EPA ICR No. 2195.06					OMB Control No. 2070-0169

Attachment I

Explanation of Methodology and Data Used to Calculate Respondent Burdens and Costs

 Burden Hours for Respondents

 As required, EPA sent consultation questions about the burden and cost estimates to three respondents  -  the Agricultural Handler Exposure Task Force (AHETF), the Antimicrobial Exposure Assessment Task Force II (AEATF), and another third-party study sponsor who has conducted human research studies. The three organizations are experienced in submitting human research to the Office of Pesticide Programs (OPP).  The workload of one organization did not allow for a response to EPA's request. Consultation responses were received from AHETF and AEATF and are provided in Attachment H. To calculate new burden and cost estimates for this renewal ICR, EPA relied upon the estimates provided in the two consultation responses and knowledge of the range of protocols/studies to be submitted for review. EPA calculated an average of the different responses, recognizing that some study types are more complicated and costly to conduct than others.

 The respondent burden and cost estimates that appear in Table 1 in the ICR, for research involving intentional exposure of human subjects, are the averages of the values in Table A (burden hour estimates for agricultural handler studies, from the AHETF's consultation response) and Table B (burden hour estimates for antimicrobial exposure studies, from the AEATF's consultation response). For activities where the AHETF did not include a burden estimate because they do not anticipate performing the activity during the next cycle, their response was not included in calculating the average.  The consultation responses influenced the expected annual number of studies used in the calculations.

 Hourly Rates for Respondents

 The two respondents indicated that the hourly rates used by EPA for calculating the estimated costs are too low.  In determining the rates, OPP uses a single source of data, the Bureau of Labor Statistics' National Industry-Specific Occupational Employment and Wage Estimates and selects the appropriate occupational category.
 Using the BLS data allows EPA to be consistent between across sectors and occupations. If OPP were to separately research wages for each ICR, the methodology in determining the wages would not be consistent and the wage rates could not be compared between sectors and occupations.  Some wages would be biased high, while others would be biased low. The BLS wages are categorized by North American Industry Classification System (NAICS) codes, and therefore are industry specific. They are, however, national averages.  Therefore, some of the high wages earned by specialists in high-cost localities are offset by others who are less specialized in lower cost localities.

 To estimate costs for regulated entities for this renewal ICR, EPA used wage rates from NAICS 541710 (Research and Development in the Physical, Engineering, and Life Sciences). The BLS fully-loaded hourly rates for this industry are $195/hour for management, $99/hour for technical staff, and $59/hour for clerical staff.

 Agency Burden and Costs

 The estimated burden and costs to the Agency are derived from input from EPA staff members who have prepared reviews for studies that were presented to the HSRB. Recognizing that some study types are more complicated and time consuming to review that others, EPA calculated a weighted average using the staff time estimates and the expected frequency of receiving different types of studies.  The weighted averages are provided in ICR Tables 3 and 4. The wage rates EPA used to estimate Agency costs for this renewal ICR were from NAICS 999100 (Federal Executive Branch). The BLS fully-loaded hourly rates for Agency staff are $139/hour for management, $92/hour for technical staff, and $51/hour for clerical staff.

  Number of Transactions

  	The estimated number of transactions is based on the responses from the two respondents received during the recent consultation, information on other types of studies received during the previous consultation, EPA's historical experience, and knowledge of upcoming submissions.

                    RESPONDENT BURDEN HOUR ESTIMATES

  Table A. Agricultural Handler Exposure Studies  -  Burden Hour Estimates from AHETF's Consultation Response

                                  Activities
                           Average Burden Hours Per
                                  Occurrence

       Total Per Response

 Total Hours
                           Cost ($) Estimated by EPA
                            Actual Cost ($) to AHETF

   Mgt
 Technical
 Clerical

  $195
                                      $99
   $59

 Rule familiarization and training (per protocol)

                                       0

                                       0

                                       0

                                       0

   0

   0
 Prepare and submit protocol for IRB review

                                       0

                                       0

                                       0

   0

  0

   0
 Prepare and submit protocol for EPA and HSRB review

                                       0

                                       0

                                       0

  0

  0

  0
 Document ethical conduct of a completed study for which EPA and the HSRB have reviewed the protocol

                                      65

   2,000

                                      60

  2,125

  196,077

  213,661

 Store, file, and maintain records

                                       5

                                       5

                                       5

                                      15

   1,412

   1,762

 TOTALS

                                      70

   2,005

                                      65

  2,140

  197,489

  215,424

  Table B. Antimicrobial Exposure Studies  -  Burden Hour Estimates from AEATF's Consultation Response

       Activities
          Average Burden Hours Per Occurrence

      Total Per Response

   Manage- ment

                                  Total Hours
                           Cost ($) Based on EPA Nos.
 Based on Industry Cost ($)

 Technical
 Clerical

   $195
                                      $99
   $59

 Rule familiarization and training (per protocol)
                                       8
                                      10
                                       7
                                      25
                                    $2,392
                                    $2,959
 Prepare and submit protocol for IRB review
                                      25
                                      225
                                      30
                                      280
                                    $25,708
                                    $28,851
 Prepare and submit protocol for EPA and HSRB review
                                      100
                                      500
                                      40
                                      640
                                    $61,970
                                    $71,223
 Document ethical conduct of a completed study for which EPA and the HSRB have reviewed the protocol
                                      60
                                     1,000
                                      60
                                     1,120
                                   $103,400
                                   $113,956
 Prepare and submit final report for EPA and HSRB review*

 Store, file, and maintain records
                                      10
                                      40
                                      10
                                      60
                                    $5,583
                                    $6,487
 TOTALS
                                      203
                                     1,775
                                      147
                                     2,125
                                    $199,052
                                   $223,476

  Note:  EPA combined the two figures in the shaded rows 4 and 5 above in order to fully reflect the respondent's input.  This was necessary because the respondent added row 5* (above) entitled "prepare and submit final report for EPA and HSRB review." From EPA's perspective, row 4 is the essential activity in light of the required activities encompassed by this ICR and the language in the federal rule on protection of human subjects.  Nonetheless, EPA combined the two figures in the shaded rows 4 and 5 above to fully reflect the respondent's input.

  Table D.  Documentation of Ethical Conduct of a Completed Study for which EPA and HSRB have NOT reviewed the Protocol (per requirements at §26.1303)  -  Using information compiled during previous ICR renewal process

     Activities
           Average Burden Hours Per Occurrence
    Total Per Response

                                  Management
                                     $139
                                   Technical
                                      $92
                                   Clerical
                                      $51
 Hours
   Cost ($)
 Document ethical conduct of a completed study for which EPA and the HSRB have not reviewed the protocol

                                                                              2

                                                                             24

                                                                              2

    28

   2,588

  Table 1. Average Burden and Cost Estimates for Respondents  -  Research Involving Intentional Exposure of Human Subjects

  Note: This table takes into account the different types of studies submitted for review.

                                   Activities
                       Average Burden Hours Per Response
                               Total Per Response

                                   Management
                                      $195
                                   Technical
                                      $99
                                    Clerical
                                      $59
                                     Hours
                                    Cost ($)
 Rule familiarization and training
                                       6
                                       7
                                       5
                                       18
                                     $2,155
 Prepare and submit protocol for IRB review
                                       18
                                       83
                                       13
                                      114
                                    $12,469
 Prepare and submit protocol for EPA and HSRB review
                                       68
                                      334
                                       28
                                      430
                                    $47,886
 Document ethical conduct of a completed study for which EPA and the HSRB have reviewed the protocol; prepare and submit completed study for IRB, EPA, and HSRB Review
                                       56
                                     1,329
                                       57
                                     1,442
                                    $145,481
 Store, file, and maintain records
                                       7
                                       20
                                       8
                                       35
                                     $3,810
 Total per response
                                      155
                                     1,773
                                      111
                                     2,039
                                    $211,801
  Annual Burden:	2,039 hours per response * 4 responses per year = 8,156 hours Annual Costs:	$211,801 per response * 4 responses per year = $847,205

  Table 2. Respondent Burden and Cost Estimates  -  All Other Submitted Research with Human Subjects
                                   Activities
                       Average Burden Hours Per Response
                               Total Per Response

                                   Management
                                      $195
                                   Technical
                                      $99
                                    Clerical
                                      $59
                                     Hours
                                    Cost ($)
 Rule familiarization and training
                                       1
                                       1
                                       0
                                       2
                                      $294
 Prepare and Submit Ethics Information of Completed Human Studies to EPA
                                       0
                                       8
                                       1
                                       9
                                      $848
 Store, file, and maintain records
                                       0
                                       0
                                       1
                                       1
                                      $59
 Total per response
                                       1
                                       9
                                       2
                                       12
                                     $1,201
  Annual Burden:  12 hours per study * 10 studies submitted per year = 120 hours Annual Costs:     $1,201 per study * 10 studies submitted per year = $12,010

  Agency Burden Hour Estimates

   Table 3.    Weighted average Agency burden and cost estimates for research involving intentional exposure

                                  Activities
                       Average Burden Hours Per Response
                              Total Per Response

                                  Management
                                    $139/hr
                                   Technical
                                    $92/hr
                                   Clerical
                                    $51/hr
                                     Hours
                                   Cost ($)
Rule familiarization and training
                                       1
                                       2
                                       0
                                       3
                                      288
Primary Review of Scientific and Ethical Aspects of a Protocol
                                       3
                                      210
                                       0
                                      213
                                    17,592
Primary Review of Scientific and Ethical Aspects of a Completed Study Report
                                       3
                                      235
                                       0
                                      238
                                    19,642
Secondary Review of Scientific and Ethical Aspects of a Protocol
                                      197
                                    4,694*
Secondary Review of Scientific and Ethical Aspects of a Completed Report
                                      197
                                    4,694*
Store, file, and maintain records
                                       0
                                       0
                                       2
                                       2
                                      102
Total per response
                                       7
                                      841
                                       2
                                      850
                                    51,581

   *	HSRB members are special government employees; their time should be reflected as part of Agency burden. Cost of HSRB members working on the HSRB report (collectively spending 197 hours per HSRB report in FY 2011, compensated at the 2014 rate of $59/hour), plus the cost of EPA Office of the Science Advisor (OSA) technical staff working on the HSRB report (30 hours per report, at the technical staff rate of $82/hour). Each HSRB report covers an average of 3 protocols and/or completed studies per report, so each topic costs an average of $4,694.

   Annual Burden:  	850 hours per response x 4 per year = 3,400 hours plus 30 for OSA review of HSRB report = 3,430 hours
   Annual Costs:	$51,581 x 4 responses/year = $206,324

   Please note that the estimated 4 "responses" per year include 4 protocols plus 4 studies.  This definition of responses is consistent with that used and approved for this ICR in previous years.

  Table 4. Weighted Average Burden and Cost Estimates for Agency  -  Research Involving Intentional Exposure  -  All Other Submitted Research with Human Subjects

                                  Activities
                       Average Burden Hours Per Response
                              Total Per Response

                                  Management
                                    $139/hr
                                   Technical
                                    $92/hr
                                   Clerical
                                    $51/hr
                                     Hours
                                   Cost ($)
Rule familiarization and training
                                       0
                                       0
                                       0
                                       0
                                       0
Primary Review of Ethical Aspects of a Completed Study Report
                                       0
                                       6
                                       0
                                       6
                                      552
Store, file, and maintain records
                                       0
                                       0
                                       0
                                       0
                                       0
Total per response
                                       0
                                       6
                                       0
                                       6
                                      552

   Annual Burden:  	6 hours per study x 20 per year = 120 hours
   Annual Costs:	492 x 20 responses/year = $11,038

   Please note that, as discussed in section 6(c), for the pre-rule human research which does not require HSRB review, EPA assumes that 10 of the 20 studies will be located at the Agency's own initiative and therefore will not be subject to 40 CFR 26.1303. This approach is consistent with that used previously for this ICR.

    Table 5.  Total Annual Bottom Line Burden and Costs/Master Table
                              Collection Activity
                              Annual Burden Hours
                                 Annual Costs
                      Annual Respondent Burden and Costs
Research Involving Intentional 	Exposure of Human Subjects (Table 1)
                                     8,156
                                   $847,205
All Other Submitted Research with Human Subjects (Table 2)
                                      120
                                    $12,010
Respondent Total
                                     8,276
                                   $859,215
                             Annual Agency Burden
Research Involving Intentional 	Exposure of Human Subjects (Table 3)
                                     3,430
                                   $206,324
All Other Submitted Research with 	Human Subjects (Table 4)
                                      120
                                      $11,038
Agency Total
                                     3,550
                                   $217,362

             Number of Transactions: September 2012  -  August 2015

Intentional Exposure Studies
 AHETF Monitoring Program
 See the consultation responses in Attachment H.
 In Table 2 of consultation responses, AHETF estimates 2 completed studies per year for FY 17 and FY 18.
 Figures used in ICR: 2 "transactions" per year

 AEATF Monitoring Program
 See the consultation responses in Attachment H.
 In Table 2 of consultation responses, AEATF estimates 4 protocols in FY 2017, 3 studies in FY 2017, and 1 study in FY 2018, for a total of 8 over 3 years.
 Figures used in ICR: 2 "transactions" per year (2 protocols + 2 completed study reports)

 Insect Repellent Efficacy Testing
 Figures used in ICR: 2 "transactions" per year (2 protocols + 2 completed study reports)

 Other Post-Rule Studies
 These could include exposure studies from sources other than the task forces, ADME studies, skin patch tests of irritation or sensitization, systemic toxicity tests, or others.
 All would require submission of a protocol before execution and of a completed report after execution; both the protocol and the report would require EPA and HSRB review.
 Estimate: 1 protocol and 1 completed study per year. (This is likely an over-estimate)

Studies which are Not Intentional Exposure
 Pre-Rule Completed Studies which do not measure or identify a toxic effect
 These studies do not go to the HSRB, but they do require an EPA ethics review. Historical level: 20 reviews per year.
 Assume workload to remain constant over the time period of the ICR
 Estimate: 20 per year (estimated that 10 studies/year are submitted from outside parties, and therefore subject to the requirements of 40 CFR 26.1303 requiring submitters to document the ethical conduct; estimated that 10 studies/year are located by the Agency at its own initiative, and therefore not subject to 40 CFR 26.1303)

 TOTAL RESPONSES PER YEAR TO BE USED IN ICR ESTIMATES:
 7 intentional exposure human studies (rule familiarization + protocol stage where applicable + completed report stage + records storage)
 20 studies/year requiring EPA ethics review, but not HSRB review (pre-rule studies that do not measure or identify a toxic effect)


[Federal Register Volume 88, Number 224 (Wednesday, November 22, 2023)]
[Notices]
[Page 81463]
[FR Doc No: 2023-25785]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 35051; 812-15511]

Jackson Credit Opportunities Fund and Jackson National Asset
Management, LLC

November 16, 2023.
AGENCY: Securities and Exchange Commission (``Commission'' or ``SEC'').

ACTION: Notice.

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

    Notice of an application under section 6(c) of the Investment
Company Act of 1940 (the ``Act'') for an exemption from sections
18(a)(2), 18(c) and 18(i) of the Act, under sections 6(c) and 23(c) of
the Act for an exemption from rule 23c-3 under the Act, and for an
order pursuant to section 17(d) of the Act and rule 17d-1 under the
Act.
    Summary of Application: Applicants request an order to permit
certain registered closed-end investment companies to issue multiple
classes of shares and to impose asset-based distribution and/or service
fees and early withdrawal charges.
    Applicants: Jackson Credit Opportunities Fund and Jackson National
Asset Management, LLC.
    Filing Dates: The application was filed on October 2, 2023.
    Hearing or Notification of Hearing: An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing on any application by emailing
the SEC's Secretary at [email protected] and serving the
Applicants with a copy of the request by email, if an email address is
listed for the relevant Applicant below, or personally or by mail, if a
physical address is listed for the relevant Applicant below. Hearing
requests should be received by the Commission by 5:30 p.m. on December
11, 2023, and should be accompanied by proof of service on the
Applicants, in the form of an affidavit, or, for lawyers, a certificate
of service. Pursuant to rule 0-5 under the Act, hearing requests should
state the nature of the writer's interest, any facts bearing upon the
desirability of a hearing on the matter, the reason for the request,
and the issues contested. Persons who wish to be notified of a hearing
may request notification by emailing the Commission's Secretary.

ADDRESSES: The Commission: [email protected]. Applicants:
Emily J. Bennett, Esq., Jackson National Asset Management, LLC,
[email protected]; with a copy to Paulita A. Pike, Esq., Ropes
& Gray LLP, [email protected].

FOR FURTHER INFORMATION CONTACT: Trace W. Rakestraw, Senior Special
Counsel, at<PHONE_NUMBER> (Division of Investment Management, Chief
Counsel's Office).

SUPPLEMENTARY INFORMATION: For Applicants' representations, legal
analysis, and conditions, please refer to Applicants' application,
dated October 2, 2023, which may be obtained via the Commission's
website by searching for the file number at the top of this document,
or for an Applicant using the Company name search field on the SEC's
EDGAR system. The SEC's EDGAR system may be searched at https://www.sec.gov/edgar/searchedgar/legacy/companysearch.html html. You may also
call the SEC's Public Reference Room at<PHONE_NUMBER>.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-25785 Filed 11-21-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 41 (Wednesday, March 2, 2016)]
[Rules and Regulations]
[Pages 10771-10776]
[FR Doc No: 2016-04598]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0879; FRL-9940-36]

Penoxsulam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
penoxsulam in or on multiple commodities which are identified and
discussed later in this document. Interregional Research Project Number
4 (IR-4) requested these tolerances associated with pesticide petition
number (PP#) 4E8330, under the Federal Food, Drug, and Cosmetic Act
(FFDCA).

DATES: This regulation is effective March 2, 2016. Objections and
requests for hearings must be received on or before May 2, 2016, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2014-0879, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

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

I. General Information

A. Does this action apply to me?

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

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2014-0879 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
May 2, 2016. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2014-0879, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of March 4, 2015 (80 FR 11611) (FRL-9922-
68), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C.

346a(d)(3), announcing the filing of a pesticide petition (PP#) 4E8330
by Interregional Research Project Number 4 (IR-4), 500 College Road
East, Princeton, NJ 08540. The petition requested that 40 CFR 180.605
be amended by establishing tolerances for residues of the herbicide
penoxsulam, (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]
triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide),
in or on fruit, pome, group 11-10 at 0.01 parts per million (ppm);
fruit, stone, group 12-12 at 0.01 ppm; fruit, small, vine climbing,
subgroup 13-07F, except fuzzy kiwifruit at 0.01 ppm; nut, tree, group
14-12 at 0.01 ppm; olive at 0.01 ppm; and pomegranate at 0.01 ppm. In
addition, the petitioner proposed removal of existing tolerances on
grape; nut, tree, group 14; and pistachio as they are superseded by
this rule. That document referenced a summary of the petition prepared
on behalf of IR-4 by Dow AgroSciences LLC, the registrant, which is
available in the docket EPA-HQ-OPP-2014-0879 at http://www.regulations.gov. There were no comments received in response to the
notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

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

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    In subchronic and chronic feeding studies in rats and dogs, the
kidney was the most sensitive target organ. Hyperplasia of the renal
pelvic epithelium was observed in both species, and in the rat, effects
on renal function and increased severity of chronic
glomerulonephropathy were also observed following chronic exposure.
Effects on the liver, hematological parameters, and body weight were
observed sporadically in some studies. In subchronic and chronic
feeding studies in mice, no effects of toxicological significance were
observed.
    There was no evidence of increased quantitative or qualitative
susceptibility of fetuses or offspring, as compared to adults. In
developmental toxicity studies in rats and rabbits, no developmental
toxicity was observed at maternally toxic dose levels. In a 2-
generation reproduction study in rats, delays in preputial separation
were noted in the presence of parental toxicity. No treatment-related
neurotoxicity or immunotoxicity were observed in any of the available
studies on penoxsulam. No systemic or dermal toxicity was noted in a
28-day dermal toxicity study in rats.
    Although an increased incidence of mononuclear cell leukemia (MNCL)
was observed in a chronic toxicity/carcinogenicity study in Fisher 344
rats, EPA determined that human cancer risk is likely to be minimal and
is not conducting a separate quantitative cancer assessment for the
following reasons: (1) Lack of a dose-response, suggesting that the
tumor may not be treatment-related; (2) the tumors were found in only
one gender and one species (they were not found in female rats or
mice); (3) the tumors are of questionable relevance to humans since
there is no similar tumor occurring in humans; (4) penoxsulam is
negative for mutagenicity; and (5) MNCL is not associated with exposure
to other triazolopyrimidines, which is the chemical class of herbicides
to which penoxsulam belongs. Therefore, based on the current (2005)
Agency guidelines for cancer assessment, EPA has determined that the
chronic assessment will be protective of any potential cancer risks.
    Specific information on the studies received and the nature of the
adverse effects caused by penoxsulam as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document, ``Penoxsulam. Human Health New Use
Risk Assessment to Support the Registration of Proposed Use on Pome
Fruit, Stone Fruit, Olive, Pomegranate, and Fruit, Small, Vine Climbing
(Subgroup 13-07F, Except Fuzzy Kiwifruit); and Crop Group Conversion
for Tree Nuts'' on pages 10-16 in docket ID number EPA-HQ-OPP-2014-
0879.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for penoxsulam used for
human risk assessment is shown in Table 1 of this unit.

                      Table 1--Summary of Toxicological Doses and Endpoints for Penoxsulam for Use in Human Health Risk Assessment
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk                  Study and toxicological effects
                                               factors                 assessment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acute dietary (All Populations,        No toxicological endpoint attributable to a single exposure was identified in the available toxicology studies on
 including Infants and Children and                   penoxsulam. This exposure scenario was therefore not assessed for human health risk.
 Females 13-49 years of age).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations).     NOAEL = 14.7 mg/kg/day.  Chronic RfD = 0.147 mg/  1 Year Chronic Feeding Study in Dogs.
                                       UFA = 10 x.............   kg/day.                 LOAEL = 46.2 mg/kg/day based on multifocal hyperplasia of the
                                       UFH = 10 x.............  cPAD = 0.147 mg/kg/day.   renal pelvic epithelium.
                                       FQPA SF = 1x...........
Incidental oral short-term (1 to 30    NOAEL= 17.8 mg/kg/day..  LOC for MOE = 100......  13-Week Feeding Study in Dogs.
 days).                                UFA = 10 x.............                           LOAEL = 49.4 mg/kg/day based on multifocal hyperplasia of the
                                       UFH = 10 x.............                            renal pelvic epithelium and crystals in the renal pelvis and
                                       FQPA SF = 1x...........                            collecting ducts.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dermal (All Durations).                An endpoint for systemic toxicity was not identified in the rat 28-day dermal study and there were no neurotoxic,
                                        developmental, or immunotoxic effects observed for penoxsulam. This exposure scenario was not assessed for human
                                                                                health risk.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inhalation Short-Term (1 to 30 days)   NOAEL= 17.8 mg/kg/day..  LOC for MOE = 100......  13-Week Feeding Study in Dogs.
 and Intermediate-Term (1 to 6         UFA = 10 x.............                           LOAEL = 49.4 mg/kg/day based on multifocal hyperplasia of the
 months).                              UFH = 10 x.............                            renal pelvic epithelium and crystals in the renal pelvis and
                                       FQPA SF = 1x...........                            collecting ducts.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation).     Classification: A separate quantitative cancer assessment is not being conducted as the cRfD is considered
                                        protective of potential carcinogenic effects.
--------------------------------------------------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/
  kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD =
  reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to penoxsulam, EPA considered exposure under the petitioned-
for tolerances as well as all existing penoxsulam tolerances in 40 CFR
180.605. EPA assessed dietary exposures from penoxsulam in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for penoxsulam; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEM-FCID) Version 3.16. This
software uses 2003-2008 food consumption data from the U.S. Department
of Agriculture's (USDA's) National Health and Nutrition Examination
Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in
food, EPA tolerance-level residues, 100 percent crop treated (PCT) for
all commodities, and DEEM (Version 7.81) default processing factors.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that the chronic assessment for penoxsulam is considered
protective of potential cancer risks. Therefore, a separate dietary
exposure assessment for the purpose of assessing cancer risk is
unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for penoxsulam. Tolerance-level residues and/or 100
PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. In drinking water, the
residues of concern include penoxsulam parent, along with the following
degradates: BSTCA; 2-amino TCA; 5-OH-penoxsulam; SFA; sulfonamide; and
5,8-diOH. The Agency used screening-level water exposure models in the
dietary exposure analysis and risk assessment for penoxsulam in
drinking water. These simulation models take into account data on the
physical, chemical, and fate/transport characteristics of penoxsulam.
Further information regarding EPA drinking water models used in
pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Penoxsulam is registered for control of aquatic weeds. For that use
pattern, the maximum application rate is 150 parts per billion (ppb) in
the water column. For chronic dietary risk assessment, the water
concentration value of 150 ppb was used to assess the contribution to
drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Penoxsulam is currently registered for the following uses that
could result in residential exposures: Residential and commercial turf
(lawns and golf courses) and aquatic use sites. EPA assessed
residential exposure using the following assumptions: For handlers, it
is assumed that residential use will result in short-term (1 to 30
days) duration dermal and inhalation exposures. Residential post-
application exposure is also assumed to be short-term (1-30 days) in
duration, resulting from the following exposure scenarios:
     Physical activities on turf: Adults (dermal) and children
1-2 years old (dermal and incidental oral);
     mowing turf: Adults (dermal) and children 11 to <16 years
old (dermal);
     exposure to golf courses during golfing: Adults (dermal),
children 11 to <16 years old (dermal), and children 6 to <11 years old
(dermal); and
     exposure during aquatic activities (e.g. swimming): Adults
(dermal, inhalation, ingestion) and children 3 to <6 years old (dermal,
inhalation, ingestion).

    Due to the lack of a dermal endpoint, EPA did not quantify exposure
and risk estimates from dermal exposure scenarios. EPA did not combine
exposure resulting from adult handler and post-application exposure
resulting from treated gardens, lawns, golfing, and/or aquatic areas in
residential settings because of the conservative assumptions and inputs
within each estimated exposure scenario. The Agency believes that
combining exposures resulting from handler and post-application
activities would result in an overestimate of adult exposure. EPA
selected the most conservative adult residential scenario (adult
handler inhalation exposure from backpack sprayer applications to
lawns/turf) as the contributing source of residential exposure to be
combined with the dietary exposure for the aggregate assessment. The
children's 3 to <6 oral exposure is based on post-application ingestion
exposures during aquatic activities. The children's 1 to <2 oral
exposure is based on post-application hand-to-mouth exposures from
applications to lawns/turf. To include exposure from object-to-mouth
and soil ingestion in addition to hand-to-mouth would overestimate the
potential for oral exposure. Further information regarding EPA standard
assumptions and generic inputs for residential exposures may be found
at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found penoxsulam to share a common mechanism of
toxicity with any other substances, and penoxsulam does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
penoxsulam does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA
either retains the default value of 10X, or uses a different additional
safety factor when reliable data available to EPA support the choice of
a different factor.
    2. Prenatal and postnatal sensitivity. No evidence of quantitative
or qualitative increased susceptibility, as compared to adults, of rat
fetuses to in utero or postnatal exposure was observed in developmental
toxicity studies in rats or rabbits or a reproduction study in rats.
Developmental toxicity was not observed in the rat or rabbit up to
doses resulting in maternal toxicity. In the rat reproductive toxicity
study, slightly increased time to preputial separation in F1 males and
decreased pup weight gain were observed in the presence of parental
toxicity (kidney lesions in females).
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for penoxsulam is complete.
    ii. There is no indication that penoxsulam is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
    iii. There is no evidence that penoxsulam results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to penoxsulam in drinking water. EPA used similarly
conservative assumptions to assess postapplication exposure of children
as well as incidental oral exposure of toddlers. These assessments will
not underestimate the exposure and risks posed by penoxsulam.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
penoxsulam is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
penoxsulam from food and water will utilize 6% of the cPAD for all
infants <1 year old the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
penoxsulam is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Penoxsulam is
currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to penoxsulam.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 5,400 for adults
and 2,100 for children 1-2 years old, the two population subgroups
receiving the greatest combined dietary and non-dietary exposure.
Because EPA's level of concern for penoxsulam is a MOE of 100 or below,
these MOEs are not of concern.

    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). An intermediate-term adverse effect was identified; however,
penoxsulam is not registered for any use patterns that would result in
intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for
penoxsulam.
    5. Aggregate cancer risk for U.S. population. As discussed in Unit
III.A., EPA determined that the chronic assessment is protective of the
potential cancer risks. Based on the chronic assessment, there is no
concern for an aggregate cancer risk from exposure to penoxsulam.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to penoxsulam residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, high performance liquid
chromatography (HPLC) methods with positive-ion electro spray interface
(ESI) and tandem mass spectroscopy-mass spectroscopy detector (LC/MS/
MS), is available to enforce the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. There are currently no
established Codex MRLs for the residues of penoxsulam.

C. Revisions to Petitioned-For Tolerances

    EPA has revised the tolerance expression to clarify first, that, as
provided in FFDCA section 408(a)(3), the tolerance covers metabolites
and degradates of penoxsulam not specifically mentioned; and second,
that compliance with the specified tolerance levels is to be determined
by measuring only the specific compounds mentioned in the tolerance
expression.

V. Conclusion

    Therefore, tolerances are established for residues of penoxsulam,
(2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4] triazolo[1,5-
c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide), in or on
fruit, pome, group 11-10 at 0.01 ppm; fruit, small, vine climbing
subgroup 13-07F, except fuzzy kiwifruit at 0.01 ppm; fruit, stone,
group 12-12 at 0.01 ppm; nut, tree, group 14-12 at 0.01 ppm; olive at
0.01 ppm; and pomegranate at 0.01 ppm. Additionally, the existing
tolerances for grape; nut, tree, group 14; and pistachio are removed.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: February 23, 2016.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.605, paragraph (a) is revised to read as follows:

Sec.  180.605  Penoxsulam; tolerances for residues.

    (a) General. Tolerances are established for residues of penoxsulam,
including its metabolites and degradates, in or on the commodities
listed in the table below. Compliance with the tolerance levels
specified below is to be determined by measuring only penoxsulam 2-
(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c] pyrimidin-
2-yl)-6-(trifluoromethyl) benzenesulfonamide, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................        0.01
Fish........................................................        0.01
Fish, shellfish, crustacean.................................        0.01
Fish, shellfish, mollusc....................................        0.02
Fruit, pome, group 11-10....................................        0.01
Fruit, small, vine climbing, subgroup 13-07F, except fuzzy          0.01
 kiwifruit..................................................
Fruit, stone, group 12-12...................................        0.01
Nut, tree, group 14-12......................................        0.01
Olive.......................................................        0.01
Pomegranate.................................................        0.01
Rice, grain.................................................        0.02
Rice, straw.................................................        0.50
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-04598 Filed 3-1-16; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 50 (Friday, March 14, 2014)]
[Notices]
[Page 14568]
[FR Doc No: 2014-05408]

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

Office of the Secretary of Transportation

[Docket No. DOT-OST-2013-0217]

Proposed Information Collection Request; Notice of Requirements
and Procedures for Grant Payment Request Submission

AGENCY: Department of Transportation (DOT).

ACTION: Notice and request for comments.

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SUMMARY: The Department of Transportation (DOT), Office of the
Secretary (OST) will be submitting the following request for extension
to the previously approved information collection request to the Office
of Management and Budget (OMB) for review and clearance in accordance
with the Paperwork Reduction Act of 1995. The information collection
was previously published in the Federal Register on December 27, 2013,
allowing for a 60-day public comment period.

DATES: April 14, 2014.

ADDRESSES: Direct comments to the Department of Transportation Desk
Officer in the Office of Information and Regulatory Affairs at the
Office of Management and Budget (OMB). You may submit comments by the
following methods:
     Email<EMAIL_ADDRESS>Include the
information collection title and OMB control number in the subject line
of your message.
     Fax:<PHONE_NUMBER>. Attn: Desk Officer for Department of
Transportation.
     Send comments regarding the information collection to the
Office of Information and Regulatory Affairs, Office of Management and
Budget, 725 Seventeenth Street NW., Washington, DC 20503, Attention:
OST Desk Officer.

FOR FURTHER INFORMATION CONTACT: You may obtain copies of the proposed
information collection and supporting documents from US Department of
Transportation, Office of Financial Management, B-30, Room W93-431,
1200 New Jersey Avenue SE., Washington, DC 20590-0001,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Title: Notice of Requirements and Procedures for Grant Payment
Request Submission.
    OMB Control Number: 2105-0564.
    Type of Request: Extension to the previously approved information
collection.
    Background: This notice sets forth requirements and procedures for
grantees that receive payments from DOT OAs,\1\ with the exception of
DOT grant recipients requesting payment electronically through the
National Highway Traffic Safety Administration's Grant Tracking System
(GTS), the Federal Highway Administration's Rapid Approval State
Payment System (RASPS), or Federal Transit Administration (FTA) grant
recipients requesting payment through the Electronic Clearing House
Operation System (ECHO-Web).
---------------------------------------------------------------------------

    \1\ The DOT OAs are: Office of the Secretary of Transportation
(OST), Federal Aviation Administration (FAA), Federal Highway
Administration (FHWA), Federal Motor Carrier Safety Administration
(FMCSA), Federal Railroad Administration (FRA),Federal Transit
Administration (FTA), Maritime Administration (MARAD), National
Highway Traffic Safety Administration (NHTSA), Office of Inspector
General (OIG), Pipeline and Hazardous Materials Safety
Administration (PHMSA), Research and Innovative Technology
Administration (RITA), Saint Lawrence Seaway Development Corporation
(SLSDC) and Surface Transportation Board (STB).
---------------------------------------------------------------------------

    The proposed procedures provide that--
     Grantees will now be required to have electronic internet
access to register in the Delphi eInvoicing system.
     Grantees will be required to submit payment requests
electronically and DOT OAs must process payment requests
electronically.
     The identities of system users must be verified prior to
receiving access to the Delphi eInvoicing system. Users must complete a
user request form and provide the following information: Full name,
work address, work phone number, work email address, home address and
home phone number. Once completed, this form must be presented to a
Notary Public for verification. Once notarized, the prospective grantee
user will return the form to receive their login credentials.
     DOT Office of Financial Management officials may allow
exceptions to the requirement that grantees register and submit payment
requests through the Delphi eInvoicing system under limited
circumstances. Recipients may apply for an exemption by submitting an
electronic Waiver Request Form to the DOT Office of Financial
Management. The exceptions will be considered on a case by case basis
via Waiver Request Form.
    Affected Public: DOT Grant Recipients.
    Estimated Number of Respondents: 3,000.
    Estimated Number of Responses: 3,000.
    Annual Estimated Total Burden Hours: 6,000 (est. 2 hours to
complete process x 3,000 recipients).
    Frequency of Collection: One time.
    Comments: Comments are invited on: Whether the proposed collection
of information is necessary for the proper performance of the functions
of the Department, including whether the information will have
practical utility; the accuracy of the Department's estimate of the
burden of the proposed information collection; ways to enhance the
quality, utility and clarity of the information to be collected; and
ways to minimize the burden of the collection of information on
respondents.

    Issued in Washington, DC on March 6, 2014.
Patricia Lawton,
Paperwork Reduction Act Clearance Officer, Department of
Transportation.
[FR Doc. 2014-05408 Filed 3-13-14; 8:45 am]
BILLING CODE 4910-9-P


[Federal Register Volume 77, Number 205 (Tuesday, October 23, 2012)]
[Rules and Regulations]
[Pages 64701-64704]
[FR Doc No: 2012-25675]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0144; Directorate Identifier 2011-NM-152-AD;
Amendment 39-17220; AD 2012-21-04]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

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

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for all
Airbus Model A300 series airplanes; Model A310 series airplanes; and
Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model
A300 C4-605R Variant F airplanes (collectively called Model A300-600
series airplanes). This AD was prompted by reports of cracked fuel pump
canister hoods located in fuel tanks. This AD requires replacing any
cracked hood halves of fuel pump canisters. We are issuing this AD to
prevent any detached canister hood fragments/debris from being ingested
into the fuel feed system, and becoming a potential source of ignition
with consequent fire or explosion.

DATES: This AD becomes effective November 27, 2012.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of November 27,
2012.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone (425)
227-2125; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on February 22, 2012
(77 FR 10409). That NPRM proposed to correct

an unsafe condition for the specified products. The MCAI states:

    This [European Aviation Safety Agency (EASA)] AD results from
findings of cracked fuel pump canister hoods located in fuel tanks.
    From the analyses, laboratory testing and examinations made so
far, it is presently thought that vibration-induced fatigue can be
identified as the root cause for the cracks found on in-service
aeroplanes. However, current data does not yet permit to exclude
some other potential contributing factors.
    This condition, if not detected and corrected, could lead to
detached canister hood fragments/debris to be ingested into the fuel
feed system. Also, the metallic debris inside the fuel tank could
result in a potential source of ignition and consequent fire or
explosion.
    For the reasons described above, this [EASA] AD requires
repetitive [detailed] inspections of all fuel pump canister hood
halves and their replacement if any [cracking] damage is found. This
[EASA] AD also requires the inspection results to be reported.
    This [EASA] AD is considered to be an interim action. The
reports that are required by this [EASA] AD will enable the
manufacturer to obtain better insight into the nature, cause, and
extent of the fuel pump canister hood cracking, and eventually to
develop final action to address the unsafe condition. Once final
action has been identified, further AD actions could be considered.

You may obtain further information by examining the MCAI in the AD
docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We have considered the comments received.

Request To Extend Reporting Time

    FedEx requested that the time for submitting reports, proposed in
the NPRM (77 FR 10409, February 22, 2012) as 30 days, be extended to 90
days, because it might not have immediate access to maintenance
vendors' records of the completed tasks, and system-wide reporting can
sometimes require longer times.
    Although EASA AD 2011-0124, dated June 30, 2011, specifies a 30-day
compliance time for submitting reports, we agree with the commenter's
request to extend the compliance time for reporting because a delay
will not compromise safety. We have changed paragraphs (j)(1) and
(j)(2) of this final rule accordingly. This difference has been
coordinated with EASA.

Request for Specific Contact Information for Reporting

    FedEx requested that we provide specific information for submitting
the reports proposed in the NPRM (77 FR 10409, February 22, 2012),
including an email address, to facilitate reporting.
    We agree with the commenter's request for the reason given, and
have added that information in paragraph (j) of this final rule.

Request To Delay the Final Rule Effective Date and Extend the
Compliance Time

    UPS requested that the AD be effective after Airbus completes
certifying the improved design for the fuel pump half hood, projected
to be completed in late 2012. UPS also requested an initial compliance
time of 36 months (versus the 30 months proposed in the NPRM (77 FR
10409, February 22, 2012)) to allow for purchasing and part lead time.
UPS stated that these changes to the NPRM would enable a one-time
through-the-fleet solution without the need for repetitive inspections.
    We do not agree with the commenter's request for extending the
compliance time. In developing an appropriate compliance time for this
action, we considered not only the degree of urgency associated with
addressing the subject unsafe condition, but the manufacturer's and
EASA's recommendations for an appropriate compliance time, and the
availability of required parts. We have not changed the AD in this
regard.
    Further, we do not agree with the request for delaying the AD. For
continued operational safety, operators need to begin the inspections,
and not delay the inspections until the part is certified. We will
consider an alternative method of compliance (AMOC) when parts are
available. Operators may request approval of an AMOC in accordance with
paragraph (k)(1) of this final rule, if sufficient data are submitted
to substantiate that the method would provide an acceptable level of
safety. We have not changed the AD in this regard.

Airplane Models Added to This AD

    We have determined that Model A300 B2-1A and A300 B4-601 airplanes
were inadvertently omitted from the Applicability of the NPRM (77 FR
10409, February 22, 2012). We have added those models to the
Applicability of this AD in paragraphs (c)(1) and (c)(3) respectively.
However, none of the airplanes added to the Applicability of this AD
are on the U.S. Register. Therefore, additional notice and opportunity
for public comment before issuing this AD are unnecessary.

Explanation of Updated Credit Language

    We have revised the heading and wording for paragraph (i) of this
AD to provide appropriate credit for previous accomplishment of certain
actions. This change does not affect the intent of that paragraph.

Conclusion

    We reviewed the available data, including the comments received,
and determined that air safety and the public interest require adopting
the AD with the changes described previously, and minor editorial
changes. We have determined that these changes:
     Are consistent with the intent that was proposed in the
NPRM (77 FR 10409, February 22, 2012) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (77 FR 10409, February 22, 2012).

Costs of Compliance

    We estimate that this AD will affect about 221 products of U.S.
registry. We also estimate that it will take up to 12 work-hours per
product to comply with the basic requirements of this AD. The average
labor rate is $85 per work-hour. Based on these figures, we estimate
the cost of this AD to the U.S. operators to be $225,420, or $1,020 per
product.
    In addition, we estimate that any necessary follow-on actions would
take about 1 work-hour. We have no way of determining the number of
products that may need these actions.
    We have received no definitive data that would enable us to provide
cost estimates for certain parts required for the on-condition actions
(replacing fuel pump canister hood halves) specified in this AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition

that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM (77 FR 10409, February 22,
2012), the regulatory evaluation, any comments received, and other
information. The street address for the Docket Operations office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2012-21-04 Airbus: Amendment 39-17220. Docket No. FAA-2012-0144;
Directorate Identifier 2011-NM-152-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective November 27,
2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the airplanes identified in paragraphs
(c)(1), (c)(2), and (c)(3) of this AD, certificated in any category,
all certificated models, all serial numbers.
    (1) Airbus Model A300 B2-1A, B2-1C, B2K-3C, B2-203, B4-2C, B4-
103, and B4-203 airplanes.
    (2) Airbus Model A310-203, -204, -221, -222, -304, -322, -324,
and -325 airplanes.
    (3) Airbus Model A300 B4-601, B4-603, B4-620, and B4-622
airplanes, Model A300 B4-605R and B4-622R airplanes, Model A300 F4-
605R and F4-622R airplanes, and Model A300 C4-605R Variant F
airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 28: Fuel.

(e) Reason

    This AD was prompted by reports of cracked fuel pump canister
hoods located in fuel tanks. We are issuing this AD to prevent any
detached canister hood fragments/debris from being ingested into the
fuel feed system, and becoming a potential source of ignition with
consequent fire or explosion.

(f) Compliance

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

(g) Initial Inspection and Replacement

    Within 30 months after the effective date of this AD, do a
detailed inspection for cracking of the fuel pump canister hood
halves installed on all fuel pump canisters having part numbers (P/
N) 2052C11, 2052C12, and C93R51-601, in accordance with the
Accomplishment Instructions of the service bulletin specified in
paragraph (g)(1), (g)(2), or (g)(3) of this AD, as applicable. If
any crack is found on any fuel pump canister hood half during any
inspection, before further flight, replace the fuel pump canister
hood half, in accordance with the Accomplishment Instructions of the
service bulletin specified in paragraph (g)(1), (g)(2), or (g)(3) of
this AD, as applicable.
    (1) For Model A300 series airplanes: Airbus Mandatory Service
Bulletin A300-28-0089, Revision 01, including Inspection Findings--
Reporting Sheet, dated April 15, 2011.
    (2) For Model A300-600 series airplanes: Airbus Mandatory
Service Bulletin A300-28-6106, Revision 01, including Inspection
Findings--Reporting Sheet, dated April 15, 2011.
    (3) For Model A310 series airplanes: Airbus Mandatory Service
Bulletin A310-28-2173, Revision 01, including Inspection Findings--
Reporting Sheet, dated April 15, 2011.

(h) Repetitive Inspections

    Within 30 months after accomplishing the actions specified in
paragraph (g) of this AD, and thereafter at intervals not to exceed
30 months, repeat the detailed inspection specified in paragraph (g)
of this AD.

(i) Credit for Previous Actions

    This paragraph provides credit for the actions required by
paragraph (g) of this AD, if those actions were performed before the
effective date of this AD using the Airbus Mandatory Service Bulletins
specified in paragraph (i)(1), (i)(2), or (i)(3) of this AD, which are
not incorporated by reference in this AD.
    (1) Airbus Mandatory Service Bulletin A300-28-0089, dated January
13, 2011.
    (2) Airbus Mandatory Service Bulletin A300-28-6106, dated January
13, 2011.
    (3) Airbus Mandatory Service Bulletin A310-28-2173, dated January
13, 2011.

(j) Reporting to Airbus

    Submit reports of the findings (both positive and negative) of the
inspections required by paragraphs (g) and (h) of this AD to Airbus at
the applicable time specified in paragraph (j)(1) or (j)(2) of this AD,
using the form ``Inspection Findings--Reporting Sheet'' provided in the
service bulletin identified in paragraph (g)(1), (g)(2), or (g)(3) of
this AD, as applicable. Submit information to Airbus, SDC32 Technical
Data and Documentation Services, fax (+33) 5 61 93 28 06, email
<EMAIL_ADDRESS>or via the operator's Resident Customer
Support Office.
    (1) If the inspection was done on or after the effective date of
this AD: Submit the report within 90 days after the inspection.
    (2) If the inspection was done before the effective date of this
AD: Submit the report within 90 days after the effective date of this
AD.

(k) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA, has
the authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send
your request to your principal inspector or local Flight Standards
District Office, as appropriate. If sending information directly to the
International Branch, send it to ATTN: Dan Rodina, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, Washington 98057-3356;

telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information may be
emailed to<EMAIL_ADDRESS>Before using any approved
AMOC, notify your appropriate principal inspector, or lacking a
principal inspector, the manager of the local flight standards district
office/certificate holding district office. The AMOC approval letter
must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority (or
their delegated agent). You are required to assure the product is
airworthy before it is returned to service.
    (3) Reporting Requirements: A federal agency may not conduct or
sponsor, and a person is not required to respond to, nor shall a person
be subject to a penalty for failure to comply with a collection of
information subject to the requirements of the Paperwork Reduction Act
unless that collection of information displays a current valid OMB
Control Number. The OMB Control Number for this information collection
is 2120-0056. Public reporting for this collection of information is
estimated to be approximately 5 minutes per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

(l) Related Information

    Refer to MCAI European Aviation Safety Agency Airworthiness
Directive 2011-0124, dated June 30, 2011; and the Airbus mandatory
service bulletins identified in paragraphs (l)(1), (l)(2), and (l)(3)
of this AD; for related information.
    (1) Airbus Mandatory Service Bulletin A300-28-0089, Revision 01,
including Inspection Findings--Reporting Sheet, dated April 15, 2011.
    (2) Airbus Mandatory Service Bulletin A300-28-6106, Revision 01,
including Inspection Findings--Reporting Sheet, dated April 15, 2011.
    (3) Airbus Mandatory Service Bulletin A310-28-2173, Revision 01,
including Inspection Findings--Reporting Sheet, dated April 15, 2011.

(m) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the incorporation
by reference (IBR) of the following service information under 5 U.S.C.
552(a) and 1 CFR part 51.
    (2) You must use the following service information to do the
actions required by this AD, unless the AD specifies otherwise.
    (i) Airbus Mandatory Service Bulletin A300-28-0089, Revision 01,
including Inspection Findings--Reporting Sheet, dated April 15, 2011.
    (ii) Airbus Mandatory Service Bulletin A300-28-6106, Revision 01,
including Inspection Findings--Reporting Sheet, dated April 15, 2011.
    (iii) Airbus Mandatory Service Bulletin A310-28-2173, Revision 01,
including Inspection Findings--Reporting Sheet, dated April 15, 2011.
    (3) For Airbus service information identified in this AD, contact
Airbus SAS--EAW (Airworthiness Office), 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61
93 44 51; email<EMAIL_ADDRESS>Internet http://www.airbus.com.
    (4) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
Washington. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.
    (5) You may also review copies of the service information that is
incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at an NARA facility, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on October 5, 2012.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-25675 Filed 10-22-12; 8:45 am]
BILLING CODE 4910-13-P