3,5-dichlorobenzoate,
expressed as the stoichiometric equivalent of propyzamide, 3,5-
dichloro-N-(1,1-dimethyl-2-propynyl)benzamide. This time-limited
tolerance expires on December 31, 2022.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited
tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under FIFRA
section 18. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
FIFRA section 18 related time-limited tolerances to set binding
precedents for the application of FFDCA section 408 and the safety
standard to other tolerances and exemptions. Section 408(e) of FFDCA
allows EPA to establish a tolerance or an exemption from the
requirement of a tolerance on its own initiative, i.e., without having
received any petition from an outside party.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' EPA has established
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Propyzamide on Cranberry and FFDCA
Tolerances

    The Massachusetts Department of Food and Agriculture (MDAR)
notified EPA that an emergency condition exists for cranberry growers
due to the presence of dodder in newly planted and renovated cranberry
fields in five

counties throughout the state. According to MDAR, dodder is a serious
and devasting pest in commercial cranberry production. The state
reported that an urgent and nonroutine situation exists because
cranberry fields are heavily infested with dodder and that the
available registered alternatives do not provide effective control.
Significant economic losses were expected due to yield and quality
decreases without a suitable pesticide tool to control dodder.
    After having reviewed the submission, EPA determined that an
emergency condition exists for this State, and that the criteria for
approval of an emergency exemption are met. EPA has authorized a
specific exemption under FIFRA section 18 for the use of propyzamide on
cranberry for control of dodder in Massachusetts.
    As part of its evaluation of the emergency exemption application,
EPA assessed the potential risks presented by residues of propyzamide
in or on cranberry. In doing so, EPA considered the safety standard in
FFDCA section 408(b)(2), and EPA decided that the necessary tolerance
under FFDCA section 408(l)(6) would be consistent with the safety
standard and with FIFRA section 18. Consistent with the need to move
quickly on the emergency exemption to address an urgent non-routine
situation and to ensure that the resulting food is safe and lawful, EPA
is issuing this tolerance without notice and opportunity for public
comment as provided in FFDCA section 408(l)(6). Although this time-
limited tolerance expires on December 31, 2022, under FFDCA section
408(l)(5), residues of the pesticide not in excess of the amounts
specified in the tolerance remaining in or on cranberry after that date
will not be unlawful, provided the pesticide was applied in a manner
that was lawful under FIFRA, and the residues do not exceed a level
that was authorized by this time-limited tolerance at the time of that
application. EPA will take action to revoke this time-limited tolerance
earlier if any experience with, scientific data on, or other relevant
information on this pesticide indicate that the residues are not safe.
    Because this time-limited tolerance is being approved under
emergency conditions, EPA has not made any decisions about whether
propyzamide meets FIFRA's registration requirements for use on
cranberry or whether a permanent tolerance for this use would be
appropriate. Under these circumstances, EPA does not believe that this
time-limited tolerance decision serves as a basis for registration of
propyzamide by a State for special local needs under FIFRA section
24(c). Nor does this tolerance by itself serve as the authority for
persons in any State other than Massachusetts to use this pesticide on
the applicable crop under FIFRA section 18 absent the issuance of an
emergency exemption applicable within that State. For additional
information regarding the emergency exemption for propyzamide, contact
the Agency's Registration Division at the address provided under FOR
FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    Consistent with the factors specified in FFDCA section
408(b)(2)(D), EPA has reviewed the available scientific data and other
relevant information in support of this action. EPA has sufficient data
to assess the hazards of and to make a determination on aggregate
exposure expected as a result of this emergency exemption request and
the time-limited tolerance for propyzamide on cranberry at 1 ppm. EPA's
assessment of exposures and risks associated with establishing this
time-limited tolerance follows.

A. Toxicological Points of Departure/Levels of Concern

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

  Table 1--Summary of Toxicological Doses and Endpoints for Propyzamide for Use in Human Health Risk Assessment
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                                    Point of  departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (Females 13 to 49    An endpoint attributable to a single exposure was not available in the
 years of age).                     database including the developmental toxicity studies in rats and rabbits.
                                  ------------------------------------------------------------------------------
Acute dietary (All Populations)..  LOAEL = 40 mg/kg/day  Acute RfD = 0.04 mg/ Acute Neurotoxicity Rat Study.
                                                          kg/day.
                                   UFA = 10x UFH = 10x   aPAD = 0.04 mg/kg/   NOAEL was not established; LOAEL =
                                    FQPA SF (UFL) = 10x   day                  40 mg/kg/day (the lowest dose
                                    (LOAEL to NOAEL                            tested) based on increased
                                    extrapolation).                            landing foot splay in females and
                                                                               decreased motor activity in both
                                                                               sexes on Day 1.
Chronic dietary (All populations)  LOAEL= 40 mg/kg/day.  Chronic RfD = 0.013  The POD of 40 mg/kg/day based on a
                                                          mg/kg/day.           weight of evidence approach from
                                                                               the 4 rat studies listed below.

                                   UFA = 10x             cPAD = 0.013 mg/kg/  Subchronic neurotoxicity (SCN)
                                                          day                  (Fischer rat): NOAEL of 2.38 mg/
                                                                               kg/day based on the significant
                                                                               decreases in body weight, body
                                                                               weight gain, and food consumption
                                                                               seen at 11.28 mg/kg/day (LOAEL)
                                                                               in males.
                                   UFH = 10x
                                   FQPA SF (UFL/UFDB) =
                                    30x (for lack of
                                    CTA study and LOAEL
                                    to NOAEL
                                    extrapolation).
                                                                              Acute neurotoxicity (ACN) (Fischer
                                                                               rat): NOAEL was not established.
                                                                               The LOAEL is 40 mg/kg/day based
                                                                               on the increase in landing foot
                                                                               splay in female rats and the
                                                                               decrease in motor activity seen
                                                                               in both genders on Day 1. (A 10X
                                                                               LOAEL to NOAEL uncertainty factor
                                                                               (UFL) yields a derived POD of 4
                                                                               mg/kg/day (40/10)).
                                                                              Combined chronic toxicity/
                                                                               carcinogenicity (CD rats): NOAEL
                                                                               of 8.46/10.69 mg/kg/day based on
                                                                               increased relative liver weight
                                                                               and histopathological lesions in
                                                                               the liver, thyroid, and ovaries
                                                                               at 42.59/55.09 mg/kg/day (LOAEL).
                                                                              Male pubertal study (CD rats):
                                                                               NOAEL of 2.5 mg/kg/day based on
                                                                               decreased serum T4 at 10 mg/kg/
                                                                               day (LOAEL).
Incidental oral short-term (1 to   LOAEL= 40 mg/kg/day.  Residential LOC for  Same as Chronic RfD.
 30 days).                                                MOE = 3000.
                                   UFA = 10x
                                   UFH = 10x...........
                                   FQPA SF.............
                                   (UFL /UFDB) = 30x
                                    (for lack of CTA
                                    study and LOAEL to
                                    NOAEL
                                    extrapolation).
Dermal short-term (1 to 30 days)   NOAEL = 100 mg/kg/    Residential LOC for  28-day dermal toxicity study in
 and intermediate-term (1 to 6      day.                  MOE = 1000.          rat: LOAEL = 500 mg/kg/day based
 months).                                                UFA = 10x..........   on decreases in body weight and
                                                         UFH = 10x..........   food consumption in males.
                                                         FQPA SF (UFDB) =10x
                                                          (for lack of CTA
                                                          study).
                                  ------------------------------------------------------------------------------
Inhalation short-term (1 to 30     LOAEL= 40 mg/kg/day.  Residential LOC for  Same as Chronic RfD.
 days) and Intermediate-term (1    UFA = 10x...........   MOE = 3,000.
 to 6 months).                     UFH = 10x...........
                                   FQPA SF (UFL/UFDB)..
                                   = 30x (for lack of
                                    CTA study and LOAEL
                                    to NOAEL
                                    extrapolation).
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: ``Not Likely to be Carcinogenic to Humans'' at doses that do
                                    not result in induction of hepatic cell proliferation or metabolic enzymes
                                    leading to disruption of thyroid or gonadal endocrine axes.
----------------------------------------------------------------------------------------------------------------
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. UFA = extrapolation from
  animal to human (interspecies). UFDB = to account for the absence of data or other data deficiency. UFH =
  potential variation in sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL
  to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to propyzamide, EPA considered exposure under the time-limited
tolerance established by this action as well as all existing
propyzamide tolerances in 40 CFR 180.317. EPA assessed dietary
exposures from propyzamide in food as follows:
    i. Acute exposure. Such effects were identified for propyzamide. In
estimating acute dietary exposure, EPA used food consumption
information from the Dietary Exposure Evaluation and Model-Food
Commodity Intake

Database (DEEM-FCID). As to residue levels in food, EPA assumed that
propyzamide residues were present at tolerance levels in all
commodities for which tolerances have been established or proposed and
that 100% of the crops were treated with propyzamide.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the Dietary Exposure
Evaluation and Model-Food Commodity Intake Database (DEEM-FCID). As to
residue levels in food, EPA assumed that propyzamide residues were
present at tolerance levels in all commodities for which tolerances
have been established or proposed and that 100% of the crops were
treated with propyzamide.
    iii. Cancer. Based on the data summarized in Unit IV.A., EPA has
concluded that propyzamide 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 percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for propyzamide. Tolerance level residues and 100%
CT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used Tier II
screening level water exposure models in the dietary exposure analysis
and risk assessment for propyzamide in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of propyzamide. Further information regarding
EPA drinking water models used in pesticide exposure assessment can be
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Tier II Surface Water Concentration Calculator (SWCC)
and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated
drinking water concentrations (EDWCs) of propyzamide for acute
exposures are estimated to be 102 parts per billion (ppb) for surface
water and 21 ppb for ground water; for chronic exposures for non-cancer
assessments are estimated to be 47 ppb for surface water and 18.6 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 102 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value of 47 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). Propyzamide is
currently registered for use on golf courses that could result in post-
application residential exposures to adults and children. EPA assessed
residential post-application dermal exposures from golfing for adults,
children 6 to <11 and children 11 to <16 and determined that there are
no post-application risk estimates of concern since the dermal margin
of exposures (MOEs) are >1,000. For the golf course post-application
scenarios for adults and children identified above, MOEs ranged from
1,900 to 2,500.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at: http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found propyzamide to share a common mechanism of
toxicity with any other substances, and propyzamide does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
propyzamide does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

C. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional SF when reliable data
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There was no evidence of
quantitative or qualitative increased susceptibility in developing
fetuses or in offspring of rats or rabbits following prenatal and/or
postnatal exposure to propyzamide. However, a comparative thyroid assay
study is required to determine whether pregnant women or developing
young are more or less susceptible, compared to adults, to thyroid
toxicity.
    3. Conclusion. EPA has determined that reliable data show that the
safety of infants and children would be adequately protected if the
FQPA SF were increased to 10X for both interspecies and intraspecies
variation, and 30X for the lack of a NOAEL and lack of a comparative
thyroid study. That decision is based on the following findings:
    i. The toxicity database for propyzamide is incomplete. The
required comparative thyroid assay and subchronic inhalation studies
have not been received for propyzamide; therefore, uncertainty factors
identified above have been applied to account for these deficiencies.
In addition, the acute dietary endpoint for the general population
(including infants and children) was chosen from an acute neurotoxicity
study with a lowest observed adverse effect level of 40 mg/kg/day based
on the increase in landing foot splay in female rats and the decrease
in motor activity observed on Day 1. As such, the lack of an
established NOAEL as well as uncertainties attributed to intraspecies
variability and interspecies extrapolations contributed to an
incomplete toxicity database for propyzamide.
    ii. There is no indication that propyzamide is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study;
however, there is need for additional UFs to account for the lack of a
comparative thyroid study and the use of a LOAEL to extrapolate a
NOAEL.
    iii. There is no evidence that propyzamide 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. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to propyzamide in drinking water. EPA used similarly
conservative assumptions to assess post-application exposure of
children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
propyzamide.

D. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute 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 propyzamide will occupy 46% 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 dietary
exposure to propyzamide from food and water will utilize 33% of the
cPAD for children 1 to 2 years old, the population group receiving the
greatest exposure.
    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). Propyzamide
is currently registered for a use that could result in short-term
residential exposure. The Agency has identified and assessed short-term
residential dermal post-application exposures for the registered golf
course use for propyzamide. There are no post-application risk
estimates of concern (i.e., dermal MOEs >=1,000) for the golf course
use. The short-term residential exposures from the golfing use pattern
were not aggregated with dietary exposures since the risk assessment
endpoints for dermal and oral toxicity were different. The acute and
chronic aggregate risk estimates are equivalent to the dietary risk
estimates and are not of concern.
    4. Intermediate-term risk. Intermediate-term residential exposures
are not anticipated from the registered propyzamide uses, therefore, an
intermediate-term aggregate assessment was not conducted.
    5. Aggregate cancer risk for U.S. population. In accordance with
the Agency's 2005 Guidelines for Carcinogenic Risk Assessment,
propyzamide is classified as ``Not likely to be Carcinogenic to
Humans'' at doses that do not result in induction of hepatic cell
proliferation or metabolic enzymes leading to disruption of thyroid or
gonadal endocrine axes. Quantification of carcinogenic risk is not
required.
    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 propyzamide residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies are available to enforce the
tolerance expression of residues in/or plant commodities (PAM II Method
I, using gas-liquid chromatography with electron-capture detection
(GLC/ECD)) and livestock commodities (Method GRM 02.21, using gas
chromatography with negative-ion chemical ionization mass spectrometry
detection (GC/MS)). These methods may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The Codex has not
established any MRLs for propyzamide.

VI. Conclusion

    Therefore, a time-limited tolerance is established for residues of
the herbicide propyzamide, including its metabolites and degradates.
Compliance with the tolerance level in or on cranberry at 1 ppm is to
be determined by measuring only those propyzamide residues convertible
to methyl 3,5-dichlorobenzoate expressed as the stoichiometric
equivalent of propyzamide, 3,5-dichloro-N-(1,1-dimethyl-
2propynyl)benzamide. This tolerance expires on December 31, 2022.

VII. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA sections 408(e) and
408(l)(6). The Office of Management and Budget (OMB) has exempted these
types of actions from review under Executive Order 12866, entitled
``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993).
Because this action has been exempted from review under Executive Order
12866, this action is not subject to Executive Order 13211, entitled
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001) or Executive
Order 13045, entitled ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997), nor is
it considered a regulatory action under Executive Order 13771, entitled
``Reducing Regulations and Controlling Regulatory Costs'' (82 FR 9339,
February 3, 2017). This action does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., nor does it require any special
considerations under Executive Order 12898, entitled ``Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established in accordance
with FFDCA sections 408(e) and 408(l)(6), 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 action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does

this action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: October 16, 2019.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--AMENDED

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

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

0
2. In Sec.  180.317, revise paragraph (b) to read as follows:

Sec.  180.317  Propyzamide; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. The time-limited tolerance
specified in the table in this paragraph (b) is established for
residues of the herbicide propyzamide, including its metabolites and
degradates, in or on the specified agricultural commodity in the table
in this paragraph (b), resulting from use of the pesticide pursuant to
FIFRA section 18 emergency exemptions. Compliance with the tolerance
level specified in the table in this paragraph (b) is to be determined
by measuring only those propyzamide residues convertible to methyl 3,5-
dichlorobenzoate, expressed as the stoichiometric equivalent of
propyzamide, 3,5-dichloro-N-(1,1-dimethyl-2-propynyl)benzamide in or on
the commodity. The time-limited tolerance expires on the date specified
in the table in this paragraph (b).

------------------------------------------------------------------------
                                 Parts per
           Commodity              million          Expiration date
------------------------------------------------------------------------
Cranberry.....................           1   December 31, 2022.
------------------------------------------------------------------------

* * * * *
[FR Doc. 2019-24295 Filed 11-8-19; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: September 1, 2006 (Volume 71, Number 170)]
[Notices]
[Page 52071-52073]
[DOCID:fr01se06-37]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0099; FRL-8090-6]

Notice of Receipt of Requests for Amendments to Delete Uses in
Certain Pesticide Registrations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In accordance with section 6(f)(1) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), as amended, EPA is issuing a
notice of receipt of request for amendments by registrants to delete
uses in certain pesticide registrations. Section 6(f)(1) of FIFRA
provides that a registrant of a pesticide product may at any time
request that any of its pesticide registrations be amended to delete
one or more uses. FIFRA further provides that, before acting on the
request, EPA must publish a notice of receipt of any request in the
Federal Register.

DATES: The deletions are effective February 28, 2007, unless the Agency
receives a written withdrawal request on or before February 28, 2007.
The Agency will consider a withdrawal request postmarked no later than
February 28, 2007.
    Users of these products who desire continued use on crops or sites
being deleted should contact the applicable registrant on or before
February 28, 2007.

ADDRESSES: Submit your withdrawal request, identified by docket
identification (ID) number EPA-HQ-OPP-2006-0099, by one of the
following methods:
     Mail: Attention: John Jamula, Information Technology and
Resources Management Division (7502P), Office of Pesticide Programs,
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
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket'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 telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: John Jamula, Information Technology
and Resources Management Division (7502P), 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?

    This action is directed to the public in general. Although this
action may be of particular interest to persons who produce or use
pesticides, the Agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the information in this notice, consult the person listed
under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPP-2006-0099. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard

copy, at the Office of Pesticide Programs (OPP) Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S.
Crystal Drive Arlington, VA. The hours of operation of this Docket
Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding
legal holidays. The Docket telephone number is<PHONE_NUMBER>.
    2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr.

II. What Action is the Agency Taking?

    This notice announces receipt by the Agency of applications from
registrants to delete uses in certain pesticide registrations. These
registrations are listed in Table 1 of this unit by registration
number, product name,

active ingredient, and specific uses deleted:

            Table 1.--Registrations With Requests for Amendments to Delete Uses in Certain Pesticides
----------------------------------------------------------------------------------------------------------------
            EPA Reg. No.                    Product Name           Active Ingredient         Delete From Label
----------------------------------------------------------------------------------------------------------------
000100-00863                          40WG Turf Fungicide      Cyproconazole              Turf Uses
----------------------------------------------------------------------------------------------------------------
000100-00864                          Cyproconazole Technical  Cyproconazole              Turf Uses
----------------------------------------------------------------------------------------------------------------
000264-00458                          MOCAP EC Nematicide-     Ethoprop                   Bananas/Plantains,
                                       Insecticide                                         cucumbers,
                                                                                pineapples, and
                                                                                Tobacco
----------------------------------------------------------------------------------------------------------------
000264-00805                          Thiacloprid Technical    Thiacloprid                Pome Fruit and Cotton
                                       Insecticide
----------------------------------------------------------------------------------------------------------------
000264-00806                          Calypso 4 Flowable       Thiacloprid                Pome Fruit and Cotton
                                       Insecticide
----------------------------------------------------------------------------------------------------------------
000264-00807                          Calypso 70 WG            Thiacloprid                Pome Fruit and Cotton
                                       Insecticide
----------------------------------------------------------------------------------------------------------------
034704-00259                          Clean Crop Phorate 20-   Phorate                    Wheat
                                       G
----------------------------------------------------------------------------------------------------------------
047870-00001                          Propylene Oxide          Propylene Oxide            Guar (edible) Gums
----------------------------------------------------------------------------------------------------------------
047870-00002                          Propylene Oxide          Propylene Oxide            Guar (edible) Gums
                                       Technical
----------------------------------------------------------------------------------------------------------------
047870-00003                          Propoxide 892            Propylene Oxide            Guar (edible) Gums
----------------------------------------------------------------------------------------------------------------
058266-00002                          Tri-Clor Fumigant        Chloropicrin               Fumigation of Enclosed
                                                                                Spaces
----------------------------------------------------------------------------------------------------------------
073049-00086                          SBP-1382 Technical with  Resmethrin                 Stored Grain
                                       Antioxidant
----------------------------------------------------------------------------------------------------------------
073049-00098                          SBP-1382 Concentrate     Resmethrin                 Stored Grain
                                       12% Formula with
                                       Residual Activity
----------------------------------------------------------------------------------------------------------------
073049-00105                          Bioallethrin Technical   Bioallethrin               Drainage Systems, Golf
                                                                                Course Turf, Wide
                                                                                Area Outdoor
                                                                                Treatments, Airports,
                                                                                Uncultivated
                                                                                Agricultural Areas,
                                                                                Boat Hulls, Large
                                                                                Paved Areas, Animal
                                                                                Premises, Perimeters
                                                                                and Foundations of
                                                                                Structures
----------------------------------------------------------------------------------------------------------------
073049-00125                          Crossfire Technical      d-trans Allethrin          Drainage Systems, Golf
                                                                                Course Turf, Wide
                                                                                Area Outdoor
                                                                                Treatments, Airports,
                                                                                Uncultivated
                                                                                Agricultural Areas,
                                                                                Boat Hulls, Large
                                                                                Paved Areas, Animal
                                                                                Premises, Perimeters
                                                                                and Foundations of
                                                                                Structures
----------------------------------------------------------------------------------------------------------------
073049-00155                          Esbiol Technical         Bioallethrin               Drainage Systems, Golf
                                                                                Course Turf, Wide
                                                                                Area Outdoor
                                                                                Treatments, Airports,
                                                                                Uncultivated
                                                                                Agricultural Areas,
                                                                                Boat Hulls, Large
                                                                                Paved Areas, Animal
                                                                                Premises, Perimeters
                                                                                and Foundations of
                                                                                Structures
----------------------------------------------------------------------------------------------------------------
073049-00156                          Crossfire Tech           Esbiothrin                 Drainage Systems, Golf
                                       (Esbiothrin Technical)                              Course Turf, Wide
                                                                                Area Outdoor
                                                                                Treatments, Airports,
                                                                                Uncultivated
                                                                                Agricultural Areas,
                                                                                Boat Hulls, Large
                                                                                Paved Areas, Animal
                                                                                Premises, Perimeters
                                                                                and Foundations of
                                                                                Structures
----------------------------------------------------------------------------------------------------------------
073049-00359                          Bioallethrin for         Bioallethrin               Drainage Systems, Golf
                                       Manufacturing and                                   Course Turf, Wide
                                       Formulating Use                                     Area Outdoor
                                                                                Treatments, Airports,
                                                                                Uncultivated
                                                                                Agricultural Areas,
                                                                                Boat Hulls, Large
                                                                                Paved Areas, Animal
                                                                                Premises, Perimeters
                                                                                and Foundations of
                                                                                Structures
----------------------------------------------------------------------------------------------------------------

    Users of these products who desire continued use on crops or sites
being deleted should contact the applicable registrant before February
28, 2007 to discuss withdrawal of the application for amendment. This
180-day period will also permit interested members of the public to
intercede with registrants prior to the Agency's approval of the
deletion.
    Table 2 of this unit includes the names and addresses of record for
all registrants of the products listed in Table 1 of this unit, in
sequence by EPA company number.

  Table 2.--Registrants Requesting Amendments to Delete Uses in Certain
                           Pesticide Products
------------------------------------------------------------------------
             EPA Company no.                 Company Name and Address
-----------------------------------------------------------------------
000100                                     Syngenta Crop Protection,
                                            Inc.,
                                            P.O. Box 18300,...........
                                            Greensboro, NC 27419......
------------------------------------------------------------------------
000264                                     Bayer Cropscience, LP,
                                            2T W. Alexander Drive,....
                                            Research Triangle Park, NC
                                            27709.
------------------------------------------------------------------------
034704                                     Loveland Products, Inc.,
                                            P.O. Box 1286,............
                                            Greeley, CO 80632.........
------------------------------------------------------------------------
047870                                     Aberco, Inc.,
                                            9430 Lanham Severn Rd.,...
                                            Seabrook, MD 20706........
------------------------------------------------------------------------
058266                                     Shadow Mountain Products
                                            Corporation,
                                            P.O. Box 1327,............
                                            Hollister, CA 95024.......
------------------------------------------------------------------------
073049                                     Valent Biosciences
                                            Corporation,
                                            870 Technology Way, Suite
                                            100,.
                                            Libertyville, IL 60048....
------------------------------------------------------------------------

III. What is the Agency's Authority for Taking this Action?

    Section 6(f)(1) of FIFRA provides that a registrant of a pesticide
product may at any time request that any of its pesticide registrations
be amended to delete one or more uses. The Act further provides that,
before acting on the request, EPA must publish a notice of receipt of
any such request in the Federal Register. Thereafter, the Administrator
may approve such a request.

IV. Procedures for Withdrawal of Request

    Registrants who choose to withdraw a request for use deletion must
submit the withdrawal in writing to John Jamula using the methods in
ADDRESSES. The Agency will consider written withdrawal requests
postmarked no later than February 28, 2007.

V. Provisions for Disposition of Existing Stocks

    The Agency has authorized the registrants to sell or distribute
product under the previously approved labeling for a period of 18
months after approval of the revision, unless other restrictions have
been imposed, as in special review actions.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: August 24, 2006.
Robert Forrest,
Acting Director, Information Technology and Resources Management
Division, Office of Pesticide Programs.

[FR Doc. 06-7312 Filed 8-31-06; 8:45 am]

BILLING CODE 6560-50-S


                               December 4, 2023

Ref: 8ARD-PM

The Honorable Julius Murray
Chairman
Ute Business Committee
P.O. Box 190
Ft. Duchesne, Utah  84026-0190
<EMAIL_ADDRESS>
Re: 	Final Part 71 Operating Permit, Permit #V-UO-000004-2019.00, Deseret Generation and Transmission Co-operative, Bonanza Power Plant

Dear Chairman Murray

This is regarding renewal of the 40 CFR part 71 title V operating permit (Part 71 permit) for Deseret Generation and Transmission Co-operative's (Deseret's) Bonanza Power Plant. In response to a request from the Ute Business Committee dated October 14, 2020, the EPA held a public hearing on the draft Part 71 permit renewal on March 11, 2021. The public comment period for the draft permit ended on March 11, 2021. The EPA received one comment letter from Deseret during the comment period. The Ute Business Committee transmitted a letter to the EPA dated March 22, 2021, providing the Tribe's comments on the draft Part 71 permit renewal.

On August 30, 2023, the EPA met with representatives from the Ute Business Committee to consult on the Part 71 permit renewal and a Minor New Source Review (MNSR) permit for a modification to add natural gas-fired peaking engines to the facility. Before that meeting, on August 29, 2023, the EPA provided an electronic copy of a draft comprehensive Response to Comments (RTC) document to the Tribe for review. The EPA transmitted a second copy of the draft RTC document to the Tribe on September 11, 2023, and had a follow-up consultation with the Tribe on September 20, 2023. On October 10, 2023, the Tribe transmitted a letter to the EPA with comments on the draft RTC document.

We have reviewed the comments on the draft Part 71 permit renewal from Deseret and provided responses in "Enclosure 1 - Response to Comments Document." We have made revisions to the draft permit in response to those comments. We have also reviewed the Tribe's comments on the draft RTC document and have enclosed a final comprehensive RTC document to address the comments in the Tribe's March 22, 2021, and October 10, 2023 letters.

Based on the information provided in Deseret's Part 71 permit renewal application, subsequent application updates and public comments on the draft permit, the EPA hereby issues the enclosed final renewed Part 71 permit for the Bonanza Power Plant. The new permit number is #V-UO-000004-2019.00.

Please review each condition carefully and note any restrictions placed on this source. Procedures for appealing this permit can be found in 40 CFR 71.11(l). A petition to the Environmental Appeals Board (EAB) must be filed within 30 days of receipt of this final permit action. The permit will be effective on January 3, 2024, provided there are no appeals filed with the EAB.

If you have any questions concerning the enclosed final permit, please contact Suman Kunwar, of my staff, at<PHONE_NUMBER> or at<EMAIL_ADDRESS>
							Sincerely,

							Adrienne Sandoval
							Director
							Air and Radiation Division

ENCLOSURES
    Response to Comments Document
    Deseret Bonanza Title V Response to Tribe Comments

cc:  Mitch Holditch, Partner, Native Law Group<EMAIL_ADDRESS>	Lonnie Favel, Air Quality Program Director, Ute Indian Tribe<EMAIL_ADDRESS>


[Federal Register Volume 87, Number 150 (Friday, August 5, 2022)]
[Notices]
[Page 48015]
[FR Doc No: 2022-16831]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER22-2518-000]

Clearwater Wind I, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Clearwater Wind I, LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is August 22, 2022.
    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 may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: August 1, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-16831 Filed 8-4-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 223 (Tuesday, November 19, 2019)]
[Notices]
[Page 63874]
[FR Doc No: 2019-25026]

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

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:

    Docket Numbers: RP20-194-001.
    Applicants: Alliance Pipeline L.P.
    Description: Tariff Amendment: Amended Contract Adjustments for
2019 (RP20-194-000) to be effective 11/1/2019.
    Filed Date: 11/7/19.
    Accession Number: 20191107-5105.
    Comments Due: 5 p.m. ET 11/19/19.

    Docket Numbers: RP20-213-000.
    Applicants: Northern Border Pipeline Company.
    Description: Sec.  4(d) Rate Filing: Contract Clean Up Filing to be
effective 12/7/2019.
    Filed Date: 11/7/19.
    Accession Number: 20191107-5024.
    Comments Due: 5 p.m. ET 11/19/19.

    Docket Numbers: RP20-214-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Neg Rate 2019-11-7 Encana to
be effective 11/7/2019.
    Filed Date: 11/7/19.
    Accession Number: 20191107-5060.
    Comments Due: 5 p.m. ET 11/19/19.

    Docket Numbers: RP20-215-000.
    Applicants: Enable Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Errata Fuel Tracker Filing--
Effective November 1 2019 to be effective 11/1/2019.
    Filed Date: 11/7/19.
    Accession Number: 20191107-5109.
    Comments Due: 5 p.m. ET 11/19/19.

    Docket Numbers: RP20-216-000.
    Applicants: Trailblazer Pipeline Company LLC.
    Description: Sec.  4(d) Rate Filing: Neg Rates 2019-11-7 RP18-922
Settlement to be effective 10/1/2019.
    Filed Date: 11/7/19.
    Accession Number: 20191107-5113.
    Comments Due: 5 p.m. ET 11/19/19.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    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.
    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: November 13, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-25026 Filed 11-18-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: November 27, 2006 (Volume 71, Number 227)]
[Notices]
[Page 68655-68657]
[DOCID:fr27no06-133]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54779; File No. SR-BSE-2006-48]

Self-Regulatory Organizations; Boston Stock Exchange, Inc.;
Notice of Filing of Proposed Rule Change To Implement a Quote
Mitigation Plan

November 17, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on November 15, 2006, the Boston Stock Exchange, Inc. (``BSE'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been substantially prepared by the BSE.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the Boston Options Exchange
(``BOX'') Rules to add a Quote Mitigation Plan. The text of the
proposed rule change is available on the BSE's Web site at http://www.bostonstock.com
, at the BSE's Office of the Secretary, and at the

Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the BSE included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
Background and Introduction
    The U.S. options industry has witnessed an explosion in market
broadcast data traffic over the past six

years due to a number of factors, including, but not limited to:
     Automation of the quote updating mechanisms used by market
makers and specialists;
     Two additional, fully automated exchanges;
     Opening of access to market making status at several
exchanges, resulting in multiple ``quote streamers'' versus the
previous environment where essentially only one market maker, the
``specialist'', was able to electronically stream quote updates into
the exchange trading systems; and
     Proliferation of additional options instruments due to
additional options classes and narrower intervals between strike prices
(``dollar pilot'').
    While the trends which have caused the dramatic increase in options
market data traffic have been to the benefit of the investor in terms
of improved market quality due to increased competition on the
liquidity provider side of the market, they are not without costs.
Specifically, according to the Exchange, the Order Flow Providers
(``OFPs'') and market data vendors find it increasingly difficult to
provide real-time and accurate market data to investors without
contemplating significant increases in the costs to the end users
(either in the form of higher rates in the case of the data vendors or
higher commissions in the case of the OFPs). It is common belief that
this trend will be exacerbated by the implementation of the ``penny
pilot program'' in January 2007.
    Many observers feel that a point of diminishing returns has been
reached where the marginal extra cost of yet more traffic is not
justified in terms of improved market quality or information to the
investor. Allowing for different levels of service whereby the end user
would pay for the level of market data he wished to receive (e.g. a
user wanting real-time, across the board data would pay more than a
user who only required market data refreshing at, say, half-second
intervals) has been rejected by the industry as presenting an ``unlevel
playing field'' which would ultimately be to the detriment of the
private investor. Furthermore, there are ``firm quote obligations''
that each exchange must take into account in any strategy it used to
reduce traffic.
Quote Mitigation
    The Exchange believes it is possible to significantly reduce
overall peak market data traffic with a relatively small impact on the
quality of information available to options market users, due to the
following:
     Diminishing Returns of Speed: ``Timeliness'' of quote
updates does indeed have a point of diminishing returns and it is
likely that, so long as all options traders and investors are receiving
information at the same rate of ``delay'' from pure ``real time'', they
are willing to allow similar information to be ``bundled'' and
broadcast with a reasonable delay. For example, a series with ten
market makers, all of whom are at the same price on the bid and the
offer, and who, in response to information on the underlying security's
price, wish to update their markets to the same new prices (an
admittedly simplistic assumption) can be managed by simply bundling
some of the updates so long as the ``slowest'' message due to this
bundling is no higher than an agreed upon lapse. Using this approach,
what would have been ten individual updates may be reduced to one
update, a reduction of 90%.
     All Series Are Not of Equal Interest to Investors: BOX
presently lists slightly fewer than 500 options classes represented by
80-85,000 different instruments. Market Makers have an obligation to
provide continuous two way markets on virtually all of them,
representing a staggering amount of update traffic if markets are
turbulent. However, not all of these instruments are of ``equal
interest'' to options investors. Indeed trading volume tends to
concentrate on a relatively small percentage of the overall universe of
instruments; arguably, investors and traders are quite willing to
tolerate reasonable update delays in those instruments deemed to be of
lesser interest. For example, over 25% of all series cleared by the
Options Clearing Corporation (``OCC'') have open interest below 100
contracts, a reasonable indication that the updates concerning over
one-quarter of the marketplace are of minimal interest.
     Certain Updates Are More ``Interesting'' Than Others:
There are three types of updates:
    a. Those that represent a change in price at the top of the book;
    b. Those that represent an increase in quantity at the same price
at the top of the book; and
    c. Those that represent a decrease in quantity at the same price at
the top of the book.
    Investors are likely in many cases to tolerate delays in (b) over
delays in (c) and consider short delays in (a) to be most important of
the three.
     Reducing Traffic ``Peaks'' Is More Important Than Reducing
Overall Quote Update Traffic: The costs of Data Vendors and Order Flow
firms providing market data services to their customers are more
sensitive to the requirements of managing peak \3\ traffic than they
are to processing ``normal'' traffic. This is true of most technology
services since systems generally must be built to manage the ``worst'',
though they will be, by definition, significantly underutilized over
the trading day as a result. In other words, the costs of managing
industry traffic will not be significantly reduced if mitigation only
reduces overall traffic. Arguably, the biggest ``bang for the buck'' is
in decreasing peak traffic levels. While the bundling algorithm
proposed by BOX is likely to be more ``efficient'' (that is, result in
a proportionally greater reduction of traffic) during busier moments
like peaks, BOX intends to bundle some of its traffic all of the time,
since the open interest threshold will be set no lower than 50
contracts and the bundling lapse at no lower than 200 milliseconds.
---------------------------------------------------------------------------

    \3\ There are many definitions of ``peaks''; it is not necessary
to agree on a precise definition here in order to understand the
goals. A peak may be defined as either the ``N'' busiest seconds
over the trading session of roughly 23,000 seconds (where ``N'' is
likely equal to 100 or fewer or it may be defined as ``those seconds
where traffic is ``N'' times greater than the average over the
23,000 seconds of the trading session and ``N'' is set to perhaps 3.
The point is that the peaks are the exceptional levels that drive
the scaling and, therefore, the costs, of the data broadcast
systems.
---------------------------------------------------------------------------

BOX Proposal
    BOX believes there are optimal compromises and the accompanying
rule proposal for ``quote mitigation'' addresses this in the following
manner:
     Rather than adopt an arbitrary definition of which
instruments are considered to be ``less interesting,'' BOX proposes to
``let the market decide'' by basing this on the open interest in
contracts at the OCC for each instrument. Clearly those series with
lower open interest are likely to be of less interest to options
traders and investors. The precise threshold of open interest which
will determine whether the broadcast of a series is subject to
mitigation or not will vary according to the degree BOX is meeting its
stated goals of reducing overall traffic. It is anticipated that this
threshold could be as high as 300 to 400 contracts, but that it will be
no lower than 50 contracts. BOX does not propose to apply mitigation to
instruments which have been listed for fewer than ten trading sessions,
regardless of the open interest.
     BOX will ``bundle'' at intervals of up to 1,000
milliseconds (and no less than 200 milliseconds) any changes to its
broadcast for those instruments which have fallen below the threshold
in the previous point.

     BOX will use variable rates of ``bundling'' delays for the
three different types of broadcast updates: changes in price, increases
in quantity without a change in price, and decreases in quantity
without a change in price. Under this proposal, changes in prices may
be subject to less delay than changes to quantity at same price. For
example, BOX may apply a ``bundling interval'' of 400 milliseconds to
updates regarding a price change while using a figure of 1,000
milliseconds for updates concerning only a change in quantity at the
same price. The appropriate mix will be determined by the relative
success BOX is meeting in its overall goals of traffic reduction.
    The Exchange does not propose to apply the above-described bundling
to traffic relating to price improvement auctions or NBBO exposure
mechanisms, nor to trade reporting messages. Furthermore, no bundling
of quotes is proposed for inbound orders and quotes which are sent to
BOX by users; messaging will only be bundled for outbound updates.
    The Exchange believes this proposal is an optimal trade-off between
costs and benefits and that it is fully compliant with its firm quote
obligations. The Exchange further believes that the proposed rule is
designed to provide the Exchange with a quote mitigation plan which
will significantly reduce overall peak market data traffic with a
relatively small impact on the quality of information available to
options market users.
     BOX's target reduction in outbound peak traffic is 15% to
20% of what the traffic would have been had no mitigation been applied.
     Reduction in overall traffic, as opposed to peaks, will be
lower, but still significant, with a target of 8% to 10%.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\4\ in general, and furthers the
objectives of Section 6(b)(5) of the Act,\5\ in particular, in that the
proposed rule change is designed to promote just and equitable
principles of trade, to prevent fraudulent and manipulative acts and
practices, to remove impediments to and perfect the mechanism of a free
and open market and a national market system, and, in general, to
protect investors and the public interest.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    Written comments on the proposed rule change were neither solicited
nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission will:
    (A) By order approve such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form http://www.sec.gov/rules/sro.shtml.
; or     Send an e-mail to<EMAIL_ADDRESS>Please include

File No. SR-BSE-2006-48 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.
    All submissions should refer to File No. SR-BSE-2006-48. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site at http://www.sec.gov/rules/sro.shtml.
 Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File No. SR-BSE-2006-48 and should be
submitted on or before December 18, 2006.
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    \6\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\6\
Nancy M. Morris,
Secretary.
[FR Doc. E6-19983 Filed 11-24-06; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 46 (Monday, March 10, 2014)]
[Notices]
[Pages 13307-13308]
[FR Doc No: 2014-05059]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-P-0768]

Determination That ZEFAZONE (Cefmetazole Sodium) Injection,
Equivalent to 1 Gram Base/Vial and Equivalent to 2 Gram Base/Vial, and
ZEFAZONE (Cefmetazole Sodium) Intravenous Solution, Equivalent to 20
Milligrams Base/Milliliter and Equivalent to 40 Milligrams Base/
Milliliter, Were Not Withdrawn From Sale for Reasons of Safety or
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined that
ZEFAZONE (cefmetazole sodium) Injection, equivalent to (EQ) 1 gram (g)
base/vial and EQ 2 g base/vial, and ZEFAZONE (cefmetazole sodium)
Intravenous (IV) Solution, EQ 20 milligrams (mg) base/milliliter (mL)
and EQ 40 mg base/mL, were not withdrawn from sale for reasons of
safety or effectiveness. This determination will allow FDA to approve
abbreviated new drug applications (ANDAs) for ZEFAZONE (cefmetazole
sodium) Injection, EQ 1 g base/vial and EQ 2 g base/vial, and ZEFAZONE
(cefmetazole sodium) IV Solution, EQ 20 mg base/mL and 40 mg base/mL,
if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Kathy Schreier, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6246, Silver Spring, MD 20993-0002, 301-
796-3432.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the Orange Book.
Under FDA regulations, drugs are removed from the list if the Agency
withdraws or suspends approval of the drug's NDA or ANDA for reasons of
safety or effectiveness or if FDA determines that the listed drug was
withdrawn from sale for reasons of safety or effectiveness (21 CFR
314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    ZEFAZONE (cefmetazole sodium) Injection, EQ 1 g base/vial and EQ 2
g base/vial, is the subject of NDA 50-637, held by Pharmacia & Upjohn,
Inc., which was initially approved on December 11, 1989; and ZEFAZONE
(cefmetazole sodium) IV Solution, EQ 20 mg base/mL and EQ 40 mg base/
mL, is the subject of NDA 50-683, held by Pharmacia & Upjohn, Inc.,
which was initially approved on December 29, 1992. ZEFAZONE is a
semisynthetic cephem antibiotic that is indicated for treatment of
urinary tract infections, lower respiratory tract infections, skin and
skin structure infections, and intra-abdominal infections.
    In a letter dated August 1, 2000, Pharmacia & Upjohn, Inc.,
notified FDA that ZEFAZONE (cefmetazole sodium) Injection, EQ 1 g base/
vial and EQ 2 g base/vial, and ZEFAZONE (cefmetazole sodium) IV
Solution, EQ 20 mg base/mL and EQ 40 mg base/mL, were no longer being
marketed and requested withdrawal of NDA 50-637 and NDA 50-683. FDA
moved the drug products to the ``Discontinued Drug Product List''
section of the Orange Book and, in the Federal Register of August 16,
2001 (66 FR 43017), announced that it was withdrawing approval of NDA
50-637 and NDA 50-683 effective September 17, 2001.
    Salus Pharma LLC submitted a citizen petition dated June 17, 2013
(Docket No. FDA-2013-P-0768), under 21 CFR 10.30, requesting that the
Agency determine whether ZEFAZONE (cefmetazole sodium) Injection, EQ 1
g base/vial and EQ 2 g base/vial, was withdrawn from sale for reasons
of safety or effectiveness. Although the citizen petition did not
request that we determine whether ZEFAZONE (cefmetazole sodium) IV
Solution, EQ 20 mg base/mL and EQ 40 mg base/mL, approved under NDA 50-
683, was withdrawn for safety or effectiveness, that product also has
been discontinued. On our own initiative, we have also determined
whether ZEFAZONE (cefmetazole sodium) IV Solution, EQ 20 mg base/mL and
EQ 40 mg base/mL, was withdrawn for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that ZEFAZONE (cefmetazole sodium) Injection, EQ 1
g base/vial and EQ 2 g base/vial, and ZEFAZONE (cefmetazole sodium) IV
Solution, EQ 20 mg base/mL and EQ 40 mg base/mL, were not withdrawn for
reasons of safety or effectiveness. The petitioner has identified no
data or other information suggesting that ZEFAZONE (cefmetazole sodium)
Injection, EQ 1 g base/vial and EQ 2 g base/vial, and ZEFAZONE
(cefmetazole sodium) IV Solution, EQ 20 mg base/mL and EQ 40 mg base/
mL, were withdrawn for reasons of safety or effectiveness. We have
carefully reviewed our files for records concerning the withdrawal of
ZEFAZONE (cefmetazole sodium) Injection, EQ 1 g base/vial and EQ 2 g
base/vial, and ZEFAZONE (cefmetazole sodium) IV Solution, EQ 20 mg
base/mL and EQ 40 mg base/mL, from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events. We have found no information that would indicate that
these products were withdrawn from sale for reasons of safety or
effectiveness.
    Accordingly, the Agency will continue to list ZEFAZONE (cefmetazole
sodium) Injection, EQ 1 g base/vial and EQ 2 g base/vial, and ZEFAZONE
(cefmetazole sodium) IV Solution, EQ 20 mg base/mL and EQ 40 mg base/
mL, in the ``Discontinued Drug Product List'' section of the Orange
Book. The ``Discontinued Drug Product List'' delineates, among other
items, drug products that have been discontinued from marketing for
reasons

other than safety or effectiveness. ANDAs that refer to ZEFAZONE
(cefmetazole sodium) Injection, EQ 1 g base/vial and EQ 2 g base/vial,
and ZEFAZONE (cefmetazole sodium) IV Solution, EQ 20 mg base/mL and EQ
40 mg base/mL, may be approved by the Agency as long as they meet all
other legal and regulatory requirements for the approval of ANDAs. If
FDA determines that labeling for these drug products should be revised
to meet current standards, the Agency will advise ANDA applicants to
submit such labeling.

    Dated: March 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-05059 Filed 3-7-14; 8:45 am]
BILLING CODE 4160-01-P