24370 Federal Register / Vol. 68, No. 88 / Wednesday, May 7, 2003 / Rules and Regulations [ FR Doc. 03   7640 Filed 5   6   03; 8: 45 am]

BILLING CODE 6560   50   P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2003   0140; FRL   7302   7]

Pesticide Tolerance Processing Fees; Annual Adjustment AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule.

SUMMARY: This rule increases fees charged for processing tolerance petitions for pesticides under the Federal Food, Drug, and Cosmetic Act ( FFDCA). As specified in 40 CFR 180.33( o), the existing fee schedule is changed annually by the same percentage as the percent change in the Federal General Schedule ( GS) pay scale. Accordingly, the revisions in this rule reflect a 4.27% increase in locality pay for civilian Federal GS employees working in the Washington, DC and Baltimore, MD metropolitan area in 2003.

DATES: This rule is effective June 6, 2003.

FOR FURTHER INFORMATION CONTACT: For general information concerning this rule contact: Ed Setren, Resources Management Staff ( 7501C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone: ( 703) 305   5927; fax: ( 703) 305   5060; e mail address: setren. edward@ epa. gov. For technical information concerning tolerance petitions and individual fees contact: Sonya Brooks, Resources Management Staff ( 7501C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone: ( 703) 308   6423; fax: ( 703) 305   5060; e mail address: brooks. sonya@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. Does this Rule Apply to Me?

This rule may directly affect any person who might petition the Agency for new tolerances, hold a pesticide registration with existing tolerances, or anyone who is interested in obtaining or retaining a tolerance in the absence of a registration. This group can include pesticide manufacturers or formulators, companies that manufacture chemicals used in formulating pesticides, importers of food, grower groups, or any person who seeks a tolerance. The vast majority of potentially affected categories and entities may include, but are not limited to:   Chemical industry ( NAICS codes 115112 and 325320) e. g., pesticide chemical manufacturers, formulators, chemical manufacturers of inert ingredients This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. Other types of entities not listed above could also be regulated. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

II. How Can I Get Additional Information or Copies of this Document or Other Documents?

1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2002   0140. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr[ 180]_ 00. html, a beta site currently under development. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the appropriate docket ID number.

III. What Action is the Agency Taking in this Rule? With this rule, the Agency is increasing the fees charged for processing tolerance petitions for pesticides under the Federal Food, Drug, and Cosmetic Act ( FFDCA). The pay raise in 2003 for Federal General Schedule ( GS) employees working in the Washington, DC/ Baltimore, MD metropolitan pay area is 4.27%. This increase in the fees charged for processing tolerance petitions reflects these recent pay raises.

IV. Why is the Agency Taking this Action? EPA is charged with the administration of section 408 of FFDCA. Section 408 authorizes the Agency to establish tolerance levels and exemptions from the requirements for tolerances for raw agricultural commodities. Section 408( o) requires the Agency to collect fees that will, in the aggregate, be sufficient to cover the costs of processing petitions for pesticide products. EPA is publishing this action pursuant to 40 CFR 180.33( o). The current fee schedule for tolerance petitions published in the Federal Register of March 13, 2002 ( 67 FR 11248) ( FRL   6774   3), codified at 40 CFR 180.33, and became effective on April 12, 2002. At that time the fees were increased by 4.94%, 3.81%, and 4.77% to reflect the 2000, 2001, and 2002 pay adjustments in accordance with a provision in the regulation that provides for automatic annual adjustments to the fees based on annual percentage changes in Federal salaries ( 40 CFR 180.33( o)). The Federal Employees Pay Comparability Act of 1990 ( FEPCA) initiated locality based comparability pay, known as `` locality pay.'' The intent of the legislation is to make Federal pay more responsive to local labor market conditions by adjusting General Schedule salaries on the basis of a comparison with non Federal rates on a geographic, locality basis. The processing and review of tolerance petitions is conducted by EPA employees working in the Washington, DC/ Baltimore, MD pay area. The pay raise in 2003 for Federal General Schedule employees working in the Washington, DC/ Baltimore, MD metropolitan pay area is 4.27%; therefore, the tolerance petition fees are being increased by 4.27%. The entire revised fee schedule is presented in § 180.33 of the regulatory text for the VerDate Jan< 31> 2003 15: 29 May 06, 2003 Jkt 200001 PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 07MYR1. SGM 07MYR1 24371 Federal Register / Vol. 68, No. 88 / Wednesday, May 7, 2003 / Rules and Regulations reader's convenience. ( All fees have been rounded to the nearest $ 25.00.)

V. Why is EPA Issuing this Action as a Final Rule? EPA is publishing this action as a final rule pursuant to 40 CFR 180.33( o), which reads in part: ( o) This fee schedule will be changed annually by the same percentage as the percent change in the Federal General Schedule ( GS) pay scale [. . .]. When automatic adjustments are made based on the GS pay scale, the new fee schedule will be published in the Federal Register as a final rule to become effective 30 days or more after publication, as specified in the rule.

VI. Statutory and Executive Order Reviews This final rule amends the fees charged for processing tolerance petitions under FFDCA to reflect automatic adjustments based on the GS pay scale and is issued as a final rule pursuant to 40 CFR 180.33( o). Under Executive Order 12866, entitled Regulatory Planning and Review ( 58 FR 51735, October 4, 1993), this action is not a `` significant regulatory action'' subject to review by the Office of Management and Budget ( OMB), nor is this final rule subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use ( 66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act ( PRA), 44 U. S. C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 ( UMRA) ( Public Law 104   4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations ( 59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks ( 62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( NTTAA), Public Law 104   113, section 12( d) ( 15 U. S. C. 272 note). Since the Agency is authorized to make automatic adjustments based on the GS pay scale by issuing a final rule under 40 CFR 180.33( o), and is not required to issue a proposed rule, the requirements of the Regulatory Flexibility Act ( RFA) ( 5 U. S. C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism ( 64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' `` Policies that have federalism implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408( n)( 4). For these same reasons, the Agency has determined that this final rule does not have any `` tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments ( 65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure `` meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' `` Policies that have tribal implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.'' This final rule will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. VII. Congressional Review Act The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of this rule in the Federal Register. This is not a `` major rule'' as defined by 5 U. S. C. 804( 2).

List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: April 25, 2003. Susan B. Hazen, Acting Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances.

 Therefore, 40 CFR chapter I is amended as follows:

PART 180   [ AMENDED]

 1. The authority citation for part 180 continues to read as follows:

Authority: 21 U. S. C. 321( q), ( 346a) and 371.

 2. Section 180.33 is revised to read as follows:

§ 180.33 Fees.

( a) Each petition or request for the establishment of a new tolerance or a tolerance higher than already established, shall be accompanied by a fee of $ 80,950, plus $ 2,025 for each raw agricultural commodity more than nine on which the establishment of a tolerance is requested, except as provided in paragraphs ( b), ( d), and ( h) of this section. ( b) Each petition or request for the establishment of a tolerance at a lower numerical level or levels than a tolerance already established for the same pesticide chemical, or for the establishment of a tolerance on additional raw agricultural commodities at the same numerical level as a tolerance already established for the same pesticide chemical, shall be accompanied by a fee of $ 18,500 plus $ 1,225 for each raw agricultural commodity on which a tolerance is requested.

VerDate Jan< 31> 2003 15: 29 May 06, 2003 Jkt 200001 PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 07MYR1. SGM 07MYR1 24372 Federal Register / Vol. 68, No. 88 / Wednesday, May 7, 2003 / Rules and Regulations ( c) Each petition or request for an exemption from the requirement of a tolerance or repeal of an exemption shall be accompanied by a fee of $ 14,925. ( d) Each petition or request for a temporary tolerance or a temporary exemption from the requirement of a tolerance shall be accompanied by a fee of $ 32,325 except as provided in paragraph ( e) of this section. A petition or request to renew or extend such temporary tolerance or temporary exemption shall be accompanied by a fee of $ 4,600. ( e) A petition or request for a temporary tolerance for a pesticide chemical which has a tolerance for other uses at the same numerical level or a higher numerical level shall be accompanied by a fee of $ 16,075, plus $ 1,225 for each raw agricultural commodity on which the temporary tolerance is sought. ( f) Each petition or request for repeal of a tolerance shall be accompanied by a fee of $ 10,125. Such fee is not required when, in connection with the change sought under this paragraph, a petition or request is filed for the establishment of new tolerances to take the place of those sought to be repealed and a fee is paid as required by paragraph ( a) of this section. ( g) If a petition or a request is not accepted for processing because it is technically incomplete, the fee, less $ 2,025 for handling and initial review, shall be returned. If a petition is withdrawn by the petitioner after initial processing, but before significant Agency scientific review has begun, the fee, less $ 2,025 for handling and initial review, shall be returned. If an unacceptable or withdrawn petition is resubmitted, it shall be accompanied by the fee that would be required if it were being submitted for the first time. ( h) Each petition or request for a crop group tolerance, regardless of the number of raw agricultural commodities involved, shall be accompanied by a fee equal to the fee required by the analogous category for a single tolerance that is not a crop group tolerance, i. e., paragraphs ( a) through ( f) of this section, without a charge for each commodity where that would otherwise apply. ( i) Objections under section 408( d)( 5) of the Act shall be accompanied by a filing fee of $ 4,050. ( j)( 1) In the event of a referral of a petition or proposal under this section to an advisory committee, the costs shall be borne by the person who requests the referral of the data to the advisory committee. ( 2) Costs of the advisory committee shall include compensation for experts as provided in § 180.11( c) and the expenses of the secretariat, including the costs of duplicating petitions and other related material referred to the committee. ( 3) An advance deposit shall be made in the amount of $ 40,400 to cover the costs of the advisory committee. Further advance deposits of $ 40,400 each shall be made upon request of the Administrator when necessary to prevent arrears in the payment of such costs. Any deposits in excess of actual expenses will be refunded to the depositor. ( k) The person who files a petition for judicial review of an order under section 408( d)( 5) or ( e) of the Act shall pay the costs of preparing the record on which the order is based unless the person has no financial interest in the petition for judicial review. ( l) No fee under this section will be imposed on the Interregional Research Project Number 4 ( IR 4 Program). ( m) The Administrator may waive or refund part or all of any fee imposed by this section if the Administrator determines in his or her sole discretion that such a waiver or refund will promote the public interest or that payment of the fee would work an unreasonable hardship on the person on whom the fee is imposed. A request for waiver or refund of a fee shall be submitted in writing to the Environmental Protection Agency, Office of Pesticide Programs, Registration Division ( 7505C), 1200 Pennsylvania Avenue, NW., Washington, DC 20460. A fee of $ 2,025 shall accompany every request for a waiver or refund, except that the fee under this sentence shall not be imposed on any person who has no financial interest in any action requested by such person under paragraphs ( a) through ( k) of this section. The fee for requesting a waiver or refund shall be refunded if the request is granted. ( n) All deposits and fees required by the regulations in this part shall be paid by money order, bank draft, or certified check drawn to the order of the Environmental Protection Agency. All deposits and fees shall be forwarded to the Environmental Protection Agency, Headquarters Accounting Operations Branch, Office of Pesticide Programs ( Tolerance Fees), P. O. Box 360277M, Pittsburgh, PA 15251. The payments should be specifically labeled `` Tolerance Petition Fees'' and should be accompanied only by a copy of the letter or petition requesting the tolerance. The actual letter or petition, along with supporting data, shall be forwarded within 30 days of payment to the Environmental Protection Agency, Office of Pesticide Programs, Registration Division ( 7505C), 1200 Pennsylvania Avenue, NW., Washington, DC 20460. A petition will not be accepted for processing until the required fees have been submitted. A petition for which a waiver of fees has been requested will not be accepted for processing until the fee has been waived or, if the waiver has been denied, the proper fee is submitted after notice of denial. A request for waiver or refund will not be accepted after scientific review has begun on a petition. ( o) This fee schedule will be changed annually by the same percentage as the percent change in the Federal General Schedule ( GS) pay scale. In addition, processing costs and fees will periodically be reviewed and changes will be made to the schedule as necessary. When automatic adjustments are made based on the GS pay scale, the new fee schedule will be published in the Federal Register as a final rule to become effective 30 days or more after publication, as specified in the rule. When changes are made based on periodic reviews, the changes will be subject to public comment. [ FR Doc. 03   11195 Filed 5   6   03; 8: 45 am]

BILLING CODE 6560   50   S GENERAL SERVICES ADMINISTRATION 48 CFR Parts 511, 516, 532, 538, 546, and 552 [ GSAR Amendment 2003   01; GSAR Case No. 2002   G505]

RIN 9000   AH76 General Services Administration Acquisition Regulation; Federal Supply Schedule Contracts   Acquisition of Information Technology by State and Local Governments Through Federal Supply Schedules AGENCIES: Office of Acquisition Policy, General Services Administration ( GSA). ACTION: Interim rule with request for comments.

SUMMARY: The General Services Administration ( GSA) is amending the General Services Administration Acquisition Regulation ( GSAR) to implement section 211 of the EGovernment Act of 2002. Section 211 authorizes the Administrator of GSA to provide for the use by States or local governments of its Federal Supply Schedules for automated data processing equipment ( including VerDate Jan< 31> 2003 15: 29 May 06, 2003 Jkt 200001 PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 07MYR1. SGM 07MYR1


[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)]
[Notices]
[Pages 32908-32910]
[FR Doc No: 2017-14982]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81129; File No. SR-NYSEArca-2017-76]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Commentary
.06 to Rule 6.8 To Extend the Pilot Program That Eliminated the
Position Limits for Options on SPDR S&P 500 ETF

July 12, 2017.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act''),\2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on July 10, 2017, NYSE Arca, Inc. (the ``Exchange'' or
``NYSE Arca'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to amend Commentary .06 to Rule 6.8 to extend
the pilot program that eliminated the position limits for options on
SPDR S&P 500 ETF (``SPY'') (``SPY Pilot Program''). The proposed rule
change is available on the Exchange's Web site at www.nyse.com, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

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 self-regulatory organization
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 those 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 parts of such statements.

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

1. Purpose
    The Exchange proposes to amend Commentary .06 to Rule 6.8 to extend
the time period of the SPY Pilot Program,\4\ which is currently
scheduled to expire on July 12, 2017, through July 12, 2018.
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    \4\ See Securities Exchange Act Release No. 68001 (October 5,
2012), 77 FR 62303 (October 12, 2012). The SPY Pilot Program was
subsequently extended. See Securities Exchange Act Release Nos.
70968 (December 3, 2013), 78 FR 73899 (December 9, 2013); 74029
(January 9, 2015), 80 FR 2161 (January 15, 2015); 75415 (July 9,
2015), 80 FR 41541 (July 15, 2015); and 78242 (July 7, 2016), 81 FR
45330 (July 13, 2016) (the ``July 2016 Extension'').
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    This filing does not propose any substantive changes to the SPY
Pilot Program. In proposing to extend the SPY Pilot Program, the
Exchange reaffirms its consideration of several factors that supported
the original proposal of the SPY Pilot Program, including (1) the
availability of economically equivalent products and their respective
position limits, (2) the liquidity of the option and the underlying
security, (3) the market capitalization of the underlying security and
the related index, (4) the reporting of large positions and
requirements surrounding margin, and (5) the potential for market on
close volatility.
    In the July 2016 Extension, the Exchange stated that if it were to
propose an extension, permanent approval or termination of the program,
the Exchange would submit, along with any filing proposing such
amendments to the program, a report providing an analysis of the SPY
Pilot Program covering the period since the previous

extension (the ``Pilot Report''). Accordingly, the Exchange is
submitting a Pilot Report detailing the Exchange's experience with the
SPY Pilot Program for the period covering twelve (12) months from June
2016 to May 2017. The Pilot Report is attached as Exhibit 3 to this
filing [sic]. The Exchange notes that it is unaware of any problems
created by the SPY Pilot Program and does not foresee any as a result
of the proposed extension. In extending the SPY Pilot Program, the
Exchange states that if it were to propose another extension, permanent
approval or termination of the program, the Exchange will submit
another Pilot Report covering the period since the previous extension,
which will be submitted at least 30 days before the end of the proposed
extension. If the SPY Pilot Program is not extended or adopted on a
permanent basis by July 12, 2018, the position limits for SPY would
revert to limits in effect at the commencement of the pilot program.
The proposed extension will allow the Exchange and the Commission
additional time to further evaluate the SPY Pilot Program and its
effect on the market.
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 prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest. The Exchange
believes that extending the SPY Pilot Program promotes just and
equitable principles of trade by permitting market participants,
including market makers, institutional investors and retail investors,
to establish greater positions when pursuing their investment goals and
needs.
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    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
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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. The proposed rule change is not
designed to address any aspect of competition, whether between the
Exchange and its competitors, or among market participants. Instead,
the proposed rule change is designed to allow the SPY Pilot Program to
continue uninterrupted. Additionally, the Exchange expects all other
SROs that currently have rules regarding the SPY Pilot Program to also
extend the pilot program for an additional year.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Because the foregoing 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, it has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6) thereunder.\7\
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    \7\ 17 CFR 240.19b-4(f)(6). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the 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.
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    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \8\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \9\ permits the
Commission to 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 Exchange
believes that waiver of the operative delay is consistent with the
protection of investors and the public interest because it will allow
the SPY Pilot Program to continue without interruption. The Commission
believes that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest. Therefore, the
Commission hereby waives the operative delay and designates the
proposed rule change operative upon filing.\10\
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    \8\ 17 CFR 240.19b-4(f)(6).
    \9\ 17 CFR 240.19b-4(f)(6)(iii).
    \10\ 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).
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    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-NYSEArca-2017-76 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2017-76. 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 such 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-NYSEArca-2017-76, and should
be submitted on or before August 8, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2017-14982 Filed 7-17-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: February 24, 2010 (Volume 75, Number 36)]
[Rules and Regulations]
[Page 8256-8261]
[DOCID:fr24fe10-9]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

EPA-HQ-OPP-2009-0569; FRL-8812-5

Nicosulfuron; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for
residues of nicosulfuron, [3-pyridinecarboxamide, 2-((((4,6-
dimethoxypyrimidin-2-yl) aminocarbonyl) aminosulfonyl))-N,N-dimethyl];
in or on Bermudagrass, forage and Bermudagrass, hay. This action is in
response to EPA granting crisis exemptions to the Texas Department of
Agriculture and the Oklahoma Department of Agriculture under section 18
of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
authorizing use of the pesticide on Bermudagrass, forage and
Bermudagrass, hay. This regulation establishes maximum permissible
levels for residues of nicosulfuron in Bermudagrass and hay. The time-
limited tolerances expire and are revoked on December 31, 2011.

DATES: This regulation is effective February 24, 2010. Objections and

requests for hearings must be received on or before April 26, 2010, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0569. All documents in the
docket are listed in the docket index available in http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Stacey Groce, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

 B. How Can I Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR cite at http://
www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a, any person may file an objection to any aspect
of this regulation and may also request a hearing on those objections.
The EPA procedural regulations which govern the submission of
objections and requests for hearings appear in 40 CFR part 178. You
must file your objection or request a hearing on this regulation in
accordance with the instructions provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-
2009-0569 in the subject line on the first page of your submission. All
requests must be in writing, and must be mailed or delivered to the
Hearing Clerk on or before April 26, 2010.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2009-0569, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and
408(l)(6) of FFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing
time-limited tolerances for residues of the herbicide nicosulfuron, in
or on Bermudagrass, forage and Bermudagrass, hay at 10 parts per
million (ppm) and 25 (ppm) respectively. These time-limited tolerances
expire and are revoked on December 31, 2011. EPA will publish a
document in the Federal Register to remove the revoked tolerances from
the Code of Federal Regulations (CFR).
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited
tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
FIFRA section 18 related time-limited tolerances to set binding
precedents for the application of section 408 of FFDCA to other
tolerances and exemptions. Section 408(e) of FFDCA allows EPA to
establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' EPA has established
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Nicosulfuron on Bermudagrass Forage and
Hay and FFDCA Tolerances

    The Texas and Oklahoma Departments of Agriculture requested
emergency exemptions for use of nicosulfuron on Bermudagrass and hay to
control field sandbur species, and issued crisis exemptions for this
use pursuant to 40 CFR part 166, subpart C of FIFRA. The states
provided information indicating that sandbur species is a serious pest
that commonly infests Bermudagrass and hay.
    As part of its evaluation of the emergency exemption applications,
EPA assessed the potential risks presented by residues of nicosulfuron
in or on Bermudagrass, forage and Bermudagrass, hay. In doing so, EPA

considered the safety standard in section 408(b)(2) of FFDCA, and EPA
decided that the necessary tolerances under section 408(l)(6) of FFDCA
would be consistent with the safety standard and with FIFRA section 18.
Consistent with the need to move quickly on the emergency exemptions in
order to address urgent non-routine situations and to ensure that the
resulting food is safe and lawful, EPA is issuing these tolerances
without notice and opportunity for public comment as provided in
section 408(l)(6) of FFDCA. Although these time-limited tolerances
expire and are revoked on December 31, 2011, under section 408(l)(5) of
FFDCA, residues of the pesticide not in excess of the amounts specified
in the tolerances remaining in or on Bermudagrass, forage and
Bermudagrass, hay after that date will not be unlawful, provided the
pesticide was applied in a manner that was lawful under FIFRA, and the
residues do not exceed a level that was authorized by these time-
limited tolerances at the time of that application. EPA will take
action to revoke these time-limited tolerances earlier if any
experience with, scientific data on, or other relevant information on
this pesticide indicate that the residues are not safe.
    Because these time-limited tolerances are being approved under
emergency conditions, EPA has not made any decisions about whether
nicosulfuron meets FIFRA's registration requirements for use on
Bermudagrass, forage and Bermudagrass, hay or whether permanent
tolerances for this use would be appropriate. Under these
circumstances, EPA does not believe that these time-limited tolerance
decisions serve as a basis for registration of nicosulfuron by a State
for special local needs under FIFRA section 24(c). Nor do these
tolerances serve as the basis for persons in any States other than
Texas and Oklahoma to use this pesticide on the applicable crops under
FIFRA section 18 absent the issuance of an emergency exemption
applicable within that State. For additional information regarding the
emergency exemptions for nicosulfuron, contact the Agency's
Registration Division at the address provided under FOR FURTHER
INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with the factors specified in section 408(b)(2)(D) of
FFDCA, EPA has reviewed the available scientific data and other
relevant information in support of this action. EPA has sufficient data
to assess the hazards of and to make a determination on aggregate
exposure expected as a result of these emergency exemption requests and
the time-limited tolerances for residues of nicosulfuron [3-
pyridinecarboxamide, 2-((((4,6-dimethoxypyrimidin-2-yl) aminocarbonyl)
aminosulfonyl))-N,N-dimethyl] in or on Bermudagrass, forage and
Bermudagrass, hay at 10 ppm and 25 ppm respectively. EPA's assessment
of exposures and risks associated with establishing time-limited
tolerances follows.

A. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a benchmark dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the level of concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for nicosulfuron used for
human risk assessment can be found at http://www.regulations.gov in the
July 14, 2009 document ``Nicosulfuron: Human Health Risk Assessment for
Proposed Section 18 Use on Bermudagrass,'' pages 10 and 11 of 30 in
docket ID number EPA-HQ-OPP-2009-0569.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to nicosulfuron, EPA considered exposure under the time-
limited tolerances established by this action as well as exposures
pursuant to existing tolerances in (40 CFR 180.454). EPA assessed
dietary exposures from nicosulfuron in food as follows:
    i. Acute exposure. No acute effects were identified in the
toxicological studies for nicosulfuron; therefore, a quantitative
assessment of acute dietary exposure was not conducted.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used tolerance level residues and 100 percent crop
treated (PCT) assumptions for all registered and proposed commodities.
    iii. Cancer. EPA has classified nicosulfuron as ``not likely to be
carcinogenic to humans'' based on the lack of tumorigenic effects in
rodent (rat and mice) bioassays at the limit doses and lack of
mutagenic effects in the in vitro and in vivo genotoxicity assays.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for nicosulfuron. Tolerance level residues and/or 100 PCT were assumed
for all registered and proposed food commodities.

    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for nicosulfuron in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of nicosulfuron. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) for
surface water and the Screening Concentration in Ground Water (SCI-
GROW) model for ground water, the estimated drinking water
concentrations (EDWCs) of nicosulfuron for chronic exposures for non-
cancer assessments are estimated to be 0.7 parts per billion (ppb) for
surface water and 0.06 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model.
    For chronic dietary risk assessment, the water concentration of
value 0.7 ppb was used to assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Nicosulfuron is not registered for any specific use patterns that
would result in residential exposure. Therefore, a residential risk
assessment was not conducted.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, 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 found nicosulfuron to share a common mechanism of
toxicity with any other substances, and nicosulfuron does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
nicosulfuron does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see the policy statements
released by EPA's Office of Pesticide Programs concerning common
mechanism determinations and procedures for cumulating effects from
substances found to have a common mechanism on EPA's website at http://
www.epa.gov/pesticides/cumulative.

C. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act (FQPA) SF. In applying this provision, EPA either
retains the default value of 10X, or uses a different additional SF
when reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There is no quantitative or
qualitative evidence of increased susceptibility observed following in
utero nicosulfuron exposure to rats or rabbits in the prenatal
developmental studies or following prenatal/postnatal exposure in young
rats in the 2-generation reproduction study. The toxicity database is
considered adequate and includes acceptable developmental toxicity
studies in the rat and rabbit and a rat reproductive study.
    There were no developmental or reproductive effects observed in
rats, but in rabbits (clinical signs, decreased body weight gain during
dosing, increased abortions), postimplantation loss and decreased fetal
body weight were observed at the maternal toxicity LOAEL. However,
these effects were only observed at maternally toxic doses.
    3. Conclusion. EPA has determined that reliable data show that the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for nicosulfuron is considered adequate
for purposes of assessing human health risk from this emergency
exemption use. Available data suggest that nicosulfuron is poorly
absorbed and that toxicity is low. Further, data suggest increased pre
and/or post natal susceptibility was not observed.
    ii. The toxicity database for nicosulfuron is generally complete
except for more recently required neurotoxicity and immunotoxicity
testing requirements.
    iii. There is no evidence of neurotoxicity or immunotoxicity in the
available studies.
    iv. There are no residual uncertainties with regard to assessing
pre-and/or postnatal toxicity.
    v. There are no residential use patterns for this chemical and the
exposure assessments are conservative and will not underestimate risks.

D. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. None of the toxicology studies available for
nicosulfuron indentified an adverse effect resulting from a single-oral
exposure; therefore, dietary exposure presents no acute risks of
concern.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
nicosulfuron from food and water will utilize <1% of the cPAD for
(children 3-5) the population subgroup receiving the greatest exposure.
There are no residential uses for nicosulfuron. As explained in the
unit regarding residential use patterns, chronic residential exposure
to residues of nicosulfuron is not expected, so chronic risk is a
function of dietary exposure alone. Thus, the chronic aggregate
exposure for the most exposed group is below EPA's level of concern.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Nicosulfuron is not registered for any use patterns that would
result in residential exposure. Therefore, the short-term aggregate
risk is the sum of

the risk from exposure to nicosulfuron through food and water and will
not be greater than the chronic aggregate risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term non-dietary, non-occupational
exposure plus chronic exposure to food and water (considered to be a
background exposure level).
    Nicosulfuron is not registered for any use patterns that would
result in intermediate-term residential exposure. Therefore, the
intermediate-term aggregate risk is the sum of the risk from exposure
to nicosulfuron through food and water, which has already been
addressed, and will not be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population.There is no cancer
risk associated with the proposed use. Nicosulfuron is ``not likely to
be carcinogenic to humans'' based on lack of tumorigenic effects in
rodent (rats and mice) bioassays at the limit doses and lack of
mutagenic effects in the in vitro and in vivo genotoxicity studies.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is reasonable certainty that no harm will result
to the general population, or to infants and children, from chronic
aggregate exposure to nicosulfuron residues from food and drinking
water.

V. Other Considerations

A. Analytical Enforcement Methodology

    An adequate enforcement methodology (Ciba-Geigy, AG-499, and High
Performance Liquid Chromatography/Ultraviolet (PLC/UV) method)) is
available to enforce the time-limited tolerance expression. The method
was recommended for inclusion in the Pesticide Analytical Manual Vol.
II (PAM II).

B. International Residue Limits

    There are currently no Canadian, Mexican, or Codex maximum residue
limits (MRLs) for nicosulfuron on the commodities for which tolerances
are being established.

VI. Conclusion

    Therefore, time-limited tolerances are established for residues of
the herbicide nicosulfuron, [3-pyridineccarboxamide, 2-((((4,6-
dimethoxypyrimidin-2-yl) aminocarbonyl)aminosulfonyl))-N,N-dimethyl],
in or on Bermudagrass, forage and Bermudagrass, hay at 10 ppm and 25
ppm respectively. These tolerances expire and are revoked on December
31, 2011.

VII. Statutory and Executive Order Reviews

    This final rule establishes tolerances under sections 408(e) and
408(l)(6) of FFDCA in response to a petition submitted to the Agency.
The Office of Management and Budget (OMB) has exempted these types of
actions from review under Executive Order 12866, entitled Regulatory
Planning and Review (58 FR 51735, October 4, 1993). Because this final
rule has been exempted from review under Executive Order 12866, this
final rule is not subject to Executive Order 13211, entitled Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order
13045, entitled Protection of Children from Environmental Health Risks
and Safety Risks (62 FR 19885, April 23, 1997). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it
require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established in accordance
with sections 408(e) and 408(l)(6) of FFDCA, such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: February 5, 2010.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.454 redesignate the existing paragraph as paragraph (a)
and add paragraph (b) to read as follows:

Sec.  180.454  Nicosulfuron; tolerances for residues.

     * * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances
specified in the following table are established for residues of the
herbicide nicosulfuron, [3-pyridineccarboxamide, 2-((((4,6-
dimethoxypyrimidin-2-yl) aminocarbonyl)aminosulfonyl))-N,N-dimethyl],
in or on the specified agricultural commodities, resulting from use of
the pesticide pursuant to FFIFRA section 18 emergency exemptions. The
tolerances expire and are revoked on the date specified in the table.

------------------------------------------------------------------------
                                                     Parts   Expiration/
                     Commodity                        per     revocation
                                                    million      date
------------------------------------------------------------------------
Bermuda grass, forage.............................       10     12/31/11
Bermuda grass, hay................................       25     12/31/11
------------------------------------------------------------------------

* * * * *

[FR Doc. 2010-3673 Filed 2-23-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 77, Number 214 (Monday, November 5, 2012)]
[Proposed Rules]
[Pages 66421-66422]
[FR Doc No: 2012-26756]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-RO1-OAR-2009-0451; A-1-FRL-9748-1]

Approval and Promulgation of Air Quality Implementation Plans;
New Hampshire; Reasonably Available Control Technology for the 1997 8-
Hour Ozone Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The EPA is proposing to approve State Implementation Plan
revisions submitted by the State of New Hampshire. These SIP revisions
consist of a demonstration that New Hampshire meets the requirements of
reasonably available control technology for oxides of nitrogen and
volatile organic compounds set forth by the Clean Air Act with respect
to the 1997 8-hour ozone standard, revisions to existing rules
controlling these pollutants, and source-specific orders for fifteen
individual sources. This action is being taken in accordance with the
Clean Air Act.

DATES: Written comments must be received on or before December 5, 2012.

ADDRESSES: Submit your comments, identified by Docket ID No. RO1-OAR-
2009-0451 by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``EPA-RO1-OAR-2009-0451,'' Anne Arnold, U.S. Environmental
Protection Agency, EPA New England Regional Office, 5 Post Office
Square--Suite 100, (Mail code OEP05-2), Boston, MA 02109-3912.
    5. Hand Delivery or Courier. Deliver your comments to: Anne Arnold,
Manager, Air Quality Planning Unit, Office of Ecosystem Protection,
U.S. Environmental Protection Agency, EPA New England Regional Office,
5 Post Office Square--Suite 100, (Mail code OEP05-2), Boston, MA 02109-
3912. Such deliveries are only accepted during the Regional Office's
normal hours of operation. The Regional Office's official hours of
business are Monday through Friday, 8:30 to 4:30, excluding legal
holidays.

Please see the direct final rule which is located in the Rules Section
of this Federal Register for detailed instructions on how to submit
comments.

FOR FURTHER INFORMATION CONTACT: Bob McConnell, Air Quality Planning
Unit, U.S. Environmental Protection Agency, EPA New England Regional
Office, 5 Post Office Square, Suite 100 (mail code: OEP05-2), Boston,
MA 02109-3912, telephone number<PHONE_NUMBER>, fax number (617) 918-
0046, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Final Rules Section of this Federal
Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this action
rule, no further activity is contemplated. If EPA receives adverse
comments, the direct final rule will be withdrawn and all public
comments received will be addressed in a subsequent final rule based on
this proposed rule. EPA will not institute a second comment period. Any
parties interested in commenting on this action should do so at this
time. Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment.

    For additional information, see the direct final rule which is
located in the Rules Section of this Federal Register.

    Dated: October 19, 2012.
H. Curtis Spalding,
Regional Administrator, EPA New England.
[FR Doc. 2012-26756 Filed 11-2-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: April 2, 2009 (Volume 74, Number 62)]
[Notices]
[Page 15048]
[DOCID:fr02ap09-103]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Public Notice for Waiver of Aeronautical Land-use Assurance;
DeKalb-Taylor Municipal Airport, DeKalb, IL

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice of intent of waiver with respect to land.

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

SUMMARY: The Federal Aviation Administration (FAA) is considering a
proposal to change a portion of airport land from aeronautical use to
non-aeronautical use and to authorize the lease of airport property.
The proposal consists of a leasing 3.528 acres of Lot 51 of the
original M.D. Shipman's Farm parcel. Lot 51 became part of Tract No. 1
(16.83 acres) that was deeded to the City of DeKalb by the United
States of America as government surplus property under the Surplus
Property Act of 1944. Tract 1 also is currently subject to the National
Emergency Use Provision (for times of National emergency), a condition
that the City of DeKalb would also like to remove from the 3.528 parcel
requesting the change in use. This subject land currently has a metal
storage building on it miscellaneous bituminous and concrete drives and
parking areas located on it. It is the intent of the City of DeKalb, as
owner and operator of the DeKalb--Taylor Municipal Airport (DKB) to
retain ownership of the 3.528 acre parcel and allow for commercial
development on said parcel. This notice announces that the FAA is
considering the proposal to authorize the change from aeronautical use
to non-aeronautical use of the subject airport property at the DeKalb--
Taylor Municipal Airport (DKB), DeKalb, IL. Approval does not
constitute a commitment by the FAA to financially assist in the lease
or development of the subject airport property nor a determination that
all measures covered by the program are eligible for grant-in-aid
funding from the FAA.
    In accordance with section 47107(h) of Title 49, United States
Code, this notice is required to be published in the Federal Register
30 days before modifying the land-use assurance that requires the
property to be used for an aeronautical purpose.

DATES: Comments must be received on or before May 4, 2009.

FOR FURTHER INFORMATION CONTACT: Richard Pur, Program Manager, 2300
East Devon Avenue, Des Plaines, IL, 60018. Telephone Number 847-294-
7527/FAX Number<PHONE_NUMBER>. Documents reflecting this FAA action may
be reviewed at this same location by appointment or at the DeKalb--
Taylor Municipal Airport, 3232 Pleasant Street, DeKalb, Illinois 60115.

SUPPLEMENTARY INFORMATION: Following is a legal description of the
property being changed to non aeronautical use located in DeKalb,
DeKalb County, Illinois, and described as follows:

Portion of Tract 1

    That part of the north 1,200 feet of Lot 51 of the M.D. Shipman's
Farm Flat on the North Half of Section 24, Township 40 North, Range 4
East of the Third Principal Meridian, except that part conveyed and
quitclaimed to DeKalb Township for the DeKalb Bypass per Document No.
8305201 in DeKalb County, Illinois, being more particularly described
as:
    Commencing at the northeast corner of said Lot 51; thence on an
assumed bearing of South 00 degrees 17 minutes 28 seconds West, 35.50
feet along the east line of said Lot 51 to the southerly right-of-way
of Pleasant Street and to the Point of Beginning; thence continuing
South 00 degrees 17 minutes 28 seconds West, 451.57 feet along said
east line; thence South 76 degrees 04 minutes 52 seconds West, 265.58
feet to the easterly right-of-way line of Peace Road conveyed per said
Document No. 8305201; thence North 12 degrees 28 minutes 32 seconds
West, 335.12 feet along said easterly right-of-way line; thence
continuing along said easterly right-of-way line, 190.96 feet, being a
curve to the right having a radius of 1,145.92 feet, the chord of said
curve bears North 07 degrees 42 minutes 09 seconds West, 190.74 feet to
the north line of said Lot 51; thence South 89 degrees 52 minutes 32
seconds East, 358.03 feet along said north line to the Point of
Beginning.
    Said parcel contains 3.528 acres, more or less.

    Issued in Des Plaines, Illinois, on March 6, 2009.
James G. Keefer,
Manager, Chicago Airports District Office, FAA, Great Lakes Region.
[FR Doc. E9-7254 Filed 4-1-09; 8:45 am]


[Federal Register: October 1, 2010 (Volume 75, Number 190)]
[Notices]
[Page 60767-60768]
[DOCID:fr01oc10-78]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0506]

Office of the Commissioner; Request for Comments on the Food and
Drug Administration Fiscal Year 2011-2015 Strategic Priorities
Document; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice; request for comments.

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

SUMMARY:  The Food and Drug Administration (FDA) is seeking public
comment on its draft Strategic Priorities FY 2011-2015. FDA has
identified these strategic priorities and goals that will guide its
efforts to achieve its public health mission. FDA is seeking public
comment to help further refine these priorities and goals.

DATES:  Submit either electronic or written comments by November 1,
2010.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Darian Tarver, Office of Planning,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm.
4219, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is posting its draft Strategic Priorities FY 2011-2015 to
ensure that key stakeholders are given an opportunity to comment on
this document.
    The purpose of this document is to outline FDA's strategic
intentions and plans for the next 5 years (fiscal year (FY) 2011
through 2015). This document identifies four key cross-cutting
strategic priorities and four strategic program goals that will guide
efforts to achieve FDA's public health mission and to fulfill its role
in supporting the larger mission and strategic goals of the Department
of

Health and Human Services. The four cross-cutting strategic priorities
are: (1) Advance Regulatory Science and Innovation, (2) Strengthen the
Safety and Integrity of the Global Supply Chain, (3) Strengthen
Compliance and Enforcement Activities to Support Public Health, and (4)
Expand Efforts to Meet the Needs of Special Populations. The four
strategic program goals are: (1) Advance Food Safety and Nutrition, (2)
Promote Public Health by Advancing the Safety and Effectiveness of
Medical Products, (3) Establish an Effective Tobacco Regulation,
Prevention, and Control Program, and (4) Manage for Organizational
Excellence and Accountability.
    The strategic planning process is an opportunity for FDA to further
refine and strengthen the strategic management structure currently in
place. For comparison purposes, the current FDA Strategic Action Plan
2007 can be viewed at http://www.fda.gov/downloads/AboutFDA/
ReportsManualsForms/Reports/StrategicActionPlan/UCM061415.pdf.
    FDA has made significant progress in its strategic planning
efforts. As we build on this progress we look forward to receiving your
comments by (see DATES). The text of the draft strategic priorities
document is available in a ``pdf'' (portable document format)
downloadable format through FDA's Web site: http://www.fda.gov/
AboutFDA/.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: September 27, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-24603 Filed 9-30-10; 8:45 am]
BILLING CODE 4160-01-S


Therefore, a new fish full life cycle study is required.  Should the
registrant choose to conduct the study on an estuarine/marine fish, then
the additional requirement for an ELS study with estuarine/marine fish
could be satisfied with just one study.

Practical Utility of the Data

How will the data be used?

The fish full life cycle study would allow the Agency to analyze chronic
effects, including effects on reproductive success and growth, to fish
species.  The effects data would be used to determine the likelihood
that the chronic risks can potentially impact aquatic communities, by
direct effects on fish.  By refining the assessment, the Agency would be
able to determine whether the mitigation imposed as part of the
registration review process was appropriate due to toxicity concerns
with bifenthrin.

How could the data impact the Agency’s future decision-making?

If future endangered species risk assessments are performed without
these data, the Agency would have to assume that bifenthrin "may affect"
endangered fish directly, and the use of bifenthrin might need to be
restricted in areas where endangered species could be exposed.  The lack
of these data will limit the flexibility the Agency and registrants have
in coming into compliance with the Endangered Species Act and could
result in use restrictions for bifenthrin which are unnecessarily
severe.

Guideline Number:  850.1010

Study Title:   Aquatic Invertebrate Acute Toxicity (Hyalella)

Rationale for Requiring the Data

Available information indicates that the freshwater amphipod, Hyalella
azteca, is substantially more sensitive to pyrethroids than Daphnia
magna, the commonly tested freshwater invertebrate (e.g., Anderson et
al. 2006; Maund et al., 2002).  Information on the acute toxicity of
bifenthrin to H. azteca was not identified in this problem formulation.
Therefore, in order to ensure that risk to sensitive aquatic
invertebrates are appropriately quantified, additional acute toxicity
testing of H. azteca is needed (water column exposure, not
sediment-spiked).

Practical Utility of the Data

How will the data be used?

The freshwater acute toxicity study with Hyalella would allow the Agency
to analyze acutely toxic effects to one of the most sensitive species of
freshwater aquatic invertebrates.  The effects data would be used to
determine the likelihood that acute risks can potentially impact aquatic
communities, either by direct effects on invertebrates or by indirect
effects by reducing the food source for their predators (e.g., fish).
By refining the assessment, the Agency would be able to determine
whether the mitigation imposed as part of the registration review
process was appropriate due to toxicity concerns with bifenthrin.

How could the data impact the Agency’s future decision-making?

If future risk assessments are performed without these data, the Agency
would have to account for the potential increased sensitivity of
Hyalella to bifenthrin using other means which may include using an
extrapolation factor based on sensitivity differences with other
pyrethroids.  Since this extrapolation factor would involve uncertainty,
it is likely that a conservative factor would be applied.  This may
impinge on the Agency’s flexibility in coming into compliance with the
Endangered Species Act and could result in use restrictions for
bifenthrin which are unnecessarily severe.

Guideline Number:  850.1350

Study Title:  Aquatic Invertebrate Life Cycle (Estuarine/Marine)

Rationale for Requiring the Data

The need for a life cycle chronic toxicity of bifenthrin to
estuarine/marine invertebrates is indicated based on its aquatic
toxicity and environmental fate properties per 40 CFR Part 158 data
requirements (October 26, 2007).   Specifically:

bifenthrin is intended for use such that its presence in
estuarine/marine environment in significant concentrations is expected;

the acute LC/EC50 for bifenthrin (e.g., 1.6 µg/L for Daphnia magna, is
substantially lower than the 40 Part 158 trigger value of 1 mg/L; and

previous risk assessments have indicated that the aquatic EECs are >
0.01 of the acute LC/EC50 values for bifenthrin, which is another
condition for triggering an estuarine/marine invertebrate life cycle
study.

In addition, the acute toxicity of estuarine/marine invertebrates (LC50
of 0.004 µg/L) is nearly three orders of magnitude lower than that for
freshwater invertebrates (EC50 of 1.6 µg/L) which suggests that
estuarine/marine invertebrates may be particularly sensitive to
bifenthrin.  Information on the chronic toxicity of bifenthrin to
estuarine/marine invertebrates is therefore needed to reduce uncertainty
in assessing risk to these non-target organisms. The preferred test
species is Americamysis bahia.

Practical Utility of the Data

How will the data be used?

The estuarine/marine life cycle study would allow the Agency to analyze
chronic effects, including effects on reproductive success and growth,
to estuarine/marine invertebrate species.  The effects data would be
used to determine the likelihood that the chronic risks can potentially
impact aquatic communities, by direct effects on invertebrates.  By
refining the assessment, the Agency would be able to determine whether
the mitigation imposed as part of the registration review process was
appropriate due to toxicity concerns with bifenthrin.

How could the data impact the Agency’s future decision-making?

If future risk assessments are performed without these data, the Agency
would have to presume chronic risk to estuarine/marine invertebrates and
the use of bifenthrin might need to be restricted in areas where
otherwise it would not need to be restricted.

Guideline Numbers: Non-Guideline

Study Title:  Chronic whole sediment:  Freshwater and marine
invertebrates

Rationale for Requiring the Data

Sediment toxicity tests for freshwater or marine invertebrates have been
submitted to the Agency and are in review.  To satisfy the Agency’s
updated data requirements for outdoor uses in 40 CFR Part 158 (October
26, 2007), for bifenthrin, available information indicates that benthic
organisms may be exposed via run-off or spray drift applications used in
agricultural, forest, and residential settings. Specifically:

The peak sediment porewater EECs predicted for bifenthrin (0.006 –
0.014 ppb for a variety of crops) exceed 0.1 of the acute LC/EC50 (0.004
ppb for M. bahia), which satisfies one of the criteria for requiring
chronic whole sediment toxicity testing under 40 CFR Part 158.

The expected half-life of bifenthrin in sediment (>250 days for
anaerobic aquatic metabolism) is substantially greater than 40 CFR Part
158 criterion of 10 days.

The Kd values are 992-5430, log KOW is 6.4, and KOC values are
131,000-275,000, all of which exceed the third set of trigger criteria
for requiring chronic testing (Kd > 50, or log KOW >3 or KOC > 1000).

Finally, the potential for persistent exposure from bifenthrin in
sediment is also indicated by open literature studies on pyrethroids
(Weston et al. 2005, Amweg et al. 2006 and Ding et al. 2009).

For sediment studies involving pyrethroids, chronic tests on Hyalella
azteca, Chironomus tentans, and Leptocheirus plumulosus are requested.
Although both are freshwater species, Hyalella  and  Chironomus differ
substantially in their ecological niche (i.e., epibenthic vs. infaunal
species), physiology, and potential sensitivities to pyrethroid
exposure.  Bifenthrin has the potential to enter estuarine/marine water
bodies based on current usuage patterns that include coastal areas.
Therefore, testing is required for Leptocheirus plumulosus, an
estuarine/marine sediment-dwelling invertebrate species.

Practical Utility of the Data

How will the data be used?

Data from sediment toxicity studies will be used to estimate potential
risks to benthic organisms associated with uses of bifenthrin.  The data
will reduce uncertainties associated with the current risk assessment
for benthic species and will improve our understanding of the potential
effects of bifenthrin.

How could the data impact the Agency’s future decision-making?

Although there was uncertainty in estimating the effect of bifenthrin on
benthic organisms in previous assessments, there was a potential risk
associated with adverse effects identified for estuarine/marine acute
and chronic organisms.  Acceptable data for benthic organisms will
reduce the uncertainty from the previous assessment   If the data
indicates that registered bifenthrin usage may pose a risk of adverse
effects to non-target benthic organisms above the Agency Level of
Concern, the Agency may explore decision options to mitigate this risk.
The lack of these data will limit the flexibility the Agency and
registrants have in coming into compliance with the Endangered Species
Act, and could result in use restrictions for bifenthrin which may
otherwise be avoided, or which are unnecessarily severe.

.

Guideline Numbers: 850.4150 and 850.4100

Study Title: Vegetative vigor and Seedling emergence with TEP, Tier
I/Tier II

Rationale for Requiring the Data

No acceptable toxicity data are currently available to assess the risk
of bifenthrin to terrestrial plants.  The Agency updated its data
requirements in 40 CFR Part 158 (October 26, 2007) to include plant
studies.

Since bifenthrin has residential outdoor uses, vegetative vigor and
seedling emergence studies using TEP are required.  These phytotoxicity
data are needed to evaluate the level of pesticide exposure to
non-target terrestrial and aquatic plants and to assess the impact of
pesticides on endangered and threatened plants.

Practical Utility of the Data

How will the data be used?

Data from terrestrial plant toxicity studies will be used to estimate
potential risks to plants associated with uses of bifenthrin.  The data
will reduce uncertainties associated with the current risk assessment
for terrestrial plants and will improve our understanding of the
potential effects of bifenthrin on plants.

How could the data impact the Agency’s future decision-making?

Because plants form the basis of most habitats and significantly
contribute to overall environmental quality, a solid understanding of
the potential risks to terrestrial plants is essential for sound
environmental management.  Without acceptable plant growth data for
bifenthrin, the Agency cannot determine the levels of bifenthrin that
result in effects to terrestrial plants.  If the data indicates that
registered bifenthrin usage may pose a risk of adverse effects to
non-target terrestrial plants plants above the Agency Level of Concern,
the Agency may explore decision options to mitigate this risk.  The lack
of these data will limit the flexibility the Agency and registrants have
in coming into compliance with the Endangered Species Act, and could
result in use restrictions for bifenthrin which may otherwise be
avoided, or which are unnecessarily severe.

Guideline Number: 850.4400

Study Title: Aquatic Vascular Plant Growth-Lemna spp. Tiers I/II

Rationale for Requiring the Data

No acceptable studies for bifenthrin have been submitted for vascular
aquatic plants. The Agency has finalized its update to the data
requirements in 40 CFR Part 158.  In these updated data requirements,
which were promulgated on October 26, 2007, vascular plant testing is
required for pesticides such as bifenthrin with outdoor uses.

Practical Utility of the Data

How will the data be used?

Data from aquatic plant toxicity studies will be used to estimate
potential risks to plants associated with uses of bifenthrin.  The data
will reduce uncertainties associated with the current risk assessment
for aquatic plants and will improve our understanding of the potential
effects on vascular aquatic plants.

How could the data change the Agency’s decision, or impact the
Agency’s future decision-making?

Because plants form the basis of most habitats and significantly
contribute to overall environmental quality, a solid understanding of
the potential risks to aquatic plants is essential for sound
environmental management.  Without plant growth data for bifenthrin, the
Agency cannot determine the levels of bifenthrin that result in effects
to vascular aquatic plants.  If the data indicates that registered
bifenthrin usage may pose a risk of adverse effects to non-target
aquatic vascular plants above the Agency Level of Concern, the Agency
may explore decision options to mitigate this risk.

If future endangered species risk assessments are performed without
these data, the Agency would have to assume that bifenthrin "may affect"
endangered plants and use of bifenthrin might need to be restricted in
areas where endangered species could be exposed.  The lack of these data
will limit the flexibility the Agency and registrants have in coming
into compliance with the Endangered Species Act and could result in use
restrictions for bifenthrin that may be unnecessarily severe.

Guideline Number:  850.5400

Study Title:  Algal toxicity test, Tier I/II

Rationale for Requiring the Data

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its data requirements in 40 CFR Part 158 (October 26, 2007) to include
plant studies.

Practical Utility of the Data

How will the data be used?

Data from Tier I/II nonvascular aquatic plant toxicity studies will be
used to estimate potential risks to plants associated with uses of
bifenthrin.  The data will reduce uncertainties associated with the
current risk assessment for nonvascular aquatic plants and will improve
our understanding of the potential effects of bifenthrin.

How could the data impact the Agency’s future decision-making?

Because plants form the basis of most habitats and significantly
contribute to overall environmental quality, a solid understanding of
the potential risks to nonvascular aquatic plants is essential for sound
environmental management.  Without plant growth data for bifenthrin, the
Agency cannot determine the levels that result in effects to aquatic
plants.  If the data indicates that registered usage may pose a risk of
adverse effects to non-target aquatic nonvascular plants above the
Agency Level of Concern, the Agency may explore decision options to
mitigate this risk.  The lack of these data will limit the flexibility
the Agency and registrants have in coming into compliance with the
Endangered Species Act, and could result in use restrictions for
bifenthrin which may otherwise be avoided, or which are unnecessarily
severe.

 Type I pyrethroids are characterized by the fact that they do not have
the cyano moiety in the alpha carbon in their chemical structure (on the
other hand Type II pyrethroids contain this moiety), see Mechanism of
Action for additional distinctions between the two types.

 See Page 18 of the SAP meeting minutes (USEPA 2009).

 μg/g)/[(760)(Vm)], where Cs is the air concentration at saturation
(μg/m3), VP is the vapor pressure in mmHg, MW is the molecular weight
(g/mol), and Vm is the volume occupied by a gas at 25°C, and a pressure
of 1 atm, according to the ideal gas constant, which is 24.45 L/mol.

  Available at url:    HYPERLINK
"http://www.epa.gov/oppbead1/methods/ecmindex.htm"
http://www.epa.gov/oppbead1/methods/ecmindex.htm

 PAGE

 PAGE   5

  PAGE   60

Stressor

Source

Attribute

Change

Bifenthrin applied to agricultural or non-agricultural use site

Direct

application

Spray drift

Terrestrial vertebrates

Terrestrial

invertebrates

Individual organisms

Reduced survival

Reduced growth

Reduced reproduction

Food chain

Reduction in prey and food

Modification of PCEs

  related to prey availability

Habitat integrity

Reduction in primary productivity

Reduced cover

Community change

Modification of PCEs related

   to habitat

Terrestrial plants

grasses/ forbs, fruit, seeds (trees, shrubs)

Runoff

Terrestrial vertebrates

Exposure Media

& Receptors

Soil

Ingestion

Ingestion

Ingestion

Dermal uptake/Ingestion

Atmospheric transport

Root uptake/contact

Wet/dry deposition

Ingestion

Leaching to

Groundwater

Irrigation

water

Stressor

Bifenthrin Applications that Could Potentially End Up
“Down-the-drain”

Source/

Transport

Pathways

Wastewater flow

Source/

Exposure

Media

Treatment Facility Discharges into Surface Waters

Exposure

Route

Gill/

 Integument Uptake

Receptors

Attribute

Changes

Aquatic Invertebrates,

Vertebrates

Individual Vertebrates and Invertebrates Reduced survival,  growth or
reproduction

Plant Population

Reduced population growth

Aquatic Plants

Uptake/ Adsorption

**Route of exposure includes only ingestion of fish and aquatic inverts.

Stressor

Source

Receptors

Attribute

Change

Bifenthrin applied to agricultural or non-agricultural use site

Spray drift

Aquatic animals

Invertebrates

Vertebrates

**Piscivorous mammals

  and birds

Individual organisms

Reduced survival2

Reduced growth

Reduced reproduction

Food chain

Reduction in algae and

   vascular plants

Reduction in prey

Modification of PCEs

   related to prey availability

Habitat integrity

Reduction in primary

   productivity

Reduced cover

Community change

Modification of PCEs related to

   habitat

Surface water/

Sediment

Runoff

Aquatic Animals

Invertebrates

Vertebrates

Exposure

Media

Uptake/gills

or integument

Ingestion

Ingestion

Atmospheric transport

Wet/dry deposition

Soil

Leaching to

Groundwater

Uptake/gills

or integument

Aquatic Plants

Non-vascular

Vascular

Uptake/cell,

roots, leaves

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Riparian plants terrestrial exposure pathways; see Figure 6.1b

Impervious Surfaces

Flow1


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