[Federal Register: September 13, 2010 (Volume 75, Number 176)]
[Notices]
[Page 55622-55623]
[DOCID:fr13se10-92]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62851; File No. SR-NYSEAmex-2010-87]

Self-Regulatory Organizations; NYSE Amex LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Adopting Commentary
.06 to Rule 935NY Related to the Exposure of Reserve Orders

September 3, 2010.
    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 27, 2010, NYSE Amex LLC (the ``Exchange'' or
``NYSE Amex'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
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.
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    \1\ 15 U.S.C.78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to adopt Commentary .06 to Rule 935NY related
to the exposure of Reserve Orders. The text of the proposed rule change
is available at the Exchange, the Commission's Public Reference Room,
and http://www.nyse.com.

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 purpose of the proposal is to adopt a Commentary to NYSE Amex
Rule 935NY to specify that the exposure

requirement contained in subsection (i) of the Rule is satisfied with
respect to the non-displayed reserve portion of a Reserve Order if the
displayable portion is displayed at its displayable price for one
second. A Reserve Order is an order where only a portion of the full
size is included in the Exchange's disseminated quotation.\4\ The
displayed size is executed according to the Exchange's regular priority
rules, and is refreshed with additional volume from the non-displayed
portion of the order. The non-displayed portion of the Reserve Order is
available for execution only after the Exchange's displayed quote is
fully exhausted.
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    \4\ NYSE Amex Rule 900.3NY(d)(3).
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    Under the proposed interpretation, after entering a Reserve Order,
an ATP Holder may enter a contra-side order for its own account or a
contra-side order that was solicited from another broker-dealer that
would execute against the displayable and non-displayed portions of the
order so long as the displayable portion of the order was displayed on
NYSE Amex (i.e., the price of the order is at the NYSE Amex Best Bid/
Offer) for at least one second. This proposed Commentary is the same as
an existing Commentary to the rule of the Nasdaq Options Market that
contains the same exposure requirements as NYSE Amex Rule 935NY.\5\
Accordingly, the Commission has previously determined that display of
the displayable portion of a reserve order is sufficient to satisfy the
exposure requirements of NYSE Amex Rule 935NY(i).
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    \5\ Nasdaq Rules, Chapter VII, Sec.12 (Order Exposure
Requirements), Commentary .03.
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2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
Section 6(b) of the Act \6\ in general, and furthers the objectives of
Section 6(b)(5) of the Act, in that it is designed to promote just and
equitable principles of trade, remove impediments to and perfect the
mechanisms of a free and open market and a national market system and,
in general, to protect investors and the public interest. In
particular, the proposal is the same as an existing rule of another
exchange,\7\ and will provide ATP Holders with certainty with respect
to the applicable exposure requirements for reserve orders.
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    \6\ 15 U.S.C. 78f (b).
    \7\ Supra, Note 2 [sic].
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

    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 \8\ and Rule 19b-4(f)(6) thereunder.\9\
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.
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    \8\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \9\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change along with a
brief description and text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has satisfied this requirement.
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    At any time within 60 days of the filing of the 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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEAmex-2010-87 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-NYSEAmex-2010-87. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (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 Section, 100
F Street, NE., Washington, DC 20549-1090. Copies of the filing will
also be available for inspection and copying at the NYSE's principal
office and on its Internet Web site at http://www.nyse.com. 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-NYSEAmex-2010-87 and should
be submitted on or before October 4, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
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    \10\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-22742 Filed 9-10-10; 8:45 am]
BILLING CODE 8010-01-P


 Continuous Release Reporting for Farms
 SECTION III: SUBSTANCE INFORMATION

                                                                      ID Number
                                                                      (CR-ERNS)
Calculation of the SSI Trigger
  Use this form to identify the SSI trigger for hazardous substance air releases at your farm.
  For EACH hazardous substance indicated in Section II, Part C, list the names of the releasing animal waste
  sources and their upper bounds
 Continuous Release Reporting for Farms
 SECTION III: SUBSTANCE INFORMATION

                                                                      ID Number
                                                                      (CR-ERNS)
Calculation of the SSI Trigger
  Use this form to identify the SSI trigger for hazardous substance air releases at your farm.
  For EACH hazardous substance indicated in Section II, Part C, list the names of the releasing animal waste
  sources and their upper bounds
OMB No. 2050-0086To calculate the SSI trigger (i.e., the upper bound of the normal range of a release) for each hazardous substance identified below, aggregate the upper bounds of the normal range of the identified hazardous substance across all animal waste sources identified in Section II, Part C.

                  Hazardous Substance: Ammonia

Animal Waste Source				 Upper Bound of the Normal Range of the Release in Pounds

Animal Waste Source				 Upper Bound of the Normal Range of the Release in Pounds

Animal Waste Source 				 Upper Bound of the Normal Range of the Release in Pounds

Animal Waste Source				 Upper Bound of the Normal Range of the Release in Pounds

TOTAL  -  SSI trigger for Hazardous Substance Releases ________________________________

                  Hazardous Substance: Hydrogen Sulfide

Animal Waste Source				 Upper Bound of the Normal Range of the Release in Pounds

Animal Waste Source				 Upper Bound of the Normal Range of the Release in Pounds

Animal Waste Source 				 Upper Bound of the Normal Range of the Release in Pounds

Animal Waste Source				 Upper Bound of the Normal Range of the Release in Pounds

TOTAL  -  SSI trigger for Hazardous Substance Releases[*] ________________________________

                                 INSTRUCTIONS
                      SECTION III: SUBSTANCE INFORMATION

  ID Number (CR-ERNS)
  The CR-ERNS Number is required for this submission. NRC will assign a CR-ERNS number for your farm when you make the initial notification.

Use this form to identify the SSI trigger for hazardous substance air releases at your farm.

Statistically Significant Increase (SSI) Notification - An SSI is any episodic release of a hazardous substance that exceeds the release quantity delineated in the upper bound of the normal range of the farm's continuous release report.  The normal range is defined to include all the releases of a hazardous substance (from all animal waste sources) occurring over any 24-hour period under normal operating conditions during the preceding year. Only those releases that are both continuous and stable in quantity and rate may be included in the normal range. The aggregated upper bounds of the normal range of each hazardous substance is referred to as the "SSI Trigger."

An SSI in a continuous release of a hazardous substance must be reported to the NRC as soon as the person in charge is aware that the release exceeds the SSI trigger. Because an SSI is a type of episodic release, it is treated as such.

It may be possible to adjust the SSI trigger (i.e., change the normal range of the release) if a particular continuous release frequently exceeds the upper bound of the normal range.

Calculation of the SSI Trigger for a Hazardous Substance

Hazardous	Upper
For purposes of this example, it is assumed that the only sources of the hazardous substance release at the farm are Barn #1, Lagoon #1, and Manure Pile #1.
For purposes of this example, it is assumed that the only sources of the hazardous substance release at the farm are Barn #1, Lagoon #1, and Manure Pile #1.
Substance (HS)	Source	Bound
Name of HS 	Barn #1 	120 lbs
            Lagoon #1 	115 lbs
            Manure Pile #1 	+130 lbs

            Upper Bound for HS	= 365 lbs


[Federal Register Volume 79, Number 153 (Friday, August 8, 2014)]
[Notices]
[Pages 46438-46439]
[FR Doc No: 2014-18816]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9914-80-OEI]

Cross-Media Electronic Reporting: Authorized Program Revision
Approval, State of California

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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SUMMARY: This notice announces the Environmental Protection Agency
(EPA's) approval of the State of California's request to revise its EPA
Administered Permit Programs: The National Pollutant Discharge
Elimination System EPA-authorized program to allow electronic
reporting.

DATES: EPA's approval is effective on August 8, 2014.

FOR FURTHER INFORMATION CONTACT: Karen Seeh, U.S. Environmental
Protection Agency, Office of Environmental Information, Mail Stop
2823T, 1200 Pennsylvania Avenue NW., Washington, DC 20460, (202) 566-
1175<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On October 13, 2005, the final Cross-Media
Electronic Reporting Rule (CROMERR) was published in the Federal
Register (70 FR 59848) and codified as part 3 of title 40 of the CFR.
CROMERR establishes electronic reporting as an acceptable regulatory
alternative to paper reporting and establishes requirements to assure
that electronic documents are as legally dependable as their paper
counterparts. Subpart D of CROMERR requires that state, tribal or local
government agencies that receive, or wish to begin receiving,
electronic reports under their EPA-authorized programs must apply to
EPA for a revision or modification of those programs and obtain EPA
approval. Subpart D provides standards for such approvals based on
consideration of the electronic document receiving systems that the
state, tribe, or local government will use to implement the electronic
reporting. Additionally, Sec.  3.1000(b) through (e) of 40 CFR part 3,
subpart D provides special procedures for program revisions and
modifications to allow electronic reporting, to be used at the option
of the state, tribe or local government in place of procedures
available under existing program-specific authorization regulations. An
application submitted under the subpart D procedures must show that the
state, tribe or local government has sufficient legal authority to
implement the electronic reporting components of the programs covered
by the application

and will use electronic document receiving systems that meet the
applicable subpart D requirements.
    On August 19, 2013, the California State Water Resources Control
Board (CA SWRCB) submitted an application titled ``Storm Water Multiple
Application and Report System'' for revision/modification of its EPA-
authorized authorized Part 123 program under title 40 CFR. EPA reviewed
CA SWRCB's request to revise its EPA-authorized Part 123--EPA
Administered Permit Programs: The National Pollutant Discharge
Elimination System program and, based on this review, EPA determined
that the application met the standards for approval of authorized
program revision/modification set out in 40 CFR part 3, subpart D. In
accordance with 40 CFR 3.1000(d), this notice of EPA's decision to
approve California's request to revise its Part 123--EPA Administered
Permit Programs: The National Pollutant Discharge Elimination System
program to allow electronic reporting under 40 CFR part 122 is being
published in the Federal Register.
    CA SWRCB was notified of EPA's determination to approve its
application with respect to the authorized program listed above.

    Dated: July 30, 2014.
Matthew Leopard,
Acting Director, Office of Information Collection.
[FR Doc. 2014-18816 Filed 8-7-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: January 11, 2010 (Volume 75, Number 6)]
[Notices]
[Page 1425]
[DOCID:fr11ja10-89]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting Notice

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday, January
14, 2010 at 2 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matters at the Closed Meeting.
    Commissioner Paredes, as duty officer, voted to consider the items
listed for the Closed Meeting in a closed session.
    The subject matter of the Closed Meeting scheduled for Thursday,
January 14, 2010 will be:

[I]nstitution and settlement of injunctive actions; institution and
settlement of administrative proceedings; consideration of amicus
participation; and
Other matters relating to enforcement proceedings.

    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

    Dated: January 7, 2010.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2010-391 Filed 1-7-10; 4:15 pm]
BILLING CODE 8011-01-P


Page 1 STUDY TITLE FQPA Supplemental Information Document for Zeta Cypermethrin DATA REQUIREMENT No Guideline Number Requirement AUTHOR Nancy J. Hilton STUDY COMPLETION DATE August 8, 2006 SPONSOR FMC Corporation Philadelphia, PA PERFORMING LABORATORY FMC Corporation PROJECT ID NUMBER FMC Zeta cypermethrin 2004CROP. rev FMC Zeta cypermethrin 2004CROP. rev Page 2 STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS No claim of confidentiality is made for any information contained in this report on the basis of its falling within the scope of FIFRA Section 10 ( d) ( 1) ( A), ( B), or ( C).

SPONSORS: FMC Corporation SPONSOR REPRESENTATIVE: Nancy J. Hilton Date Product Registrations Manager FMC Corporation FMC Zeta cypermethrin 2004CROP. rev Page 3 GOOD LABORATORY PRACTICE COMPLIANCE STATEMENT The following exposure assessments are not subject to the principles of 40 CFR 160, GOOD LABORATORY PRACTICE STANDARDS ( FIFRA), as promulgated in Federal Register, 54, No. 158, 34067 34704, 17 August 1989. Several studies used as references for this document were conducted in accordance with the appropriate GLP standards as verified by the GLP compliance statements found in those study reports.

AUTHOR/ SPONSOR/ SUBMITTER:

Nancy J. Hilton Date Product Registrations Manager FMC Corporation FMC Zeta cypermethrin 2004CROP Page 2 FQPA Supplemental Information Document for Zeta Cypermethrin EPA Registration Division contact George T. LaRocca. ( 703) 305 6100.

1. FMC Corporation, 1735 Market Street, Philadelphia, PA 19103.

PP 5F6896 EPA has received pesticide petition ( PP 5F6896) from FMC Corporation, 1735 Market Street, Philadelphia, PA 19103, proposing pursuant to section 408 ( d) of the Federal Food, Drug and Cosmetic Act, 21 U. S. C. 346a( d), to amend 40 C. F. R. § 180.418 by establishing a tolerance for residues of the insecticide zetacypermethrin (__ Cyano( 3 phenoxyphenyl) methyl (_) cis, trans 3( 2,2 dichloroethenyl) 2,2 dimethylcyclopropanecarboxylate and its inactive isomers) in or on the raw agricultural commodity berries, group 13, 0.5 ppm; tree nuts, group 14, nutmeat, 0.05 ppm, and hulls, 3.00 ppm; grapes, 1.0 ppm, grape, juice, 0.05 ppm, and raisins, 0.20 ppm; canola, seed, 0.05 ppm, canola, meal, 0.05 ppm, and canola, oil, 0.6 ppm; nongrass animal feeds, group 18, forage, 10.00 ppm, and hay, 33.00 ppm; grass forage, fodder, and hay, group 17, forage, 7.00 ppm, hay, 22.00 ppm, straw, 8.00 ppm, and seed screenings, 12.00 ppm. EPA has determined that the petition contains data or information regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry 1. Plant metabolism. The metabolism of cypermethrin in plants is adequately understood. Studies have been conducted to delineate the metabolism of radiolabelled cypermethrin in various crops all showing similar results. The residue of concern is the parent compound only.

2. Analytical method. There is a practical analytical method for detecting and measuring levels of cypermethrin in or on food with a limit of detection that allows monitoring of food with residues at or above the levels set in these tolerances ( Gas Chromatography with Electron Capture Detection ( GC/ ECD).

3. Magnitude of residues. Crop field trial residue data from studies conducted at the maximum label rates for representative commodities for the berries group, tree nuts group, grapes, canola, nongrass animal feeds group, and grass forage, fodder and hay group show that the proposed zeta cypermethrin tolerances on berries, group 13, at 0.5 ppm; tree nuts, group 14, nutmeat, at 0.05 ppm, and hulls, at 3.00 ppm; grapes, at 1.0 ppm, grape, juice, at 0.05 ppm, and raisins, at 0.20 ppm; canola, seed, at 0.05 ppm, canola, meal, at 0.05 ppm, and canola, oil, at 0.6 ppm; nongrass animal feeds, group 18, forage, at 10.00 ppm, and hay, at 33.00 ppm; grass forage, fodder, and hay, group 17, forage, at 7.00 ppm, hay, at 22.00 ppm, straw, at 8.00 ppm, and seed screenings, at 12.00 ppm will not be exceeded when the zeta cypermethrin products labeled for these uses are used as directed.

B. Toxicological Profile FMC Zeta cypermethrin 2004CROP Page 3 1. Acute toxicity. For the purposes of assessing acute dietary risk, FMC has used the NOEL of 10.0 mg/ kg/ day from the zeta cypermethrin acute neurotoxicity study in rats. The LOAEL of 50.0 mg/ kg/ day was based on clinical signs. This acute dietary endpoint is used to determine acute dietary risks to all population subgroups.

2. Genotoxicity. The following genotoxicity tests were all negative: in vivo chromosomal aberration in rat bone marrow cells; in vitro cytogenic chromosome aberration; unscheduled DNA synthesis; CHO/ HGPTT mutagen assay; weakly mutagenic: gene mutation ( Ames).

3. Reproductive and developmental toxicity. No evidence of additional sensitivity to young rats was observed following pre or postnatal exposure to zeta cypermethrin. a. A two generation reproductive toxicity study with zeta cypermethrin in rats demonstrated a NOEL of 7.0 mg/ kg/ day and a LOEL of 27.0 mg/ kg/ day for parental/ systemic toxicity based on body weight, organ weight, and clinical signs. There were no adverse effects in reproductive performance. The NOEL for reproductive toxicity was considered to be > 45.0 mg/ kg/ day ( the highest dose tested). b. A developmental study with zeta cypermethrin in rats demonstrated a maternal NOEL of 12.5 mg/ kg/ day and a LOEL of 25 mg/ kg/ day based on decreased maternal body weight gain, food consumption and clinical signs. There were no signs of developmental toxicity at 35.0 mg/ kg/ day, the highest dose level tested. c. A developmental study with cypermethrin in rabbits demonstrated a maternal NOEL of 100 mg/ kg/ day and a LOEL of 450 mg/ kg/ day based on decreased body weight gain. There were no signs of developmental toxicity at 700 mg/ kg/ day, the highest dose level tested.

4. Subchronic toxicity. Short and intermediate term toxicity ( incidental oral exposure). The NOEL of 10.0 mg/ kg/ day based on clinical signs at the LEL of 50.0 mg/ kg/ day in the zeta cypermethrin acute neurotoxicity study in rats would also be used for short term % aPAD and MOE calculations ( as well as acute, discussed in ( 1) above), and the NOEL of 5.0 mg/ kg/ day based on decreased motor activity in the zeta cypermethrin subchronic neurotoxicity study in rats, would be used for intermediate term MOE calculations.

5. Chronic toxicity. a. The chronic reference dose ( RfD) of 0.06 mg/ kg/ day for zeta cypermethrin is based on a NOEL of 6.0 mg/ kg/ day from a cypermethrin chronic feeding study in dogs and an uncertainty factor of 100. The endpoint effect of concern was based on clinical signs. b. Cypermethrin is classified as a Group C chemical ( possible human carcinogen with limited evidence of carcinogenicity in animals) based upon limited evidence for carcinogenicity in female mice; assignment of a Q* has not been recommended.

6. Animal metabolism. The metabolism of cypermethrin in animals is adequately understood. Cypermethrin has been shown to be rapidly absorbed, distributed, and excreted in rats when administered orally. Cypermethrin is metabolized by hydrolysis and oxidation.

7. Metabolite toxicology. The Agency has previously determined that the metabolites of cypermethrin are not of toxicological concern and need not be included in the tolerance expression nor in the risk exposure assessments.

8. Endocrine Disruption. No special studies investigating potential estrogenic or other endocrine effects of cypermethrin have been conducted. However, no evidence of such effects were reported in the standard battery of required toxicology studies which have been completed and found acceptable. Based on these studies, there is no evidence to suggest that cypermethrin has an adverse effect on the endocrine system.

C. Aggregate Exposure 1. Dietary exposure. a. Food. Permanent tolerances, in support of registrations, currently exist for residues of zeta cypermethrin on: alfalfa hay, alfalfa forage, alfalfa seed, aspirated grain fractions, sugar beets ( roots and tops), head, stem and leafy Brassica vegetables, cabbage, field corn grain, pop corn grain, field corn forage, field corn stover, pop corn stover, sweet corn ( K+ CWHR), sweet corn forage, sweet corn FMC Zeta cypermethrin 2004CROP Page 4 stover, cottonseed, dried shelled peas and beans, edible podded legume vegetables, fruiting vegetables ( except Cucurbits), leafy vegetables, head lettuce, bulb and green onions, pecans, rice grain, rice hulls, rice straw, sorghum forage, sorghum grain, sorghum stover, soybean seed, succulent shelled peas and beans, sugarcane, wheat forage, wheat grain, wheat hay, wheat straw, meat, fat and meat byproducts of cattle, goats, hogs, horses and poultry, eggs, milk and milk fat. For the purposes of assessing the potential dietary exposure for these existing and the subject proposed tolerances, FMC has utilized available information on anticipated residues, monitoring data and percent crop treated as follows: i. Acute exposure and risk. Acute dietary exposure risk assessments are performed for a food use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. For the purposes of assessing acute dietary risk for zeta cypermethrin, FMC has used the NOEL of 10.0 mg/ kg/ day from the zeta cypermethrin acute neurotoxicity study in rats with an uncertainty factor ( UF) of 100 ( acute RfD = 0.10 mg/ kg/ day). The LEL of 50.0 mg/ kg/ day was based on clinical signs. This acute dietary endpoint is used to determine acute dietary risks to all population subgroups. Available information on anticipated residues, monitoring data and percent crop treated was incorporated into a Tier 3 analysis, using Monte Carlo modeling for commodities that may be consumed in a single serving. These assessments show that the percent acute Population Adjusted Dose (% aPAD) all fall below the EPA's level of concern (  100%). The 95th percentile of exposure for the overall U. S. population was estimated to be 0.002448 mg/ kg/ day (% aRfD of 2.45); 99th percentile 0.007176 mg/ kg/ day (% aRfD of 7.18); and 99.9th percentile 0.024759 mg/ kg/ day (% aRfD of 24.76). The 95th percentile of exposure for all infants (< 1 year) was estimated to be 0.005153 mg/ kg/ day (% aRfD of 5.15); 99th percentile 0.012833 mg/ kg/ day (% aRfD of 12.83); and 99.9th percentile 0.035742 mg/ kg/ day (% aRfD of 35.74). The 95th percentile of exposure for children 1 to 2 years old and children 3 to 5 years old was estimated to be, respectively, 0.006932 mg/ kg/ day (% aRfD of 6.93) and 0.004758 mg/ kg/ day (% aRfD of 4.76); 99th percentile 0.016035 mg/ kg/ day (% aRfD of 16.03) and 0.011416 (% aRfD of 11.42); and 99.9th percentile 0.053308 mg/ kg/ day (% aRfD of 53.31) and 0.047651 (% aRfD of 47.65). The 95th percentile of exposure for females ( 13 49 years) was estimated to be 0.001983 mg/ kg/ day (% aRfD of 1.98); 99th percentile 0.005391 mg/ kg/ day (% aRfD of 5.39); and 99.9th percentile 0.020292 mg/ kg/ day (% aRfD of 20.29). Therefore, FMC concludes that the acute dietary risk of zeta cypermethrin, as estimated by the dietary risk assessment, does not appear to be of concern.

Chronic exposure and risk. The chronic reference dose ( cRfD) of 0.06 mg/ kg/ day for zeta cypermethrin is based on a NOEL of 6.0 mg/ kg/ day from a cypermethrin chronic feeding study in dogs and an uncertainty factor of 100. The endpoint effect of concern was based on clinical signs. A chronic dietary exposure/ risk assessment has been performed for zeta cypermethrin using the above cRfD. Available information on anticipated residues, monitoring data and percent crop treated was incorporated into the analysis to estimate the anticipated residue contribution ( ARC). The ARC is generally considered a more realistic estimate than an estimate based on tolerance level residues. The ARC are estimated to be 0.000958 mg/ kg body weight ( bwt)/ day and utilize 1.6 percent of the cRfD for the overall U. S. population. The ARC for all infants (< 1 year) are estimated to be 0.001486 mg/ kg bwt/ day and utilizes 2.5 percent of the cRfD. The ARC for children 1 to 2 years old and children 3 to 5 years old are estimated to be 0.003881 mg/ kg bwt/ day and 0.002680 mg/ kg bwt/ day and utilizes 6.5 percent and 4.5 percent of the cRfD, respectively. The ARC for females ( 13 49 years) is estimated to be 0.000631 mg/ kg bwt/ day and utilizes 1.1 percent of the RfD. Generally speaking, the EPA has no cause for concern if the total dietary exposure from residues for uses for which there are published and proposed tolerances is less than 100 percent of the cRfD. Therefore, FMC concludes that the chronic dietary risk of zeta cypermethrin, as estimated by the dietary risk assessment, does not appear to be of concern.

Drinking water. Laboratory and field data have demonstrated that cypermethrin is immobile in soil and will not leach into groundwater. Other data show that cypermethrin is virtually insoluble in water and extremely lipophilic. As a result, FMC concludes that residues reaching surface waters from field runoff will quickly adsorb to sediment particles and be partitioned from the water column. Drinking water estimated concentrations ( DWEC) and the corresponding drinking water level of comparison ( DWLOC) values were calculated for chronic and acute exposures. The results show that all DWLOC values exceed the DWEC values. Thus, exposure to zetacypermethrin and cypermethrin residues in drinking water is not of concern. FMC Zeta cypermethrin 2004CROP Page 5 US EPA's draft SOP for Incorporating Estimates of Drinking Water Exposure Into Aggregate Risk Assessments was used to perform a drinking water analysis. This SOP utilizes a variety of tools to conduct drinking water assessment. These tools include water models such as FQPA Index Reservoir Screening Tool ( FIRST), PRZM/ EXAMS, SCIGROW and monitoring data. If monitoring data are not available then the models are used to predict potential residues in drinking water. The technique recommended in the drinking water SOP compares a calculated Drinking Water Level of Comparison ( DWLOC) value to the Drinking Water Estimated Concentration ( DWEC) value. The DWEC value results from either the monitoring data residues or modeled water residues. If the DWLOC value exceeds the DWEC value then there is reasonable certainty that no harm will result from the acute or chronic aggregate exposure.

In the case of cypermethrin and zetacypermethrin, monitoring data do not exist. Therefore, the FIRST model was used to estimate a surface water residue. The risk assessment for drinking water compares two values: the DWLOC and the DWEC. The DWLOC is the drinking water level of comparison. This is the maximum allowable drinking water concentration ( in ppb). The DWEC is the drinking water environmental concentration, which is derived either from monitoring studies or from modeling. If the DWLOC is greater than the DWEC, then the overall exposure from water, food, and residential is considered to be acceptable. The calculated DWLOC values for acute and chronic exposures for all adults, adult females and children exceed the modeled DWEC surface water residues. Therefore, there is reasonable certainty that no harm will result from cumulative and aggregate ( food and water) exposure to cypermethrin and zetacypermethrin residues.

2. Non dietary exposure. Zeta cypermethrin is registered for agricultural crop applications only, therefore nondietary exposure assessments are not warranted.

D. Cumulative Effects. In consideration of potential cumulative effects of cypermethrin and other substances that may have a common mechanism of toxicity, to our knowledge there are currently no available data or other reliable information indicating that any toxic effects produced by cypermethrin would be cumulative with those of other chemical compounds; thus only the potential risks of cypermethrin have been considered in this assessment of its aggregate exposure. FMC intends to submit information for the EPA to consider concerning potential cumulative effects of cypermethrin consistent with the schedule established by EPA at 62 Federal Register 42020 ( August 4, 1997) and other EPA publications pursuant to the Food Quality Protection Act. FMC Zeta cypermethrin 2004CROP Page 6 E. Safety Determination 1. U. S. population. The chronic reference dose ( cRfD) of 0.06 mg/ kg/ day for zeta cypermethrin is based on a NOEL of 6.0 mg/ kg/ day from a cypermethrin chronic feeding study in dogs and an uncertainty factor of 100. The endpoint effect of concern was based on clinical signs. A chronic dietary exposure/ risk assessment has been performed for zeta cypermethrin using the above cRfD. Available information on anticipated residues, monitoring data and percent crop treated was incorporated into the analysis to estimate the anticipated residue contribution ( ARC). The ARC is generally considered a more realistic estimate than an estimate based on tolerance level residues. The ARC are estimated to be 0.000958 mg/ kg body weight ( bwt)/ day and utilize 1.6 percent of the cRfD for the overall U. S. population. The ARC for all infants (< 1 year) are estimated to be 0.001486 mg/ kg bwt/ day and utilizes 2.5 percent of the cRfD. The ARC for children 1 to 2 years old and children 3 to 5 years old are estimated to be 0.003881 mg/ kg bwt/ day and 0.002680 mg/ kg bwt/ day and utilizes 6.5 percent and 4.5 percent of the cRfD, respectively. The ARC for females ( 13 49 years) is estimated to be 0.000631 mg/ kg bwt/ day and utilizes 1.1 percent of the RfD. Generally speaking, the EPA has no cause for concern if the total dietary exposure from residues for uses for which there are published and proposed tolerances is less than 100 percent of the cRfD. Therefore, FMC concludes that the chronic dietary risk of zeta cypermethrin, as estimated by the dietary risk assessment, does not appear to be of concern.

Acute dietary exposure risk assessments are performed for a food use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. For the purposes of assessing acute dietary risk for zeta cypermethrin, FMC has used the NOEL of 10.0 mg/ kg/ day from the zeta cypermethrin acute neurotoxicity study in rats with an uncertainty factor ( UF) of 100 ( acute RfD = 0.10 mg/ kg/ day). The LEL of 50.0 mg/ kg/ day was based on clinical signs. This acute dietary endpoint is used to determine acute dietary risks to all population subgroups. Available information on anticipated residues, monitoring data and percent crop treated was incorporated into a Tier 3 analysis, using Monte Carlo modeling for commodities that may be consumed in a single serving. These assessments show that the percent acute Population Adjusted Dose (% aPAD) all fall below the EPA's level of concern (  100%). The 95th percentile of exposure for the overall U. S. population was estimated to be 0.002448 mg/ kg/ day (% aRfD of 2.45); 99th percentile 0.007176 mg/ kg/ day (% aRfD of 7.18); and 99.9th percentile 0.024759 mg/ kg/ day (% aRfD of 24.76). The 95th percentile of exposure for all infants (< 1 year) was estimated to be 0.005153 mg/ kg/ day (% aRfD of 5.15); 99th percentile 0.012833 mg/ kg/ day (% aRfD of 12.83); and 99.9th percentile 0.035742 mg/ kg/ day (% aRfD of 35.74). The 95th percentile of exposure for children 1 to 2 years old and children 3 to 5 years old was estimated to be, respectively, 0.006932 mg/ kg/ day (% aRfD of 6.93) and 0.004758 mg/ kg/ day (% aRfD of 4.76); 99th percentile 0.016035 mg/ kg/ day (% aRfD of 16.03) and 0.011416 (% aRfD of 11.42); and 99.9th percentile 0.053308 mg/ kg/ day (% aRfD of 53.31) and 0.047651 (% aRfD of 47.65). The 95th percentile of exposure for females ( 13 49 years) was estimated to be 0.001983 mg/ kg/ day (% aRfD of 1.98); 99th percentile 0.005391 mg/ kg/ day (% aRfD of 5.39); and 99.9th percentile 0.020292 mg/ kg/ day (% aRfD of 20.29). Therefore, FMC concludes that the acute dietary risk of zeta cypermethrin, as estimated by the dietary risk assessment, does not appear to be of concern.

2. Infants and children. a. General. In assessing the potential for additional sensitivity of infants and children to residues of zeta cypermethrin, FMC considered data from developmental toxicity studies in the rat and rabbit, and a two generation reproductive study in the rat. The data demonstrated no indication of increased sensitivity of rats to zeta cypermethrin or rabbits to cypermethrin in utero and/ or postnatal exposure to zeta cypermethrin or cypermethrin. The developmental toxicity studies are designed to evaluate adverse effects on the developing organism resulting from pesticide exposure during prenatal development to one or both parents. Reproduction studies provide information relating to effects from exposure to the pesticide on the reproductive capability of mating animals and data on systemic toxicity. FFDCA section 408 provides that EPA may apply an additional margin of safety for infants and children in the case of threshold effects to account for pre and post natal toxicity and the completeness of the database. b. Developmental toxicity studies. In the prenatal developmental toxicity studies in rats and rabbits, there was no evidence of developmental toxicity at the highest doses tested ( 35.0 mg/ kg/ day in rats and 700 FMC Zeta cypermethrin 2004CROP Page 7 mg/ kg/ day in rabbits). Decreased body weight gain was observed at the maternal LOEL in each study; the maternal NOEL was established at 12.5 mg/ kg/ day in rats and 100 mg/ kg/ day in rabbits. c. Reproductive toxicity study. In the two generation reproduction study in rats, offspring toxicity ( body weight) and parental toxicity ( body weight, organ weight, and clinical signs) was observed at 27.0 mg/ kg/ day and greater. The parental systemic NOEL was 7.0 mg/ kg/ day and the parental systemic LOEL was 27.0 mg/ kg/ day. There were no developmental ( pup) or reproductive effects up to 45.0 mg/ kg/ day, highest dose tested. d. Pre and post natal sensitivity. i. Pre natal. There was no evidence of developmental toxicity in the studies at the highest doses tested in the rat ( 70.0 mg/ kg/ day) or in the rabbit ( 700 mg/ kg/ day). Therefore, there is no evidence of a special dietary risk ( either acute or chronic) for infants and children which would require an additional safety factor. ii. Post natal. Post natal. Based on the absence of pup toxicity up to dose levels which produced toxicity in the parental animals, there is no evidence of special post natal sensitivity to infants and children in the rat reproduction study. e. Conclusion. Based on the above, FMC concludes that reliable data support use of the standard 100 fold uncertainty factor, and that an additional uncertainty factor is not needed to protect the safety of infants and children. As stated above, aggregate exposure assessments utilized significantly less than 1 percent of the RfD for either the entire U. S. population or any of the 26 population subgroups including infants and children. Therefore, it may be concluded that there is reasonable certainty that no harm will result to infants and children from aggregate exposure to cypermethrin residues.

F. International Tolerances. There are no Canadian, or Mexican residue limits for residues of cypermethrin or zeta cypermethrin in or on representative commodities for the berries group, tree nuts group, grapes, canola, nongrass animal feeds group, and grass forage, fodder and hay group.

The Codex MRLs for cypermethrin are 0.5 ppm for berries and other small fruit, 0.2 ppm for oilseed, except peanut, and 0.5 ppm for vegetable oils, edible.


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing to let you know how the proposed Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491 effects me as an individual consumer.  Given that the FDA has thousands of employees and massive annual budgets and still took them three years to come up with these proposals, and given the fact that they have requested over 100 times in them for additional information and research to be provided, I am requesting that the comment period for the Proposed Rule be extended for 180 days.  Giving the public less than one day per request to submit information is a bit extreme.  I would like to submit my comments and related research on many of these items, but if the FDA seriously wants the public and those who are going to be governed by these regulations to supply the information requested, they should allow us the time to gather it.  As this will be our ONLY occasion to provide such feedback, and as the FDA has admitted that they do not have this information and need it for proper evaluation, I ask that enough time be given so that these important issues can be evaluated in an objective way based on actual research.

I appreciate your consideration of my request and look forward to the opportunity to provide you with further input.


Reader’s Guide Foemesafen

CRM: Wilhelmena Livingston

EPA/OPPTS/OPP/SRRD

Reader’s Guide to Fomesafen Docket # EPA-HQ-OPP-2006-0239

Publication Date: March 28, 2007

	EPA has created this document to provide an organizational structure to
the Registration Review Fomesafen Docket for Public Comments.  The
docket index groups related documents.  The first group contains the
Federal Register and Docket Organizational Documents, the second group
contains the Human Health Assessment, the third group contains the
Environmental Risk Assessment documents, and the fourth group contains
use/usage information and other information pertaining to the fomesafen
registration review.   The Agency is providing the “Reader’s
Guide” to allow the reader to more easily access and navigate the
various items contained in the Fomesafen docket.

Federal Register and Docket Organizational Documents:

Docket Item 1.	Federal Register Notice:  Fomesafen

Docket Item 2.	Reader’s Guide to the Fomesafen Docket #
EPA-HQ-OPP-2006-				0239

Docket Item 3.	Fomesafen Summary Document

Human Health Documents for Registration Review

Docket Item 4.	Fomesafen:  HED Registration Review Problem Formulation
		Document   (February 28, 2007).

This document describes the scope of work necessary to support the
registration review.

Docket Item 5.	Fomesafen Sodium:  Human Health Risk Assessment for a
	Proposal to Amend Use on Soybeans, and Proposals to Add Uses 				on
Cotton, Dry Bean, and Snap Bean, PC Code:  123802, Petition 				Nos:
1E6228, 9F50568, 6E4653, DP Barcode D325797

			(February 28, 2006).

This document describes all the human health risks from the use of
fomesafen.

Environmental Fate and Effects Documents for Registration Review

Docket Item 6.	EFED Problem Formulation for Fomesafen Registration
Review 				(February 13, 2007).

This is the transmittal memo for the ecological risk problem
formulation.

Docket Item 7.	Registration Review – Ecological Risk Assessment
Problem 				Formulation for Fomesafen

This document describes the ecological risk problem formulation.

Docket Item 8.	Ecological Risk Assessment for New Uses of Fomesafen on
		Cotton (DP 302766), Snap beans (DP 314014), and Dry Beans (DP
314112) (January 30, 2007)

This is the transmittal memo for the Ecological Risk Assessment.

Docket Item 9.	Ecological Risk Assessment for Use of Fomesafen on Cotton
				(DP302766), Snap Beans (DP314014) and Dry Beans (DP314112)

			(January 2006)

This document describes the toxicity of fomesafen to animals and plants
in the environment.

Appendices for the EFED Ecological Risk Assessment (ERA) for new uses of
fomesafen on cotton, snap beans, dry beans

Docket Item 10:	Appendix A – Environmental Fate Studies

Docket Item 11.	Appendix B – PRZM EXAMS Output

Docket Item 12.	Appendix C - TREX Output

Docket Item 13.	Appendix D - TerrPlant Output

Docket Item 14.	Appendix E - Ecological Effects Data

Docket Item 15.	Appendix F - EIIS Output

Docket Item 16.	Appendix G - RQ Method and LOCs

Docket Item 17.	Appendix H-1 – Endangered and Threatened Species

Docket Item 18.	Appendix H-2 – ES Exclusion Chart

Use and Usage Information for Registration Review

Docket Item 19.	Fomesafen Screening-Level Usage Analysis (SLUA)

			(November 24, 2006)

This document provides the available estimates of pesticide usage data
for fomesafen that is used on agricultural crops in the United States.

Docket Item 20.	Appendix A

			(November 22, 2006)

This table list the food/feed and non-food/non-feed uses eligible for
reregistration

Docket Item 21.	Tolerance Salt of Fomesafen Summary Report

This document list the tolerances established for fomesafen.

Docket Item 22.	Fomesafen Registrations

This document lists the pending and active registrations for fomesafen.

Incident Reports for Fomesafen

Docket Item 23.	Review of Fomesafen Incident Reports

			(July 25, 2006)

This document reports poisoning incident data on the active ingredient
Fomesafen.

Docket Item 24.	Ecological Incident Summary for Registration Review
Snapshot

Docket Item 25.	Incident Report (Part A)

			(November 15, 2006)

Docket Item 26.	Incident Report (Part B)

			November 15, 2006)

These documents report incidents of damage to non-target species
attributed to the use of fomesafen on various agricultural crops.


[Federal Register Volume 83, Number 89 (Tuesday, May 8, 2018)]
[Notices]
[Pages 20817-20818]
[FR Doc No: 2018-09771]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OLEM-2018-0012; FRL-9977-71-OLEM]

Agency Information Collection Activities; Proposed Collection;
Comment Request; State Program Adequacy Determination (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency is planning to submit an
information collection request (ICR), ``State Program Adequacy
Determination: Municipal Solid Waste Landfills (MSWLFs) and Non-
Municipal, Non-Hazardous Waste Disposal Units that Receive
Conditionally Exempt Small Quantity Generator (CESQG) Hazardous
Waste.'' (EPA ICR No. 1608.08, OMB Control No. 2050-0152) to the Office
of Management and Budget (OMB) for review and approval in accordance
with the Paperwork Reduction Act. Before doing so, EPA is soliciting
public comments on specific aspects of the proposed information
collection as described below. This is a proposed extension of the ICR,
which is currently approved through September 30, 2018. An Agency may
not conduct or sponsor and a person is not required to respond to a
collection of information unless it displays a currently valid OMB
control number.

DATES: Comments must be submitted on or before July 9, 2018.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OLEM-
2018-0012, online using www.regulations.gov (our preferred method), by
email to [email protected] or by mail to: EPA Docket Center,
Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania
Ave. NW, Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Craig Dufficy, Materials Recovery and
Waste Management Division, Office of Resource Conservation and
Recovery, mail code 5304P, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 703-308-
9037; fax number:<PHONE_NUMBER>; email address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (i) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: Section 4010(c) of the Resource Conservation and Recovery
Act (RCRA) of 1976 requires that EPA revise the landfill criteria
promulgated under paragraph (1) of Section 4004(a) and Section
1008(a)(3). Section 4005(c) of RCRA, as amended by the Hazardous Solid
Waste Amendments (HSWA) of 1984, requires states to develop and

implement permit programs to ensure that MSWLFs and non-municipal, non-
hazardous waste disposal units that receive household hazardous waste
or CESQG hazardous waste are in compliance with the revised criteria
for the design and operation of non-municipal, non-hazardous waste
disposal units under 40 CFR part 257, subpart B and MSWLFs under 40 CFR
part 258. (40 CFR part 257, subpart B and 40 CFR part 258 are
henceforth referred to as the ``revised federal criteria''.) Section
4005(c) of RCRA further mandates the EPA Administrator to determine the
adequacy of state permit programs to ensure owner and/or operator
compliance with the revised federal criteria. A state program that is
deemed adequate to ensure compliance may afford flexibility to owners
or operators in the approaches they use to meet federal requirements,
significantly reducing the burden associated with compliance.
    In response to the statutory requirement in Sec.  4005(c), EPA
developed 40 CFR part 239, commonly referred to as the State
Implementation Rule (SIR). The SIR describes the state application and
EPA review procedures and defines the elements of an adequate state
permit program.
    The collection of information from the state during the permit
program adequacy determination process allows EPA to evaluate whether a
program for which approval is requested is appropriate in structure and
authority to ensure owner or operator compliance with the revised
federal criteria. The SIR does not require the use of a particular
application form. Section 239.3 of the SIR, however, requires that all
state applications contain the following five components:
    (1) A transmittal letter requesting permit program approval.
    (2) A narrative description of the state permit program, including
a demonstration that the state's standards for non-municipal, non-
hazardous waste disposal units that receive CESQG hazardous waste are
technically comparable to the Part 257, Subpart B criteria and/or that
its MSWLF standards are technically comparable to the Part 258
criteria.
    (3) A legal certification demonstrating that the state has the
authority to carry out the program.
    (4) Copies of state laws, regulations, and guidance that the state
believes demonstrate program adequacy.
    (5) Copies of relevant state-tribal agreements if the state has
negotiated with a tribe for the implementation of a permit program for
non-municipal, non-hazardous waste disposal units that receive CESQG
hazardous waste and/or MSWLFs on tribal lands.
    The EPA Administrator has delegated the authority to make
determinations of adequacy, as contained in the statute, to the EPA
Regional Administrator. The appropriate EPA Regional Office, therefore,
will use the information provided by each state to determine whether
the state's permit program satisfies the statutory test reflected in
the requirements of 40 CFR part 239. In all cases, the information will
be analyzed to determine the adequacy of the state's permit program for
ensuring compliance with the federal revised criteria.
    Form numbers: None.
    Respondents/affected entities: Entities potentially affected by
this section are States.
    Respondent's obligation to respond: Mandatory under Section 4005(c)
of the Resource Conservation and Recovery Act (RCRA) of 1976.
    Estimated number of respondents: 12.
    Frequency of response: On occasion.
    Total estimated burden: 2,405 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $135,315 (per year) All costs are labor
costs, there are no capital/start-up or O&M costs associated with this
ICR.
    Changes in estimates: There is no change of 2,405 hours in the
total estimated respondent burden compared with the ICR currently
approved by OMB. This is a continuation of states revising or updating
their state programs.

    Dated: April 24, 2018.
Barnes Johnson,
Director, Office of Resource Conservation and Recovery.
[FR Doc. 2018-09771 Filed 5-7-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 189 (Monday, September 30, 2019)]
[Notices]
[Pages 51599-51601]
[FR Doc No: 2019-21197]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0007]

Fee for Using a Rare Pediatric Disease Priority Review Voucher in
Fiscal Year 2020

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the fee rate for using a rare pediatric disease priority
review voucher for fiscal year (FY) 2020. The Federal Food, Drug, and
Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration
Safety and Innovation Act (FDASIA), authorizes FDA to determine and
collect rare pediatric disease priority review user fees for certain
applications for review of human drug and biological products when
those applications use a rare pediatric disease priority review
voucher. These vouchers are awarded to sponsors of rare pediatric
disease product applications that meet all the requirements of this
program and are submitted 90 days or more after July 9, 2012, upon FDA
approval of such applications. The amount of the fee for using a rare
pediatric disease priority review voucher is determined each FY, based
on the difference between the average cost incurred by FDA to review a
human drug application designated as priority review in the previous
FY, and the average cost incurred in the review of an application that
is not subject to priority review in the previous FY. This notice
establishes the rare pediatric disease priority review fee rate for FY
2020 and outlines the payment procedures for such fees.

FOR FURTHER INFORMATION CONTACT: Melissa Hurley, Office of Financial
Management, Food and Drug Administration, 4041 Powder Mill Rd, Rm.
61075, Beltsville, MD 20705-4304,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 908 of FDASIA (Pub. L. 112-144) added section 529 to the
FD&C Act (21 U.S.C. 360ff). In section 529 of the FD&C Act, Congress
encouraged development of new human drugs and biological products for
prevention and treatment of certain rare pediatric diseases by offering
additional incentives for obtaining FDA approval of such products.
Under section 529 of the FD&C Act, the sponsor of an eligible human
drug application submitted 90 days or more after July 9, 2012, for a
rare pediatric disease (as defined in section 529(a)(3)) shall receive
a priority review voucher upon approval of the rare pediatric disease
product application. The recipient of a rare pediatric disease priority
review voucher may either use the voucher for a future human drug
application submitted to FDA under section 505(b)(1) of the FD&C Act
(21 U.S.C. 355(b)(1)) or section 351(a) of the Public Health Service
Act (42 U.S.C. 262(a)), or transfer (including by sale) the voucher to
another party. The voucher may be transferred (including by sale)
repeatedly until it ultimately is used for a human drug application
submitted to FDA under section 505(b)(1) of the FD&C Act or section
351(a) of the Public Health Service Act. A priority review is a review
conducted with a Prescription Drug User Fee Act (PDUFA) goal date of 6
months after the receipt or filing date, depending on the type of
application. Information regarding current PDUFA goals is available at
https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm511438.pdf.
    The sponsor that uses a rare pediatric disease priority review
voucher is entitled to a priority review of its eligible human drug
application, but must pay FDA a rare pediatric disease priority review
user fee in addition to any user fee required by PDUFA for the
application. Information regarding the rare pediatric disease priority
review voucher program is available at: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm375479.htm.
    This notice establishes the rare pediatric disease priority review
fee rate for FY 2020 at $2,167,116 and outlines FDA's payment
procedures for rare pediatric disease priority review user fees. This
rate is effective on October 1, 2019, and will remain in effect through
September 30, 2020.

II. Rare Pediatric Priority Review User Fee for FY 2020

    Under section 529(c)(2) of the FD&C Act, the amount of the rare
pediatric disease priority review user fee is determined each fiscal
year based on the difference between the average cost incurred by FDA
in the review of a human drug application subject to priority review in
the previous fiscal year, and the average cost incurred by FDA in the
review of a human drug application that is not subject to priority
review in the previous fiscal year.
    A priority review is a review conducted with a PDUFA goal date of 6

months after the receipt or filing date, depending on the type of
application. Under the PDUFA goals letter, FDA has committed to
reviewing and acting on 90 percent of the applications granted priority
review status within this expedited timeframe. Normally, an application
for a human drug or biological product will qualify for priority review
if the product is intended to treat a serious condition and, if
approved, would provide a significant improvement in safety or
effectiveness. An application that does not receive a priority
designation receives a standard review. Under the PDUFA goals letter,
FDA has committed to reviewing and acting on 90 percent of standard
applications within 10 months of the receipt or filing date depending
on the type of application. A priority review involves a more intensive
level of effort and a higher level of resources than a standard review.
    FDA is setting a fee for FY 2020, which is to be based on standard
cost data from the previous fiscal year, FY 2019. However, the FY 2019
submission cohort has not been closed out yet, thus the cost data for
FY 2019 are not complete. The latest year for which FDA has complete
cost data is FY 2018. Furthermore, because FDA has never tracked the
cost of reviewing applications that get priority review as a separate
cost subset, FDA estimated this cost based on other data that the
Agency has tracked. The Agency expects all applications that received
priority review would contain clinical data. The application categories
with clinical data for which FDA tracks the cost of review are: (1) New
drug applications (NDAs) for a new molecular entity (NME) with clinical
data and (2) biologics license applications (BLAs).
    The total cost for FDA to review NME NDAs with clinical data and
BLAs in FY 2018 was $335,338,639. There were a total of 74 applications
in these two categories (53 NME NDAs with clinical data and 21 BLAs).
(Note: These numbers exclude the President's Emergency Plan for AIDS
Relief NDAs; no investigational new drug review costs are included in
this amount.) Forty-eight of these applications (35 NDAs and 13 BLAs)
received priority review and the remaining 26 received standard
reviews. Because a priority review compresses a review schedule that
ordinarily takes 10 months into 6 months, FDA estimates that a
multiplier of 1.67 (10 months / 6 months) should be applied to non-
priority review costs in estimating the effort and cost of a priority
review as compared to a standard review. This multiplier is consistent
with published research on this subject, which supports a priority
review multiplier in the range of 1.48 to 2.35 (Ref. 1). Using FY 2018
figures, the costs of a priority and standard review are estimated
using the following formula:

(48 [alpha] x 1.67) + (26 [alpha]) = $335,338,639

where ``[alpha]'' is the cost of a standard review and ``[alpha]
times 1.67'' is the cost of a priority review. Using this formula,
the cost of a standard review for NME NDAs and BLAs is calculated to
be $3,158,804 (rounded to the nearest dollar) and the cost of a
priority review for NME NDAs and BLAs is 1.67 times that amount, or
$5,275,203 (rounded to the nearest dollar). The difference between
these two cost estimates, or $2,116,399, represents the incremental
cost of conducting a priority review rather than a standard review.

    For the FY 2020 fee, FDA will need to adjust the FY 2018
incremental cost by the average amount by which FDA's average costs
increased in the 3 years prior to FY 2019, to adjust the FY 2018 amount
for cost increases in FY 2019. That adjustment, published in the
Federal Register on August 2, 2019 (84 FR 37882), setting the FY 2020
PDUFA fees, is 2.3964 percent for the most recent year, not compounded.
Increasing the FY 2018 incremental priority review cost of $2,116,399
by 2.3964 percent (or 0.023964) results in an estimated cost of
$2,167,116 (rounded to the nearest dollar). This is the rare pediatric
disease priority review user fee amount for FY 2020 that must be
submitted with a priority review voucher for a human drug application
in FY 2020, in addition to any PDUFA fee that is required for such an
application.

III. Fee Schedule for FY 2020

    The fee rate for FY 2020 is set out in table 1:

  Table 1--Rare Pediatric Disease Priority Review Schedule for FY 2020
------------------------------------------------------------------------
                                                         Fee rate for FY
                      Fee category                             2020
------------------------------------------------------------------------
Application submitted with a rare pediatric disease          $2,167,116
 priority review voucher in addition to the normal
 PDUFA fee.............................................
------------------------------------------------------------------------

IV. Implementation of Rare Pediatric Disease Priority Review User Fee

    Under section 529(c)(4)(A) of the FD&C Act, the priority review
user fee is due (i.e. the obligation to pay the fee is incurred) when
an sponsor notifies FDA of its intent to use the voucher. Section
529(c)(4)(B) of the FD&C Act specifies that the application will be
considered incomplete if the priority review user fee and all other
applicable user fees are not paid in accordance with FDA payment
procedures. In addition, section 529(c)(4)(C) specifies that FDA may
not grant a waiver, exemption, reduction, or refund of any fees due and
payable under this section of the FD&C Act.
    The rare pediatric disease priority review fee established in the
new fee schedule must be paid for any fee that is received on or after
October 1, 2019. In order to comply with this requirement, the sponsor
must notify FDA 90 days prior to submission of the human drug
application that is the subject of a priority review voucher of an
intent to submit the human drug application, including the estimated
submission date.
    Upon receipt of this notification, FDA will issue an invoice to the
sponsor who has incurred for the rare pediatric disease priority review
voucher fee. The invoice will include instructions on how to pay the
fee via wire transfer, check, or online payments.
    As noted in section II, if a sponsor uses a rare pediatric disease
priority review voucher for a human drug application, the sponsor would
incur the rare pediatric disease priority review voucher fee in
addition to any PDUFA fee that is required for the application. The
sponsor would need to follow FDA's normal procedures for timely payment
of the PDUFA fee for the human drug application.
    Payment must be made in U.S. currency by electronic check, check,
bank draft, wire transfer, credit card, or U.S. postal money order
payable to the order of the Food and Drug Administration. The preferred
payment method is online using electronic check (Automated Clearing
House (ACH) also known as eCheck). Secure electronic payments can be
submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay (Note: Only full payments are accepted. No partial

payments can be made online). Once you search for your invoice, select
``Pay Now'' to be redirected to Pay.gov. Note that electronic payment
options are based on the balance due. Payment by credit card is
available for balances that are less than $25,000. If the balance
exceeds this amount, only the ACH option is available. Payments must be
made using U.S. bank accounts as well as U.S. credit cards.
    If paying by paper check the invoice number should be included on
the check, followed by the words ``Rare Pediatric Disease Priority
Review.'' All paper checks must be in U.S. currency from a U.S. bank
made payable and mailed to: Food and Drug Administration, P.O. Box
979107, St. Louis, MO 63197-9000.
    If checks are sent by a courier that requests a street address, the
courier can deliver the checks to: U.S. Bank, Attention: Government
Lockbox 979107, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This
U.S. Bank address is for courier delivery only. If you have any
questions concerning courier delivery contact the U.S. Bank at 314-418-
4013. This telephone number is only for questions about courier
delivery). The FDA post office box number (P.O. Box 979107) must be
written on the check. If needed, FDA's tax identification number is 53-
0196965.
    If paying by wire transfer, please reference your invoice number
when completing your transfer. The originating financial institution
may charge a wire transfer fee. If the financial institution charges a
wire transfer fee it is required to add that amount to the payment to
ensure that the invoice is paid in full. The account information is as
follows: U.S. Dept. of the Treasury, TREAS NYC, 33 Liberty St., New
York, NY 10045, Account Number: 75060099, Routing Number: 021030004,
SWIFT: FRNYUS33.

V. Reference

    The following reference is on display at the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is not
available electronically at https://www.regulations.gov as this
reference is copyright protected. FDA has verified the website address,
as of the date this document publishes in the Federal Register, but
websites are subject to change over time.

1. Ridley, D.B., H.G. Grabowski, and J.L. Moe, ``Developing Drugs
for Developing Countries,'' Health Affairs, vol. 25, no. 2, pp. 313-
324, 2006, available at: https://www.healthaffairs.org/doi/full/10.1377/hlthaff.25.2.313.

    Dated: September 25, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21197 Filed 9-27-19; 8:45 am]
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[Federal Register Volume 81, Number 149 (Wednesday, August 3, 2016)]
[Notices]
[Page 51198]
[FR Doc No: 2016-18394]

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ENVIRONMENTAL PROTECTION AGENCY

[Petitions IV-2014-5 and -6; FRL-9950-17-Region 4]

Clean Air Act Operating Permit Program; Petitions for Objection
to State Operating Permits for ABC Coke and Walter Coke (Jefferson
County, Alabama)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of final order on petitions to object to state operating
permits.

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

SUMMARY: The Environmental Protection Agency (EPA) Administrator signed
an Order, dated July 15, 2016, denying petitions to object to Clean Air
Act (CAA) title V operating permits issued by the Jefferson County
Department of Health (JCDH) to ABC Coke for its facility located in
Tarrant and Walter Coke for its facility located in North Birmingham,
both in Jefferson County, Alabama. This Order constitutes a final
action on the petitions submitted by Gasp (Petitioner) and received by
EPA on October 3, 2014, and December 2, 2014, respectively.

ADDRESSES: Copies of the Order, the petitions, and all pertinent
information relating thereto are on file at the following location: EPA
Region 4; Air, Pesticides and Toxics Management Division; 61 Forsyth
Street SW., Atlanta, Georgia 30303-8960. The Order is also available
electronically at the following address: https://www.epa.gov/sites/production/files/2016-07/documents/gasp_response2014.pdf.

FOR FURTHER INFORMATION CONTACT: Art Hofmeister, Air Permits Section,
EPA Region 4, at<PHONE_NUMBER> or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The CAA affords EPA a 45-day period to
review and, as appropriate, the authority to object to operating
permits proposed by state permitting authorities under title V of the
CAA, 42 U.S.C. 7661-7661f. Section 505(b)(2) of the CAA and 40 CFR
70.8(d) authorize any person to petition the EPA Administrator to
object to a title V operating permit within 60 days after the
expiration of EPA's 45-day review period if EPA has not objected on its
own initiative. Petitions must be based only on objections to the
permit that were raised with reasonable specificity during the public
comment period provided by the state, unless the petitioner
demonstrates that it was impracticable to raise these issues during the
comment period or the grounds for the issues arose after this period.
Pursuant to sections 307(b) and 505(b)(2) of the CAA, a petition for
judicial review of those parts of the Order that deny issues in the
petition may be filed in the United States Court of Appeals for the
appropriate circuit within 60 days from the date this notice is
published in the Federal Register.
    Petitioners submitted petitions regarding the aforementioned ABC
Coke and Walter Coke facilities, requesting that EPA object to the CAA
title V operating permits (#4-07-0001-03 and 4-07-0355-03,
respectively). Petitioner alleged that the permits were not consistent
with the CAA because: (1) They lack the conditions necessary to assure
compliance with the general prohibition against ``air pollution''; (2)
they contain conditions governing fugitive dust that are too vague or
too restrictive; and (3) JCDH failed to provide Petitioner with
sufficient emissions information to participate meaningfully in the
permitting process with respect to Walter Coke.
    On July 15, 2016, the Administrator issued an Order denying the
petitions. The Order explains EPA's rationale for denying the
petitions.

    Dated: July 26, 2016.
Heather McTeer Toney,
Regional Administrator, Region 4.
[FR Doc. 2016-18394 Filed 8-2-16; 8:45 am]
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[Federal Register Volume 78, Number 104 (Thursday, May 30, 2013)]
[Notices]
[Pages 32472-32473]
[FR Doc No: 2013-12810]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2007-0039]

Intertek Testing Services NA, Inc.: Application for Expansion of
Recognition and Request To Remove a Condition of Recognition

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

ACTION: Notice.

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

SUMMARY: In this notice, OSHA announces the application of Intertek
Testing Services NA, Inc. for expansion of its recognition as a
Nationally Recognized Testing Laboratory and presents the Agency's
preliminary finding to grant the application and request. Intertek
Testing Services NA, Inc. requests the addition of two new sites and
for OSHA to remove a special condition of its recognition that involves
testing hazardous-location equipment. This preliminary finding does not
constitute an interim or temporary approval of the application and
request.

DATES: Submit comments, information, and documents in response to this
notice, or requests for an extension of time to make a submission on or
before July 1, 2013.

ADDRESSES: You may submit comments by any of the following methods:
    Electronically: Tender submissions electronically to the Federal
eRulemaking Portal at http://www.regulations.gov. Follow the
instructions online for making electronic submissions.
    Facsimile: If submissions, including attachments, are not longer
than ten (10) pages, commenters may fax them to the OSHA Docket Office
at<PHONE_NUMBER>.
    Regular or express mail, hand delivery, or messenger (courier)
service: Tender submissions to the OSHA Docket Office, Docket No. OSHA-
2013-0012, Technical Data Center, Room N-2625, U.S. Department of
Labor, 200 Constitution Avenue NW., Washington, DC 20210; telephone:
(202) 693-2350 (TTY number:<PHONE_NUMBER>). Note that security
procedures may result in significant delays in receiving submissions
sent by regular mail. Contact the OSHA Docket Office for information
about security procedures concerning delivery of materials by regular
or express mail, hand delivery, or messenger (courier) service. The
hours of operation for the OSHA Docket Office are 8:15 a.m.-4:45 p.m.,
e.t.
    Instructions: All submissions must include the Agency name and the
OSHA docket number (OSHA-2007-0039). OSHA places comments and other
materials, including any personal information, in the public docket
without revision, and these materials may be available online at http://www.regulations.gov. Therefore, the Agency cautions commenters about
submitting statements they do not want made available to the public, or
submitting comments that contain personal information (either about
themselves or others) such as Social Security numbers, birth dates, and
medical data.
    Docket: To read or download submissions or other material in the
docket, go to http://www.regulations.gov or to the OSHA Docket Office
at the address above. All documents in the docket 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 this Web site. All submissions, including copyrighted material,
are available for inspection and copying at the OSHA Docket Office.
    Extension of Comment Period: You may submit requests for an
extension of the comment period on or before June 14, 2013 to the
Office of Technical Programs and Coordination Activities, NRTL Program,
Occupational Safety and Health Administration, U.S. Department of
Labor, 200 Constitution Avenue NW., Room N-3655, Washington, DC 20210,
or by fax to<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Director, OSHA Office of Communications,
Room N-3647, U.S. Department of Labor, 200 Constitution Avenue NW.,
Washington, DC 20210; telephone:<PHONE_NUMBER>.
    General and technical information: Contact David Johnson, NRTL
Program, Occupational Safety and Health Administration, U.S. Department
of Labor, 200 Constitution Avenue NW., Room N-3655, Washington, DC
20210; telephone<PHONE_NUMBER>. OSHA's Web page includes information
about the NRTL Program (see http://www.osha.gov and select ``N'' in the
``A to Z Index'' located at the top of the Web page).
    Copies of the Federal Register notice: Electronic copies of this
Federal Register notice are available at http://www.regulations.gov.
This Federal Register notice, as well as other relevant information, is
also available on OSHA's Web page at http://www.osha.gov.

SUPPLEMENTARY INFORMATION:

I. Notice of the Application for Expansion of NRTL Recognition and
Request To Remove a Condition of Recognition

    The Occupational Safety and Health Administration (OSHA) is
providing notice that Intertek Testing Services NA, Inc. (ITSNA) is
applying for expansion of its current recognition as a Nationally
Recognized Testing Laboratory (NRTL). ITSNA also is requesting to
remove a special condition for testing and evaluating hazardous-
location equipment.
    OSHA recognition of an NRTL signifies that the organization meets
the requirements specified in Title 29, Code of Federal Regulations,
Section 1910.7 (29 CFR 1910.7). Recognition is an acknowledgment that
the organization can perform independent safety testing and
certification of the specific products covered within its scope of
recognition, and is not a delegation or grant of government authority.
Recognition enables employers to use products approved by the NRTL to
meet OSHA standards that require product testing and certification.
    The Agency processes applications by an NRTL for initial
recognition and for an expansion or renewal of this recognition,
following requirements in Appendix A to 29 CFR 1910.7. This appendix
requires that the Agency publish two notices in the Federal Register in
processing an application. In the first notice, OSHA announces the
application and provides its preliminary finding. In the second notice,
the Agency provides its final decision on the application. These
notices set forth the NRTL's scope of recognition or modifications of
that scope. OSHA maintains an informational Web page for each NRTL,
including ITSNA, which details the NRTL's scope of recognition. These
pages are available from the OSHA Web site at http://www.osha.gov/dts/otpca/nrtl/index.html.
    Each NRTL's scope of recognition has three elements: (1) The type
of products the NRTL may test, with each type specified by its
applicable test standard; (2) the recognized site(s) that has/have

the technical capability to perform the product-testing and product-
certification activities for test standards within the NRTL's scope;
and (3) the supplemental program(s) that the NRTL may use. Each of
these elements allows the NRTL to rely on other parties to perform
activities necessary for product testing and certification.
    ITSNA currently has 14 facilities (sites) recognized by OSHA for
product testing and certification, with its headquarters located at:
Intertek Testing Services NA, Inc., 3933 U.S. Route 11, Cortland, New
York 13045. A complete list of ITSNA sites recognized by OSHA is
available at http://www.osha.gov/dts/otpca/nrtl/its.html.

II. General Background on the Application and Request

    ITSNA submitted an application, dated June 8, 2007 (Ex. 1: ITSNA
Application), to expand its recognition to include three additional
facilities (sites) located at: 545 East Algonquin Road, Suite F,
Arlington Heights, IL 60005 (ITSNA Chicago); 420 North Dorothy Drive,
Richardson, TX 75081 (ITSNA Dallas); and 2307 East Aurora Road, Suite
B7, Twinsburg, OH 44087 (ITSNA Cleveland). ITSNA later amended its
application to remove the ITSNA Cleveland site from the application,
and to change the address for the ITSNA Dallas site to 1809 10th
Street, Suite A, Plano, TX 75074 (Ex. 2: ITSNA Amended Applications
dated 7/22/2009 and 10/20/2009).
    On November 6, 2009, ITSNA submitted a letter seeking to relax or
remove a special condition of its recognition which states: ``All
safety test reports for hazardous location products must undergo a
documented review and approval at the Cortland testing facility by a
test engineer qualified in hazardous location safety testing, prior to
ITSNA's initial or continued authorization of the certifications
covered by these reports. The above limitations apply solely to ITSNA's
operations as an NRTL'' (Ex. 3: ITSNA Hazardous Location Letter).
    In connection with these requests, NRTL Program staff performed on-
site reviews of ITSNA's testing facilities in January 2010 (ITSNA
Chicago) and February 2010 (ITSNA Dallas), and recommended expansion of
ITSNA's recognition to include these two sites (Ex. 4: ITSNA On-site
Review Reports). Additionally, audits of these and other ITSNA NRTL
sites determined that ITSNA has the appropriate training programs and
controls in place to remove the special condition for testing
hazardous-location equipment (Ex. 5: Memorandum Regarding Removal of
Hazardous Location Restriction). As a result, the Agency preliminarily
determined that it should (1) expand ITSNA's scope of recognition to
include the ITSNA Chicago and ITSNA Dallas sites, and (2) remove the
special condition stated above from ITSNA's scope of recognition.

III. Preliminary Finding on the Application and Request

    ITSNA submitted an acceptable application for expansion of its
scope of recognition. OSHA's review of the application file, and the
results of the Agency's on-site reviews and other audits, indicate that
ITSNA can meet the requirements prescribed by 29 CFR 1910.7 for
expanding its recognition to use the facilities at the ITSNA Chicago
and ITSNA Dallas sites for NRTL testing and certification. The on-site
reviews and audits also indicate that the special condition of ITSNA's
recognition is no longer necessary. This preliminary finding does not
constitute an interim or temporary approval of ITSNA's application and
request. ITSNA corrected the discrepancies noted by OSHA during the on-
site reviews, and the on-site review reports describes these
corrections (Ex. 4: ITSNA On-site Review Reports).
    OSHA welcomes public comment as to whether ITSNA meets the
requirements of 29 CFR 1910.7 for expansion of its recognition as an
NRTL and removal of the special condition of recognition. Comments
should consist of pertinent written documents and exhibits. Commenters
needing more time to comment must submit a request in writing, stating
the reasons for the request. Commenters must submit the written request
for an extension by the due date for comments. OSHA will limit any
extension to 10 days unless the requester justifies a longer period.
OSHA may deny a request for an extension if it is not adequately
justified. To obtain or review copies of the publicly available
information in ITSNA's application and request, including pertinent
documents (e.g., exhibits) and all submitted comments, contact the
Docket Office, Room N-2625, Occupational Safety and Health
Administration, U.S. Department of Labor, at the above address; these
materials also are available online at http://www.regulations.gov under
Docket No. OSHA-2007-0039.
    The NRTL Program staff will review all comments to the docket
submitted in a timely manner and, after addressing the issues raised by
these comments, will recommend to the Assistant Secretary whether to
grant ITSNA's application for expansion and its request to remove the
special condition of recognition. The Assistant Secretary will make the
final decision on granting the application and request. In making this
decision, the Assistant Secretary may undertake other proceedings
prescribed in Appendix A to 29 CFR 1910.7. OSHA will publish a public
notice of this final decision in the Federal Register.

IV. Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, 200 Constitution Avenue NW.,
Washington, DC 20210, authorized the preparation of this notice.
Accordingly, the Agency is issuing this notice pursuant to 29 U.S.C.
657(g)(2), Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25,
2012), and 29 CFR 1910.7.

    Signed at Washington, DC, on May 23, 2013.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2013-12810 Filed 5-29-13; 8:45 am]
BILLING CODE 4510-26-P