TECHNICAL MEMORANDUM

TO:	Bill Schrock, U.S. EPA/OAQPS/SPPD  -  Natural Resources Group

FROM:	Eastern Research Group, Inc.

DATE:	March 31, 2019

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SUBJECT:	Costs for the Solvent Extraction for Vegetable Oil Production Source Category Risk and Technology Review  -  Proposed Amendments
INTRODUCTION
      This memorandum describes the methodologies for estimating costs to comply with the amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP): Solvent Extraction for Vegetable Oil Production (40 CFR part 63, subpart GGGG) Risk and Technology Review. In this regulatory action, the EPA proposes to eliminate the startup, shutdown, and malfunction (SSM) exemption included in the 2004 NESHAP, consistent with the United States Court of Appeals decision in Sierra Club v. EPA 551 F.3d 1019 (D.C. Cir. 2008). Eliminating the SSM exemption will remove the requirements and associated burden for SSM plans and periodic SSM reports. The EPA is proposing work practice standards for periods of initial startup for new facilities, and associated recordkeeping and reporting to document compliance with the work practice standards during these periods. We estimate that there will be a one-time burden for reviewing requirements of the amended rule, and one-time burden associated with the recordkeeping and reporting for initial startup periods for new facilities. The adjustments, for the 89 affected facilities, are expected to result in a total industry-wide annual cost of $9,874 and are discussed in section 2.0.
TOTAL COSTS
      To estimate the costs associated with these changes to recordkeeping and reporting requirements, information previously developed as part of the Information Collection Request (ICR) process was consulted.
      The proposed removal of the SSM exemption would result in the emissions standards in the rule applying at all times. The rule amendments include adding work practice standards for initial startup periods and associated recordkeeping and reporting.
      Based on discussions with affected entities, we believe all existing and new facilities are: 1) already operating control technologies during all periods of that solvent is extracted for vegetable oil production and 2) currently performing the proposed work practice standards for initial startup periods as best industry standard practices. Additionally, any new facilities constructed in the next three years would be anticipated to adopt these work practice standards. Therefore, no costs associated with additional operation of controls and work practice standards would be incurred. We estimate that the burden associated with the records and reporting for initial startup periods and associated work practice standards to be less than the burden associated separate recordkeeping and reporting requirements for periods of SSM that are being removed. For example, although we are proposing to require the submittal of an initial startup report, the proposed report would be a one-time submittal at the end of the initial startup period; currently, facilities must submit a periodic SSM report at the end of each calendar month within the initial startup period.
      We also proposed to eliminate the requirement for the development of a SSM plan as required under 40 CFR 63.2852. The 2004 NESHAP required this plan to be developed by the compliance date of May 26, 2003, for existing sources and May 26, 2000 or startup, for new or reconstructed sources, with no requirement for updates to the plan. Because there is no requirement for updates, no cost savings are estimated for the proposed removal of this provision. All affected facilities are anticipated to experience a small cost savings associated with the proposed removal of recordkeeping and reporting requirements specific to SSM events. Currently, facilities are required to report on SSM events, as outlined under 40 CFR 63.2861(c) and (d).
      The proposed amendments add a requirement for electronic reporting of initial notifications, annual compliance certifications, and performance test reports. We assume the costs to prepare electronic reports is equivalent to paper reports, therefore, there is no burden associated with these proposed revisions.
      Four hours have been estimated for all affected facilities to read and understand the requirements of the amended rule. Four hours have been estimated for the submittal of the initial startup report and 96 hours have been estimated for recordkeeping for initial startup periods from one new, modified, or reconstructed facility each year. The total national costs to comply with the rule are $9,874 (see "Solvent Extraction for Vegetable Oil Production RTR Cost Memo Workbook - Proposed Amendments," available in Docket ID No. EPA-HQ-OAR-2004-0006). We estimate that, in the first year following promulgation of these final amendments, each of the 89 affected facilities will spend 4 technical labor hours, 0.4 clerical labor hours, and 0.2 managerial labor hours to review the revised rule. New facilities who choose to operate under an initial startup period will spend 100 technical labor hours, 10 clerical labor hours, and 5 managerial labor hours for the submittal of the initial startup report and recordkeeping for initial startup periods. United States Department of Labor rates of $51.19, $19.05, and $57.63 (labor rates are in May 2017 dollars) were used for the technical, clerical, and managerial labor categories, respectively. For the purposes of this cost analysis, these rates were increased by 110 percent to account for the benefit packages available to those employed by private industry.  Due to the cost savings associated with the proposed removal of recordkeeping and reporting requirements specific to SSM events, the costs associated with the proposed amendments are minimal.
REFERENCES
 United States Department of Labor, Bureau of Labor Statistics, table titled "May 2017 National Industry-Specific Occupational Employment and Wage Estimates NAICS 311200 - Grain and Oilseed Milling," available at: https://www.bls.gov/oes/current/naics4_311200.htm.

Table 1.  "Costs for the Solvent Extraction for Vegetable Oil Production Operations Source Category Risk and Technology Review
- Proposed Amendments,"

                                New Requirement
             (A)
Respondent Hours per Occurrence (Technical hours)
                      (B)
Non-Labor Costs Per Occurrence
              (C)
Number of Occurrences Per Respondent Per Year
             (D)
Technical Hours per Respondent Per Year
 (A X C)
                      (E)
Number of Respondents Per Year
                     (F)
Technical Hours per Year
(D X E)
                    (G)
Clerical Hours per Year
(F X 0.1)
                    (H)
Management Hours per Year
(F X .05)
                     (I)
Total Hours per Year
(F + G + H)
                        (J)
Total Labor Costs Per Year
                (K)
Total Non-Labor Costs Per Year
(B x C x E)
                (L)
Total Number of Responses per Year
(C X E)
                                   Footnotes
Familiarization with Regulatory Requirements
                                       4
                                      $0
                                       1
                                       4
                                      89
                                      356
                                      36
                                      18
                                      409
                                    $41,848
                                      $0
                                       0
                                     a, b
Develop SSM plan
                                     100
                                     ($0)
                                      (1)
                                     (100)
                                      1
                                     (100)
                                     (10)
                                      (5)
                                     (115)
                                   ($11,755)
                                     ($0)
                                       0
                                       c
Periodic startup, shutdown, malfunction report
                                      24
                                     ($0)
                                      (1)
                                     (24)
                                      5
                                     (120)
                                     (12)
                                      (6)
                                     (138)
                                   ($14,106)
                                     ($0)
                                       0
                                       d
Immediate startup, shutdown malfunction report
                                      8
                                     ($0)
                                      (1)
                                      (8)
                                      1
                                      (8)
                                      (1)
                                      (0)
                                      (9)
                                    ($940)
                                     ($0)
                                       0
                                       d
Initial Startup Report
                                      4
                                      $0
                                      1
                                      4
                                      1
                                      4
                                      0
                                      0
                                      5
                                     $470
                                      $0
                                       0
                                       e
Records of initial startup periods
                                      8
                                      $0
                                      12
                                      96
                                      1
                                      96
                                      10
                                      5
                                     110
                                   $11,285
                                      $0
                                       0
                                      f
Records of startup, shutdown, malfunction activities
                                      12
                                     ($0)
                                      (1)
                                     (12)
                                      1
                                     (144)
                                     (14)
                                      (7)
                                     (22)
                                   ($16,927)
                                     ($0)
                                      (0)
                                     c, g

                                     Total
                                    $9,874

Footnotes:

(a) Facilities must read the revised requirements to Subpart GGGG, first year only.

(b) We have assumed that there are 89 sources that are currently subject to the standard.

(c) The proposed amendments remove requirements for a SSM plan. The previous ICR assumed that 1 new source per year would submit an SSM report.
(d) The proposed amendments remove requirements for periodic or immediate startup, shutdown, or malfunction reports; The previous ICR assumed 5% of facilities would submit a periodic report and one source would submit an intermediate SSM report.
(e) The proposed amendments require a one-time submittal of an initial start-up report for new, modified, or reconstructed sources at the end of the initial startup period.
(f) The proposed amendments require records for initial startup periods for new, modified, or reconstructed sources each month. We estimate that the burden associated with the records for initial startup periods to be less than the burden associated separate recordkeeping for periods of SSM that are being removed and therefore, reflect a reduced burden.
(g) The proposed amendments remove requirements for keeping records of SSM events for the SSM plan; therefore, 0 facilities would be subject to these requirements.


[Federal Register Volume 82, Number 6 (Tuesday, January 10, 2017)]
[Notices]
[Pages 2999-3002]
[FR Doc No: 2017-00193]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0008]

Agency Information Collection Activities: Proposed Collection;
Comment Request; Citizen Petitions and Petitions for Stay of Action
Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection in
the guidance on citizen petitions and petitions for stay of action
subject to section 505(q) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act).

DATES: Submit either electronic or written comments on the collection
of information by March 13, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2009-D-0008 for ``Citizen Petitions and Petitions for Stay of
Action Subject to Section 505(q) of the Federal Food, Drug, and
Cosmetic Act.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets

Management. If you do not wish your name and contact information to be
made publicly available, you can provide this information on the cover
sheet and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North 10A12M, 11601
Landsdown St., North Bethesda, MD 20852<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance for Industry on Citizen Petitions and Petitions for Stay of
Action Subject to Section 505(q) of the Federal Food, Drug, and
Cosmetic Act, OMB Control Number 0910-0679--Extension

    FDA's guidance for industry entitled ``Citizen Petitions and
Petitions for Stay of Action Subject to Section 505(q) of the Federal
Food, Drug, and Cosmetic Act'' provides information regarding FDA's
current thinking on interpreting section 914 of Title IX of the Food
and Drug Administration Amendments Act (FDAAA) (Pub. L. 110-85).
Section 914 of FDAAA added new section 505(q) to the FD&C Act (21
U.S.C. 355(q)) and governs certain citizen petitions and petitions for
stay of Agency action that request that FDA take any form of action
related to a pending application submitted under section 505(b)(2) or
505(j) (21 U.S.C. 355(b)(2) or 21 U.S.C. 355(j)) of the FD&C Act. The
guidance describes FDA's interpretation of section 505(q) of the FD&C
Act regarding how the Agency will determine if: (1) The provisions of
section 505(q) addressing the treatment of citizen petitions and
petitions for stay of Agency action (collectively, petitions) apply to
a particular petition and (2) a petition would delay approval of a
pending abbreviated new drug application (ANDA) or a 505(b)(2)
application. The guidance also describes how FDA will interpret the
provisions of section 505(q) requiring that: (1) A petition includes a
certification and (2) supplemental information or comments to a
petition include a verification. Finally, the guidance addresses the
relationship between the review of petitions and pending ANDAs and
505(b)(2) applications for which the Agency has not yet made a decision
on approvability.
    The Food and Drug Administration Safety and Innovation Act (FDASIA)
was signed into law on July 9, 2012 (Pub. L. 112-144). Section 1135 of
FDASIA amended section 505(q) of the FD&C Act in two ways. First, it
shortened FDA's deadline from 180 days to 150 days for responding to
petitions subject to section 505(q) of the FD&C Act. Second, it
expanded the scope of section 505(q) of the FD&C Act to include certain
petitions concerning applications submitted under section 351(k) of the
Public Health Service (PHS) Act (42 U.S.C. 262), the abbreviated
pathway for the approval of biosimilar biological products.
Accordingly, we are now including submissions pertaining to biosimilar
biological product applications in the information collection burden
estimates in this document.
    Section 505(q)(1)(H) of the FD&C Act requires that citizen
petitions and petitions for stay of Agency action that are subject to
section 505(q) include a certification to be considered for review by
FDA. Section 505(q)(1)(I) of the FD&C Act requires that supplemental
information or comments to such citizen petitions and petitions for
stay of Agency action include a verification to be accepted for review
by FDA. The guidance sets forth the criteria the Agency will use in
determining if the provisions of section 505(q) of the FD&C Act apply
to a particular citizen petition or petition for stay of Agency action.
The guidance states that one of the criteria for a citizen petition or
petition for stay of Agency action to be subject to section 505(q) of
the FD&C Act is that a related ANDA or 505(b)(2) application is pending
at the time the citizen petition or petition for stay is submitted.
Because petitioners or commenters may not be aware of the existence of
a pending ANDA or 505(b)(2) application, the guidance recommends that
all petitioners challenging the approvability of a possible ANDA or
505(b)(2) application include the certification required in section
505(q)(1)(H) of the FD&C Act and that petitioners and commenters
submitting supplements or comments, respectively, to a citizen petition
or petition for stay of action challenging the approvability of a
possible ANDA or 505(b)(2) application include the verification
required in section 505(q)(1)(I) of the FD&C Act. The guidance also
recommends that if a petitioner submits a citizen petition or petition
for stay of Agency action that is missing the required certification
but is otherwise within the scope of section 505(q) of the FD&C Act,
and the petitioner would like FDA to review the citizen petition or
petition for stay of Agency action, the petitioner should submit a
letter withdrawing the deficient petition and submit a new petition
that contains the required certification.
    FDA currently has OMB approval for the collection of information
entitled ``General Administrative Procedures: Citizen Petitions;
Petition for Reconsideration or Stay of Action; Advisory Opinions''
(OMB control

number 0910-0191). This collection of information includes, among other
things: (1) The format and procedures by which an interested person may
submit to FDA, in accordance with Sec.  10.20 (21 CFR 10.20), a citizen
petition requesting the Commissioner of Food and Drugs (Commissioner)
to issue, amend, or revoke a regulation or order, or to take or refrain
from taking any other form of administrative action (Sec.  10.30(b) (21
CFR 10.30(b))); (2) the submission of written comments on a filed
citizen petition (Sec.  10.30(d)); (3) the submission of a supplement
or amendment to or a letter to withdraw a filed citizen petition (Sec.
10.30(g)); (4) the format and procedures by which an interested person
may request, in accordance with Sec.  10.20, the Commissioner to stay
the effective date of any administrative action (Sec.  10.35(b) (21 CFR
10.35(b))); and (5) the submission of written comments on a filed
petition for administrative stay of action (Sec.  10.35(c)). This
information collection includes citizen petitions, petitions for
administrative stay of action, comments to petitions, supplements to
citizen petitions, and letters to withdraw a citizen petition, as
described previously in this document, which are subject to section
505(q) of the FD&C Act and described in the guidance.
    We are requesting OMB approval for the following collection of
information submitted to FDA under section 505(q) of the FD&C Act and
the guidance:
     The certification required under section 505(q)(1)(H) of
the FD&C Act for citizen petitions that are subject to section 505(q)
and/or that are challenging the approvability of a possible ANDA,
505(b)(2) application, or biosimilar biological product application.
Although the submission of a certification for citizen petitions is
approved under OMB control number 0910-0191, the certification would be
broadened under section 505(q) of the FD&C Act and the guidance.
     The certification required under section 505(q)(1)(H) of
the FD&C Act for petitions for stay of Agency action that are subject
to section 505(q) and/or that are challenging the approvability of a
possible ANDA, 505(b)(2) application, or biosimilar biological product
application.
     The verification required under section 505(q)(1)(I) of
the FD&C Act for comments to citizen petitions.
     The verification required under section 505(q)(1)(I) of
the FD&C Act for comments to petitions for stay of Agency action.
     The verification required under section 505(q)(1)(I) of
the FD&C Act for supplements to citizen petitions.
     Supplements to petitions for stay of Agency action.
     The verification required under section 505(q)(1)(I) of
the FD&C Act for supplements to petitions for stay of Agency action.
     The letter submitted by a petitioner withdrawing a
deficient petition for stay of Agency action that is missing the
required certification but is otherwise within the scope of section
505(q) of the FD&C Act.
    Section 505(q)(1)(B) and (C) of the FD&C Act and the guidance state
that if FDA determines that a delay in approval of an ANDA, 505(b)(2)
application, or biosimilar biological product application is necessary
based on a petition subject to section 505(q), the applicant may submit
to the petition docket clarifications or additional data to allow FDA
to review the petition promptly. This information collection is not
included in this analysis because it is currently approved under OMB
control number 0910-0001 (21 CFR 314.54, 314.94, and 314.102).
    Based on FDA's knowledge of citizen petitions and petitions for
stay of Agency action subject to section 505(q) of the FD&C Act that
have been submitted to FDA, as well as the Agency's familiarity with
the time needed to prepare a supplement, a certification, and a
verification, FDA estimates the burden of this collection of
information as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Annual
               FD&C Act section                   Number of     frequency per   Total annual               Hours per response               Total hours
                                                 respondents      response        responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Certification for citizen petitions                        38            1.37              52  0.5 (30 minutes).........................              26
 (505(q)(1)(H)).
Certification for petitions for stay of                     3               1               3  0.5 (30 minutes).........................             1.5
 Agency action (505(q)(1)(H)).
Verification for comments to citizen                       12            1.66              20  0.5 (30 minutes).........................              10
 petitions (505(q)(1)(I)).
Verification for comments to petitions for                  1               1               1  0.5 (30 minutes).........................              .5
 stay of Agency action (505(q)(1)(I)).
Verification for supplements to citizen                     7            2.29              16  0.5 (30 minutes).........................               8
 petitions (505(q)(1)(I)).
Supplements to petitions for stay of Agency                 1               1               1  6........................................               6
 action.
Verification for supplements to petitions for               1               1               1  0.5 (30 minutes).........................             0.5
 stay of Agency action (505(q)(1)(I)).
Letter withdrawing a petition for stay of                   3               1               3  0.5 (30 minutes).........................             1.5
 Agency action.
                                              ----------------------------------------------------------------------------------------------------------
    Total hours..............................  ..............  ..............  ..............  .........................................              54
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: January 3, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00193 Filed 1-9-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 58 (Tuesday, March 26, 2013)]
[Notices]
[Pages 18372-18373]
[FR Doc No: 2013-06791]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2007-0042]

TUV Rheinland of North America, Inc.; Expansion of Recognition

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

ACTION: Notice.

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SUMMARY: This notice announces the Occupational Safety and Health
Administration's final decision expanding the recognition of TUV
Rheinland of North America, Inc., as a Nationally Recognized Testing
Laboratory under 29 CFR 1910.7.

DATES: The expansion of recognition becomes effective on March 26,
2013.

FOR FURTHER INFORMATION CONTACT: David W. Johnson, Director, 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 phone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Notice of Final Decision

    The Occupational Safety and Health Administration (``OSHA'' or
``Agency'') hereby gives notice of the expansion of recognition of TUV
Rheinland of North America, Inc. (``TUV''), as a Nationally Recognized
Testing Laboratory (``NRTL''). TUV's expansion covers the addition of a
new site and the use one additional test standard. OSHA's current scope
of recognition for TUV is available at the following informational Web
page: http://www.osha.gov/dts/otpca/nrtl/tuv.html.
    OSHA recognition of an NRTL signifies that the organization meets
the requirements in Section 1910.7 of Title 29, Code of Federal
Regulations (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. As a result of
recognition, employers may use products properly approved by the NRTL
to meet OSHA standards that require testing and certification.
    The Agency processes applications by an NRTL for initial
recognition, or for expansion or renewal of this recognition, following
requirements in Appendix A to 29 CFR 1910.7. This appendix requires
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 and, 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 that details its scope of recognition. These pages are
available from our Web site at http://www.osha.gov/dts/otpca/nrtl/index.html.
    TUV submitted an application, dated February 24, 2006 (see Exhibit
1, TUV Application, as cited in the preliminary notice), to expand its
recognition to include one additional site, located at 2324 Ridgepoint
Drive, Suite E, Austin, Texas 78754, and one additional test standard.
In response to OSHA's requests for clarification, TUV amended its
application to provide additional technical details, and then provided
further details in a later update (Ex. 2: TUV Amended Application dated
8/22/2007 and 2/10/2009, as cited in the preliminary notice). The NRTL
Program staff determined that the additional test standard is an
``appropriate test standard'' within the meaning of 29 CFR 1910.7(c).
In connection with this request, OSHA performed an on-site review of
TUV's NRTL testing facility in August 2010 and recommended expansion of
TUV's recognition to include the one additional facility listed above,
and recommended expansion of TUV's recognition to include the one
additional test standards listed below (Ex. 2).
    OSHA published the preliminary notice announcing TUV's expansion
application in the Federal Register on July 24, 2012 (77 FR 43370). The
Agency requested comments by August 8, 2012, but it received no
comments in response to this notice. OSHA now is proceeding with this
final notice to grant TUV's expansion application.
    You may obtain or review copies of all public documents pertaining
to the TUV application by contacting the Docket Office, Occupational
Safety and Health Administration, U.S. Department of Labor, 200
Constitution Avenue NW., Room N-2625, Washington, DC 20210. Docket No.
OSHA-2007-0042 contains all materials in the record concerning TUV's
recognition.

    The current address of the TUV facility (site) already recognized
by OSHA is: TUV Rheinland of North America, Inc., 12 Commerce Road,
Newton, CT 06470.

Final Decision and Order

    The NRTL Program staff examined TUV's expansion application, the
assessor's recommendation, and other pertinent information. Based on
its review of this evidence, OSHA finds that TUV meets the requirements
of 29 CFR 1910.7 for expansion of its recognition, subject to the
limitation and conditions listed below. Pursuant to the authority in 29
CFR 1910.7, OSHA hereby expands the recognition of TUV, subject to this
limitation and these conditions.

Limitation

    OSHA limits the expansion of TUV's recognition to testing and
certification of products for demonstration of conformance to the
following test standard, which OSHA determined is an appropriate test
standard, within the meaning of 29 CFR 1910.7(c):
    UL 913: Intrinsically Safe Apparatus and Associated Apparatus for
Use in Class I, II, and III, Division 1, Hazardous Locations
    The designation and title of the above-mentioned test standard was
current at the time of the preparation of the preliminary notice.
    OSHA limits recognition of TUV, or any NRTL, for a particular test
standard to equipment or materials (i.e., products) for which OSHA
standards require third-party testing and certification before use of
the products in the workplace. Consequently, if a test standard also
covers any product(s) for which OSHA does not require such testing and
certification, an NRTL's scope of recognition does not include that
product(s).
    The American National Standards Institute (ANSI) may approve the
test standard listed above as American National Standards. However, for
convenience, we use the designation of the standards-developing
organization for the standard, as opposed to the ANSI designation.
Under OSHA's NRTL procedures, any NRTL recognized for an ANSI-approved
test standard may use either the latest proprietary version of the test
standard or the latest ANSI version of that standard. Interested
parties may contact ANSI to determine whether or not a test standard is
currently ANSI approved.

Conditions

    TUV also must abide by the following conditions of the recognition,
in addition to those conditions already required by 29 CFR 1910.7:
    1. TUV must allow OSHA access to TUV's facilities and records for
purposes of ascertaining continuing compliance with the terms of its
recognition, and to conduct investigations that OSHA deems necessary;
    2. If TUV has reason to doubt the efficacy of any test standard it
is using under the NRTL Program, it must promptly inform the test
standard-developing organization of this concern and provide that
organization with appropriate relevant information upon which it bases
its concern;
    3. TUV must not engage in, or permit others to engage in, any
misrepresentation of the scope or conditions of its recognition. As
part of this condition, TUV agrees that it will allow no representation
that it is either a recognized or an accredited NRTL without clearly
indicating the specific equipment or material for which it has
recognition, or that its recognition is limited to specific products;
    4. TUV must inform OSHA as soon as possible, in writing, of any
change of ownership, facilities, or key personnel, and of any major
change in its operations as an NRTL, and provide details of the
change(s);
    5. TUV must meet all the terms of its recognition and comply with
all OSHA policies pertaining to this recognition; and
    6. TUV must continue to meet the requirements for recognition in
all areas for which it has recognition.

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 Section
8(g)(2) of the Occupational Safety and Health Act of 1970 (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 March 20, 2013.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2013-06791 Filed 3-25-13; 8:45 am]
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[Federal Register: April 2, 2008 (Volume 73, Number 64)]
[Proposed Rules]
[Page 17939]
[DOCID:fr02ap08-19]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2008-0100; FRL-8549-5]

Approval and Promulgation of Implementation Plans; State of
Missouri

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing a revision to the Missouri State
Implementation Plan (SIP) to include the State's recently revised ozone
season NOX cap and trade rules for electric generating units
(EGUs) and non-electric generating units (Non-EGUs) submitted on May
18, 2007. Two existing rules were revised by the State to allow for the
transition into the State's recently adopted ozone season trading rule
to meet the requirements of the Clean Air Interstate Rule (CAIR). The
ozone season rules, an interstate cap and trade rule for EGUs and Non-
EGUs in the eastern one-third of the State and a statewide intrastate
trading rule for EGUs, were revised to include language that will
rescind their requirements in the year 2009, the year CAIR compliance
begins. The CAIR ozone season trading rule is more restrictive than the
aforementioned rules, and this action is needed to avoid imposing
duplicative requirements for the affected sources in the year 2009 and
thereafter.

DATES: Comments on this proposed action must be received in writing by
May 2, 2008.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
OAR-2008-0100, by mail to Michael Jay, Environmental Protection Agency,
Air Planning and Development Branch, 901 North 5th Street, Kansas City,
Kansas 66101. Comments may also be submitted electronically or through
hand delivery/courier by following the detailed instructions in the
ADDRESSES section of the direct final rule located in the rules section
of this Federal Register.

FOR FURTHER INFORMATION CONTACT: Michael Jay at<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the final rules section of this Federal
Register, EPA is approving the state's SIP revision as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial revision amendment and anticipates no relevant adverse
comments to this action. A detailed rationale for the approval is set
forth in the direct final rule. If no relevant adverse comments are
received in response to this action, no further activity is
contemplated in relation to this action. If EPA receives relevant
adverse comments, the direct final rule will be withdrawn and all
public comments received will be addressed in a subsequent final rule
based on this proposed action. EPA will not institute a second comment
period on this action. Any parties interested in commenting on this
action should do so at this time. Please note that if EPA receives
adverse comment on part of this rule and if that part can be severed
from the remainder of the rule, EPA may adopt as final those parts of
the rule that are not the subject of an adverse comment. For additional
information, see the direct final rule which is located in the rules
section of this Federal Register.

    Dated: March 24, 2008.
John B. Askew,
Regional Administrator, Region 7.
[FR Doc. E8-6661 Filed 4-1-08; 8:45 am]

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[Federal Register: September 24, 2009 (Volume 74, Number 184)]
[Notices]
[Page 48735-48737]
[DOCID:fr24se09-51]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8959-1; Docket ID No. EPA-HQ-ORD-2009-0203]

Draft Toxicological Review of Trichloroacetic Acid: In Support of
the Summary Information in the Integrated Risk Information System
(IRIS)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period and listening session.

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

SUMMARY: EPA is announcing a public comment period and a public
listening session for the external review draft document titled,
``Toxicological Review of Trichloroacetic Acid: In Support of Summary
Information on the Integrated Risk Information System (IRIS)'' (EPA/
635/R-09/003A). The draft document was prepared by the National Center
for Environmental Assessment (NCEA) within the EPA's Office of Research
and Development (ORD). The public comment period and the external peer-
review workshop, which will be scheduled at a later date and announced
in the Federal Register, are separate processes that provide
opportunities for all interested parties to comment on the document.
EPA intends to forward the public comments that are submitted in
accordance with this notice to the external peer-review panel prior to
the meeting for their consideration. When finalizing the draft
document, EPA intends to consider any public comments that EPA receives
in accordance with this notice.
    EPA is also announcing a listening session to be held on November
4, 2009, during the public comment period for this draft document. This
listening session is a step in EPA's revised IRIS process, announced on
May 21, 2009, to develop human health assessments for inclusion in the
IRIS database. The purpose of the listening session is to allow all
interested parties to present scientific and technical comments on
draft IRIS health assessments to EPA and other interested parties
during the public comment period and before the external peer review
meeting. EPA welcomes the scientific and technical comments that will
be provided to the Agency by the listening session participants. The
comments will be considered by the Agency as it revises the draft
assessment in response to the independent external peer review and the
public comments. All presentations will become part of the official
public record.
    EPA is releasing this draft document solely for the purpose of pre-
dissemination peer review under applicable information quality
guidelines. This document has not been formally disseminated by EPA. It
does not represent and should not be construed to represent any Agency
policy or determination.

DATES: The public comment period begins September 24, 2009, and ends
November 23, 2009. Technical comments should be in writing and must be
received by EPA by November 23, 2009.
    The listening session on the draft IRIS health assessment for
trichloroacetic acid will be held on November 4, 2009, beginning at 9
a.m. and ending at 4 p.m., Eastern Daylight Time. If you want to make a
presentation at the listening session, you should register by October
28, 2009, indicate that you wish to make oral comments at the session,
and indicate the length of your presentation. When you register, please
indicate if you will need audio-visual aid (e.g., lap top and slide
projector). In general, each presentation should be no more than 30
minutes. If, however, there are more requests for presentations than
the allotted time allows, then the time limit for each presentation
will be adjusted. A copy of the agenda for the listening session will
be available at the meeting.

If no speakers have registered by October 28, 2009, the listening
session will be cancelled and EPA will notify those registered of the
cancellation.
    Listening session participants who want EPA to share their comments
with the external peer reviewers should also submit written comments
during the public comment period using the detailed and established
procedures described in the SUPPLEMENTARY INFORMATION section of this
notice. Comments submitted to the docket prior to the end of the public
comment period will be submitted to the external peer reviewers and
considered by EPA in the disposition of public comments. All comments
must be submitted to the docket, but comments received after the public
comment period closes will not be submitted to the external peer
reviewers.

ADDRESSES: The draft ``Toxicological Review of Trichloroacetic Acid: In
Support of Summary Information on the Integrated Risk Information
System (IRIS)'' is available primarily via the Internet on the NCEA
home page under the Recent Additions and Publications menus at http://
www.epa.gov/ncea. A limited number of paper copies are available from
the Information Management Team, NCEA; telephone:<PHONE_NUMBER>;
facsimile:<PHONE_NUMBER>. If you are requesting a paper copy, please
provide your name, mailing address, and the document title.
    Comments may be submitted electronically via http://
www.regulations.gov, by mail, by facsimile, or by hand delivery/
courier. Please follow the detailed instructions as provided in the
SUPPLEMENTARY INFORMATION section of this notice.
    The listening session on the draft trichloroacetic acid assessment
will be held at the EPA offices at Two Potomac Yard (North Building),
7th Floor, Room 7100, 2733 South Crystal Drive, Arlington, Virginia
22202. To attend the listening session, register by October 28, 2009,
via e-mail at<EMAIL_ADDRESS>(subject line: Trichloroacetic Acid
Listening Session), by phone:<PHONE_NUMBER> extension 579, or by faxing
a registration request to<PHONE_NUMBER> (please reference the
``Trichloroacetic Acid Listening Session'' and include your name,
title, affiliation, full address and contact information). Please note
that to gain entrance to this EPA building to attend the meeting,
attendees must have photo identification with them and must register at
the guard's desk in the lobby. The guard will retain your photo
identification and will provide you with a visitor's badge. At the
guard's desk, attendees should give the name Christine Ross and the
telephone number,<PHONE_NUMBER>, to the guard on duty. The guard will
contact Ms. Ross who will meet you in the reception area to escort you
to the meeting room. When you leave the building, please return your
visitor's badge to the guard and you will receive your photo
identification.
    A teleconference line will also be available for registered
attendees/speakers. The teleconference number is<PHONE_NUMBER> and the
access code is<PHONE_NUMBER>, followed by the pound sign ().
The teleconference line will be activated at 8:45 am, and you will be
asked to identify yourself and your affiliation at the beginning of the
call.
    Information on Services for Individuals with Disabilities: EPA
welcomes public attendance at the ``Trichloroacetic Acid Listening
Session'' and will make every effort to accommodate persons with
disabilities. For information on access or services for individuals
with disabilities, please contact Christine Ross at<PHONE_NUMBER> or
<EMAIL_ADDRESS>To request accommodation of a disability,
please contact Ms. Ross, preferably at least 10 days prior to the
meeting, to give EPA as much time as possible to process your request.

FOR FURTHER INFORMATION CONTACT: For information on the public comment
period, contact the Office of Environmental Information Docket;
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or e-mail:
<EMAIL_ADDRESS>    For information on the public listening sessions, please contact
Christine Ross, IRIS Staff, National Center for Environmental
Assessment, (8601P), U.S. EPA, 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460; telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>;
or e-mail<EMAIL_ADDRESS>    If you have questions about the document, contact Diana Wong,
National Center for Environmental Assessment, (8601P), U.S. EPA, 1200
Pennsylvania Avenue, NW., Washington, DC 20460; telephone: 703-347-
8633; facsimile:<PHONE_NUMBER>; or e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Information About IRIS

    IRIS is a database that contains potential adverse human health
effects information that may result from chronic (or lifetime) exposure
to specific chemical substances found in the environment. The database
(available on the Internet at http://www.epa.gov/iris) contains
qualitative and quantitative health effects information for more than
540 chemical substances that may be used to support the first two steps
(hazard identification and dose-response evaluation) of a risk
assessment process. When supported by available data, the database
provides oral reference doses (RfDs) and inhalation reference
concentrations (RfCs) for chronic health effects, and oral slope
factors and inhalation unit risks for carcinogenic effects. Combined
with specific exposure information, government and private entities can
use IRIS data to help characterize public health risks of chemical
substances in a site-specific situation and thereby support risk
management decisions designed to protect public health.

II. How To Submit Technical Comments to the Docket at http://
www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2009-
0203 by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Office of Environmental Information (OEI) Docket
(Mail Code: 2822T), U.S. Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460. The phone number is 202-
566-1752.
     Hand Delivery: The OEI Docket is located in the EPA
Headquarters Docket Center, EPA West Building, Room 3334, 1301
Constitution Ave., NW., Washington, DC. The EPA Docket Center's 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>. Such deliveries are only accepted during
the docket's normal hours of operation, and special arrangements should
be made for deliveries of boxed information. If you provide comments by
mail or hand delivery, please submit one unbound original with pages
numbered consecutively, and three copies of the comments. For
attachments, provide an index, number pages consecutively with the
comments, and submit an unbound original and three copies.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2009-0203. Please ensure that your comments are submitted within the
specified comment period. Comments received after the closing date will
be marked ``late,'' and may only be considered if time permits. It is
EPA's policy to

include all comments it receives in the public docket without change
and to make the comments available online at http://
www.regulations.gov, including any personal information provided,
unless a comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://www.regulations.gov or e-
mail. The http://www.regulations.gov Web site is an ``anonymous
access'' system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through http://
www.regulations.gov, your e-mail address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket visit the
EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the http://
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the OEI Docket in the
EPA Headquarters Docket Center.

    Dated: August 28, 2009.
Rebecca Clark,
Acting Director, National Center for Environmental Assessment.
[FR Doc. E9-23050 Filed 9-23-09; 8:45 am]

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