[Federal Register Volume 84, Number 204 (Tuesday, October 22, 2019)]
[Rules and Regulations]
[Pages 56376-56378]
[FR Doc No: 2019-22956]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0580; Product Identifier 2019-NM-019-AD; Amendment
39-19765; AD 2019-20-12]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
Airbus SAS Model A330-243, -243F, -341, -342, and -343 airplanes. This
AD was prompted by a determination that cracks can develop on the
ripple damper weld of the hydraulic pressure tube assembly and reports
of failure of the ripple damper of the hydraulic pressure tube
assembly. This AD requires replacement of the affected hydraulic
pressure tube assembly or modification of both engines, as specified in
a European Union Aviation Safety Agency (EASA) AD, which is
incorporated by reference. The FAA is issuing this AD to address the
unsafe condition on these products.

DATES: This AD is effective November 26, 2019.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of November 26,
2019.

ADDRESSES: For the material incorporated by reference (IBR) in this AD,
contact the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 89990 1000; email<EMAIL_ADDRESS>internet
www.easa.europa.eu. You may find this IBR material on the EASA website
at https://ad.easa.europa.eu. You may view this IBR material at the
FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA.
For information on the availability of this material at the FAA, call
206-231-3195. It is also available in the AD docket on the internet at
http://www.regulations.gov by searching for and locating Docket No.
FAA-2019-0580.

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-2019-
0580; 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 address for Docket Operations is U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, Aerospace Engineer,
International Section, Transport Standards Branch, FAA, 2200 South
216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2019-0031, dated February 13, 2019
(``EASA AD 2019-0031'') (also referred to as the Mandatory Continuing
Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for all Airbus SAS Model A330-243, -243F, -341, -342, and -
343 airplanes.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to all Airbus SAS Model
A330-243, -243F, -341, -342, and -343 airplanes. The NPRM published in
the Federal Register on July 31, 2019 (84 FR 37162). The NPRM was
prompted by a determination that cracks can develop on the ripple
damper weld of the hydraulic pressure tube assembly and reports of
failure of the ripple damper of the hydraulic pressure tube assembly.
The NPRM proposed to require replacement of the affected hydraulic
pressure tube assembly or modification of both engines.
    The FAA is issuing this AD to address cracking of the ripple damper
weld of the hydraulic pressure tube assembly, which could lead to
hydraulic fluid leakage and consequent loss of the green hydraulic
system. This condition, if combined with other system failures, could
result in reduced control of the airplane. See the MCAI for additional
background information.

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The FAA received no comments on the NPRM or
on the determination of the cost to the public.

Conclusion

    The FAA reviewed the relevant data and determined that air safety
and the public interest require adopting this final rule as proposed,
except for minor editorial changes. The FAA has determined that these
minor changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related IBR Material Under 1 CFR Part 51

    EASA AD 2019-0031 describes procedures for replacement of the
affected hydraulic pressure tube assembly with a serviceable hydraulic
pressure tube assembly or modification of both engines. This material
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.

Costs of Compliance

    The FAA estimates that this AD affects 53 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
4 work-hours x $85 per hour = $340...........................         $20,000          $20,340       $1,078,020
----------------------------------------------------------------------------------------------------------------

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.
    The FAA is 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 transport category airplanes and
associated appliances to the Director of the System Oversight 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) Will not affect intrastate aviation in Alaska, and
    (3) 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):

2019-20-12 Airbus SAS: Amendment 39-19765; Docket No. FAA-2019-0580;
Product Identifier 2019-NM-019-AD.

(a) Effective Date

    This AD is effective November 26, 2019.

(b) Affected ADs

    This AD affects AD 2017-07-03, Amendment 39-18841 (82 FR 15985,
March 31, 2017; corrected April 13, 2017 (82 FR 17749)) (``AD 2017-
07-03'').

(c) Applicability

    This AD applies to all Airbus SAS Model A330-243, -243F, -341, -
342, and -343 airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 71, Powerplant.

(e) Reason

    This AD was prompted by a determination that cracks can develop
on the ripple damper weld of the hydraulic pressure tube assembly
and reports of failure of the ripple damper of the hydraulic
pressure tube assembly. The FAA is issuing this AD to address
cracking of the ripple damper weld of the hydraulic pressure tube
assembly, which could lead to hydraulic fluid leakage and consequent
loss of the green hydraulic system. This condition, if combined with
other system failures, could result in reduced control of the
airplane.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2019-0031, dated February 13, 2019 (``EASA AD 2019-0031'').

(h) Exceptions to EASA AD 2019-0031

    (1) For purposes of determining compliance with the requirements
of this AD: Where EASA AD 2019-0031 refers to its effective date,
this AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2019-0031 does not apply
to this AD.

(i) Terminating Action for AD 2017-07-03

    Accomplishing the actions required by this AD terminates all
requirements of AD 2017-07-03 for that airplane only.

(j) No Reporting Requirement

    Although the service information referenced in EASA AD 2019-0031
specifies to submit certain information to the manufacturer, this AD
does not include that requirement.

(k) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards 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 International Section, send it to the attention of
the person identified in paragraph (l) of this AD. Information may
be emailed to<EMAIL_ADDRESS>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.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, International
Section, Transport Standards Branch, FAA; or EASA; or Airbus SAS's
EASA Design Organization Approval (DOA). If approved by the DOA, the
approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): For any service information
referenced in EASA AD 2019-0031 that contains RC procedures and
tests: Except as required by paragraph (k)(2) of this AD, RC
procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be done and the airplane can be put back in an airworthy
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.

(l) Related Information

    For more information about this AD, contact Vladimir Ulyanov,
Aerospace Engineer, International Section, Transport Standards
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>.

(m) 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 this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2019-0031,
dated February 13, 2019.
    (ii) [Reserved]
    (3) For information about EASA AD 2019-0031, contact the EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
89990 6017; email<EMAIL_ADDRESS>Internet www.easa.europa.eu.
You may find this EASA AD on the EASA website at https://ad.easa.europa.eu.
    (4) You may view this material at the FAA, Transport Standards
Branch, 2200 South 216th St., Des Moines, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. This
material may be found in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-
2019-0580.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
<EMAIL_ADDRESS>or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Des Moines, Washington, on October 11, 2019.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2019-22956 Filed 10-21-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 230 (Thursday, November 29, 2012)]
[Notices]
[Pages 71193-71194]
[FR Doc No: 2012-28907]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0099]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Revision of the Requirements for Constituent Materials

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments regarding the requirement for the
use of constituent materials in licensed biological products.

DATES: Submit either electronic or written comments on the collection
of information by January 28, 2013.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Revision of the Requirements for Constituent Materials in Biological
Products--21 CFR 610.15(d) (OMB Control Number 0910-0666)--Extension

    In the Federal Register of April 13, 2011 (76 FR 20513), FDA issued
a final rule amending the regulation for the use of constituent
materials in licensed biological products. Under 21 CFR 610.15(d), the
Director of the Center for Biologics Evaluation and Research (CBER) or
the Director of the Center for Drugs Evaluation and Research (CDER) may
approve, as appropriate, a manufacturer's request for exceptions or
alternatives to the regulation for constituent materials. Thus, the
provision provides manufacturers of biological products with
flexibility, as appropriate, to employ advances in science and
technology as they become available, without diminishing public health
protections. Manufacturers seeking approval of an exception or
alternative must submit a request in writing. The request must be
clearly identified with a brief statement describing the basis for the
request and the supporting data. The request may be submitted as part
of the original biologics application, as an amendment to the original,
pending application or as a prior approval supplement to an approved
application. The information to be collected assists FDA in identifying
and reviewing requests for an exception or alternative to the
requirements for constituent materials.
    Respondents to this information collection provision are
manufacturers of biological products. Since implementation of the final
rule, FDA has received no submissions of requests for an exception or
alternative for constituent materials. Therefore, FDA is estimating one
respondent and annual response annually to account for a possible
submission to CBER or CDER of a request for an exception or alternative
for constituent materials. The average burden per response is based on
FDA experience with similar information collection requirements.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                No. of
                           21 CFR section                                 No. of       responses  per    Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
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610.15.............................................................               1                1                1                1                1
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: November 26, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28907 Filed 11-28-12; 8:45 am]
BILLING CODE 4160-01-P


ORAL ARGUMENT HEARD OCTOBER 17, 2005 _______________________________________________ _______________________________________________

IN THE UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT No. 04 1438 NATURAL RESOURCES DEFENSE COUNCIL Petitioner, v.

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY and MICHAEL O. LEAVITT, Administrator, U. S. Environmental Protection Agency Respondents.

Petition for Review of Final Action of the United States Environmental Protection Agency SUPPLEMENTAL BRIEF FOR PETITIONER David D. Doniger ( D. C. Bar No. 305383) Amanda C. Leiter Natural Resources Defense Council 1200 New York Ave., N. W., Suite 400 Washington, D. C. 20005 ( 202) 289 6868 ( phone) ( 202) 789 0859 ( fax)

Attorneys for Natural Resources Defense Council DATED: November 7, 2005 i TABLE OF CONTENTS TABLE OF CONTENTS............................................................................................................. i TABLE OF AUTHORITIES....................................................................................................... ii GLOSSARY.............................................................................................................................. iii INTRODUCTION...................................................................................................................... 1 ARGUMENT ............................................................................................................................. 1 I. Under the Clean Air Act, EPA May Exempt the Production or Consumption of Methyl Bromide for Critical Uses Only to the Extent Consistent with the Montreal Protocol............................................................................................................ 1 II. The 1997 Protocol Adjustment Prohibits Post 2004 Production or Consumption of Methyl Bromide Unless Authorized by a Decision of the Parties................................................................ 3 III. EPA's 2005 Exemption Rule Violates the Clean Air Act Unless It Complies with the Conditions in the Protocol Parties' Critical Use Decisions................................................................. 4 CONCLUSION .......................................................................................................................... 5 RELEVANT STATUTORY SECTIONS ii TABLE OF AUTHORITIES STATUTES & TREATIES 1999 Omnibus Consolidated and Emergency Supplemental Appropriations Act ( Pub. L. 105 277, Oct. 21, 1998) .................................................................. 2 Clean Air Act § 601( 9), 42 U. S. C. § 7671( 9) .......................................................................... 1, 2 * Clean Air Act § 604, 42 U. S. C. § 7671c.......................................................................... passim Clean Air Act § 614( b), 42 U. S. C. § 7671m( b) ........................................................................... 2 * Montreal Protocol on Substances that Deplete the Ozone Layer, Sept. 16, 1987, 26 I. L. M. 1550 ( entered into force Jan. 1, 1989) ........................................ passim United Nations Environment Programme, Report of the Ninth Meeting of the Parties to the Montreal Protocol on Substances that Deplete the Ozone Layer, UNEP/ OzL. Pro. 9/ 12 25 ( 1997) ................................................... 1 Decision IX/ 6: United Nations Environment Programme, Report of the Ninth Meeting of the Parties to the Montreal Protocol on Substances that Deplete the Ozone Layer, UNEP/ OzL. Pro. 9/ 12 26 27 ( 1997) ...................................................................................... 1, 4, 5 Decision Ex. I/ 3: United Nations Environment Programme, Report of the First Extraordinary Meeting of the Parties to the Montreal Protocol on Substances that Deplete the Ozone Layer, UNEP/ OzL. Pro. ExMP/ 1/ 3 14 15 ( 2004) ....................................................... 1, 4, 5 FEDERAL REGISTER 69 Fed. Reg. 76,982 ( Dec. 23, 2004)........................................................................................... 1 ________________________________________________________ * Authorities upon which we chiefly rely are marked with asterisks. iii GLOSSARY Pursuant to Circuit Rule 28( a)( 3), the following is a glossary of all acronyms used in this brief:

CAA Clean Air Act EPA United States Environmental Protection Agency NRDC Natural Resources Defense Council INTRODUCTION Following oral argument in this matter, the Court issued an Order directing the Parties to " address[] whether ` Decisions' issued by the parties to the Montreal Protocol are cognizable ` Adjustments' under article 2( 9) of the Protocol and/ or whether such Decisions are otherwise cognizable in federal court actions brought to enforce the Protocol and the relevant terms of the Clean Air Act (` CAA'), see 42 U. S. C. § 7671( 9)." Order of Oct. 18, 2005, at 1. Petitioner Natural Resources Defense Council (" Petitioner" or " NRDC") does not believe that the relevant Decisions, IX/ 6 [ JA 223] and Ex. I/ 3 [ JA 255], are " Adjustments" as defined in Protocol Article 2, ¶ 9.1 Nevertheless, the criteria contained in those Decisions are binding on the Environmental Protection Agency (" EPA") and enforceable by this Court, because those criteria define the scope of EPA's authority under Section 604( d)( 6) of the Clean Air Act, 42 U. S. C. § 7671c( d)( 6),

to allow post 2004 production and consumption of methyl bromide for critical uses.

ARGUMENT I. Under the Clean Air Act, EPA May Exempt the Production or Consumption of Methyl Bromide for Critical Uses Only to the Extent Consistent with the Montreal Protocol.

The Clean Air Act itself authorizes this Court to rule on the merits of Petitioner's claim that the 2005 exemption rule2 violates the criteria established in Decisions IX/ 6 and Ex. I/ 3. To 1 Under Article 2 of the Montreal Protocol, " adjustments" are adopted by " decisions" of the Parties. Montreal Protocol Art. 2, ¶ 9 [ JA 177]. Not all Decisions are adjustments, however. Adjustments have been made at five meetings of the Montreal Protocol Parties: London in 1990, Copenhagen in 1992, Vienna in 1995, Montreal in 1997, and Beijing in 1999. Ozone Secretariat, United Nations Environment Programme, Adjustments to Montreal Protocol, at http:// hq. unep. org/ ozone/ Treaties_ and_ Ratification/ montreal_ protocol_ adjustments. asp. Decision IX/ 6 was adopted during the Ninth Meeting of the Parties in 1997 in Montreal at the same time as the Montreal Adjustments ( Decisions IX/ 1 through IX/ 3). UNEP, Report of the Ninth Meeting of the Parties to the Montreal Protocol on Substances that Deplete the Ozone Layer, UNEP/ OzL. Pro. 9/ 12 24 44 ( 1997), at http:// hq. unep. org/ ozone/ Meeting_ Documents/ mop/ 09mop/ 9mop 12. e. pdf. As explained below, the Montreal Adjustments authorize the Parties to " decide" upon critical use exemptions, and Decision IX/ 6, adopted concurrently, supplies the " criteria" for those exemptions.

2 Protection of Stratospheric Ozone: Process for Exempting Critical Uses from the Phaseout of Methyl Bromide, 69 Fed. Reg. 76,982 ( December 23, 2004) ( hereinafter " 2005 exemption rule"). [ JA 39]. 2 begin, the 1990 amendments to the Act incorporate the entire Montreal Protocol, including " adjustments adopted by Parties thereto." CAA § 601( 9), 42 U. S. C. § 7671( 9); see also CAA §

614( b), 42 U. S. C. § 7671m( b). Moreover, the same amendments forbid EPA or a court from " constru[ ing], interpret[ ing], or appl[ ying]" the Act's terms " to abrogate the responsibilities and obligations of the United States to implement fully the provisions of the   Protocol." CAA §

614( b), 42 U. S. C. § 7671m( b).

Even clearer and more relevant than these general incorporation provisions are specific amendments relating to methyl bromide that were added to the Clean Air Act eight years later, in 1998. These amendments were enacted shortly after the adoption in 1997 of both the Protocol adjustment that established the current methyl bromide phaseout requirements3 and the accompanying Decision IX/ 6 setting forth the criteria for critical use exemptions. The 1998 Clean Air Act amendments, contained in Section 764 of the 1999 Omnibus Consolidated and Emergency Supplemental Appropriations Act, Pub. L. 105 277 ( Oct. 21, 1998), 4 and codified in Section 604 of the Clean Air Act, 42 U. S. C. § 7671c, authorize EPA to provide exemptions for critical uses, but that exemption authority is strictly limited: EPA may grant exemptions only " in 3 Those requirements are laid out in Article 2H, ¶ 5. The enforceability and cognizability of that paragraph are not themselves doubt. In September 1997, at their Ninth Meeting, the Parties adopted the paragraph as an adjustment to the Protocol. UNEP, Report of the Ninth Meeting of the Parties to the Montreal Protocol on Substances that Deplete the Ozone Layer, UNEP/ OzL. Pro. 9/ 12 25 ( 1997), at http:// hq. unep. org/ ozone/ Meeting_ Documents/ mop/ 09mop/ 9mop 12. e. pdf ( agreeing, in Decision IX/ 3, "[ t] o adopt, in accordance with the procedure laid down in paragraph 9 of Article 2 of the Montreal Protocol and on the basis of the assessments made pursuant to Article 6 of the Protocol, the adjustments and reductions of production and consumption of [ methyl bromide], as set out in annex III to the report of the Ninth Meeting of the Parties"); id. at Annex III ( laying out the text of the adjustments, including Article 2H, ¶ 5). Moreover, as the Court noted during oral argument, Clean Air Act section 601( 9) makes clear that Congress considers such adjustments to be enforceable Protocol provisions. 42 U. S. C. § 7671( 9) ( defining the Montreal Protocol to " includ[ e] adjustments adopted by the Parties thereto").

4 At oral argument, Petitioner's counsel mistakenly stated that these amendments were included in a farm bill. As noted above, they actually were passed in 1998 as part of the 1999 Omnibus Consolidated and Emergency Supplemental Appropriations Act. Counsel was correct, however, that there is no legislative history elaborating on these provisions. 3 accordance with" the Protocol's methyl bromide " phaseout schedule   as in effect on October 21, 1998," and only "[ t] o the extent consistent with the Montreal Protocol":

Section 604( h): Methyl bromide. The Administrator shall promulgate rules for reductions in, and terminate the production, importation, and consumption of, methyl bromide under a schedule that is in accordance with, but not more stringent than, the phaseout schedule of the Montreal Protocol Treaty as in effect on October 21, 1998. 42 U. S. C. § 7671c( h) ( emphasis added).

Section 604( d)( 6): Critical uses. To the extent consistent with the Montreal Protocol, the Administrator, after notice and the opportunity for public comment,   may exempt the production, importation, and consumption of methyl bromide for critical uses. 42 U. S. C. § 7671c( d)( 6) ( emphasis added).

In short, the Clean Air Act incorporated the Protocol's 1997 methyl bromide provisions.

Accordingly, the Court unquestionably has authority to review and decide whether the 2005 exemption rule is consistent with those provisions.

II. The 1997 Protocol Adjustment Prohibits Post 2004 Production or Consumption of Methyl Bromide Unless Authorized by a Decision of the Parties.

As Petitioner noted in its opening brief, the Montreal Protocol " bans post 2004 production or consumption of methyl bromide unless authorized by a Decision" of the Parties.

Pet. Op. Br. at 25 ( emphasis added). Specifically, under the 1997 Protocol adjustment:

Each Party shall ensure that for the twelve month period commencing on 1 January 2005, and in each twelve month period thereafter, its calculated level of consumption of [ methyl bromide] does not exceed zero. Each Party   shall, for the same periods, ensure that its calculated level of production of [ methyl bromide] does not exceed zero. This paragraph will apply save to the extent that the Parties decide to permit the level of production or consumption that is necessary to satisfy uses agreed by them to be critical uses. Montreal Protocol Art. 2H, ¶ 5 [ JA 190] ( emphasis added).

In other words, consistency with the Protocol allows only two outcomes: zero production or consumption after 2004, or whatever level of production or consumption the Parties " decide to permit" for agreed critical uses. Id ( emphasis added). 4 III. EPA's 2005 Exemption Rule Violates the Clean Air Act Unless It Complies with the Conditions in the Protocol Parties' Critical Use Decisions.

It follows, then, that EPA's exemptions must be consistent with the Parties' exemption Decisions, and that this Court can and must take cognizance of those Decisions when reviewing EPA's rule. Specifically, Clean Air Act section 604( d)( 6) authorizes EPA to issue production or consumption exemptions only if those exemptions are " consistent" with the Montreal Protocol,

and the Protocol allows exemptions only " to the extent that" the Parties " decide" to permit them.

Montreal Protocol Art. 2H, ¶ 5 [ JA 190]. Therefore, under the Act, EPA has no authority to issue exemptions unless the agency complies with the relevant Decisions of the Parties   that is, as relevant here, Decisions IX/ 6 and Ex. I/ 3. In turn, those two Decisions are cognizable in this Court because they define the scope of EPA's Clean Air Act authority.

The only remaining question is whether, as counsel for EPA tentatively suggested at oral argument, EPA may pick and choose which parts of the Parties' Decisions to follow, and which parts to ignore. Counsel appeared to suggest that while EPA must heed paragraph 1 of Decision Ex. I/ 3, which sets the maximum levels of 2005 production and consumption and identifies the crops or other applications that are deemed " critical uses," the agency is free to ignore the stockpile and other conditions imposed in paragraph 5 of the same Decision. This partial compliance argument is absurd. The Parties did not agree to paragraph 1 in isolation, they adopted paragraph 1 subject to paragraph 5. Decision Ex. I/ 3 would have an entirely different meaning without paragraph 5. Under Clean Air Act section 604( d)( 6), EPA has no discretion to refashion the Parties' Decision by disregarding paragraph 5 and the conditions it imposes.

In sum, under Section 604( d)( 6) of the Clean Air Act, EPA may allow post 2004 production and consumption of methyl bromide only " to the extent consistent with" the Parties'

exemption Decisions   that is, Decisions IX/ 6 and Ex. I/ 3. The Clean Air Act itself makes the 5 terms of those Decisions binding on the agency, and this Court has eminent authority to ensure that the agency's actions conform to federal law.

CONCLUSION For the reasons stated above, the terms of the Montreal Protocol Parties' Decisions constrain EPA's federal statutory authority to exempt post 2004 production, importation, and consumption of methyl bromide for critical uses. As such, those terms are both binding on the Agency and enforceable by this Court. Accordingly, Petitioner respectfully requests that the Court grant its petition and enter the relief sought in its opening brief.

Respectfully submitted,

___________________ David D. Doniger ( D. C. Bar No. 305383) Amanda C. Leiter Natural Resources Defense Council 1200 New York Ave., N. W., Suite 400 Washington, D. C. 20005 ( 202) 289 6868 Attorneys for Natural Resources Defense Council DATED: November 7, 2005. 6 CERTIFICATE OF SERVICE I hereby certify that two copies of the foregoing Supplemental Brief for Petitioner have been served by hand this 7th day of November 2005, upon the following:

Mr. Steven E. Rusak U. S. Department of Justice Environment and Natural Resources Division Environmental Defense Section Post Office Box 23986 Washington, DC 20026 3986 steve. rusak@ usdoj. gov For US EPA, et al. Diane E. McConkey Air and Radiation Office ( 2344A) Office of General Counsel U. S. Environmental Protection Agency 1101A EPA Headquarters Ariel Rios Building 1200 Pennsylvania Avenue, NW Washington, DC 20004 mcconkey. diane@ epa. gov For US EPA, et al.

Tracy Heinzman David B. Weinberg Wiley Rein & Fielding LLP 1776 K Street, NW Washington, DC 20006 theinzman@ wrf. com For the Methyl Bromide Industry Panel of the American Chemistry Council __________________________ David D. Doniger Natural Resources Defense Council RELEVANT STATUTORY SECTIONS Clean Air Act § 601( 9), 42 U. S. C. § 7671( 9) .............................................................................. 2 Relevant portions of Clean Air Act § 604, 42 U. S. C. § 7671c...................................................................................... 3 Clean Air Act § 614( b), 42 U. S. C. § 7671m( b) ........................................................................... 4 2 CLEAN AIR ACT § 601( 9)

42 U. S. C. § 7671( 9). Montreal Protocol The terms " Montreal Protocol" and " the Protocol" mean the Montreal Protocol on Substances that Deplete the Ozone Layer, a protocol to the Vienna Convention for the Protection of the Ozone Layer, including adjustments adopted by Parties thereto and amendments that have entered into force. 3 RELEVANT PORTIONS OF CLEAN AIR ACT § 604 42 U. S. C. § 7671c( d)( 6). Critical uses To the extent consistent with the Montreal Protocol, the Administrator, after notice and the opportunity for public comment, and after consultation with other departments or instrumentalities of the Federal Government having regulatory authority related to methyl bromide, including the Secretary of Agriculture, may exempt the production, importation, and consumption of methyl bromide for critical uses.

42 U. S. C. § 7671c( h). Methyl bromide Notwithstanding subsections ( b) and ( d) of this section, the Administrator shall not terminate production of methyl bromide prior to January 1, 2005. The Administrator shall promulgate rules for reductions in, and terminate the production, importation, and consumption of, methyl bromide under a schedule that is in accordance with, but not more stringent than, the phaseout schedule of the Montreal Protocol Treaty as in effect on October 21, 1998. 4 CLEAN AIR ACT § 614( b)

42 U. S. C. § 7671m( b). Montreal Protocol This subchapter as added by the Clean Air act Amendments of 1990 shall be construed, interpreted, and applied as a supplement to the terms and conditions of the Montreal Protocol, as provided in Article 2, paragraph 11 thereof, and shall not be construed, interpreted, or applied to abrogate the responsibilities or obligations of the United States to implement fully the provisions of the Montreal Protocol. In the case of conflict between any provision of this subchapter and any provision of the Montreal Protocol, the more stringent provision shall govern. Nothing in this subchapter shall be construed, interpreted, or applied to affect the authority or responsibility of the Administrator to implement Article 4 of the Montreal Protocol with other appropriate agencies.


[Federal Register Volume 79, Number 200 (Thursday, October 16, 2014)]
[Notices]
[Pages 62239-62241]
[FR Doc No: 2014-24544]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-73330; File No. SR-Phlx-2014-64]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change to Options
Floor Procedure Advice F-27, Options Exchange Official Rulings

October 9, 2014.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on October 2, 2014, NASDAQ OMX PHLX LLC (``Phlx'' or ``Exchange'')
filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the Exchange. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to correct Options Floor Procedure Advice
(``Advice'') F-27, Options Exchange Official Rulings, by updating an
obsolete reference.
    The text of the proposed rule change is below; proposed new
language is in italics; proposed deletions are in brackets.
* * * * *

F-27 Options Exchange Official Rulings

    Options Exchange Officials are empowered to render rulings on the
trading floor to resolve trading disputes occurring on and respecting
activities on the trading floor. All rulings rendered by Options
Exchange Officials are effective immediately and must be complied with
promptly. Failure to promptly comply with a ruling concerning a trading
dispute may result in referral to the Business Conduct Committee.
Failure to promptly comply with other rulings issued pursuant to Order
and Decorum Regulations or Floor Procedure Advices and not concerning a
trading dispute may result in an additional violation. Options Exchange
Officials need not render decisions in any instance where the request
for a ruling was not made within a reasonable period of time. An
Options Exchange Official should not render a decision or authorize a
citation where such Options Exchange Official was involved in or
affected by the dispute, as well as in any situation where the Options
Exchange Official is not able to objectively and fairly render a
decision.
    Options Exchange Officials shall endeavor to be prompt in rendering
decisions. However, in any instance where an Options Exchange Official
has determined that the benefits of further discovery as to the facts
and circumstances of any matter under review outweigh the monetary
risks of a delayed ruling, the Options Exchange Official may determine
to delay rendering the ruling until such time as that further discovery
is completed. In issuing decisions for the resolution of trading
disputes, Options Exchange Officials shall institute the course of
action deemed by the ruling Options Exchange Official to be more fair
to all parties under the circumstances at the time. An Options Exchange
Official may direct the execution of an order on the floor, or adjust
the transaction terms or participants to an executed order on the
floor. However, an Options Exchange Official may nullify a transaction
if they determine the transaction to have been in violation of Rule
Rules 1014 (Obligations and Restrictions Applicable to Specialists and
Registered Options Traders), Rule 1017 (Openings In Options), Rule 1033
(Bids And Offers-Premium) or Rule 1080 (Phlx XL and Phlx XL II).
    Exchange staff may determine that an Options Exchange Official is
ineligible to participate in a particular ruling where it appears that
such Options Exchange Official has a conflict of interest. For purposes
of this Rule, and without limitation, a conflict of interest exists
where an Options Exchange Official: (a) Is directly or indirectly
affiliated with a party seeking an Options Exchange Official ruling;
(b) is a participant or is directly or indirectly affiliated with a
participant in a transaction that is the subject of an Options Exchange
Official ruling; (c) is a debtor or creditor of a party seeking an
Options Exchange Official ruling; or (d) is an immediate family member
of a party seeking an Options Exchange Official ruling. Exchange staff
may consider other circumstances, on a case-by-case basis, in
determining the eligibility or ineligibility of a particular Options
Exchange Official to participate in a particular ruling due to a
conflict of interest.
    All Options Exchange Official rulings concerning the adjustment and
nullification of transactions are reviewable by the [Referee (as
defined in Rule 124)] Market Operations Review Committee.
    (i)-(v) No change.
FINE SCHEDULE
$250.00

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of

the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of the proposal is to correct an Exchange provision
respecting how disputes are settled. Advice F-27 generally parallels
Rule 124 and governs how disputes are settled on the Exchange's options
trading floor. Specifically, Advice F-27 (as well as Rule 124) provides
that Options Exchange Officials are empowered to render rulings on the
trading floor to resolve trading disputes occurring on and respecting
activities on the trading floor. It also governs the process for
rendering rulings and situations where the Options Exchange Official
may have a conflict.
    Some time ago, Options Exchange Official rulings were appealable to
the Exchange Referee, an Exchange employee who was empowered to review
Options Exchange Official rulings. In 2009,\3\ the Exchange replaced
the Referee with a committee, the Market Operations Review
Committee,\4\ and inadvertently left one reference to the Referee in
Advice F-27. At this time, the Exchange proposes to delete that
reference and replace it with reference to the Market Operations Review
Committee. This change to Advice F-27 ensures that the terms used in
the Advice and the Rule are consistent and up-to-date.
---------------------------------------------------------------------------

    \3\ Securities Exchange Act Release Nos. 60687 (September 18,
2009), 74 FR 49060 (September 25, 2009) (SR-Phlx-2009-59) (Replacing
Referee with Options Trade Review Committee); and 64338 (April 25,
2011), 76 FR 24069 (April 29, 2011) (SR-Phlx-2011-13) (Renaming the
Options Trade Review Committee as the Market Operations Review
Committee).
    \4\ Options Exchange Official rulings (including those
concerning the nullification or adjustment of transactions) may be
sustained, overturned or modified by the Market Operations Review
Committee. See Rule 124(d) and By-Law Article V, Section 5-3(d).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \5\ in general, and furthers the objectives of Section
6(b)(5) of the Act \6\ in particular, in that it is designed to promote
just and equitable principles of trade, and, to protect investors and
the public interest, by providing a clear rule on how rulings can be
appealed.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act, because it merely corrects a
reference.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \7\ and Rule 19b-4(f)(6) thereunder.\8\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate, the proposed rule change has become effective
pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-4(f)(6)(iii)
thereunder.\9\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \8\ 17 CFR 240.19b-4(f)(6).
    \9\ In addition, Rule 19b-4(f)(6)(iii) requires the Exchange to
give the Commission written notice of the Exchange's intent to file
the proposed rule change, along with a brief description and text of
the proposed rule change, at least five business days prior to the
date of filing of the proposed rule change, or such shorter time as
designated by the Commission. The Exchange has satisfied this
requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative prior to 30 days after the date of the filing.
However, pursuant to Rule 19b-4(f)(6)(iii),\10\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing. The Commission believes
that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest. Specifically, the
Commission believes that the proposal would eliminate confusion in the
Exchange's rules and provide clarification to the public. Therefore,
the Commission hereby waives the 30-day operative delay and designates
the proposal operative upon filing.\11\
---------------------------------------------------------------------------

    \10\ 17 CFR 240.19b-4(f)(6)(iii).
    \11\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

 IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2014-64 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-Phlx-2014-64. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of

10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-Phlx-2014-64 and should be
submitted on or before November 6, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

    \12\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-24544 Filed 10-15-14; 8:45 am]
BILLING CODE 8011-01-P


COMPANY FEDERAL REGISTER NOTICE OF FILING

EPA Registration Division contact: Susan Stanton<PHONE_NUMBER>

Interregional Research Project No. 4 (IR-4)

PP #8E7473

	EPA has received a pesticide petition (PP#8E7473) from Interregional
Research Project No. 4, Rutgers University, 500 College Road East, Suite
201W, Princeton, NJ 08540, 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 establishing a tolerance for residues of propamocarb hydrochloride;
propyl[3-(dimethylamino)propyl]carbamate mono-hydrochloride, in or on
the raw agricultural commodity bean, lima, succulent at 2.0 parts per
million (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 supports granting of the
petition. Additional data may be needed before EPA rules on the
petition.

A. Residue Chemistry

	1. Plant metabolism. The fate of propamocarb hydrochloride in plants is
clearly understood.  Metabolism studies in cucumbers, potatoes and
spinach demonstrated that propamocarb is degraded to carbon dioxide
which is reincorporated into natural plant constituents.  The primary
residue found in all crops, and the only residue of concern, is the
parent, propamocarb hydrochloride.

	2. Analytical method. A practical analytical method utilizing
gas/liquid chromatography and N-FID or MSD is available and has been
validated for detecting and measuring levels of propamocarb
hydrochloride in or on food. The limit of quantification (LOQ) is 0.05
mg/kg (ppm).

	3. Magnitude of residues. Five residue trails were conducted in the US
over a two-year period in accordance with the proposed label use
directions. The maximum residue detected in/on lima beans was 1.20 ppm.

B. Toxicological Profile

	1. Acute toxicity.  There are no acute toxicity concerns with
propamocarb hydrochloride. The acute rat oral LD50 is 2900 mg/kg in
males and 2000 mg/kg in females. The acute rat dermal LD50 is >3000
mg/kg. The acute (4-hour) inhalation LC50 in rats is >7.9 mg/l.
Propamocarb hydrochloride is not considered a skin sensitizer.
Propamocarb hydrochloride has been classified as Toxicity Category III
for acute oral and dermal toxicity and eye irritation and Category IV
for acute inhalation toxicity and skin irritation. An acute
neurotoxicity study was performed in rats at dose levels of 0, 20, 200
and 2000 mg/kg of propamocarb hydrochloride. The overall NOAEL for this
study was determined to be 200 mg/kg based on decreased weight gain,
soiled fur and decreased motor activity in males and/or females at 2000
mg/kg.

	2. Genotoxicty. No evidence of genotoxicity was observed in a battery
of studies including Salmonella and E. Coli gene mutation assays, two
mouse micronucleus assays, an in vitro mammalian cytogenetic assay using
cultured human lymphocytes, a yeast mitotic gene conversion assay and a
yeast mitotic recombination assay.

	3. Reproductive and developmental toxicity. In a developmental toxicity
study, rats were administered propamocarb hydrochloride by gavage at
dose levels of 0, 74, 221, 740, or 2210 mg/kg/day on gestation days
6-19. The NOAEL for maternal toxicity was 740 mg/kg/day based on
mortality, clinical observations and decreased body weight gain at 221
mg/kg/day. The NOAEL for developmental toxicity was 221 mg/kg/day based
on increased post-implantation loss, decreased fetal weights and
increased incidence of minor skeletal anomalies (retarded ossification)
at 740 and/or 2210 mg/kg/day.

In another developmental toxicity study, rabbits were administered
propamocarb hydrochloride by gavage at dose levels of 0, 15, 45, 150,
300 or 600 mg/kg/day on gestation days 6-18. The NOAEL for both maternal
toxicity and developmental toxicity was 150 mg/kg/day, based on
decreased maternal body weight gain and increased post-implantation loss
at 300 mg/kg/day.

A three-generation reproduction study was conducted using rats fed diet
containing propamocarb hydrochloride at dietary concentrations of 0, 40,
200, and 1000 ppm for 100 days and then continuously through three
successive generations. No treatment-related effects were noted on
either the parents or offspring.

A two-generation reproduction study was conducted with albino rats.
Animals received propamocarb hydrochloride at dietary concentration of
0, 200, 1250 and 8000 ppm. Reduced body weights were observed in the F0
and Fl parental animals and the F1 and F2 offspring at 8000 ppm. Based
on these findings, the NOAEL is 1250 ppm for parental and neonatal
toxicity (65.41 mg/kg/day for males and 76.78 mg/kg/day for females) and
8000 ppm for reproductive toxicity.

	4. Subchronic toxicity. In a 90-day feeding study, propamocarb
hydrochloride was administered to albino rats at concentrations of 0,
20, 50, 100, and 500/1000 ppm in the diet. The only effects noted were
slightly reduced food efficiency and body weight gains at 1000 ppm.

In a 90-day feeding study in beagle dogs, propamocarb was administered
in the diet at concentrations of 0, 50, 100, 500, and 1000/2000 ppm. No
treatment-related findings were observed. In a 90-day feeding study with
albino mice, propamocarb was administered at concentrations of 0, 1404,
2808, 5616 and 11,232 ppm in the diet. No treatment-related findings
were observed.

A 21-day dermal toxicity study was performed with propamocarb in
Sprague-Dawley rats at dose levels of 0, 100, 500 and 1000 mg/kg/day,
six hours per day, five days per week over a 21-day period. No treatment
related effects were observed.

A 21-day dermal toxicity study was performed with propamocarb
hydrochloride in rabbits at dose levels of 0, 150, 525 and 1500
mg/kg/day, six hours per day, five days per week, over a 21-day period.
EPA assessed the NOAEL to be 150 mg/kg/day based on dose-related skin
irritation in mid- and high-dose animals and a decrease in weight gain
in mid-dose females.

A 90-day neurotoxicity study was conducted in rats at dietary
concentrations of propamocarb hydrochloride of 0, 200, 2,000 and 20,000
ppm. No evidence of neurotoxicity (FOB, motor activity or
neuropathology) was observed at any dose level. Plasma, red blood cell
and brain cholinesterase levels were also not affected. The NOAEL was
determined to be 2000 ppm (142 mg/kg/day) based on decreased weight gain
at 20,000 ppm.

	5. Chronic toxicity. A two-year feeding chronic
toxicity/carcinogenicity study was performed in Sprague- Dawley rats
with propamocarb hydrochloride at dietary concentrations of 0, 40, 200
or 1000 ppm.  There was no evidence of carcinogenicity or other
treatment-related effect except for a possible reduction in food intake
in female rats at the highest level tested. Thus, 1000 ppm (41
mg/kg/day) was considered to be the NOAEL. However, this study did not
satisfy the EPA's criteria for a Maximum Tolerated Dose (MTD). In a
second two-year chronic toxicity/ oncogenicity study, albino rats
received diets containing propamocarb hydrochloride at concentrations of
0, 350, 2800 and 22,400 ppm. Animals receiving 22,400 ppm exhibited
decreased body weights, body weight gain and food consumption.
Additionally, these animals revealed moderate vacuolation of the choroid
plexis ependymal cells. There was no evidence of oncogenicity. Based on
these findings, EPA assessed the NOAEL to be 2800 ppm (84 mg/kg/day in
males and 112 mg/kg/day in females).

A two-year feeding chronic toxicity/carcinogenicity study was performed
in CD-1 mice with propamocarb hydrochloride at dietary concentrations of
0, 20, 100 and 500 ppm. No evidence of carcinogenicity or toxicity was
noted at any dose level.

An 18-month mouse oncogenicity study was conducted in CD-1 mice exposed
to propamocarb hydrochloride at dietary concentrations of 0, 105, 840
and 6720 ppm. Reduced body weights were reported for animals in the 840
and 6720 ppm groups. There was no evidence of oncogenicity. Based on
these findings, EPA assessed the NOAEL to be (12 mg/kg/day) based on the
body weight effects in females.

A two-year feeding study was performed in beagle dogs with propamocarb
hydrochloride at dietary concentrations of 0, 1000, 3000, 10000 ppm.
Decreased weight gain, decreased food efficiency and an increased
incidence of acute gastric mucosal erosions and/or chronic erosive
gastritis were noted in all treated groups. Thus, a NOAEL for this study
was not determined but was considered to be slightly lower than the
lowest dose level tested (22.75 mg/kg/day).

	6. Animal metabolism. The absorption, distribution, metabolism and
excretion of propamocarb hydrochloride have been evaluated in rats.
Propamocarb hydrochloride was rapidly absorbed, extensively metabolized
and rapidly eliminated, primarily via the urine (>90% excreted within 24
hours), following oral administration. Metabolite profiles were similar
following single and repeated oral dosing and following intravenous
dosing. The primary route of metabolism was oxidative degradation with
hydrolytic cleavage occurring as a secondary pathway.

The metabolism of propamocarb hydrochloride has been evaluated in
ruminants. The majority of the orally administered dose was excreted via
the urine and feces. Total radioactive residues in tissues and bile
accounted for 0.7% of the administered dose. The majority of the residue
was comprised of propamocarb, an N-oxide metabolite, an oxazolidine
metabolite, and a 2-hydroxy metabolite.

	7. Metabolite toxicology. NA

	8. Endocrine disruption. No special studies have been conducted to
investigate the potential of propamocarb hydrochloride to induce
estrogenic or other endocrine effects. However, the standard battery of
required toxicity studies has been completed. These studies include an
evaluation of the potential effects on reproduction and development, and
an evaluation of the pathology of the endocrine organs following
repeated or long-term exposure. These studies are generally considered
to be sufficient to detect any endocrine effects yet no such effects
were detected. Thus, the potential for propamocarb hydrochloride to
produce any significant endocrine effects is considered to be minimal.

C. Aggregate Exposure

	1. Dietary exposure. For acute dietary analysis, an acute reference
dose (aRfD) of 1.5 mg/kg/day was derived for females 13 - 50 based on
increased post implantation loss in a rabbit developmental study and an
uncertainty factor of 100. For the general U.S. population including
infants and children the aRfD of 2.0 mg/kg/day was derived from
decreased body weight gain and decreased motor activity in the acute
neurotoxicity screening battery in the rat and an uncertainty factor of
100. For chronic dietary analysis, a chronic reference dose (cRfD) of
0.12 mg/kg/day was derived from body weight changes in the mouse
carcinogenicity study and an uncertainty factor of 100. EPA has
evaluated the potential for increased susceptibility of infants and
children from exposure to propamocarb hydrochloride and concluded that
the toxicology database is complete for FQPA purposes and that there are
no residual uncertainties for pre-/post-natal toxicity. The special FQPA
SF has been reduced to 1X. Acute and chronic Population Adjusted Doses
(aPAD and cPAD) are, therefore, the same as the reference doses for the
populations and subpopulations of interest.

was estimated from potential residues on food using the DEEM-FCID™
software. The Tier One assessments for acute and chronic analyses used
100% crop treated and tolerance level residue values. Established
tolerances for propamocarb hydrochloride include the cucurbit vegetable
crop group 9 (1.5 ppm), the fruiting vegetable crop group 8 (2.0 ppm)
with tomato paste at 5.0 ppm, head lettuce (50 ppm), leaf lettuce (90
ppm) and potatoes (0.06 ppm).  The proposed tolerance for lima beans is
2.0 ppm.  Secondary tolerances are established for meat and meat
by-products (0.15ppm), liver (0.65 ppm), kidney (0.2 ppm), fat (0.05ppm)
and milk (0.85 ppm). Acute exposure utilizes 6.1% of the aPAD for
Females 13-50 (aPAD=1.5 mg/kg bw/day) and 4.2% and 5.4% of the aPAD for
the US Population and Children 1-2 respectively (aPAD=2.0 mg/kg bw/day).
  Chronic exposure (cPAD=0.12 mg/kg bw/day) utilizes 17.5% for the US
Population and 36.3% for Children 1-2, the most highly exposed
subpopulation. These are conservative estimates and actual exposures are
likely to be much less.

	ii. Drinking Water. The surface water estimated drinking water
concentrations (EDWCs) were estimated using PRZM/EXAMS (Pesticide Root
Zone Model/Exposure Analysis Modeling System) for propamocarb
hydrochloride use on turf (Florida turf scenario) and lima beans
(Michigan bean scenario).   Ground water EDWCs, calculated using
SCI-GROW (Screening Concentration in Ground Water), model were lower
than the surface water EDWCs. The surface water estimates from the
Michigan bean scenario were slightly higher than the estimates from the
Florida turf scenario. Acute (peak) and chronic (annual average) EDWCs
representing the upper 1-in-10 year concentration were 153.5 and 10.4
ppb, respectively. These conservative single point values were added
directly to the Tier One acute and chronic dietary analyses described
above.  Acute exposure utilizes 6.4% of the aPAD for Females 13-50, 4.3%
for the US Population and 5.7% for Children 1-2, the most highly exposed
subpopulation.  Chronic exposure utilizes 17.7% of the cPAD for the US
Population and 36.6%% for Children 1-2, the most highly exposed
subpopulation. These conservative estimates indicate there is no concern
for dietary exposures from food and drinking water from potential
residues of propamocarb hydrochloride in food and drinking water.

	2. Non-dietary exposure. EPA has determined that there is a potential
for short-term post-application exposures for the adult and adolescent
golfer. An MOE of 100 is adequate to ensure protection from propamocarb
hydrochloride via the dermal and inhalation routes for residential
exposures.  Golfer exposure is expected through minimal hand contact
with the golf ball and dermal contact to the lower legs from treated
plant surfaces. Since it is assumed that the adolescent golfer would
have a proportionally similar exposure to adults, a dermal
post-application assessment was performed for the adult golfer only. A
TC (transfer coefficient) of 500 cm2/hr has been used to estimate
post-application exposure and all exposure estimates were assessed on
the day of treatment. The appropriate endpoint for short term dermal
exposure is NOAEL of 150 mg/kg/day based on weight gain changes in the
rabbit in a 21-day dermal absorption study. The calculated MOE for the
golfer is 980 and, therefore, does not exceed EPA’s level of concern.

D. Cumulative Effects

	Section 408(b)(2)(D)(v) requires that, when considering whether to
establish, modify, or revoke a tolerance, the Agency consider
“available information” concerning the cumulative effects of a
particular pesticide’s residues and “other substances that have a
common mechanism of toxicity.”   EPA has not made a common mechanism
of toxicity finding as to propamocarb hydrochloride and any other
substances and propamocarb hydrochloride does not appear to produce a
toxic metabolite produced by other substances.

E. Safety Determination

	1. U.S. population. Risk assessments for propamocarb hydrochloride are
based on based on a complete and reliable toxicity data package and
highly conservative assumptions. Chronic aggregate exposure (food and
water) from the proposed uses of propamocarb hydrochloride will utilize
less than 18% of the cPAD for the US Population. EPA generally has no
concern for exposures below 100% of the cPAD because the cPAD represents
the level at or below which daily aggregate exposure over a lifetime
will not pose appreciable risk to human health. For acute aggregate
exposure (food and water) females 13+ represent the most sensitive
subpopulation of the overall U.S. adult population but this group still
utilizes less than 7% of the aPAD using highly conservative assumptions.
 In addition to acute and chronic exposure, there is the potential for
short term aggregate exposure to adult and youth golfers. The proposed
uses on lima beans do not add significantly to aggregate dietary
exposure (food and water).  EPA has determined that MOEs for short term
aggregate exposure from food and residential exposure are greater than
100, and therefore below EPA’s level of concern. For surface and
ground water, the estimated average concentrations of propamocarb
hydrochloride are less than EPA's calculated DWLOCs (Drinking Water
Levels of Comparison) for propamocarb hydrochloride in drinking water as
a contribution to short-term aggregate exposure. Therefore, there is a
reasonable certainty that no harm will occur to the US Population from
aggregate exposure (food, drinking water and non-dietary) to residues of
propamocarb hydrochloride.

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ildren. Therefore, there is a reasonable certainty that no harm will
occur to infants and children from aggregate exposure to residues of
propamocarb hydrochloride.

F. International Tolerances

	Codex and other import tolerances are currently not available for
propamocarb hydrochloride on lima beans.