Comment Info: =================

General Comment: Dear Mr. Zeller:

I am writing as a consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for at least an additional 105 days, from its current 75-day period, to a minimum of 180 days.

I have already spent many hours over the last 18 months researching and dissecting the issues of E-Cigarettes and Nicotine. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to study and comment on it. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited.

This is our only opportunity, as consumers, to provide our feedback.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to.

Additionally, I find that review of the 194 cited references is extremely difficult due to:  1. The overwhelming number of citations that are copyrighted and otherwise difficult if not impossible for the general public to access

 2. Citation numbering errors within the document itself and discrepancies between internet published versions on regulations.gov and federalregister.gov (i.e., references 153, 154, and 154a)

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account.

I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy (eager) to discuss this issue with you further.


[Federal Register Volume 79, Number 146 (Wednesday, July 30, 2014)]
[Notices]
[Pages 44201-44202]
[FR Doc No: 2014-17904]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA[endash]2009-0025]

Underwriters Laboratories Inc.: Application for Expansion of
Recognition

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice.

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

SUMMARY: In this notice, OSHA announces the application of Underwriters
Laboratories Inc. for expansion of its recognition as a Nationally
Recognized Testing Laboratory (NRTL) and presents the Agency's
preliminary finding to grant the application.

DATES: Submit comments, information, and documents in response to this
notice, or requests for an extension of time to make a submission, on
or before August 14, 2014.

ADDRESSES: Submit comments by any of the following methods:
    1. Electronically: Submit comments and attachments electronically
at http://www.regulations.gov, which is the Federal eRulemaking Portal.
Follow the instructions online for making electronic submissions.
    2. Facsimile: If submissions, including attachments, are not longer
than 10 pages, commenters may fax them to the OSHA Docket Office at
(202) 693-1648.
    3. Regular or express mail, hand delivery, or messenger (courier)
service: Submit comments, requests, and any attachments to the OSHA
Docket Office, Docket No. OSHA-2009-0025, Technical Data Center, U.S.
Department of Labor, 200 Constitution Avenue NW., Room N-2625,
Washington, DC 20210; telephone:<PHONE_NUMBER> (TTY number: (877) 889-
5627). Note that security procedures may result in significant delays
in receiving comments and other written materials by regular mail.
Contact the OSHA Docket Office for information about security
procedures concerning delivery of materials by express mail, hand
delivery, or messenger service. The hours of operation for the OSHA
Docket Office are 8:15 a.m.-4:45 p.m., e.t.
    4. Instructions: All submissions must include the Agency name and
the OSHA docket number (OSHA-2009-0025). OSHA places comments and other
materials, including any personal information, in the public docket
without revision, and these materials will be available online at
http://www.regulations.gov. Therefore, the Agency cautions commenters
about submitting statements they do not want made available to the
public, or submitting comments that contain personal information
(either about themselves or others) such as Social Security numbers,
birth dates, and medical data.
    5. Docket: To read or download submissions or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the address above. All documents in the docket are listed in the http://www.regulations.gov index; however, some information (e.g.,
copyrighted material) is not publicly available to read or download
through the Web site. All submissions, including copyrighted material,
are available for inspection and copying at the OSHA Docket Office.
Contact the OSHA Docket Office for assistance in locating docket
submissions.
    6. Extension of comment period: Submit requests for an extension of
the comment period on or before August 14, 2014 to the Office of
Technical Programs and Coordination Activities, Directorate of
Technical Support and Emergency Management, Occupational Safety and
Health Administration, U.S. Department of Labor, 200 Constitution
Avenue NW., Room N-3655, Washington, DC 20210, or by fax to (202) 693-
1644.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, U.S. Department of Labor, 200 Constitution Avenue
NW., Room N-3647, Washington, DC 20210; telephone:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    General and technical information: Contact Mr. David W. Johnson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration, U.S. Department of Labor, 200
Constitution Avenue NW., Room N-3655, Washington, DC 20210; phone:
(202) 693-2110 or email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Notice of the Application for Expansion

    The Occupational Safety and Health Administration is providing
notice that Underwriters Laboratories Inc. (UL), is applying for
expansion of its current recognition as an NRTL. UL requests the
addition of two test standards to its NRTL scope of recognition.
    OSHA recognition of an NRTL signifies that the organization meets
the requirements specified in 29 CFR 1910.7. Recognition is an
acknowledgment that the organization can perform independent safety
testing and certification of the specific products covered within its
scope of recognition. Each NRTL's scope of recognition includes (1) the
type of products the NRTL may test, with each type specified by its
applicable test standard; and (2) the recognized site(s) that has/have
the technical capability to perform the product-testing and product-
certification activities for test standards within the NRTL's scope.
Recognition is not a delegation or grant of government authority;
however, recognition enables employers to use products approved by the
NRTL to meet OSHA standards that require product testing and
certification.
    The Agency processes applications by an NRTL for initial
recognition and for an expansion or renewal of this recognition,
following requirements in Appendix A to 29 CFR 1910.7. This appendix
requires that the Agency publish two notices in the Federal Register in
processing an application. In the first notice, OSHA announces the
application and provides its preliminary finding. In the second notice,
the Agency provides its final decision on the application. These
notices set forth the NRTL's scope of recognition or modifications of
that scope. OSHA maintains an informational Web page for each NRTL,
including UL, which details the NRTL's scope of recognition. These
pages are available from the OSHA Web site at http://www.osha.gov/dts/otpca/nrtl/index.html.
    UL currently has 15 facilities (sites) recognized by OSHA for
product testing and certification, with its headquarters located at:
Underwriters Laboratories Inc., 333 Pfingsten Road, Northbrook, IL
60062. A complete list of UL's scope of recognition is available at
http://www.osha.gov/dts/otpca/nrtl/ul.html.

II. General Background on the Application

    UL submitted an application, dated April 3, 2014 (Exhibit 14-2--UL
Application for Expansion of Test Standards), to expand its recognition
to include two additional test standards. OSHA staff performed a
comparability analysis and reviewed other pertinent information. OSHA
did not perform any on-site reviews in relation to this application.
    Table 1 below lists the appropriate test standards found in UL's
application for expansion for testing and certification of products
under the NRTL Program.

  Table 1--Proposed List of Appropriate Test Standards for Inclusion in
                     UL's NRTL Scope of Recognition
------------------------------------------------------------------------
            Test standard                     Test standard title
------------------------------------------------------------------------
AAMI ES60601-1.......................  Medical electrical equipment-Part
                                        1: General requirements for
                                        basic safety and essential
                                        performance.
UL 1004-1............................  Rotating Electrical Machines.
------------------------------------------------------------------------

III. Preliminary Findings on the Application

    UL submitted an acceptable application for expansion of its scope
of recognition. OSHA's review of the application file and the
comparability analysis indicate that UL can meet the requirements
prescribed by 29 CFR 1910.7 for expanding its recognition to include
the addition of these two test standards for NRTL testing and
certification listed above. This preliminary finding does not
constitute an interim or temporary approval of UL's application.
    OSHA welcomes public comment as to whether UL meets the
requirements of 29 CFR 1910.7 for expansion of its recognition as an
NRTL. Comments should consist of pertinent written documents and
exhibits. Commenters needing more time to comment must submit a request
in writing, stating the reasons for the request. Commenters must submit
the written request for an extension by the due date for comments. OSHA
will limit any extension to 10 days unless the requester justifies a
longer period. OSHA may deny a request for an extension if the request
is not adequately justified. To obtain or review copies of the exhibits
identified in this notice, as well as comments submitted to the docket,
contact the Docket Office, Room N-2625, Occupational Safety and Health
Administration, U.S. Department of Labor, at the above address. These
materials also are available online at http://www.regulations.gov under
Docket No. OSHA-2009-0025.
    OSHA staff will review all comments to the docket submitted in a
timely manner and, after addressing the issues raised by these
comments, will recommend to the Assistant Secretary for Occupational
Safety and Health whether to grant UL's application for expansion of
its scope of recognition. The Assistant Secretary will make the final
decision on granting the application. In making this decision, the
Assistant Secretary may undertake other proceedings prescribed in
Appendix A to 29 CFR 1910.7. OSHA will publish a public notice of its
final decision in the Federal Register.

IV. Authority and Signature

    David Michaels, PhD., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, 200 Constitution Avenue NW.,
Washington, DC 20210, authorized the preparation of this notice.
Accordingly, the Agency is issuing this notice pursuant to 29 U.S.C.
657(g)(2), Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25,
2012), and 29 CFR 1910.7.

    Signed at Washington, DC, on July 25, 2014.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2014-17904 Filed 7-29-14; 8:45 am]
BILLING CODE 4510-26-P


                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                         WASHINGTON, D.C. 20460

                                                 	OFFICE OF CHEMICAL SAFETY AND
                                                                                POLLUTION PREVENTION

MEMORANDUM

Date:		01/13/2011

SUBJECT:	Dichlormid; Human Health Risk Assessment for the Purpose of Making Time-Limited Tolerances on Field Corn Commodities Permanent.

PC Code:  900497
DP Barcode:  D385691
Decision No.:  419811
Registration No.:  62719-367, 62719-368, 62719-369, 62719-370, 62719-371, 62719-372, 62719-373
Petition No.:  NA
Regulatory Action: Section 3 Registration
Risk Assessment Type:  Single chemical aggregate
Case No.:  NA
TXR No.:  NA
CAS No.:  37764-25-3
MRID No.:  NA
40 CFR:  180.469

FROM:	Debra Rate, Ph.D., Biologist
		Alternative Risk Integration and Assessment (ARIA) Team
		Risk Integration, Minor Use, and Emergency Response Branch (RIMUERB)
		Registration Division (RD; 7505P)

THROUGH:	Pv Shah, Branch Chief
		Inert Ingredients Assessment Branch (IIAB)/RD (7505P)

TO:		Susan Stanton
		Herbicide Branch (HB)/RD (7505P)

ARIA/RD of the Office of Pesticide Programs (OPP) is charged with re-evaluating the risk to human health that will result from converting the time-limited tolerances to permanent tolerances for the registered uses of the chemical, dichlormid (N,N-diallyl-2,2-dichloroacetamide) when used as an herbicide safener (inert ingredient) in pesticide formulations with the active ingredient, acetochlor on corn commodities.  The time-limited tolerances for dichlormid in/on corn (field, pop, and sweet) commodities were due to expire 12/30/2010.

The risk assessment recommendations were prepared by Debra Rate (ARIA/RD).  The risk assessment incorporates new toxicology assessments prepared by Anwar Dunbar (RAB1/HED), recent residue chemistry reviews prepared by William Cutchin (ARIA/RD), and a drinking water assessment was prepared by Alex Clem (Environmental Fate and Effects Division (EFED)).  The current document reassesses the exposure and risk to human health from dichlormid resulting from the registered uses.  The most recent human health risk assessment for dichlormid was prepared by B. Hanson (DP#321928, 11/15/2005).

I.	CONCLUSIONS

ARIA recommends that the current time-limited tolerances supporting the use of the herbicide safener, dichlormid, in/on corn, field (forage, grain, and stover), corn, pop (grain and stover), and corn, sweet (grain and stover) at 0.05 ppm (40 CFR§180.469) be converted to permanent tolerances.

The Hazard Identification Assessment Review Committee (HIARC) previously recommended that the FQPA SF be retained at 10X for enhanced sensitivity to infants and children since there was qualitative evidence of increased susceptibility in the rabbit developmental study and data gaps (HED DOC. NO. 013614, 08/05/1999)  Based on the recent submission and evaluation of required toxicological studies and residue chemistry data, ARIA recommends that the Food Quality Protection Act (FQPA) Safety Factor (SF) be reduced from 10X (acute) and 30X (chronic) to 1X, eliminating the need for additional database uncertainty factors (UFDB).  The reviews of the recently submitted toxicological studies did not result in a lower no-observable adverse-effect level (NOAEL) or lowest-observable adverse-effect level (LOAEL) for dichlormid.  Therefore, the HIARC recommended toxicological endpoints and doses used for risk assessment remain unchanged.

The current request does not require any change in tolerance value or use patterns.  With the submission of data and studies that fulfill the previously cited data gaps, and the recommended reduction of the FQPA SF, a new comprehensive risk assessment for dichlormid is not required at this time.  The most recent risk assessment (DP#321928, B. Hanson, 11/15/2005), is highly conservative and supports the current use patterns and tolerances.  The risk assessment indicates there is a reasonable certainty that no harm will result from aggregate exposure to dichlormid residues, including all anticipated dietary exposures from food and drinking water.  The risk assessment also indicates aggregate and occupational risks are not of concern.

In accordance with HED's Interim Guidance on Tolerance Expressions (5/27/2009, S. Knizner), and as requested in an Agency memo (DP#372259, W. Cutchin, 03/31/2010), the tolerance expression for dichlormid should be revised to state:
      Tolerances are established for residues of dichlormid, including its metabolites and degradates, in or on the commodities in the table below.  Compliance with tolerance levels specified below is to be determined by measuring only dichlormid (2,2-dichloro-N,N-di-2-propenylacetamide) in or on the following commodities:

An adequate enforcement method for residues of dichlormid in corn has been developed and submitted to the Agency.  Analysis is carried out using gas chromatography with nitrogen selective thermionic detection.  The limit of quantitation is 0.01 ppm.  Previously requested method modifications have been received and reviewed by the Agency, thus fulfilling this outstanding deficiency (MRID No. 44960101).

II.	ACTION REQUESTED

Dow AgroSciences, Inc., has submitted a request to convert the current time-limited tolerances for corn commodities (40 CFR§180.469) to permanent tolerances.  Data submitted by the petitioner to fulfill data gaps cited in previous risk assessments and chemistry reviews have been evaluated by the Agency.

III.	BACKGROUND
DP#321928, B. Hanson, 11/15/2005
DP#318075, D. Rate, 09/14/2005

Dichlormid is an herbicide safener used in pesticide formulations with the active ingredient, acetochlor, for use on corn commodities to control grass and broadleaf weeds.  No new requested uses or tolerances are associated with this petition to make current time-limited tolerances permanent.

There are no existing or proposed residential uses for dichlormid, therefore the risk associated with residential exposure is below the Agency's level of concern (LOC).  Due to the data gaps cited in the previous risk assessment, the time-limited tolerances were extended, rather than made permanent in the most recent assessment (DP#321928, B. Hanson, 11/15/2005).

The following data gaps were cited in the previous risk assessment and needed to be addressed prior to establishing permanent tolerances on the corn commodities, as requested:

Chemistry
1.  860.1300: Nature of the Residue - Plants
The studies submitted (MRID No. 46015801) for the purpose of fulfilling the Guideline 860.1300 is scientifically unacceptable and does not satisfy the requirements.  It may be upgraded if additional metabolites are identified, including unknown A, to allow a more complete characterization of the nature of the residue of dichlormid in corn.

2.  860.1300: Nature of the Residue - Livestock
The studies submitted (MRID No. 46015802, 46015803) for the purpose of fulfilling the Guideline 860.1300 are scientifically unacceptable and do not satisfy the requirements. The studies do not adequately define the nature of the residues or the residue(s) of concern for dichlormid.  They may be upgraded upon further identification of residues representing 10% and/or 0.05 ppm.

3.  860.1340: Residue Analytical Methods
The requested revised method has not yet been received.

4.  860.1900: Field Accumulation in Rotational Crops
No studies in field accumulation in rotational crops have been submitted.  The registrant should submit a field accumulation in rotational crop study in accordance with OPPTS Guideline, 860.1900.

Toxicology:
1.  Subchronic dermal and inhalation study
2.  Neurotoxicity study
3.  Metabolism studies
4.  As per revisions to the 40CFR158:
	Immunotoxicy studies

Due to the nature and number of data gaps and qualitative evidence of increased susceptiblilty in the rabbit developmental study, the FQPA SF was previously established at 10X for the acute assessment, and 30X for the chronic assessment.  Both FQPA SFs contribute to the highly conservative nature of the results obtained in the previous risk assessment.

The previous risk assessment (DP#321928, B. Hanson, 11/15/2005) was highly conservative using tolerance level residues in the dietary assessment, 100% crop treated, default processing factors, and maximum use rates for determining field trial and water exposure modeling residues.  Previously, the dietary risk (food only) associated with the use of dichlormid was below the Agency's LOC.  The acute dietary risk estimates were 3.4% of the acute population-adjusted dose (aPAD) for the general U.S. population and 7.5% of the aPAD for the highest exposure group, all infants (< 1 year old).  Chronic dietary risk estimates were 6.1% of the chronic population-adjusted dose (cPAD) for the general U.S. population and 15% of the cPAD for the highest exposure group, children 3-5 years old (DP#321927, B. Hanson, 11/07/2005).  Previously, exposure and risk to drinking water was evaluated through the use of drinking water level of comparison (DWLOCs).  A DWLOC is a theoretical upper limit on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, drinking water, and through residential uses.  A DWLOC will vary depending on the toxic endpoint, with drinking water consumption, and body weights.  Different populations will have different DWLOCs.  HED previously used DWLOCs internally in the risk assessment process as a surrogate measure of potential exposure associated with pesticide exposure through drinking water.  In the absence of monitoring data for pesticides, it was used as a point of comparison against conservative model estimates of a pesticide's concentration in water.  As calculated in the most recent human health risk assessment for dichlormid (DP#321928, B. Hanson, 11/15/2005), all DWLOCs exceeded the EFED modeled drinking water residue values provided for risk evaluation (DP#258095, A. Clem, 8/3/99). Therefore the Agency's level of concern for drinking water exposure was not exceeded.

Since the last risk assessment was completed, studies have been reviewed that address the data gaps listed above.  The results below discuss the reviews and the impact of this data on the risk and exposure from use of dichlormid as a safener on corn (field, pop, and sweet).

IV.	RESULTS/DISCUSSION
DP#372259, W. Cutchin, 03/31/2010
DP#369088 and 369089, A. Dunbar, 04/07/2010
DP#378513, A. Dunbar, 08/24/2010

The Agency has recently evaluated the residue chemistry deficiencies (DP#372259, W. Cutchin, 03/31/2010) and the toxicology data gaps (DP#369088 and 369089, A. Dunbar, 04/07/2010 and DP#378513, A. Dunbar, 08/24/2010).

Chemistry (DP#372259, W. Cutchin, 03/31/2010):
860.1300: Nature of the Residue  -  Plants:  Upon evaluation of the registrant's responses to the cited data deficiencies (above), and re-evaluation of the original studies submitted, the Agency has determined that the previously submitted plant metabolism study is adequate.  The residue of concern was determined to be the parent, dichlormid.  It was also determined that should additional uses of dichlormid on crops other than corn be requested, the nature of the residue data on those commodities will be required.

860.1300: Nature of the Residue  -  Livestock:  Upon consideration of the registrant's comments and responses to the cited data deficiencies (above), and re-evaluation of the original submitted studies, the Agency has determined that the previously submitted livestock metabolism study is adequate for the current use on corn.

860.1340: Residue Analytical Methods:  The requested revised method has since been received by the Agency and a copy will be forwarded to the FDA.

860.1900: Field Accumulation in Rotational Crops:  Following consideration of the registrants responses and re-evaluation of the original studies, the Agency determined that no field rotational crop data is required for the current uses of dichlormid.  However, it was also determined that additional data will be required should the registrant request higher use rates or shorter plant back intervals (PBIs).

Toxicology (DP#369088 and 369089, A. Dunbar, 04/07/2010 and DP#378513, A. Dunbar, 08/24/2010):

In response to the registrant's comments the following studies were determined to be acceptable/guideline: Subchronic Inhalation in rats (MRID No. 00155678), Acute Neurotoxicity in rats (MRID No. 46353805), and Metabolism (MRID No. 46353802 and 46353803).  The third metabolism study (MRID No. 46366001) was determined to be acceptable/non-guideline.  The final study reviewed in Agency memo (DP#369088 and 369089, A. Dunbar, 04/07/2010), Subchronic Neurotoxicity (MRID No. 46353806) was determined to be unacceptable/guideline.  The Agency also reviewed an immunotoxicity study (rat feeding) and determined that the study is acceptable/guideline (DP#378513, A. Dunbar, 08/24/2010).

All of the toxicology and residue chemistry data gaps for use on corn (field, pop, and sweet), have been fulfilled.  Uncertainty factors associated with database deficiencies can be removed.

Impact on Aggreaget Risk:
There are no existing or proposed residential uses for dichlormid, therefore aggregate risk is based on dietary exposure from food and water.  A dietary (food and water) exposure and risk assessment was performed incorporating the EDWCs (DP#258095, A. Clem, 08/03/1999) into water, direct (all sources) and water, indirect (all sources), and the HIARC determined toxicological endpoints in the Agency's dietary exposure model (DEEM-FCID(TM), Version 2.03).  Analysis using the current FQPA SFs (10X acute, 30X chronic) and appropriate toxicological endpoints (See Attachment 1) resulted in acute risk (95[th] percentile) at 16% of the aPAD for the general US population and 56% of the aPAD for the highest exposed population (All infants <1year) and chronic risk at 13% of the cPAD for the general US population and 34% of the cPAD for the highest exposed population subgroup (All infants < 1year).  Using the same residue values, appropriate toxicological endpoints and the recommended FQPA SF reduced values (1X) resulted in an acute risk (95[th] percentile) of 2% of the aPAD for the general US population and 6% of the aPAD for the highest exposed population (All infants <1 year), and <1% cPAD, for the general US population and 1% of the cPAD for the highest exposed subpopulation (All infants <1 year).  All of the dietary analyses (food and water) were well below the Agency's LOC for the general US population and all population subgroups, whether the new recommended FQPA SF was included or not.

Permanent tolerances for corn commodities are supported by the previous risk assessment, recently reviewed studies, and the new dietary analyses discussed above.  A comprehensive risk assessment for dichlormid to make current time-limited tolerances on corn commodities permanent, is not required at this time.

Occupational Exposure and Risk Associated with the Use of Dichlormid on Corn
Occupational exposures may occur via dermal and/or inhalation routes.  The HIARC has identified toxicological endpoints of concern for occupational exposure.  However, based on the use patterns for dichlormid on corn (pre-emergence soil or early post-emergence foliar applications) no potentially significant post-application or long-term exposure is expected.  Therefore, the previous occupational assessment (DP#321928, B. Hanson, 11/15/2005) is protective for the proposed use pattern.  For dichlormid, margins of exposure (MOEs) of 100 are required for handlers of agricultural crops in order for risks not to be of concern to HED.  For all previously assessed handler scenarios, short- and intermediate-term MOEs were greater than the target MOE of 100 and, therefore, risks do not exceed HED's level of concern.  Therefore, there are no risk concerns associated with the use pattern.

Attachment 1:  Toxicological Endpoints for Dichlormid.

Table 1.  Summary of Toxicological Dose and Endpoints for Dichlormid Use in Human Risk Assessment 1.

Exposure
Scenario

Dose (mg/kg/day) and Factors

FQPA SF and Endpoint for Risk Assessment

Study and Toxicological Effects

Acute Dietary
all populations including infants and children

NOAEL= 10 mg/kg
UF = 100
Acute RfD = 0.10 mg/kg/day

FQPA SF = 10
aPAD = acute RfD
FQPA SF

= 0.010 mg/kg/day

Developmental Toxicity Study - rat

Maternal LOAEL = 40 mg/kg/day based on decreased body weight gain and food consumption (most significant on days 7-10 of dosing).

Chronic Dietary
all populations

NOAEL= 6.5 mg/kg/day
UF = 100
Chronic RfD = 0.065 mg/kg/day

FQPA SF = 30
cPAD = chr RfD
FQPA SF

= 0.0022 mg/kg/day
Extra 3x UF due to data gap for the chronic toxicity study in dogs.

2-year Study  - Rat

LOAEL = 32.8 mg/kg/day (c?) based liver clinical pathology / histopathology and increased liver weight.
Dermal Absorption
100% default; neither a dermal aborption study nor a dermal toxicity study (for extrapolation) is available in the database.
Short-Term Dermal

Oral NOAEL = 10.0

MOE = 100
Developmental toxicity Study  -  rats

Maternal LOAEL = 40 mg/kg/day based on decreased body weight gain and food consumption (most significant on days 7-10 of dosing).  This dose/endpoint/study was used for deriving the aRfD.  Dermal toxicity study is not available.  100% dermal absorption factor should be used for this risk assessment.

Intermediate- and Long-Term
(Dermal)

Oral NOAEL =  6.5

MOE = 100

2-year study - rat

LOAEL = 32.8 mg/kg/day () based on liver clinical pathology/histopathology and increased liver weight.
This dose/endpoint/study was used for deriving the cRfD.  100% dermal absorption factor should be used for this risk assessment.

Inhalation
(All Durations)

2 μg/L

14-week inhalation study

LOAEL = 19.9 μg/L based on clinical signs, increased liver and kidney weights, gross pathology and non-neoplastic histopathology.  The route of exposure in this study is appropriate for this risk assessment.

Cancer

NOAEL = 6.5

LOAEL = 32.8 mg/kg/day based on decreased BWG, decreased FE, increased liver weight, and liver histopath.
No evidence of carcinogenicity.

Feeding/
Carcinogenicity Study in rats
1 UF = uncertainty factor; FQPA SF = FQPA Safety Factor; NOAEL = no observed adverse effect level; LOAEL = lowest observed adverse effect level; PAD = population adjusted dose (a=acute, c=chronic); RfD = reference dose; LOC = level of concern; MOE = margin of exposure.


[Federal Register: December 5, 2008 (Volume 73, Number 235)]
[Notices]
[Page 74165]
[DOCID:fr05de08-66]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13271-000]

FFP Project 1, LLC; Notice of Preliminary Permit Applications
Accepted for Filing and Soliciting Comment, Motions To Intervene, and
Competing Applications

November 28, 2008.
    On August 11, 2008, FFP Project 1, LLC filed an application,
pursuant to section 4(f) of the Federal Power Act, proposing to study
the feasibility of the Crescent City Project, to be located on the
Mississippi River Jefferson, Orleans, St Bernard Parishes, Louisiana.
    The proposed Crescent City Project consists of: (1) 4,850 proposed
20 kilowatt free flow generating units having a total installed
capacity of 97 megawatts, (2) a proposed transmission line, and (3)
appurtenant facilities. The FFP Project 1, LLC, project would have an
average annual generation of 420.86 gigawatt-hours and be sold to a
local utility.
    Applicant Contact: Mr. Dan Irvin, FFP Project 1, LLC, 33 Commercial
Street, Gloucester, MA 01930, phone<PHONE_NUMBER>.
    FERC Contact: Robert Bell,<PHONE_NUMBER>.
     Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Comments, motions to intervene, notices of intent, and competing
applications may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For
more information on how to submit these types of filings please go to
the Commission's Web site located at http://www.ferc.gov/filing-
comments.asp. More information about this project can be viewed or
printed on the ``eLibrary'' link of the Commission's Web site at http:/
/www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-
13271) in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-28776 Filed 12-4-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: September 19, 2007 (Volume 72, Number 181)]
[Notices]
[Page 53550]
[DOCID:fr19se07-59]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. NJ07-7-000]

Southwest Transmission Cooperative, Inc.; Notice of Filing

September 12, 2007.
    Take notice that on September 5, 2007, Southwest Transmission
Cooperative, Inc. filed a request for a declaratory order and submit
its Safe Harbor Reciprocity Open Access Transmission Tariff, in order
to update its rates, effective September 1, 2007, pursuant to the
Arizona Corporation Commission's rate increase.
    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, 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: 5 p.m. Eastern Time on October 5, 2007.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-18442 Filed 9-18-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 248 (Tuesday, December 27, 2011)]
[Notices]
[Pages 81014-81015]
[FR Doc No: 2011-33162]

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

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Agency Information Collection Activities: Proposed Collection;
Comment Request; Generic Clearance for the Collection of Qualitative
Feedback on Agency Service Delivery

AGENCY: Office of Hazardous Materials Safety, Pipeline and Hazardous
Materials Safety Administration, Department of Transportation.

ACTION: 30-Day Notice and request for comments.

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

SUMMARY: As part of a Federal Government-wide effort to streamline the
process to seek feedback from the public on service delivery, the
Pipeline Hazardous Materials Safety Administration will submit a
Generic Information Collection Request (Generic ICR): ``Generic
Clearance for the Collection of Qualitative Feedback on Agency Service
Delivery'' to the Office of Management and Budget (OMB) for approval
under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.).

DATES: Comments must be submitted January 26, 2012.

ADDRESSES: Submit comments regarding the burden estimate, including
suggestions for reducing the burden by mail: to the Office of
Management and Budget (OMB), Attention: Desk Officer for PHMSA, 725
17th Street NW., Washington, DC 20503; by email at
<EMAIL_ADDRESS>or by fax at<PHONE_NUMBER>.
Comments are invited on: whether the proposed collection of information
is necessary for the proper performance of the functions of the
Department, including whether the information will have practical
utility; the accuracy of the Department's estimate of the burden of the
proposed information collection; ways to enhance the quality, utility
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information on respondents, including
the use of automated collection techniques or other forms of
information technology. A comment to OMB is most effective if OMB
receives it within 30 days of publication.

FOR FURTHER INFORMATION CONTACT: Steven Andrews or T. Glenn Foster,
U.S. Department of Transportation, Standards and Rulemaking Division
(PHH-10), Pipeline and Hazardous Materials Safety Administration, 1200
New Jersey Avenue SE., East Building, 2nd Floor, Washington, DC 20590-
0001, Telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Title: Generic Clearance for the Collection of Qualitative Feedback
on Agency Service Delivery Abstract. The information collection
activity will garner qualitative customer and stakeholder feedback in
an efficient, timely manner, in accordance with the Administration's
commitment to improving service delivery. Such feedback will provide
useful insights on perceptions and opinions that yield quantitative
results that can be generalized to the population of study. This
feedback will provide insights into customer or stakeholder
perceptions, experiences and expectations, provide an early warning of
issues with service, or focus attention on areas where communication,
training or changes in operations might improve delivery of products or
services. These collections will allow for ongoing, collaborative and
actionable communications between the Agency and its customers and
stakeholders. It will also allow feedback to contribute directly to the
improvement of program management.
    Feedback collected under this generic clearance will provide useful
information, but it will not yield data that can be generalized to the
overall population. This type of generic clearance for qualitative
information will not be used for quantitative information collections
that are designed to yield reliably actionable results, such as
monitoring trends over time or documenting program performance. Such
data uses require more rigorous designs that address: the target
population to which generalizations will be made; the sampling frame;
the sample design (including stratification and clustering); the
precision requirements or power calculations that justify the proposed
sample size; the expected response rate; methods for assessing
potential non-response bias; the protocols for data collection; and any
testing procedures that were or will be undertaken prior to fielding
the study. Depending on the degree of influence the results are likely
to have, such collections may still be

eligible for submission for other generic mechanisms that are designed
to yield quantitative results.
    The Agency did not receive comments in response to the 60-day
notice published in the Federal Register on December 22, 2010 [75 FR
80542].
    The Pipeline and Hazardous Materials Safety Administration's
projected average annual estimate for burden is provided as follows:
    Current Actions: PHMSA Feedback.
    Type of Review: New Collection.
    Affected Public: Individuals and Households, Businesses and
Organizations, State, Local or Tribal Government.
    Respondents: 2,670.
    Annual responses: 2,670.
    Frequency of Response: On occasion.
    Burden hours: 2,670.
    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 Office of Management and Budget Control Number.

Delmer F. Billings,
Acting Director, Standards and Rulemaking Division.
[FR Doc. 2011-33162 Filed 12-23-11; 8:45 am]
BILLING CODE P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

	Date:	2/22/06

	Subject:	Dichlobenil.  Use on Rhubarb.  Summary of Analytical Chemistry and Residue Data. Petition Number 2E6398.

		DP Number: D315266	Decision Number:  354590

		PC Code: 027401	MRID Numbers:  45572201

		40 CFR 180.231	Chemical Class: nitrile herbicide

	From:	W. Cutchin, Chemist

		ARIA/TRB

		Registration Division (7505C)

	Through:	P. Shah, Toxicologist

		RAB1

		Health Effects Division (7509C)

	To:	S. Brothers

		MURIEB

		Registration Division (7505C)

Executive Summary

Interregional Research Project No. 4 (IR-4) has submitted field trial data for dichlobenil (2,6-dichlorobenzonitrile) on rhubarb.  Dichlobenil is a nitrile herbicide that acts by inhibiting germination of actively dividing meristems and acts primarily on growing points and root tips.  Dichlobenil, formulated as the 4% granular product Casoron® 4G (EPA Reg. No. 400-168), is to be applied at 2.0 lb ai/A to rhubarb.  The product is applied directly to soil while the target crop is dormant.  Three field trials were conducted in the United States encompassing Regions XI (WA) and XII (OR [2]) during the 1999 growing season.  No specific Regions are indicated in OPPTS 860.1500 guidelines for rhubarb.  Since Region XII accounts for 72% of the domestic rhubarb production, the location and number of field trials are adequate.

The qualitative nature of the residue in plants is adequately understood based on acceptable plant metabolism studies on apples and grapes.  Both studies indicate that the major residue of concern is 2,6-dichlorobenzamide (BAM).  The parent compound, dichlobenil, was not detected in either of the studies.  The OPP Metabolism Committee met and concluded that BAM is the major terminal residue of dichlobenil in plants, and should be added to the tolerance expression.  Since there are no rhubarb animal feed items of regulatory concern, a discussion of the nature of the residues of dichlobenil in livestock commodities is not germane to this action.

PAM Vol. II, Method A is a gas-liquid chromatography/electroconductivity detector (GLC/ECD) method with a detection limit of 0.05 ppm, which can be used for determination of residues of dichlobenil in/on plant commodities.  This method was judged adequate for tolerance enforcement.  However, the registrant was required to revise the method or develop an alternative method using safer solvents.  The revised method is not adequate and will require additional modification before it can be accepted as a tolerance enforcement method.  A GLC/ECD method, L 3-53-71, for determination of residues of BAM in/on fruits and nuts has undergone a successful independent laboratory validation and has been validated by the EPA Analytical Chemistry Laboratory (ACL).  However, a revised method incorporating ACL's comments must be submitted before the requirements for an analytical method for BAM can be considered fulfilled.  Dichlobenil is completely recovered using the multiresidue methods in the Pesticide Analytical Manual (PAM) Vol. I Sections 302 and 304.  BAM is also completely recovered using Section 302.  Since the multiresidue methods adequately quantitate dichlobenil and BAM, there is adequate enforcement methodology for this action.

The analytical methods SOP# Meth-83, Determination of Dichlobenil Residues in Cherries and SOP# Meth-84, Determination of 2,6-dichlorobenzamide Residues in Cherries, developed by Morse Laboratories were used with minor modifications for the analysis of dichlobenil residues on rhubarb.  Dichlobenil residues were extracted from the raw agricultural commodity (RAC) by extracting with ethyl acetate/hexane and clean up using a Florisil column.  BAM residues were extracted from the raw agricultural commodity (RAC) by extracting with ethyl acetate and clean up using a Florisil column.  Samples were analyzed using a gas chromatograph with a Hall detector (electrolytic conductivity detector) in halogen mode.  The analytical method was validated for rhubarb at 0.05, 0.1, and 0.5 ppm for dichlobenil and 0.01, 0.02, and 0.1 ppm for BAM.  At the range of the fortification levels, method recoveries were 63-96% dichlobenil and 76-110% for BAM. The lower limit of method validation (LLMV) was reported for dichlobenil and BAM as 0.05 ppm and 0.01 ppm, respectively.  The limit of detection (LOD) was 0.006 ppm for both dichlobenil and BAM.  The method used for data collection is adequate.  No residues above the LLMV of 0.05 ppm for dichlobenil or 0.01 ppm for BAM were found in any rhubarb sample.

	There are no rhubarb processed commodities of regulatory interest.  Rhubarb is not rotated on a regular basis, therefore inadvertent residues in rotational crops is not a concern for this action.

Regulatory Recommendations and Residue Chemistry Deficiencies

Pending receipt of the corrected Section F and the forthcoming human health risk assessment, TRB recommends for the proposed tolerance for the combined residues of the herbicide dichlobenil (2,6- dichlorobenzonitrile) and its metabolite 2,6-dichlorobenzamide in rhubarb at 0.06 ppm.

Background

Dichlobenil is a nitrile herbicide that acts by inhibiting germination of actively dividing meristems and acts primarily on growing points and root tips.

TABLE 1.  Test Compound Nomenclature.

Compound	Chemical Structure

Common name	dichlobenil

Company experimental name	DCBN

IUPAC name	2,6-dichlorobenzonitrile

CAS name	2,6-dichlorobenzonitrile

CAS #	1194-65-6

End-use product/(EP)	Casoron® 4G (EPA Reg. No. 400-168)

TABLE 2.  Physicochemical Properties of Dichlobenil.

Parameter	Value	Reference

Melting point/range	145°C	RED Chapter, 6/29/95

pH	NA

	Density	1.3 g/cm3	IPS Inchem, 4/05

Water solubility ( 25°C)	0.0021g/100mL	RED Chapter, 6/29/95

Solvent solubility (g/100mL at 25°C)	xylene 5.3

ethanol 1.5

cyclohexane 0.37

	Vapor pressure at 20°C	5.5 x 10-4 mmHg	IPS Inchem, 4/05

Dissociation constant (pKa)	NA

	Octanol/water partition coefficient Log(KOW)	2.64	IPS Inchem, 4/05

UV/visible absorption spectrum	NA

860.1200  Directions for Use

Table 3.  Summary of Directions for Use of Dichlobenil.

Applic. Timing, Type, and Equip.

Formulation

[EPA Reg. No.]

Applic. Rate

(lb ai/A)

Max. No. Applic. per Season

Max. Seasonal Applic. Rate

(lb ai/A)

PHI

(days)

Use Directions and Limitations

Rhubarb

Apply while crop is dormant using granular applicator

Casoron® 4G [400-168]

2

1

2

NA

Conclusions.  The label is adequate to allow evaluation of the residue data relative to the proposed use.

860.1300 Nature of the Residue - Plants

Dichlobenil RED, 10/98

The qualitative nature of the residue in plants is adequately understood based on acceptable plant metabolism studies on apples and grapes.  Both studies indicate that the major residue of concern is 2,6-dichlorobenzamide (BAM).  The parent compound, dichlobenil, was not detected in either of the studies.  On June 8, 1992, the OPP Metabolism Committee met and concluded that BAM is the major terminal residue of dichlobenil in plants, and should be added to the tolerance expression.  Because dichlobenil plant metabolism studies demonstrate that 2,6-dichlorobenzoic acid (2,6-DCBA) is not a plant metabolite, the Committee has recommended removing 2,6-DCBA from the tolerance expression for dichlobenil.  Therefore, residue data for 2,6-DCBA are no longer required.  All conclusions specified here regarding the status of residue chemistry data requirements and the adequacy of the established tolerances reflect the Metabolism Committee's determination to add BAM to the tolerance expression and remove 2,6-DCBA from the tolerance expression.

Conclusions.  The residues of concern in plants are the parent dichlobenil and the metabolite BAM.

860.1300 Nature of the Residue - Livestock

Since there are no rhubarb animal feed items of regulatory concern, a discussion of the nature of the residue of dichlobenil is not germane to this action.

860.1340 Residue Analytical Methods

Dichlobenil RED, 10/98

45572201.der.doc, W. Cutchin, in process

PAM Vol. II, Method A is a gas-liquid chromatography/electroconductivity detector (GLC/ECD) method with a detection limit of 0.05 ppm, which can be used for determination of residues of dichlobenil in/on plant commodities.  This method was judged adequate for tolerance enforcement; however, Method A uses benzene as a solvent.  The registrant was required to revise the method or develop an alternative method using safer solvents.  The revised method (MRID 43805301) is currently under review.  However, this method is not adequate and will require additional modification before it can be accepted as a tolerance enforcement method.  The Dichlobenil Guidance Document required development of an analytical method for the detection and quantitation of BAM in plant commodities.  The former basic producer, Solvay Duphar, submitted a GLC/ECD method (L 3-53-71) for determination of residues of BAM in/on fruits and

nuts.  This method has undergone a successful independent laboratory validation and has been validated by the EPA Beltsville Analytical Chemistry Laboratory (ACL).  However, a revised method incorporating ACL's comments must be submitted before the requirements for an analytical method for BAM can be considered fulfilled.

The analytical methods SOP# Meth-83, Determination of Dichlobenil Residues in Cherries and SOP# Meth-84, Determination of 2,6-dichlorobenzamide Residues in Cherries, developed by Morse Laboratories were used with minor modifications for the analysis of dichlobenil residues on rhubarb.  Dichlobenil residues were extracted from the raw agricultural commodity (RAC) by homogenizing the samples with ethyl acetate/hexane and rotovaping the supernatant almost to dryness.  The residue is then redissolved in hexane and cleaned up using a Florisil column.  The dichlobenil residues are eluted with ethyl acetate/hexane, rotovaping the eluant almost to dryness, and the sample redissolved in hexane for analysis.  BAM residues were extracted from the raw agricultural commodity (RAC) by homogenizing the samples with ethyl acetate and taking the supernatant almost to dryness.  The residue is then redissolved in hexane and cleaned up using a Florisil column.  The BAM residues are eluted with ethyl acetate/hexane, taking the eluant almost to dryness, and the sample redissolved in hexane for analysis.  A gas chromatograph with a Hall detector (electrolytic conductivity detector) in halogen mode was used for the analysis.  The analytical method was validated for rhubarb at 0.05, 0.1, and 0.5 ppm for dichlobenil and 0.01, 0.02, and 0.1 ppm for BAM.  At the range of the fortification levels, method recoveries were 63-96% dichlobenil and 76-110% for BAM.  The petitioner presented adequate sample chromatograms and calibration curves.  The LLMV was reported for dichlobenil and BAM as 0.05 ppm and 0.01 ppm, respectively.  The LOD was 0.006 ppm for both dichlobenil and BAM.

Conclusions.  The previously submitted methods proposed for tolerance enforcement for dichlobenil and BAM on plants are not adequate for the reasons described above.  However, as the multiresidue methods adequately quantitate dichlobenil and BAM (see, 860.1360, below), there is no deficiency for this action.  The method used for data collection is adequate.

860.1360 Multiresidue Methods

Dichlobenil RED, 10/98

The FDA PESTDATA database dated 1/94 (PAM Vol I, Appendix I) indicates that dichlobenil is completely recovered (>80%) using multiresidue methods PAM Vol. I Sections 302 (Luke method) and 304 (Mills fatty food method), and has partial recovery (50-80%) using Section 303 (Mills, Onley, Gaither method).  The database also indicates that BAM is completely recovered (>80%) using Section 302.

860.1380 Storage Stability

45572201.der.doc, W. Cutchin, in process

Since the rhubarb samples were store for only 34 days at -18ºC between harvest and analysis, storage stability data is not required for this action.

860.1480 Meat, Milk, Poultry, and Eggs

Since there are no rhubarb livestock feed items of regulatory concern, a discussion of dichlobenil residues in livestock commodities is not germane to this action.

860.1500 Crop Field Trials

45572201.der.doc, W. Cutchin, in process

TABLE 4.  Summary of Residue Data from Crop Field Trials with Dichlobenil.

Commodity	Total Applic. Rate

 (lb ai/A)

 (g ai/ha)	PHI (days)	Residue Levels

 (ppm)

	n	Min.	Max.	HAFT*	Median

(STMdR)	Mean

(STMR)	Std. Dev.

Dichlobenil

Rhubarb	2.0

(2240)	64-83	3	<0.05	<0.05	<0.05	<0.05	<0.05	NA

BAM

Rhubarb	2.0

(2240)	64-83	3	<0.01	<0.01	<0.01	<0.01	<0.01	NA

* HAFT = Highest Average Field Trial.

	Interregional Research Project No. 4 (IR-4) has submitted field trial data for dichlobenil on rhubarb.  Three field trials were conducted in the United States encompassing Regions XI (WA) and XII (OR [2]) during the 1999 growing season.  No specific Regions are indicated in OPPTS 860.1500 guidelines for rhubarb.  Since Region XII accounts for 72% of the domestic rhubarb production, the location and number of field trials are adequate.

In each trial, dichlobenil was applied to rhubarb with a granular applicator as a single soil surface broadcast application at 2.0 lb ai/A.  Applications were made at pre-emergence or when the crop was just breaking ground.  In each trial, marketable rhubarb was harvested at 64 to 83 days PHI.  The analytical methods SOP# Meth-83, Determination of Dichlobenil Residues in Cherries and SOP# Meth-84, Determination of 2,6-dichlorobenzamide Residues in Cherries, developed by Morse Laboratories were used with minor modifications for the analysis of dichlobenil residues on rhubarb.  Dichlobenil residues were extracted by homogenizing the samples with ethyl acetate/hexane and cleaned up using a Florisil column.  The metabolite 2,6-dichlorobenzamide (BAM) residues were extracted by homogenizing the samples with ethyl acetate and cleaned up using a Florisil column.  A gas chromatograph with a Hall detector (electrolytic conductivity detector) in halogen mode was used for the analysis.  Method recoveries were 63-96% dichlobenil and 76-110% for BAM.  The LLMV was reported for dichlobenil and BAM as 0.05 ppm and 0.01 ppm, respectively.  The LOD was 0.006 ppm for both dichlobenil and BAM.  No residues above the LLMV of 0.05 ppm for dichlobenil or 0.01 ppm for BAM were found in any rhubarb sample.

Conclusions.  The crop field trials were conducted according to the proposed use pattern.  The studies were supported by adequate storage stability data and analytical methods suitable for data gathering purposes.  No residues above the LLMV of 0.05 ppm for dichlobenil or 0.01 ppm for BAM were found in any rhubarb sample.  The proposed tolerance of 0.15 ppm for dichlobenil residues is too high.  The expected residues of dichlobenil on rhubarb when treated according to the proposed use pattern will not exceed the combined LLMV of 0.06 ppm for rhubarb; therefore, a tolerance at that level would be appropriate.  TRB recommends for the establishment of a tolerance for dichlobenil residues on rhubarb at 0.06 ppm.  A revised Section F is required.

Because there were so few samples submitted and no residues were found above the LLMV, no MRL spreadsheet analysis was conducted for this proposed use.

860.1520 Processed Food and Feed

45572201.der.doc, W. Cutchin, in process

Since there are no rhubarb processed food items of regulatory concern, a discussion of dichlobenil residues in processed commodities is not germane to this action.

860.1650 Submittal of Analytical Reference Standards

No analytical reference standards are available in the Agency=s Pesticide Repository.  However, both dichlobenil and BAM are available as reference standards in the commercial market place.

860.1850 & 860.1900 Confined and Field Accumulation in Rotational Crops

	Rhubarb is a perennial crop; therefore a discussion of residues in rotational crops is not germane to this action.

860.1550 Proposed Tolerances

Dichlobenil residues of concern are parent dichlobenil and the metabolite BAM (2,6-dichlorobenzamide) as stated in 40 CFR §180.231.  There are no international harmonization issues associated with this action.

Table 5.  Tolerance Summary for Dichlobenil

Commodity

Established/Proposed Tolerance (ppm)

Recommended Tolerance (ppm)

Comments (correct commodity definition)

Rhubarb

0.15

0.06

Template Version November 2003

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name:

Common Name:  Dichlobenil

   Proposed tolerance

 Reevaluated tolerance

 Other

Date: 2/7/06

Codex Status

(Maximum Residue Limits)

U. S. Tolerances

 No Codex proposal step 6 or above

 No Codex proposal step 6 or above for the crops requested

Petition Numbers:  2E6398

DP Barcodes:  D315266

Other Identifier:

Residue definition (step 8/CXL): N/A

Reviewer/Branch: W. Cutchin

Proposed Residue definition:  Combined residues of dichlobenil and metabolite 2,6-dichlorobenzamide

Crop (s)

MRL (mg/kg)

Crop(s)

Tolerance 瀨浰ܩഇഇഇ桲扵牡ݢ」ㄮܵഇഇഇഇ܇܍܍܍܍ഇഇഇഇ܇ ܍܍܍܍ഇ楌業獴映牯䌠湡摡ݡ䰍浩瑩⁳潦⁲敍楸潣܇

Ç

烰

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à

à

à

à

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ᶐ

à

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ࠀ  No Limits

  No Limits for the crops requested

   No Limits

  No Limits for the crops requested

Residue definition: N/A

Residue definition: N/A

Crop(s)

MRL (mg/kg)

Crop(s)

MRL (mg/kg)

Notes/Special Instructions:S.Funk, 02/09/2006.

Dichlobenil	Summary of Analytical Chemistry and Residue Data	Barcode: D315266

 PAGE  8  of   NUMPAGES  8


[Federal Register Volume 80, Number 147 (Friday, July 31, 2015)]
[Notices]
[Pages 45666-45667]
[FR Doc No: 2015-18853]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[USCG-2015-0475; OMB Control Number 1625-0095]

Information Collection Request to Office of Management and Budget

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an Information Collection Request
(ICRs) to the Office of Management and Budget (OMB), Office of
Information and Regulatory Affairs (OIRA), requesting approval of an
extension of a currently approved collection: 1625-0095, Oil and
Hazardous Material Pollution Prevention and Safety Records,
Equivalents/Alternatives and Exemptions. Our ICR describes the
information we seek to collect from the public. Before submitting this
ICR to OIRA, the Coast Guard is inviting comments as described below.

DATES: Comments must reach the Coast Guard on or before September 29,
2015.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2015-0475] to the Docket Management Facility (DMF) at the
U.S. Department of Transportation (DOT). To avoid duplicate
submissions, please use only one of the following means:
    (1) Online: http://www.regulations.gov.
    (2) Mail: DMF (M-30), DOT, West Building Ground Floor, Room W12-
140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
    (3) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    (4) Fax:<PHONE_NUMBER>. To ensure your comments are received in a
timely manner, mark the fax, to attention Desk Officer for the Coast
Guard.
    The DMF maintains the public docket for this Notice. Comments and
material received from the public, as well as documents mentioned in
this Notice as being available in the docket, will become part of the
docket and will be available for inspection or copying at Room W12-140
on the West Building Ground Floor, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. You may also find the docket on the Internet
at http://www.regulations.gov.
    Copies of the ICR(s) are available through the docket on the
Internet at http://www.regulations.gov. Additionally, copies are
available from: COMMANDANT (CG-612), ATTN. PAPERWORK REDUCTION ACT
MANAGER, U.S. COAST GUARD, 2703 MARTIN LUTHER KING, JR. AVE. SE., STOP
7710, WASHINGTON, DC 20593-7710.

FOR FURTHER INFORMATION CONTACT:  Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents. Contact Ms. Cheryl Collins, Program
Manager, Docket

Operations,<PHONE_NUMBER>, for questions on the docket.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection.
    The Coast Guard invites comments on whether these ICRs should be
granted based on the Collections being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology. In response to
your comments, we may revise these ICRs or decide not to seek approval
of revisions of the Collection. We will consider all comments and
material received during the comment period.
    We encourage you to respond to this request by submitting comments
and related materials. Comments must contain the OMB Control Number of
the ICR and the docket number of this request, [USCG-2015-0475], and
must be received by September 29, 2015. We will post all comments
received, without change, to http://www.regulations.gov. They will
include any personal information you provide. We have an agreement with
DOT to use their DMF. Please see the ``Privacy Act'' paragraph below.

Submitting Comments

    If you submit a comment, please include the docket number [USCG-
2015-0475], indicate the specific section of the document to which each
comment applies, providing a reason for each comment. You may submit
your comments and material online (via http://www.regulations.gov), by
fax, mail, or hand delivery, but please use only one of these means. If
you submit a comment online via www.regulations.gov, it will be
considered received by the Coast Guard when you successfully transmit
the comment. If you fax, hand deliver, or mail your comment, it will be
considered as having been received by the Coast Guard when it is
received at the DMF. We recommend you include your name, mailing
address, an email address, or other contact information in the body of
your document so that we can contact you if we have questions regarding
your submission.
    You may submit your comments and material by electronic means,
mail, fax, or delivery to the DMF at the address under ADDRESSES; but
please submit them by only one means. To submit your comment online, go
to http://www.regulations.gov, and type ``USCG-2015-0475'' in the
``Search'' box. If you submit your comments by mail or hand delivery,
submit them in an unbound format, no larger than 8\1/2\ by 11 inches,
suitable for copying and electronic filing. If you submit comments by
mail and would like to know that they reached the Facility, please
enclose a stamped, self-addressed postcard or envelope. We will
consider all comments and material received during the comment period
and will address them accordingly.
    Viewing comments and documents: To view comments, as well as
documents mentioned in this Notice as being available in the docket, go
to http://www.regulations.gov, click on the ``read comments'' box,
which will then become highlighted in blue. In the ``Search'' box
insert ``USCG-2015-0475'' and click ``Search.'' Click the ``Open Docket
Folder'' in the ``Actions'' column. You may also visit the DMF in Room
W12-140 on the ground floor of the DOT West Building, 1200 New Jersey
Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

Privacy Act

    Anyone can search the electronic form of comments received in
dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act statement
regarding Coast Guard public dockets in the January 17, 2008, issue of
the Federal Register (73 FR 3316).

Information Collection Request

    1. Title: Oil and Hazardous Material Pollution Prevention and
Safety Records, Equivalents/Alternatives and Exemptions.
    OMB Control Number: 1625-0095.
    Summary: The information is used by the Coast Guard to ensure that
an oil or hazardous material requirement alternative or exemption
provides an equivalent level of safety and protection from pollution.
    Need: Under 33 U.S.C. 1321 and Executive Order 12777 the Coast
Guard is authorized to prescribe regulations to prevent the discharge
of oil and hazardous substances from vessels and facilities and to
contain such discharges. Coast Guard regulations in 33 CFR parts 154-
156 are intended to: (1) Prevent or mitigate the results of an
accidental release of bulk liquid hazardous materials being transferred
at waterfront facilities; (2) ensure that facilities and vessels that
use vapor control systems are in compliance with the safety standards
developed by the Coast Guard; (3) provide equipment and operational
requirements for facilities and vessels that transfer oil or hazardous
materials in bulk to or from vessels with a 250 or more barrel
capacity; and (4) provide procedures for vessel or facility operators
who request exemption or partial exemption from the requirements of the
pollution prevention regulations.
    Forms: None.
    Respondents: Owners and operators of bulk oil and hazardous
materials facilities and vessels.
    Frequency: On occasion.
    Burden Estimate: The estimated burden remains unchanged at 1,440
hours a year.

    Authority:  The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended.

    Dated: July 24, 2015.
Thomas P. Michelli,
U.S. Coast Guard, Deputy Chief Information Officer.
[FR Doc. 2015-18853 Filed 7-30-15; 8:45 am]
 BILLING CODE 9110-04-P


TECHNICAL SUPPORT DOCUMENT (TSD)

FOR THE STATE OF WEST VIRGINIA 111(d)/129 PLAN

REVISION #2 FOR THE CONTROL OF EMISSIONS FROM EXISTING

HOSPITAL/MEDICAL/INFECTIOUS WASTE

INCINERATOR (HMIWI) UNITS

Submitted By the West Virginia Department of Environmental Protection,
Division of Air Quality (DAQ) on September 7, 2011

TSD Prepared by Mike Gordon

Office of Permits and Air Toxics, 3AP10

U.S. Environmental Protection Agency, Region 3

1650 Arch Street

Philadelphia, Pennsylvania 19103

(215)814-2039

Reviewed By:

	/s/							/s/

Kathleen Cox					Andrew Hass

Acting Associate Director		Acting Associate Director

Office of Permits				Office of Air Monitoring

and Air Toxics                  	and Analysis

	11/7/2011						11/7/2011

	Date Signed					Date Signed

	/s/

James B. Topsale, P.E.

Office of Air Monitoring

and Analysis

11/7/2011

Date Signed

TABLE OF CONTENTS

                 Page

I.     General provisions . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .       3

       A.   What action is EPA approving?  . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . .       3

       B.   What pollutant(s) will this action control? . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . .      3

       C.   What are the expected environmental and public health
benefits from controlling

              hospital/medical/infectious waste incinerator (HMIWI)
emissions?  . . . . . . . . .  . . . .      3

II.   Federal requirements the West Virginia (WV) 111(d)/129 Plan
revision must meet

       for approval . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  3

                   A.	 What general requirements must the WV Department
of Environmental Protection

                         meet in order to receive approval of its HMIWI
111(d)/129 plan revision ?  . . . . . . . .      3

       B.   What does the WV plan revision contain? . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . .      3

                   C.   Does the WV plan revision meet all EPA
requirements for approval?  . . . . . . . . . . . .      4

            III.   Requirements for affected HMIWI unit owners/operators
 . . . . . . . . . . . . . . . . . . . . . . . . . .  16

        A.   What general requirements must I meet under the approved
plan revision?  . . . . . .  . .  16

        B.    Is there a requirement for obtaining a Title V permit?  .
. . . . . . . . . . . . . . . . . . . . . . . .  16

IV. Conclusion  . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
16

        WEST VIRGINIA HOSPITAL/MEDICAL/INFECTIOUS SOLID WASTE

INCINERATOR (HMIWI) 111(d)/129 PLAN REVISION #2

I. General Provisions

Q. What action is EPA approving?

A.  On September 7, 2011, the West Virginia Department of Environmental
Protection, Division of Air Quality (DAQ) forwarded to EPA revisions of
state rule 45 CSR 18, “Control of Air Pollution From Combustion of
Solid Waste,” as changes to the approved 111(d)/129 plan (the
“plan”) for existing HMIWI units, 40 CFR 62, Subpart XX.  The
revision addresses the October 6, 2009 amendments to 40 CFR 60, Subparts
Ce and Ec (74 FR 51367). This rulemaking action will supersede EPA’s
August 3, 2009 (74 FR 38348) approval of West Virginia’s initial plan
revision. The scope of this plan revision and EPA’s approval is
limited to Part 60 and 62 provisions relevant to existing HMIWI units,
and the related new source performance standard provisions, subpart Ec,
as amended October 6, 2009.  Other types of Section 129 incinerator
units and rules are not included in this approval action.

Q. What pollutant(s) will this action control?

A. The pollutants are dioxins/furans, carbon monoxide, metals (cadmium,
lead, mercury, particulate matter), opacity, and acid gases (hydrogen
chloride, sulfur dioxide, and nitrogen oxides).

Q. What are the expected environmental and public health benefits from
controlling HMIWI emissions?

A. The benefits are explained in the original EPA plan approval
technical support document dated May 23, 2000.  Also, this action will
help mitigate toxics deposition on streams and lakes.

II. Federal Requirements the WV HMIWI 111(d)/129 plan revision must meet
for approval

Q. What general requirements must the DAQ meet to receive approval of
its 111(d)/129 plan revision?

A.  The West Virginia plan must meet the requirements of 1) 40 CFR Part
60, Subpart B, Sections 60.23 through .26, except the provisions
relating to electric generating units; 2) 40 CFR Part 60, Subpart Ce,
Sections 60.30e through 60.39e.; and 3) 40 CFR Part 62, Subpart A.

Q. What does the WV plan revision contain?

The revision contains a modified DAQ rule, 45 CSR 18, revised as a
result of the October 6, 2009 amendments to federal Emissions Guidelines
and New Source Performance Standards for HMIWI units.  The submitted
plan revision contains all the required elements as listed in EPA’s WV
plan approval Federal Register notice of June 13, 2000.  (65 FR37046).

Q.  Does the WV 111(d)/129 plan revision meet all EPA requirements for
approval?

A. Yes. The completeness and approvability of the WV plan revision in
the context of 40 CFR Part 60, Subparts B, and Ce; and 40 CFR Part 62,
section 62.09 are summarized below.WV 45CSR18 Rule Review

WV45CSR18, June 16, 2011 Amendments for Hospital/Medical Infectious
Waste Incinerator (HMIWI) Units,

Subpart Ce (((60.30e through 60.39e) Model Rule Requirements

   HMIWI RULE (WV 45CSR18, as amended)
       Page 1 of 2

Subpart Ce – Federal Requirements, Rule Section(s).	State Rule 18
Series	45CSR 18 6/16/11 Amendments Meet Subpart Ce  Requirements?
                            Comment(s)

	6/16/11 Amended DAQ Series [§45-18-     ]

60.30e,  Scope	1.1.c	Yes

	60.31e,  Definitions	2	Yes	1.  Section 2 contains no definition of
“Continuous HMIWI”; however, the related NSPS, subpart Ec,
definition is incorporated by reference (IBR) under para. 2.87.   2.
Section 2.36.a – The definition needs to reference subsection 2.36.b,
not 2.33.b. ; 3.  Section 2.75.a -  The definition needs to reference
subdivision 2.75.b, not 2.62.b.  DAQ recognizes the typographical errors
under comments 2 and 3, but argues the errors are not cause for plan
disapproval considering the subpart Ec IBR provision of paragraph 2.87.

60.32e(a) through (j), Designated facilities	7.2	Yes	4.  In response to
EPA plan comments, DAQ acknowledges that 111(d)/129 plan enforceability
is under the provisions of 40 CFR Part 62, Subpart XX, as amended, as
stipulated under paragraph 7.2.j.  This acknowledgement is also stated
under Section IX, Compliance Schedules, of the plan narrative.  During
the 2012 legislative session, DAQ will provide additional clarification
in amendments to 45CFR18.

60.33e(a)-(c), MACT emission limits.	7.3, and Tables 18-1A, 2A, 1B, and
2B	Yes

	60.34e, 60.39e(e), and 60.53c Operator Training & Certification	7.4	Yes

	60.35e, Waste Management Plan 	7.5	Yes	5. The need for a revised WMP is
acknowledged in the response to EPA plan comments, and comment 4 above.

60.36e, Rural Unit Inspections	7.6.a through f	Yes	6. See comment 4
above.

Note:  The scope of this review does not include any 45 CSR18 provisions
relating to SMWC, CISWI, and OSWI units.

WV 45CSR18 Rule Review

WV45CSR18, June 16, 2011 Amendments for Hospital/Medical Infectious
Waste Incinerator (HMIWI) Units,

Subpart Ce (((60.30e through 60.39e) Model Rule Requirements

HMIWI RULE (WV 45CSR18, as amended)
                      Page 2 of 2

Subpart Ce – Federal Requirements, Rule Section(s).	State Rule 18
Series	6/16/11 Amendments Meet Subpart Ce  Requirements?
                       Comment(s)

	6/16/11 Amended DAQ Series [§45-18-     ]

60.37e, Compliance Performance, Testing, and Monitoring	7.7.a through f
Yes	7.  In the response to EPA plan comments, DAQ states that it will
interpret the plan and rule as closely as possible with respect to the
repeat performance test provisions set forth in 40 CFR 60.37e(c)(4).

60.38e, Reporting and Recordkeeping	7.8.a through c	Yes	8.  Paragraph
7.8.c is not a Subpart Ce requirement. The paragraph requires
certification on reports with respect to accuracy and completeness.

60.39e, Compliance Time	7.9	Yes	9.  Paragraphs 7.9.a, e, and h.3 – See
comment 4 above.

10.  Compliance time for small rural units is moot considering WV has
none.

Note:  The scope of this review does not include any 45 CSR18 provisions
relating to SMWC, CISWI, and OSWI units.

Evaluation of the West Virginia Plan Revision #2 against the
requirements of 40 CFR Parts 60, Subpart B, Sections 60.23 through
60.26, excluding electric generating unit provisions, and Part 62,
Section 62.09

40 CFR 60.23 - Adoption and submittal of State plan revision; public
hearings.

Federal Requirements

DAQ Submittal

(60.23(a)(1) Within nine months after notice of the availability of a
final guideline document is published under (60.22(a), each State shall
adopt and submit to the Administrator, in accordance with (60.4, a plan
for the control of the designated pollutant to which the guideline
document applies.

CAA section 129(b)(2) supersedes this provision.  States are allowed up
to one year after rule promulgation to submit a plan.

          (2) Within nine months after notice of the  availability of a
final revised guideline document is published as provided in
(60.22(d)(2), each State shall adopt and submit to the Administrator any
plan revision necessary to meet the requirements of this subpart.

Subpart Ce, (60.39e(a)(2) supersedes (60.23. State plan revisions were
due October 6, 2010.

(60.23(b) If no designated facility is located within a State, the State
shall submit a letter of certification to that effect to the
Administrator within the time specified in paragraph (a) of this
section.  Such  certification shall exempt the State from the
requirements of this subpart for that designated pollutant.

Not applicable.

(60.23(c)(1)  Except as provided in paragraphs (c)(2) and (c)(3) of this
section, the State shall, prior to the adoption of any plan or revision
thereof, conduct one or  more public hearings within the State on such
plan or plan revision.

A public hearing on the plan revision was held in Charleston, WV on
August 8, 2011.

( 60.23(d) Any hearing required by paragraph (c) of this section shall
be held only after reasonable notice. Notice shall be given at least 30
days prior to the date of such hearing.

A certified copy of the required public notice was provided.  The plan
revision narrative states the hearing was held in accordance with (
60.23(d) requirements.

( 60.23(e)  The State shall prepare and retain, for a minimum of 2
years, a record of each hearing for inspection by any interested party.
The record shall contain, as a minimum, a list of witnesses together
with the text of each presentation.

The plan revision narrative states hearing records will be maintained
for at least 2 years. A list of witnesses was provided.

( 60.23(f)  The State shall submit with the plan or revision:

          (1)  Certification that each paragraph (c) of this section was
held in accordance with the notice required by paragraph (d) of this
section; and

          (2)  A list of witnesses and their organizational
affiliations, if any, appearing at the hearing and a brief written
summary of each presentation or written submission.

The DAQ submitted the required certification.

( 60.23(g) provides for alternate procedures to insure public
participation.

Not applicable.

40 CFR 60.24  --  Emission standards and compliance schedules

( 60.24(a)  Each plan shall include emission standards and compliance
schedules.

The plan revision is consistent with the provisions of Subpart Ce, as
amended October 6, 2009.

( 60.24(b)(1) Emission standards shall prescribe allowable rates of
emissions except when it is clearly impracticable.  Such cases will be
identified in the guideline documents issued under ( 60.22.  Where
emission standards prescribing equipment specification are established,
the plan shall, to the degree possible, set forth the emission
reductions achievable by implementation of such specifications, and may
permit compliance by the use of equipment determined by the State to be
equivalent to that prescribed.

Not applicable.

          (2) Test methods and procedures for determining compliance
with the emission standards shall be specified in the plan.  Methods
other than those specified in Appendix A to this part may be specified
in the plan if shown to be equivalent or alternative methods are defined
in ( 60.2(t) and (u).

The 45CSR18 revision contains the required regulatory revisions.

          (3) Emission standards shall apply to all designated
facilities within the State.  A plan may contain emission standards
adopted by local jurisdictions provided that the standards are
enforceable by the State.

The 45CSR18 revision applies to all designated facilities.

( 60.24(c)  Except as provided in paragraph (f) of this section where
the Administrator has determined that a designated pollutant may cause
or contribute to endangerment or public health, emission standards,
shall be no less stringent than the corresponding emission guideline(s)
specified in Subpart C of this part, and final compliance shall be
required as expeditiously as practicable but no later than the
compliance times specified in Subpart C of this part.

Paragraph 7.9.f of 45CFR18, as revised, requires expeditious compliance

( 60.24(d)  Where the Administrator has determined that a designated
pollutant may cause or contribute to endangerment of public welfare but
that adverse effects on public health have not been demonstrated, States
may balance the emission guidelines, compliance times, and other
information provided in the applicable guideline document against other
factors of public concern in establishing emission standards, compliance
schedules, and variances.  Appropriate consideration shall be given to
the factors specified in ( 60.22(b) and to information presented at the
public hearing(s) conducted under ( 60.23(c).

Not applicable under section 129 rules.

( 60.24(e)(1)  Any compliance schedule extending more than 12 months
from the date required for submittal of the plan shall include legally
enforceable increments of progress to achieve compliance for each
designated facility or category of facilities.  Increments of progress
shall include, where practicable, each increment of progress specified
in ( 60.21(h) and such additional increments of progress as may be
necessary to permit close and effective supervision of progress toward
final compliance.

Expeditious plan compliance is required under the revised rule,
paragraph 7.9.f.

          (2)  A plan may provide that compliance schedules for
individual sources or categories of sources will be formulated after
plan submittal.  Any such schedule shall be the subject of a public
hearing held accordingly to ( 60.23 and shall be submitted to the
Administrator within 60 days after the date of adoption of the schedule
but in no case later than the date prescribed for submittal of the first
semiannual report required by

( 60.25(e).

Not applicable for section 129 sources.

( 60.24(f)  On a case-by-case basis for particular designated
facilities, or classes of facilities, States may provide for the
application of less stringent emission standards or longer compliance
schedule than those otherwise required by paragraph (c) of this section,
provided that the State demonstrated with respect to each facility (or
class of facilities):

          (1)  Unreasonable cost of control resulting from plant age,
location or basic process design:

          (2)  Physical impossibility of installing

This provision is superseded by 129 (b)(2) that requires state plan
emission standards to be at “least as protective” as the emission
guidelines.  The revised rule 45CSR18 emission limitations are at least
as protective as those in the 10/6/09 subpart Ce revision.

necessary control equipment; or

          (3)  Other factors specific to the facility (or class of
facilities) that make application of a less stringent standard or final
compliance time significantly more reasonable.

( 60.24(g)  Nothing in this subpart shall be construed to preclude any
State or political subdivision thereof from adopting or enforcing:

          (1)  emission standards more stringent than emission
guidelines specified in Subpart C of this part or in applicable
guideline  documents, or

          (2)  compliance schedules requiring final compliance at
earlier times than those specified in Subpart C or in applicable
guideline documents.

The state is not imposing more stringent emission standards than those
under subpart Ce, as revised 10/6/09.

( 60.24(h)  States requirements of EGU budgets.

Not applicable.

40 CFR 60.25  --  Emission inventories, source surveillance, reports.

( 60.25(a)  Each plan shall include an inventory of all designated
facilities, including emission data for the designated pollutants and
information related to emissions as specified in Appendix D to this
part.  Such data shall be  summarized in the plan, and emission rates of
designated facilities shall be correlated with applicable emission
standards.  As used in this subpart, “correlated” means presented in
such a manner as to show the relationship between measured or estimated
amounts of emissions and the amounts of such emissions allowable under
applicable emission standards.

The plan revision contains the required source emission inventories –
Tables 18-3, 4, and 5.  Any affected source not listed in the inventory
must comply with applicable requirements.

( 60.25(b)  Each plan shall provide for monitoring the status of
compliance with applicable emission standards.  Each plan shall, as a
minimum, provide for:

Included in plan narrative section on legal authority.

          (1)  Legally enforceable procedures for requiring owners and
operators of designated facilities to maintain records and periodically
report to the State information on the nature and amount of emissions
from such facilities, and/or such information as may be necessary to
enable the State to determine whether such facilities are in compliance
with applicable portions of the plan.

          (2)  Periodic inspection and, when applicable, testing of
designated facilities.

The EPA Administrator retains authority for several tasks, as stipulated
in (45-18-11.1.

( 60.25(c)  Each plan shall provide that information obtained by the
State under paragraph (b) of this section shall be correlated with
applicable emission standards (see ( 60.25(a)) and made available to the
general public.

DAQ has the authority to make emissions data available to the public.

( 60.25(d)  The provisions referred to in          paragraphs (b) and
(c) of this section shall be specifically identified.  Copies of such
provisions shall be submitted with the plan unless:

          (1) They have been approved as portions of a preceding plan
submitted under this subpart or as portions of an implementation plan
submitted under Section 110 of the Act, and

          (2) The State demonstrates:

(i) That the provisions are applicable to the designated pollutant(s)
for which the plan is submitted, and

(ii) That the requirements of (60.26 are met.

Copies of the HMIWI plan revision,       including applicable rules
(WV45CSR18, as amended 6/16/11), were made available during the public
comment periods.

( 60.25(e)  The State shall submit reports on progress in plan
enforcement to the Administrator on an annual (calendar year) basis,
commencing with the first full report period after approval of a plan or
after promulgation of a plan by the Administrator.  Information required
under this paragraph must be included in the annual report required by (
51.321 of this chapter.

The DAQ has been submitting progress reports in June of each year for
the preceding calendar year.  The first report, under the plan revision,
will be due one year after EPA approval of the HMIWI plan revision.

( 60.25(f)  Each progress report shall include:

(1) Enforcement actions initiated against designated facilities during
the reporting period, under any emission standard or compliance schedule
of the plan.

(2) Identification of the achievement of any increment of progress
required by the applicable plan during the reporting period.

(3) Identification of designated facilities that have ceased operation
during the report period.

(4) Submission of emission inventory data as described in paragraph (a)
of this section for designated facilities that were not in operation at
the time of plan development but began operation during the reporting
period.

The content of the reports are stipulated in Section X of the plan
narrative; the content is consistent with ( 60.25(f).

(5)  Submission of additional data as necessary to update the
information submitted under paragraph (a) of this section or in previous
progress reports.

(6)  Submission of copies of technical reports on all performance
testing on designated facilities conducted under paragraph (b)(2) of
this section, complete with concurrently recorded process data.

	40 CFR 60.26  --  Legal authority

( 60.26(a)  Each plan shall show that the State has legal authority to
carry out the plan, including authority to:

          (1)  Adopt emission standards and compliance schedules
applicable to designated facilities.

          (2)  Enforce applicable laws, regulations, standards, and
compliance schedules, and seek injunction relief.

          (3)  Obtain information necessary to determine whether
designated facilities are in compliance with applicable laws,
regulations, standards, and compliance schedules, including authority to
require recordkeeping and to make inspections and conduct tests of
designated facilities.

          (4)  Require owners or operators of designated facilities to
install, maintain, and use emission monitoring devices and to make
periodic reports to the State on the nature and amounts of emissions
from such facilities; also authority for the State to make such data
available to the public as reported and as correlated with applicable
emission standards.

See EPA’s May 23, 2000 TSD for the initial plan approval.

( 60.26(b)  The provisions of law or regulations which the State
determines provide the authorities required by this section shall be
specifically identified.  Copies of such laws or regulations shall be
submitted with the plan unless:

(1)  They have been approved as portions of a preceding plan submitted
under this subpart or as portions of an implementation plan submitted
under section 110 of the Act, and

(2)  The State demonstrates that the laws or regulations are applicable
to the designated pollutant(s) for which the plan is submitted.

Same as above. EPA has approved previous WV 111(d)/129 plans – CISWI,
HMIWIs and landfills.

( 60.26(c)    The plan shall show that the legal authorities specified
in this section are available to the State at the time of submission of
the plan.  Legal authority adequate to meet the requirements of
paragraphs (a)(3) and (4) of this section may be delegated to the State
under section 114 of the Act.

Same as above. Legal authority cited in the submitted plan.

( 60.26(d)  A State governmental agency other than the State air
pollution control agency may be assigned responsibility for carrying out
a portion of a plan if the plan demonstrates to the Administrator's
satisfaction that the State governmental agency has the legal authority
necessary to carry out that portion of the plan.

Not applicable.

( 60.26(e)  The State may authorize a local agency to carry out a plan
or portion thereof, within the local agency's jurisdiction if the plan
demonstrates to the Administrator's satisfaction that the local agency
has the legal authority necessary to implement the plan or portion
thereof, and that the authorization does not relieve the State of
responsibility under the Act for carrying out the plan or portion
thereof.

Not applicable.

III. Requirements affected HMIWI owners/operators must meet

Q. What general requirements must an owner/operator meet under the
approved EPA 111(d)/129 plan revision?

A. An owner/operator must meet the same applicability, emission limits,
operating, testing, monitoring, recordkeeping, reporting, compliance
schedules, and other applicable requirements contained in the revised
plan. While 45 CSR 18 contains provisions for various types of solid
waste incineration units, theses revisions and subsequent approval of
the plan deal only with HMIWI units.

Q. Is there a requirement for obtaining a Title V permit revision?

A. Yes, as with the previous plan approval, an affected facility will
need to submit a Title V permit application revision.  Accordingly, the
DAQ will complete the Title V permit revision as soon as practicable.
The level of public participation in revising the Title V permit will
depend on the type of revision needed under 40 CFR 70.7 and West
Virginia 45 CSR 30.6.

IV. Conclusion

While EPA did offer comments on the rule, West Virginia’s rulemaking
procedures would not enable them to make changes until the summer of
2012 at the earliest. EPA rule comments were related to minor
typographical errors under the definition section; the need to
acknowledge rule enforceability under 40 CFR Part 62, subpart XX; and
the consistency of conditions for repeat performance testing with
subpart Ce.  The DAQ responses to EPA comments are consistent with plan
requirements and clarify the intent of certain rule provisions. DAQ
stated in its response to comments that EPA concerns are not significant
enough to warrant disapproval of the plan, and EPA agrees. The submitted
West Virginia HMIWI plan revision to address October 6, 2009 amendments
to the emission guidelines, subpart Ce, and the related new source
performance standard provisions, subpart Ec, is approvable, and fully
enforceable.

The EPA Administrator continues to retain authority for several tasks,
as stipulated in 45 CSR 18, (45-18-11.1 this retention of federal
authority also includes the granting of waivers for initial and annual
compliance testing requirements.

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