Docket Number EPA-HQ-OPP-2013-0749

    HYPERLINK http://www.regulations.gov/  www.regulations.gov

Aminopyralid Preliminary Work Plan

Registration Review: Initial Docket

Case Number 7267

March 2014

Approved by:

Director

Pesticide Re-evaluation Division

Date:

Aminopyralid Preliminary Work Plan - Table of Contents

OVERVIEW ........................................................................ ............................................................4

AN'flCIPATED DATA NEEDS ........................................................................ .............................5

STATUTORY AND REGULATORY  AUTHORITY ...................................................................5

CHEMICAL FACTS ........................................................................ ...............................................6

USE AND USAGE INFORMATION ........................................................................ .....................? RECENT ACTIONS ........................................................................ ...............................................9

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW.................................9

TIMELINE ........................................................................ ............................................................11

NEXT STEPS ........................................................................ ........................................................12

Appendix - Additional Areas Considered in the Aminopyralid Registration Review ..............13

                                                     References:

This Preliminary Work Plan su mmarizes the Environmental Protection Agency's current position based on the following documents:

1.  Registration Review: Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Human Health Drinking Water Exposure Assessments for Aminopyralid, Potassium Salt of Aminopyralid, and Triisopropanolamine Salt of Aminopyralid. EFED!Edward Scollon, Ph.D. and Katrina White, Ph.D. February 12, 2014.

2.  Aminopyralid. Human Health Assessment Scoping Document in Support of Registration Review. HED/Douglas Dotson, Ph.D., Jaime D'Agostino, Ph.D. and Zaida Figueroa, February 12, 2014.

3.  Aminopyralid:  Tier l Review of Human Incidents. Shanna Recore. November 12, 2013.

4.   BEAD Chemical Profile (BCP )for Registration Review: Aminopyralid Case Level

Composed of Aminopyralid (005100), Aminopyralid, Potassium Salt (005219) and

Triisopropcmolamine Salt of Aminopyralid (005209). BEAD/Sunil Ratnayake, Rafael A. Prieto and Stephen Smearman, March 31,2014.

5.  Aminopyralid (005100, 005209, 005219). Screening Level Usage Analysis (S LUA ),

March 18, 2014.

6.  Environmental Fate and Effects Division Label Data Report Spreadsheet:  PC Codes:

005100, 005209,005219. August 23, 2013.

7.  Health Effects Division Master Label Report Spreadsheet: PC Codes: 005100,

005209,005219. August 23, 2013.

These and other supporting documents for the aminopyralid registration review case may be found in the docket EPA-HQ-OPP-2013-0749 at http://www.re!!ulalions.gov.

OVERVIEW

The docket for aminopyralid is now open, initiating the first public comment period for this registration rev iew (docket number EPA-HQ-OPP-2013-0749). This case includes the aminopyralid acid along with its potassium and triisopropanolamine salts.  Aminopyralid, 4- amino-3,6-dichloro-2-pyridinecarboxylic acid, is a systemic herbicide which is registered  for use to control a number of noxious and invasive annual, biennial and perennial weed species.  This pesticide belongs to the pyridine carboxylic acid family and is registered for use as a precausing abnormal growth patterns in the plants.  Aminopyralid may be applied via aircraft, ground sprayer, hand-held sprayer, and boom sprayer.  Aminopyral id may also be applied to forest plantings via broadcast, high volume spray, spot treatment, stump treatment, girdle treatment, frill treatment, tree wound treatment, and tree injection.  This  Preliminary Work Plan (PWP) document explains what EPA's Off ice of Pesticide Progra ms knows about aminopyrlid, highlighting anticipated data and assessment needs, identifying the types of information that would be especially useful to the Agency in conducting the review, and providing an anticipated timeline for completing the registration review for aminopyralid.

The registration review process was designed to include a public participation component to solicit input from interested stakeholders.  The Agency intends, by sharing this information in the docket, to inform the public of what it knows about aminopyralid and what types of new data or other information would be helpful for the Agency to receive as it moves toward a decision on aminopyralid.  The Agency encourages all interested stakeholders to review the PWP and Appendix and to provide comments and additional information that will help the Agency's decision-making process for this chemical.  In addition to general areas on which persons may wish to comment, there are some areas identified in the PWP and Appendix about which the Agency specif ically seeks comments and information.  Interested stakeholders could include: environmental non-prof it or in terest groups; pesticide manufacturers; agricultural labor or commodity groups; commercial, institutional, residential, and other users of pesticides; or the public at large.

The Preliminary- Work Plan begins by listing the anticipated data needs for aminopyralid.  Next, it discusses the statutory and regulatory authority for Registration Review.  Then the document provides chemical facts, use and usage information, recent actions, the anticipated risk assessments, and a projected registration review timeline for aminopyralid.  Finally, the Appendix to this document includes identification and discussion of some areas that are considered generally in Registration Review along with some additional chemical case-specific information.

 ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data needs for aminopyralid.  For additional discussion of the anticipated data: needs, see the Registration Review Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Human Health Drinking Water Exposure Assessments for Aminopyralid, Potassium Salt of Aminopyralid, and Triisopropanolamine  Salt of Aminopyralid and the Human Health Assessment Scoping Donrment in Support of Registration Review.

TGAI ==  techmca l grade acttve mgredtent; TEP = typ1cal end-use product

 STATUTORY AND REGULATORY AUTHORITY

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program.  All pesticides distributed or sold in the United States (U.S.) generally must be registered by the Environmental Protection Agency (EPA or the Agency), based on scientif ic data showing that they will not cause unreasonable risks to human health or the environment when used as directed

                                                     1 On June 27, 2012, EPA announced certain revisions in harmon ized guideline series 850-Ecological Effects Tests

- incl uding re numberin g and other designations or changes for some guideline studies.  See "Final Test Guidelines; OCSPP 850 Series; Notice of Availability" 77 FR 38282, June 27,2012.

2 For these Guideline Numbers, data and/or waiver requests are currently under review.

3 Data are anticipated to be needed for representative Typical End-Use Products (TEPs) that conta in i) aminopyralid and 2,4-D; ii) aminopyralid and triclopyr; iii) aminopyralid and clopyralid ; iv) aminopyra lid and metsulfuron; and v) aminopyralid and fluroxypyr-l-methylheptyl ester

on product labeling.  The registration review program is intended to make sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no unreasonable adverse effects to human health or the e.nvironment.  Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review program, the Agency periodically reevaluates pesticides to make sure that as change occurs, products in the marketplace can be used safely.  Information on this program is provided on EPA's website.4

The Agency is implementing the registration review program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act(FIFRA), and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration.  The regulations governing registration review begin at 40 CPR 155.40.  The Agency will consider benefits information and data as required by FIFRA.  The public phase of registration review begins when the initial docket is opened for each case.  The docket is the

Agency's opportunity to state what it knows about the pesticide and what additional risk analyses and data or information it believes are needed to make a registration review decision.  After reviewing and responding to comments and data received in the docket during this initial comment period, the Agency will develop a Final Work Plan (FWP) and anticipated schedule for the registration review of aminopyralid.

 CHEMICAL FACTS

Table 2 provides a summary of the chemical facts for aminopyralid.

 Table 2:  Chemical Facts for Aminopyralid PC codes 005100 (aminopyralid acid), 005219 (aminopyralid potassium salt),   005209 (aminopyralid triisopropanolamine [TIPA] salt) Case Number 7267 CAS Numbers 150114-71-9 (aminopyralid acid),  566192-87 (aminopyralid

potassium salt), 566191-89-7 (aminopyralid TIPA salt)Year first registered2005Pesticide TypeHerbicideChemical classPyridine carboxylic acidReregistration Eligibility

Decision (RED)Aminopyralid was registered after November 1984; therefore, it

was not subject to reregistration.Tolerance Reassessment

Eligibility Decision (TRED)Aminopyralid was registered after November 1984; therefore, it

was not subject to tolerance reassessment.Cumulative groupNo cumulative risk assessment is required at this time since the

Agency has not made a determination regarding a common mode of action.40 CFR CitationTolerances for aminopyralid are established in 40 CPRand has no registered antimicrobial or bioNon-pesticidal usesThere are no identified non-pesticidal uses of aminopyralid.

                                                     4     HYPERLINK http://www.epa.gov/oppsrrd1/registration_review/  http://www.epa.gov/oppsrrd 1/registration_review/

 Table 2: Chemical Facts for Aminopyralid Pesticide Re-evaluation Division, Chemical Review Manager

Veronica Dutch,  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS> (703) 308-8585Registration Division,

Product Manager

Kathryn Montague,  HYPERLINK<EMAIL_ADDRESS>montague.kathryn @ega.gov,<PHONE_NUMBER>

 USE AND USAGE INFORMATION

Table 3 summarizes the use and usage information for aminopyralid.  Please see the BEAD Chemical Profile ( BCP) for Registration Review: Aminopyralid Case Level Composed of Aminopyralid (005100), Aminopyralid, Potassium Salt (005219) and Triisopropanolamine  Salt of Aminopyralid (005209) in the registration review docket for more details.

 Table 3: Aminopyralid Use and Usage Information Summary of Use Aminopyralid. is a systemic herbicide registered for broadleaf weed

management in agricultural and non-agricultural lands. Arninopyralid can be applied as pre-emergence or post-emergence treatments using aerial and ground application methods. Aminopyralid acts like a plant growth regulator by mimicking natural plant growth hormones (auxins).Use SitesUse sites for amlnopyralid are wheat, hay, and pasture crops.

Use sites for aminopyralid potassium salt are forestry plantings, wheat, hay, and pasture crops.  It is also registered for use on Conservation Reserve Program (CRP) lands, rights-of-way,  and fallow and non-agricultural uncultivated areas, including seasonally flooded wetland areas when dry.

Use sites for aminopyralid TIPA salt include forest plantings, wheat, corn (silage, f ield), and hay and pasture crops.  It is also registered for use on CRP areas, airports/landing fields, industrial and construction areas, fallow and non-agricultural uncultivated agricultural uncultivated areas, including seasonally flooded wetland areas when dry.

The predominant use for these active ingredients is on pasture

(98+% of usage).Summary of UsageBased on proprietary data from 2006-2012, average usage was approximately 92,000 pounds of active ingredient (a.i.) applied

annually on 1.3 million acres.  The average a.i. rate over this time period was 0.07 pounds a.i./acre.  There are limited usage data available for non-agricultural use sites.Formulation Type(s)Ami

Aminopyralid is formulated as an emulsifiable concentrate. nopyralid potassium salt is formulated as a dry flowable and

 Table 3: Aminopyralid Use and Usage Information emulsifiable concentrate. Aminopyralid triisopropanolainine salt is formulated as an emulsifiable concentrate, liquid soluble concentrate, and flowable concentrate. Application Method(s) Products can be applied as a broadcast treatment by aircraft, ground

sprayer, or hand-held sprayer. Additional treatments are spot treatment, stump treatment, girdle treatment, frill treatment, tree wound treatment, and tree injection.Technical RegistrantDow Agro $ciences LLCNo. of Registrations15 Section 3 products:> and 36 Special Local Needs (SLN; Section

24c) registrations.Restricted UseNo

Guidance for Commenters:  Additional areas of use and usage related information

requested for this registration review, and of particular interest to EPA, are described  below.

•	Certain current labels with instructions for applications to trees (e.g., cut surface, cut-stump treatment, tree injection, hack and squirt treatment, and frill and girdle method) do not specify the maximum amount of aminopyralid that may be applied per tree ( e.g ., as a function of trunk diameter), or the maximum number of trees that may be treated per acre. Maximum application rates (both single and seasonal) in lbs a.i or a.e./A for modeling exposures resulting from these types of uses may also be l acking as is the maximum number of applications per year and minimum retreatment interval.

•	Some labels list nonspecific use sites.  Without specific use site information, the Agency must employ the assumption that aminopyralid can be used at any of the specif ic use sites that fall within the broad range of agricultural, commercial, residential, and forest sites named on the label, and  that applications may be made to both aquatic and terrestrial environments.  The following are examples of nonspecific use sites:

o 	Non-irrigation ditch banks, seasonally dry wetlands (such as flood plains, deltas,

marshes, swamps, or bogs), transitional areas between upla nd and lowland sites when dry, ditch bank weeds, shoreline weeds, non-cropland areas, and natural areas.

•	Some label restrictions are specif ied on a product basis. rather than on an a.i. basis.

•	Some labels Jack maximum annual or seasonal application rates, maximum number of applications, and minimum retreatment intervals.

•	Some labels with multiple a.i.s provide application rate information on an acid equivalent basis but do not specify to which a.i. the rates apply.

•	Confirmation of additional label information:  application methods and equipment, and geographic limitations on use.

•	Use distribution (e.g., acreage and geographical distribution of relevant use sites).

                                                     5 Section 3 product labels can be obtained from the Pesticide Product Label System (PPLS) website

(http://oaCpub.epa.gln,foestlabllppls.home).

o 	Median and 90th percentile reported use rates (l bs ai/A) from usage data - national, state, and county.

f) 	Typical application timing (date of first application and application intervals)- national, state, and county.

o 	Usage/use information for non-agricultural sites.

o 	State or local use restrictions.

o 	Foreign technical registrantthat supply technical aminopyralid to the US market.

RECENT ACTIONS

In 2013, an amendment to registration for a Section 3 new use of aminopyralid for control of broadleaf and woody plants and annual weeds in aquatic sites was submitted.  The proposed labels defined aquatic sites as "non-irrigation ditch banks; seasonally dry wetlands such as flood

plains, deltas, marshes, swamps, or bogs; transitional areas between upland and lowland sites as well as along shorelines; and shallow areas of still and moving water."  The submission is currently under review. .

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for aminopyralid was completed in 2009.  The most recent ecological and environmental fate risk assessment was completed  in

2010.  Findings and conclusions from these risk assRegistration Review Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Human Health Drinking Water Exposure Assessments for Aminopyralid, Potassium Salt of Aminopyralid, and Triisopropanolamine Salt of Aminopyralid.

During registration review, the Agency anticipates the need to conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of aminopyral id. For human health, EPA anticipates the need to conduct revised dietary and aggregate risk assessments during registration review.  If toxicological endpoints or points of departure are revised based on the data that are anticipated to be required for registration review, they will be considered, as will any changes to the standard operating procedures or default exposure assumptions.

Table 4 below summarizes the anticipated registration review risk assessments based on the

EFED Problem Formulation and HED Scoping Document.

 Table 4:  Anticipated Risk Assessments for the Aminopyralid Registration Review Type of Risk Assessment Conduct? Notes Ecolofdcal and Environ mental Fate Comprehensive ecological

(species to be assessed

include terrestrial and aquatic organisms), including endangered species

y

The Agency will cond uct a comprehensive ecological assessment, including an endangered species assessment.  Effects of residues in compost will be addressed.Incidents

Will check for updatesFor discussion of reported ecological incidents for

a minopyral id, see page 17 of the Problem

Formulation.Human  HealthDietaryFood

yIf new policies are put into place, or new toxicity and

crop treated data become available, the Agency will revisit.Drinking wateryDrinking water will be examined as part of registration review.OccupationalHandlers (mixers, loaders, applicators)

yThe Agency will consider the need for a new handler

assessment to account for any policy changes that take place during registration review.Post-application

NAn occupational quantitative post-application

assessment will not be necessary during registration review because a dermal endpoint has not been selected for aminopyral id.ResidentialHandlers

NAminopyralid is not applied by homeowners;

therefore, a residential handler assessment will not be conducted for registration review.Post-application

yDuring registration review, a revised residential

exposure assessment that includes post-appl ication incidental oral exposure to children (1 <2 years old) playing on treated recreational sites may be needed. The Agency may determine that a bystander spray drift risk assessment is needed for aminopyralid during registration review.OtherAggregate

yIf food, drinking water, or residential port-application

reassessments are conducted, a new aggregate risk assessment may be needed.

 Cumulative

NAminopyralid has not been identified as belonging to

a cumulative group, so the Agency does not anticipate that a cumulative risk assessment will be performed.TolerancesyThe Agency will revisit the tolerances during

registration review.Incidents

Will check for updatesFor a discussion of reported human incidents for

aminopyralid, see page 10 of the Seeping Document and Aminopyralid:  Tier I Review of Human Incidents.

Guidance for Commenters:  Additional ecological information requested for this registration review, and of particular interest to EPA, is described below.

o 	Ecological incidents (non-target plant damage and avian, fish, rep_tilian, amphibian and mammalian mortalities) not already reported to the Agency.

o 	The application of aminopyralid to vegetative matter that is subsequently used as compost or animal feed has been found to retain aminopyralid residues and affect

non-target plants. Residues in food items that end up in compost may also be found in

compost.  The Agency is interested in additional information about this issue, which may include incident reports and environmental fate data.

o 	Water quality monitoring data (see Appendix for further details).

TIMELINE

EPA has created the following estimated timeline for the completion of the aminopyralid registration review in Table 5 below.

 Table 5:  Projected Aminopyralid Registration Review Timeline Activities Estimated Date Opening the Docket Open Docket and 60-day Public Comment Period March-2014 Close Public Comment May-2014 Case Development Fi nal Work Plan August-2014 Issue DCI October-December-2014 Data Submission October-December-2016 60-day Public Comment Period for Draft Risk Assessments0 April-June-2018 Registration Review Decision 60-day Public Comment Period for Proposed Registration

Review DecisionJanuary-March-2019Registration Review Decision and Begin Post-Decision

Follow-up2020Total (years)6

                                                     6 The regu lations governing Registration Review generally require the Agency to provide a public comment period of at least 30 calendar days for draft risk assessments; see 40 CFR Part 155.53(c).  For conventional pesticides, the Agency plans to provide a 60 calendar day public comment period generally for draft risk assessments.

NEXT STEPS

After the 60-day public comment period closes, the Agency will review and respond to any comments received in a timely manner and then issue a Final Work Plan for the registration review of aminopyralid.

Appendix - Additional Areas Considered in the Aminopyralid Registration Review

.  PUBLIC COMMENTS  AND FEEDBACK:

Guidance for Commenters: The areas below highlight topics of special interest to the Agency where your comments, data submissions, or reference to sources of additional information could be of particular use.

Trade Irritants:

Through the registration review process, the Agency intends to solicit information on trade irritants and, to the extent feasible, take steps toward facilitating irritant resolution.  The Agency will work to harmonize tolerances and international maximum residue limits (MRLs) and may modify tolerance levels to do so, when possible. Growers and other stakeholders are asked to comment on any trade irritant issues resulting from lack of MRLs or disparities between U.S. tolerances and MRLs in key export markets, providing as much specificity as possible regarding the nature of the concern.

Water Quality:

Aminopyralid is not identified as a cause of impairment for any watebodies  listed as impaired under section 303(d) of the Clean Water Act.7  In addition, no Total Maximum Daily Loads (TMDLs) have been developed for aminopyralid.8  More information on impaired water bodies and TMDLs can be found at the Agency's website.9 The Agency invites submission of water quality data for this pesticide. To the extent possible, data should conform to the quality

standards in Appendix A of the OPP Standard Operating Procedure: Inclusion of Impaired Water Bod y and Other Water Quality Data in OPP's Registration Review Risk Assessment and Management Proces/ 0 in order to ensure they can be used quantitatively or qualitatively in

pesticide risk assessments.

Environmental Justice:

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all people, regardless of race, color, national origin, or income, in the development, implementation, and enforcement of environmental laws, regulations, and policies.  To help address potential environmental justice issues, V!e Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical, unusually high exposure to aminopyralid compared to the general population.  Please comment if you are aware of any sub-populations that may have atypical, unusually high exposure compared to the general population.

                                                     7      HYPERLINK http://ias.pub.epa.gov/tmdl   http://ias.pub.epa.gov/tmdl   waters I 0/attamnation  cyxause  detail  303d'?p  cause  group  id-!Hl5

8    HYPERLINK http://iaspub.cpa.gov/tmdl  http://iaspub.cpa.gov/tmdl C'>aters I0/attains  nation.tmdl pollutant detail?p pollutant l!fOUQ id-885&p pollutant

 group name=PESTICIDES

9     HYPERLINK http://www.epa.gov/owow/tmdl/  http://www.epa.gov/owow/tmdl/

10     HYPERLINK http://www.epa.gov/oppsnd   http://www.epa.gov/oppsnd  !/registration reC ieCC /water quality '>Op.htm

ENDANGER ED SPECIES:

A risk assessment that supports a complete endangered species determination has not been conducted for aminopyralid.  The ecological risk assessment plaiUled during registration review will allow the Agency to determine whether use of aminopyralid has "no effect" or "may affect" and/or National Marine Fisheries Service (the Services), as appropriate.

 ENDOCRINE DISRUPTOR SCREENING PROGRAM:

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals.  Collectively, these studies include acute, subchronic and chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be  , susceptible to endocrine influence, including effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring.  For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, developmental and reproductive effects in different taxonomic groups.  As part of its most recent registration decision for aminopyralid, EPA reviewed these data and selected  the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database.  However, as required by FFDCA section 408(p), aminopyralid is subject to the endocrine screening part of the Endocrine Disrupter Screening

EPA has developed the EDSP to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a "naturally occurring estrogen, or other such endocrine effects as the Administrator may designate."  The EDSP employs a two-tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal systems.  Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any adverse endocrine-related effects caused by the substance, and establish a dose-response relationship between the dose and the E, A, or T effect.

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals.  Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients.  A second list

of chemicals identified for EDSP screening was published on June 14, 20131 1  and includes some pesticides scheduled for registration review and chemicals found in water.  Neither of these lists

should be construed as a list of known or likely endocrine disrupters.

                                                     11 See  http://wCvw.regulation-,.gov/#!documcntDetaii:D-EPA-HO-OPPT-2009-0477-0 074 for the final second list of chemicals.

.   14

For further information on the status of the EDSP, the policies and procedures, the lists of chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website. 12

HUMAN STUDIES:

Past aminopyralid risk assessments rel y in part on data from studies in which adult human subjects were intentionally exposed to a pesticide to determine their dermal and inhalation exposure.  Many such studies, involving exposure to many different pesticides, comprise generic pesticide exposure databases such as the Pesticide Handlers Exposure Database (PHED), the Agricultural Reentry Task Force (ARTF) Database, and the Outdoor Residential Exposure Task Force (ORETF) Database.  EPA has reviewed all the studies supporting these multi-pesticide generic exposure databases, and has found no clear and convincing evidence that the conduct of any of them was either fundamentally unethical or significantly deficient relative to the ethical standards prevailing at the time the research was conducted.  All applicable requirements of EPA's Rule for the Protection of Human Subjects of Research (40 CFR Part 26) have been satisfied, and there is no regulatory barrier to continued reliance on these studies.

                                                     12     HYPERLINK http://www.epa.gov/endo/  http://www.epa.gov/endo/

15


[Federal Register Volume 76, Number 87 (Thursday, May 5, 2011)]
[Notices]
[Pages 25702-25703]
[FR Doc No: 2011-10993]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[USCG-2011-0310]

National Maritime Security Advisory Committee; Meeting

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ACTION: Notice of teleconference meeting.

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    Dated: May 2, 2011.
K.C. Kiefer,
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[FR Doc. 2011-10993 Filed 5-4-11; 8:45 am]
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[Federal Register Volume 87, Number 200 (Tuesday, October 18, 2022)]
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Virginia: Final Authorization of State Hazardous Waste Management
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requirements needed to qualify for final authorization and is hereby
authorizing Virginia's revisions through this direct final rule. In the
``Proposed Rules'' section of this issue of the Federal Register, EPA
is also publishing a separate document that serves as the proposal to
authorize these revisions. EPA believes this action is not
controversial and does not expect comments that oppose it.
Authorization of Virginia's revisions to its hazardous waste program
will take effect 30 days after the conclusion of the public comment
period unless EPA receives written comments that oppose this
authorization. If EPA receives adverse comments pertaining to this
State revision, then EPA will publish in the Federal Register a timely
withdrawal of this direct final rule before it takes effect, and the
separate document in the ``Proposed Rules'' section of the Federal
Register will serve as the proposal to authorize any revisions made
based on comments received.

DATES: This final authorization will become effective on December 19,
2022, unless EPA receives adverse written comments by November 17,
2022. If EPA receives any such comments, then EPA will publish a timely
withdrawal of this direct final rule in the Federal Register.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R03-
RCRA-2022-0351 at www.regulations.gov. Follow the online instructions
for submitting comments. Once submitted, comments cannot be edited or
removed from www.regulations.gov. The EPA may publish any comment
received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information the disclosure of which is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e., on the web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit
www.epa.gov/dockets/commenting-epa-dockets. The EPA encourages
electronic submittals, but if you are unable to submit electronically
or need other assistance, please contact Jacqueline Morrison, the
contact listed in the FOR FURTHER INFORMATION CONTACT provision below.
Please also contact Jacqueline Morrison if you need assistance in a
language other than English or if you are a person with disabilities
who needs a reasonable accommodation at no cost to you.

FOR FURTHER INFORMATION CONTACT: Jacqueline Morrison, RCRA Programs
Branch, Land, Chemicals and Redevelopment Division, U.S. Environmental
Protection Agency Region III, Four Penn Center, 1600 John F. Kennedy
Blvd. (Mail code 3LD30), Philadelphia, PA 19103-2852, Phone number:
(215) 814-5664; email: [email protected].

SUPPLEMENTARY INFORMATION:

A. Why are revisions to the State programs necessary?

    States that have received final authorization from EPA under RCRA
section 3006(b), 42 U.S.C. 6926(b), must maintain a hazardous waste
program that is equivalent to, consistent with, and no less stringent
than the Federal program. As the Federal program is revised to become
more stringent or broader in scope, States must revise their programs
and apply to EPA to authorize the revisions. Authorization of revisions
to state programs may be necessary when Federal or State statutory or
regulatory authority is modified or when certain other revisions occur.
Most commonly, States must revise their programs because of revisions
to the EPA's regulations in 40 Code of Federal Regulations (CFR) parts
124, 260 through 268, 270, 273, and 279.

B. What decisions have we made in this rule?

    On January 10, 2022, Virginia submitted a final program revision
application (with subsequent corrections) seeking authorization of
revisions to its hazardous waste program that correspond to certain
Federal rules promulgated through February 22, 2019.
    EPA concludes that Virginia's application to revise its authorized
program meets all of the statutory and regulatory requirements
established by RCRA, as set forth in RCRA section 3006(b), 42 U.S.C.
6926(b), and 40 CFR part 271. Therefore, EPA grants Virginia final
authorization to operate its hazardous waste program with the revisions
described in its authorization application, as outlined below in
Section G of this document. Virginia has responsibility for permitting
treatment, storage, and disposal facilities (TSDFs) within its borders
and for carrying out the aspects of the RCRA program described in its
application, subject to the limitations of the Hazardous and Solid
Waste Amendments of 1984 (HSWA). New Federal requirements and
prohibitions imposed by Federal regulations that EPA promulgates under
the authority of HSWA take effect in authorized States before they are
authorized for the requirements. Thus, EPA will implement those HSWA
requirements and prohibitions for which Virginia has not been
authorized, including issuing HSWA permits, until the State is granted
authorization to do so.

C. What is the effect of this authorization decision?

    This action serves to authorize revisions to Virginia's authorized
hazardous waste program. This action does not impose additional
requirements on the regulated community because the regulations for
which Virginia is being authorized by this action are already effective
and are not changed by this action. Virginia has enforcement
responsibilities under its State hazardous waste program for violations
of its program, but EPA retains its authority under RCRA sections 3007,
3008, 3013, and 7003, which include, among others, authority to:
     Perform inspections, and require monitoring, tests,
analyses or reports;
     Enforce RCRA requirements and suspend or revoke permits;
and

     Take enforcement actions regardless of whether Virginia
has taken its own actions.

D. Why was there not a proposed rule before this rule?

    Along with this direct final rule, EPA is publishing a separate
document in the ``Proposed Rules'' section of this issue of the Federal
Register that serves as the proposed rule to authorize these State
program revisions. EPA did not publish a proposed rule before this
issue of the Federal Register because EPA views this action as a
routine program change and does not expect comments that oppose its
approval. EPA is providing an opportunity for public comment now, as
described in Section E of this document.

E. What happens if EPA receives comments that oppose this action?

    If EPA receives adverse comments pertaining to this State revision,
EPA will withdraw this direct final rule by publishing a document in
the Federal Register before the rule becomes effective. EPA will base
any further decision on the authorization of Virginia's program
revisions on the proposed rule mentioned in the previous section, after
considering all comments received during the comment period. EPA will
then address all relevant comments in a later final rule. You may not
have another opportunity to comment. If you want to comment on this
authorization, you must do so at this time.

F. What has Virginia previously been authorized for?

    Virginia initially received final authorization of its hazardous
waste program effective December 18, 1984 (49 FR 47391). EPA granted
authorization for revisions to Virginia's regulatory program effective
August 13, 1993 (58 FR 32855); September 29, 2000 (65 FR 46607); June
20, 2003 (68 FR 36925); July 10, 2006 (71 FR 27204); July 30, 2008 (73
FR 44168); and November 4, 2013 (78 FR 54178).

G. What revisions are we authorizing with this action?

    On January 10, 2022, Virginia submitted a final program revision
application (with subsequent corrections) seeking authorization of
additional revisions to its hazardous waste program, as published in
the Code of Federal Regulations from June 13, 2011, through February
22, 2019.
    EPA now makes a direct final rule, subject to receipt of written
comments that oppose this action, that Virginia's hazardous waste
program revision application satisfies all of the requirements
necessary to qualify for final authorization. Therefore, EPA grants
Virginia final authorization for the following program revisions:

1. Program Revision Changes for Federal Rules

    Virginia seeks authority to administer the Federal requirements
that are listed in Table 1 of this document. Virginia incorporates by
reference these Federal provisions, in accordance with the dates
specified in Title 9, Virginia Administrative Code (9VAC 20-60-18).
This Table 1 lists the Virginia analogs that are being recognized as no
less stringent than the analogous Federal requirements.
    The Virginia Waste Management Act (VWMA) enacted by the 1986
session of Virginia's General Assembly and recodified in 1988 as
Chapter 14, Title 10.1, Code of Virginia, forms the basis of the
Virginia program. These regulatory references are to Title 9, Virginia
Administrative Code (9 VAC) effective through August 23, 2019. On
November 4, 2013 (78 FR 54178, September 3, 2013), Virginia received
approval of Program Revision V to its hazardous waste management
program. Since then, Virginia's regulations have been updated to
include Federal regulatory changes. This application, Program Revision
VI, addresses certain changes made to Virginia's hazardous waste
program between January 1, 2011, and August 23, 2019.

         Table 1--Virginia's Analogs to the Federal Requirements
------------------------------------------------------------------------
    Description of Federal
    requirement  (revision       Federal Register    Analogous Virginia
        checklists \1\)           page and date          authority
------------------------------------------------------------------------
                            RCRA Cluster VIII
------------------------------------------------------------------------
Exclusion of Recycled Wood      63 FR 28556, May   9VAC20-60-18; 9VAC20-
 Preserving Wastewaters,         26, 1988.          60-261 A.
 Revision Checklist 167F.
------------------------------------------------------------------------
                            RCRA Cluster XXI
------------------------------------------------------------------------
Revisions of the Treatment      76 FR 34147, June  9VAC20-60-18; 9VAC20-
 Standards for Carbamate         13, 2011.          60-268.
 Wastes, Revision Checklist
 227.
------------------------------------------------------------------------
                            RCRA Cluster XXII
------------------------------------------------------------------------
Hazardous Waste Technical       77 FR 22229,       9VAC20-60-18; 9VAC20-
 Corrections and                 April 13, 2012.    60-260; 9VAC20-60-
 Clarifications, Revision                           266.
 Checklist 228.
------------------------------------------------------------------------
                           RCRA Cluster XXIII
------------------------------------------------------------------------
Conditional Exclusions for      78 FR 46448, July  9VAC20-60-18; 9VAC20-
 Solvent Contaminated Wipes,     31, 2013.          60-260; 9VAC20-60-
 Revision Checklist 229.                            261.
Conditional Exclusion for       79 FR 350,         9VAC20-60-18; 9VAC20-
 Carbon Dioxide (CO2) Streams    January 3, 2014.   60-260; 9VAC20-60-
 in Geologic Sequestration                          261.
 Activities, Revision
 Checklist 230.
Hazardous Waste Electronic      79 FR 7518,        9VAC20-60-18; 9VAC20-
 Manifest Rule, Revision         February 7, 2014.  60-260; 9VAC20-60-
 Checklist 231.                                     262; 9VAC20-60-263;
                                                    9VAC20-60-264;
                                                    9VAC20-60-265.
Revisions to the Export         79 FR 36220, June  9VAC20-60-18; 9VAC20-
 Provisions of the Cathode Ray   26, 2014.          60-260; 9VAC20-60-
 Tube Rule, Revision Checklist                      261.
 232.
------------------------------------------------------------------------
                            RCRA Cluster XXIV
------------------------------------------------------------------------
Revisions to the Definition of  80 FR 1694,        9VAC20-60-18; 9VAC20-
 Solid Waste: Changes            January 13, 2015.  60-260; 9VAC20-60-
 affecting all non-waste                            1390; 9VAC20-60-
 determinations and variances,                      1420.
 Revision Checklist 233A.
Revisions to the Definition of  80 FR 1694,        9VAC20-60-18; 9VAC20-
 Solid Waste: Speculative        January 13, 2015.  60-261.
 Accumulation, Revision
 Checklist 233C.

Revisions to the Definition of  80 FR 1694,        9VAC20-60-18; 9VAC20-
 Solid Waste: 2008 DSW           January 13, 2015.  60-260; 9VAC20-60-
 exclusions and non-waste       83 FR 24664 May     261; 9VAC20-60-1390;
 determinations, including       30, 2018.          9VAC20-60-1420.
 revisions from 2015 DSW final
 rule and 2018 DSW final rule,
 Revision Checklist 233D2.
Revisions to the Definition of  80 FR 1694,        9VAC20-60-18; 9VAC20-
 Solid Waste: Remanufacturing    January 13, 2015.  60-260; 9VAC20-60-
 exclusion, Revision Checklist                      261.
 233E.
Response to Vacaturs of the     80 FR 18777,       9VAC20-60-18; 9VAC20-
 Comparable Fuels Rule and the   April 8, 2015.     60-260; 9VAC20-60-
 Gasification Rule, Revision                        261.
 Checklist 234.
Disposal of Coal Combustion     80 FR 21302,       9VAC20-60-18; 9VAC20-
 Residuals from Electric         April 17, 2015.    60-261.
 Utilities, Revision Checklist
 235.
------------------------------------------------------------------------
                            RCRA Cluster XXV
------------------------------------------------------------------------
Imports and Exports of          81 FR 85696,       9VAC20-60-18; 9VAC20-
 Hazardous Waste, Revision       November 28,       60-260, 261, 262,
 Checklist 236.                  2016.              263, 264, 265, 266,
                                82 FR 41015,        267, and 273.
                                 August 29, 2017.
                                83 FR 38263,
                                 August 6, 2018.
Hazardous Waste Generator       81 FR 85732,       9VAC20-60-18; 9VAC20-
 Improvements Rule, Revision     November 28,       60-260, 261, 262,
 Checklist 237.                  2016.              263, 264, 265, 267,
                                                    268, 270, 273, and
                                                    279.
------------------------------------------------------------------------
                            RCRA Cluster XXVI
------------------------------------------------------------------------
Confidentiality Determinations  82 FR 60894,       9VAC 20-60-18; 9VAC20-
 for Hazardous Waste Export      December 26,       60-260, 261, and
 and Import Documents,           2017.              262.
 Revision Checklist 238.
------------------------------------------------------------------------
                           RCRA Cluster XXVII
------------------------------------------------------------------------
Safe Management of Recalled     83 FR 61552,       9VAC20-60-18; 9VAC20-
 Airbags, Revision Checklist     November 30,       60-260, 261, 262.
 240.                            2018.
Management Standards for        84 FR 5816,        9VAC20-60-18; 9VAC20-
 Hazardous Waste                 February 22,       110-110; 9VAC20-60-
 Pharmaceuticals and Amendment   2019.              261, 262, 264, 265,
 to the P075 Listing for                            266, 268, 270, and
 Nicotine, Revision Checklist                       273.
 241.
------------------------------------------------------------------------
\1\ A Revision Checklist is a document that addresses the specific
  revisions made to the Federal regulations by one or more related final
  rules published in the Federal Register. EPA develops these checklists
  as tools to assist States in developing their authorization
  applications and in documenting specific State analogs to the Federal
  Regulations. For more information see EPA's RCRA State Authorization
  web page at https://www.epa.gov/rcra/state-authorization-under-resource-conservation-and-recovery-act-rcra.

2. State-Initiated Revisions

    In addition, Virginia will be authorized to carry out, in lieu of
the Federal program, State-initiated revisions to provisions of the
State's program. These State-initiated revisions to some of Virginia's
existing regulations are for the purpose of correcting errors and
adding consistency or clarification to the existing regulations. The
following State provisions were previously equivalent, more stringent,
or broader in scope and now they are all equivalent and analogous to
the RCRA provisions found at Title 40 of the Code of Federal
Regulations: 9VAC20-60-315 H, 9VAC20-60-420 E, 9VAC20-60-430 F, 9VAC20-
60-440 A, B, C, C 1, D, and E, 9VAC20-60-450 (repealed), 9VAC20-60-480
E 1, L, and M, 9VAC20-60-490 B 3, and 9VAC20-60 Forms.

H. Where are the revised Virginia rules different from the Federal
rules?

    When revised State rules differ from the Federal rules in the RCRA
State authorization process, EPA determines whether the State rules are
equivalent to, more stringent than, or broader in scope than the
Federal program. Pursuant to RCRA section 3009, 42 U.S.C. 6929, State
programs may contain requirements that are more stringent than the
Federal regulations. Such more stringent requirements can be federally
authorized and, once authorized, become federally enforceable.

1. Virginia Requirements That Are More Stringent Than the Federal
Program

    The following Virginia provisions are more stringent than the
Federal program.
     Virginia is more stringent than the Federal program at
9VAC20-60-490 C 4 by requiring that reports be submitted to the State
as well as to Federal authorities.
     Virginia is more stringent than the Federal program at
9VAC20-60-262 B 4 by requiring that large quantity generators notify
the State of each location where hazardous waste is accumulated.
     Virginia is more stringent than the Federal program at
9VAC20-60-262 B 6 by requiring any receiving treatment, storage, or
disposal facility to hold a permit; Virginia is also more stringent
than the Federal program by requiring an EPA identification number for
transporters.
     Virginia's regulations, at 9VAC20-60-260 A, incorporate by
reference the Federal regulations at 40 CFR part 260, with some
additions, modifications, and exceptions, including the modification at
9VAC20-60-260 B 2. This provision is more stringent than the Federal
program in that it imposes additional requirements for the management
of hazardous secondary materials in a land-based unit.
     On January 13, 2015, EPA issued a final rule that became
effective on July 13, 2015, revising several recycling-related
provisions associated with the definition of solid waste used to
determine hazardous waste regulation under RCRA subtitle C (80 FR
1694). The revisions included adding conditions to certain exclusions
and adding a codified definition of ``contained.'' On May 30, 2018, EPA
issued the final rule: ``Response to Vacatur of Certain Provisions of
the Definition of Solid Waste Rule,'' 83 FR 24664. Because the 2018
rule included provisions that are less stringent than the 2015
revisions, states that adopted the 2015 rule were not required to adopt
the 2018 rule. The Virginia regulations, at 9VAC20-60-18, 9VAC20-60-260
B 9, 9VAC20-60-260 B 14, and 9VAC20-60-261 B 14, specify that Virginia
is retaining the 2015 rules. In that respect, the Virginia regulations
are more stringent than the Federal program.

2. Virginia Requirements That Are Broader in Scope Than the Federal
Program

    Although the statute does not prevent States from adopting
regulations that are broader in scope than the Federal program, States
cannot receive authorization for such regulations. EPA cannot enforce
requirements that are broader in scope, although compliance with such
provisions is required by Virginia law.
    The following Virginia provisions are broader in scope than the
Federal program in that they require the payment of fees that are not
required by the Federal program:
     9VAC20-60-1280 B requires the payment of permit
application fees.
     9VAC20-60-1284 B 2 requires the payment of annual fees.
     9VAC20-60-1260 B, C, D, E, F, and G 3, insofar as these
provisions address hazardous waste program fees.
     9VAC20-60-1270 B, C, C 5, D, and E set forth the method by
which application fee amounts shall be determined.
     9VAC20-60-1283 A, B, and C set forth the method by which
annual fee amounts shall be determined.
     9VAC20-60-1285 Table 1 sets forth the schedule of permit
application fees.

I. Who handles permits after this authorization takes effect?

    After this authorization revision, Virginia will continue to issue
permits covering all the provisions for which it is authorized and will
administer all such permits. EPA will continue to administer any RCRA
hazardous waste permits or portions of permits that it issued prior to
the effective date of this authorization until the timing and process
for effective transfer to the State are mutually agreed upon. Until
such time as EPA formally transfers responsibility for a permit to
Virginia and EPA terminates its permit, EPA and Virginia agree to
coordinate the administration of such a permit in order to maintain
consistency. EPA will not issue any more new permits or new portions of
permits for the provisions listed in Section G of this document after
the effective date of this authorization. EPA will continue to
implement, and issue permits for HSWA requirements for which Virginia
is not yet authorized.

J. How does this action affect Indian country in Virginia?

    Virginia is not authorized to carry out the hazardous waste program
in Indian country (18 U.S.C. 1151) within the State. EPA will implement
and administer the RCRA program on these lands.

K. What is codification and is EPA codifying Virginia's hazardous waste
program as authorized in this rule?

    Codification is the process of placing a State's statutes and
regulations that comprise the State's authorized hazardous waste
program into the Code of Federal Regulations. EPA does this by
referencing the authorized State rules in 40 CFR part 272. EPA is not
proposing to codify the authorization of Virginia's revisions at this
time. However, EPA reserves the amendment of 40 CFR part 272, subpart
VV, for this authorization of Virginia's program revisions until a
later date.

L. Administrative Requirements

    The Office of Management and Budget has exempted this action from
the requirements of Executive Order 12866 (58 FR 51735, October 4,
1993) and 13563 (76 FR 3821, January 21, 2011). Therefore, this action
is not subject to review by OMB. This action authorizes State
requirements for the purpose of RCRA 3006 and imposes no additional
requirements beyond those imposed by State law. Accordingly, I certify
that this action will not have a significant economic impact on a
substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.). Because this action authorizes pre-existing
requirements under State law and does not impose any additional
enforceable duty beyond that required by State law, it does not contain
any unfunded mandate or significantly or uniquely affect small
governments, as described in the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4). For the same reason, this action also does not
significantly or uniquely affect the communities of Tribal governments,
as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    This action will not have substantial direct effects on the States,
on the relationship between the National Government and the States, or
on the distribution of power and responsibilities among the various
levels of government, as specified in Executive Order 13132 (64 FR
43255, August 10, 1999), because it merely authorizes State
requirements as part of the State RCRA hazardous waste program without
altering the relationship or the distribution of power and
responsibilities established by RCRA. This action also is not subject
to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is
not economically significant, and it does not make decisions based on
environmental health or safety risks that may disproportionately affect
children. This rule is not subject to Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355 (May 22, 2001)) because it is not a
significant regulatory action under Executive Order 12866.
    Under RCRA 3006(b), EPA grants a State's application for
authorization as long as the State meets the criteria required by RCRA.
It would thus be inconsistent with applicable law for EPA, when it
reviews a State authorization application to require the use of any
particular voluntary consensus standard in place of another standard
that otherwise satisfies the requirements of RCRA. Thus, the
requirements of section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required
by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996),
in issuing this rule, EPA has taken the necessary steps to eliminate
drafting errors and ambiguity, minimize potential litigation, and
provide a clear legal standard for affected conduct. EPA has complied
with Executive Order 12630 (53 FR 8859, March 18, 1988) by examining
the takings implications of the rule in accordance with the Attorney
General's Supplemental Guidelines for the Evaluation of Risk and
Avoidance of Unanticipated Takings issued under the executive order.
This rule does not impose an information collection burden under the
provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et
seq.).
    Executive Order 12898 (59 FR 7629, February 16, 1994) establishes
Federal executive policy on environmental justice. Its main provision
directs Federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States. EPA believes that this action does
not have disproportionately high and adverse human health or
environmental effects on minority populations, low-income populations
and/or indigenous peoples, because it approves pre-existing State rules
that are no less stringent than existing Federal requirements and
imposes no additional requirements beyond those imposed by State law.
For these reasons, this rule is not subject to Executive Order 12898.

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this document 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 in the Federal Register. A major rule cannot take effect
until 60 days after it is published in the Federal Register. This
action is not a ``major rule'' as defined by 5 U.S.C. 804(2). However,
this action will not be effective until December 19, 2022 because it is
a direct final rule.

List of Subjects in 40 CFR Part 271

    Environmental protection, Administrative practice and procedure,
Confidential business information, Hazardous waste, Hazardous waste
transportation, Indian lands, Intergovernmental relations, Penalties,
Reporting and record keeping requirements.

    Authority: This action is issued under the authority of sections
2002(a), 3006 and 7004(b) of the Solid Waste Disposal Act, as
amended, 42 U.S.C. 6912(a), 6926, 6974(b).

Adam Ortiz,
Regional Administrator, EPA Region III.
[FR Doc. 2022-22578 Filed 10-17-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 165 (Friday, August 24, 2018)]
[Notices]
[Pages 42899-42900]
[FR Doc No: 2018-18311]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2018-P-0964 and FDA-2018-P-0967]

Determination That PLASMA-LYTE M AND DEXTROSE 5% and PLASMA LYTE
148 AND DEXTROSE 5% Were Not Withdrawn From Sale for Reasons of Safety
or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that PLASMA-LYTE M AND DEXTROSE 5% (calcium chloride, 37
milligrams (mg)/100 milliliters (mL); dextrose, 5 grams (g)/100 mL;
magnesium chloride, 30 mg/100 mL; potassium chloride, 119 mg/100 mL;
sodium acetate, 161 mg/100 mL; sodium chloride, 94 mg/100 mL; sodium
lactate, 138 mg/100 mL) and PLASMA LYTE 148 AND DEXTROSE 5% (dextrose,
5 g/100 mL; magnesium chloride, 30 mg/100 mL; potassium chloride, 37
mg/100 mL; sodium acetate, 368 mg/100 mL; sodium chloride, 526 mg/100
mL; sodium gluconate, 502 mg/100 mL) were not withdrawn from sale for
reasons of safety or effectiveness. This determination means that FDA
will not begin procedures to withdraw approval of abbreviated new drug
applications (ANDAs) that refer to these drug products, and it will
allow FDA to continue to approve ANDAs that refer to these products as
long as they meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Heather A. Dorsey, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6219, Silver Spring, MD 20993-0002, 301-
796-3601.

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.
    PLASMA-LYTE M AND DEXTROSE 5% (calcium chloride, 37 mg/100 mL;
dextrose, 5 g/100 mL; magnesium chloride, 30 mg/100 mL; potassium
chloride, 119 mg/100 mL; sodium acetate, 161 mg/100 mL; sodium
chloride, 94 mg/100 mL; sodium lactate, 138 mg/100 mL) is the subject
of NDA 017390, held by Baxter Healthcare Corp., and initially approved
on February 1, 1979. PLASMA LYTE 148 AND DEXTROSE 5% (dextrose, 5 g/100
mL; magnesium chloride, 30 mg/100 mL; potassium chloride, 37 mg/100 mL;
sodium acetate, 368 mg/100 mL; sodium chloride, 526 mg/100 mL; sodium
gluconate, 502 mg/100 mL) is the subject of NDA 017451, held by Baxter
Healthcare Corp., and initially approved on February 2, 1979. PLASMA
LYTE M AND DEXTROSE 5% is indicated as a source of water, electrolytes,
and calories or as an alkalinizing agent. PLASMA LYTE 148 AND DEXTROSE
5% is indicated as a source of water, electrolytes, and calories, or as
an alkalinizing agent.
    PLASMA-LYTE M AND DEXTROSE 5% (calcium chloride, 37 mg/100 mL;
dextrose, 5 g/100 mL; magnesium chloride, 30 mg/100 mL; potassium
chloride, 119 mg/100 mL; sodium acetate, 161 mg/100 mL; sodium
chloride, 94 mg/100 mL; sodium lactate, 138 mg/100 mL) and PLASMA LYTE
148 AND DEXTROSE

5% (dextrose, 5 g/100 mL; magnesium chloride, 30 mg/100 mL; potassium
chloride, 37 mg/100 mL; sodium acetate, 368 mg/100 mL; sodium chloride,
526 mg/100 mL; sodium gluconate, 502 mg/100 mL) are currently listed in
the ``Discontinued Drug Product List'' section of the Orange Book. In
the Federal Register of October 13, 2015 (80 FR 61426), FDA announced
that it was withdrawing approval of NDAs 017390 and 017451, effective
November 12, 2015.
    Fresenius Kabi USA, LLC, submitted two citizen petitions dated
March 2, 2018 (Docket No. FDA-2018-P-0964), and March 5, 2018 (Docket
No. FDA-2018-P-0967), under 21 CFR 10.30, requesting that the Agency
determine whether PLASMA-LYTE M AND DEXTROSE 5% (calcium chloride, 37
mg/100 mL; dextrose, 5 g/100 mL; magnesium chloride, 30 mg/100 mL;
potassium chloride, 119 mg/100 mL; sodium acetate, 161 mg/100 mL;
sodium chloride, 94 mg/100 mL; sodium lactate, 138 mg/100 mL) and
PLASMA LYTE 148 AND DEXTROSE 5% (dextrose, 5 g/100 mL; magnesium
chloride, 30 mg/100 mL; potassium chloride, 37 mg/100 mL; sodium
acetate, 368 mg/100 mL; sodium chloride, 526 mg/100 mL; sodium
gluconate, 502 mg/100 mL) were withdrawn from sale for reasons of
safety or effectiveness.
    After considering the citizen petitions and reviewing Agency
records and based on the information we have at this time, FDA has
determined under Sec.  314.161 that PLASMA-LYTE M AND DEXTROSE 5%
(calcium chloride, 37 mg/100 mL; dextrose, 5 g/100 mL; magnesium
chloride, 30 mg/100 mL; potassium chloride, 119 mg/100 mL; sodium
acetate, 161 mg/100 mL; sodium chloride, 94 mg/100 mL; sodium lactate,
138 mg/100 mL) and PLASMA LYTE 148 AND DEXTROSE 5% (dextrose, 5 g/100
mL; magnesium chloride, 30 mg/100 mL; potassium chloride, 37 mg/100 mL;
sodium acetate, 368 mg/100 mL; sodium chloride, 526 mg/100 mL; sodium
gluconate, 502 mg/100 mL) were not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that these drug products were withdrawn for
reasons of safety or effectiveness.
    We have carefully reviewed our files for records concerning the
withdrawal of PLASMA-LYTE M AND DEXTROSE 5% (calcium chloride, 37 mg/
100 mL; dextrose, 5 g/100 mL; magnesium chloride, 30 mg/100 mL;
potassium chloride, 119 mg/100 mL; sodium acetate, 161 mg/100 mL;
sodium chloride, 94 mg/100 mL; sodium lactate, 138 mg/100 mL) and
PLASMA LYTE 148 AND DEXTROSE 5% (dextrose, 5 g/100 mL; magnesium
chloride, 30 mg/100 mL; potassium chloride, 37 mg/100 mL; sodium
acetate, 368 mg/100 mL; sodium chloride, 526 mg/100 mL; sodium
gluconate, 502 mg/100 mL) from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events. We have reviewed the available evidence and determined
that these drug products were not withdrawn from sale for reasons of
safety or effectiveness.
    Accordingly, the Agency will continue to list PLASMA-LYTE M AND
DEXTROSE 5% (calcium chloride, 37 mg/100 mL; dextrose, 5 g/100 mL;
magnesium chloride, 30 mg/100 mL; potassium chloride, 119 mg/100 mL;
sodium acetate, 161 mg/100 mL; sodium chloride, 94 mg/100 mL; sodium
lactate, 138 mg/100 mL) and PLASMA LYTE 148 AND DEXTROSE 5% (dextrose,
5 g/100 mL; magnesium chloride, 30 mg/100 mL; potassium chloride, 37
mg/100 mL; sodium acetate, 368 mg/100 mL; sodium chloride, 526 mg/100
mL; sodium gluconate, 502 mg/100 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 these drug products 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: August 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-18311 Filed 8-23-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 169 (Thursday, August 30, 2012)]
[Notices]
[Pages 52774-52776]
[FR Doc No: 2012-21390]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67728; File No. SR-NYSEArca-2012-96]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Amending NYSE Arca
Rule 6.47, ``Crossing'' Orders--OX

August 24, 2012.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on August 20, 2012, NYSE Arca, Inc. (the ``Exchange'' or
``NYSE Arca'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C.78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend NYSE Arca Rule 6.47, ``Crossing''
Orders--OX. The text of the proposed rule change is available on the
Exchange's Web site at www.nyse.com, at the principal office of the
Exchange, 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 self-regulatory organization
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 those 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 parts of such statements.

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

1. Purpose
    The Exchange proposes to amend NYSE Arca Rule 6.47 to adopt a new
procedure that provides for the execution of Customer-to-Customer
Crosses on the Trading Floor. The proposal is based on a nearly
identical customer-to-customer cross functionality provided in NYSE
Amex Rule 934NY(a).\4\
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 59472 (February 27,
2009), 74 FR 9843 (March 6, 2009) (SR-NYSEAlternext-2008-14).
---------------------------------------------------------------------------

    NYSE Arca Options Rule 6.47 currently provides procedures for
executing four different cross order types: (i) Non-Facilitation Cross
(Regular way Cross); (ii) Facilitation Cross; (iii) Solicited Order
Cross; and (iv) Mid-Point Cross.\5\ Each of the existing methods to
cross orders is designed to provide a useful order execution
functionality to market participants. The Exchange now proposes to add
a new cross order type, the Customer-to-Customer Cross, in order to
provide customers with a new method to get executions on the Trading
Floor while allowing them to benefit from price improvement from the
Trading Crowd quotes.
---------------------------------------------------------------------------

    \5\ See NYSE Arca Options Rule 6.47.
---------------------------------------------------------------------------

    Currently, if a Floor Broker intends to cross customer orders, to
buy and sell the same option contract, the orders are executed pursuant
to the Non-Facilitation Cross procedures.\6\ When utilizing these
procedures, a Floor Broker must request bids and offers for the option
series involved and make the trading crowd and the Trading Official
aware of the request for a market via open outcry. Then, after
providing an opportunity for such bids and offers to be made, the Floor
Broker must bid above the highest bid in the crowd, or offer below the
lowest offer in the crowd, by at least the MPV. If such higher bid or
lower offer is not taken by members of the trading crowd, the Floor
Broker may cross the orders at such higher bid or lower offer by
announcing by open outcry that he is crossing the orders and giving the
quantity and price. The crossing of the orders is contingent on the
requirements that: (i) the execution price must be equal to or better
than the NBBO; and (ii) the Floor Broker may not trade through any bids
or offers on the Consolidated Book that are priced equal to or better
than the proposed execution price. If there are bids or offers on the
Consolidated Book at or better than the proposed execution price, the
Floor Broker must trade against such bids or offers in the Consolidated
Book on behalf of the customer order(s). Once bids or offers in the
Consolidated Book are satisfied, the Floor Broker may cross the
remaining balance of the orders, if any. The orders will be cancelled
or posted in the Consolidated Book if an execution would take place at
a price that is inferior to the NBBO.\7\
---------------------------------------------------------------------------

    \6\ See NYSE Arca Options Rule 6.47(a).
    \7\ The Floor Broker, at the direction of the Customer, will
cancel or post the order to the Consolidated Book.
---------------------------------------------------------------------------

    The Exchange proposes to make available a new crossing procedure
for Customer orders in situations when a Floor Broker who holds a
Customer order to buy and a Customer order to sell the same option
contract.\8\ Under the proposal, to conduct a Customer-to-Customer
Cross, a Floor Broker would be required to request bids and offers for
the option series involved and make the Trading Crowd and the Trading
Official aware of the request for a market via

open outcry and provide opportunity for such bids and offers to be
made, in a manner similar to the current Non-Facilitation Cross
procedures. Once the best bids and offers are established in the
trading crowd, the Floor Broker would be required to bid above the
highest bid in the crowd, and offer below the lowest offer in the
crowd.\9\ Upon doing so, a Floor Broker could cross the orders at such
higher bid and lower offer by announcing he is crossing orders on
behalf of Customers, provided that: (i) the execution price is equal to
or better than the NBBO; and (ii) the execution price does not trade
through any equal or better priced bids or offers in the Consolidated
Book. Thus, the Customers that are party to the order would benefit
from price improvement over bids/offers in the Trading Crowd, yet still
respect the priority of orders resting in the Consolidated Book.
Finally, similar to the Non-Facilitation Cross procedures, Customer-to-
Customer cross orders will be cancelled or posted in the Consolidated
Book if an execution would take place at a price that is inferior to
the NBBO.
---------------------------------------------------------------------------

    \8\ ``Customer'' for purposes of the proposed Customer-to-
Customer Order type is defined in NYSE Arca Options Rule 6.1A(a)(4).
NYSE Arca Options Rule 6.1A(a)(4) provides that the term
``Customer'' shall not include a broker or dealer. See NYSE Arca
Options Rule 6.1A(a)(4). NYSE Amex uses a nearly identical
definition of customer for purposes of its customer-to-customer
cross order. NYSE Amex Options Rule 900.2NY(18) provides that
``[t]he term ``Customer'' means an individual or organization that
is not a Broker/Dealer; when not capitalized, ``customer'' refers to
any individual or organization whose order is being represented,
including a Broker/Dealer.'' See NYSE Amex Options Rule 900.2NY(18).
    \9\ If the Floor Broker is unable to bid above the highest bid
or below the lowest offer in the crowd, then the cross will not be
able to be executed.
---------------------------------------------------------------------------

    The Exchange notes that the Customer-to-Customer Cross procedure is
almost identical to the existing Non-Facilitation Cross; except that in
contrast to the procedures for executing a Non-Facilitation Cross as
detailed above, when a Customer-to-Customer Cross is properly
announced, and after the execution price is established, the Customer
orders will have priority over equal priced bids/offers in the Trading
Crowd and would be executed against each other.\10\
---------------------------------------------------------------------------

    \10\ See NYSE Arca Options Rule 6.47(a) and Proposed NYSE Arca
Options Rule 6.47(e).
---------------------------------------------------------------------------

    The Exchange believes that Customers will benefit by have [sic]
another method to execute their transactions on the Trading Floor,
while allowing them to benefit from price improvement from the Trading
Crowds quotes. While the Exchange currently has four crossing
procedures to meet the execution needs of its market participants, the
Exchange does not have one that is narrowly tailored to Customer only
transactions that other competing options market have. The Exchange
believes that having the ability to offer similar functionality on the
Exchange will help the Exchange compete for Customer orders and
facilitate transitions on the Exchange in the competitive marketplace
for order flow. In addition, the Exchange believes that all market
participants will benefit from the enhanced liquidity from facilitating
the execution of these transactions on the Exchange. The Exchange notes
that this proposal raises no novel issues and that several other
options exchanges have similar crossing functionality.\11\
---------------------------------------------------------------------------

    \11\ See NYSE Amex Options Rule 934NY(a) and Phlx Rule 1064(a).
---------------------------------------------------------------------------

2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Securities Exchange Act of 1934 (the ``Act''),\12\ in general, and
furthers the objectives of Section 6(b)(5),\13\ in particular, in that
it is designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, and to remove impediments to and perfect
the mechanism of a free and open market and a national market system.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The new Customer-to-Customer Cross procedure will provide a new
method for Customers to get executions on the Trading Floor, while
allowing them to benefit from price improvement from the Trading
Crowd's quotes in a manner designed to promote just and equitable
principles of trade on the Exchange. The Customer-to-Customer Cross
will allow Customers an additional opportunity to trade their orders in
situations where they do not want the risk of their order being broken-
up and thus facilitate additional transactions on the Exchange and
boost liquidity for all market participants.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \14\ and Rule 19b-4(f)(6) thereunder.\15\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \15\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \16\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b4(f)(6)(iii),\17\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest.
---------------------------------------------------------------------------

    \16\ 17 CFR 240.19b-4(f)(6).
    \17\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

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 email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2012-96 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEArca-2012-96. This
file number should be included on the subject line if email 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 (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 Web site viewing and printing in the
Commission's Public Reference Room, 100 F Street NE., Washington, DC
20549, on official business days between the hours of 10 a.m. and 3
p.m. 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 Number SR-NYSEArca-2012-96 and should be submitted
by September 20, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
---------------------------------------------------------------------------

    \18\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-21390 Filed 8-29-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: August 24, 2010 (Volume 75, Number 163)]
[Notices]
[Page 52033-52034]
[DOCID:fr24au10-95]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2010-0038]

Rigging Equipment for Material Handling; Extension of the Office
of Management and Budget's (OMB) Approval of Information Collection
(Paperwork) Requirements

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

ACTION: Request for public comment.

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

SUMMARY: OSHA solicits public comments concerning its proposal to
extend the Office of Management and Budget's (OMB) approval of the
information collection requirements contained in paragraphs (b)(1),
(b)(6)(i), (b)(6)(ii), (c)(15)(ii), (e)(1)(i), (ii), and (iii) and
(f)(2) of the Standard on Rigging Equipment for Material Handling (29
CFR 1926.251). These paragraphs require affixing identification tags or
markings on rigging equipment, developing and maintaining inspection
records, and retaining proof-testing certificates.

DATES: Comments must be submitted (postmarked, sent, or received) by
October 25, 2010.

ADDRESSES:
    Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit three copies of your comments
and attachments to the OSHA Docket Office, OSHA Docket No. OSHA-2010-
0038, U.S. Department of Labor, Occupational Safety and Health
Administration, Room N-2625, 200 Constitution Avenue, NW., Washington,
DC 20210. Deliveries (hand, express mail, messenger, and courier
service) are accepted during the Department of Labor's and Docket
Office's normal business hours, 8:15 a.m. to 4:45 p.m., e.t.
    Instructions: All submissions must include the Agency name and OSHA
docket number for the Information Collection Request (ICR) (OSHA Docket
No. 2010-0038). All comments, including any personal information you
provide, are placed in the public docket without change, and may be
made available online at http://www.regulations.gov. For further
information on submitting comments see the ``Public Participation''
heading in the section of this notice titled SUPPLEMENTARY INFORMATION.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the address above. All documents in the docket (including this Federal
Register notice) are listed in the http://www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download through the Web site. All submissions,
including copyrighted material, are available for inspection and
copying at the OSHA Docket Office. You may also contact Theda Kenney at
the address below to obtain a copy of the ICR.

FOR FURTHER INFORMATION CONTACT: Theda Kenney or Todd Owen, Directorate
of Standards and Guidance, OSHA, U.S. Department of Labor, Room N-3609,
200 Constitution Avenue, NW., Washington, DC 20210; telephone (202)
693-2222.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of its continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance consultation program to provide the public with an
opportunity to comment on proposed and continuing information
collection requirements in accordance with the Paperwork Reduction Act
of 1995 (PRA-95) (44 U.S.C. 3506(c)(2)(A)). This program ensures that
information is in the desired format, reporting burden (time and costs)
is minimal, collection instruments are clearly understood, and OSHA's
estimate of the information collection burden is accurate. The
Occupational Safety and Health Act of 1970 (the OSH Act) (29 U.S.C. 651
et seq.) authorizes information collection by employers as necessary or
appropriate for enforcement of the OSH Act or for developing
information regarding the causes and prevention of occupational
injuries, illnesses, and accidents (29 U.S.C. 657). The OSH Act also
requires that OSHA obtain such information with minimum burden upon
employers, especially those operating small businesses, and to reduce
to the maximum extent feasible unnecessary duplication of efforts in
obtaining information (29 U.S.C. 657).
    Paragraph (b)(1) requires that alloy steel chains have permanently
affixed durable identification tags stating size, grade, rated capacity
and sling manufacturer. Paragraph (b)(6)(i) requires the employer to
make a thorough periodic inspection of alloy steel chain slings in use
on a regular basis, but at least once a year. Paragraph (b)(6)(ii)
requires the employer to make and maintain a record of the most recent
month in which each alloy steel chain was inspected and make the record
available for examination.
    Paragraph (c)(15)(ii) requires that all welded end attachments of
wire rope slings be proof tested by the manufacturer at twice their
rated capacity prior to initial use, and that the employer retain a
certificate of the proof test and make it available for examination.
    Paragraphs (e)(1)(i), (ii), and (iii) require that synthetic web
slings be marked or coded to show the manufacturer's name or trademark,
the rated capacity for the type of hitch and the type of synthetic
webbing material.
    Paragraph (f)(2) requires that all hooks for which no applicable
manufacturer's recommendations are available be tested twice before
they are put into use. The employer shall maintain a record of the
dates and results of the tests.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed information collection requirements
are necessary for the proper performance of the Agency's functions,
including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
costs) of the information collection requirements, including the
validity of the methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on employers who must comply;
for example, by using automated or other technological information
collection and transmission techniques.

III. Proposed Actions

    OSHA is requesting that OMB extend its approval of the information
collection requirements contained in the Standard on Rigging Equipment
for Material Handling (29 CFR 1926.251). The Agency is requesting an
adjustment decrease of 4,520 burden hours (from 56,335 hours to 51,815
hours). This decrease is a result of new data indicating a drop in the
number of cranes and derricks from 132,737 to 122,091. The Agency will
summarize

the comments submitted in response to this notice and will include this
summary in the request to OMB.
    Type of Review: Extension of a currently approved collection.
    Title: Rigging Equipment for Material Handling (29 CFR 1926.251).
    OMB Control Number: 1218-0233.
    Affected Public: Business or other for-profits.
    Number of Respondents: 1,220,910.
    Frequency: On occasion.
    Average Time per Response: Average of 3 minutes (.05 hour) for an
employer to maintain and disclose a certificate to 30 minutes (.50
hour) for an employer to acquire information and make a tag for a
sling.
    Estimated Total Burden Hours: 51,815.
    Estimated Cost (Operation and Maintenance): $0.

IV. Public Participation--Submission of Comments on This Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) Electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal; (2) by facsimile (fax); or (3) by hard copy. All
comments, attachments, and other material must identify the Agency name
and the OSHA docket number for the ICR (OSHA Docket No. 2010-0038). You
may supplement electronic submissions by uploading document files
electronically. If you wish to mail additional materials in reference
to an electronic or facsimile submission, you must submit them to the
OSHA Docket Office (see the section of this notice titled ADDRESSES).
The additional materials must clearly identify your electronic comments
by your name, date, and the docket number so the Agency can attach them
to your comments.
    Because of security procedures, the use of regular mail may cause a
significant delay in the receipt of comments. For information about
security procedures concerning the delivery of materials by hand,
express delivery, messenger, or courier service, please contact the
OSHA Docket Office at<PHONE_NUMBER>, (TTY<PHONE_NUMBER>).
    Comments and submissions are posted without change at http://
www.regulations.gov. Therefore, OSHA cautions commenters about
submitting personal information, such as social security numbers and
date of birth. Although all submissions are listed in the http://
www.regulations.gov index, some information (e.g., copyrighted
material) is not publicly available to read or download through this
Web site. All submissions, including copyrighted material, are
available for inspection and copying at the OSHA Docket Office.
Information on using the http://www.regulations.gov Web site to submit
comments and access the docket is available at the Web site's ``User
Tips'' link. Contact the OSHA Docket Office for information about
materials not available through the Web site and for assistance in
using the Internet to locate docket submissions.
    Electronic copies of this Federal Register document are available
at http://www.regulations.gov. This document as well as news releases
and other relevant information also are available at OSHA's Web page at
http://www.osha.gov.

V. Authority and Signature

    David Michaels, PhD, MPH, Assistant Secretary of Labor for
Occupational Safety and Health, directed the preparation of this
notice. The authority for this notice is the Paperwork Reduction Act of
1995 (44 U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 5-2007
(72 FR 31160).

    Signed at Washington, DC, on August 19, 2010.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2010-21050 Filed 8-23-10; 8:45 am]
BILLING CODE 4510-26-P