[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)]
[Notices]
[Pages 30751-30752]
[FR Doc No: 2018-14006]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1896]

Quality Metrics Site Visit Program for Center for Drug Evaluation
and Research and Center for Biologics Evaluation and Research Staff;
Information Available to Industry

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Center for Drug Evaluation and Research (CDER) and the
Center for Biologics Evaluation and Research (CBER) in the Food and
Drug Administration (FDA or Agency) are announcing a 2018 CDER and CBER
staff experiential learning site visit program specific to FDA's
Quality Metrics Program. FDA is proposing this program, in part, in
response to input from a variety of stakeholders over the past couple
of years. The purpose of this 2018 Quality Metrics Site Visit Program
is to provide experiential and firsthand learning opportunities to FDA
staff involved in the development of the FDA Quality Metrics Program
and to provide stakeholders with an opportunity to explain the
advantages and challenges associated with implementing and managing a
robust Quality Metrics Program. This notice invites pharmaceutical
companies interested in participating in this program to submit a
Quality Metrics Site Visit proposal.

DATES: Submit either an electronic or written proposal to participate
in this program by August 28, 2018. See section IV of this notice for
information on what to include in such proposals.

FOR FURTHER INFORMATION CONTACT: Tara Gooen Bizjak, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2109, Silver Spring, MD 20993-0002, 301-
796-3257, email: [email protected] or Stephen Ripley, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7268, Silver Spring, MD 20993-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    More than a decade ago, FDA launched an initiative to encourage the
implementation of a modern, risk-based pharmaceutical quality
assessment system. As part of this initiative, and in recognition of
the increasing complexity of pharmaceutical manufacturing, FDA
developed a 21st century vision for manufacturing and quality with
input from academia and industry. The desired state was described as
follows: ``A maximally efficient, agile, flexible pharmaceutical
manufacturing sector that reliably produces high-quality drug products
without extensive regulatory oversight.'' \1\
---------------------------------------------------------------------------

    \1\ See ``FDA Pharmaceutical Quality Oversight: One Quality
Voice'' at https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM442666.pdf.
---------------------------------------------------------------------------

    There has been significant progress toward this vision in the
intervening years as evidenced by programs and guidances from FDA
around major initiatives such as pharmaceutical development and quality
by design, quality risk management and pharmaceutical quality systems,
process validation, and emerging technology, among others. These
programs and guidances are intended to promote effective use of the
modern pharmaceutical science and engineering principles and knowledge
throughout the life cycle of a product.
    FDA sought input from industry on the establishment of an FDA
Quality Metrics Program as another mechanism to promote continual
improvement in manufacturing quality. FDA has also consulted with other
stakeholders to identify mutually useful and objective quality metrics.
The Agency heard that it should perform further studies of existing
quality metrics programs and conduct additional discussions with
stakeholders. Based on this input, CDER and CBER are initiating this
2018 Quality Metrics Site Visit Program to assist the Agency in
understanding existing programs. This voluntary site visit program is
designed to offer experiential and firsthand learning opportunities to
CDER and CBER staff involved in the development of FDA's Quality
Metrics Program and to provide stakeholders with an opportunity to
explain the advantages and challenges associated with implementing and
managing a robust quality metrics program. One goal of these visits is
to provide CDER and CBER staff exposure to existing quality metrics
programs through onsite visits, tour of operations, and discussions
with establishments to assist staff in further developing FDA's Quality
Metrics Program. Another goal is to provide a forum for industry to
engage in the process and provide additional feedback into improving
the FDA Quality Metrics Program.

II. The Site Visit Program

    During a quality metrics site visit, CDER and CBER staff will
observe how quality metrics data are gathered, collected, and reported
to management. We anticipate 5 to 10 FDA representatives (involved in
the development of FDA's Quality Metrics Program) would participate in
a site visit taking place over a 1- to 2-day period. To facilitate the
learning process, the host establishment may present overviews of the
development and management of their quality metrics program. The
presentation(s) will allow the participating establishments an
opportunity to showcase technologies that support their program.
    CDER and CBER encourage covered establishments, including
establishments that do not perform physical manipulation of drugs,
engaging in the development and manufacturing of both active
pharmaceutical ingredients (small and large molecules) and drug
products to submit quality metrics site visit proposals. A covered
establishment is an owner or operator of an establishment that is
engaged in the manufacture, preparation, propagation, compounding, or
processing of a covered drug product, or an active pharmaceutical
ingredient (API) used in the manufacture of a covered drug product.
CDER and CBER staff participating in this program will benefit by
gaining a better understanding of current industry practices,
processes, and procedures for quality metrics programs.
    CDER and CBER identified a number of establishment types that are
of particular interest to their staff. The following list identifies
some examples of these establishments but is not intended to be
exhaustive, mutually exclusive, or to limit industry response to the
notice:
     Manufacturer of brand, generic, biotechnology, APIs, and
non-application product(s) marketed under the over-the-counter (OTC)
monograph system, and any combination of these products;
     contract development and manufacturing organizations;
     establishments with small and large portfolios; and
     establishments with past or current product availability
issues (e.g., history of a drug supply issue, recall).

    The Quality Metrics Site Visit Program does not supplement or
replace a regulatory inspection (e.g., a preapproval inspection, pre-
license inspection, or a surveillance inspection).

III. Site Selection

    Selection of potential facilities will be based on the priorities
developed for CDER and CBER staff training, the facility's current
compliance status with FDA, and in consultation with the appropriate
FDA district office. All travel expenses associated with this program
will be the responsibility of FDA; therefore, selection will be based
on the availability of funds and resources for the fiscal year. FDA
will not provide financial compensation to the pharmaceutical site as
part of this program.

IV. Proposals for Participation

    Companies interested in offering a site visit or learning more
about this site visit program should respond by submitting a proposal
directly to Tara Gooen Bizjak or Stephen Ripley (see FOR FURTHER
INFORMATION CONTACT). To aid in FDA's site selection and planning, your
proposal should include the following information:
     A contact person;
     site visit location(s);
     Facility Establishment Identifier and Data Universal
Numbering System numbers, as applicable;
     maximum number of FDA staff that can be accommodated
during a site visit (maximum of 10),
     a description of the development, history, and ongoing
management of the quality metrics program;
     a sample agenda outlining the proposed learning objectives
and associated activities for the site visit; and
     preferred dates for a quality metrics site visit.
    Proposals submitted without this minimum information will not be
considered.

    Dated: June 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14006 Filed 6-28-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 35 (Monday, February 23, 2015)]
[Notices]
[Pages 9454-9456]
[FR Doc No: 2015-03577]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2007-0269; FRL-9923-38-OAR]

Proposed Information Collection Request; Comment Request;
Transportation Conformity Determinations for Federally Funded and
Approved Transportation Plans, Programs and Projects

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) is planning to
submit an information collection request (ICR), ``Transportation
Conformity Determinations for Federally Funded and Approved
Transportation Plans, Programs, and Projects'' (EPA ICR No. 2130.05,
OMB Control No. 2060-0561) to the Office of Management and Budget (OMB)
for review and approval in accordance with the Paperwork Reduction Act
(44 U.S.C. 3501 et seq.). Before doing so, EPA is soliciting public
comments on specific aspects of the proposed information collection as
described below. This is a proposed extension of the ICR.

DATES: Comments must be submitted on or before April 24, 2015.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2007-0269 online using www.regulations.gov (our preferred method) or by
mail to: EPA Docket Center, Environmental Protection Agency, Mail Code
28221T, 1200

Pennsylvania Ave. NW., Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Astrid Larsen, Transportation and
Climate Division, State Measures and Transportation Planning Center,
Environmental Protection Agency, 2000 Traverwood Drive, Ann Arbor, MI
48105; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Supporting documents which explain in detail the information that
the EPA will be collecting are available in the public docket for this
ICR. The docket can be viewed online at www.regulations.gov or in
person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution
Ave. NW., Washington, DC. The telephone number for the Docket Center is
202-566-1744. For additional information about EPA's public docket,
visit www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (i) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: Transportation conformity is required under Clean Air Act
section 176(c) (42 U.S.C. 7506(c)) to ensure that federally supported
transportation activities are consistent with (``conform to'') the
purpose of the state air quality implementation plan (SIP).
Transportation activities include transportation plans, transportation
improvement programs (TIPs), and federally funded or approved highway
or transit projects. Conformity to the purpose of the SIP means that
transportation activities will not cause or contribute to new air
quality violations, worsen existing violations, or delay timely
attainment of the relevant national ambient air quality standards
(NAAQS or ``standards'') or interim milestones.
    Transportation conformity applies under EPA's conformity
regulations at 40 CFR part 93, subpart A, to areas that are designated
nonattainment, and those redesignated to attainment after 1990
(``maintenance areas'' with plans developed under Clean Air Act section
175A) for the following transportation-related criteria pollutants:
ozone, particulate matter (PM2.5 and PM10),
carbon monoxide (CO), and nitrogen dioxide (NO2). The EPA
published the original transportation conformity rule on November 24,
1993 (58 FR 62188), and subsequently published several revisions. EPA
develops the conformity regulations in coordination with the Federal
Highway Administration (FHWA) and Federal Transit Administration (FTA).
    Transportation conformity determinations are required before
federal approval or funding is given to certain types of transportation
planning documents as well as non-exempt highway and transit
projects.\1\
---------------------------------------------------------------------------

    \1\ Some projects are exempt from all or certain conformity
requirements; see 40 CFR 93.126, 93.127, and 93.128.
---------------------------------------------------------------------------

    EPA considered the following in renewing the existing ICR:
     Burden estimates for transportation conformity
determinations (including both regional and project-level) in current
nonattainment and maintenance areas for the ozone, PM2.5,
PM10, CO, and NO2 NAAQS;
     Federal burden associated with EPA's adequacy review
process for submitted SIP motor vehicle emissions budgets that are to
be used in conformity determinations;
     Efficiencies in areas making conformity determinations for
multiple NAAQS;
     Differences in conformity resource needs in large and
small metropolitan areas and isolated rural areas;
     Burden estimates for the transition from MOVES2010 to
MOVES2014:
     Reduced burden as a result of areas no longer determining
conformity for the 1997 ozone NAAQS due to revocation \2\ anticipated
in early 2015; and,
---------------------------------------------------------------------------

    \2\ See 78 FR 34178 (June 3, 2013).
---------------------------------------------------------------------------

     Reduced burden as a result of areas completing 20 years of
maintenance for the PM10 and CO NAAQS, at which time
transportation conformity is no longer required.
    This ICR does not include burden associated with the general
development of transportation planning and air quality planning
documents for meeting other federal requirements.
    Form numbers: None.
    Respondents/affected entities: Entities potentially affected by
this action are metropolitan planning organizations, local transit
agencies, state departments of transportation, and state and local air
quality agencies. Federal agencies potentially affected by this action
include FHWA, FTA, and EPA.
    Respondent's obligation to respond: Mandatory pursuant to Clean Air
Act section 176(c) (42 U.S.C. 7506(c)) and 40 CFR part 51 and 93.
    Estimated number of respondents: EPA estimates that 126 MPOs will
be subject to conformity requirements during the period covered by this
ICR and that EPA Regional Offices, the FHWA, and FTA will be involved
in interagency consultation, and review of transportation-related
conformity determinations performed by MPOs during this process. EPA
also estimates that similar consultation will occur for projects in
isolated rural areas.
    Frequency of response: The information collections described in
this ICR must be completed before a transportation plan, TIP, or
project conformity determination is made. The Clean Air Act requires
conformity to be determined for transportation plans and TIPs every
four years. Conformity determinations on projects in metropolitan and
isolated rural areas are required on as as-needed bases.
    Total estimated burden: 63,237 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $3,768,668 (per year), includes zero
annualized capital or operation and maintenance costs.
    Changes in estimates: There is a decrease of 136,200 hours in the
total estimated respondent burden compared with the ICR currently
approved by OMB. This decrease is due to less burden associated with
decreased conformity analysis for PM10, CO and 1997 ozone
NAAQS, the transition from MOVES2010 to MOVES2014, decreased

project-level conformity analyses, and decreased EPA adequacy findings.

    Dated: February 12, 2015.
Karl Simon,
Director, Transportation and Climate Division, Office of Transportation
and Air Quality.
[FR Doc. 2015-03577 Filed 2-20-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 227 (Tuesday, November 30, 2021)]
[Notices]
[Pages 67943-67947]
[FR Doc No: 2021-26036]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC21-40-000]

Commission Information Collection Activities (Ferc-549b, Ferc-
549d, Ferc-556, and FERC-561); Comment Request; Extension

AGENCY: Federal Energy Regulatory Commission.

ACTION: Notice of information collections and request for comments.

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

SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, the Federal Energy Regulatory Commission (Commission or
FERC) is soliciting public comment on the currently approved
information collections: FERC-549B (Gas Pipeline Rates: Annual Capacity
Reports and Index of Customers); FERC-549D (Quarterly Transportation
and Storage Report For Intrastate Natural Gas and Hinshaw Pipelines);
FERC-556 (Certification of Qualifying Facility (QF) Status for a Small
Power Production or Cogeneration Facility); FERC-561 (Annual Report of
Interlocking Directorates). The above four collections are a part of
this combined notice only and are not being combined into one OMB
Control Number.

DATES: Comments on the collections of information are January 31, 2022.

ADDRESSES: You may submit copies of your comments (identified by Docket
No. IC21-40-000) by one of the following methods:
    Electronic filing through http://www.ferc.gov, is preferred.
     Electronic Filing: Documents must be filed in acceptable
native applications and print-to-PDF, but not in scanned or picture
format.
     For those unable to file electronically, comments may be
filed by USPS mail or by hand (including courier) delivery:
    [cir] Mail via U.S. Postal Service Only: Addressed to: Federal
Energy Regulatory Commission, Secretary of the Commission, 888 First
Street NE, Washington, DC 20426.
    [cir] Hand (including courier) Delivery to: Federal Energy
Regulatory Commission, 12225 Wilkins Avenue, Rockville, MD 20852.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov. For user
assistance, contact FERC Online Support by email at
[email protected], or by phone at<PHONE_NUMBER> (toll-free).
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
[email protected], telephone at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

1. FERC-549B

    Title: FERC-549B, Gas Pipeline Rates: Capacity Reports and Index of
Customers.
    OMB Control No.: 1902-0169.
    Type of Request: Three-year extension of the FERC-549B information
collection requirements with no changes to the current reporting
requirements.
    Abstract: As described below, FERC-549B is comprised of information
collection activities at 18 CFR 284.13(b), 284.13(c), 284.13(d)(1), and
284.13(d)(2). The purpose of these

information collection activities is to provide reliable information
about capacity availability and price that shippers need to make
informed decisions in a competitive market, and to enable shippers and
the Commission to monitor marketplace behavior to detect, and remedy
anti-competitive behavior.
    The regulations at 18 CFR 284.13(b) and 284.13(d)(1) require each
interstate pipeline to post information about firm and interruptible
service on its internet website, and in downloadable file formats. The
information required at 18 CFR 284.13(b) includes identification of the
shippers receiving service, and details about contracts for firm
service, capacity release transactions,\1\ and agreements for
interruptible service. The pipeline must maintain access to that
information for a period not less than 90 days from the date of
posting. The regulation at 18 CFR 284.13(d)(1) requires equal and
timely access to information relevant to the availability of all
transportation services whenever capacity is scheduled. In addition,
each interstate pipeline must provide information about the volumes of
no-notice transportation \2\ provided. This information collection
activity enables shippers to release transportation and storage
capacity to other shippers wanting to obtain capacity. The information
results in reliable capacity information availability and price data
that shippers need to make informed decisions in a competitive market
and enables shippers and the Commission to monitor the market for
potential abuses.
---------------------------------------------------------------------------

    \1\ As provided at 18 CFR 284.8, an interstate pipeline that
offers transportation service on a firm basis must include in its
tariff a mechanism for firm shippers to release firm capacity to the
pipeline for resale.
    \2\ No-notice transportation allows for the reservation of
pipeline capacity on demand without incurring any penalties.
---------------------------------------------------------------------------

    The regulation at 18 CFR 284.13(c) requires each interstate
pipeline to file with the Commission an index of all its firm
transportation and storage customers under contract on the first
business day of each calendar quarter. The index of customers also must
be posted on the pipeline's own internet website, in downloadable file
formats, and must be made available until the next quarterly index is
posted. The requirements for the electronic index can be obtained from
the Federal Energy Regulatory Commission, Division of Information
Services, Public Reference and Files Maintenance Branch, Washington, DC
20426.
    The regulation at 18 CFR 284.13(d)(2) requires an annual peak-day
capacity report of all interstate pipelines, including natural gas
storage-only companies. This report is generally a short report showing
the peak day design capacity or the actual peak day capacity achieved,
with a short explanation, if needed. The regulation provides that an
interstate pipeline must make an annual filing by March 1 of each year
showing the estimated peak day capacity of the pipeline's system, and
the estimated storage capacity and maximum daily delivery capability of
storage facilities under reasonably representative operating
assumptions and the respective assignments of that capacity to the
various firm services provided by the pipeline.
    Types of Respondents: Respondents for this data collection are
interstate pipelines and storage facilities subject to FERC regulation
under the Natural Gas Act.
    Estimate of Annual Burden: The Commission estimates the annual
public reporting burden \3\ and cost \4\ for FERC-549B as shown in the
following table:
---------------------------------------------------------------------------

    \3\ For FERC-549B, FERC-549D, FERC-556, and FERC-561, ``burden''
is defined as the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. For further
explanation of what is included in the information collection
burden, refer to 5 CFR 1320.3.
    \4\ For FERC-549B, the Commission staff believes that industry
is similarly situated to the Commission in terms of wages and
benefits. Therefore, cost estimates are based on FERC's 2021 average
annual wage (and benefits) for a full-time employee of $180,703 (or
$87.00/hour).

                                        FERC-549B--(Gas Pipeline Rates: Capacity Reports and Index of Customers)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Annual number                    Average burden &     Total annual burden
                                                 Number of     of responses    Total number       cost ($) per       & total annual cost     Cost per
                                                respondents   per respondent   of responses         response                 ($)          respondent ($)
                                                         (1)             (2)     (1) * (2) =                   (4)       (3) * (4) = (5)       (5) / (1)
                                                                                (3)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Capacity Reports under 284.13(b) &                       168               6           1,008     145 hrs.; $12,615         146,160 hrs.;         $75,690
 284.13(d)(1)...............................                                                                                $12,715,920
Peak Day Annual Capacity Report under                    168               1             168         10 hrs.; $870  1,680 hrs.; $146,160             870
 284.13(d)(2)...............................
Index of Customers under 284.13(c) \5\......             168               4             672          3 hrs.; $261  2,016 hrs.; $175,392           1,044
                                             -----------------------------------------------------------------------------------------------------------
        Total...............................  ..............  ..............           1,848  ....................         149,856 hrs.;          77,604
                                                                                $13,037,47240
--------------------------------------------------------------------------------------------------------------------------------------------------------

2. FERC-549D
---------------------------------------------------------------------------

    \5\ The burden per response is based on burden expended on
similar forms and other similar FERC reporting requirements (e.g.
capacity reports).
---------------------------------------------------------------------------

    Title: FERC-549D, Quarterly Transportation and Storage Report for
Intrastate Natural Gas and Hinshaw Pipelines.
    OMB Control No.: 1902-0253.
    Type of Request: Three-year extension of the FERC-549D information
collection requirements with no changes to the current reporting
requirements.
    Abstract: The reporting requirements under FERC-549D are required
to carry out the Commission's policies in accordance with the general
authority in Section 1(c) of the Natural Gas Act (NGA) \6\ and Section
311 of the Natural Gas Policy Act of 1978 (NGPA).\7\ This collection
promotes transparency by making available intrastate and Hinshaw
pipeline transactional information. The Commission collects the data on
a standardized form with all requirements outlined in 18 CFR 284.126.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 717(c).
    \7\ 15 U.S.C. 3371.
---------------------------------------------------------------------------

    The FERC-549D collects the following information:

     Full legal name and identification number of the shipper
receiving service, including whether the pipeline and the shipper are
affiliated;
     Type of service performed;
     The rate charged under each contract;
     The primary receipt and delivery points for each contract;
     The quantity of natural gas the shipper is entitled to
transport, store, or deliver for each transaction;
     The duration of the contract, specifying the beginning and
(for firm contracts only) ending month and year of current agreement;
     Total volumes transported, stored, injected or withdrawn
for the shipper; and
     Annual revenues received for each shipper, excluding
revenues from storage services.
    Filers submit the Form-549D on a quarterly basis.
    Type of Respondents: Intrastate natural gas pipelines under NGPA
Section 311 authority and Hinshaw pipelines.
    Estimate of Annual Burden: The Commission estimates the annual
public reporting burden and cost \8\ for the information collection as
follows:
---------------------------------------------------------------------------

    \8\ For FERC-549D, the hourly wage figure is $92.92/hour
(rounded). This cost represents the average hourly cost (for wages
plus benefits) of four career fields: 23-0000 Legal ($142.25/hour),
13-2011 Accountants ($57.41/hour), 13-1111 Management Analyst
($68.39/hour), and 11-3021 Computer and Information Sys. ($103.61/
hour). These June 2021 figures were compiled using Bureau of Labor
Statistics data that were specific to each occupational category:
http://bls.gov/oes/current/naics2_22.htm.

                         FERC-549D--Quarterly Transportation and Storage Report for Intrastate Natural Gas and Hinshaw Pipelines
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Average annual
                                              Average annual     number of    Average annual   Average burden hrs.   Total annual burden     Cost per
                                                 number of     responses per   total number      & cost ($) per     hours & total annual  respondent ($)
                                                respondents     respondent     of responses         response         cost ($) (rounded)
                                                         (1)             (2)     (1) * (2) =                   (4)       (3) * (4) = (5)       (5) / (1)
                                                                                (3)
--------------------------------------------------------------------------------------------------------------------------------------------------------
PDF filings.................................             120               4             480   12.5 hrs. $1,161.50   6,000 hrs. $557,520          $4,646
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............             480  ....................  6,000 hrs.; $557,520  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------

3. FERC-556

    Title: FERC-556, Certification of Qualifying Facility (QF) Status
for a Small Power Production or Cogeneration Facility.
    OMB Control No.: 1902-0075.
    Type of Request: Three-year extension of the FERC-556 information
collection requirements with no changes to the current reporting
requirements.
    Abstract: Form No. 556 is required to implement sections 201 and
210 of the Public Utility Regulatory Policies Act of 1978 \9\ (PURPA).
FERC is authorized, under those sections, to encourage cogeneration and
small power production and to prescribe such rules as necessary to
carry out the statutory directives.
---------------------------------------------------------------------------

    \9\ 16 U.S.C. 796 and 824i.
---------------------------------------------------------------------------

    A primary statutory objective is efficient use of energy resources
and facilities by electric utilities. One means of achieving this goal
is to encourage production of electric power by cogeneration facilities
which make use of reject heat associated with commercial or industrial
processes, and by small power production facilities which use other
wastes and renewable resources. PURPA encourages the development of
small power production facilities and cogeneration facilities that meet
certain technical and corporate criteria through establishment of
various regulatory benefits. Facilities that meet these criteria are
called Qualifying Facilities (QFs).
    FERC's regulations in 18 CFR part 292, as relevant here, specify:
(a) The certification procedures which must be followed by owners or
operators of small power production and cogeneration facilities; (b)
the criteria which must be met; (c) the information which must be
submitted to FERC in order to obtain qualifying status; and (d) the
PURPA benefits which are available to QFs to encourage small power
production and cogeneration.
    18 CFR part 292 also exempts QFs from certain corporate,
accounting, reporting, and rate regulation requirements of the Federal
Power Act,\10\ certain state laws, and the Public Utility Holding
Company Act of 2005.\11\
---------------------------------------------------------------------------

    \10\ 16 U.S.C. 791a, et seq.
    \11\ 42 U.S.C. 16451 through 165463.
---------------------------------------------------------------------------

    Type of Respondents: Facilities that are self-certifying their
status as a cogenerator or small power producer or that are submitting
an application for FERC certification of their status as a cogenerator
or small power producer.
    Estimate of Annual Burden: The Commission estimates the burden and
cost for this information collection as follows:
---------------------------------------------------------------------------

    \12\ The Commission staff believes that industry is similarly
situated in terms of wages and benefits. Therefore, cost estimates
are based on FERC's 2021 average annual wage (and benefits) for a
full-time employee of $180,703 (or $87.00/hour).
    \13\ MW = megawatt.
    \14\ The regulation at 18 CFR 292.203(d) exempts small power
production facilities and cogeneration facilities from self-
certification if they have a net power production capacity of 1 MW
or less. However, we are disclosing burdens for these filings
because some facilities seek status as qualifying facilities
regardless of their capacity.

                       FERC-556--Certification of Qualifying Facility Status for a Small Power Production or Cogeneration Facility
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Average burden     Total annual
                                                   Number of      Number of      Total number of    hours and cost     burden hours         Cost per
         Facility type             Filing type    respondents   responses per       responses        per response    and total annual    respondent ($)
                                                                 respondent                              \12\          cost (rounded)      (rounded)
                                                          (1)             (2)    (1) * (2 ) = (3)  (4).............  (3) * (4) = (5).          (5) / (1)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cogeneration Facility >1 MW     Self-                      68            2.14              145.52  3.54 hrs;         515.14 hrs;                 $659.07
 \13\.                           certification.                                                     $307.98.          $44,817.18.
Cogeneration Facility >1 MW...  Application for         28.89            2.14               61.81  50 hrs; $4,350..  3,090.52 hrs;                930.26
                                 FERC                                                                                $268,875.24.
                                 certification.
Small Power Production          Self-                   2,698            2.14            5,773.72  3.54 hrs;         20,438.97 hrs;               659.07
 Facility >1 MW.                 certification.                                                     $307.98.          $1,778,190.39.
Small Power Production          Application for             0            2.14                   0  50 hrs; $4,350..  0 hrs; $0.......                  0
 Facility >1 MW.                 FERC
                                 certification.
Cogeneration and Small Power    Self-                     697            2.14            1,491.58  3.54 hrs;         2,237.37 hrs;                279.27
 Production Facility <=1 MW      certification.                                                     $307.98.          $194,651.19.
 (Self-Certification) \14\.
                                                 -------------------------------------------------------------------------------------------------------
    Total.....................  ................        3,469  ..............            7,423.66  ................  26,282 hrs;       .................
                                                                                $2,286,534.
--------------------------------------------------------------------------------------------------------------------------------------------------------

4. FERC-561

    Title: FERC-561, Interlocking Directorates.
    OMB Control No.: 1902-0099.
    Abstract: The FERC Form 561 responds to the Federal Power Act (FPA)
requirements for annual reporting of similar types of positions which
public utility officers and directors hold with financial institutions,
insurance companies, utility equipment and fuel providers, and with any
of an electric utility's 20 largest purchasers of electric energy
(i.e., the 20 entities with high expenditures of electricity). The FPA
specifically defines most of the information elements in the Form 561
including the information that must be filed, the required filers, the
directive to make the information available to the public, and the
filing deadline.
    The Commission uses the information required by 18 CFR 131.31 and
collected by the Form 561 to implement the FPA requirement that those
who are authorized to hold interlocked directorates annually disclose
all the interlocked positions held within the prior year. The Form 561
data identifies persons holding interlocking positions between public
utilities and other entities, allows the Commission to review these
interlocking positions, and allows identification of possible conflicts
of interest.
    Type of Respondents: Each officer or director of a public utility
also holding the position of officer, director, partner, appointee, or
representative of any other entity listed in section 305(c)(2) of the
FPA (including but not limited to organizations primarily engaged in
the business of providing financial services or credit, insurance
companies, security underwriters, electrical equipment suppliers, fuel
provider, and any entity which is controlled by one or more of these
entities).
    Estimate of Annual Burden: The Commission estimates the total
annual burden and cost \15\ for this information collection as follows:
---------------------------------------------------------------------------

    \15\ Commission staff estimates that the industry's skill set
and cost (for wages and benefits) for FERC-561 are approximately the
same as the Commission's average cost. The FERC 2021 average salary
plus benefits for one FERC full-time equivalent (FTE) is $180,703/
year (or $87.00/hour).

                                                FERC Form 561, Annual Report of Interlocking Directorates
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                      Annual number
       Number of respondents           of responses    Total number      Average burden and cost per      Total annual burden hours and      Cost per
                                      per respondent   of responses               response                      total annual cost         respondent ($)
(1)                                              (2)     (1) * (2) =  (4).............................  (3) * (4) = (5).................       (5) / (1)
                                                                 (3)
--------------------------------------------------------------------------------------------------------------------------------------------------------
2,700..............................                1           2,700  0.25 hrs.; $21.75...............  675 hrs.; $58,725...............          $21.75
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Comments are invited on FERC-549B, FERC-549D, FERC-556, and/or
FERC-561, regarding: (1) Whether each collection of information is
necessary for the proper performance of the functions of the
Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of each collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of each information collection; and (4) ways to
minimize the burden of each collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.

    Dated: November 23, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-26036 Filed 11-29-21; 8:45 am]
BILLING CODE 6717-01-P


                  Federal Food, Drug, and Cosmetic Act (FFDCA)               Considerations for Pseudomonas fluorescens strain D7

                                Docket ID Number: EPA-HQ-OPP-2013-0569                                                Date: August 22, 2014

Section 408(c)(2)(A)(i) of FFDCA allows the EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if the EPA determines that the exemption is "safe." Section 408(c)(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. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, the EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require the EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance exemption, 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...." Additionally, FFDCA section 408(b)(2)(D) requires that the EPA consider "available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity."

The EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, the EPA determines the toxicity of pesticides. Second, the EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

I. Summary of Petitioned-for Tolerance Exemption

In the Federal Register of September 12, 2013 (78 FR 56185) (FRL-9399-7), the EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 2F8103) by Northwest Agricultural Products  821 South Chestnut Avenue, Pasco, WA 99301. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of Pseudomonas fluorescens strain D7 in or on growing crops and rangeland. The notice referenced a summary of the petition prepared by the petitioner, Northwest Agricultural Products, which is available in Docket ID Number EPA-HQ-OPP-2013-0569 via http://www.regulations.gov. While rangeland is not a food commodity and "growing crops" is not a recognized commodity term used by the Agency in tolerance actions, the Agency is interpreting the petitioner's request as seeking a tolerance exemption for "all food commodities."  The term "growing crops" is quite broad and does not limit that types of food commodities that it covers; therefore, the Agency believes a reasonable interpretation of that term allows for establishment of an exemption from the requirement of a tolerance for "all food commodities."       One comment concerning the general impact of pesticides on bees was filed in the Pseudomonas fluorescens D7 docket.  The comment is not relevant to this tolerance action as the comment does not concern the safety of this microbe or have any bearing on the Agency's assessment under section 408 of the FFDCA.

II. Toxicological Profile

Consistent with section 408(b)(2)(D) of FFDCA, the EPA reviewed the available scientific data and other relevant information on Pseudomonas fluorescens strain D7, and considered its validity, completeness, and reliability, as well as the relationship of this information to human risk. The EPA also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

A.  Overview of Pseudomonas fluorescens strain D7

The D7 EP is for use as an herbicide in the United States in field applications for suppression of downy brome (cheatgrass), medusahead, Japanese brome, and jointed goatgrass on fields of turf and grasses grown for seed, alfalfa; wheat, barley, triticale, oat, and rangeland. It is for application as a seed treatment and by ground or aerial spray to listed field sites.  The D7 EP is to be applied directly to the soil surface, in autumn or spring when temperatures are cooler, and the plants are in preemergence. P. fluorescens occurs naturally in soil and water (Ref. 1), and strain D7 is a root-associated bacterium which was isolated originally from winter wheat roots from the West Coast region of the United States.

B.  Microbial Pesticide Toxicology Data Requirements

All applicable mammalian toxicology data requirements supporting the request for an exemption from the requirement of a tolerance for residues of Pseudomonas fluorescens strain D7 in or on all food commodities have been fulfilled with data submitted by the petitioner or scientific rationale. The toxicity and pathogenicity tests (dermal, toxicity) and irritation tests (acute eye and primary dermal irritation) that address potential routes of exposure to the active ingredient are all classified in Toxicity Category IV (see below or Ref. 2, 3 and 4)  and revealed little to no toxicity attributed to Pseudomonas fluorescens strain D7.  Finally, the petitioner reported that no hypersensitivity incidents occurred during the research, development, and testing of this active ingredient.

The overall conclusions from all toxicological information submitted by the petitioner are briefly described below, and more in-depth synopses of study results can be found in the associated draft Biopesticides Registration Action Document (BRAD) for Pseudomonas fluorescens strain D7, provided as a reference in Section VII of this document (Ref. 2).

   1. Acute Injection Toxicity/Pathogenicity  -  Rat (MRID 49349701)  A study was repeated to re-evaluate the acute intravenous toxicity infectivity and pathogenicity, of a microbial pest control agent (MPCA), Pseudomonas fluorescens D7, at a single exposure of 10[6] and 10[7] doses. The MPCA test substance, inactivated MPCA, or sterile filtrate was injected into the tail vein of one of four groups of rats. A control group (untreated) was conducted concurrently. The animals were observed frequently on day of dosing for mortality and signs of pharmacological and/or toxicological effects and once  daily thereafter for 21 days. Tissue and blood samples taken at interim sacrifices from the group receiving the active test substance were cultured to provide quantitative measurements of the test microbe's clearance pattern. There was no mortality in any group during the study. During observations for clinical signs, all animals appeared normal for the duration of the study. The gross necropsy conducted at termination of the study revealed no observable abnormalities. The test organism had cleared completely from Groups IV and V (MPCA) blood, kidneys, mesenteric lymph nodes, lungs, and brain, liver, spleen and cecum contents by Day 7. After two consecutive interim sacrifices showed no growth of test organism in the organs plated, no further tissue samples were taken. The test substance Pseudomonas fluorescens D7 was determined to be non-toxic  and not pathogenic or infective to rats when injected intravenously at a dose of 3.4 x 107 CFU/rat or 3.7 x 106 CFU/rat.  EPA determined this study to be acceptable

This study (MRID 49349701) addresses EPA recommendations to repeat an acute injection toxicity study using a lower dose of the microorganisms that includes additional controls such as filtered culture medium, and autoclaved medium to account for the observed injection results.  This study supersedes the previously submitted acute injection toxicity/pathogenicity in rat study (MRID 48966402) that tested Pseudomonas fluorescens strain D7 and showed adverse effects to rats following a single intravenous injection administration of 1.3 x 10[8] CFU/rat including mortality, abnormal clinical signs; transient weight loss, abnormal gross necropsy findings, and altered organ weights.

   2. Acute Oral Toxicity/Pathogenicity  -  Rat (MRID 48966403) Sprague-Dawley rats, 8 week old, (12/sex) were given a single oral dose of MPCA Pseudomonas fluorescens strain D7 of 1.3 X 109 CFU/animal. The animals were observed three times on day 0 after dosing and daily through day 21 with interim scheduled sacrifices on Days 3, 7, and 14.  Five males and five females were treated with autoclaved Pseudomonas fluorescens strain D7 as inactive MPCA controls, two untreated animals per sex were used as "shelf controls," and two animals per sex were designated as untreated controls.

No observable abnormalities were found during observations for clinical signs or at necropsy, and there were no toxicologically relevant differences between the body weights of the treated animals and those of controls.  Relative to their respective controls, MPCA-treated females had increased relative liver weights (+16.0%; p<0.05), and MPCA-treated males had increased relative spleen weights (+16.7%; p<0.05), and these differences correlated with increased mean absolute weights of these same organs (+11.7% and +27.1% for MPCA-treated female absolute liver and MPCA-treated male absolute spleen weights, respectively).  No CFUs (or in one instance a single individual count of <100 CFU/g) were recovered from the brain, lungs, liver, kidneys, or lymph nodes of any active-treated animal.  Pseudomonas fluorescens strain D7 was found in feces, urine, and cecum contents of MCPA-treated animals and appeared to be completely cleared by day 14 following oral administration to rats.  Based on the results of this study, Pseudomonas fluorescens strain D7 does not appear to be toxic, infective, and/or pathogenic in rats, when dosed at 1.3 X 109 CFU/animal. The EPA rated this study as acceptable.

   3. Acute Pulmonary Toxicity/Pathogenicity  -  Rat (MRID 48966404) Groups of 12 week old Sprague Dawley rats (3/sex/Group) were exposed by the intratracheal route to Pseudomonas fluorescens strain D7 in sterile PBS at a constant dose volume of 0.1 mL/ animal and a dose of 4.6 x 108 cfu/animal.  Eight males and eight females were treated with autoclaved Pseudomonas fluorescens strain D7 as autoclaved controls; five males and five females were not treated and used as untreated control; and four males and four females were not treated and used as shelf controls.  The animals were then observed for up to 21 days, with interim sacrifices on day 0 (all groups) and days 3, 7, and 14 (active-MCPA group).

There were no test substance related clinical signs, gross necropsy findings, or differences in organ weights.  Two males in the active test material treated group sacrificed on day 3 lost weight and one female in autoclaved test material treated group sacrificed on day 21 did not gain weight during the first week but gained weight by day 14.  All other animals gained weight prior to scheduled sacrifice.  The test organisms were not seen or were present at < 100 cfu/g in lungs from the animals sacrificed after dosing on day 0.  The test organisms were not seen or were present at < 100 cfu/g in blood, brain, lungs, spleen, liver, kidneys, mesenteric lymph nodes, and cecum content removed from animals sacrificed on days 3 and 7. Based on these results, Pseudomonas fluorescens strain D7 does not appear to be toxic, infective, and/or pathogenic in rat, when dosed at 4.6 x 108 cfu /animal. The EPA rated this study as acceptable.

   4. Acute Dermal Toxicity/ Pathogenicity  -  Rabbit (MRID 48966405) Five male and five female New Zealand White rabbits, 16-18 weeks old, were dermally exposed to a 2000 mg/kg bw dose of Pseudomonas fluorescens strain D7 moistened with 2.0 mL of deionized water/g test substance for 24 hours to an area of approximately 10% of body surface area. Following exposure, the animals were observed for a period of 14 days. All animals survived and had no abnormal systemic clinical signs during the study. Very slight to well-defined Erythema was noted on all dose sites on day 1 and resolved by day 4.  With the exception of one female that lost weight during the second week, all animals gained weight throughout the study.  No observable abnormalities were found at necropsy.  The dermal LD50 for males was greater than 2000 mg/kg bw; for females was greater than 2000 mg/kg bw; and for both sexes combined was greater than 2000 mg/kg bw.  Based on the results of this study, Pseudomonas fluorescens Strain D7 is of low toxicity.  EPA classified the acute dermal toxicity of Pseudomonas fluorescens strain D7 as Toxicity Category IV and rated this study as acceptable.

   5. Primary Eye Irritation  -  Rabbit   (MRID 49100801) 100 mg of undiluted Pseudomonas fluorescens strain D7 (Batch No.<PHONE_NUMBER>01; purity 95%; pH not reported) was instilled as supplied into the conjunctival sac of the right eye of three male and three female New Zealand White rabbits.  Untreated left eyes served as controls.  Animals were observed at 1, 24, 48, and 72 hours after test material instillation.  Irritation was scored by the method of Draize and classified by the system of Kay and Calandra.

No corneal opacity, iritis, or conjunctival irritation was noted on any rabbit throughout the study. Pseudomonas fluorescens strain D7 was not irritating to the eye and EPA classified the acute eye irritation as Toxicity Category IV for primary eye irritation. The EPA rated this study as acceptable.

   6. Primary Dermal Irritation  -  Rabbit   (MRID 49100802) Three male and three female New Zealand White rabbits were dermally exposed to 500 mg of Pseudomonas fluorescens strain D7 moistened with 1.0 mL of DI water for 4 hours on an approximately 2.5 x 2.5 cm area of the body surface.  The animals were observed at 1, 24, 48, and 72 hours after patch removal.  Irritation was scored by the method of Draize. No dermal irritation was noted on any animal during the study.   The primary irritation index was 0.0. Pseudomonas fluorescens strain D7 was not irritating and EPA classified the dermal irritation toxicity as Toxicity Category IV. The EPA rated this study as acceptable.

6. Hypersensitivity incidents The petitioner reported that no hypersensitivity incidents, including immediate-type or delayed-type reactions of humans and domestic animals, occurred during research, development, or testing of Pseudomonas fluorescens strain D7 (Ref. 2).

III.  Aggregate Exposure

In examining aggregate exposure, section 408 of FFDCA directs EPA to consider  available information concerning exposures from the pesticide residue in food and all other nonoccupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

Food Exposure and Risk Characterization: The EPA found that increased dietary exposure to Pseudomonas fluorescens strain D7 a naturally occurring bacterium is anticipated to be negligible For the proposed use of Pseudomonas fluorescens strain D7 as an herbicide, the applications are made before crop plants emerge, or as seed treatment and consequently oral exposure to residues from such use is expected to be minimal.  Pseudomonas fluorescens strain D7 and other closely related Pseudomonas fluorescens bacteria already exist in the soil environment.  The EPA concluded that the risk posed to adults, infants, and children is likely to be minimal because of the low acute oral toxicity/pathogenicity potential of Pseudomonas fluorescens strain D7.

Drinking Water Exposure and Risk Characterization: Exposure to residues of Pseudomonas fluorescens strain D7 in consumed drinking water is not likely to increase because there are no use sites for the pesticide with direct applications to water.  There is a possibility of spray drift from aerial applications or runoff of prepared fields and rangelands into surface waters. Ground water is not expected to have significant exposure to Pseudomonas fluorescens strain D7since, like other microorganisms, this microbial pesticide would likely be filtered out by the particulate nature of many soil types. If it were to be transferred to surface or ground waters that are intended for eventual human consumption (e.g., through spray drift or runoff) and directed to wastewater treatment systems or drinking water facilities, it likely would not survive the conditions water is subjected to in such systems or facilities, including chlorination, pH adjustments, filtration, and/or occasionally high temperatures (Ref 5, 6 and 7). In the remote likelihood that Pseudomonas fluorescens strain D7 is present in drinking water (e.g., water not subject to treatment systems or facilities), its target pest specificity and available data indicate no toxicity and/or pathogenicity is likely to occur with any drinking water exposure to Pseudomonas fluorescens strain D7 that results from pesticide applications made in accordance with good agricultural practices (see additional discussion in Section II of this document).

Non-occupational, Residential Risk Characterization: Given that Pseudomonas fluorescens strain D7 use sites do not include residential settings and because the bacterium is naturally-occurring  EPA determined that non-occupational exposure to the bacterium is unlikely. Repeated exposures to the Pseudomonas fluorescens strain D7 microorganism from pesticidal applications do not exceed EPA's level of concern, particularly in light of available data that demonstrate Pseudomonas fluorescens strain D7  is not toxic (acute dermal toxicity and acute pulmonary toxicity/ pathogenicity), is non-irritating (primary dermal irritation), and is not pathogenic when used as labeled in accordance with good agricultural practices (acute pulmonary toxicity/pathogenicity, and acute injection toxicity/pathogenicity).

IV. 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 exemption, the EPA consider "available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity."  The EPA has not found Pseudomonas fluorescens strain D7 to share a common mechanism of toxicity with other substances. Pseudomonas fluorescens strain D7 does not appear to be toxic to humans via dietary, dermal and pulmonary exposure. For the purposes of the tolerance action, therefore, the EPA has assumed that Pseudomonas fluorescens strain D7 does not have a common mechanism of toxicity with other substances. Thus, section 408(b)(2)(D)(v) of the FFDCA does not apply. For information regarding the EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the EPA's website at http://www.epa.gov/pesticides/cumulative. .

V.  Determination of Safety for the United States Population, Infants and Children

In considering the establishment of a tolerance or tolerance exemption for a pesticide chemical residue, FFDCA section 408 (b) (2) (C) provides that the EPA shall assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues, and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity. In addition, FFDCA section 408(b) (2) (C) provides that the EPA shall apply an additional tenfold (10X) margin of exposure (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 the EPA determines that a different margin of exposure (safety) will be safe for infants and children. This additional margin of exposure (safety) is commonly referred to as the Food Quality Protection Act Safety Factor. In applying this provision, the EPA either retains the default value of 10X or uses a different additional safety factor when reliable data available to the EPA support the choice of a different factor.

Based on the acute toxicity and pathogenicity data/information discussed in section II above (and Ref. 2), the EPA concludes that there are no threshold effects of concern to infants, children, or adults when Pseudomonas fluorescens strain D7 is used as labeled in accordance with good agricultural practices. As a result, the EPA concludes that no additional margin of exposure (safety) is necessary to protect infants and children and that not adding any additional margin of exposure (safety) will be safe for infants and children.

Moreover, based on the same data/information and EPA analysis as presented directly above, the Agency is able to conclude that there is a reasonable certainty that no harm will result to the United States population, including infants and children, from aggregate exposure to the residues of Pseudomonas fluorescens strain D7 when it is used -- as labeled and in accordance with good agricultural practices -- as an herbicide. Such exposure includes all anticipated dietary exposures and all other exposures for which there is reliable information. The EPA has arrived at this conclusion because, considered collectively, the data and information available on Pseudomonas fluorescens strain D7 do not demonstrate toxic or pathogenic potential to mammals, including infants and children.

.   VI. Conclusions

The EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of Pseudomonas fluorescens strain D7. Therefore, an exemption from the requirement of a tolerance is established for residues of Pseudomonas fluorescens strain D7 in or on all food commodities when applied or used in accordance with label directions and good agricultural practices.

VII. References

   1. Palleroni, N. J. 2005.  Pseudomonas. Pp. 323  -  379. In: Bergey's Manual of Systematic Bacteriology, Vol. 2. D. J. Brenner, N. R. Krieg, and J. T. Staley (Eds.) Springer, New York, New York

   2. Biopesticides Registration Action Document (BRAD) for Pseudomonas fluorescens strain D7

   3. U.S. EPA. 2014a.  Memorandum from I. Barsoum (OPP/BPPD) to S. Cerrelli, Re:  Review of Acute Toxicity/Pathogenicity study for section 3 registration of the TGAI, Fluorescens Technical, and the EP, D7, containing the active ingredient Pseudomonas fluorescens strain D7.  Dated April 15, 2014.

   4. U.S. EPA. 2014b.  Memorandum from I. Barsoum (OPP/BPPD) to S. Cerrelli, Re:  Review of Acute Toxicity/Pathogenicity study for section 3 registration of the TGAI, Fluorescens Technical, and the EP, D7, containing the active ingredient Pseudomonas fluorescens strain D7.  Dated April 22, 2014.

   5. Centers for Disease Control and Prevention. 2009. Drinking Water - Water Treatment. Available from http://www.cdc.gov/healthywater/drinking/public/water_treatment.html.

   6. U.S. EPA. 2004. Primer for Municipal Wastewater Treatment Systems. EPA 832-R-04-001.  Available from http://www.epa.gov/npdes/pubs/primer.pdf

   7. DeFelice K, Wollenhaupt N, Buchholz D. 1993. Aquifers and Soil Filter Effect. Available from http://extension.missouri.edu/p/WQ24.