[Federal Register Volume 77, Number 239 (Wednesday, December 12, 2012)]
[Notices]
[Pages 73999-74000]
[FR Doc No: 2012-29949]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OEI-2012-0547, FRL-9525-4]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Regulations.gov Information
Collection

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA)(44 U.S.C.
3501 et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR, which is abstracted below, describes the
nature of the information collection and its estimated burden and cost.

DATES: Additional comments may be submitted on or before January 11,
2013.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OEI-
2012-0547 to (1) EPA online using www.regulations.gov (our preferred
method), by email<EMAIL_ADDRESS>or by mail to: EPA Docket
Center, Environmental Protection Agency, Office of Environmental
Information Docket, mail code 28221T, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460, and (2) OMB by mail to: Office of Information and
Regulatory Affairs, Office of Management and Budget (OMB), Attention:
Desk Officer for EPA, 725 17th Street NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Bryant Crowe, OEI/OIC/CStD at the
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., (MC 2822-
T), Washington, DC 20460; telephone number<PHONE_NUMBER>; fax number
(202) 566-1611: email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On July 18, 2012 (77 FR 42305), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any
additional comments on this ICR should be submitted to EPA and OMB
within 30 days of this notice.
    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OEI-2012-0547, which is available for online viewing at
www.regulations.gov, or in person viewing at the Office of
Environmental Information Docket in the EPA Docket Center (EPA/DC), EPA
West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The EPA/DC
Public Reading Room is open from 8 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Reading
Room is<PHONE_NUMBER>, and the telephone number for the Environmental
Information Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at
www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at www.regulations.gov as EPA receives
them and without change, unless the comment contains copyrighted
material, confidential business information (CBI), or other information
whose public disclosure is restricted by statute. For further
information about the electronic docket, go to www.regulations.gov.
    Title: Regulations.gov Information Collection.
    ICR numbers: EPA ICR No. 2357.04, OMB Control No. 2025-0008 .
    ICR Status: This ICR is scheduled to expire on December 31, 2012.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information, unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, are displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: In response to the Presidential memorandum, the
eRulemaking Program launched the Regulations.gov `feedback exchange'
Web site in May 2009. This interactive Web site showcases new
technologies being considered for the Regulations.gov `feedback
exchange' and Regulations.gov, as well as other agency-specific
initiatives and rulemaking activities. The `feedback exchange' serves
as a learning laboratory for open government, enabling the public to
provide input on the Regulations.gov interface, build a community of
practice on the Federal regulatory development process, and ensure that
the eRulemaking Program can efficiently manage federal resources by
testing new tools before they are launched.
    New technologies considered for Regulations.gov and the
Regulations.gov `feedback exchange' include: User Profiles; Comment
Threads and Wikis; Ratings, Polls, and Tagging; an interactive
Educational Tool; and Information Export and Sharing capabilities, such
as application programming interfaces (or APIs). These technologies
have been deployed iteratively, with components deployed upon the
site's release in May 2009, and others deployed during updates
throughout the last three years. Other components are still being
considered and will be released during subsequent upgrades to the
Regulations.gov `feedback exchange' and Regulations.gov. User profiles
enable the public to register on the site and pre-load submitter
information for later use as well as save their own personalized
searches, RSS feeds, and email alerts without the use of persistent
cookies. Comment Threads allow the public to enter into virtual
conversations with one another about a topic. Wikis enable the public
to collaboratively develop and modify narrative descriptions about a
topic. Ratings and Polls allow the public to indicate a preference for
a topic or issue via the selection of stars or thumbs up/thumbs down
icons which graphically provide an at-a-glance indication of public
sentiment and can simplify navigation. Tagging provides the public with
the ability to tag or label information they or someone else has posted
to the site to ease navigation and to promote the formation of common
interest categories. The Educational Tool will inform the public about
the Federal rulemaking process through interactive text and images. The
Data Export capability enables the public to download and review the
contents of a rulemaking docket as well

as mix and match such information with other information in a new way
(also known as a ``mash-up''). The Regulations.gov `feedback exchange'
will rely on voluntary feedback from Government, Industry, Academia and
Citizenry to improve Regulations.gov as time goes on.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 451
hours per year. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Anyone who chooses to visit
Regulations.gov.
    Estimated Number of Respondents: 13,000.
    Estimated Number of Potential Responses: 91,000.
    Frequency of Response: Occasionally.
    Estimated Total Annual Hour Burden: 451 hours.
    Estimated Capital or Operations & Maintenance Annual Costs: $0.
    Changes in the Estimates: There is a decrease of 4 burden hours
from 455 to 451 in the total estimated burden currently identified in
the OMB Inventory of Approved ICR Burdens due to a minor mathematical
adjustment.

John Moses,
Director, Collection Strategies Division.
[FR Doc. 2012-29949 Filed 12-11-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 226 (Friday, November 25, 2022)]
[Notices]
[Pages 72472-72473]
[FR Doc No: 2022-25720]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project Nos. 346-071; 2454-084; 2532-092; 2663-061]

Notice of Application Accepted for Filing and Soliciting
Comments, Motions To Intervene, and Protests; ALLETE, Inc.

    Take notice that the following hydroelectric application has been
filed

with the Commission and is available for public inspection:
    a. Application Type: Amendment of License Terms.
    b. Project Nos.: P-346-071, P-2454-084, P-2532-092, and P-2663-061.
    c. Date Filed: October 20, 2022.
    d. Applicant: ALLETE, Inc.
    e. Name of Project: Blanchard (P-346), Sylvan (P-2454), Little
Falls (P-2532), and Pillager (P-2663) Hydroelectric Projects.
    f. Location: The Blanchard and Little Falls projects are located on
the Mississippi River in Morrison County, Minnesota; the Sylvan and
Pillager projects are located on the Crow Wing River, in Cass, Crow
Wing, and Morrison Counties, Minnesota.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Greg Prom, Senior Environmental Compliance
Specialist, Minnesota Power, 30 West Superior Street, Duluth, Minnesota
55802,<PHONE_NUMBER>, [email protected].
    i. FERC Contact: Ashish Desai,<PHONE_NUMBER>,
[email protected]
    j. Deadline for filing comments, motions to intervene, and
protests: December 19, 2022.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at [email protected],<PHONE_NUMBER> (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, you may
submit a paper copy. Submissions sent via the U.S. Postal Service must
be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852. The first page of any filing should
include the docket numbers P-346-071, P-2454-084, P-2532-092, or P-
2663-061. Comments emailed to Commission staff are not considered part
of the Commission record.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency.
    k. Description of Request: Allete, Inc., licensee for the Blanchard
Project No. 346, Sylvan Project No. 2454, Little Falls Project No.
2532, and the Pillager Project No. 2663, filed a request to accelerate
the license term for the Blanchard Project and extend the license terms
for the Sylvan, Little Falls, and Pillager projects to August 24, 2040,
so that they would be relicensed concurrently. Currently the licenses
for the Sylvan, Little Falls, and Pillager projects expire on March 31,
2028, and the license for the Blanchard Project expires on August 24,
2043. The licensee states that aligning the expiration dates for the
projects would significantly enhance process efficiencies and allow for
the combining of relicensing efforts for all the projects. In addition,
the licensee states that aligning the expiration dates of adjacent
projects would facilitate a more comprehensive analysis of common
resources.
    l. Locations of the Application: This filing may be viewed on the
Commission's website at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
[email protected], for TTY, call<PHONE_NUMBER>. Agencies may
obtain copies of the application directly from the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214, respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title ``COMMENTS'', ``PROTEST'', or ``MOTION TO
INTERVENE'' as applicable; (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person commenting, protesting or intervening; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis. Any filing made by an intervenor must be accompanied
by proof of service on all persons listed in the service list prepared
by the Commission in this proceeding, in accordance with 18 CFR
385.2010.

    Dated: November 18, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-25720 Filed 11-23-22; 8:45 am]
BILLING CODE 6717-01-P


From:
Jones, DonnaLee<EMAIL_ADDRESS>Sent:
Wednesday, March 2, 2016 5:52 PM
To:
David Ailor<EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS>Cc:
Raymond, Gabrielle<EMAIL_ADDRESS>Subject:
draft testing scheme as per COETF comments

Hello  -  We are considering one of the suggestions made by the COETF in regard to reducing the impact of the ICR on the coke industry. I liked one of the suggestions that was made in the recent COETF comments (last page of COETF edits on Enclosure 2 from 2/26/16) that proposed a couple of scenarios to require testing at fewer facilities to cover all tests, similar to the scheme I had already created for quench tower tests.

One attachment here (draft coke testing scheme) shows the scheme that would be most amenable to us that incorporates all of the ICR tests and subsumes the quench tower reduced testing as well as the simultaneous test method groupings.

The second attachment shows my current facility lists for both Enclosure 1 and 2, with both the previous/current facility lists and the proposed scheme for Enclosure 2.

We are prepared to talk about this scheme whenever you are ready, if we need to actually talk; emails may suffice. I am free all day Friday 3/4 (between 11:00 a.m. and 5:00 pm and can set up a call with Chuck and myself on this issue. On the other issues, i.e., the specific edits and method requests, this will take until early next week before I complete the enclosure revisions as well prepare responses to some of the major comments made by the COETF. My time suggestions for these discussions are below. I'd like to separate the discussion on the test scheme from the ICR content since the subjects will involve different EPA staff.

Please pass on to the COETF that I appreciated the suggestions and edits made on the ICR drafts; many of these were very useful. I/we also appreciated the alternatives provided when included.

My available times for teleconference discussing ICR method details and questions:

Tuesday 3/8 between 11:00 am and 2:00 pm
Wednesday 3/9 1:00 pm onward
Friday 3/11 11:00 am onward (may not be good for other EPA staff; will need to check)
_____________________________________________________________
Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D 243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

<< Coke-Draft-ICR-testing-scheme-03-02-16.docx >>
<< Coke-114-facilities-03-02-16-current&proposed scheme.pdf >>


° Label amendments are required pertaining to the proposed uses on fruiting vegetables. The use directions should be amended as two different maximum seasonal use rates are specified ( 1.6 or 1.66 lb ai/ A). The available field trial data will support a maximum seasonal rate of 1.66 lb ai/ A, which is equivalent to 1.75 pt product/ A.

° In addition, a revised copy of the 7.6 lb/ gal EC label should be submitted including all the proposed changes in the use directions.

° Field trial data on representative succulent, shelled peas and beans are required to support the proposed general use on legume vegetables, except soybeans.

° The requirements pertaining to rotational crops cited in the revised Metolachlor and SMetolachlor TRED ( D292881, S. Kinard, 8/ 15/ 03) remain outstanding:

For confined rotational crops, additional information is needed on the percentage of the 14C residues measured by the current enforcement method, supporting storage stability data, and sample storage conditions and intervals. With regard to field accumulation in rotational crops, " Residue data are required for both metolachlor and S metolachlor on grain, forage, hay, and straw of representative cereal grains ( wheat and oats) supporting the 4.5 month plantback interval."

In addition, a revised Section B for the use on pumpkin is required. 52 9.3 Occupational and Residential Exposure None.

References TRED, DP Num: 288263, S. Kinard, 2/ 12/ 03 EFED, DP Num: 296726, M. Corbin, 6/ 16/ 04 HED MARC, TXR# 0052788, DP Num: 274326, V. Dobozy, 8/ 14/ 01 HED ORE, DP Num: 296725, M. Collantes, 4/ 10/ 06 DP Num: 226780, L. Kutney, 11/ 12/ 96 PP# 3E6787, DP Num: 304120, R. Loranger, 4/ 17/ 06 DP Num: 279110, S. Kinard, 8/ 15/ 03 DP Num: 280216; MRID 44615401, S. Kinard, 2/ 28/ 02 MRID 46707501, S Metolachlor: Magnitude of the Residue on Squash ( Winter), D. Dotson, in process Dietary Analysis, ID# s: 06OH05, DP Num: 329632, W, Cutchin, in process HED ORE for the New Uses on Pumpkin and Winter Squash, DP Num: 330187, M. Collantes, 6/ 21/ 06 Residential Exposure, DP Num: 274331, R. Griffin, 2/ 20/ 02 Reviewer's Guide and Summary of HED ChemSAC Approvals for Amending Commodity Definitions [ 40 CFR § 180.1( h)] and Crop Group/ Subgroups [ 40 CFR § 180.41], B. Schneider, 6/ 14/ 02 53 Appendix A Table 1: Toxicity Profile for Metolachlor ( PC Code 108801)

Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results 870.3100 90 Day oral toxicity rodents 44775401 ( 1999) Acceptable/ guideline 0, 30, 300, 3000 ppm ( M/ F: 0, 2.00/ 2.32, 20.2/ 23.4, 210/ 259 mg/ kg/ day) NOAEL for males = 3000 ppm LOAEL for males not established NOAEL for females = 300 ppm LOAEL for females = 3000 ppm based on decreased body weight/ body weight gain 870.3150 180 Day oral toxicity in nonrodents 00032174 ( 1980), 43244001 acceptable/ guideline 0, 100, 300, 1000 ppm ( M/ F: 0, 2.92/ 2.97, 9.71/ 8.77, 29.61/ 29.42) NOAEL = 300 ppm LOAEL = 1000 ppm based on decreased body weight gain 870.3200 21/ 28 Day dermal toxicity 41833101 ( 1987) acceptable/ guideline 0, 10, 100 or 1000 mg/ kg/ day systemic NOAEL = 1000 mg/ kg/ day. systemic LOAEL was not established dermal irritation NOAEL was not established dermal irritation LOAEL = 10 mg/ kg/ day based on very slight erythema, dry skin and fissuring ( one animal)

870.3700a Prenatal developmental in rodents 00151941 ( 1985) acceptable/ guideline 0, 30, 100, 300 or 1000 mg/ kg/ day maternal toxicity NOAEL = 300 mg/ kg/ day. maternal toxicity LOAEL = 1000 mg/ kg/ day based on an increased incidence of death, clinical signs of toxicity ( clonic and/ or toxic convulsions, excessive salivation, urine stained abdominal fur and/ or excessive lacrimation) and decreased body weight gain.

developmental toxicity NOAEL = 300 mg/ kg/ day developmental toxicity LOAEL = 1000 mg/ kg/ day based on slightly decreased number of implantations per dam, decreased number of live fetuses/ dam, increased number of resorptions/ dam and significant decrease in mean fetal body weight 870.3700b Prenatal developmental in nonrodents 00041283 ( 1980) acceptable/ guideline 0, 36, 120 or 360 mg/ kg/ day maternal toxicity NOAEL = 120 mg/ kg/ day. maternal toxicity LOAEL = 360 mg/ kg/ day based on an increased incidence of clinical observations ( persistent anorexia) and decreased body weight gain developmental toxicity NOAEL = 360 mg/ kg/ day developmental toxicity LOAEL was not established. 54 Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results 870.3800 Reproduction and fertility effects 00080897 ( 1981) acceptable/ guideline 0, 30, 300 or 1000 ppm ( F0 males: 0, 2.4, 23.5 and 75.8 mg/ kg/ day; F0 females: 0, 2.5, 26.0 and 85.7 mg/ kg/ day; F1males: 0, 2.3, 23.7 and 76.6 mg/ kg/ day; F1 females: 0, 2.6, 25.7 and 84.5 mg/ kg/ day). Parental toxicity NOAEL = 1000 ppm ( F0 males/ females: 75.8/ 85.7 mg/ kg/ day; F1males/ females: 76.6/ 84.5 mg/ kg/ day). Parental toxicity LOAEL was not established Reproduction toxicity NOAEL = 1000 ppm ( F0 males/ females: 75.8/ 85.7 mg/ kg/ day; F1males/ females: 76.6/ 84.5 mg/ kg/ day). Reproduction toxicity LOAEL was not established Offspring NOAEL = 300 ppm ( F0 males/ females: 23.5/ 26.0 mg/ kg/ day; F1males/ females: 23.7/ 25.7 mg/ kg/ day). Offspring LOAEL = 1000 ppm ( F0 males/ females: 75.8/ 85.7 mg/ kg/ day; F1males/ females: 76.6/ 84.5 mg/ kg/ day) based on decreased body weight.

870.4100b Chronic toxicity dogs 40980701, 41164501, 42218601 and 42218602. ( 1989) acceptable/ guideline 0, 100, 300 or 1000 ppm ( males: 0, 3.5, 9.7 and 32.7 mg/ kg/ day, respectively; females: 0, 3.6, 9.7 and 33.0 mg/ kg/ day, respectively) for one year. NOAEL = 300 ppm ( 9.7 mg/ kg/ day) for females LOAEL = 1000 ppm for females ( 33.0 mg/ kg/ day) based on decreased body weight gain LOAEL for males was not established; NOAEL = 1000 ppm ( 32.7 mg/ kg/ day).

870.4300 Chronic toxicity/ carcinogenicity rodents 00129377 ( 1983) acceptable/ guideline 0, 30, 300 or 3000 ppm ( 0, 1.5, 15 or 150 mg/ kg/ day based on 1 ppm in food equals 0.05 mg/ kg/ day) NOAEL = 300 ppm ( 15 mg/ kg/ day) for females LOAEL = 3000 ppm ( 150 mg/ kg/ day) for females based on slightly decreased body weight gain and food consumption.

The LOAEL was not established for males. The NOAEL was 3000 ppm ( 150 mg/ kg/ day).

Administration of doses up to 3000 ppm was associated with statistically significant increases in liver adenomas and combined adenoma/ carcinoma in female rats. In male rats, there was a statistically significant trend but not pair wise significance for liver tumors.

870.4300 Carcinogenicity mice 00117597 ( 1982) acceptable/ guideline 0, 300, 1000 or 3000 ppm ( 0, 45, 150 or 450 mg/ kg/ day based on 1 ppm in food equals 0.150 mg/ kg/ day) NOAEL = 1000 ppm ( 150 mg/ kg/ day) LOAEL = 3000 ppm ( 450 mg/ kg/ day) based on possible treatmentrelated deaths in females and decreased body weight/ body weight gain in males and females no evidence of carcinogenicity Gene Mutation 870.5100  bacterial reverse mutation 00015397 ( 1976) acceptable/ guideline 10, 100, 1000 and 10,000 ug/ plate negative up to cytotoxic doses ( 1000 ug/ plate) 55 Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results Gene Mutation 870.5300  mouse lymphoma 00158929 ( 1984) acceptable/ guideline 9.5 190 nl/ ml without activation; 10.5 280 nl/ ml with activation no effect on the incidence of mutations in the presence or absence of metabolic activation Cytogenetics 870.5395  micronucleus assay in Chinese hamsters 00158925 ( 1984) acceptable/ guideline 0, 1250, 2500 or 5000 mg/ kg no effect of treatment on incidence of micronuclei induction Cytogenetics 870.5450  dominant lethal assay in mice 00015630 ( 1978) acceptable/ guideline 100 or 300 mg/ kg no effect on embryonic death, pre and post implantation or fertility rates in mated females Other Effects 870.5550  DNA Damage/ Repair in rat hepatocytes 00142828 ( 1984) acceptable/ guideline 0.25, 1.25, 6.25, or 31.25 nl/ ml negative Other Effects 870.5550  DNA Damage/ Repair in human fibroblasts 00142827 acceptable/ guideline 0.125, 0.625, 3.125 or 15.625 nl/ ml negative Other Effects 870.5550  Unscheduled DNA synthesis in rat hepatocytes 43244003 ( 1994) acceptable/ guideline 1250, 2500 or 4000 mg/ kg to males; 500, 1000 or 1500 mg/ kg to females negative for induction of UDS; however, significant increases in percentage of cells in S phase were observed in females dosed at 500 mg/ kg ( but not at 1000 or 1500 mg/ kg) and sacrificed at 15 hours 56 Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results 870.7485 Metabolism and pharmacokinetics MRID 00015425 ( 1974) unacceptable 52, 28 or 33 mg/ kg to male rats Conclusions: Urinary metabolites of CGA 24705 ( N( 2 methoxy 1 methylethyl) 2 ethyl 6 methyl chloroacetanilide) were identified following oral administration of 52 mg/ kg, 28 mg/ kg, and 33 mg/ kg to male rats. Two metabolites, each comprising approximately 5% of chloroform extractable urinary radioactivity, were identified from oral administration of CGA 24705. These were the products CGA 37735 ( 2 ethyl 6 methyl hydroxyacetanilide), in which Ndealkylation of R1 ( the N( 2 methoxy 1 methylethyl side chain) and side chain dechlorination and oxidation of R2 ( the N chloroacetyl side chain) have occurred, and CGA 46129 ( N( 1 carboxy ethyl) 2 ethyl 6 methyl hydroxyacetanilide) in which the ether bond of R1 has been split and oxidized to the corresponding carboxylic acid, while R2 is similar to R2 found in CGA 37735. In study # 7/ 74, these 2 metabolites each represented approximately 5% of organic extractable urinary radioactivity, while in study # 12/ 74, the percentage found as CGA 46129 was between 20 25% of urinary radioactivity, and CGA 37735 represented between 3 5% of organic extractable radioactivity.

The major metabolic pathway proposed from analysis of urinary as well as fecal metabolites is one of cleavage of the ether bond and subsequent oxidation to the carboxylic acid, as well as hydrolytic removal of the chlorine atom. Conjugation of CGA 24705 or metabolites with gluronic acid or sulfate does not appear to occur.

Aqueous extractable urinary radioactivity contained 58% of the total urinary radioactivity and was composed of 5 different radioactive fractions, which were not identified.

Current guideline recommendations as to dose levels and use of both sexes in metabolism studies were not followed. Thus, whether the metabolic pattern is altered with dose or repeated exposure cannot be evaluated from these data. 57 Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results 870.7485 Metabolism and pharmacokinetics 40114401 ( 1987) unacceptable Single low ( 1.5 mg/ kg), single high ( 300 mg/ kg) and repeated low ( 1.5 mg/ kg/ day for 15 days) Conclusions: Single low ( 1.5 mg/ kg), single high ( 300 mg/ kg) and repeated low ( 1.5 mg/ kg/ day for 15 days) oral doses of metolachlor were readily absorbed and eliminated by male and female rats. Urinary and fecal elimination of radioactivity associated with orally administered [ 14C] metolachlor was essentially complete within 48 to 72 hours after dosing. Low and high dose females eliminated 14C more rapidly ( p< 0.003, half lives of elimination, 16.6 and 15.6 hours, respectively) than low and high dose males and repeateddose animals of both sexes ( half lives, 18.2 and 20.0 hours). Elimination by all animals followed first order kinetics. Approximately one half to two thirds ( 48 to 64 percent) of the 14C administered was recovered from the urine within 7 days; similar amounts were present in the feces. Low dose males eliminated slightly more of the radioactive dose in the feces ( 55 percent) than the urine ( 48 percent). The opposite trend was seen in the low dose females and repeated dose rats of both sexes; these animals excreted approximately 58 to 64 percent of the 14C dose in the urine and 42.5 to 46.5 percent in the feces within 7 days after dosing. High dose animals excreted similar amounts ( 58 to 60 percent) of the radioactive dose in the urine and feces. Total recoveries of 14C ( urine, feces, and tissues) tended to be high and were between 105 and 122.5 percent.

Relatively low levels of radioactivity were present in the tissues of all animals at 7 days postdosing. Tissues of low and repeated dose rats contained approximately 1.6 to 2.5 percent of the 14C dose; tissues of high dose rats accounted for 3.2 ( females) and 4.2 ( males) percent. For all groups, most of the tissue radioactivity ( 1.1 to 3.0 percent of the dose) was associated with red blood cells ( RBCs); RBCs also contained the highest concentrations of radio labeled compound ( 0.6 to 0.9 ppm, low and repeated dose rats; 232 and 247 ppm, high dose females and males, respectively), indicating that [ 14C] metolachlor and/ or its metabolites bind extensively to these cells. The next highest concentrations of radiolabel ( 0.03 to 0.13 ppm, low and repeated dose rats; 7.3 to 37 ppm, high dose animals) were present in metabolically active tissues, including the heart, lung, kidney, liver and spleen. Brain, bone and muscle contained the smallest amounts of radioactivity ( 0.004 to 0.015 ppm, low and repeated dose rats; 1.7 to 3.5 ppm, high dose rats). Tissue 14C residues in high dose males were approximately 250 to 500 times greater than those of low dose males, indicating that the ratio of tissue concentrations ( high dose: low dose) was much larger than the corresponding dose ratio of 200: 1 ( 300 mg/ kg: 1.5 mg/ kg). In contrast, tissue 14C levels of females were, in general, proportionate to dose. Tissues of low and repeated dose rats contained similar amounts of radioactivity. These data indicate that some 14C was retained by all animals and that the greatest potential for accumulation of radioactivity was in male rats given a single high oral dose of [ 14C] metolachlor. 58 Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results 870.7485 Metabolism and pharmacokinetics 43164201 ( 1992) acceptable/ guideline low oral dose ( 1.5 mg/ kg x 14 days), and a single high dose ( 300 mg/ kg) In a rat metabolism study ( MRID # 431642 01), 14C Metolachlor was administered orally in PEG 200 [ HWI 6117 208] or corn oil [ ABR 94001] to groups ( 5 sex/ dose) of male and female Sprague Dawley rats at a low oral dose ( 1.5 mg/ kg), repeated low oral dose ( 1.5 mg/ kg x 14 days), and a single high dose ( 300 mg/ kg). Control animals ( 1/ sex) received blank formulation.

Comparison of oral and intravenous data showed that of the administered dose, between 69.6% and 93.2% was absorbed. Distribution data showed that the only significant sites of residual radioactivity at 7 days post dose were residual carcass ( 0.9  2.2% of the administered dose) and red blood cells ( 0.95 1.53 Fg equivalents/ gram in blood cells for all low dose male and female rats). Dosing regimen did not result in any apparent accumulation of residual radioactivity.

Excretion data showed that urine and feces were both significant routes for elimination of metolachlor derived radioactivity. In the low dose groups, the urine appeared more of a predominant route for excretion in female rats than in males, whereas fecal excretion was slightly higher in males. However, at the high oral dose, there were no apparent sex related differences in the pattern of urinary excretion. Examination of urinary excretion data as presented in graphical format indicated that at the 300 mg/ kg dose, excretion was delayed vs the low oral dose, suggesting saturation of elimination.

Metabolism of metolachlor in this study was complex, with up to 32 metabolites identified in urine and/ or feces. The " major" urinary metabolite found in all dose groups was the metabolite designated CGA 46129. This metabolite was present as 5.6 13.1% of the total radioactive residue ( TRR) in rat urine across all dose groups, and was highest in the intravenously dosed group. In the orally dosed rats, the percentage of this metabolite decreased from approximately 13% of TRR to between 5.6 9.2% of TRR. Other metabolites identified in urine which constituted near or at 5% of TRR were U10 ( CGA 37735), U13, U17, U1, " polar 1", and " polar 2." The radioactivity constituting the ` polar 1' and ` polar 2' regions was further broken down to at least 12 components by TLC, but the identity of the metabolites in these regions was not demonstrated.

In feces, a similarly complex metabolite profile was obtained. The " major" metabolite observed in feces, F9, was identical to U7, or CGA 46129. Except for intravenously dosed rats, where the percentage of this metabolite in feces was equivalent in male and female rats ( 11.6 and 13.2% of TRR, respectively), the percentage of F9 in feces of orally dosed rats was always higher in males than in females. Other fecal metabolites identified at or near 5% of TRR in feces included F2 ( CGA 41638), F3 ( CGA 133275), F7, F8 and F8', F16, F14, and F17.

Based on these data, a scheme for metabolism of metolachlor was proposed. 59 Appendix A Table 2: Toxicity Profile for S Metolachlor ( PC Code 108800)

Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results 870.3100 90 Day oral toxicity rodents 43928923 ( 1995) acceptable/ guideline 0, 30, 300, 3000 or 10000 ppm ( 0, 1.5, 15, 150 or 500 mg/ kg/ day) NOAEL = 300 ppm LOAEL = 3000 ppm based on lower body weights/ body weight gains, reduced food consumption and food efficiency and increased kidney weights in males 870.3100 90 Day oral toxicity rodents 44775402 ( 1999) unacceptable/ guideline 0, 30, 300, 3000 ppm ( M/ F: 0, 1.90/ 2.13, 20.4/ 23.9 and 208.0/ 236.0 mg/ kg/ day0 NOAEL = 3000 ppm ( equivalent to 208 mg/ kg/ day in males and 236 mg/ kg/ day in females LOAEL cannot be defined 870.3150 90 Day oral toxicity in nonrodents 43928922 ( 1995) acceptable/ nonguideline 0, 300, 500, 1000 or 2000 ppm ( M/ F: 0, 9/ 10, 15.1/ 17.2, 31.1/ 31.5 or 62/ 74 mg/ kg/ day) NOAEL = 2000 ppm ( M/ F: 62/ 74 mg/ kg/ day) LOAEL = not established 870.3700a Prenatal developmental in rodents 43928925 ( 1995) acceptable/ guideline 0, 5, 50, 500 or 1000 mg/ kg/ day Maternal NOAEL = 50 mg/ kg/ day LOAEL = 500 mg/ kg/ day based on increased clinical signs of toxicity, decreased body weights/ body weight gains, food consumption and food efficiency. Developmental NOAEL = 1000 mg/ kg/ day LOAEL = not established 870.3700b Prenatal developmental in nonrodents 43928924 ( 1995) acceptable/ guideline 0, 20, 100 or 500 mg/ kg/ day Maternal NOAEL = 20 mg/ kg/ day LOAEL = 100 mg/ kg/ day based on clinical signs of toxicity Developmental NOAEL = 500 mg/ kg/ day LOAEL = not established Gene Mutation 870.5100 Salmonella & Escherichia/ Mammalia n Microsome Mutagenicity Test 43928927 ( 1995) acceptable/ guideline 78.13 1250.0 ug/ plate In independently performed microbial mutagenicity assays, Salmonella typhimurium TA1535, TA1537, TA98, TA100 and TA102 and Escherichia coli WP2 uvrA were initially exposed to 312.5 5000.0 Fg/ plate CGA 77102 technical ( 95.6%) in the presence and absence of S9 activation. For the confirmatory trial, doses of 78.13 1250.0 Fg/ plate ± S9 were evaluated with S. typhimurium strains TA1535, TA1537, TA100 and TA102; concentrations of 312.5 5000.0 Fg/ plate ± S9 were examined with S. typhimurium TA 98 and E. coli WP2 uvrA.

In general, doses $ 1250.0 Fg/ plate ± S9 were cytotoxic for S. typhimurium TA1535, TA1537, TA100 and TA102 and 5000.0 Fg/ plate ± S9 was slightly cytotoxic for S. typhimurium TA98 and E. coli WP2 uvrA. There was, however, no indication that CGA 77102 technical induced of a mutagenic effect in any tester strain either in the presence or the absence of S9 activation. 60 Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results Cytogenetics 870.5395 Micronucleus test 43928926 ( 1995) acceptable/ guideline 500, 1000 or 2000 mg/ kg Groups of five male and five female Tif: MAGf( SPF) mice received single oral gavage administrations of 500, 1000 or 2000 mg/ kg CGA 77102 technical ( 95.6%).

Toxic signs, similar to those seen in the preliminary range finding studies ( i. e., ataxia, tremors and/ or hunched posture) were recorded for high dose males and females throughout the 48 hour postexposure. No bone marrow cytotoxicity was seen at any dose or sacrifice time. The positive control induced the expected high yield of MPEs in males and females. There was, however, no evidence that CGA 77102 technical induced a clastogenic or aneugenic effect in either sex at any dose or sacrifice time.

Other Effects 870.5550 Unscheduled DNA synthesis 43928928 ( 1995) acceptable/ guideline 500, 1500, 3200 ( females), 5000 ( males) mg/ kg Groups consisting of three to four rats per sex received single oral gavage administrations of CGA 77102 Technical ( 95.6%) at doses of 500, 1500 or 5000 mg/ kg ( males) or 500, 1500 or 3200 mg/ kg ( females). Hepatocytes harvested at 15 and 38 hours were evaluated for viability and replicative DNA synthesis ( RDS). For the UDS determination, additional groups ( 3/ sex/ dose) were exposed to 500 or 1500 mg/ kg and the recovered hepatocytes were scored at 2 or 15 hours postexposure.

Two of four females in the 3200 mg/ kg group and 2 of 4 males in the 5000 mg/ kg group died prior to the scheduled sacrifice at 38 hours. Severe cytotoxicity was seen in the hepatocytes recovered from 1 of 2 surviving males and both female survivors in the highdose groups. Lower levels were neither toxic to the animals nor cytotoxic to the target cells. A clear dose related increase in the percentage of cells in S phase ( RDS) was obtained from hepatocytes harvested 38 hours posttreatment of the male rats. The response ranged from a 5.3 fold increase at 1500 mg/ kg to a 16.1 fold increase at the high dose ( 5000 mg/ kg). In females, a marked increase in RDS was initially seen at 1500 mg/ kg but the response declined over time with a 24.4 fold increase at 15 hours and a 12.2 fold increase at 38 hours. There was, however, no evidence that the CGA 77102 Technical at doses of 500 or 1500 mg/ kg induced a genotoxic response at 2 or 15 hours posttreatment. We conclude, therefore, that the data indicate that CGA 77102 Technical was negative for genotoxicity but positive for cellular proliferation when tested up to overtly toxic and cytotoxic doses in this in vivo/ in vitro rat hepatocyte RDS/ UDS assay. 61 Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results 870.7485 Metabolism and pharmacokinetics 44491401 ( 1996) acceptable/ guideline single dose of 0.5 ( group B1) or 100 mg/ kg ( group D1) radio labeled CGA 77102; 100 mg/ kg/ day non radio labeled CGA 77102 for 14 days followed by 0.5 mg/ kg radio labeled CGA 77102 ( Group V1); single dose of 0.5 or 100 mg/ kg radio labeled CGA 77102 for bilecannulation study In all three dose groups ( B1, D1, and V1), the seven day combined levels of radioactivity in urine were 31.1  36.5% for males and 40.8  45.5% for females; the fecal levels were 60.2  62.5% for males and 48.9  55.0% for females. Only 0.1% or less was eliminated in the expired air. The total recovery ranged from 96.5 ± 2.3% to 99.3 ± 0.9%. The route or extent of excretion was slightly influenced by the sex of the animal but not by pretreatment with non radio labeled CGA 77102 or by the dose level. The degree of absorption, based on adding the cumulative urinary excretion to the total residues in tissues, was 35  39% in males and 43  49% in females of both dose groups. However, based on the bile duct cannulation study, most of CGA 77102 was absorbed from the gastrointestinal tract since 85% of the dose was recovered in urine, bile fluid, and tissues during the 48 hours study period. Therefore, the biliary excretion and enterohepatic circulation play a significant role in the elimination process of CGA 77102.

Irrespective of the dose and sex, there seems to be a biphasic plasma profile with two concentration maxima ( Cmax); a fast rising first Cmax was reached at 0.25  1 hour post dosing which was succeeded by a second Cmax at 8 and at 12  24 hours following administration of the low and high dose, respectively. In the low dose group ( B1), the first and second Cmax were nearly identical (~ 0.03 Fg/ ml); in the high dose group ( D1), the first and second Cmax were, respectively, 4.6 and > 3.9 Fg/ ml in males and 2.2 and 4.5 Fg/ ml in females. The time to half maximum plasma concentration ( tcmax/ 2) in males/ females was 31/ 24 hours at the low dose and 44/ 32 hours at the high dose. Bioavailability, or the area under the plasma concentration curve ( AUC0 48hr), was nearly identical (~ 0.8 mg/ kg. hr) among males and females of the low dose group. Also, both sexes in the high dose group had similar plasma AUC0 48hr ( M/ F: 143/ 125 mg/ kg. hr) which increased almost proportionately with the 200 fold increase in the dose level. The residues in RBC increased steadily with time reaching peak levels ( at 24  48 hours post dosing) of 0.5 0.6 and 90 ppm ( or Fg/ g) CGA 77102 equivalents for the low ( B1) and high ( D1) dose groups, respectively. The peak levels in RBC remained high and were nearly 20 fold higher than the respective plasma Cmax levels. 62 Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results The kinetics of tissue distribution and depletion in both sexes were also followed for up to 144 hours following a single low or high oral dose ( Groups F1  F4). Peak residue levels were reached within 12  24 hours and ranged from 0.007 ppm ( female muscle) to 0.123 ppm ( male kidneys) at the low dose, and from 1.29 ppm ( male brain) to 16.82 ppm ( male liver) at the high dose, with the highest levels being among some of the well perfused tissues ( e. g., liver, kidneys, spleen, and lungs). The extent of residue depletion was variable among the tissue types but was minimally affected by the dose or the sex of the animal. The radiolabel was most persistent in some of the well perfused organs ( e. g., the heart, lungs, and spleen) in addition to the brain and bone where, after 144 hours, the levels were decreased to only 45  94% of their maximal concentrations. In Groups F1  F4, peak residue concentration in the whole blood ( 0.2 and 42  47 Fg/ ml in the low and high dose groups, respectively) was reached at 24 hours and was maintained throughout the study. Overall, the high/ low dose peak tissue levels ( including blood) ranged from 132 to 282 which approximates the 200 fold increase in dosage.

CGA 77102 has a high affinity for and a long half life in blood ( especially RBC) which might contribute to the retarded depletion of tissue residues. 63 Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results 870.7485 Metabolism and pharmacokinetics 44491402 ( 1996) unacceptable/ guideline single dose of 0.5 ( group B1) or 100 mg/ kg ( group D1) radio labeled CGA 77102; 100 mg/ kg/ day non radio labeled CGA 77102 for 14 days followed by 0.5 mg/ kg radio labeled CGA 77102 ( Group V1); single dose of 0.5 or 100 mg/ kg radio labeled CGA 77102 for bilecannulation study ( from MRID 44491401) single oral low dose ( 0.5 mg/ kg, Group B2) of [ Phenyl U 14C] CGA 24705 ( R/ S metolachlor, racemate) The 72 hour mean recovery of radioactivity in urine, feces, and carcass following administration of 0.5 mg/ kg of [ Phenyl U 14C] CGA 24705 was 43.1%, 47.0%, and 7.4% in males and 54.0%, 39.4%, and 4.1% in females, respectively. In contrast, both sexes excreted more of the label in the feces ( M: F 59.7%: 53.4%) than in the urine ( M: F 29.4%: 39.8%) during the same period following administration of the same dose of [ Phenyl U 14C] CGA 77102 ( the S enantiomer) ( MRID 44491401).

The urinary and fecal metabolite profiles, with 31 and 15 metabolite fractions, respectively, were qualitatively similar among all groups; however, there were large quantitative differences, based on the dosing formulation, on one hand, and the sex of the animal, on the other. Based on a percentage of the dose, several of the major urinary metabolite fractions ( e. g., U1, U2, U3, U18, U24, and U30) were more abundant in the case of the racemic Metolachlor ( CGA 24705) than the S metolachlor ( CGA 77102); in contrast, several fecal metabolite fractions ( e. g., F9, F10, F12, and F13) were present at higher levels in the case of CGA 77102 than CGA 24705. On the other hand, there were sex related differences regardless of the dosing formulation where, for instance, females had greater urinary concentrations than males of several metabolite fractions, including U3, U4, U8, U9, U18, U20, and U30; the males, however, excreted more of fractions U1 and U24 than the females. Also, several fecal fractions including F1, F3, F5, F6, F7, F8, and F13 were influenced by the sex regardless of the dose level ( e. g. B1 vs. D1) or the stereochemical make up of Metolachlor ( B1 vs. B2). Other metabolite fractions were dependent on both the sex and the chemical formulation as, for instance, in the case of metabolite U2 which, relative to the opposite sex within the same group, was more abundant in the urine of the females of Group B2 ( CGA 24705) and in the urine of the males of Group B1 ( CGA 77102).

The bile fluid accounted for 79.8% of the administered low or high dose of CGA 77102 ( Groups G1 and G2) where the 2D TLC showed 14 biliary metabolite fractions ( G1 G14) in the high dose Group and only six metabolites in the low dose Group. The two metabolite fractions G7 and G8 accounted, respectively, for 33.3% and 9.6% of the administered low dose and 31.3% and 14.6% of the administered high dose. Other major biliary metabolites were G3, G9, and G10 which accounted for about 5%, 5 7%, and 3 5%, respectively, of either dose group. 64 Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results The results clearly show that the metabolite profile in excreta and bile fluid is very complex and that Metolachlor ( racemate or Senantiomer is extensively metabolized. This was also shown earlier by another rat metabolism study on the absorption, distribution, excretion, and metabolite identification of racemic CGA 24705 ( MRID 43164201, reviewed by T. McMahon, HED doc. no. 010990 dated May 23, 1994). No actual metabolites or pathways were identified in the current study and there were no data to support or refute the previous findings of four major degradation pathways with more than 30 metabolites. However, knowing the enantiomeric stereospecific reactions/ metabolites is not likely to help in making comparative risk assessments between R/ Smetolachlor ( CGA 24705) and S metolachlor ( CGA 77102) since the contribution of each metabolite to the overall toxicity of Metolachlor is not well understood. Furthermore, other bridging animal studies with CGA 77102 should highlight possible toxicity differences from the well studied CGA 24705 due to variations in the metabolite profiles.

The Registrant is requested to comment on or provide information on a number of issues including: 1) The stereoisomeric purity of CGA 24705 and CGA 77102. 2) The adequacy of the storage conditions and the validity of the metabolite profile results in light of the storage related results variability. 3) Explain why, relative to the other dosing formulation, some metabolite fractions ( e. g., F10, F12, and F13) were up to 7 fold higher in the case of the S enantiomer ( CGA 77102) while some urinary metabolite fractions ( e. g., U1, U2, and U3) were up to 4 fold higher in the case of CGA 24705. 4) Provide rational for dose selection. 5) The Registrant might also have to comment on the possible formation and the level of methylethylaniline from either dosing formulation and the possible contribution of this metabolite to the carcinogenicity of Metolachlor. This issue was raised earlier by T. McMahon ( HED document no. 010990 dated May 23, 1994) and might need to be followed up by HED's risk assessors who are in charge of Smetolachlor 65 Appendix A Table 3: Structure of S Metolachlor ( PC Code 108800) and Metabolites S metolachlor and Metabolites Chemical Structure S metolachlor ( 2 Chloro N( 2 ethyl 6 methylphenyl) N{ S( 2 methoxy 1 methylethyl)} acetamide)

CGA 37913 ( 2[( 2 ethyl 6 methylphenyl) amino] 1 propanol)

C H 3 NH CH 3 O H CH 3 CGA 49751 ( 4( 2 ethyl 6 methylphenyl) 2 hydroxy 5 methyl 3 morpholinone)

C H 3 CH 3 N O O OH C H 3 ESA ( metolachlor ethane sulfonic acid)

OA ( metolachlor oxanilic acid) 66 Appendix B International Residue Status Sheet INTERNATIONAL RESIDUE LIMIT STATUS Chemical Name: Common Name: Smetolachlor Proposed tolerance Reevaluated tolerance Other Date: 6/ 12/ 06 Codex Status ( Maximum Residue Limits) U. S. Tolerances X No Codex proposal step 6 or above No Codex proposal step 6 or above for the crops requested Petition Numbers: 06NY08 DP Barcodes: D329176 Other Identifier: 108800 Reviewer/ Branch: W. Cutchin Residue definition ( step 8/ CXL): N/ A Proposed Residue definition: S metolachlor [ S 2 chloro N ( 2 ethyl 6 methylphenyl) N( 2 methoxy 1 methylethyl) acetamide], its R enantiomer, and its metabolites, determined as the derivatives, 2[ 2 ethyl 6 methylphenyl) amino] 1 propanol and 4( 2 ethyl 6 methylphenyl) 2 hydroxy 5 methyl 3 morpholinone, each expressed as the parent compound Crop ( s) MRL ( mg/ kg) Crop( s) Tolerance ( ppm)

Cilantro 1.0 Kale 1.0 Collards 1.0 Mustard greens 1.0 Pumpkins 0.1 Limits for Canada Limits for Mexico No Limits X No Limits for the crops requested No Limits X No Limits for the crops requested Residue definition: 2 chloro N( 2 ethyl 6 methylphenyl) N[( 1S) 2 methoxy 1 methylethyl) acetamide and 2 chloro N( 2 ethyl 6 methylphenyl) N[( 1R) 2 methoxy 1 methylethyl) acetamide, including the metabolites2[( 2 ethyl 6 methylphenyl) amino] 1 propanol and 4( 2 ethyl 6 methylphenyl) 2 hydroxy 5 methyl 3 morpholinone Residue definition: metolaclor Crop( s) MRL ( mg/ kg) Crop( s) MRL ( mg/ kg)

Notes/ Special Instructions: S. Funk, 25/ 06/ 2006.


[Federal Register Volume 87, Number 89 (Monday, May 9, 2022)]
[Notices]
[Pages 27679-27681]
[FR Doc No: 2022-09856]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-94839; File No. SR-NYSE-2022-20]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing of Proposed Rule Change To Modify Rule 7.31 To Add
Subparagraph (f)(1) Regarding Directed Orders

May 3, 2022.
    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 April 20, 2022, New York Stock Exchange LLC (``NYSE'' or
the ``Exchange'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I,
II, and III 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.
---------------------------------------------------------------------------

    \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 Substance
of the Proposed Rule Change

    The Exchange proposes to modify Rule 7.31 to add subparagraph
(f)(1) regarding Directed Orders and make other conforming changes. The
proposed rule change is available on the Exchange's website 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to modify Rule 7.31 (Orders and Modifiers) to
designate subparagraph (f) as describing orders with specific routing
instructions and to add new subparagraph (f)(1) to provide for Directed
Orders. The Exchange also proposes to make other conforming changes to
its Rules in connection with the addition of this new order type on the
Exchange. The Directed Order, as further defined below, would be an
order sent to the Exchange to be routed directly to an alternative
trading system (``ATS'') specified by a member organization.
    The Exchange proposes to rename Rule 7.31(f), which is currently
designated as Reserved, to ``Orders with Specific Routing
Instructions.'' The Exchange also proposes to add Rule 7.31(f)(1),
which would define a Directed Order as a Limit Order with instructions
to route on arrival at its limit price to a specified ATS with which
the Exchange maintains an electronic linkage. Proposed Rule 7.31(f)(1)
would further provide that Directed Orders would be available for all
securities eligible to trade on the Exchange. Proposed Rule 7.31(f)(1)
would also provide that a Directed Order would not be assigned a
working time or interact with interest on the Exchange Book. The
Exchange also proposes to provide in Rule 7.31(f)(1) that the ATS to
which a Directed Order is routed would be responsible for validating
whether the order is eligible to be accepted, and if such ATS
determines to reject the order, the order would be cancelled.
    Proposed Rule 7.31(f)(1)(A) would provide that a Directed Order
must be designated for the Exchange's Core Trading Session, as defined
in Rule 7.34(a)(2).\4\
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    \4\ Because the Exchange proposes that Directed Orders may only
be designated for the Core Trading Session, the Exchange also
proposes conforming changes to Rule 7.34 (Trading Sessions).
Specifically, the Exchange proposes to add Rule 7.34(c)(1)(E) to
provide that Directed Orders designated for the Early Trading
Session would be rejected. The Exchange also proposes to update Rule
7.34(c)(1) to refer to ``paragraphs (c)(1)(A)-(E)'' to reflect the
addition of subparagraph (E).
---------------------------------------------------------------------------

    Proposed Rule 7.31(f)(1)(A) would further provide that a Directed
Order must be designated with a Time in Force modifier of IOC \5\ or
Day \6\ and would be routed to the specified ATS with such modifier.
The Exchange proposes that a Directed Order designated IOC would be
traded in whole or in part on the ATS to which

it is routed after receipt of the order, and any untraded quantity
would be cancelled. The Exchange proposes that a Directed Order
designated Day would expire at the end of the Core Trading Session on
the day it is entered. Proposed Rule 7.31(f)(1)(A) would also provide
that a Directed Order may not be designated with any other modifiers
defined in Rule 7.31.
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    \5\ See Rule 7.31(b)(2), which provides that a Limit Order may
be designated with an Immediate-or-Cancel (``IOC'') modifier.
    \6\ See Rule 7.31(b)(1), which provides that orders may be
designated with a Day modifier, and that an order to buy or sell
designated Day, if not traded, will expire at the end of the
designated session on the day on which it was entered.
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    Proposed Rule 7.31(f)(1)(B) would provide that a Directed Order in
a security to be opened in an initial public offering (``IPO'') or a
Direct Listing would be rejected if received before the IPO Auction or
Direct Listing Auction concludes.
    Proposed Rule 7.31(f)(1)(C) would provide that, during a trading
halt or pause, an incoming Directed Order would be rejected.
    Proposed Rule 7.31(f)(1)(D) would provide that a request to cancel
a Directed Order designated Day would be routed to the ATS to which the
order was routed.
    The Exchange also proposes the following conforming changes to Rule
7.19 (Pre-Trade Risk Controls) and Rule 104 (Dealings and
Responsibilities of DMMs):
     The Exchange proposes to modify Rule 7.19(a)(5), which
sets forth the definition of Gross Credit Risk Limit and currently
provides that unexecuted orders in the Exchange Book, orders routed on
arrival pursuant to Rule 7.37(a)(1), and executed orders are included
for purposes of calculating the Gross Credit Risk Limit. The Exchange
proposes to modify Rule 7.19(a)(5) to specify that orders routed on
arrival pursuant to Rule 7.31(f)(1) would also be included for purposes
of the Gross Credit Risk Limit calculation.
     The Exchange proposes to modify Rule 104(b)(6), which
specifies the orders and modifiers that DMM units are not permitted to
enter. The Exchange proposes to add Directed Orders to Rule 104(b)(6)
as an order type that DMM units may not enter.
    The Exchange believes that the proposed rule change would
facilitate additional trading opportunities by offering member
organizations the ability to designate orders submitted to the Exchange
to be routed to an ATS of their choosing for execution. The Exchange
believes the proposed change would encourage member organizations to
utilize the Exchange as a venue for order entry and further believes
that the proposed change could create efficiencies for member
organizations by enabling them to send orders that they wish to route
to an alternate destination through the Exchange, thereby enabling them
to leverage order entry protocols and specifications already configured
for their interactions with the Exchange. The Exchange notes that the
Directed Order, as proposed, would operate similarly to the Primary
Only Order already offered by NYSE American LLC (``NYSE American''),
NYSE Arca, Inc. (``NYSE Arca''), NYSE Chicago, Inc. (``NYSE Chicago''),
and NYSE National, Inc. (``NYSE National'') (collectively, the
``Affiliated Exchanges''). On the Affiliated Exchanges, a Primary Only
Order is an order that is routed directly to the primary listing market
on arrival, without being assigned a working time or interacting with
interest on the order book of the exchange to which it was
submitted.\7\ The Exchange also believes that the Directed Order would
offer member organizations functionality akin to order types and
routing options that currently exist on other equities exchanges.\8\
---------------------------------------------------------------------------

    \7\ See NYSE American Rule 7.31-E(f)(1); NYSE Arca Rule 7.31-
E(f)(1); NYSE Chicago Rule 7.31(f)(1); NYSE National Rule
7.31(f)(1). The Affiliated Exchanges also offer variations of the
Primary Only Order, including the Primary Only Until 9:45 Order,
which is a Limit or Inside Limit Order that, on arrival and until
9:45 a.m. Eastern Time, routes to the primary listing market, and
the Primary Only Until 3:55 Order, which is a Limit or Inside Limit
Order entered on the Exchange until 3:55 p.m. Eastern Time, after
which time the order is cancelled on the Exchange and routed to the
primary listing market. See NYSE American Rules 7.31-E(f)(2) and
(f)(3); NYSE Arca Rules 7.31-E(f)(2) and (f)(3); NYSE Chicago Rules
7.31(f)(2) and (f)(3); NYSE National Rules 7.31(f)(2) and (f)(3).
    \8\ See, e.g., Nasdaq Stock Market LLC (``Nasdaq''), Equity 4,
Equity Trading Rules, Rule 4758(a)(ix) (defining the Nasdaq Directed
Order as an order designed to use a routing strategy under which the
order is directed to an automated trading center other than Nasdaq,
as directed by the entering party, without checking the Nasdaq
Book); Cboe EDGX Exchange, Inc. (``EDGX'') Rules 11.8(c)(7)
(defining the Routing/Directed ISO order type as an ISO that
bypasses the EDGX system and is immediately routed by EDGX to a
specified away trading center for execution) and 11.11(g)(2)
(providing for the DRT routing option, in which an order is routed
to an alternative trading system as instructed); Cboe EDGA Exchange,
Inc. (``EDGA'') Rules 11.8(c)(7) (defining the Routing/Directed ISO
order type as an ISO that bypasses the EDGA system and is
immediately routed by EDGA to a specified away trading center for
execution) and 11.11(g)(2) (providing for the DRT routing option, in
which an order is routed to an alternative trading system as
instructed); Cboe BZX Exchange, Inc. (``BZX'') Rules 11.13(b)(3)(D)
(providing for the DRT routing option, in which an order is routed
to an alternative trading system as instructed) and 11.13(b)(3)(F)
(defining the Directed ISO routing option, under which an ISO order
would bypass the BZX system and be sent to a specified away trading
center); Cboe BYX Exchange, Inc. (``BYX'') Rules 11.13(b)(3)(D)
(providing for the DRT routing option, in which an order is routed
to an alternative trading system as instructed) and 11.13(b)(3)(F)
(defining the Directed ISO routing option, under which an ISO order
would bypass the BYX system and be sent to a specified away trading
center). The Exchange also believes that the Directed Order would
provide functionality similar to the C-LNK routing strategy formerly
offered by EDGA, in which C-LNK orders bypassed EDGA's local book
and routed directly to a specified Single Dealer Platform
destination. See Securities Exchange Act Release No. 82904 (March
20, 2018), 83 FR 12995 (March 26, 2018) (SR-CboeEDGA-2018-004)
(Notice of Filing and Immediate Effectiveness of a Proposed Rule
Change To Expand an Offering Known a Cboe Connect To Provide
Connectivity to Single-Dealer Platforms Connected to the Exchange's
Network and To Propose a Per Share Executed Fee for Such Service).
---------------------------------------------------------------------------

    Because of the technology changes associated with this proposed
rule change, the Exchange will announce the implementation date by
Trader Update.\9\ Subject to effectiveness of this proposed rule
change, the Exchange anticipates that the proposed change will be
implemented in the second quarter of 2022.
---------------------------------------------------------------------------

    \9\ The Exchange will also provide information regarding the
ATS(s) to which a Directed Order may be designated to route by
Trader Update.
---------------------------------------------------------------------------

2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Securities Exchange Act of 1934,\10\ in general, and furthers the
objectives of Section 6(b)(5),\11\ in particular, because it is
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in facilitating transactions in
securities, 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.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed rule change is designed to
remove impediments to and perfect the mechanism of a free and open
market and promote just and equitable principles of trade because the
Directed Order would offer member organizations access to additional
trading opportunities by permitting them to designate orders submitted
to the Exchange to be routed directly to a specified ATS for execution.
The Exchange further believes that the proposed change would remove
impediments to and perfect the mechanism of a free and open market by
offering member organizations the option to send orders that they wish
to route to an alternate destination for execution through the
Exchange, which would create efficiencies to the extent member
organizations are able to leverage existing protocols and
specifications. Finally, the Exchange notes that the proposed
functionality is not novel as the Affiliated Exchanges and other
exchanges offer their members functionality whereby an exchange

routes orders on behalf of a member to a specified trading center
without such order interacting with the Exchange's book.\12\
---------------------------------------------------------------------------

    \12\ See notes 7 & 8, supra.
---------------------------------------------------------------------------

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 that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange believes that
the proposed rules governing Directed Orders would promote competition
because they would provide for an order type on the Exchange that would
facilitate additional trading opportunities for market participants.
The Exchange further believes that the proposed rules would allow it to
offer its member organizations functionality similar to order types and
routing options that exist on other equities exchanges, thereby
enabling the Exchange to compete with such exchanges.\13\
---------------------------------------------------------------------------

    \13\ See note 8, supra.
---------------------------------------------------------------------------

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

    Within 45 days of the date of publication of this notice in the
Federal Register or up to 90 days (i) as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or (ii) as to which the self-regulatory
organization consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be 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 protected]. Please include
File Number SR-NYSE-2022-20 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSE-2022-20. 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 website (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 website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NYSE-2022-20 and should be submitted on
or before May 31, 2022.
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-09856 Filed 5-6-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: January 28, 2010 (Volume 75, Number 18)]
[Notices]
[Page 4550]
[DOCID:fr28ja10-44]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AC10-12-000]

Black Marlin Pipeline Company; Notice of Filing

January 21, 2010.
    Take notice that on November 4, 2009, Black Marlin Pipeline Company
submitted a request for a waiver of the reporting requirement to
provide its certified public accountant (CPA) certification statement
for the FERC Form No. 2-A for 2009.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 or 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: February 1, 2010.

Kimberly Bose,
Secretary.
[FR Doc. 2010-1679 Filed 1-27-10; 8:45 am]
BILLING CODE 6717-01-P


E [C]/R Incorporated                   Providing Environmental Technical Support Since 1989

MEMORANDUM

DATE:		May 11, 2011

TO:		Melanie King, EPA OAQPS/SPPD/ESG

FROM:	Tanya Parise, EC/R, Inc.

SUBJECT:	Summary of Calls with Vendors of Diesel Particulate Filters (DPF)

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

      The purpose of this memorandum is to present a summary of information obtained during calls with vendors of diesel particulate filters (DPF) for stationary diesel engines.  Below is a summary of the April 4, 2011 discussion with Scott McBryde of Miratech and April 5, 2011 discussion with Jim McDonald of Rypos.        Miratech

	Scott McBryde of Miratech conservatively estimated that DPF cleaning for ash accumulation would occur every 2,000 to 2,500 hours of operation, or roughly three times per year.  The estimated frequency of cleanings was based on assuming that a low ash lube oil is being used.  The Miratech DPF system consists of 9 blocks, in a 3" x 3" array for a 200 kilowatt (KW) (268 horsepower (HP)).  The DPF could be cleaned on-site by vacuuming or blowing out the ash, Scott explained.  It would take 1 day or less to do the cleaning and the cleaning would not require a skilled technician, according to Scott.

Rypos

	Jim McDonald of Rypos indicated that for engines in the 117 KW to 372 KW (157 HP to 499 HP) size range, the capital cost of the Rypos DPF system is approximately $12,000 to $18,000) and the system is an active DPF system.  It has a wire mesh filter, and it is continuously regenerated with a current that is run from the engine.  According to Jim, the DPF should still achieve the desired reductions even at lower exhaust temperatures.  The DPF can tolerate up to 500 parts per million sulfur fuel, but there could be issues if the fuel has used oil blended into it, Jim said.  In terms of the maintenance, the ash that drops to the bottom would have to be vacuumed out approximately once a year.  This can be done by the engine operator with a shop vac.  In response to the Alaska concerns about the engine shutting down if there is a problem with the DPF, there is a system available that is used for fire pump engines that could be used, where the engine would continue to operate even if there was a problem with the DPF.  Jim noted that the operator could install a timer that would lead to engine shutdown if the problem is not fixed in a certain period of time.


[Federal Register: November 23, 2009 (Volume 74, Number 224)]
[Notices]
[Page 61182-61183]
[DOCID:fr23no09-98]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61006; File No. SR-OCC-2009-15]

Self-Regulatory Organizations; The Options Clearing Corporation;
Order Approving Proposed Rule Change To Revise the Minimum Eligibility
Criteria for Common Stock Loaned Through Stock Loan Programs and
Deposited as Margin Collateral

November 16, 2009.

I. Introduction

    On August 28, 2009, The Options Clearing Corporation (``OCC'')
filed with the Securities and Exchange Commission (``Commission'')
proposed rule change SR-OCC-2009-15 pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (``Act'').\1\ The proposed rule change
was published for comment in the Federal Register on October 6,
2009.\2\ No comment letters were received on the proposal. This order
approves the proposal.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ Securities Exchange Act Release No. 60743 (September 29,
2009), 74 FR 51348.
---------------------------------------------------------------------------

II. Description

    The proposed rule change revises minimum eligibility criteria
applicable to common stock loaned through OCC's Stock Loan Programs and
deposited as margin collateral.
    OCC's clearing services involve common stock \3\ in several ways.
Stocks are: (i) Underlying securities for exchange-traded equity option
contracts; (ii) constituent securities of stock indexes that underlie
stock index options or of indexes on which underlying ETFs are based;
(iii) constituent securities of ETFs that although are not underlying
securities are based on indexes that underlie index options (``Index
Option Related ETFs''); (iv) the subject of stock loan or borrow
transactions cleared pursuant to OCC's Stock Loan Programs; and (v)
deposited with OCC as margin collateral. Rationalizing the
interrelationship among the criteria applied to stocks for these
various purposes will maximize the potential for offsets and reduce
risk in the clearing system.
---------------------------------------------------------------------------

    \3\ The term ``common stock'' or ``stock'' is broadly used in
this rule change to refer to different types of equity securities
including ETFs but not preferred stock.
---------------------------------------------------------------------------

    Under OCC's Stock Loan Programs, only loans of stocks that are
either underlying securities for options or futures or ETFs based on a
stock index underlying an index option contract are eligible for
clearance through OCC (collectively, ``Options-Related Stocks''). OCC
restricted stock loan activity to limit its risk to loans supporting
short sales that might be serving as hedges for options transactions or
helping to add liquidity to the options markets. At the time this
criterion was implemented in 2002, OCC managed the risk of stock loan
transactions for most clearing members on a credit basis--that is OCC
did not collect margin on such transactions. As noted above, OCC now
requires margin on all stock loan transactions thus reducing the risk
associated with this activity. Accordingly, OCC believes that it is no
longer necessary or appropriate to limit stock loan transactions to
Options-Related Stocks.
    In connection with the foregoing change, OCC is supplementing its
existing criteria for stock eligible for the Stock Loan Programs by
requiring that in order to qualify as an ``Eligible Stock'' for
purposes of the Stock Loan Programs a stock must be a ``covered
security'' as defined in Section 18(b)(1) of the Securities Act of
1933.\4\ By agreement with the options exchanges, OCC already requires
that all underlying stocks meet this criterion, and OCC believes that
it is an appropriate minimum assurance of quality. In addition, OCC is
imposing a $3 minimum share price requirement that is applicable only
to stocks other than Options-Related Stocks.\5\ OCC, however, retains
the ability to waive the $3 minimum price where specified other factors
suggest that the stock is nevertheless suitable for inclusion in the
Stock Loan Programs.
---------------------------------------------------------------------------

    \4\ ``Covered securities'' are securities that are authorized
for listing on the New York Stock Exchange, the American Stock
Exchange (now known as NYSE Amex LLC), the National Market System of
the Nasdaq Stock Market (collectively, ``Exchanges''), or any other
national securities exchange, or tiers thereof, that the Commission
determines are substantially similar to the listing standards
applicable to securities on the Exchanges. 15 U.S.C. 77r(b)(1).
    \5\ This minimum price requirement corresponds to the minimum
price standard contained in the criteria used by the options
exchanges for initial selection of underlying securities that are
also ``covered securities.''
---------------------------------------------------------------------------

Common Stock as Collateral

    Under current OCC Rule 604(b)(4), clearing members can deposit
common stocks that meet the following criteria: Minimum price of $3 per
share and traded on a national securities exchange or traded in the
Nasdaq Global Market or the Nasdaq Capital Market. The aggregate value
of margin attributed to a single stock cannot exceed 10% of a clearing
member's total margin requirement. Stocks are haircut by 30% for margin
valuation purposes. Stocks that have been suspended from trading by or
are subject to special margin requirements under the rules of a listing
market because of volatility, lack of liquidity, or similar
characteristics are not eligible for deposit as margin.
    Under the approved but not yet implemented Collateral in Margins
program, any common stock that meets the above criteria except the
minimum price requirement and that is deliverable upon exercise or
maturity of a cleared contract (i.e., is an underlying security), as
well as index option related ETFs, will be afforded collateral value as
determined by STANS. Moreover, the margin concentration requirement
will be inapplicable to such deposits. Thus, upon implementation of the
Collateral in Margins proposal, the minimum price requirement and
margin concentration requirement will be eliminated for common stocks
that are underlying securities or index option related ETFs. The
minimum price requirement is being eliminated for these securities in
order to provide a greater opportunity for members to hedge their
equity options positions with pledges of the underlying securities.
This decision also reflects OCC's judgment that the minimum price
requirement is less important in the current environment where OCC is
able to closely monitor collateral in the form of common stock and to
apply the sophisticated risk management technique incorporated in STANS
in order to determine the appropriate value to assign to such
collateral. The concentration test requirement is being eliminated
because STANS contains its own built-in functionality that adequately
handles concentrated options and collateral holdings.
    In anticipation of the implementation of the Collateral in Margins
program, and effective with such implementation, OCC further amends
Rule 604(b)(4)(i) as follows:
    (1) Replace the requirement of listing on a national securities
exchange or specific Nasdaq markets with the requirement that all
common stocks

deposited as margin must be ``covered securities'' as described above;
    (2) Provide that the $3 minimum share price requirement will apply
to deposits of common stocks that are not Options Related Stocks;
    (3) Permit OCC to waive the $3 minimum share price if it determines
that other factors, including trading volume, the number of
shareholders, the number of outstanding shares, and current bid/ask
spreads warrant such action; and
    (4) Delete Interpretation and Policy .13, adopted in SR-OCC-2009-
08, which made the 10% concentration test inapplicable to certain ETFs
because the 10% test will be eliminated for all stocks (including ETFs)
when Collateral in Margins is implemented.
    In addition, OCC is amending Rule 1001 to provide that the
determination of ``average aggregate daily margin requirement'' and
``daily margin requirement'' are performed without reference to any
deposits of securities (e.g., common stocks including fund shares) that
were valued within STANS pursuant to Rule 601. This change ensures that
contributions to the clearing fund will be determined without taking
into account any reduction in margin requirements resulting from
valuing deposits of such securities under STANS. Other proposed changes
to Rule 1001 are conforming or clarifying in nature.
    The changes proposed in this rule filing more closely align both
the stock collateral and stock loan eligibility criteria with the
criteria for selection of underlying equity securities. While some
differences still exist, OCC believes that the discretionary authority
provides OCC with sufficient flexibility to treat equity options, stock
loan transactions, and stock collateral in a consistent manner when
appropriate. For example, the $3 minimum price requirement is similar
or identical to requirements contained in the equity options listing
criteria of the options exchanges. In addition, the factors that OCC
will consider in determining whether an exception to the $3 minimum may
be granted are consistent with those reflected in such criteria. These
factors are widely regarded as among the most relevant in determining
whether a stock is liquid.
    STANS's functionality permits OCC to propose these changes. STANS
considers a security's historical price volatility in generating its
simulated market moves resulting in coverage parameters that vary based
on the overall risk of a particular underlying security. STANS also
identifies and addresses concentrated positions. By incorporating
equity options positions, stock loan positions, and upon implementation
of the Collateral in Margins changes common stock deposits within a
single concentration analysis, OCC can identify where hedged positions
exist and can also identify areas of cumulative exposure where
additional collateral may be appropriate (e.g., where a clearing member
has long options, stock loan positions, and margin deposits all
relating to the same security).
    OCC will implement the changes to stock loan eligibility criteria
immediately. The changes in eligibility criteria for common stock
deposited as margin will be implemented concurrently with
implementation of the Collateral in Margins program, which is scheduled
for implementation in the fourth quarter 2009.

III. Discussion

    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a registered clearing agency. In particular,
the Commission believes that by amending its rules to revise minimum
eligibility criteria applicable to common stock loaned through OCC's
Stock Loan Programs and deposited as margin collateral, the proposal is
consistent with the requirements of Section 17A(b)(3)(F),\6\ which
requires, among other things, that the rules of a clearing agency are
designed to promote the prompt and accurate clearance and settlement of
securities transactions.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

IV. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposal is consistent with the requirements of the Act and in
particular with the requirements of Section 17A of the Act \7\ and the
rules and regulations thereunder.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\8\ that the proposed rule change (File No. SR-OCC-2009-15) be, and
hereby is, approved.\9\
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(2).
    \9\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition, and
capital formation. 15 U.S.C. 78c(f).

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-28023 Filed 11-20-09; 8:45 am]

BILLING CODE 8011-01-P