[Federal Register Volume 77, Number 232 (Monday, December 3, 2012)]
[Rules and Regulations]
[Pages 71561-71567]
[FR Doc No: 2012-28840]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 716

[EPA-HQ-OPPT-2011-0363; FRL-9355-9]
RIN 2070-AJ89

Health and Safety Data Reporting; Addition of Certain Chemicals

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This final rule requires manufacturers (including importers)
of cadmium or cadmium compounds, including as part of an article, that
have been, or are reasonably likely to be, incorporated into consumer
products to report certain unpublished health and safety studies to
EPA. The Interagency Testing Committee (ITC), established under section
4(e) of the Toxic Substances Control Act (TSCA) to recommend chemicals
and chemical mixtures to EPA for priority testing consideration, amends
the TSCA section 4(e) Priority Testing List through periodic reports
submitted to EPA. The ITC added cadmium and cadmium compounds to the
Priority Testing List through its 69th ITC Report.

DATES: This final rule is effective January 2, 2013. For purposes of
judicial review, this final rule shall be promulgated at 1 p.m. eastern
daylight/standard time on December 17, 2012. (See 40 CFR 23.5.)
    A request to withdraw a chemical from this final rule pursuant to
Sec.  716.105(c) must be received on or

before December 17, 2012. (See Unit IV. of the SUPPLEMENTARY
INFORMATION.)
    For dates for reporting requirements, see Unit III.B. of the
SUPPLEMENTARY INFORMATION.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2011-0363, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Mail: Document Control Office (2822-1T), Office of
Chemical Safety and Pollution Prevention, Environmental Protection
Agency, 1301 Constitution Ave. NW., Washington, DC 20004.
     Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. ATTN:
Docket ID Number EPA-HQ-OPPT-2011-0363. The DCO is open from 8 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The telephone
number for the DCO is<PHONE_NUMBER>. Such deliveries are only accepted
during the DCO's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2011-0363. EPA's policy is that all comments received will be included
in the docket without change and may be made available online at http://www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through regulations.gov or email. The
regulations.gov Web site is an ``anonymous access'' system, which means
EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at http://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number of the EPA/DC Public Reading Room
is<PHONE_NUMBER>, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Robert Jones, Chemical Control
Division (7405M), Office of Chemical Safety and Pollution Prevention,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be affected by this rule if you are a manufacturer
(including importer) of cadmium or cadmium compounds, including as part
of an article, that have been, or are reasonably likely to be,
incorporated into consumer products.
    In addition to this final rule, EPA plans to propose, under a
separate notice and comment rulemaking, to require the submission of
TSCA section 8(d) health and safety studies from processors and
distributors of cadmium or cadmium compounds, including as part of an
article, that have been, or are reasonably likely to be, incorporated
into consumer products to report certain unpublished health and safety
studies to EPA. The proposed rule will be published in a subsequent
Federal Register document. As provided in this rule, health and safety
studies regarding cadmium or cadmium compounds in articles must be
reported, with the exception of studies not subject to reporting as
described at Sec.  716.20.
    While EPA has broad authority to require submission of health and
safety studies on chemical substances, for the purposes of this rule
EPA has limited the scope of this rule to those chemical substances
within the listed category that have been, or are reasonably likely to
be, incorporated into consumer products, based on EPA's determination
of what is necessary to carry out the purposes of TSCA. ``Consumer
product'' is defined in Sec.  716.21(a)(9)(iii) of this rule to mean
``any product that is sold or made available to consumers for their use
in or around a permanent or temporary household or residence, in or
around a school, or in or around recreational areas.'' This definition
is based on the definition of ``consumer use'' promulgated in 40 CFR
710.43 and the definition of ``consumer product'' promulgated in 40 CFR
721.3. Potentially affected entities may include but are not limited
to:
     Manufacturers of basic inorganic chemicals (except
industrial gases, inorganic dyes and pigments, alkalis and chlorine,
and carbon black) (NAICS code 325188).
     Manufacturers (including importers) of inorganic dyes and
pigments (NAICS code 325131).
     Manufacturers of basic organic chemical products (except
aromatic petrochemicals, industrial gases, synthetic organic dyes and
pigments, gum and wood chemicals, cyclic crudes and intermediates, and
ethyl alcohol) (NAICS code 325199).
     Establishments primarily engaged in the primary production
of nonferrous metals by smelting ore and/or the primary refining of
nonferrous metals by electrolytic methods or other processes (except
copper and aluminum) (NAICS code 331419).
     Establishments engaging in secondary smelting, refining,
and alloying of nonferrous metal (except copper and aluminum) (NAICS
code 331492).
     Wholesalers of toy and hobby goods, establishments with
product line 12812 (NAICS code 42392).
     Discount department stores (NAICS code 452112).

     Warehouse clubs and supercenters (NAICS code 45291).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the technical person listed under FOR FURTHER
INFORMATION CONTACT.

B. How do I submit CBI information?

    If you wish to claim information submitted to be CBI, it will be
handled in accordance with procedures set forth in 40 CFR part 2,
subpart B. If you do not assert a confidentiality claim at the time of
submission, the information may be made available to the public by EPA
without further notice. See 40 CFR 2.203 (Ref. 1). Do not submit this
information to EPA through regulations.gov or by email. Clearly mark
the part of the information that you claim to be CBI. For CBI
information in a disk or CD-ROM that you mail to EPA, mark the outside
of the disk or CD-ROM as CBI and then identify electronically within
the disk or CD-ROM the specific information that is claimed as CBI.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2 and in Sec.  716.55. Pursuant to
Sec.  716.55, to assert a claim of confidentiality for information
contained in a submitted record, you must submit two copies of the
document. One copy must be complete, and you must indicate what
information, if any, is claimed as confidential by marking the specific
information on each page with a label such as ``company confidential,''
``proprietary,'' or ``trade secret'' and briefly state the basis of the
claim. The second copy must be complete, except that all the
information claimed as CBI in the first copy must be deleted. The
second copy will be placed in the public docket. Failure to furnish a
second copy when information is claimed as CBI in the first copy will
be considered a presumptive waiver of confidentiality. EPA will notify
the respondent by certified mail that a finding of a presumptive waiver
of the claim of confidentiality has been made. The respondent will be
given 30 days from the date of receipt of notification to submit the
required second copy. If the respondent fails to submit the second copy
within the 30 days, EPA will place the first copy in the docket.

II. Background

A. Why is the agency taking this action?

    EPA has classified cadmium as a Group B1, probable human carcinogen
(Ref. 2). Further, EPA has determined acute (short-term) effects of
cadmium in humans through inhalation exposure consisting mainly of
effects on the lung, such as pulmonary irritation. Chronic (long-term)
inhalation or oral exposure to cadmium leads to a build-up of cadmium
in the kidneys which can cause kidney disease. Cadmium has been shown
to be a developmental toxicant in animals, resulting in fetal
malformations and other effects, but no conclusive evidence exists in
humans. Animal studies have demonstrated an increase in lung cancer
from long-term inhalation exposure to cadmium (Refs. 2-4). Due to the
potential health effects of exposure to cadmium or cadmium compounds,
EPA and the Consumer Product Safety Commission (CPSC) are concerned
about the possible presence and bioavailability of cadmium or cadmium
compounds in consumer products generally and especially those consumer
products used by or around children (Ref. 5).

B. What action is the agency taking?

    EPA is issuing a final TSCA section 8(d) rule under procedures in
the Health and Safety Data Reporting rule, 40 CFR part 716, to require
manufacturers (including importers) of cadmium or cadmium compounds,
including as part of an article, that have been, or are reasonably
likely to be, incorporated into consumer products to submit certain
unpublished health and safety studies to EPA.
    EPA has reviewed CPSC's recalls of cadmium-contaminated children's
products. Most of the recalled products were produced abroad and
imported from other countries (Ref. 6). Based in part on this
information, EPA expects to capture health and safety studies conducted
by importers of such products through this final rule. These parties
are located primarily in the United States and may be subject to CPSC
certification requirements and, depending on the product, may be
conducting testing using Standard Consumer Safety Specification for Toy
Safety, ASTM International (ASTM) F-963 (Ref. 7).
    The regulatory text of this final rule lists the category cadmium
and cadmium compounds. The regulatory text also lists the data
reporting requirements imposed by this amendment to the TSCA section
8(d) model rule.

C. What is the agency's authority?

    Section 8(d) of TSCA authorizes EPA to require ``any person who
manufactures, processes, or distributes in commerce or who proposes to
manufacture, process, or distribute in commerce, any chemical substance
or mixture'' to submit lists of health and safety studies conducted or
initiated by or for such person with respect to such substance or
mixture at any time, known to such person, or reasonably ascertainable
by such person; and copies of any study contained on a list submitted
pursuant to section (8)(d)(1) of TSCA or otherwise known by such
person. Under TSCA section 3(7), import is included in the definition
of ``manufacture.''
    The term health and safety study should be interpreted broadly and
is defined in Sec.  716.3.
    Since the TSCA section 8(d) model rule is codified in 40 CFR part
716, EPA uses this TSCA section 8(d) model rule to quickly gather
information on chemical substances. The TSCA section 8(d) model rule
requires past, current, and prospective manufacturers (including
importers) and (if specified by EPA in a particular rule or notice
under TSCA section 8(d)) processors to submit to EPA copies and lists
of health and safety studies on the listed chemical substances that
they manufacture, import, or process. These studies provide EPA with
useful information and have provided significant support for EPA's
decisionmaking under TSCA sections 4, 5, 6, 8, and 9.
    The TSCA section 8(d) model rule provides for the addition of TSCA
section 4(e) Priority Testing List chemical substances or categories of
chemical substances. EPA s amending the TSCA section 8(d) model rule by
adding the recommended category of chemical substances consistent with
Sec.  716.105(b) and (c). In doing so, EPA must provide a 14-day
period, which starts upon publication of the amendments to the TSCA
section 8(d) model rule in the Federal Register, for persons to submit
information showing why a chemical substance, mixture, or category of
chemical substances should be withdrawn from the amendment. The
amendment adding these chemical substances to the TSCA section 8(d)
model rule is effective 30 days after date of publication in the
Federal Register. If the EPA Administrator withdraws a chemical
substance from the amendment, then no later than 30 days after the date
of publication of the amendment in the Federal Register, a Federal
Register document announcing this decision will publish.

D. Why is this action being issued as a final rule?

    EPA is publishing this action as a final rule pursuant to the
procedures set forth in Sec.  716.105(b) and (c). EPA finds that there
is ``good cause'' under the Administrative Procedure Act (APA) (5
U.S.C. 553(b)(3)(B)) to make these amendments without prior notice and
comment. EPA believes notice and an opportunity for comment on this
action are unnecessary. TSCA directs the ITC to add chemical substances
to the Priority Testing List for which EPA should give priority
consideration. EPA also lacks the authority to remove a chemical
substance from the Priority Testing List once it has been added by the
ITC. As explained earlier in this preamble, pursuant to Sec.
716.105(b) and (c), once the ITC adds a chemical substance to the
Priority Testing List, EPA adds that chemical substance to the list of
chemical substances subject to the TSCA section 8(d) model rule
reporting requirements, unless the ITC designated and recommended more
than 50 chemical substances or categories of chemical substances in a
calendar year or EPA withdraws the chemical substance from the TSCA
section 8(d) model rule for good cause. EPA promulgated this procedure
in 1985 after having solicited public comment on the need for and
mechanics of this procedure (Ref. 8). Because that rule established the
procedure for adding ITC chemical substances to the TSCA section 8(d)
model rule, it is unnecessary to request comment on the procedure in
this action. Finally, Sec.  716.105(b) and (c) do provide EPA with the
discretion to withdraw a chemical substance from the TSCA section 8(d)
model rule for good cause, including if a party submits to EPA
information showing good cause that a chemical substance should be
removed from the TSCA section 8(d) model rule.

III. Final Rule

A. What chemicals are to be added?

    EPA is adding the category of cadmium and cadmium compounds to the
TSCA section 8(d) model rule as requested by the ITC in the 69th ITC
Report (Ref. 9). This final rule requires manufacturers (including
importers) of cadmium or cadmium compounds, including as part of an
article, that have been, or are reasonably likely to be, incorporated
into consumer products to report certain unpublished health and safety
studies to EPA.

B. What are the general reporting requirements and deadlines?

    This final rule, issued pursuant to TSCA section 8(d) and its
regulations, requires manufacturers (including importers) of cadmium or
cadmium compounds, including as part of an article, that have been, or
are reasonably likely to be, incorporated into consumer products to
report certain unpublished health and safety studies to EPA. Listed in
this unit are the reporting requirements for the chemical substances
being added by this action to the TSCA section 8(d) model rule.
    The following types of persons need to report:
    1. Persons who, in the 10 years preceding the date a chemical
substance is listed at Sec.  716.120, either have proposed to
manufacture or import or have manufactured or imported the listed
substance must submit to EPA, during the 60-day reporting period
specified in Sec.  716.65 and according to the reporting schedule set
forth at Sec.  716.60, a copy of each health and safety study which is
in their possession at the time the chemical substance is listed.
    2. Persons who, at the time the chemical substance is listed,
propose to manufacture or import, or are manufacturing or importing the
listed chemical substance must submit to EPA during the 60-day
reporting period specified in Sec.  716.65 and according to the
reporting schedule set forth at Sec.  716.60:
    i. A copy of each health and safety study which is in their
possession at the time the chemical substance is listed.
    ii. A list of the health and safety studies known to them but not
in their possession at the time the chemical substance is listed.
    iii. A list of the health and safety studies that are ongoing at
the time the chemical substance is listed and are being conducted by or
for them.
    iv. A list of the health and safety studies that are initiated
after the date the chemical substance is listed and will be conducted
by or for them.
    v. A list of unpublished studies which have been sent to a Federal
agency with no claims of confidentiality or copies of each such study.
    vi. A copy of each health and safety study that was previously
listed as ongoing or subsequently initiated (i.e., listed in accordance
with reporting requirements described at Unit III.B.2.iii. and iv.
respectively) when complete--regardless of completion date.
    3. Persons who, after the time the substance is listed, propose to
manufacture or import the listed chemical substance must submit to EPA
during the reporting period specified in Sec.  716.65 and according to
the reporting schedule set forth at Sec.  716.60:
    i. A copy of each health and safety study which is in their
possession at the time they propose to manufacture or import the listed
chemical substance.
    ii. A list of the health and safety studies known to them but not
in their possession at the time they propose to manufacture or import
the listed chemical substance.
    iii. A list of the health and safety studies that are ongoing at
the time they propose to manufacture or import the listed chemical
substance, and are being conducted by or for them.
    iv. A list of the health and safety studies that are initiated
after the time they propose to manufacture or import the listed
chemical substance, and will be conducted by or for them.
    v. A list of unpublished studies which have been sent to a Federal
agency with no claims of confidentiality or copies of each such study.
    vi. A copy of each health and safety study that was previously
listed as ongoing or subsequently initiated (i.e., listed in accordance
with reporting requirements described in Unit III.B.3.iii. and iv.
respectively) when complete--regardless of the completion date.
    Generally, the reporting described in Unit III.B. is required by
March 4, 2013. Any person who manufactures or imports, or who proposes
to manufacture or import, the listed chemical substance as described in
Unit III.B. from January 2, 2013 to March 4, 2013 must inform EPA by
submitting a list of any studies initiated during the period from
January 2, 2013 to March 4, 2013 within 30 days of their initiation,
but in no case later than April 2, 2013. In addition, if any such
person has submitted lists of studies that were ongoing or initiated
during the period from January 2, 2013 to March 4, 2013 to EPA, such
person must submit a copy of each study within 30 days after its
completion, regardless of the study's completion date. See Sec. Sec.
716.60 and 716.65.
    Detailed requirements for reporting unpublished health and safety
studies are published in 40 CFR part 716. Also found there are
explanations of the reporting exemptions.

C. What are the chemical specific reporting requirements?

    Pursuant to Sec.  716.20(b)(5), the types of health, and/or
environmental effects studies that need to be reported and the chemical
substance grade/purity

requirements that need to be met or exceeded in individual studies for
cadmium and cadmium compounds are as follows:
    1. For the category ``cadmium and cadmium compounds'' (defined as
compounds including any unique chemical substance that contains cadmium
as part of that chemical's structure), reporting would extend to all
unpublished health and safety studies generally reportable under
Sec. Sec.  716.10 and 716.20, for example but not limited to those
that:
    i. Relate to the cadmium content (either from cadmium or cadmium
compounds) of consumer products (including the specific cadmium
compound (defined in Unit III.A.) used in the products such as surface
coatings and filler), data related to the product formulations, and
function of the cadmium (e.g., stabilizer, colorant, etc.) in the
products.
    ii. Relate to the assessment of consumer exposure to cadmium from
such products (including studies of bioavailability, description of the
consumer use (e.g., paints used on plastics), physical form of the
product containing cadmium, method of consumer product application
(e.g., spray applied, etc.), number of potentially exposed consumers).
    iii. Include data on cadmium migration from products (e.g.,
conducted using acid extraction or saline solution tests).
    iv. Include bio-monitoring data on cadmium presence in tissues.
    v. Focus on route, duration, and frequency of exposure to cadmium
in products.
    vi. Provide toxicity data on cadmium or cadmium compounds including
in vitro, in vivo, epidemiological, computational, or other studies on
effects of exposure to or use of the cadmium-containing product,
material, or component.
    vii. Discuss the function or use of cadmium or cadmium compounds in
a product, material or component including typical concentration.
    viii. Include data conducted in compliance with ASTM certification
standards and studies focusing on the effects of the cadmium or cadmium
compounds in consumer products on the health and safety of children.
    2. With regard to purity, studies showing any measurable content of
cadmium or cadmium compounds must be submitted.

D. What are the economic implications of this action?

    EPA's economic analysis for the addition of cadmium and cadmium
compounds to the Health and Safety Data Reporting rule is entitled
``TSCA Section 8(d): Economic Impact Analysis for the Addition of
Manufacturers and Importers of Consumer Products Containing Cadmium and
Cadmium Compounds From the Sixty-Ninth Report of the TSCA Interagency
Testing Committee to the Health and Safety Data Reporting Rule'' (Ref.
10), and can be found in the docket for this rule.
    EPA has estimated that 1,384 firms are subject to the rule and that
28 firms will have relevant studies to submit to EPA. EPA believes
firms that are subject to the rule will need to perform various
activities in order to comply with its requirements. The estimated cost
of this TSCA section 8(d) rule to firms is approximately $481,000.
    The estimated cost of this TSCA section 8(d) rule to the Federal
Government is approximately the time of 300 hours. That will amount to
a cost to the Federal Government of approximately $23,500.

IV. Requesting a Chemical Substance Be Withdrawn From the Final Rule

    As specified in Sec.  716.105(c), EPA may remove a chemical
substance or category of chemical substances from this final rule for
good cause prior to the effective date of this final rule. Any person
who believes that the reporting required by this final rule is not
warranted for a chemical substance, or the category of chemical
substances listed in this final rule may submit to EPA reasons for that
belief. You must submit your request to EPA on or before December 17,
2012 and in accordance with the instructions provided in Sec.
716.105(c) and (d), which are briefly summarized here. In addition, to
ensure proper receipt by EPA, you should identify docket ID number EPA-
HQ-OPPT-2011-0363 on your request and must submit that request in
accordance with the instructions in Sec.  716.105(c) and (d). If the
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention, withdraws a chemical substance or the category of chemical
substances from this TSCA section 8(d) amendment, in accordance with
Sec.  716.105(c), a Federal Register document announcing this decision
will be published no later than January 2, 2013.

V. References

    The docket for this final rule has been established under docket ID
number EPA-HQ-OPPT-2011-0363. The docket is available for review as
specified in ADDRESSES. The following is a listing of the documents
referenced in this preamble that have been placed in the docket for
this final rule:

    1. EPA. Requests for Information; Confidentiality of Business
Information; Final Rule. Federal Register (41 FR 36902, September 1,
1976).
    2. EPA. Integrated Risk Information System. Cadmium (CASRN 7440-
43-9) IRIS Summary. June 1992. Available online at: http://www.epa.gov/iris/subst/0141.htm.
    3. Agency for Toxic Substances and Disease Registry (ATSDR),
U.S. Department of Health and Human Services (HHS). ATSDR
Toxicological Profile for Cadmium (Draft). September 2008. Available
online at: http://www.atsdr.cdc.gov/toxprofiles/tp.asp?id=48&tid=15.
    4. Technology Transfer Network Air Toxics Web Site, Cadmium
Compounds (A). January 2000. Available online at: http://epa.gov/ttn/atw/hlthef/cadmium.html.
    5. ITC. Sixty-Eighth Report of the TSCA Interagency Testing
Committee to the Administrator of the Environmental Protection
Agency; Receipt of Report and Request for Comments; Notice. Federal
Register (76 FR 46174, August 1, 2011) (FRL-8879-3). Available
online at: http://www.gpo.gov/fdsys/pkg/FR-2011-08-01/pdf/2011-19414.pdf.
    6. CPSC. Recalls and Product Safety News. Available online at:
http://www.cpsc.gov/cgi-bin/haz.aspx and select ``Cadmium.''
    7. Standard Consumer Safety Specification for Toy Safety, ASTM
F-963. Available online at: http://www.astm.org/Standards/F963.htm
and also available online at: http://www.regulations.gov in docket
ID number EPA-HQ-OPPT-2011-0363.
    8. EPA. Chemical Information Rules; Additional Automatic
Reporting; Final Rule. Federal Register (50 FR 34809, August 28,
1985).
    9. ITC. Sixty-Ninth Report of the TSCA Interagency Testing
Committee to the Administrator of the Environmental Protection
Agency; Receipt of Report and Request for Comments; Notice. Federal
Register (77 FR 30856, May 23, 2012) (FRL-9346-3). Available online
at: http://www.gpo.gov/fdsys/pkg/FR-2012-05-23/pdf/2012-12493.pdf.
    10. EPA. TSCA Section 8(d): Economic Impact Analysis for the
Addition of Manufacturers and Importers of Consumer Products
Containing Cadmium and Cadmium Compounds From the Sixty-Ninth Report
of the TSCA Interagency Testing Committee to the Health and Safety
Data Reporting Rule. May 14, 2012.

VI. Statutory and Executive Order Reviews

A. Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993),
entitled ``Regulatory Planning and Review,'' this action is not a
``significant regulatory action'' and was therefore not reviewed by the
Office of Management and Budget (OMB) under Executive Orders 12866 and
13563, entitled ``Improving

Regulation and Regulatory Review'' (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act

    The information collection requirements contained in TSCA section
8(d) model rules have already been approved by OMB under the provisions
of the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., and OMB
control number 2070-0004 (EPA ICR No. 0575). The collection activities
in this final rule are captured by the existing approval and do not
require additional review and/or approval by OMB.
    EPA estimates that the information collection activities related to
health and safety data reporting for the category of cadmium and
cadmium compounds in this final rule will result in a total public
reporting burden of 7,019 hours. Of that total, an estimated 2,768
hours are estimated to be spent performing an initial review of the
final rule. The remaining hours are associated with the actual required
reporting activities (Ref. 10). As defined by PRA and 5 CFR 1320.3(b),
``burden'' means 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. This includes the time
needed to: Review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements
which have subsequently changed; train personnel to be able to respond
to a collection of information; search data sources; complete and
review the collection of information; and transmit or otherwise
disclose the information.
    Under PRA, an agency may not conduct or sponsor, and a person is
not required to respond to, an information collection request unless it
displays a currently valid OMB control number. The OMB control numbers
for EPA's regulations, including its regulations implementing TSCA
section 8(d) at 40 CFR part 716, are listed in the table in 40 CFR part
9 and included on the related collection instrument. This listing of
the OMB control numbers and their subsequent codification in the CFR
satisfies the display requirements of PRA and OMB's implementing
regulations at 5 CFR part 1320.

C. Regulatory Flexibility Act

    This final rule is not subject to the Regulatory Flexibility Act
(RFA), which generally requires an agency to prepare a regulatory
flexibility analysis for any rule that will have a significant economic
impact on a substantial number of small entities. RFA applies only to
rules subject to notice and comment rulemaking requirements under the
Administrative Procedure Act (APA) or any other statute. This rule is
not subject to notice and comment requirements under the APA or any
other statute because although the rule is subject to the APA, the
Agency has invoked the ``good cause'' exemption under 5 U.S.C.
553(b)(3)(B), therefore it is not subject to the notice and comment
requirement.

D. Unfunded Mandates Reform Act

    Pursuant to Title II of the Unfunded Mandates Reform Act, 2 U.S.C.
1531-1538, EPA has determined that this final rule does not contain a
Federal mandate that may result in expenditures of $100 million or more
for State, local, and tribal governments, in the aggregate, or the
private sector in any 1 year. In addition, EPA has determined that this
final rule will not significantly or uniquely affect small governments.
Accordingly, the final rule is not subject to the requirements of UMRA
sections 202, 203, 204, or 205.

E. Federalism

    Under Executive Order 13132, entitled ``Federalism'' (64 FR 43255,
August 10, 1999), EPA has determined that this final rule does not have
federalism implications because it will not have substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in the Executive Order. The rule establishes reporting requirements
that apply to manufacturers (including importers) of a category of
cadmium and cadmium compounds. The requirements of this final rule are
not expected to apply to States and localities and would not affect
State and local governments.

F. Indian Tribal Governments

    This action will not have tribal implications as specified in
Executive Order 13175, entitled ``Consultation and Coordination With
Indian Tribal Governments'' (65 FR 67249, November 9, 2000). EPA has
determined that this final rule will not have tribal implications
because it will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and the
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in the
Executive Order. EPA has no information to indicate that any tribal
government manufactures or imports the chemical substances covered by
this action.

G. Protection of Children

    This action is not subject to Executive Order 13045, entitled
``Protection of Children From Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because this action is not an
economically significant regulatory action as defined by Executive
Order 12866. However, cadmium and cadmium compounds are used in toys
that are intended for use by children, and thus presents a
disproportionate risk to children. The agency adequately considered
children's health issues during rule development.

H. Effect on Energy Supply, Distribution, or Use

    This action is not a ``significant energy action'' as defined in
Executive Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply Distribution'' (66 FR 28355, May 22,
2001), because this action is not an economically significant
regulatory action as defined by Executive Order 12866, and it is not
likely to have a significant adverse effect on the supply,
distribution, or use of energy.

I. Technical Standards

    Because this action will not involve any technical standards,
section 12(d) of the National Technology Transfer and Advancement Act,
15 U.S.C. 272 note, does not apply to this action.

J. Environmental Justice

    This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898, entitled
``Federal Actions To Address Environmental Justice in Minority
Populations and Low-Income Populations'' (59 FR 7629, February 16,
1994). This action is expected to have a positive impact on children in
low-income and minority communities by increasing the amount of cadmium
health and safety data available to EPA and consumers.

VII. Congressional Review Act

    Pursuant to the Congressional Review Act, 5 U.S.C. 801 et seq., EPA
will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to

publication of the rule in the Federal Register. This action is not a
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 716

    Environmental protection, Chemicals, Hazardous substances, Health
and safety studies, Reporting and recordkeeping requirements.

    Dated: November 20, 2012.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.

    Therefore, 40 CFR chapter I is amended as follows:

PART 716--[AMENDED]

0
1. The authority citation for part 716 continues to read as follows:

    Authority: 15 U.S.C. 2607(d).

0
2. In Sec.  716.21, add new paragraph (a)(9) to read as follows:

Sec.  716.21  Chemical specific reporting requirements.

    (a) * * *
    (9) (i) Reporting requirements for the category ``cadmium and
cadmium compounds'' apply only to persons that manufacture (including
import) cadmium or cadmium compounds that have been, or are reasonably
likely to be, incorporated into consumer products.
    (A) All unpublished health and safety studies generally reportable
under 40 CFR 716.10 and 716.20 must be reported.
    (B) [Reserved]
    (ii) With regard to purity, studies showing any measurable content
of cadmium or cadmium compounds in such products must be reported.
    (iii) For the purposes of this paragraph (a)(9), consumer product
means any product that is sold or made available to consumers for their
use in or around a permanent or temporary household or residence, in or
around a school, or in or around recreational areas.
* * * * *
    3. In Sec.  716.120, add, before the entry ``Chlorinated benzenes,
mono-, di-, tri-, tetra-, and penta-,'' the category ``Cadmium and
cadmium compounds'' and its entry in alphabetical order to the table in
paragraph (c) to read as follows:

Sec.  716.120  Substances and listed mixtures to which this subpart
applies.

* * * * *
    (c) * * *

----------------------------------------------------------------------------------------------------------------
                                       CAS No.
            Category                (examples for   Special exemptions     Effective date        Sunset date
                                      category)
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Cadmium and cadmium compounds     ................  ..................  January 2, 2013....  March 4, 2013.
 (any unique chemical substance
 that contains cadmium as part
 of that chemical's structure).
Manufacturers (including          ................                Sec.
 importers).                                              716.21(a)(9)

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

[FR Doc. 2012-28840 Filed 11-30-12; 8:45 am]
BILLING CODE 6560-50-P


"King, Heidi R."<EMAIL_ADDRESS> 12/06/2007 09:40 AM

To

Kathy Kaufman/RTP/USEPA/US@EPA

cc

Subject

RE: FW: Dates for Pb RIA Issues

No need for confusino - do you have a moment to chat on the phone and

I'll explain?

Heidi

202 395 4551

-----Original Message-----

From<EMAIL_ADDRESS> <EMAIL_ADDRESS> Sent: Thursday, December 06, 2007 9:39 AM

To: King, Heidi R.

Cc<EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS> Subject: Re: FW: Dates for Pb RIA Issues

Heidi -- I was struggling for what to tell Margaret to title each

meeting before I had a clear idea how to divide the discussion up, so I

apologize for the lack of clarity.

By scope, I meant the data sources (monitoring, emissions inventory) and

also what we will realistically be able to accomplish analytically given

the data we've got, and the time available.

By elements I meant a walk-through of the steps in the analysis --

developing emissions / air quality relationships, costs, and benefits.

That'll have to stretch over more than one briefing, I expect.

I'm a little confused, given the message I'm getting from Lydia per your

phone call with her, that you are expecting the first briefing to focus

solely on the target levels we're going to analyze?  I wonder if such a

discussion would quickly devolve into Zach and Deirdre's bailiwick (the

risk assessment issues).  Because we don't have decisions yet  on the

NAAQS levels to be proposed next spring, we're planning on looking at a

wide range of levels right now as we get started with the analysis, as

it'll be easier to narrow it later than broaden it later.

So I'm confused about whether Zach and the other health people need to

be at this meeting.

Thanks.

-- Kathy

Kathy Kaufman

EPA/OAQPS Mail Code C539-03

Research Triangle Park, NC 27711

Phone<PHONE_NUMBER>

Fax<PHONE_NUMBER>

             "King, Heidi R."

             <Heidi_R._King@o

             mb.eop.gov>                                             To

                                      Kathy Kaufman/RTP/USEPA/US@EPA

             12/05/2007 07:09                                        cc

             PM

                                                                Subject

                                      FW: Dates for Pb RIA Issues

 Hi Kathy, follow up to previous email.

1) Does "scope" refer to standards to be included in the analysis?

2) And Elements refers to the Monitoring system, monitoring data, and

Emiss Inventory data?

Thanks!

heidi

-----Original Message-----

From<EMAIL_ADDRESS> <EMAIL_ADDRESS> Sent: Tuesday, December 04, 2007 11:05 AM

To: King, Heidi R.; Beck, Nancy

Cc<EMAIL_ADDRESS><EMAIL_ADDRESS> Subject: Dates for Pb RIA Issues

Heidi, these are the dates/times I have been able to come up with.

1.  Scope of the Pb NAAQS RIA - Tuesday, 12/11/07 @ 9:30am - 10:30am 2.

Elements of the Analysis - Friday, 12/14/07 @ 2:00pm - 3:00pm 3.  Cont'd

Scope & Elements mtg - Monday, 12/17/07 - 1:00pm - 2:00pm

Margaret Morrison (MC C504-02)

US EPA/OAQPS/HEID/IO

Telephone:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>

<EMAIL_ADDRESS> ----- Forwarded by Kathy Kaufman/RTP/USEPA/US on 04/28/2008 10:20 AM -----

"King, Heidi R."<EMAIL_ADDRESS> 12/14/2007 10:17 AM

To

Kathy Kaufman/RTP/USEPA/US@EPA

cc

Subject

RE: materials for Pb NAAQS RIA call at 2 today

Thanks -

-----Original Message-----

From<EMAIL_ADDRESS> <EMAIL_ADDRESS> Sent: Friday, December 14, 2007 10:06 AM

To: King, Heidi R.

Subject: materials for Pb NAAQS RIA call at 2 today

Heidi -- sorry for the delay.  Here you go..

(See attached file: Pb NAAQS Getting to the emissions to air quality

relationships 12-14-07.ppt)

Kathy Kaufman

EPA/OAQPS Mail Code C539-03

Research Triangle Park, NC 27711

Phone<PHONE_NUMBER>

Fax<PHONE_NUMBER>

----- Forwarded by Kathy Kaufman/RTP/USEPA/US on 04/28/2008 10:20 AM -----

"King, Heidi R."<EMAIL_ADDRESS> 12/18/2007 02:09 PM

To

Lydia Wegman/RTP/USEPA/US@EPA

cc

Kathy Kaufman/RTP/USEPA/US@EPA, "Johansson, Robert" <EMAIL_ADDRESS>"Beck, Nancy" <EMAIL_ADDRESS> Subject

Lydia: Topics for Thu NAAQS Pb NAAQS Risk Assessment Interagency Briefing

Lydia,

Below are a few points to help Zach identify topics that would be helpful to include in Thursdays interagency briefing on the Pb NAAQs Risk Assessment.  Recall that I promised these to you last week, summarizing the types of questions I've been hearing from out interagency colleagues:

Overview of how the risk assessment is constructed, and how the various components are used, including

 Case Studies (supporting the continued control of Pb?)

 Calculation of threshold (supporting selection of the standard?

How does risk assessment manage “old air” versus “new air”

How are various exposure pathways parsed out

Paint vs air vs Point Source vs crustal etc

Relationship btw monitored air levels and exposure

Key sources of uncertainty, as well as areas of greater certainty (eg endpoints)

Thanks,

heidi

OMB/OIRA

(202) 395-4551


[Federal Register Volume 87, Number 175 (Monday, September 12, 2022)]
[Notices]
[Page 55801]
[FR Doc No: 2022-19632]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 3021-091]

Allegheny Hydro LLC, Allegheny Hydro LP, H2O All Dam LLC; Notice
of Application for Transfer of License and Soliciting Comments, Motions
To Intervene, and Protests

    On June 29, 2022, Allegheny Hydro LLC (transferor) and H2O All Dam
LLC (transferee) filed jointly an application for the transfer of
license of the 30.4-Megawatts Allegheny River Lock and Dam Nos. 8 & 9
Hydroelectric Project No. 3021. The project is located on Allegheny
River, Armstrong County, Pennsylvania.
    The applicants seek Commission approval to transfer the license for
the Allegheny River Lock and Dam Nos. 8 & 9 Hydroelectric Project from
the transferor to the transferee. The applicants are also requesting
approval for the transfer of the license from Allegheny Hydro LLC to
Allegheny Hydro LP that occurred when the transferor converted from
limited liability company to a limited partnership. The transferee will
be required by the Commission to comply with all the requirements of
the license as though it were the original licensee.
    Applicants Contact: For transferor and transferee: Mr. Stephen L.
Pike, FirstLight Power Services LLC, 111 South Bedford Street, Suite
103, Burlington, MA 01803, Phone:<PHONE_NUMBER>, Email:
[email protected] and Ms. Julia S. Wood, Rock Creek Energy
Group, LLP, 1 Thomas Circle NW, Suite 700, Washington, DC 20005, Phone:
(202) 998-2770, Email: [email protected].
    FERC Contact: Anumzziatta Purchiaroni,<PHONE_NUMBER>,
[email protected].
    Deadline for filing comments, motions to intervene, and protests:
30 days from the date that the Commission issues this notice. The
Commission strongly encourages electronic filing. Please file comments,
motions to intervene, and protests using the Commission's eFiling
system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at [email protected],<PHONE_NUMBER> (toll free), or
(202) 502-8659 (TTY).
    In lieu of electronic filing, you may submit a paper copy.
Submissions sent via U.S. Postal Service must be addressed to, Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First
Street NE, Room 1A, Washington, DC 20426. Submissions sent via any
other carrier must be addressed to, Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville,
Maryland 20852. The first page of any filing should include docket
number P-3021-091. Comments emailed to Commission staff are not
considered part of the Commission record.

    Dated: September 6, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-19632 Filed 9-9-22; 8:45 am]
BILLING CODE 6717-01-P


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: [Emily Schmid;<PHONE_NUMBER>]

INSTRUCTIONS: Please utilize this outline in preparing the pesticide petition. In cases where the outline element does not apply, please insert "NA-Remove" and maintain the outline. Please do not change the margins, font, or format in your pesticide petition. Simply replace the instructions that appear in green, i.e., "[insert company name]," with the information specific to your action.

TEMPLATE:

[Bayer CropScience]

[Insert petition number]

EPA has received a pesticide petition ([insert petition number]) from [Bayer CropScience], [800 N. Lindbergh Blvd. St. Louis, MO 63167] proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by

 Establish indaziflam tolerances for plant matrices are based on the combined residues of indaziflam ({1,3,5-triazine-2,4-diamine,N-[(1R,2S)-2,3-dihydro-2,6-dimethyl-1H-inden-1-yl]-6-[1-fluoroethyl]} and its metabolite {6-[1-fluoroethyl]-1,3,5-triazine-2,4-diaminotriazine} calculated as indaziflam equivalents. in or on the raw agricultural commodities: Crop group 17 (Grass Forage, Fodder, and Hay Group) grass forage at 30 parts per million (ppm) and grass hay at 10 ppm; in sugarcane, cane at 0.01 ppm.   Establish indaziflam tolerances for residues of indaziflam ({1,3,5-triazine-2,4-diamine,N-[(1R,2S)-2,3-dihydro-2,6-dimethyl-1H-inden-1-yl]-6-[1-fluoroethyl]}for animal fat, meat, meat by-products, milk, and milk fat at: 0.07, 0.01, 0.2, 0.01 and 0.25 ppm respectively.

EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

1. Plant and livestock metabolism. [The nature of the indaziflam residues in plants and livestock is adequately understood.

The plant residues of concern for tolerance enforcement are the combined residues of indaziflam (N-[(1R,2S)-2,6-Dimethyl-2,3-dihydro-1H-inden-1-yl]-6-[(1R)-1-fluoroethyl]-1,3,5-triazine-2,4-diamine] and its fluoroethyl-indaziflam metabolite [6-[(1R)-1-Fluoroethyl]-1,3,5-triazine-2,4-diamine-]

In livestock the residue of concern for risk assessment is: indaziflam parent compound (N-[(1R,2S)-2,6-Dimethyl-2,3-dihydro-1H-inden-1-yl]-6-[(1R)-1-fluoroethyl]-1,3,5-triazine-2,4-diamine), indaziflam-acid ((2S,3R)-3-[[4-Amino-6-[(1R)-1-fluoroethyl]-1,3,5-triazin-2-yl]amino]-2,3-dihydro-2-methyl-1H-indene- 5-carboxylic acid), indaziflam-3 hydroxyindane ((2R,3R)-3-[[4-amino-6-[(1R)-1-fluoroethyl]-1,3,5-triazin-2-yl]amino]-2,5-dimethyl-indan-1-ol), indaziflam-3-ketohydroxymethyl ((2R,3R)-3-[[4-amino-6-[(1R)-1-fluoroethyl]-1,3,5- triazin-2-yl]amino]-5-(hydroxymethyl)-2-methyl-indan-1-one) and indaziflam-triazinediamine (6-[(1R)-1-Fluoroethyl]-1,3,5-triazine-2,4-diamine).]  Bayer proposes that the residue definition for enforcement be indaziflam parent only.

      2. Analytical method. [Indaziflam residues are quantified in raw agricultural commodities by high pressure liquid chromatography/triple stage quadrupole mass spectrometry (LC/MS/MS) using the stable isotopically labeled analytes as internal standards. The limit of quantification (LOQ) for each analyte is 0.005 ppm for all commodities.

Indaziflam residues are quantified in commodities of animal origin by high pressure liquid chromatography/triple stage quadrupole mass spectrometry (LC/MS/MS) using the stable isotopically labeled analytes as internal standards. The LOQ of each analyte is 0.01 ppm for fat, meat, meat by-produucts and feces.  The LOQ of each analyte is 0.005 ppm for milk.]

      3. Magnitude of residues. [A total of twelve field trials were conducted to measure the magnitude of indaziflam {1,3,5-triazine-2,4-diamine, N-[(1R,2S)-2,3-dihydro-2,6-dimethyl-1H-inden-1-yl]-6-[1-fluoroethyl]} residues grass (forage and hay) following broadcast applications of indaziflam. Indaziflam was applied as either a single application of 0.065 ib ai/A (0.073 Kg ai/ha) or as two applications at a rate of 0.039 lb ai/ha (0.44 Kg ai/ha) per application with a 60 day interval.         Following one foliar application of Alion at a rate of 0.064 to 0.068 lb indaziflam/A (0.072 to 0.076 kg indaziflam/ha) to grass, the total indaziflam residues in grass hay collected at earliest commercial harvest (ECH) ranged from <0.010 to 21 ppm, and the total indaziflam residues in grass forage collected at a 0-day PHI ranged from 2.2 to 18 ppm.  Following two foliar applications of Alion at a total seasonal rate of 0.076 to 0.080 lb indaziflam/A (0.086 to 0.089 kg indaziflam/ha) to grass (TRTD2), the total indaziflam residues in grass hay collected at ECH ranged from 0.020 to 8.0 ppm, and the total indaziflam residues in grass forage collected at a 0-day PHI ranged from 1.4 to 5.4 ppm.

 A total of eight field trials were conducted to measure the magnitude of indaziflam {1,3,5-triazine-2,4-diamine, N-[(1R,2S)-2,3-dihydro-2,6-dimethyl-1H-inden-1-yl]-6-[1-fluoroethyl]} residues in sugar cane (stalk) following broadcast applications of indaziflam.  Indaziflam was applied as either a single application of 0.065 ib ai/A (0.073 Kg ai/ha) or as two applications at a rate of 0.039 lb ai/ha (0.044 Kg ai/ha) per application with a 58 to 60 day interval.  Following both treatment regimens all total residue of indaziflam, in sugar cane stalk collected at ECH was below the limit of quantitation (0.01 ppm).        Two processing trials were conducted to measure the magnitude of indaziflam {1,3,5-triazine-2,4-diamine, N-[(1R,2S)-2,3-dihydro-2,6-dimethyl-1H-inden-1-yl]-6-[1-fluoroethyl]} residues in sugar cane and sugarcane processed commodities following  a single broadcast applications of indaziflam at a rate of 0.326 lb ai/A (0.065 Kg ai/ha), five times the maximum proposed single application use rate.        Following a five-fold exaggerated application of Alion to two separate processing trials of sugarcane, the total indaziflam residues in the sugarcane stalk samples were all less than the LOQ (0.01 ppm.  Since no indaziflam residues above the LOQ were observed in the sugarcane RAC study, the sugarcane processed commodities were not analyzed and no processing factors were derived.

Three trials each were conducted with wheat, turnip and soybean planted as rotational crops 22 months after a single application of indaziflam to bare soil at a rate of 0.078 lb ai/A (0.088 Kg ai/ha).   Total indaziflam residues in wheat (forage hay, grain and straw), turnip (roots and tops) and soybean seed were all less than the limit of quantitation (0.01 ppm).  The highest average field trial (HAFT) residues in soybean forage and hay were 0.021 ppm and 0.029 ppm, respectively.

 A feeding study was conducted to measure total indaziflam residue in milk, cream (milk fat), skim milk (whey), mesenteric (omental) fat, perirenal fat, subcutaneous fat, liver, kidney, muscle and excrement (feces or faeces) from lactating Holstein dairy cows (Bos taurus) following 29 consecutive days of dosing with indaziflam.  The base daily dose of indaziflam was calculated to be 31 mg/kg dry matter feed.  Three groups of cows were fed at 31 (1x), 934 (3X) and 311 (10x) mg/kg dry matter feed.  Average total indaziflam residues in milk, at the 28th day were 0.028 ppm, 0.038 ppm and 0.15 ppm, respectively at the 1x, 3x and 10x rates.  Average total indaziflam residues in fat ranged from 0.068 to 0.082 ppm, from 0.11 ppm to 0.12 ppm and from 0.27 ppm to 0.36 ppm, respectively, at the 1x, 3X and 10x rates.  Average total indaziflam residues in kidney were 0.10 ppm, 0.22 ppm and 0.74 ppm, respectively, at the 1x, 3X and 10x rates.  Average total indaziflam residues in liver were 0.20 ppm, 0.31 ppm and 1.3 ppm, respectively, at the 1x, 3X and 10x rates.  Average total indaziflam residues in muscle were < 0.05 ppm, 0.05 ppm and 0.08 ppm, respectively, at the 1x, 3X and 10x rates.  In the depuration phase, residues in all tissues and milk declined rapidly after the end of dosing.]

B. Toxicological Profile

      1. Acute toxicity. Indaziflam has low acute oral (LD50 > 2,000 mg/kg-bw; Category III), dermal (LD50 > 2,000 mg/kg-bw; Category III), and inhalation toxicity (LC50 > 2.30 mg/L air; Category IV) in male and female rats.  Indaziflam is not an eye or skin irritant (both Category IV) and is not a skin sensitizer.

      2. Genotoxicity. Indaziflam is not genotoxic; it was negative for mutagenicity in reverse and forward gene mutation assays and negative for clastogenicity in vitro and in vivo.

      3. Immunotoxicity. Immunotoxicity potential was evaluated with a subacute oral (diet) exposure to rats.  Immunotoxicity was not observed with indaziflam exposure, and as such the no observable adverse effect level for immunotoxicity was defined as the highest dose tested (10,000/6,000 ppm in diet, equivalent to 528 and 738 mg/kg-bw/day in males and females, respectively).

      4. Reproductive and developmental toxicity. No effects on reproduction and development were observed in the reproductive and developmental studies conducted with indaziflam, demonstrating that indaziflam is not a reproductive toxicant.  Offspring effects in the rat developmental toxicity study (i.e. decreased fetal weight) were observed only in the presence of maternal toxicity, including decreased body weight gain and food consumption.  No developmental effects were observed in rabbits up to maternally toxic doses.  Decreased pup weights and delays in preputial separation and vaginal opening were observed in the rat 2-generation reproductive toxicity study, but only in the presence of parental toxicity characterized by coarse tremors, renal toxicity, and decreased weight gain. Further, there was no indication of a teratogenic effect of indaziflam in either the rat or the rabbit.               5. Neurotoxicity. Based on evaluations in the rat (acute, chronic, and developmental neurotoxicity studies) and in the dog (subchronic and chronic studies), the nervous system is considered the major target for indaziflam toxicity, with the dog being the more sensitive species. A single oral dose of indaziflam decreased motor and locomotor activity in male (at 500 mg/kg and 2000 mg/kg) and in female ( >= 100 mg/kg) rats, with recovery within seven days. Other effects included urine, oral and perianal stains (generally resolved one to five days after treatment); tremors; increased reactivity and decreased activity (generally resolved the following day after treatment); increased salivation; cool to touch; clonic convulsions; ventrum wet/staining; and death in three females (at 2000 mg/kg only).  In male rats, acute indaziflam treatment (2000 mg/kg only) also corresponded to microscopic lesions described as focal to multi-focal individual nerve fiber degeneration, observed in the Gasserian ganglion and peripheral nerves (sciatic and tibial).  Based on these results, indaziflam exposures of 50 and 100 mg /kg-bw are the acute NOAELs for neurotoxicity in female and male rats, respectively. In the subchronic rat study, there were no mortalities.  However, similar effects in motor and locomotor activity, as well as clinical signs of neurotoxicity (tremors, repetitive chewing motion, and perianal and lacrimal staining), were noted at the highest doses tested, 10,000 ppm (585.7 mg/kg-bw/day) for male rats and 8,000 ppm (580.9 mg/kg-bw/day) for female rats.  These results establish a NOAEL for subchronic neurotoxicity in rats at 4000 ppm (243.6 mg/kg-bw/day in males and 306.9 mg/kg-bw/day in females).  In the developmental rat neurotoxicity study, the dam and offspring NOAEL was 1000 ppm (83.8 mg/kg-bw/day), based on clinical signs of toxicity in dams (tremor, dilated pupils, nasal stains, and repetitive chewing movements), marked decrease in body weight and body weight gain, and decreased food consumption in dams and offspring. There were no effects on neuropathology in this developmental neurotoxicity study. The neurotoxic effects of indaziflam in dogs, which were more sensitive than rats, are described further in subsequent sections describing subchronic and chronic toxicity.

      6. Subchronic toxicity. Short- and intermediate-term exposures to indaziflam were assessed in the mouse, rat, and dog.  Indaziflam is not toxic by the dermal route, as there was no toxicity noted at the highest dose tested (1000 mg/kg-bw/day) in a 28-day dermal toxicity study in rats.  The only adverse treatment related effects noted in the mouse following a 90-day oral exposure were reduced body weights, body weight gain, and food consumption at the highest dose tested.  Minimal to moderate follicular cell hypertrophy of the thyroid gland was seen in male rats with a 90-day exposure (5000 and 10,000 ppm), and decreased body weights were seen with 10,000 ppm exposures in male and female rats. Adaptive, reversible findings were seen in the liver of rats, and were restricted to increased liver weight, hepatocellular hypertrophy, increased cholesterol, and lower total bilirubin.  Kidneys were enlarged in the rat, but without any corresponding weight change or pathology.  Neurotoxicity was evident in both rats and dogs receiving subchronic oral exposures to indaziflam.  Effects observed in rats included tremors; repetitive chewing movements; perianal, lacrimal, and nasal staining; and decreased motor and locomotor activity in female rats.  In dogs, effects observed included tremors, ataxia, labored breathing, and seizures in high-dose group male and female dogs.  Neuropathological lesions including axonal swelling and degeneration, as well as individual nerve fiber degeneration, were also observed in male and female dogs.  These findings were located in the brain, spinal cord, and peripheral (sciatic and tibial) nerve tracts.  The dog was the most sensitive species overall after subchronic administration of indaziflam, with the lowest NOAEL of 7.5 mg/kg-bw/day based on neurotoxicity findings in males and female dogs in the 90-day oral gavage study.

      7. Chronic toxicity. Chronic toxicity of indaziflam was evaluated in the mouse, rat, and dog, and there was no evidence of carcinogenicity in any of these species.  There were no treatment-related neoplasms in rat or mouse. Therefore, following chronic exposure, there is no indication of oncogenic potential relevant for the human health risk assessment of indaziflam.  Target organs in mice and rats included liver and kidney, and effects on the thyroid and nervous system were also targets in rats.  Following chronic exposure, mice demonstrated decreased body weight, body weight gain, and food consumption in both sexes; increased incidence of renal and hepatotoxicity in males; and, increased incidence of non-neoplastic changes in the stomach and ovaries of females, at the highest dose tested (1000 ppm).  High dose female rats (10,000 ppm) demonstrated similar signs to those observed in the acute and subchronic neurotoxicity studies (e.g. dilated pupil, reduced motor activity, limited use of limbs, uncoordinated movements, tremors, hindlimbs splayed, low alertness) following chronic administration. The incidence of treatment-related clinical signs in females decreased significantly after the dietary administration for the top dose group was decreased from 10,000 to 6000 ppm due to manifestation of clinical signs.  Clinical signs were not evident in the chronic dog at any dose level.  Organ effects noted in these studies included increased liver, kidney and thyroid weights, with centrilobular hepatocellular hypertrophy in the liver, tubular hyperplasia (male mouse only) and brown pigment in the kidney, and follicular cell hypertrophy in the thyroid (male rat only), histopathological changes to the central and peripheral nerve tracts were noted only in the dog. The dog was the most sensitive species overall after chronic administration of indaziflam, with the lowest NOAEL at 2.0 mg/kg-bw/day in males and females in the 1-year oral feeding study.

      8. Animal metabolism. A metabolism study for indaziflam, in which male rats were given single oral doses of [indane-3-14C]- or [triazine-2,4-14C]-labeled indaziflam, demonstrated that the uptake and excretion of indaziflam was rapid.  Following oral administration, greater than 87% of the administered dose was excreted within 24 hours.  In general, the majority of the radioactivity was excreted in the feces with fecal:renal excretion ratios ranging from approximately 1:1 for the low dose experiments to approximately 10:1 for the high dose experiments.  No volatile residues were detected, and no mineralization was observed.  Residue levels in tissues were highest in gastrointestinal tract and liver.  Higher residue levels were found in the residual carcass of animals in the bile cannulation experiments.        Both uptake and clearance of indaziflam from the blood was rapid.  Females appeared to absorb slightly more material compared to for males.  Blood residues smoothly declined in all dose groups over time, indicating an absence of reuptake.        Once absorbed, the metabolism of indaziflam was rapid, occurring mainly through oxidative pathways.  The portion of the administered dose recovered as parent in the feces, particularly in the high dose experiments, was likely not absorbed.

      9. Metabolite toxicology. The two major metabolites of indaziflam are AE 2158969 (BCS-AA10717-carboxylic acid) and BCS-AA10365 (BCS-AA10717-fluoroethyldiaminotriazine, FDAT).  As AE 2158969 was a major metabolite in the rat, toxicity studies conducted with indaziflam are adequate to assess any potential toxicity of this metabolite.  An additional study of BCS-AA10365 demonstrated its lack of relevance for the neurotoxic effects of indaziflam that drive the risk assessment.  Primary mutagenicity screening tests were negative for both of these indaziflam metabolites, and therefore these metabolites are not genotoxic.

      10. Endocrine disruption. The toxicology database for indaziflam (BCS-AA10717) is current and complete.  Studies in this database include evaluation of the potential effects on reproduction and development and an evaluation of the pathology of the endocrine organs following short- or long-term exposure.  No effects on reproduction and development were observed in the reproductive and developmental studies conducted with indaziflam.

C. Aggregate Exposure

1. Dietary exposure. [The proposed new uses of indaziflam on grass and sugarcane will have minor effects on the previous dietary aggregate risk assessment conducted for all registered uses (EPA, D408152, 2013).  Residues for the additional crop group were based on recommended tolerances.  Assessments, using the DEEM FCID Version 4.02 software, were conducted to evaluate potential risks due to chronic and acute dietary exposure of the U.S. population and selected population subgroups to residues of indaziflam.  Consumption data used in this program were taken from NHANES WWEIA 2005-2010.

The toxicological and exposure database for indaziflam is considered complete.  There was no indication of an increased sensitivity of the young in any studies including the reproductive and developmental studies in rats and rabbits.  Therefore, the special FQPA safety factor can be reduced to 1X and an uncertainty factor of 100 is adequate to account for inter- and intra- species variability.  Acute and chronic Population Adjusted Doses (aPAD and cPAD) are, therefore, the same as the reference doses for the populations and subpopulations of interest.  Acute dietary exposure was expressed as a percentage of the aPAD of 0.075 mg/kg bw/day from a NOAEL of 7.5 mg/kg bw/day, based on axonal degenerative findings in the dog subchronic gavage toxicity study, with an uncertainty factor of 100.  Chronic dietary exposure was expressed as a percentage of the chronic Population Adjusted Dose (cPAD) of 0.02 mg/kg bw/day based on a NOAEL of 2 mg/kg bw/day in the dog chronic dietary toxicity study with an uncertainty factor of 100.]

      i. Food. [Assessments were conducted to evaluate potential risks due to acute and chronic dietary exposure of the U.S. population and selected population subgroups to residues of indaziflam including all registered crops and proposed crops.  This conservative, unrefined assessment assumed recommended tolerance levels for all commodities, 100% Percent Crop Treated (PCT) and default processing factors to adjustment crop residue values.  Acute exposure (95th percentile) for food only utilizes 1.3% of the aPAD for the US Population and 4.4% for Children 1-2 yrs., the most highly exposed subpopulation.  Chronic exposure utilizes 1.3% of the cPAD for the US Population and 8% of the cPAD for Children 1-2 yrs., the most highly exposed subpopulation.]              ii. Drinking water. [Estimated Drinking Water Concentrations (EDWCs) associated with indaziflam use on all crops were calculated by EFED (EPA, D356141, 2010) using SCI-GROW v2.3 and PRZM-EXAMS to calculate ground water and surface water EDWCs, respectively.  EDWCs were calculated for total indaziflam based on parent and degradates FDAT and ROI1 (a degradate of FDAT).  The maximum acute and chronic surface water concentrations estimated by SCI-GROW were 84 ppb and 26 ppb, respectively, and were higher than the ground water estimates.  The value from the highest surface water exposure scenarios were incorporated into the dietary risk assessment.  The addition of the acute estimated drinking water concentration (EDWC) of 84 ppb resulted in 7% of the aPAD utilized for the US Population and 21% utilized for Infants (< 1 yr.), the most highly exposed subpopulation.  The addition of the chronic EDWC of 26 ppb utilized 4% of the cPAD for the US Population and 12% of the cPAD for Infants (< 1 yr.), the most highly exposed subpopulation.  In conclusion, the results of the acute and chronic Tier 1 dietary exposure analyses (including drinking water) are acceptable for all population subgroups examined.  Addition of tolerance residues for the proposed crops shows a slight increase in %aPAD and %cPAD but these additions are well below the EPA level of concern of 100% of the PAD.]

2. Non-dietary exposure. Short- and intermediate-term occupational exposures were assessed. The occupational exposure and risk scenarios adequately cover the use on rangeland and pastureland grasses and sugarcane, and the risk estimates are not of concern.

The restricted entry interval (REI) listed on proposed labels is based on the acute toxicity of the technical material. Indaziflam has low acute dermal toxicity (Toxicity Category III) and is not an ocular or dermal irritant or a dermal sensitizer (Category IV). Acute toxicity Category III and IV chemicals require a 12- hour REI. Furthermore, all short-term, post-application dermal exposures resulted in MOEs greater than the level of concern (MOE>100) and therefore were not of concern. Therefore, the 12-hour REI that appears on the proposed labels is adequate and not of concern to HED.

D. Cumulative Effects

The toxicological properties of indaziflam indicate that it does not have a common mechanism of toxicity with any other compounds.  Although it contains a triazine ring it does not exhibit the toxicological properties of the chlorotriazine common mechanism group.  Therefore it is not necessary to cumulate its exposure with any other compounds.

E. Safety Determination

      1. U.S. population. [Using the conservative exposure assumptions described above and based on a completeness of toxicity data, it can be concluded that aggregate exposure to residues of indaziflam present a reasonable certainty of no harm.  Chronic aggregate dietary exposure (food and water) will utilize less than 4% of the cPAD for the US Population.  Acute aggregate dietary exposure (food and water) for the U.S. population, utilizes 7% of the aPAD.  Non-dietary and aggregate MOEs (food, drinking water, and non-dietary) are above the Level of Concern.  Therefore, the aggregate assessment for all proposed uses for indaziflam demonstrates that there is a reasonable certainty that no harm will result to the US Population and subpopulations from the use of indaziflam noted here.]

      2. Infants and children. [The developmental and reproductive toxicity of indaziflam were evaluated in developmental toxicity studies in the rat and rabbit, a 2 generation reproduction study in the rat and a developmental neurotoxicity study in the rat.  These studies are discussed under Section B (Toxicology Profile) above.  The developmental toxicity data demonstrated no increased sensitivity of rats or rabbits to in utero exposure to indaziflam.  In addition, the multi generation reproductive toxicity study did not identify any increased sensitivity of rats to in utero or post natal exposure.  The developmental toxicity studies are designed to evaluate adverse effects on the developing organism resulting from maternal pesticide exposure during gestation.  Reproduction studies provide information relating to effects from exposure to the pesticide on the reproductive capability of mating animals and data on systemic toxicity.        FFDCA section 408 provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for pre and post natal toxicity and the completeness of the data base unless EPA determines that a different margin of safety will be safe for infants and children.  The indaziflam database is complete for FQPA purposes and there are no residual uncertainties for pre-/post-natal toxicity for indaziflam.  Therefore, the Special FQPA Safety Factor can be reduced to 1X.        Based on the exposure assessments described above and on the completeness and reliability of the toxicity data, it can be concluded that the dietary exposure from all proposed uses of indaziflam consumes 21% of the aPAD at the 95th percentile and 12% of the cPAD for the most sensitive population subgroup of infants.  Short-term aggregate risk assessment of indaziflam which includes food, drinking water and residential pathways calculated a MOE of 1,400 for adults and a MOE of 530 for Children.  This is well above the Level of Concern of 100 for indaziflam.  Thus, it can be concluded that there is a reasonable certainty that no harm will result from aggregate exposure to indaziflam residues.]

F. International Tolerances

[Currently, there currently are no international (CODEX) tolerances/MRLs for indaziflam.  Several jurisdictions Canada, European Union and Japan maintain MRLs at 0.01 ppm for tree, nut and vine crops.   Korea maintains MRLs at 0.05 ppm for orchard fruits and 0.01 ppm for tree nuts.]