[Federal Register Volume 77, Number 93 (Monday, May 14, 2012)]
[Rules and Regulations]
[Pages 28281-28282]
[FR Doc No: 2012-11493]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 799

[EPA-HQ-OPPT-2005-0033; FRL-9350-2]
RIN 2070-AD16

Withdrawal of Revocation of TSCA Section 4 Testing Requirements
for One High Production Volume Chemical Substance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: In the Federal Register issue of March 16, 2012, EPA published
a direct final rule revoking certain testing requirements promulgated
under the Toxic Substances Control Act (TSCA) for 10 chemical
substances, including benzenesulfonic acid, [[4-[[4-
(phenylamino)phenyl][4-(phenylimino)-2,5-cyclohexadien-1-
ylidene]methyl]phenyl]amino]- (CAS No. 1324-76-1), also known as C.I.
Pigment Blue 61. EPA received an adverse comment regarding C.I. Pigment
Blue 61. This document withdraws the revocation of testing requirements
for C.I. Pigment Blue 61 as described in the March 16, 2012 direct
final rule. In withdrawing the revocation, this document also restores
the original testing requirements as currently shown in the Code of
Federal Regulations (CFR). Elsewhere in today's Federal Register, EPA
is publishing a proposed rule revoking the same testing requirements
for C.I. Pigment Blue 61 that were published in the March 16, 2012
direct final rule.

DATES: This final rule is effective May 15, 2012.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Catherine Roman, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-8157; 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. Does this action apply to me?

    A list of potentially affected entities is provided in the Federal
Register issue of March 16, 2012 (77 FR 15609) (FRL-9335-6). If you
have questions regarding the applicability of this action to a
particular entity, consult the technical person listed under FOR
FURTHER INFORMATION CONTACT.

II. What rule is being withdrawn?

    In the March 16, 2012 Federal Register, EPA issued a revocation of
some or all of the TSCA section 4 testing requirements for 10 chemical
substances by direct final rule. In accordance with the procedures
described in the March 16, 2012 Federal Register document, EPA is
withdrawing the revocation of certain testing requirements for C.I.
Pigment Blue 61 and also restoring the original testing requirements
found in the CFR, because the Agency received an adverse comment
concerning this chemical substance. The final rule revoking testing
requirements for the other 9 chemical substances described in the March
16, 2012 Federal Register document is otherwise unaffected by the
withdrawal of the revocation for C.I. Pigment Blue 61. Elsewhere in
today's Federal Register, EPA is proposing a rule to revoke certain
test rule requirements for C.I. Pigment Blue 61.
    The docket identification (ID) number for the test rule concerning
this chemical substance was established at EPA-HQ-OPPT-2005-0033. That
docket includes information considered by the Agency in developing
those rules and the adverse comment.

III. How do I access the docket?

    To access the docket, please go to http://www.regulations.gov and
follow the online instructions using the docket ID number EPA-HQ-OPPT-
2005-0033. Additional information about the Docket Facility is also
provided under ADDRESSES in the March 16, 2012 Federal Register
document. If you have questions, consult the technical person listed
under FOR FURTHER INFORMATION CONTACT.

List of Subjects in 40 CFR Part 799

    Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.

    Dated: May 8, 2012.
James J. Jones,
Acting Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.

    Therefore, 40 CFR chapter I is amended as follows:

PART 799--[AMENDED]

0
1. The authority citation for part 799 continues to read as follows:

    Authority:  15 U.S.C. 2603, 2611, 2625.

0
2. In Sec.  799.5085, revise the entry ``CAS No. 1324-76-1'' in Table 2
of paragraph (j) to read as follows:

Sec.  799.5085  Chemical testing requirements for first group of high
production volume chemicals (HPV1).

* * * * *
    (j) * * *

                              Table 2--Chemical Substances and Testing Requirements
----------------------------------------------------------------------------------------------------------------
                                                                          Required tests (see table 3 of this
           CAS No.                     Chemical name           Class                    section)
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
1324-76-1....................  Benzenesulfonic acid, [[4-[[4-       2  A, B, C1, D, E1, E2, F1.
                                (phenylamino)phenyl][4-
                                (phenylimino)-2,5-
                                cyclohexadien-1-
                                ylidene]methyl]phenyl]amino]-
                                .

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

* * * * *
[FR Doc. 2012-11493 Filed 5-11-12; 8:45 am]
BILLING CODE 6560-50-P


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Agenda

US Interagency GHS Coordinating Group

Public Meeting

November 30, 2010

Sub-Committee of Experts on the Globally Harmonized

System of Classification and Labelling of Chemicals

Twentieth session

Geneva, 7 – 9 December 2010

Item 1 of the provisional agenda

Opening Statement

Updating of the third revised edition of the Globally Harmonized System
of Classification and Labelling of Chemicals (GHS)

	(a)	Physical hazards

ST/SG/AC.10/C.4/2010/9 (Germany)	Classification of chemically unstable
gases and gas mixtures

ST/SG/AC.10/C.4/2010/10 (Germany)	Determination of chemical instability
of gases

ST/SG/AC.10/C.4/2010/16 (United States of America)	Proposal to address
simple asphyxiants in the GHS

	(b)	Health hazards

The Sub-Committee will be informed about the progress of the work of the
informal correspondence groups dealing with matters related to health
hazards.

	(c)	Environmental hazards

At the time of writing no document has been submitted under this agenda
item.

	(d)	Annexes

ST/SG/AC.10/C.4/2010/12 (United Kingdom)	Revision of annexes 1, 2 and 3
of the GHS: Precautionary statements

	(e)	Miscellaneous proposals

ST/SG/AC.10/C.4/2010/6

(Secretariat)	Draft amendments to the GHS adopted in principle by the
Sub-Committee at its nineteenth session

Hazard communication issues

ST/SG/AC.10/C.4/2010/13

(United Kingdom/FEA)	Hazard communication for supply and use of aerosols

ST/SG/AC.10/C.4/2010/14 (RPMASA)	Proposal for revision of P410 for gases
in transportable gas cylinders under pressure

ST/SG/AC.10/C.4/2010/18 (EIGA)	Hazard communication for gases under
pressure: proposal resulting from ST/SG/AC.10/C.4/2010/9

ST/SG/AC.10/C.4/2010/19 (Australia)	Information relating to
nanomaterials for inclusion on the guidance on the preparation of Safety
Data Sheets (SDS)

Implementation of the GHS

	(a)	Implementation issues

ST/SG/AC.10/C.4/2010/7

(AISE, SDA, IPPIC, CEFIC)	Proposal to address potential issues
associated with the adoption of “corrosive to metals” for supply/use
situations

ST/SG/AC.10/C.4/2010/15 (United States of America)	Proposals to address
issues from the programme of work for the practical classification
issues correspondence group

ST/SG/AC.10/C.4/2010/20 (Australia)	Proposals from the informal working
group on GHS implementation issues: Global list of GHS classified
chemicals

	(b)	Reports on the status of implementation

Experts, observers and organizations may wish to inform the
Sub-Committee about progress in the GHS implementation in their
respective countries or areas of work.

	(c)	Cooperation with other bodies or international organizations

At the time of writing no document has been submitted under this agenda
item.

	(d)	Miscellaneous

At the time of writing no document has been submitted under this agenda
item.

Programme of work for the biennium 2011–2012

ST/SG/AC.10/C.4/2010/8 (United States of America)	Proposed terms of
reference for the dust explosion hazards correspondence group

ST/SG/AC.10/C.4/2010/11 (Netherlands)	Alignment with GHS, corrosivity
criteria in Chapter 2.8

ST/SG/AC.10/C.4/2010/17 (Secretariat)	Draft terms of reference for the
work on corrosivity criteria

The Sub-Committee may wish to consider any other proposal for inclusion
in its programme of work for the biennium 2011–2012.

  PAGE  \* MERGEFORMAT  2

	  PAGE  \* MERGEFORMAT  3

GE.10-


32 Table 4d. Summary of Spandex Production Source Category Burden Labor hours Dollars Year after promulgation Existing New Total Existing New Total sources sources sources sources Year 1 1,387 0 1,387 $ 61,736 $ 0 $ 61,736 Year 2 566 0 566 25,186 0 25,186 Year 3 566 0 566 25,186 0 25,186 Annual average 840 0 840 $ 37,369 $ 0 $ 37,369


[Federal Register Volume 83, Number 247 (Thursday, December 27, 2018)]
[Rules and Regulations]
[Pages 66609-66612]
[FR Doc No: 2018-27926]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0938; Product Identifier 2018-NE-36-AD; Amendment
39-19480; AD 2018-22-07]
RIN 2120-AA64

Airworthiness Directives; Engine Alliance Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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SUMMARY: We are adopting a new airworthiness directive (AD) for all
Engine Alliance (EA) GP7270, GP7272, and GP7277 model turbofan engines.
This AD requires inspection of the stage 6 seal ring for correct
installation and inspection of the high-pressure compressor (HPC)
stages 2-5 spool for cracks. This AD also requires replacement of the
HPC stages 2-5 spool if the stage 6 seal ring is incorrectly installed
or if the HPC stages 2-5 spool is found cracked. This AD was prompted
by a shop finding of axial cracks in the interstage 5-6 seal teeth of
the HPC stages 2-5 spool spacer arm, due to an incorrectly installed
stage 6 seal ring. We are issuing this AD to address the unsafe
condition on these products.

DATES: This AD is effective January 11, 2019.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of January 11,
2019.
    We must receive comments on this AD by February 11, 2019.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this final rule, contact
Engine Alliance, 411 Silver Lane, East Hartford, CT 06118; phone: 800-
565-0140; email<EMAIL_ADDRESS>website:
www.engineallianceportal.com. You may view this service information at
the FAA, Engine and Propeller Standards Branch, 1200 District Avenue,
Burlington, MA 01803. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available on the
internet at http://www.regulations.gov by searching for and locating
Docket No. FAA-2018-0938.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0938; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the regulatory evaluation, any comments received, and
other information. The street address for the Docket Operations (phone:
800-647-5527) is listed above. Comments will be available in the AD
docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Matthew Smith, Aerospace Engineer, ECO
Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-
238-7735; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We were informed about the discovery of axial cracks in the
interstage 5-6 seal teeth of the HPC stages 2-5 spool spacer arm, due
to an incorrectly installed stage 6 seal ring, in a GP7270 model
turbofan engine. The incorrect installation of the stage 6 seal ring
created a leakage path from the aft cavity to the forward cavity of the
HPC stage 6 disk. This leakage elevated the

temperature in the cavity and adversely affected the material
properties of the HPC stages 2-5 spool. This condition, if not
addressed, could result in failure of the HPC stages 2-5 spool, an
uncontained HPC stages 2-5 spool release, damage to the engine, and
damage to the airplane. We are issuing this AD to address the unsafe
condition on these products.

Related Service Information Under 1 CFR Part 51

    We reviewed EA Alert Service Bulletin (ASB) EAGP7-A72-395, Revision
No. 2, dated August 2, 2018. The SB describes procedures for performing
a borescope inspection of the installed HPC stages 2-5 spool for
cracks, visual inspection of the stage 6 seal ring for correct
installation, visual inspection of the interstage 5-6 seal teeth for
damage, and removal and replacement of parts if damage or defects are
found that are outside serviceable limits, within the identified
cycles. This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

FAA's Determination

    We are issuing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

AD Requirements

    This AD requires inspection of the stage 6 seal ring for correct
installation and inspection of the HPC stages 2-5 spool for cracks.
This AD also requires removal and replacement of the HPC stages 2-5
spool if the stage 6 seal ring is incorrectly installed or the
interstage 5-6 seal teeth are found cracked.

FAA's Justification and Determination of the Effective Date

    No domestic operators use this product. Therefore, we find good
cause that notice and opportunity for prior public comment are
unnecessary. In addition, for the reason stated above, we find that
good cause exists for making this amendment effective in less than 30
days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety and was not preceded by notice and an opportunity for public
comment. However, we invite you to send any written data, views, or
arguments about this final rule. Send your comments to an address
listed under the ADDRESSES section. Include the docket number FAA-2018-
0938 and Product Identifier 2018-NE-36-AD at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this final rule. We will
consider all comments received by the closing date and may amend this
final rule because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this final rule.

Costs of Compliance

    We estimate that this AD affects zero engines installed on
airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Borescope inspection of stage 6 seal    4 work-hours x $85 per                $0            $340              $0
 ring and interstage 5-6 seal teeth      hour = $340.
 forward and aft faces only.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary replacements
that would be required based on the results of the inspection. We have
no way of determining the number of aircraft that might need these
replacements:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                   Action                                 Labor cost                Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replacement of HPC stages 2 to 5 spool.....  8 work-hours x $85 per hour = $680.        $346,540        $347,220
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation Programs''
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to engines, propellers, and
associated appliances to the Manager, Engine and Propeller Standards
Branch, Policy and Innovation Division.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the

distribution of power and responsibilities among the various levels of
government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

AD 2018-22-07 Engine Alliance: Amendment 39-19480; Docket No. FAA-
2018-0938; Product Identifier 2018-NE-36-AD.

(a) Effective Date

    This AD is effective January 11, 2019.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Engine Alliance (EA) GP7270, GP7272, and
GP7277 model turbofan engines.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7230, Turbine Engine
Compressor Section.

(e) Unsafe Condition

    This AD was prompted by a shop finding of axial cracks in the
interstage 5-6 seal teeth of the high-pressure compressor (HPC)
stages 2-5 spool spacer arm, due to an incorrectly installed stage 6
seal ring. We are issuing this AD to prevent failure of the HPC
stage 5-6 seal teeth and uncontained HPC stages 2-5 spool release.
The unsafe condition, if not addressed, could result in an
uncontained failure of the HPC stages 2-5 spool, damage to the
engine, and damage to the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    (1) Borescope inspect the stage 6 seal ring location in
accordance with the Accomplishment Instructions, paragraph 1.F, in
EA Alert Service Bulletin (ASB) EAGP7-A72-395, Revision No. 2, dated
August 2, 2018, and within the compliance times specified in Table 1
to paragraph (g) of this AD. If the stage 6 seal ring is incorrectly
installed, remove the HPC stages 2-5 spool from service within 50
cycles and replace with a part eligible for installation.
    (2) Borescope inspect the interstage 5-6 seal tooth aft face and
interstage 5-6 forward face for cracks and missing coating in
accordance with the Accomplishment Instructions, paragraphs 2.C and
2.E, in EA ASB EAGP7-A72-395, Revision No. 2, dated August 2, 2018,
and within the compliance times specified in Table 1 to paragraph
(g) of this AD.
    (i) If coating is missing on the interstage 5-6 seal tooth
forward or aft faces, repeat the borescope inspection required by
paragraph (g)(2) of this AD for cracks every 150 cycles.
    (ii) If cracks are found in the interstage 5-6 seal tooth
forward or aft faces, remove the HPC stages 2-5 spool from service
and replace with a part eligible for installation before further
flight.
[GRAPHIC] [TIFF OMITTED] TR27DE18.041

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, ECO Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the manager of the
certification office, send it to the attention of the person
identified in paragraph (i) of this AD. You may email your request
to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(i) Related Information

    For more information about this AD, contact Matthew Smith,
Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
(j) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Engine Alliance (EA) Alert Service Bulletin EAGP7-A72-395,
Revision No. 2, dated August 2, 2018.
    (ii) [Reserved]

    (3) For EA service information identified in this AD, contact
Engine Alliance, 411 Silver Lane, East Hartford, CT 06118; phone:
800-565-0140; email<EMAIL_ADDRESS>website:
www.engineallianceportal.com.
    (4) You may view this service information at FAA, Engine and
Propeller Standards Branch, 1200 District Avenue, Burlington, MA
01803. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Burlington, Massachusetts, on December 19, 2018.
Robert J. Ganley,
Manager, Engine and Propeller Standards Branch, Aircraft Certification
Service.
[FR Doc. 2018-27926 Filed 12-26-18; 8:45 am]
BILLING CODE 4910-13-P


EPA REGISTRATION DIVISION - COMPANY NOTICE OF FILING FOR PESTICIDE PETITION

Docket ID Number: EPA-HQ-OPP-2014-0397

EPA Registration Division contact: Sidney Jackson<PHONE_NUMBER>

Interregional Research Project Number 4
Pesticide Petition Number: 4E8282
      EPA has received a pesticide petition (PP#) number 4E8282 from the Interregional Research Project Number 4 (IR-4), IR-4 Project Headquarters,  Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08450  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 180.361 by establishing a tolerance for the residues of the herbicide pendimethalin, including its metabolites and degradates, in or on food commodities. Compliance with the tolerance levels specified is to be determined by measuring only pendimethalin, N-(1-ethylpropyl)-3,4-dimethyl-2,6dinitrobenzenamine, and its metabolite, 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl alcohol, calculated as the stoichiometric equivalent of pendimethalin in or on the raw agricultural commodities caneberry, subgroup 13-07A at 0.1 parts per million (ppm), bushberry subgroup 13-07B at 0.1 ppm, and nut, tree, group 14-12 at 0.1 ppm.  In addition, the petitioner proposes that upon approval of the abovementioned tolerances to remove existing tolerances at 40 CFR 180.361 for juneberry at 0.1 ppm, nut, tree, group 14 at 0.1 ppm and pistachio at 0.1 ppm.  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of the FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. The qualitative nature of the residues of pendimethalin in plants is understood based on adequate studies conducted with 14C pendimethalin on various crops.  Pendimethalin and its 3,5-dinitrobenzyl alcohol metabolite (CL202347) are the established residues of concern.

	2. Analytical method. Section 408 (b)(3) of the amended FDCA requires EPA to determine that there is a practical method for detecting and measuring levels of the pesticide chemical residue in or on food and that the tolerance be set at a level at or above of the limit of detection of the designated method.  In plants, the method is aqueous organic solvent extraction, column clean up, and quantitation by gas chromatography (GC).  The method has a limit of quantitation (LOQ) of 0.05 ppm for pendimethalin and the alcohol metabolite.

	3. Magnitude of residues. Field trials in major growing areas were conducted in order to determine the magnitude of residues in caneberry and bushberry commodities. Field trials were carried out using the maximum label rate and shortest pre-harvest interval (PHI) in berries at 30 days. No field trial data were generated in order to determine the magnitude of residues in raw agricultural commodities in crop group 14-12 as EPA has determined that the tolerance on this crop commodity may be safely extrapolated from the established tolerances for the crop group 14.  EPA has determined that the petition contains data or information regarding the above aforementioned crops.

B. Toxicological Profile

	1. Acute toxicity.  Pendimethalin technical demonstrates low acute toxicity via the oral, dermal, and inhalation routes of exposure.  The acute toxicity studies place technical pendimethalin in toxicity category III for the acute oral, category IV for acute dermal, and category IV for acute inhalation.  The acute reference dose is based on reduced motor activity at Day 0 in the acute neurotoxicity study. Technical pendimethalin is category IV for skin irritation and category III for eye irritation. Pendimethalin did not cause skin sensitization in guinea pigs.  Two formulated end use products are registered for use on crops, an Emulsifiable Concentrate (EC) and an Encapsulated Suspension (CS).  The EC has an acute oral category of III, acute dermal category of III, an acute inhalation category of III, eye and skin irritation of III, and is not a dermal sensitizer.  The CS has an acute oral category of IV, an acute dermal category of IV, an acute inhalation category of IV, eye and skin irritation category of IV, and is not a dermal sensitizer.

	2. Genotoxicty. Extensive mutagenicity studies conducted to investigate point and gene mutations, DNA damage and chromosomal aberration, both using in vitro and in vivo test systems demonstrate pendimethalin to be non-genotoxic.

Pendimethalin has been classified as a Group C "possible human carcinogen," based on a statistically significantly increased incidence of benign follicular cell adenomas of the thyroid gland in male and female rats at 5000 ppm (250 mg/kg body weight (b.w.)/day) (highest concentration tested).  For risk assessment, OPP recommends using the reference dose (RfD) non-linear approach for quantification of human risk.  The Agency Committee has determined that the hypothesis, that benign thyroid tumors associated with pendimethalin are due to a thyroid-pituitary imbalance, can be supported.  Finally, pendimethalin's mechanism of threshold oncogenic activity only occurs at high doses in rats, a mammalian species that is expected to be much more sensitive than humans to the induction of thyroid tumors via conditions which result in hypothyroidism.

	3. Reproductive and developmental toxicity. Pendimethalin is not a selective developmental toxicant.  There is no indication of increased susceptibility following prenatal/postnatal exposure to pendimethalin.

In a developmental (teratology) toxicity study in the rat, the results demonstrated that the no-observed-adverse-effect-levels (NOAELs) for both maternal toxicity and fetal (prenatal)/developmental toxicity were 500 mg/kg b.w./day (highest dose tested) (HDT).  In addition, there were no indications of any teratogenic effects in the rat fetuses at 500 mg/kg b.w./day (HDT).  Therefore, pendimethalin is considered to be neither a developmental toxicant nor a teratogenic agent in the rat.

In a developmental (teratology) toxicity study in the rabbit, the results demonstrated the NOAEL for maternal toxicity was 30 mg/kg b.w./day, based on increased clinical signs of toxicity and decreased body weight gain during the treatment period at 60 mg/kg b.w./day (HDT).  The NOAEL for fetal (prenatal)/developmental toxicity was 60 mg/kg b.w./day (HDT).  In addition, there were no indications of any teratogenic effects in the rabbit fetuses at 60 mg/kg b.w./day.  Therefore, pendimethalin is considered to be neither a developmental toxicant nor a teratogenic agent in the rabbit.

A two-generation reproductive toxicity study in the rat demonstrated an absence of increased sensitivity for the developing offspring to pendimethalin.  The NOAEL for parental toxicity was 500 ppm (approximately 38.5 mg/kg b.w./day), based on reduced food consumption and decreased body weight/weight gain at 2500 ppm (mid-dietary concentration).  The NOAEL for pup/offspring toxicity was also 500 ppm, based on decreased pup body weight gain at 2500 ppm.  Lastly, the NOAEL for reproductive toxicity was 2500 ppm (approximately 194 mg/kg b.w./day), based on reduced mean live litter size at 5000 ppm (highest concentration tested) (HCT).  These reductions in mean live litter size and pup body weight gain were only observed at dietary concentrations that were parentally toxic.  As such, there is no evidence that prenatal or postnatal exposure to pendimethalin results in an increased sensitivity to developing offspring.

	4. Sub-chronic toxicity. Sub-chronic (90-day) feeding studies were conducted in rats and dogs.  For the rat, the NOAEL for systemic toxicity was 500 ppm (41 mg/kg b.w./day), based on slightly decreased body weight, increased absolute and relative liver weights, and liver histopathology (hepatocellular hypertrophy) in males and females at 5000 ppm (HCT).  For the dog, the NOAEL for systemic toxicity was 2500 ppm (62.5 mg/kg b.w./day), based on decreased body weight at 10000 ppm (250 mg/kg b.w./day).

	5. Chronic toxicity. The chronic RfD was established based on the results of sub-chronic special studies demonstrating the thyroid hormone related endpoint in rats.  The NOAEL of 10 mg/kg b.w./day was established from the collective results of the sub-chronic oral 92-day thyroid function study, the sub-chronic oral 56-day thyroid function study, and the 14-day intrathyroidal metabolism study.  The lowest-observed-adverse-effect-level (LOAEL) of 31 mg/kg b.w./day was based on hormonal and histopathological changes in the thyroid gland.  The chronic RfD was calculated to be 0.3 mg/kg b.w./day using an Uncertainty Factor (UF) of 30X (3X for interspecies extrapolation and 10X for intraspecies variability).  EPA/HED currently recommends a FQPA Safety Factor of 1X.  Therefore, the chronic Population Adjusted Dose (PAD) is 0.3 mg/kg b.w./day.

Chronic toxicity studies were conducted in rats, mice, and dogs.  For the 2-year rat feeding study, the NOAEL for systemic toxicity was 500 ppm (25 mg/kg b.w./day), based on decreased body weight gain (approximately 20-30%), increased clinical signs of toxicity, increased relative liver weights, and slight but statistical increase in the incidence of benign follicular cell adenomas of the thyroid gland in males and females at 5000 ppm (250 mg/kg b.w./day), the highest concentration tested (HCT).  For the 18-month mouse feeding study, the NOAEL for systemic toxicity was 500 ppm (75 mg/kg b.w./day), based on slightly decreased mean body weights and reduced survival at 5000 ppm (750 mg/kg b.w./day) (HCT).  There were no oncogenic effects up to 5000 ppm (750 mg/kg b.w./day) (HCT).  Lastly, for the 1-year oral (via gelatin capsules) chronic dog study, the NOAEL for systemic toxicity was 200 mg/kg b.w./day, the highest dose tested.

	6. Animal metabolism. Adequate goat and poultry metabolism studies are available for pendimethalin. In the rat, pendimethalin is metabolized mainly through oxidation of the 4-methyl group attached to the benzene ring as well as oxidation of the alkyl side chain of the N-substituted dinitroaniline compound.  When C14-pendimethalin is administered to rats, about 70% of the administered radioactivity is excreted via feces and 20% via urine within 24 hours.  Within 96 hours, the total radioactive residues (TRR) found in the tissues was 0.3 ppm, except fat which was 0.9 ppm.  The major portion of the radioactivity that was excreted in the feces was identified as the unchanged parent compound.  In the goat metabolism study following administration of radiolabeled pendimethalin equivalent to 15.35 ppm in the diet for 5 consecutive days, approximately 94% of the administered radioactivity was recovered in feces, urine and tissues.  Among the edible tissues, only liver (0.32 ppm) and kidney (0.042 ppm) contained residues >0.01 ppm.  With the exception of Metabolite 6 (13% TRR), no other component exceeded 10% of the TRR in liver.  The major metabolite (Metabolite 6) was identified in feces, bile and urine by LC/MS and high resolution mass spectrometry.  Only trace levels of unchanged parent were detected.

	7. Metabolite toxicology. The main pendimethalin plant metabolite, CL 202347, has been tested for acute oral toxicity in the mouse, as well as genotoxicity (Ames assay).  The acute oral lethal dose (LD)50 in the mouse was determined to be 2140 mg/kg b.w., which is considered to be "slightly toxic by ingestion in single doses."  An Ames assay demonstrated that the plant metabolite is non-mutagenic.  In addition, since goat Metabolite 6 was observed in a recent rat metabolism study, it is considered to have been evaluated in the existing mammalian toxicity database for the active ingredient.

	8. Endocrine disruption. It is known that pendimethalin affects the hypothalamus-pituitary-thyroid axis.  However, as the chronic RfD (0.3 mg/kg b.w./day) is based on the thyroid hormone related endpoint in rats, as noted in the sub-chronic special studies in Section 5 above, which additionally demonstrated reversibility of the thyroid effects in the oral 56-day thyroid function study, these effects are already taken into consideration in the characterization of potential risks to humans.

C. Aggregate Exposure Pendimethalin is a pre-emergent herbicide used to control broadleaf and grass weeds in food and non-food crops, as well as non-agricultural use sites including residential lawns. In examining aggregate exposure, FQPA directs EPA to consider available information concerning exposures from the pesticide residue in food and water (dietary) and all other non-occupational exposures. The primary non-food sources of exposure are through pesticide use in gardens, lawns, or buildings (residential and other indoor uses). The potential for aggregate exposure from all registered and proposed uses is discussed below.

	1. Dietary exposure. The updated dietary assessments employed the EPA posted Dietary Exposure Evaluation Model- Food Consumption Intake Database (DEEM-FCID) version 3.18 and the residue input files from their July 2012 dietary assessment DP 401100 for any concentration factors as a starting point.

	i. Food. An assessment was conducted to evaluate the potential risk due to dietary exposure of the U.S. population to residues of pendimethalin.  The current tolerance values are listed in the U.S. 40 CFR § 180.361.  The Tier 1 dietary exposure estimates were based on established and proposed tolerance values, and 100% CT values.  An updated analysis included all the crops with established tolerance values as of May 2014 and: the proposed tolerances for hops, dried cones at 1.0 ppm (pending EPA review, submitted October 2013); the proposed crop group expansion tolerances to replace current existing pendimethalin tolerances including onion-bulb subgroup 3-07A = 0.10 ppm, onion-green subgroup 3-07B = 0.20 ppm, low growing berry subgroup 13-07G = 0.10 ppm, vegetable-fruiting group 8-10 = 0.10 ppm, fruit-citrus group 10-10 = 0.10 ppm, fruit-pome group 11-10 = 0.10 ppm, fruit-stone group 12-12 = 0.10 ppm, and sunflower subgroup = 0.1 ppm (pending EPA review, submitted October 2013); the proposed amended tolerances for alfalfa forage and hay (pending EPA review, submitted February 2014); the proposed tolerances on animal commodities which support the proposed amended tolerances on forage grasses (pending EPA review, submitted March 2014); and the proposed new tolerances on caneberry sub group 13-07A and bushberry sub group 13-07B, and the newly proposed crop group expansion tolerances to replace current existing pendimethalin tolerances on tree nut group 14-12 = 0.10 ppm.

Acute Dietary (food + drinking water) Exposure Assessment
No special dietary assessment for females age 13  -  49 years old is required by EPA because no endpoint was identified for sensitive populations.  EPA has determined that an acute dietary assessment is required for the general populations which cover infants and children. The acute population adjusted dose (aPAD) is 1 mg active ingredient (ai)/kg b.w./day based on a NOAEL = 100 mg/kg b.w./day and a total safety factor of 100.  The acute dietary exposure to pendimethalin residues was low for all populations.  At the 95[th] percentile, the most highly exposed valid sub-population was "Infants (<1 year old)" and this group utilized only 1.8% aPAD.

Chronic Dietary (food + water) Exposure Assessment
Dietary exposure estimates were compared against the chronic Population Adjusted Dose (cPAD) of 0.3 mg/kg b.w./day for all populations subgroups. Results of the chronic dietary assessments are listed in Table 1 below. The estimated chronic dietary exposure from crops and animals (both established and proposed tolerances) was <2.2% of the cPAD for all subpopulations.  Additional refinements such as the use of anticipated residues, PDP data and percent crop treated values for the established crop uses would further reduce the estimated chronic dietary exposure. The results in Table 1 below demonstrate there are no risk concerns for any subpopulation based on established and new uses, and that the results clearly meet the FQPA standard of reasonable certainty of no harm.

            Table 1. Summary of Chronic Dietary Exposure (food + drinking water) Assessment considering crops with established and proposed tolerances for pendimethalin.
 Population
 Subgroups
                               Exposure Estimate
                               (mg/kg b.w./day)
                                     %cPAD
                                 US Population
                                   0.001928
                                      0.6
                           All infants (< 1 year)
                                   0.003616
                                      1.2
                                 Children 1-2
                                   0.006486
                                      2.2
                                 Children 3-5
                                   0.004922
                                      1.6
                                 Children 6-12
                                   0.002923
                                      1.0
                                  Youth 13-19
                                   0.001635
                                      0.5
                                 Adults 20-49
                                   0.001500
                                      0.5
                                Adults 50+ yrs.
                                   0.001395
                                      0.5
                             Females 13 - 49 yrs.
                                   0.001463
                                      0.5
 %cPAD = percent of chronic population adjusted dose
 Exposure estimates based on tolerance values and 100 % CT values

	ii. Drinking Water. The drinking water exposure values used in this assessment were obtained from the most recent pendimethalin assessment conducted by EPA published on July 25, 2012. The estimated acute and chronic surface water concentrations from EPA models were 80.5 ug/L and 6.2 ug/L, respectively. The estimated groundwater concentration was 0.036 ug/L.  These estimated drinking water exposures were included directly in the dietary assessments. The DEEM critical exposure contribution analysis calculates estimated model water contributions (indirect and direct) makeup over 60% of the potential exposure of pendimethalin for infants within the acute assessment; the modelled water estimates are understood to be conservative.

	2. Non-dietary exposure. The post-application short-term dermal and incidental oral exposure and risk assessment was determined for pendimethalin use on residential turf, residential gardens, and golf course turf. The residential exposure shown in the Table 2 reflects the most recent EPA human health risk assessment published on July 25, 2012.  No new uses would impact reuse of this assessment.  The residential assessment was conducted using the updated Standard Operating Procedures for Residential Pesticide Exposure Assessment.  The calculated margin of exposures (MOEs) are all greater than the MOE level of concern, which is a value of 30.

Table 2.	Pendimethalin Residential Exposure after the use on Residential Turf, Residential Gardens, and Golf Course Turf.
                                  Population
                                   Scenario-
                                     Route
                                  Exposure
                                      MOE
Adult
                               Turf-residential
                                    Dermal
                                     0.032
                                      320
Child 1-2
                               Turf-residential
                                    Dermal
                                     0.06
                                      170

                                 Hand to mouth
                                     0.042
                                      240

                                Object to mouth
                                    0.0013
                                     7,700

                                soil ingestion
                                   0.000065
                                    150,000

                              Granular ingestion
                                     0.071
                                      140
Adult
                                   Turf-golf
                                    Dermal
                                    0.0037
                                     2,700
Children 11-16
                                   Turf-Golf
                                    Dermal
                                    0.0043
                                     2,300
Children 6-11
                                   Turf-Golf
                                    Dermal
                                    0.0051
                                     2,000
Adult
                                   Gardening
                                    Dermal
                                     0.078
                                      130
Children 6-11
                                  Gardening
                                    Dermal
                                     0.053
                                      190

Acute Aggregate Exposure and Risk (Food and water)
It has been previously determined by EPA that the acute aggregate assessments includes only food and drinking water exposure (DP390457).  Residential exposure is not included in the acute or chronic aggregate assessment.  The results showed that the acute aggregate exposure from pendimethalin residues does not exceed the level of concern for any population.

Short- and Intermediate-Term Aggregate Exposure and Risk (food, water, and residential)
Short-term aggregate risk from pendimethalin takes into account exposures from dietary consumption (food and water) and residential exposure from turf use.  Post application exposure from the turf use is considered short-term.  The residential exposure used in this assessment is from the most recent EPA human health risk assessment published July 25, 2012, no new residential uses impact the aggregate, so only an update to the dietary components is needed.  The residential assessment was conducted using the updated Standard Operating Procedures for Residential Pesticide Exposure Assessment.  The post-application residential exposure was determined for the use on residential turf, residential gardens, and golf course turf.  The highest post-application exposure from adults was from the garden use and residential turf use for children 1-2 years old.  The children exposure included dermal and hand-to-mouth exposure.  The aggregate MOE from food, water, and residential exposure for children 1-2 years old was 92 and for adults 125.  These MOEs are greater than the target MOE of 30, which indicates there is no risk concern from the aggregate exposure from pendimethalin.  The results of the analysis are shown in Tables 3.

Table 3. 	Estimated short/intermediate term aggregate exposure and risk of pendimethalin.
                                  Population
                               NOAEL (mg/kg/day)
                                 Target MOE[1]
           Food + Drinking Water Exposure               (mg/kg/day)

                       Residential Exposure (mg/kg/day)
                          Total Exposure (mg/kg/day)
                                    MOE[2]

                                     Adult
                                      10
                                      30
                                   0.001928
                                     0.078
                                   0.079928
                                      125
                                     Child
                                  1-2 yr old
                                      10
                                      30
                                   0.006486
                                     0.102
                                   0.108486
                                      92

1 HED's LOC for the MOE is 30.
[2] Aggregate MOE = (NOAEL / (Food + Water + Residential Exposure)

Chronic Aggregate Exposure and Risk (food and water)
It has been previously determined by EPA that the chronic aggregate assessments includes only food and drinking water exposure (Table 1), because exposure is not expected for residential (dermal and inhalation) exposure pathway (DP390457). Exposures from residential uses are not included in the chronic aggregate assessment.  The results demonstrate there are no risk concerns for any subpopulation based on established and new uses.

D. Cumulative Effects

	Exposure to Substances with Common Mechanism of Toxicity.  The Agency has not yet published guidelines to determine whether pendimethalin has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment.  Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, pendimethalin does not appear to produce a toxic metabolite produced by other substances.  For the purposes of this tolerance action, therefore, it is assumed that pendimethalin does not have a common mechanism of toxicity with other substances.

E. Safety Determination

	1. U.S. population. Based on these risk assessments, there is a reasonable certainty that the aggregate exposure to the general population or any subpopulation from pendimethalin residues does not result in an unacceptable risk.

	2. Infants and children. EPA has previously recommended the 10X FQPA safety factor be removed (reduced to 1X) based on reliable data.  Based on these risk assessments, there is a reasonable certainty that the aggregate exposure to infants or children, or any subpopulation from pendimethalin residues does not result in an unacceptable risk.

F. International Tolerances

	There are no CODEX, Canadian or Mexican International Maximum Residue Levels (MRL's) established for residues of pendimethalin in these crops at this time.