[Federal Register Volume 85, Number 66 (Monday, April 6, 2020)]
[Rules and Regulations]
[Pages 19089-19093]
[FR Doc No: 2020-06585]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2019-0148; FRL-10007-04-Region 4]

Air Quality Plans; Florida; Infrastructure Requirements for the
2015 8-Hour Ozone National Ambient Air Quality Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving
portions of the State Implementation Plan (SIP) submission provided by
the State of Florida, through the Florida Department of Environmental
Protection (FDEP), through a letter dated September 18, 2018. This
submission pertains to the infrastructure requirements of the Clean Air
Act (CAA or Act) for the 2015 8-hour ozone national ambient air quality
standards (NAAQS). Whenever EPA promulgates a new or revised NAAQS, the
CAA requires that each state adopt and submit a SIP submission to
establish that the state's implementation plan meets infrastructure
requirements for the implementation, maintenance, and enforcement of
each such NAAQS. FDEP made the required SIP submission to assure that
the Florida SIP contains provisions that ensure the 2015 8-hour ozone
NAAQS is implemented, enforced, and maintained in Florida. EPA has in
this action determined that Florida's infrastructure SIP submission
satisfies certain required infrastructure elements for the 2015 8-hour
ozone NAAQS.

DATES: This rule is effective May 6, 2020.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2019-0148. All documents in the docket
are listed on the www.regulations.gov website. Although listed in the
index, some information may not be publicly available, i.e.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Air Regulatory Management Section, Air Planning and
Implementation Branch, Air and Radiation Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia
30303-8960. EPA requests that if at all possible, you contact the
person listed in the FOR FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional Office's official hours of
business are Monday through Friday 8:30 a.m. to 4:30 p.m., excluding
Federal holidays.

FOR FURTHER INFORMATION CONTACT: Sean Lakeman, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air and
Radiation Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW, Atlanta, 30303-8960. Mr. Lakeman can be reached via
electronic mail at<EMAIL_ADDRESS>or via telephone at (404) 562-
9043.

SUPPLEMENTARY INFORMATION:

I. Background

    On October 1, 2015 (80 FR 65292, October 26, 2015), EPA promulgated
revised primary and secondary NAAQS for ozone revising the 8-hour ozone
NAAQS from 0.075 parts per million to a new more protective level of
0.070 ppm. Pursuant to section 110(a)(1) of the CAA, states are
required to make a

SIP submission meeting the applicable requirements of section 110(a)(2)
within three years after promulgation of a new or revised NAAQS or
within such shorter period as EPA may prescribe. Section 110(a)(2)
requires states to address basic SIP elements such as requirements for
monitoring, basic program requirements and legal authority that are
designed to assure attainment and maintenance of the NAAQS. This
particular type of SIP submission is commonly referred to as an
``infrastructure SIP.'' EPA required states to submit these
infrastructure SIP submissions for the 2015 8-hour ozone NAAQS to EPA
no later than October 1, 2018.\1\
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    \1\ In these infrastructure SIP submissions, states generally
certify evidence of compliance with sections 110(a)(1) and (2) of
the CAA through a combination of state regulations and statutes,
some of which have been incorporated into the federally-approved
SIP. In addition, certain federally-approved, non-SIP regulations
may also be appropriate for demonstrating compliance with sections
110(a)(1) and (2).
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    This action is approving portions of Florida's September 18, 2018
\2\ ozone infrastructure SIP submission for the applicable requirements
of the 2015 8-hour ozone NAAQS. EPA is not acting on the interstate
transport requirements of section 110(a)(2)(D)(i)(I) related to
attainment and maintenance of the NAAQS. EPA will consider these
requirements for Florida for the 2015 8-hour ozone NAAQS separately.
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    \2\ The September 18, 2018, SIP submission provided by FDEP was
received by EPA on September 26, 2018.
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    In a notice of proposed rulemaking (NPRM) published on December 17,
2019 (84 FR 68863), EPA proposed to approve portions of Florida's SIP
submission dated September 18, 2018, intended to address the applicable
infrastructure SIP requirements for the 2015 8-hour ozone NAAQS. The
NPRM provides additional detail regarding the background and rationale
for EPA's action.

II. Response to Comments

    EPA received one comment seeking clarification and one set of
adverse comments which are summarized and responded to below. The full
set of comments are in the docket for this final rule.
    Comment 1: A Commenter notes that EPA may have misidentified a
website in the NPRM and seeks a clarification.
    Response 1: EPA agrees with the Commenter. In the December 17,
2019, NPRM, EPA noted that Florida is required to submit emissions data
to EPA for purposes of the National Emissions Inventory (NEI) pursuant
to subpart A to 40 CFR part 51--``Air Emissions Reporting Rule.'' The
NEI is EPA's central repository for air emissions data and Florida made
its latest update to the NEI on December 17, 2014. EPA compiles the
emissions data, supplementing it where necessary, and releases it to
the general public through the website. In the December 17, 2019 (84 FR
68868), NPRM, EPA indicated the website was http://www.epa.gov/ttn/chief/eiinformation.html. However, as identified by the Commenter, the
correct website is https://www.epa.gov/air-emissions-inventories.
    Comment 2: A Commenter asserts that EPA cannot approve Florida's
infrastructure SIP submission as demonstrating compliance with the
CAA's interstate transport requirements in 110(a)(2)(D)(i)(II) with
respect to interference with prevention of significant deterioration
(PSD) and visibility programs for any other state because Florida's
September 18, 2018, SIP submission did not address the interstate
transport requirements of section 110(a)(2)(D)(i)(II). By way of
background, CAA section 110(a)(2)(D)(i) contains two subsections:
(D)(i)(I) and (D)(i)(II) that a state must address in infrastructure
SIP submissions. Each of these subsections has two subparts resulting
in four distinct components, commonly referred to by EPA as ``prongs.''
The first two prongs, which are codified in section 110(a)(2)(D)(i)(I),
are provisions that prohibit any source or other type of emissions
activity in one state from contributing significantly to nonattainment
of the NAAQS in another state (``prong 1'') and interfering with
maintenance of the NAAQS in another state (``prong 2''). The third and
fourth prongs, which are codified in section 110(a)(2)(D)(i)(II), are
provisions that prohibit emissions activity in one state from
interfering with measures required for PSD of air quality in another
state (``prong 3''), or to protect visibility in another state (``prong
4'').
    The Commenter asserts that Florida did not address section
110(a)(2)(D)(i)(II) for PSD and visibility in the September 18, 2018,
SIP submission because the State does not ``even mention the words
`Prong 3' or `Prong 4.' '' As further evidence that the SIP submission
does not address these requirements, the Commenter points to the fact
that the State sent an email to EPA on November 13, 2019, to confirm
that the State did intend the submission to meet those substantive
requirements. The Commenter contends that ``EPA cannot act on email
messages from states and pretend they are official SIP submissions from
the states'' and that no state public notice was advertised on Prongs 3
or 4. As to the substance of the November 13, 2019 email, the Commenter
claims that the State wrongly attempts to suggest that prong 3 and 4
are met by pointing to the prong 1 discussion in the September 18,
2018, SIP submission, and points to prior court cases pertaining to
interstate transport that indicate EPA is required to give independent
analysis to each prong of the interstate transport provisions of
section 110(a)(2)(D). The Commenter also suggests that EPA has
additional correspondence with the State related to the State's
November 13, 2019, clarification email that should be included in the
docket for the rulemaking.
    Response 2: EPA disagrees with the Commenter's assertion that
Florida did not address section 110(a)(2)(D)(i)(II) in its September
18, 2018, infrastructure SIP submission. In its September 13, 2013
``Guidance on Infrastructure State Implementation Plan (SIP) Elements
under Clean Air Act Sections 110(a)(1) and 110(a)(2)'' (2013 Guidance),
EPA explains that a state may meet 110(a)(2)(D)(i)(II) (prong 3) by
establishing in its infrastructure SIP submission that new major
sources and major modifications are already subject to a comprehensive
EPA-approved PSD permitting program.\3\ EPA also notes in the 2013
Guidance that sources in nonattainment areas are not subject to PSD
permitting and that states may rely on an existing EPA-approved
nonattainment new source review (NNSR) program with respect to sources
located in nonattainment areas.\4\ For the visibility component of
110(a)(2)(D)(i)(II) (prong 4), EPA provides in the 2013 Guidance that
states may meet this requirement by establishing in its infrastructure
SIP submission that it already has an EPA-approved regional haze SIP
that fully meets the requirements of 40 CFR 51.308.\5\
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    \3\ 2013 Guidance, p. 31.
    \4\ 2013 Guidance, pp. 31-32.
    \5\ 2013 Guidance, p. 33.
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    EPA's analysis of Florida's September 18, 2018, infrastructure SIP
submission focused on whether the State provided relevant information
to establish that Florida's existing SIP adequately prohibits emissions
activities within the State that will ``interfere with measures
required to be included in the applicable implementation plan for any
other State . . . to prevent significant deterioration of air quality
or to protect visibility,'' consistent with the requirements of CAA
section 110(a)(2)(D)(i)(II). Based on Florida's transmittal letter for
the September 18,

2018, SIP submission, and the actual content of the September 18, 2018,
SIP submission, EPA believes Florida satisfied these requirements. In
its September 18, 2018, transmittal letter, Florida states that the
submission ``addresses each [emphasis added] of the CAA infrastructure
elements for the 2015 Revised National Ambient Air Quality Standards
(NAAQS) for Ozone (O3).'' The State did not identify any
sections it did not intend to address and further explained the
provisions that it did intend to address in the introduction section of
the September 18, 2018, SIP submission: ``[FDEP] Hereby confirms that
the requirements of sections 110(a)(1) and the infrastructure elements
required by sections 110(a)(2)(A) through (M) of the CAA are adequately
addressed in Florida's existing approved SIP with respect to the
implementation of the 2015 revised NAAQS.'' Moreover, on page 5 of the
SIP submission, the State properly describes the requirements of CAA
section 110(a)(2)(D)(i) to include the provisions of subparagraph (II)
requiring states to prohibit emissions activity from the State from
``interfering with any other state's required plan under Part C of the
CAA for prevention of significant deterioration and protection of
visibility.'' Thus, though broadly worded in some cases, there are
several indications in the September 18, 2018, SIP submission that the
State intended the submission to address all of the applicable
requirements of CAA section 110(a)(2), including the prong 3 and prong
4 requirements.
    While EPA acknowledges that the September 18, 2018, SIP submission
did not use the terms ``prong 3'' or ``prong 4'' to describe the
requirements the State was addressing in the SIP submission, these are
not statutory terms but rather EPA-developed shorthand for the two
requirements in CAA section 110(a)(2)(D)(i)(II). Thus, EPA disagrees
that it is a deficiency for the State not to include these specific
terms in its SIP submission nor is the absence of these terms an
indication that the State failed to perform the necessary analysis of
these statutory requirements. Consistent with the 2013 Guidance
regarding how a state may address the prong 3 requirements,\6\ the SIP
submission confirms on both pages 5 and 7 of the section
110(a)(2)(D)(i) analysis that the State has both PSD and NNSR
permitting programs already in its existing SIP. In particular, the
State notes on those pages that the approved SIP requires ``any new
major source or major modification to undergo PSD or NNSR permitting
and thereby demonstrate that it will not cause or contribute to a
violation of any NAAQS or PSD increment in Florida or any other state''
(emphasis added). This language from the SIP submission is consistent
with the language of CAA section 110(a)(2)(D)(i)(II) requiring that a
state's plan demonstrate that emissions from the state will not
interfere with another state's PSD permitting plan, as the PSD
requirements are specifically concerned with ensuring that the
construction of new or modified major sources will not lead to new
violations of the NAAQS or increments. See CAA section 165(a)(3).
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    \6\ 2013 Guidance, pp. 30-32.
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    Similarly, the SIP submission is consistent with the 2013 Guidance
regarding how a state may address the prong 4 requirements because the
SIP revision explains at page 5 that Florida has a fully-approved
regional haze SIP.\7\ The State further explained on the same page
that: ``This plan ensures that Florida will not interfere with
visibility protection in other states.'' That statement is clearly in
reference to the language describing the prong 4 requirements in
110(a)(2)(D)(i)(II).
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    \7\ 2013 Guidance, pp. 32-35.
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    EPA agrees with the Commenter that it would have been clearer if
the State had provided sections in its September 18, 2018, SIP
submission explicitly labeled ``prong 3'' and ``prong 4,'' or otherwise
demarcated its analysis of these specific requirements in the same
manner as the sections entitled ``prong 1'' and ``prong 2,'' but EPA
does not agree that the exclusion of the terms ``prong 3'' and ``prongs
4'' in the submission means that the State did not in fact make a
submission that addresses the interstate transport requirements with
respect to the PSD and visibility prongs for the 2015 8-hour ozone
NAAQS.
    EPA also agrees with the Commenter that each of the four prongs of
section 110(a)(2)(D)(i) are separate requirements that states and EPA
must address, and that there are prior court decisions that confirm
this basic point. EPA disagrees, however, that the State has failed to
address prong 3 and 4 in the September 18, 2018, SIP submission, or
that EPA has failed to evaluate the submission with respect to these
prongs. EPA and the State have provided independent analysis for prongs
3 and 4, as discussed above. Florida's SIP submission satisfies the
prong 3 requirements based on its SIP-approved PSD and NNSR permit
programs, which require analysis and control of emissions that may
impact another state's compliance with its own PSD requirements and
satisfies the prong 4 requirements based on the State's fully-approved
regional haze SIP. Not providing individual headings for each
requirement of 110(a)(2)(D)(i) or prong within the submission does not
support Commenter's assertion that the State or EPA failed to address
each of these prongs independently.
    EPA also disagrees with the Commenter's assertion that, by
proposing to approve the September 18, 2018, SIP revision, EPA is
inappropriately relying on the November 13, 2019, email from Florida
instead of requiring a supplemental SIP submission. As previously
acknowledged, EPA agrees that the SIP submission could have been
clearer with respect to the infrastructure SIP requirements that the
State was addressing, but the content of that SIP submission in fact
did substantively address the requirements of section
110(a)(2)(D)(i)(II). In an abundance of caution, however, EPA requested
confirmation of that fact from the State to include in the docket
during EPA's public comment period for the proposed approval of
Florida's September 18, 2018, SIP submission. The email merely
confirmed Florida's intent regarding its September 18, 2018, SIP
submission and did not provide new information regarding the Florida
SIP or include new analysis to demonstrate that the Florida SIP meets
the requirements of 110(a)(2)(D)(i)(II).
    Additionally, the Commenter does not provide support for its
contention that ``no state public notice was advertised on Prongs 3 and
4.'' EPA has re-examined the notice that the State provided concerning
the content of the SIP submission. The State's September 18, 2018,
revision that underwent public notice clearly stated that it addressed
``each [emphasis added] of the CAA infrastructure elements for the 2015
Revised National Ambient Air Quality Standards (NAAQS) for Ozone
(O3),'' and did not exclude any infrastructure SIP
requirements. EPA does not agree that use of the specific terms prong 3
or prong 4 was necessary for public notice purposes, given the broad
statement concerning the subject matter of the proposed SIP submission
and given the actual substantive content of that proposed SIP
submission.
    Finally, the Commenter asserted that EPA has ``emails, records, and
correspondence (including meeting minutes/notes)'' related to Florida's
September 18, 2018, SIP submission, and in particular, related to the
interstate transport requirements for PSD and visibility, that it did
not include in the rulemaking docket. In response to the comment, EPA
has

reviewed the docket and confirmed that it contains the appropriate
documents necessary to reflect the basis for the agency's proposed and
final action on the SIP submission. The relevant EPA staff have checked
their individual files and have confirmed that they do not have any
additional documents that should be included in the docket for this
rulemaking. EPA notes that agency staff have regular communications
with the states concerning SIP submissions and air quality planning
generally. Such communications between a state and EPA are part of the
normal SIP process.

III. Final Action

    With the exception of interstate transport provisions pertaining to
contribution to nonattainment or interference with maintenance in other
states of section 110(a)(2)(D)(i)(I) (prongs 1 and 2), EPA is approving
Florida's infrastructure submission provided on September 18, 2018, for
the 2015 8-hour ozone NAAQS. EPA is approving Florida's infrastructure
SIP submission for certain elements for the 2015 8-hour ozone NAAQS
because the submission is consistent with section 110 of the CAA for
those elements.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
would not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Public Law 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it
impose substantial direct costs on tribal governments or preempt tribal
law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by June 5, 2020. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

 List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Reporting and recordkeeping requirements, Volatile organic compounds.

    Dated: March 13, 2020.
Mary S. Walker,
Regional Administrator, Region 4.

    Title 40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart K--Florida

0
2. Section 52.520(e) is amended by adding the entry ``110(a)(1) and (2)
Infrastructure Requirements for the 2015 8-Hour Ozone NAAQS'' at the
end of the table to read as follows:

Sec.  52.520  Identification of plan.

* * * * *
    (e) * * *

                                 EPA-Approved Florida Non-Regulatory Provisions
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                                         State         EPA
              Provision                effective     approval   Federal Register notice        Explanation
                                          date         date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
110(a)(1) and (2) Infrastructure        9/18/2018     4/6/2020  [Insert citation of      With the exception of
 Requirements for the 2015 8-Hour                                publication].            Prongs 1 and 2 of
 Ozone NAAQS.                                                                             section
                                                                                110(a)(2)(D)(i)(I).
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[FR Doc. 2020-06585 Filed 4-3-20; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: December 15, 2006 (Volume 71, Number 241)]
[Notices]
[Page 75535-75536]
[DOCID:fr15de06-69]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM06-22-000]

Mandatory Reliability Standards for Critical Infrastructure
Protection; Notice of Comment Period

December 11, 2006.
    On August 28, 2006, the North American Electric Reliability
Council, on behalf of its wholly-owned subsidiary, the North American
Electric Reliability Corporation (collectively NERC), filed eight
proposed Reliability Standards concerning Critical Infrastructure
Protection (CIP) for Commission approval, pursuant to its role as the
Electric Reliability Organization (ERO) under section 215 of the
Federal Power Act (FPA). On September 18, 2006, the Commission issued a
notice announcing that it established a new rulemaking proceeding,
Docket No. RM06-22-000, to address the proposed CIP Reliability
Standards.\1\
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    \1\ In addition, the Notice explained that nineteen other new
and revised proposed Reliability Standards submitted by NERC in the
same August 28, 2006 filing would be addressed in Docket No. RM06-
16-000.
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    Concurrent with today's notice, the Commission is releasing a staff
preliminary assessment of the eight proposed CIP Reliability Standards.
This assessment is a preliminary technical analysis by staff and does
not offer legal conclusions or recommend any particular action to be
taken by the Commission. The Commission will issue a Notice of Proposed
Rulemaking (NOPR) with its proposal on each Reliability Standard after
receiving comments on the staff preliminary assessment. Interested
persons will also have an opportunity to file comments on the NOPR.
    NERC should respond to this preliminary assessment by February 12,
2007. We also invite other interested persons to file comments on the
staff preliminary assessment by the comment date. Comments should
respond to issues discussed in the preliminary assessment in the order
in which they appear, and take care to identify which issue,
Reliability Standard, or specific provision of a Reliability Standard
is being addressed. Commenters may also address related issues not
raised in the staff preliminary assessment to assist the Commission to
make more informed decisions regarding the proposed CIP Reliability
Standards.
    The Commission encourages electronic submission of comments using
the ``eFiling'' link at http://www.ferc.gov. Persons unable to file

electronically should submit an original and 14 copies of their
comments to the Secretary of the Commission, Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426.
    The staff preliminary assessment is accessible online at http://www.ferc.gov
, using the ``eLibrary'' link and is available for review

in the Commission's Public Reference Room in Washington, DC. There is
an ``eSubscription'' link on the Web site that enables subscribers to
receive e-mail notification when a document is added to a subscribed
docket(s). For assistance with any FERC Online

service, please e-mail<EMAIL_ADDRESS>or call (866) 208-
3676 (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. eastern time on February 12, 2007.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-21412 Filed 12-14-06; 8:45 am]

BILLING CODE 6717-01-P


 USEPA Draft Interim Recommendations to Address Groundwater Contaminated with               Perfluorooctanoic Acid and Perfluorooctane Sulfonate

       PURPOSE

This guidance provides interim recommendations for addressing groundwater contaminated with perfluorooctanoic acid (PFOA) and/or perfluorooctane sulfonate (PFOS) at sites being evaluated and addressed under federal cleanup programs, including the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund) and corrective action under the Resource Conservation and Recovery Act (RCRA). In addressing PFOA and PFOS contamination, EPA's statutory and regulatory authorities provide the Agency with flexibility in how it ensures protectiveness of human health and the environment. Depending on site-specific circumstances, a CERCLA response action may be appropriate (including an interim action, interim measure, or an early action to abate releases and limit exposure, as discussed in the National Oil and Hazardous Substances Pollution Contingency Plan (NCP) (e.g., 40 CFR 300.430 (e) and (f), 40 C.F.R. 300.415(b)(2)(ii) and associated provisions), and existing EPA guidance. The information and recommendations in this guidance may also be useful for state, tribal, or other regulatory authorities (e.g., federal facility cleanup programs, approved state RCRA corrective action programs).

Broadly, this guidance provides interim recommendations for screening levels, and preliminary remediation goals (PRGs) to inform final cleanup levels for PFOA and/or PFOS contamination of groundwater that is a current or potential source of drinking water. The recommendations in this document are consistent with existing EPA guidance and standard practices, in addition to applicable statutes and regulations. For groundwater contaminated with PFOA or PFOS, Regions should consult on a case-by-case basis with the Office of Land and Emergency Management (OLEM) prior to using the Fund and the Office of Enforcement and Compliance Assurance (OECA) prior to taking enforcement action.

INTERIM RECOMMENDATIONS

As explained more fully below, this guidance recommends the following:

 Screening sites using a screening level set to a Hazard Quotient of 0.1 for PFOA or PFOS individually, which is currently 40 ng/L or parts per trillion (ppt);  Using the PFOA and PFOS HAs of 70 ppt as the PRG for groundwater that is a current or potential source of   drinking water, where no state or tribal MCL or other applicable or relevant and appropriate requirements (ARARs) exist.

     In situations where groundwater is being used for drinking water, EPA expects that responsible parties will address levels of PFOA and/or PFOS over 70 ppt. This guidance is based on EPA's current scientific understanding of the toxicity of PFOA and PFOS and is consistent with other relevant EPA guidance. For these reasons, EPA considers the recommendations to be interim and may revise this guidance's recommendations as new information becomes available.

BACKGROUND

PFOA and PFOS are synthetic fluorinated organic chemicals belonging to a large group commonly referred to as per- and poly-fluoroalkyl substances (PFAS). Manufacturers have produced PFAS for a variety of industries and products, including surface treatments for soil/stain/water resistance; surface treatments of textiles; paper; metals; and for specialized applications, such as fire suppression for hydrocarbon fires. PFOA and PFOS are resistant to metabolic and environmental degradation; and therefore, are highly persistent in the environment and can bioaccumulate in humans.

In 2009, EPA developed provisional HAs for PFOA and PFOS in response to concerns about drinking water contamination. Subsequently, EPA conducted a thorough evaluation of literature on human health effects associated with PFOA and PFOS and issued draft health effects support documents in 2014 for public comment and independent panel peer review. In 2016, EPA finalized a lifetime drinking water HA of 70 ppt, for the individual or combined concentrations of PFOA and PFOS (USEPA, 2016a,b).

EPA established the PFOA and PFOS HAs based upon the Agency's assessment of the best-available peer-reviewed science. These advisories are non-enforceable, non-regulatory values, which provide technical information to federal, state, and tribal agencies, and other public health officials on health effects, analytical methodologies, and treatment technologies associated with drinking water contamination (USEPA, 2016a,b). The HAs may change as new information becomes available (USEPA, 2016a,b).

ADDRESSING GROUNDWATER CONTAMINATED WITH PFOA AND PFOS Role of Screening and Screening Levels                                                                                Cleanup programs, including Superfund and RCRA corrective action, typically use a risk-based approach to determine when contaminants present at a site may warrant further investigation or cleanup.  EPA has developed several guidance documents and tools to support these efforts, including regional screening levels (RSLs).   Consistent with EPA Soil Screening Guidance: User's Guide (USEPA, 1996) and other guidance, "screening" generally refers to the process of identifying and defining areas, contaminants, and conditions at a particular site that may warrant further attention. Under CERCLA, RCRA, and other regulatory programs, at sites where contaminant concentrations are below risk-based screening levels, no further action or study is generally warranted. It is important to note that screening levels are not the same as cleanup levels. Screening a site for further evaluation does not necessarily indicate that additional response action is appropriate beyond assessing the actual or potential risk posed by releases or threatened releases at the site. A decision to take remedial cleanup action typically is based on the results of a baseline risk assessment performed following the recommendations provided in existing EPA guidance, which typically considers the risks posed by all contaminants at a site (e.g., USEPA, 1991).   For non-cancer effects, the Superfund program typically uses a hazard quotient (HQ) of 1.0 for screening when there is a single contaminant and 0.1 when more than one contaminant is present. A HQ of 0.1 is recommended for screening PFOA and/or PFOS for several reasons, including: (1) the specific and limited purpose of a screening level; (2) the additive toxicity of PFOA and PFOS; and (3) the possibility that other PFAS compounds, which may be toxic but for which toxicity values may not currently be available, may be co-located with PFOA and/or PFOS. Using a HQ of 0.1 is recommended to ensure that PFOA- and PFOS-contaminated sites are further evaluated rather than prematurely screened out. The EPA's reference doses (RfD), which were used to derive the HAs for PFOA and PFOS (USEPA 2016 c,d), when put into Superfund risk equations (USEPA, 1989) for a HQ of 0.1, yield a recommended screening value of 40 ppt for each chemical.

For carcinogenic effects, the Superfund program generally uses a one-in-a-million excess cancer risk as the screening level. Under the EPA 2005 cancer guidelines, the evidence for the carcinogenicity of PFOA and PFOS is considered suggestive (USEPA 2016 c,d).  In the case of PFOS, the existing evidence does not support a strong correlation between the tumor incidence and dose to justify a quantitative assessment (USEPA 2016 c,d).  For PFOA, the data are sufficient for a quantitative analysis to provide a sense of the magnitude of potential carcinogenic risk for comparison with the noncancer risk. This analysis showed that the equivalent drinking water concentration derived from the RfD for noncancer effects of PFOA is lower than the concentration associated with a one-in-a-million risk, indicating that a screening value derived from the developmental endpoint for the RfD will be protective for the cancer endpoint as well (USEPA 2016 c,d).

Preliminary Remediation Goals                                                                                PRGs are used to set initial targets for cleanup, which can be adjusted on a site-specific basis as more information becomes available during the remedial investigation/feasibility study (RI/FS) process. Groundwater cleanup levels under CERCLA, and similar programs, are often established based on chemical-specific promulgated standards (e.g., federal or state MCLs, or other standards found to be ARARs) (USEPA, 2009). In situations where ARARs are not available or are not sufficiently protective, EPA generally establishes site-specific, risk-based cleanup levels for: (1) carcinogens at a level that represents an excess upper bound lifetime cancer risk to an individual of between one-in-ten-thousand to one-in-a-million excess cancer risk (denoted as 10[-4] to 10[-6]); and (2) non-carcinogens such that the cumulative risks from exposure would not reasonably be expected to result in adverse effects to human populations (including sensitive sub-populations) that may be exposed during a lifetime or part of a lifetime, incorporating an adequate margin of safety (USEPA, 2011). These risk-based concentrations are typically derived from recommended equations that utilize available exposure and toxicity information, as discussed in EPA CERCLA risk assessment guidance (e.g., Risk Assessment Guidance for Superfund; Role of Baseline Risk Assessment guidance USEPA, 1991a,b).

As the remedial investigation proceeds and information from the baseline risk assessment becomes available, PRGs are often modified. Modification can be based on several factors, including consideration of site/aquifer-related exposure through multiple exposure pathways or exposure to multiple chemicals -- either of which may raise the cumulative risk of site-related chemicals out of the acceptable exposures and risk range. It is also possible that other site-specific considerations could lead to a different cleanup level.

In circumstances where a groundwater cleanup program is addressing PFOA and/or PFOS contaminated groundwater, and where no state or tribal laws or regulations qualify as ARAR, EPA recommends using the HA of 70 ppt for the combined concentration of PFOA and PFOS as the PRG, or equivalent preliminary cleanup goal for other programs. Where state or tribal laws or regulations qualify as ARARs for PFOA or PFOS, those standards should be used to develop PRGs.

At Superfund sites, final remediation goals and remedy selection decisions should be made consistent with CERCLA, the NCP (e.g., 40 CFR 300.430 (d), (e), and (f) and associated provisions), and existing EPA guidance.

REFERENCES

USEPA, 1991a. Role of the Baseline Risk Assessment in Superfund Remedy Selection Decisions. OSWER Directive 9355.0-30. https://nepis.epa.gov/Exe/ZyPURL.cgi?Dockey=910165CR.TXT

USEPA, 1991b.  Risk Assessment Guidance for Superfund: Volume 1  -  Human Health Evaluation Manual (Part B, Development of Risk-Based Preliminary Remediation Goals).  EPA/540/R-92/003. https://www.epa.gov/risk/risk-assessment-guidance-superfund-rags-part-b

USEPA, 1991c. Superfund Removal Procedures: Guidance on the Consideration of ARARs During Removal Actions. EPA/540/P-091/011. https://nepis.epa.gov/Exe/ZyPURL.cgi?Dockey=10001YMN.TXT

USEPA, 1994. National Oil and Hazardous Substances Pollution Contingency Plan; Final Rule. 59 FR 47384. https://www.govinfo.gov/content/pkg/CFR-2015-title40-vol28/xml/CFR-2015-title40-vol28-part300.xml

USEPA, 1996. Soil Screening Guidance: User's Guide. https://www.epa.gov/superfund/superfund-soil-screening-guidance

USEPA, 1997. The Rules of Thumb for Superfund Remedial Selection. https://www.epa.gov/superfund/key-principles-superfund-remedy-selection

USEPA, 2009. Summary of Key Existing CERCLA Policies and Groundwater Restoration. OSWER Directive 9283.1-33.  https://semspub.epa.gov/work/HQ/175202.pdf    USEPA, 2011. Groundwater Road Map: Recommendation Process for Restoring Contaminated Groundwater at Superfund Sites. OSWER Directive 9283.1-34.  https://semspub.epa.gov/work/HQ/174480.pdf USEPA, 2016a. Drinking Water Health Advisory for Perfluorooctanoic Acid (PFOA). EPA 822-R-16-005. https://www.epa.gov/sites/production/files/2016-05/documents/pfoa_health_advisory_final_508.pdf USEPA, 2016b. Drinking Water Health Advisory for Perfluorooctanoic Sulfonate (PFOS). EPA 822-R-16-004. https://www.epa.gov/sites/production/files/2016-05/documents/pfos_health_advisory_final_508.pdf USEPA, 2016c.  Health Effects Support Document for Perfluorooctanoic Acid (PFOA).  EPA 822-R-16-003 https://www.epa.gov/sites/production/files/2016-05/documents/pfoa_hesd_final_508.pdf -------------------------------------------------------------------------------- USEPA, 2016d. Health Effects Support Document for Perfluorooctanoic Sulfonate (PFOS). EPA 822-R-16-002. https://www.epa.gov/sites/production/files/2016-05/documents/pfos_hesd_final_508.pdf

 HYPERLINK "https://www.epa.gov/risk/regional-removal-management-levels-rmls-frequently-asked-questions%20"


* Chronic effects to estuarine/marine fish and estuarine/marine invertebrates:  No chronic data were submitted for estuarine/marine fish or estuarine/marine invertebrates. An acute-to-chronic ratio could not be calculated due to lack of available data on definitive acute toxicity endpoints for any aquatic taxa. The expected chronic exposure of fluopyram to aquatic organisms is low (60-day EEC = 0.286 ug a.i./L). The level-of-concern for chronic risk to aquatic organisms was not exceeded for freshwater fish or freshwater aquatic invertebrates (LOC >1.0; freshwater fish chronic RQ = 0.001, Table 17; freshwater invertebrate chronic RQ = 0.0006, Table 18). On an acute basis, both freshwater and estuarine/marine fish showed low sensitivity to fluopyram exposure (LC50 > 0.98 mg a.i./L and NOAEC = 0.98 mg a.i./L for sheepshead minnow; LC50 >1.78 mg a.i./L and NOAEC = 1.78 mg a.i./L for rainbow trout; Table 15). Freshwater and estuarine/marine invertebrates also showed low sensitivity on an acute basis (EC50 > 17 mg a.i./L and NOAEC = 17 mg a.i./L for Daphnia magna; EC50 >0.51 mg a.i./L and NOAEC = 0.98 mg a.i./L for saltwater mysid; Table 15). In addition, the maximum chronic predicted exposure concentration in the water column is approximately four orders of magnitude less than the available chronic estuarine/marine benthic invertebrate toxicity endpoint (NOAEC) based on pore water concentrations. Based on these lines of evidence, chronic testing with estuarine/marine fish or estuarine/marine invertebrates is not requested at this time.

   * Differences in TGAI vs. TEP:  In this risk assessment, ecological effects studies with the fluopyram technical grade active ingredient were compared to predicted exposure concentrations based on movement of the chemical via runoff/erosion and spray drift. However, in EFED risk assessments, toxicity endpoints from studies with water column dwelling animals and the typical end use product (TEP) are used quantitatively to estimate risk resulting from exposure to spray drift only. Formulated products containing fluopyram are expected to be directly deposited to aquatic systems via spray drift. Therefore, to provide a realistic representation of the expected effects and risk to aquatic animals associated with spray drift, toxicity endpoints based on concentrations of the active ingredient in laboratory studies with the formulated product are compared to estimated exposure concentrations from expected concentrations of the active ingredient to aquatic environments via drift only. Because the spray drift is only a fraction of the total aquatic EECs, and the TEP does not show greatly enhanced toxicity compared to the TGAI (see Table 15), the risk quotients calculated with the spray drift + runoff/erosion EECs and fluopyram technical toxicity endpoints are expected to be a more conservative estimate of risk than estimates with spray drift only and fluopyram TEP toxicity endpoints. However, the solubility of the TEP may be greater than that of the TGAI, which can result in increased bioavailability in the environment (see discussion of solubility in aquatic tests below).

   * Solubility in aquatic tests:  According to the submitted fate information, fluopyram is characterized by a water solubility ranging from 15 to 16 mg a.i./L in acidic to alkaline conditions. However, acute fish studies with technical-grade fluopyram were conducted up to the limits of solubility determined under the specific test conditions, which ranged from 1 to 6 mg a.i./L. In the TEP toxicity study, treatment levels were up to fluopyram concentrations of 46.4 mg ai/L for freshwater fish. In the submitted acute study for mysid, a solvent was used without adverse impacts on the solvent control test organisms (0.1 mL/L DMF). However, the solubility of the test material was also low in this study, as fluopyram levels were only tested up to 0.51 mg ai/L. In acute studies with Daphnia magna, studies were conducted up to the limit of solubility that was determined to be 17 mg a.i./L for the technical product and 38.2 for the formulated fluopyram 500 SC, under the specific test conditions. One submitted aquatic study with the formulated product noted the presence of undissolved test material (highest three treatment levels that were nominally 8.72 to 49.8 mg ai/L, acute test with rainbow trout, MRID 473723333). In another test with the technical product, the presence of undissolved test material was observed at all treatment levels (nominal concentrations of 11.8 to 189 mg ai/L, acute test with carp, MRID 47372332). No undissolved test material was noted in any other submitted studies with the formulated or technical product. It is unclear why the solubility of fluopyram technical would be much lower in the test conditions of some of the aquatic toxicity tests.

The higher solubility of the formulated product in some toxicity studies indicates that the solubility of fluopyram in the environment may be higher than the concentrations of active ingredient that were tested. However, the TEP showed low solubility in a study with rainbow trout. The maximum potential for exposure to aquatic ecosystems, utilizing the value for water solubility (16 mg a.i./L) reported in the available fate information, is much lower than any of the levels at which effects were observed in the submitted aquatic organism toxicity tests (see Risk Characterization section).

   * Terrestrial plant toxicity studies: No acceptable Tier II study is available for buckwheat, which showed a 50% reduction in biomass in the acceptable Tier I study. The submitted Tier II study did not allow reliable calculation of an EC25 or NOAEC.

   * Fluopyram co-formulations:  Based on the toxicity data submitted for the fluopyram coformulations with tebuconazole and trifloxystrobin, these products are more toxic to aquatic organisms than fluopyram only. This increase in toxicity appears to be attributable to the presence of the non-fluopyram active ingredients, which are more toxic to aquatic taxa. Although no data were submitted for the coformulated products, both pyrimethanil and prothioconazole are more toxic to aquatic organisms than fluopyram, with the potential exception of pyrimethanil effects to freshwater fish. Therefore, it appears as if use of the fluopyram co-formulated products with tebuconazole, trifloxystrobin, pyrimethanil, and prothioconazole have a higher potential to adversely impact aquatic ecosystems than use of the proposed fluopyram-only product. Overall, the coformulations for all fluopyram products with dual active ingredients appear to have low acute toxicity to terrestrial organisms, but no avian data were submitted for any co-formulated product. However, only rat acute oral studies were submitted for pyrimethanil and prothioconazole coformulations. Although these studies indicate that the products show low acute toxicity to mammals, there is uncertainty regarding the effects of these products on other terrestrial taxa.

All four fungicides in the coformulation have different modes-of-action than fluopyram (FRAC, 2009). Fluopyram is a succinate dehydrogenase inhibitor that alters cellular respiration. Tebuconazole and prothioconazole are demethylation inhibitors that affect sterol biosynthesis in membranes. Trifloxystrobin is the most similar to fluopyram, as quinine outside inhibitor that also affects respiration. Pyrimethanil is an aniline-pyrimidine that impacts amino acid and protein synthesis. This indicates that these chemicals should act independently within an exposed organism, with the potential exception of trifloxystrobin.

 		a.  Age Class and Sensitivity of Effects Thresholds

 It is generally recognized that test organism age may have a significant impact on the observed sensitivity to a toxicant.  The screening risk assessment acute toxicity data for fish are collected on juvenile fish and aquatic invertebrate acute testing is performed on recommended immature age classes. Similarly, acute dietary testing with birds is also performed on juveniles, with mallard being 5-10 days old and quail at 10-14 days of age.

 Testing of juveniles may overestimate the toxicity of direct acting pesticides in adults. As juvenile organisms do not have fully developed metabolic systems, they may not possess the ability to transform and detoxify xenobiotics equivalent to the older/adult organism. The screening risk assessment has no current provisions for a generally applied method that accounts for this uncertainty.  In so far as the available toxicity data may provide ranges of sensitivity information with respect to age class, the risk assessment uses the most sensitive life-stage information as the conservative screening endpoint.

 		b.  Lack of Effects Data for Amphibians and Reptiles

 Currently, toxicity studies on amphibians and reptiles are not required for pesticide registration.  Since these data are lacking, the Agency uses fish as surrogates for aquatic phase amphibians and birds as surrogates for terrestrial phase amphibians and reptiles. If other species are more or less sensitive to fluopyram than the surrogates, risks may be under- or overestimated, respectively. The Agency is not limited to a base set of surrogate toxicity information in establishing risk assessment conclusions. The Agency also considers toxicity data on non-standard test species when available. Further research is needed to determine whether, in general, reptiles and terrestrial-phase amphibians are suitably represented by bird species in assessing risks for fluopyram and fish are an appropriate surrogate for aquatic-phase amphibians.

 		c.  Use of the Most Sensitive Species Tested

 Although the screening risk assessment relies on a selected toxicity endpoint from the most sensitive species tested, it does not necessarily mean that the selected toxicity endpoints reflect sensitivity of the most sensitive species existing in a given environment.  The relative position of the most sensitive species tested in the distribution of all possible species is a function of the overall variability among species to a particular chemical.  The relationship between the sensitivity of the most sensitive tested species versus wild species (including listed species) is unknown and a source of significant uncertainty. In addition, in the case of listed species, there is uncertainty regarding the relationship of the listed species' sensitivity and the most sensitive species tested. 	Literature Cited

Environmental Fate Studies

47372247
Bogdoll, B.; Eyrich, U. (2005) Water Solubility of AE C656948 at pH 4, pH 7, pH 9 and in Distilled Water (Flask Method). Project Number: PA05/074. Unpublished study prepared by Bayer Cropscience Gmbh. 22 p.
47372249
Smeykal, H. (2008) 1st Amendment to Report No. 20050612.01: AE C656948; Substance, Pure: AE C656948 00 1B99 0001: Vapour Pressure A.4. (OECD 104). Project Number: 20050612/01. Unpublished study prepared by Siemens Axiva GmbH & Co. KG. 19 p.
47372245
Eyrich, U.; Bogdoll, B. (2006) Partition Coefficients 1-Octanol / Water of AE C656948 (Shake Flask Method). Project Number: PA06/065. Unpublished study prepared by Bayer Cropscience Gmbh. 22 p.
47372248
Bogdoll, B.; Lemke, G. (2006) Solubility in Organic Solvents: AE C656948: Pure Substance. Project Number: PA05/113. Unpublished study prepared by Bayer Cropscience Gmbh. 21 p.
47372303
Doble, M.; Oddy, A. (2006) [Carbon 14]-AE C656948: Aqueous Hydrolysis at pH 4, 7 and 9. Project Number: CX/06/015, M/282473/01/2. Unpublished study prepared by Battelle UK, Ltd. 69 p.
47372304
Oddy, A.; Brett, R. (2008) [Carbon 14]-AE C656948: Aqueous Photolysis in Buffer at pH 7. Project Number: CX/06/016, M/297180/02/2. Unpublished study prepared by Battelle UK, Ltd. 121 p.
47372305
Stupp, H.; Koehn, D. (2007) [Phenyl-UL-(Carbon 14)]AE C656948 and [Pyridyl-2-6-(Carbon 14)]AE C656948: Phototransformation in Natural Water. Project Number: M1121681/0, MEF/07/227, M/296408/01/2. Unpublished study prepared by Bayer CropScience AG. 81 p.
47372306
Doble, M.; Oddy, A. (2007) [Carbon 14]-AE C656948: Soil Photolysis. Project Number: CX/06/022, M286872/01/3. Unpublished study prepared by Battelle UK, Ltd. 82 p.
47372307
Babczinski, P. (2008) [Phenyl-UL-(Carbon 14)]AE C656948: Aerobic Soil Metabolism/Degradation and Time-Dependent Sorption in Four Soils. Project Number: MEF/06/295, BCP/133, M1311501/2. Unpublished study prepared by Bayer CropScience AG. 145 p.
47372308
Menke, U.; Telscher, M. (2008) [Pyridine-2,6-(Carbon 14)] AE C656948: Aerobic Metabolism/Degradation and Time-Dependent Sorption in Soils. Project Number: M165/1679/1, MEF/07/424, M298413/01/2. Unpublished study prepared by Bayer CropScience AG. 148 p.
47372309
Meyer, B. (2008) [Phenyl-UL-(Carbon 14)] and [Pyridyl-2-6-(Carbon 14)]AE C656948: Aerobic Soil Metabolism in Two US Soils. Project Number: MEGMP069/1, M/299548/02/1. Unpublished study prepared by Bayer CropScience. 91 p.
47372310
Meyer, B. (2008) [Phenyl-UL-(Carbon 14)] and [Pyridyl-2-6-(Carbon 14)]AE C656948: Anaerobic Soil Metabolism . Project Number: MEGMP070/1, M292022/02/1. Unpublished study prepared by Bayer CropScience. 82 p.
47372311
Allan, J.; Shepherd, J. (2007) [Pyridyl-Ring-UL-(Carbon 14)]-AE C656948 and [Triflurobenzamide-Ring-UL-(Carbon 14)]-AE C656948: Aerobic Aquatic Metabolism. Project Number: MEGMP064, M/290531/01/2. Unpublished study prepared by Bayer CropScience. 109 p.
47372312
Dallstream, K.; Mislankar, S.; Desmarteau, D. (2007) [(Carbon 14)-Phenyl-UL]AE C656948: Anaerobic Aquatic Metabolism. Project Number: MEGMP063, M/293275/01/2. Unpublished study prepared by Bayer CropScience. 68 p.
47372313
Dallstream, K.; Mislankar, S.; Desmarteau, D. (2007) [Pyridyl-2,6-(Carbon 14)]AE C656948: Anaerobic Aquatic Metabolism. Project Number: MEGMP063, M293276/01/2. Unpublished study prepared by Bayer CropScience. 68 p.
47372301
Henk, F.; Haas, M. (2005) AE C656948: Adsorption/Desorption on Five Soils. Project Number: MEF/04/499, M1311423/5, MO/05/006241. Unpublished study prepared by Bayer CropScience AG. 84 p.
47372302
Heinemann, O.; Dehner, D. (2007) [Pyridine-2,6-(Carbon 14)] AE C656948-7-Hydroxy: Adsorption/Desorption on Four EU Soils. Project Number: MEF/07/149, M1311630/5, M289570/01/2. Unpublished study prepared by Bayer CropScience. 79 p.
47567001
Xu, T. (2008) Terrestrial Field Dissipation of AE C656948 in a Washington Soil, 2006. Project Number: MEGMP065, M/306817/01/2, 01023. Unpublished study prepared by Bayer CropScience, Agvise Laboratories. and Qualls Ag Laboratory. 235 p.
47567002
Xu, T. (2008) Terrestrial Field Dissipation of AE C656948 in a New York Soil, 2006. Project Number: MEGMP084, M/306809/01/2, P601060020. Unpublished study prepared by Bayer CropScience, Agvise Laboratories and Agricultural Chemistry Development Services, Inc. (ACDS). 238 p.
47567003
Xu, T. (2008) Terrestrial Field Dissipation of AE C656948 in a North Dakota Soil, 2006. Project Number: M/306812/01/2, MEGMP085, 01023. Unpublished study prepared by Bayer CropScience, Agvise Laboratories and Agvise Research. 237 p.
47567004
Xu, T. (2008) Terrestrial Field Dissipation of AE C656948 in a Georgia Soil, 2006. Project Number: MEGMP086, M/306814/01/2, 01023. Unpublished study prepared by Bayer CropScience, Agvise Laboratories and Ag Research Associates. 234 p.
47567005
Lembrich, D.; Rapp, V.; Neumann, B.; et al. (2008) Terrestrial Field Dissipation of AE C656948 in California Soil, 2006. Project Number: MEGMP087, M/306820/01/2. Unpublished study prepared by Agvise Laboratories, California Agricultural Research Inc. and Bayer CropScience. 150 p.
47372337
Bruns, E.; Weber, E. (2008) [Pyridyl-2,6-(Carbon 14)]- Fluopyram Bioconcentration and Biotransformation in Fish (Lepomis macrochirus). Project Number: EBGMP116, E/244/3300/6, M/298506/01/2. Unpublished study prepared by Bayer CropScience AG. 251 p.
EU study No MRID
Heinemann, O.; Telscher, M. (2007) Determination of the Residues of AE C656948 in/on Soil after Spraying of AE C656948 (250 SC) in the Field in Germany, United Kingdom, Sweden, France, Spain and Italy
EU study No MRID
Heinemann, O.; Telscher, M. (2007) Interim Report: Determination of the Residues of AE C656948 in/on Soil after Spraying of AE C656948 (250 SC) in Germany and France

 B.  Ecological Effects Studies Submitted to EPA
MRID
Author(s)
Year
Title
47372349
Bach, F.; Nguyen, D. H.
2008
AE C656948 SC 500A G effect on seedling emergence and seedling growth test of ten species of non-target terrestrial plants (Tier 1 and 2)
SE07/037 BCS

47372350
Bach, F.; Nguyen, D. H.
2008
AE C656948 SC 500A G - Effect on the vegetative vigour of ten species of non-target terrestrial plants (Tier 1)
VV07/038 BCS

47372403
Banman, C. S.; Lam, C. V.
2007
Toxicity of AE C656948 technical to the green alga Pseudokirchneriella subcapitata
EBGMP048 BCS

47372406
Banman, C. S.; Lam, C. V.
2007
Toxicity of AE C656948 technical to the  freshwater diatom Navicula pelliculosa
EBGMP040 BCS

47372404
Banman, C. S.; Lam, C. V.
2007
Toxicity of AE C656948 technical to the blue-green algae Anabaena flos-aquae
EBGMP049 BCS

47372330
Banman, C. S.; Lam, C. V.
2006
Acute toxicity of AE C656948 technical to the sheepshead minnow (Cyprinodon variegatus) under static conditions
EBGMP053 BCS

47372405
Banman, C. S.; Lam, C. V.
2007
Toxicity of AE C656948 technical to the saltwater diatom Skeletonema costatum
EBGMP050 BCS

47372341
Barfknecht, R.
2008
Acute oral toxicity for bobwhite quail (Colinus virginianus) with AE C656948 technical
BAR/LD 074 BCS

47372343
Barfknecht, R.
2007
AE C656948 technical 5-day-dietary LC50 for bobwhite quail (Colinus virginianus)
BAR/LC 023 BCS

47372342
Barfknecht, R.
2007
AE C656948 technical 5-day-dietary LC50 mallard duck (Anas platyrhynchos)
BAR/LC 020 BCS

47372324
Bruns, E.
2007
Acute toxicity of AE C656948 (tech.) to the waterflea Daphnia magna in a static laboratory test system
EBGMP046 BCS

47372334
Bruns, E.
2008
Influence of AE C656948 (tech.) on development and reproductive output of the waterflea Daphnia magna in a static renewal laboratory test system
EBGMP047 BCS

47372325
Bruns, E.
2008
Acute toxicity of AE C656948 SC 500A G to the waterflea Daphnia magna in a static laboratory test system
EBGMP067 BCS
GLP: Y, published: N
1783598 /
47372337
Bruns, E.;  Weber, E.
2008
[pyridyl-2,6-14C]- fluopyram bioconcentration and biotransformation in fish (Lepomis macrochirus)
EBGMP116 BCS

47372346
Christ, M.T.; Lam, C. V.
2008
Effect of AE C656948 technical on reproduction of the mallard duck (Anas platyrhynchos)
EBGMP041 BCS

47567008
Desmarteau, D.; Sabbagh,G.
2008
Foliar half-life calculation for AE C656948 in grass forage and hay
EBGMP158 BCS

47372418
Dorgerloh, M.
2008
Pseudokirchneriella subcapitata growth inhibition test with fluopyram-lactame
EBGMP155 BCS

47372340
Dorgerloh, M.
2008
Chironomus riparius 28-day chronic toxicity test with fluopyram (tech.) in a water-sediment system using spiked water
EBGMP121 BCS

47372401
Dorgerloh, M.
2007
Lemna gibba G3 - Growth inhibition test with AE C656948 under static conditions
EBGMP051 BCS

47372333
Dorgerloh, M.
2008
Acute toxicity of fluopyram SC 500 G to fish (Oncorhynchus mykiss) under static conditions
EBGMP066 BCS

47372407
Dorgerloh, M.
2008
Pseudokirchneriella subcapitata growth inhibition test with fluopyram SC 500
EBGMP068 BCS

47372402
Dorgerloh, M.
2008
Lemna gibba G3 growth inhibition test with fluopyram SC 500A G under static conditions
EBGMP151 BCS

47372432
Eiben, R.
2005
AE C656948 SC 500 - Acute toxicity in the rat after dermal application
AT02500 BCS
47372435
Folkerts, Andree
2007
AE C656948 SC 500 - Acute inhalation toxicity in rats
AT03663 BCS
47372434
Folkerts, Andree
2006
AE C656948 SC 500 - Acute inhalation toxicity in rats
AT03464 BCS
47372344
Frey, L. T.; Martin, K. H.; Beavers, J. B.; Jaber, M.
2008
AE C656948: A reproduction study with the Northern bobwhite
EBGMP152 BCS

47372426

Frommholz, U.
2007
AE C656948 SC 500A G: Influence on the reproduction of the collembola species Folsomia candida tested in artificial soil with 5 % peat
FRM-COLL-50/07 BCS

47372409
Heimbach, F.
2008
AE C656948 SC 500: Effects on survival, growth and reproduction on the earthworm Eisenia fetida tested in artifical soil with 5 percent peat
LKC-RG-R-20/06 BCS

47372418
Hills, M.
2008
Evaluation of the pre-emergence (PPI) biological activity of AE C656948 SC 500
PPI-07002 BCS

47372441
Kennel, P.
2005
AE C656948 90-day toxicity study in the rat by dietary administration
SA04048 BCS
47372425
Kratz, M. A.
2007
Fluopyram SC 500: Influence on mortality and reproduction on the soil mite species Hypoaspis aculeifer tested in artificial soil with 5 % peat
KRA-HR-3/07 BCS

47372408
Lechelt-Kunze, C.
2005
AE C656948: Acute toxicity  to earthworms (Eisenia fetida) tested in artificial soil with 5 percent peat
LKC/RG-A-57/05 BCS

47372410
Leicher, T.
2006
AE C656948 SC 500: acute toxicity to earthworms (Eisenia fetida) tested in artificial soil with 5 percent peat
LRT/RG-A-78/06 BCS

47372331
Matlock, D.; Lam, C. V.
2008
Acute toxicity of AE C656948 technical to the fathead minnow (Pimephales promelas) under static conditions
EBGMP237 BCS

47372328
Nieden, D.
2008
Acute toxicity of AE C656948 (tech.) to fish (Oncorhynchus mykiss) under static conditions
EBGMP017 BCS

47372329
Nieden, D.
2008
Acute toxicity of AE C656948 (tech.) to fish (Lepomis  macrochirus) under static conditions
EBGMP052 BCS

47372332
Nieden, D.
2008
Acute toxicity of AE C656948 (tech.) to fish (Cyprinus carpio) under static conditions
EBGMP020 BCS

47372336
Nieden, D.
2007
Early-life stage toxicity of AE C656948 (tech.) to fish Pimephales promelas)
EBGMP054 BCS

47372327

Palmer, S. J.; Kendall, T. Z.; Krueger, H. O.
2007
AE C656948: A 96-hour flow-through acute toxicity test with the saltwater mysid (Americamysis bahia)
EBGMP043 BCS

47372326
Palmer, S. J.; Sutherland, C. A.; Kendall, T. Z.; Krueger, H. O.
2006
AE C656948: A 96-hour shell deposition test with the eastern oyster (Crassostrea virginica)
EBGMP045 BCS

47372338
Putt, A. E.
2008
AEC656948 - Toxicity to marine amphipods (Leptocheirus plumulosus) during a 10-day sediment exposure
EBGMP119 BCS

47372339
Putt, A. E.
2008
AEC656948 - Life-cycle toxicity test exposing midges (Chironomus tentans) to a test substance applied to sediment under static-renewal conditions following EPA test methods
EBGMP128 BCS

47372335
Putt, A. E.
2008
AEC656948 - Toxicity to estuarine amphipods (Leptocheirus plumulosus) during a 28-day sediment exposure
EBGMP153 BCS

47372427
Roehlig, U.
2007
Dose-response toxicity (LR50) of AE C656948 SC 500 to the parasitic wasp Aphidius rhopalosiphi   under laboratory conditions
06 10 48 187 BCS

47372428

Roehlig, U.
2007
Dose-response toxicity (LR50) of AE C656948 SC 500  to the predatory mite Typhlodromus pyri under laboratory conditions
06 10 48 188 BCS

47372424
Roehlig, U.
2007
Chronic dose-response toxicity (ER50) of AE C656948 SC 500 to the rove beetle Aleochara bilineata under extended laboratory conditions
07 10 48 018 A BCS

47372347
Schmitzer, S.
2007
Effects of AE C656948 (acute contact and oral) on honey bees (Apis mellifera L.) in the laboratory
24851035 BCS

47372348
Schmitzer, S.
2008
Effects of AE C656948 SC 500A G (acute contact and oral) on honey bees (Apis mellifera L.) in the laboratory
34481035 BCS

47372430
Schuengel, M.
2008
AE C656948 SC 500 - Acute toxicity in the rat after oral administration
AT03603 BCS

47567007
Stafford, J. M.
2008
AE C656948 - Acute oral toxicity test (LD50) with the zebra finch (Taeniopygia guttata) following OECD draft guideline 223
EBGMP117-1 BCS

47372345
Stoughton, T. L.; Lam, C. V.
2008
Effect of AE C656948 technical on reproduction of the northern bobwhite quail
EBGMP004-1 BCS

 C.  Open Literature and Government Reports

 Burns, Lawrence, 1997. Exposure Analysis Modeling System (EXAMS): User Manual and System Documentation. Ecosystem Research Division, National Exposure Research Laboratory. U. S. Environmental Protection Agency, Athens, GA.

 Carsel, R. F., J. C. Imhoff, P. R. Humel, J. M. Cheplick, and A. S. Donigian, Jr. 1997. PRZM-3, A Model for Predicting Pesticide and Nitrogen Fate in the Crop Root and Unsaturated Zones: User's Manual for Release 3.0. National Exposure Research Laboratory, Office of Research and Development, U. S. Environmental Protection Agency, Athens, GA.

Di Toro, D.M., C. Zarba, D.J. Hansen, W. Berry, R.C.Swartz, C.E. Cowan, S.P. Pavlou, and H.E. Allen.
1991. Technical basis for establishing sediment quality criteria for nonionic organic chemicals using
equilibrium partitioning. Environ. Toxicol.Chem. 10:1541-1583.

 Fletcher, J.S., J.E. Nellesson and T. G. Pfleeger. 1994.  Literature review and evaluation of the EPA food-chain (Kenaga) nomogram, an instrument for estimating pesticide residues on plants.  Environ. Tox. And Chem. 13(9):1383-1391.

 Fungicide Resistance Action Committee. FRAC code list:  Fungicides sorted by mode of action. 2009. http://www.frac.info/frac/publication/anhang/FRAC_CODE_LIST.pdf

 Hoerger, F. and E.E. Kenaga. 1972.  Pesticide residues on plants: correlation of representative data as a basis for estimation of their magnitude in the environment.  IN: F. Coulston and F. Corte, eds., Environmental Quality and Safety: Chemistry, Toxicology and Technology. Vol 1.  George Theime Publishers, Stuttgart, Germany.  pp. 9-28.

 Terrestrial Residue Exposure Model (T-REX), Version 1.4.1.  October 2008.  Environmental Fate and Effects Division, Office of Pesticide Programs, U.S. Environmental Protection Agency, Washington, D.C.

 US EPA. 1993. Wildlife Exposure Factors Handbook. Volume I of II.  EPA/600/R-93/187a. Office of Research and Development, Washington, D. C. 20460.

 US EPA. 1996. Ecological Effects Test Guidelines, 850.2100 Avian Acute Oral Toxicity Test. Office of Chemical Safety and Pollution Prevention. EPA 712-C-96-139.

 US EPA. 2002. Technical Basis for the Derivation of Equilibrium Partitioning Sediment Guidelines (ESGs) for the Protection of Benthic Organisms:  Nonionic Organics. Office of Science and Technology and Office of Research and Development. Washington, DC 20460. EPA/822-R-02-041.

 US EPA. 2004a. Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs, U.S. Environmental Protection Agency: Endangered and Threatened Species Effects Determinations.  Office of Prevention, Pesticide, and Toxic Substances.

 USEPA. 2004b.  Scientific Advisory Panel.  March 30 - April 2, 2004: Refined (Level II) Terrestrial and Aquatic Models for Probabilistic and Ecological Assessment of Pesticides.  Available: http://www.epa.gov/scipoly/sap/meetings/2004/033004_mtg.htm

 USEPA, 2005. Procedures for the Derivation of Equilibrium Partitioning Sediment Benchmarks (ESBs) for the Protection of Benthic Organisms:  Metal Mixtures (Cadmium, Copper, Lead, Nickel, Silver and Zinc). Office of Research and Development. Washington, DC 20460. EPA/600/R-02/011.

USEPA 2009.  Evaluation of Potential Ecological Risks from the Proposed New Use of Tebuconazole on Fruiting Vegetables (Crop Group 8). DP Barcode:  DP362764. Office of Chemical Safety and Pollution Prevention. Washington, DC. November 13, 2009.

USEPA 2010a. Ecological risk assessment for the new use of Trifloxystrobin [Trifloxystrobin Flowable Fungicide, EPA Reg. No. 264-989] on alfalfa seed. DP Barcode:  D378918. Office of Chemical Safety and Pollution Prevention. Washington, DC. December 17, 2010.

US EPA 2010b. Environmental Fate and Ecological Risk Assessment for New Uses of Prothioconazole, DP Barcodes:  D378999, 373681, 378623, 381890. Office of Chemical Safety and Pollution Prevention. Washington, DC. December, 2010

USEPA 2011a. Drinking water and ecological risk for an increase of maximum use rate of tebuconazole on golf course turf. DP Barcode(s): 389256, 389288, 386328. Office of Chemical Safety and Pollution Prevention. Washington, DC. July 28, 2011.

USEPA 2011b. Ecological Risk Assessment for Use of Fluopyram/Trifloxystrobin 500 SC on Almonds, Apples, Cherries, Cucurbit Vegetables, Peanuts, Pecans, Pistachios, Potatoes, Sugar Beets, Stone Fruits, Tree Nuts, and Wine Grapes. DP Barcode(s): D385876, D387594. Office of Chemical Safety and Pollution Prevention. Washington, DC. June 13, 2011.

USEPA 2011c. Prothioconazole:  Evaluation of Proposed New Fungicide Products Containing Prothioconazole and Fluopyram. DP Barcode:  D385873. Office of Chemical Safety and Pollution Prevention. Washington, DC. May 17, 2011.

USEPA 2011d.  Section 3 New Use: Ecological Risk Assessment for the proposed use of pyrimethanil (co-formulated with fluopyram) on almond, apple, pistachio, potato, stone fruit (except cherries), and wine grapes. DP Barcode:  D387590. Office of Chemical Safety and Pollution Prevention. Washington, DC. July 26, 2011.

US Office of the Federal Registrar. 2011. Code of Federal Regulations 40, Parts 150-189.

 Willis and McDowell, 1987. Pesticide persistence on foliage. Environ. Contam. Toxicol.  100:23-73.