[Federal Register Volume 88, Number 55 (Wednesday, March 22, 2023)]
[Notices]
[Page 17207]
[FR Doc No: 2023-05893]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 [Project No. 2701-061]

Erie Boulevard Hydropower, L.P.; Notice of Denial of Water
Quality Certification

    On February 26, 2021, Erie Boulevard Hydropower, L.P. (Erie) filed
an application for a license for the West Canada Creek Hydroelectric
Project (project) in the above captioned docket. Erie filed with the
New York State Department of Environmental Conservation (New York DEC)
a request for water quality certification for the project under section
401(a)(1) of the Clean Water Act on March 9, 2022. On March 7, 2023,
New York DEC denied certification for the project. Pursuant to 40 CFR
121.8, we are providing notice that New York DEC's denial satisfies the
requirements of 40 CFR 121.7(e).

    Dated: March 16, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-05893 Filed 3-21-23; 8:45 am]
BILLING CODE 6717-01-P


1 OMB 83 SUPPORTING STATEMENT ENVIRONMENTAL PROTECTION AGENCY STRATOSPHERIC OZONE PROTECTION A. JUSTIFICATION 1. Identification of the Information Collection a) Title: Recordkeeping and Periodic Reporting of the Production Import, Export, Recycling, Destruction, Transhipment and Feedstock Use of Ozone Depleting Substances.

OMB Number: 2060 0170 EPA Number: 1432.21 b) Short Characterization:

With this ICR, the Office of Air and Radiation ( OAR) is revising the previously approved information collection by the same title ( ICR # 1432.18) to include an exemption for the ozonedepleting substance, methyl bromide, specifically for use in quarantine or preshipment applications.

2. Need For, and Use Of, the Collection a) Authority for the Collection This information collection is authorized under section 603( b) of the Clean Air Act Amendments of 1990 ( CAAA). Although not authorized by an international treaty, this information collection is conducted to meet U. S. obligations under Article 7, Reporting Requirements, of the Montreal Protocol on Substances that Deplete the Ozone Layer ( Protocol).

b) Practical Utility/ Users of the Data The addition of these reporting requirements to those already established is designed to: 1) Ensure compliance with the restrictions on production, import and export of class I, Group VI controlled ozone depleting substances ( methyl bromide); 2) To allow exempted production and import for quarantine and preshipment applications and the consequent tracking of that production and import; 3) Satisfy U. S. obligations under the international treaty, the Montreal Protocol on Substances that Deplete the Ozone Layer ( Protocol), to report data under Article 7; 2 4) Fulfill statutory obligations under Section 603( b) and ( c) of Title VI of the Clean Air Act Amendments of 1990 ( CAAA) for reporting and monitoring; 5) Provide information to report to Congress on the production, use and consumption of class I and class II controlled substances as statutorily required in Section 603( d) of Title VI of the CAAA. This action revises the reporting requirements of the established regulations so companies may produce and import for special exempted uses of methyl bromide for quarantine and preshipment applications during the interim period when production and consumption is capped at 50% of the 1991 baseline level. In order to monitor each company's production, import, export, destruction, and transformation, the reporting system continues to require information which can be used to check industry compliance with the stratospheric ozone protection regulations. Compliance during the reduction steps for methyl bromide mean that companies can produce and import 50% of 1991 baseline levels, except for the specific exemption created by this action for quarantine and preshipment applications. The information required satisfies statutory mandates for reporting and monitoring under section 603 of Title VI of CAAA and will be used to generate reports to Congress as mandated under section 603( d) of Title VI. To ensure that the quantities produced or imported under the quarantine and preshipment exemption are used solely for these exempted purposes, this action creates reporting and recordkeeping requirements in addition to those already required by existing regulations and collected under an approved Information Collection Request. Information is collected to provide reports to the Secretariat of Protocol to meet U. S. international treaty obligations. Requirements to report data are listed in Article 7 of the Protocol. The information reported to EPA is entered into an electronic tracking system to ensure companies do not exceed the exempted production and import limits and to guarantee the U. S. does not violate it obligations under the Protocol. Thus, the information is used for compliance monitoring for individual companies and for monitoring U. S. compliance with obligations under the Montreal Protocol.

3. Non Duplication, Consultations, and Other Collection Criteria a) Non Duplication The amended information collection required by this notice was not previously collected by EPA. The collection is limited to a unique universe and specific information related to ozonedepleting substances. To certify the specific quarantine or preshipment requirement, EPA is accepting forms provided directly to the applicator by an official from a national plant, animal, environmental protection or health authority requesting the treatment of commodities to control quarantine pests, such as the phytosanitary certificates ( PPQ Form 577, PPQ Form 578, and PPQ Form 579) issued by USDA/ APHIS or an authorized State agency b) Public Notice Required Prior to ICR submissions to OMB 3 Since this is a rule related ICR, public notice soliciting public comments on the ICR and estimates of burden were done as part of the preamble.

c) Consultations EPA held two large meetings with stakeholders, including representatives from the affected industries, at the initiation of the process of developing this methyl bromide quarantine and preshipment regulation. The industry representatives made a few suggestions for reducing information collection burden. Based on an analysis of the industry suggestions, EPA amended a few of the reporting requirements.

d) Effects of Less Frequent Collection Less frequent collection of information would place an undue burden on both EPA and industry to ensure accuracy of data. Any inaccuracy would be compounded by the greater time between an actual event and the efforts needed to correct the historical information. Inaccuracies in information would compromise EPA's ability to implement the program. Inaccuracies would also reduce the validity of both reports to Congress and reports to the Secretariat of the Montreal Protocol. Companies expressed a desire to continue quarterly reporting to ensure accuracy of submitted data and ease the overall reporting burden. Several companies said semi annual or annual reporting would hinder their ability to monitor their own compliance with regulatory limits. Companies stated that internal processes to collect and report information work more smoothly on a quarterly basis than on a less frequent basis. Less frequent collection of data would compromise statutory requirement under Section 603 of the CAAA to monitor production, import and export levels. Less frequent collection of information would hinder EPA's ability to identify a violation of the regulation. Penalties for exceeding the regulatory limits are assessed daily at $ 27,500 per kilogram per day which necessitates frequent information collection. Violations would be much more complex to pursue and enforce if the information was submitted less frequently. Less frequent reporting would potentially put the United States in a non compliance status under the Montreal Protocol. If the U. S. were to exceed the limits established by international treaty it would jeopardize the ability of the U. S. to negotiate and secure favorable positions in the international forum. Quarterly reporting allows EPA the necessary time to take actions if production, import or export begin to exceed Protocol limits or the limits set in Section 604 of Title VI in the CAAA.

e) General Guidelines None of these reporting or recorrdkeeping requirements violate any of the regulations established by OMB in 5 CFR 1320.5.

f) Confidentiality and Sensitive Questions 4 EPA informs respondents that they may assert claims of business confidentiality for any of the information they submit. Information claimed confidential will be treated in accordance with the procedures for handling information claimed as confidential under 40 CFR Part 2, Subpart b, and will be disclosed only if EPA determines that the information is not entitled to confidential treatment. If no claim of confidentiality is asserted when the information is received by EPA, it may be made available to the public without further notice to the respondents ( 40 CFR 2.203).

g) Sensitive Questions This section is not applicable because this ICR does not involve matters of a sensitive nature.

4. The Respondents and the Information Requested a) Respondents/ NAIC Codes Respondents to this added segment of the information collection request include producers, feedstock users, importers, exporters, and destroyers of ozone depleting substances in NAIC Category 32532, Pesticide and Other Agricultural Chemical Manufacturing; NAIC Category 115, Support Activities for Agriculture and Forestry; NAIC Category 311, Food Manufacturing; NAIC Category 4225, Farm Product Raw Material Wholesalers; NAIC Category 56171, Exterminating and Pest Control Services; NAIC Category 4889, Other Support Activities for Transportation b) Information Requested i) Data Items, including Recordkeeping Requirements Methyl bromide producers and importers continue to report quarterly expenditure of production and consumption allowances. The current methyl bromide reporting identifies gross quantities produced and imported and then subtracts the exempted quantities that are transformed or destroyed. This action creates an additional category of exempted production and import of methyl bromide solely for use in quarantine and preshipment applications. The additional reporting for the methyl bromide quarantine and preshipment exemption is:

Producers Reporting:

! production of methyl bromide solely for quarantine or preshipment applications Importers Reporting ! imports of methyl bromide solely for quarantine or preshipment applications Exporters ! certification to producers/ importers that purchased quantity will be exported solely for quarantine or preshipment applications ! quantity exported for quarantine or preshipment applications. 5 Distributors ! certification to producers/ importers that purchased quantity will be solely for quarantine or preshipment applications;

! quantity distributed solely for quarantine or preshipment applications Applicators ! certification to distributors that purchased quantity will be used solely for quarantine or preshipment applications Commodity Owners, Shippers or their Agents ! documentation that the use of methyl bromide is to meet an official control or official requirement.

Requirements for keeping records associated with the reports listed above are for three years. These recordkeeping requirements pertain to original documents that are held by companies in the normal course of conducting business, such as Customs entry forms, accounts of daily production runs, sales invoices, and bills of lading. Information from these recordkeeping documents are summarized in reports. Recordkeeping requirements are designed to aid EPA in compliance monitoring, site inspection and enforcement actions.

( ii) Respondent Activities Since 1994, the producers, importers and exporters of methyl bromide have participated in the accelerated phaseout program for ozone depleting substances submitted reports on a quarterly basis. This change in information collection for the producers, importers and exporters will require the designation of exempted quantities of methyl bromide as being distinct from other current categories. Distributors of methyl bromide will need to review the reporting and recordkeeping instructions and send a Quarantine and Preshipment Certification Form to any person who places an order for a quantity of methyl bromide that is explicitly and solely for quarantine and preshipment applications as defined. A draft copy of this form is attached. At the end of the calendar year, distributors will compile the total quantity ordered solely for quarantine and preshipment applications ( for which certifications were received) and transmit this summary data to EPA. Applicators will need to review instructions regarding completion of the Quarantine and Preshipment Certification Form, but once understood the process will simply involve writing down the quantity of methyl bromide being ordered and signing the form before tranmitting it back to the distributor. For quarantine applications, the applicator will need to collect documentation citing the regulatory requirement that justifies the use of the exempted methyl bromide. This documentation will be maintained by the applicator as a record.

5. The Information Collected, Agency Activities, Collection Methodology, and Information Management a) Agency Activities ! Refine new Post Phaseout Tracking System to incorporate changes to post 6 phaseout regulatory requirements;

! Enter and store information submitted from companies in the electronic Post Phaseout Tracking System;

! Review information and conduct compliance monitoring activities related to restrictions on production, import, export, transformation and destruction of ozone depleting controlled substances for individual companies comparing data with information from U. S. Customs for imports ( quarterly), exports to Article 5 countries ( quarterly), and with information from the International Trade Commission for production;

! Inspect records maintained by producers, importers, exporters, transformers, and destroyers of ozone depleting substances;

! Review information in tracking system to ensure U. S. is not exceeding obligations under the Montreal Protocol limiting production and imports;

! Review information in tracking system to ensure exempted production and imports do not exceed limits statutorily set in Section 604 of Title VI of the CAAA.

! Compile reports mandated by U. S. obligations under the Montreal Protocol and Title VI of the Clean Air Act Amendments of 1990, including Reports to Congress.

b) Collection and Methodology and Management After the many current separate rulemakings pertaining to 40 CFR Part 82, Subpart A are published as final rules, the Agency will revise forms distributed to companies in a newly revised Guidance Document. A copy of the current Guidance Document for Stratospheric Ozone Protection Program after January 1, 1996 is attached. The forms are also being prepared as " pdf" file for easy access on the web. Procedures for allowing direct electronic input of data in " pdf" versions of the forms are being investigated. Allowing for direct electronic input of data into a form may permit companies to save a form electronically   with a unique name according to a recommended file naming protocol   and may possibly permit the submission of the form by e mail ( if confidentiality concerns can be met). Although the use of the forms is voluntary, they are generally used by every participant in the regulatory program. In the past, the forms greatly facilitated and eased submission of data for respondents. The reporting requirements, first promulgated in the July 30, 1992 final rule, were significantly simplified through amendments published in the Federal Register on May 10, 1995, and the administrative and reporting burden were greatly reduced and eased. An electronic version of the Post Phaseout Tracking System is available for distribution to companies to allow electronic reporting by diskette. The system is operated using a Microsoft Access 97 format. The diskette sent to companies will contain a stand alone executable file of 7 Microsoft Access so they may operate the reporting system without needing the specific software.

c) Small Entity Flexibility The information required is collected for U. S. reporting obligations under Article 7 of the Montreal Protocol. EPA believes the information collection is required to ensure allowance holders have intended access to their allowances and to allow production and import of exempted quantities of methyl bromide. The information collection is also required to produce nationally mandated reports under Section 603 of the CAA and internationally mandated reports under Article 7 of the Montreal Protocol, and to ensure compliance with sections 604 and 606 of the Clean Air Act Amendments of 1990. The burden on all affected entities, and especially the burden on small entities, has been reduced to every extent possible. Distributors, possibly the only small entities required to submit information to EPA, are required to certify purchases of exempted class I, Group VI methyl bromide one time per year, indicating that it will be sold only to a person who certifies it will be solely be used for quarantine and preshipment applications. This requirement is to ensure proper use of exempted production and import and allow the U. S. to report specific information to the Montreal Protocol regarding the use of ozone depleting substances for quarantine and preshipment applications as required under Decision IX/ 28. All the producers and importers of methyl bromide are large companies.

d) Collection Schedule For 2001 and 2002 calendar years ( control periods):

! Producers, importers and exporters will report quarterly, with reports due 45 days after the end of each quarter.

! Distributors will report annually.

! Applicators submit a certification to distributors for each shipment of methyl bromide solely for quarantine and preshipment applications ! Commodity owners, shippers or their agents submit a document to the applicators for each request that a commodity be fumigated with methyl bromide to meet a specified official quarantine control or official preshipment requirement. Some companies expressed a desire to report quarterly rather than annually in order to ease their overall burden and increase the accuracy of their submissions. Companies claimed that quarterly submissions allow more accurate self monitoring for maintaining compliance with the regulations. Companies claim that smaller quarterly reports are easier to compile than larger semi annual or annual reports.

6) Estimating the Burden and Cost of Collection a) Estimating the Burden and b) Estimating the Respondent Cost The basis of the analysis, unchanged from the previously approved ICR relating to ODS 8 reporting requirements, is identification of the principal steps involved in complying with EPA reporting requirements and the estimated costs associated with each step. These costs have been estimated by identifying the number of times the step will be undertaken, the number of hours required to complete each step, and the total dollar costs. Each hour of industry time is assigned an average value of $ 83.00. This value represents an average hourly labor rate plus overhead for a private firm and is based on anecdotal information gleaned through the operation of the allowance tracking system during the 10 past years. The number of occurrences of each of the activities is based on quarterly reporting requirements, or less frequent reporting, as well as EPA experience with the allowance tracking system.

c) Estimating Agency Burden and Cost The basis of this analysis, also unchanged from previous submissions, is the identification of the steps involved in modifying the existing tracking system, and the identification of the steps involved in the operation of this system. The costs associated with each step have been estimated by identifying the number of times the step will be undertaken, the number of hours required to complete each step, and the total dollar cost. Costs are subdivided into Agency and contractor costs. Based on the FY2001 GS pay schedule, EPA estimates an average hourly labor cost of Grade 14, Step 5 at $ 40.56 for managerial staff, Grade 12, Step 5 at $ 28.87 for technical staff, and Grade 9, Step 5 at $ 19.90 for clerical staff. These hourly basic rates are from the Office of Personnel Management website. EPA then multiplied hourly rates by the standard government benefits multiplication factor of 1.6. The cost of contractor time and overhead is valued at $ 75.00 per hour and a 6 percent contract fee is included. The number of occurrences of each activity is based on quarterly reporting requirements as well as EPA experience with the allowance tracking system.

d) Estimating the Respondent Universe and Total Burden and Cost EPA estimated the respondent universe by taking the number of respondents identified in the previous reporting requirement ICR and adding those respondents effected by this additional requirement, specifically, those producers, importers, exporters, distributors, applicators and commodity owners, shippers and their agents of methyl bromide involved in the use of the chemical for quarantine or preshipment applications. Estimation of total burden and cost is described above in Sections 6 a and b.

e) Bottom Line Burden Hours and Cost Tables EPA intends to revise the current Guidance Document for the Stratospheric Ozone Protection Program After January 1, 1996 to reflect the changes in this information collection. EPA's development and dissemination of the Guidance Document for the Stratospheric Ozone Protection Program After January 1, 1996, is designed to inform all entities potentially subject to the reporting and recordkeeping requirements of the amended accelerated phaseout regulation. The Guidance Document explains the reasons the information is collected and the ways in which the information is used by the Agency. In addition, the Guidance Document cites the applicable 9 part of section 82.13 on reporting and recordkeeping requirements for each type of respondent published in the Federal Register. The preamble to the regulation and the Guidance Document both cite the authority under which respondents may claim information to be confidential. The Guidance Document, the forms and the final industry version of the electronic reporting diskette will be amended to include a clear burden statement. All forms currently cite the OMB Control Number and will be amended to include the expiration date once approved. The reporting burden for the reporting of methyl bromide quarantine and preshipment uses is estimated for one calendar year in the following table and added to the burden previously approved for the EPA reporting requirements. The estimate includes the time needed to comply with EPA's reporting requirements, as well as that used for the completion of the reports under the amended regulations for a calendar year.

TABLE I  RESPONDENT BURDEN HOURS PER YEAR COLLECTION ACTIVITY No. of Respondents Responses/ Respondent Total Responses Hours per Response Total Hours Producers & Importers Report 4 4 16 1 16 Exporters Report 2 4 8 8 64 Applicator Certification 15 6 90 0.5 45 Distributor Report 15 1 15 16 240 Commodity Owner, Shipper or Agent Recordkeeping 500 10 500 1 500 Previously Approved ODS Reporting Requirements 1081 25 1213 283 6492 TOTAL BURDEN HRS 1617 50 1842 309.5 7357 The methyl bromide quarantine and preshipment interim final rule requires respondents to submit reports to the Agency and maintain records. Operating and maintenance ( O& M) costs include file storage, photocopying, and postage. Operating and maintenance costs also include the general upkeep of start up capital equipment, as well as any purchase of services such as contractor or auditing services. The O& M costs are estimated at $ 141.87 for the methyl bromide quarantine and preshipment rule bringing the total O& M costs when combined with the previously approved reporting requirements to $ 3,173.87. No additional cost will be added as a result of this renewal.

TABLE II  AGENCY BURDEN HOURS 10 Hours per Response Managerial $ 40.56/ Hour Technical $ 28.87/ Hour Agency Hours/ Year Agency Costs/ Year Enter and store information in Tracking System 0.00 0.5 0.50 $ 14 Respond to companies submitting information 0.10 0.5 0.60 $ 18 Conduct compliance monitoring review of information 0.25 0.25 0.50 $ 17 Inspect records at plants 0.10 0.25 0.35 $ 11 Previously Approved ODS Reporting Requirements 1,759.00 $ 81,145 TOTAL 1,761 $ 81,207 Summary Bottom Line Burden Hours and Costs ( associated with the addition of this action to the previously approved reporting requirements of ICR # 1432.18 ): a) Respondent's annual burden hours 7,357 b) Respondent's annual labor costs $ 610,631 c) Respondent's capital/ start up costs $ 43 d) Respondent's O & M costs $ 3,173.87 e) Agency's annual burden hours 1,761 f) Agency's annual labor costs $ 81,207 f) Reason for Change in Burden The changes are to meet reporting requirements under Section 603 of the Clean Air Act and fulfill the reporting obligations of the United States under Article 7 of the Montreal Protocol on Substances that Deplete the Ozone Layer. The changes are also to monitor and track quantities of exempted methyl bromide to ensure that these exempted quantities are, in fact, solely used for quarantine or preshipment applications in accordance with the restrictions under the CAA and Protocol. The changes made are those associated with the addition of the methyl bromide quarantine and preshipment reporting requirements, there are no additional changes made to the overall reporting burden as a result of this renewal.

g) Burden Statement Table I presents the average annual respondent burden for companies affected by this rule exempting methyl bromide for quarantine and preshipment applications. The reporting burden is estimated to be an average of 1.38 hours per respondent per year. This estimate includes time for preparing and submitting reports and adjusts the calculation for duplicate respondents who submit 11 several reports in a year. The recordkeeping burden for companies affected by the accelerated phaseout regulations for ozone depleting substances is estimated to average 4.56 hours per respondent per year. This estimate includes time for gathering information, and developing and maintaining records. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15. Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to Ms Susan Auby, Collection Strategies Division ( Mail Code 2822), Office of Environmental Information, United States Environmental Protection Agency, 1200 Pennsylvania Avenue, NW, Washington, DC 20460 0001; and to the Office of Information and Regulatory Affairs , Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention Desk Officer for EPA. Include the EPA ICR number 1432.21 and OMB Control Number 2060 0170 in any correspondence. 12 APPENDIX I Collection Activity CFR Citation for Recordkeeping and Reporting Producer's Report 82.13( f)

Importer's Report 82.13( g)( q)( r)

Notification of Trade 82.9( c), 82.12 Export Report 82.13( h)

Lab Certification 82.13( y)

Class II Report 82.13( o)

Transformation & Destruction 82.13( i)( j)( k)( l)( m)

Essential Use Allowance Holders 82.13( u)

Lab Suppliers 82.13( v)( w)( x)

Lab Suppliers  Reference Standards 82.13( z)


[Federal Register Volume 75, Number 242 (Friday, December 17, 2010)]
[Rules and Regulations]
[Page 78883]
[FR Doc No: C1-2010-27614]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0279; Directorate Identifier 2009-NM-148-AD;
Amendment 39-16496; AD 2010-23-07]
RIN 2120-AA64

Airworthiness Directives; Airbus Model A318, A319, A320, and A321
Series Airplanes

Correction

    In rule document 2010-27614 beginning on page 68181 in the issue of
Friday, November 5, 2010, make the following corrections:

Sec.  39.13  [Corrected]

    1. On page 68183, in Sec.  39.13(c), in the second column, in the
first column of the table, in the 30th entry, ``D554 71000 000 00'',
should read ``D554 71001 000 00''.
    2. On the same page, in the same section, in the third column, in
the second column of the table, in the 19th entry, ``TS-Z072'', should
read ``TS-2072''.
    3. On page 68184, in the same section, in the first column, in the
first column of the table, in the 12th entry, ``D554 11002 000 00 003''
should read ``D554 71002 000 00 0003''.
    4. On the same page, in the same section, in the same column, in
the same column of the table, in the 14th entry, ``D554 11004 000 00
0000'' should read ``D554 71004 000 00 0000''.

[FR Doc. C1-2010-27614 Filed 12-16-10; 8:45 am]
BILLING CODE 1505-01-D


[Federal Register Volume 81, Number 181 (Monday, September 19, 2016)]
[Notices]
[Pages 64257-64265]
[FR Doc No: 2016-22452]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2016-0220]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation.

ACTION: Notice of applications for exemptions; request for comments.

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SUMMARY: FMCSA announces receipt of applications from 58 individuals
for exemption from the prohibition against persons with insulin-treated
diabetes mellitus (ITDM) operating commercial motor vehicles (CMVs) in
interstate commerce. If granted, the exemptions would enable these
individuals with ITDM to operate CMVs in interstate commerce.

DATES: Comments must be received on or before October 19, 2016.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2016-0220 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket numbers for this notice. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading below
for further information.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The Federal Docket Management System (FDMS) is
available 24 hours each day,

365 days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments on-line.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Christine A. Hydock, Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-113,
Washington, DC 20590-0001. Office hours are 8:30 a.m. to 5 p.m., e.t.,
Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

I. Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the Federal Motor Carrier Safety Regulations for a 2-year period
if it finds ``such exemption would likely achieve a level of safety
that is equivalent to or greater than the level that would be achieved
absent such exemption.'' The statute also allows the Agency to renew
exemptions at the end of the 2-year period. The 58 individuals listed
in this notice have recently requested such an exemption from the
diabetes prohibition in 49 CFR 391.41(b)(3), which applies to drivers
of CMVs in interstate commerce. Accordingly, the Agency will evaluate
the qualifications of each applicant to determine whether granting the
exemption will achieve the required level of safety mandated by
statute.

II. Qualifications of Applicants

Ardell M. Banta, Sr.

    Mr. Banta, 67, has had ITDM since 2012. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Banta understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Banta meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Iowa.

Ronald I. Barker

    Mr. Barker, 59, has had ITDM since 2012. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Barker understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Barker meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a CDL from Michigan.

William J. Bartlett

    Mr. Bartlett, 45, has had ITDM since 2015. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Bartlett understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Bartlett meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Iowa.

Griselda R. Begay

    Ms. Begay, 57, has had ITDM since 2003. Her endocrinologist
examined her in 2016 and certified that she has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
Her endocrinologist certifies that Ms. Begay understands diabetes
management and monitoring has stable control of her diabetes using
insulin, and is able to drive a CMV safely. Ms. Begay meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). Her
ophthalmologist examined her in 2016 and certified that she has stable
nonproliferative diabetic retinopathy. She holds an operator's license
from Utah.

Darrell L. Boehning

    Mr. Boehning, 58, has had ITDM since 2015. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Boehning understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Boehning meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Indiana.

John M. Bracken

    Mr. Bracken, 63, has had ITDM since 2000. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Bracken understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Bracken meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Pennsylvania.

Thomas E. Brennan

    Mr. Brennan, 55, has had ITDM since 2013. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist

certifies that Mr. Brennan understands diabetes management and
monitoring, has stable control of his diabetes using insulin, and is
able to drive a CMV safely. Mr. Brennan meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His optometrist examined him
in 2016 and certified that he does not have diabetic retinopathy. He
holds a Class B CDL from Pennsylvania.

Matthew W. Brown

    Mr. Brown, 47, has had ITDM since 2015. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Brown understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Brown meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2016 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class A CDL from
Oklahoma.

Norman Brown

    Mr. Brown, 62, has had ITDM since 2012. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Brown understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Brown meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Maine.

Walter L. Coon, II

    Mr. Coon, 54, has had ITDM since 2009. His endocrinologist examined
him in 2016 and certified that he has had no severe hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the last 5 years. His
endocrinologist certifies that Mr. Coon understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Coon meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His optometrist examined him
in 2016 and certified that he does not have diabetic retinopathy. He
holds an operator's license from California.

Roy L. Cox

    Mr. Cox, 66, has had ITDM since 2003. His endocrinologist examined
him in 2016 and certified that he has had no severe hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the last 5 years. His
endocrinologist certifies that Mr. Cox understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Cox meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined
him in 2016 and certified that he has stable nonproliferative diabetic
retinopathy. He holds an operator's license from North Carolina.

Robert S. Downie, Jr.

    Mr. Downie, 55, has had ITDM since 2012. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Downie understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Downie meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2016 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class A CDL from
Pennsylvania.

Frank A. Eagen

    Mr. Eagen, 47, has had ITDM since 2012. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Eagen understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Eagen meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Wisconsin.

Joseph F. Figueroa

    Mr. Figueroa, 52, has had ITDM since 2015. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Figueroa understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Figueroa meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Wisconsin.

Ernest R. Grasso

    Mr. Grasso, 51, has had ITDM since 2014. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Grasso understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Grasso meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2016 and certified that he does not
have diabetic retinopathy. He holds an operator's license from
Massachusetts.

Nolan Graves

    Mr. Graves, 75, has had ITDM since 2010. His endocrinologist
examined him in 2016 and certified that he has had no

severe hypoglycemic reactions resulting in loss of consciousness,
requiring the assistance of another person, or resulting in impaired
cognitive function that occurred without warning in the past 12 months
and no recurrent (2 or more) severe hypoglycemic episodes in the last 5
years. His endocrinologist certifies that Mr. Graves understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Graves meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2016 and certified that he does not
have diabetic retinopathy. He holds an operator's license from
Michigan.

Darryl W. Grimes

    Mr. Grimes, 47, has had ITDM since 2016. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Grimes understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Grimes meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2016 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Tennessee.

Henry L. Hardin

    Mr. Hardin, 75, has had ITDM since 2010. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Hardin understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Hardin meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Georgia.

John L. Hargis, Jr.

    Mr. Hargis, 50, has had ITDM since 2014. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Hargis understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Hargis meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2016 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Missouri.

Michael G. Haskins

    Mr. Haskins, 61, has had ITDM since 2016. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Haskins understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Haskins meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Virginia.

Howard C. Hayes

    Mr. Hayes, 52, has had ITDM since 2013. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Hayes understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Hayes meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Oklahoma.

Kevin L. Hess

    Mr. Hess, 21, has had ITDM since 2002. His endocrinologist examined
him in 2016 and certified that he has had no severe hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the last 5 years. His
endocrinologist certifies that Mr. Hess understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Hess meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His optometrist examined him
in 2016 and certified that he does not have diabetic retinopathy. He
holds an operator's license from Washington.

Joshua P. Hewson

    Mr. Hewson, 29, has had ITDM since 2001. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Hewson understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Hewson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds an operator's license from North Dakota.

Karen A. Holzwarth

    Ms. Holzwarth, 64, has had ITDM since 2011. Her endocrinologist
examined her in 2016 and certified that she has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
Her endocrinologist certifies that Ms. Holzwarth understands diabetes
management and monitoring has stable control of her diabetes using
insulin, and is able to drive a CMV safely. Ms. Holzwarth meets the
requirements of the vision

standard at 49 CFR 391.41(b)(10). Her optometrist examined her in 2016
and certified that she does not have diabetic retinopathy. She holds a
Class B CDL from Pennsylvania.

Michael R. Jacklin

    Mr. Jacklin, 47, has had ITDM since 2016. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Jacklin understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Jacklin meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Wisconsin.

Richard P. Janney

    Mr. Janney, 70, has had ITDM since 2001. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Janney understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Janney meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2016 and certified that he has stable
nonproliferative diabetic retinopathy. He holds an operator's license
from Delaware.

Hershell D. Jones

    Mr. Jones, 37, has had ITDM since 2004. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Jones understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Jones meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2016 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class A CDL from
Kentucky.

William H. Kline

    Mr. Kline, 60, has had ITDM since 2016. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Kline understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Kline meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2016 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Ohio.

Mitchell A. Langford

    Mr. Langford, 55, has had ITDM since 2014. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Langford understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Langford meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Oregon.

Michael J. Lipovsky

    Mr. Lipovsky, 27, has had ITDM since 2006. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Lipovsky understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Lipovsky meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2016 and certified that he does not
have diabetic retinopathy. He holds an operator's license from
Connecticut.

Edward J. Manley

    Mr. Manley, 45, has had ITDM since 2014. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Manley understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Manley meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Pennsylvania.

Joshua L. Mattas

    Mr. Mattas, 32, has had ITDM since 2016. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Mattas understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Mattas meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Pennsylvania.

Raymond E. McGuire

    Mr. McGuire, 51, has had ITDM since 2016. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or

more) severe hypoglycemic episodes in the last 5 years. His
endocrinologist certifies that Mr. McGuire understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. McGuire meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Pennsylvania.

Ismael Mejia

    Mr. Mejia, 67, has had ITDM since 2013. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Mejia understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Mejia meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Washington.

James L. Morgan, Jr.

    Mr. Morgan, 39, has had ITDM since 2016. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Morgan understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Morgan meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from North Carolina.

Shane M. Olden

    Mr. Olden, 31, has had ITDM since 2014. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Olden understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Olden meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Pennsylvania.

Wade B. Patrick

    Mr. Patrick, 61, has had ITDM since 2012. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Patrick understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Patrick meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2016 and certified that he does not
have diabetic retinopathy. He holds a Class B CDL from New York.

Shawn B. Persinger

    Mr. Persinger, 46, has had ITDM since 2015. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Persinger understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Persinger meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Wyoming.

Timothy J. Peterson

    Mr. Peterson, 30, has had ITDM since 1999. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Peterson understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Peterson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Nebraska.

Donald E. Ramper, Jr.

    Mr. Ramper, 62, has had ITDM since 2014. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Ramper understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Ramper meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2016 and certified that he does not
have diabetic retinopathy. He holds an operator's license from
Maryland.

Jose W. Rodriguez

    Mr. Rodriguez, 56, has had ITDM since 2015. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Rodriguez understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Rodriguez meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class B CDL from Wisconsin.

Stewart R. Rowell

    Mr. Rowell, 58, has had ITDM since 2016. His endocrinologist
examined him

in 2016 and certified that he has had no severe hypoglycemic reactions
resulting in loss of consciousness, requiring the assistance of another
person, or resulting in impaired cognitive function that occurred
without warning in the past 12 months and no recurrent (2 or more)
severe hypoglycemic episodes in the last 5 years. His endocrinologist
certifies that Mr. Rowell understands diabetes management and
monitoring, has stable control of his diabetes using insulin, and is
able to drive a CMV safely. Mr. Rowell meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His optometrist examined him
in 2016 and certified that he does not have diabetic retinopathy. He
holds an operator's license from Texas.

William T. Shreeve

    Mr. Shreeve, 55, has had ITDM since 1974. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Shreeve understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Shreeve meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2016 and certified that he has stable
nonproliferative diabetic retinopathy. He holds an operator's license
from Tennessee.

David L. Smith

    Mr. Smith, 49, has had ITDM since 1999. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Smith understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Smith meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Texas.

James A. Stock

    Mr. Stock, 49, has had ITDM since 2015. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Stock understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Stock meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Wisconsin.

Marlon Taylor

    Mr. Taylor, 53, has had ITDM since 2011. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Taylor understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Taylor meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Ohio.

Eddie B. Thacker

    Mr. Thacker, 25, has had ITDM since 1995. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Thacker understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Thacker meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2016 and certified that he has stable
nonproliferative diabetic retinopathy. He holds an operator's license
from Kentucky.

Earnest A. Tillman, III

    Mr. Tillman, 56, has had ITDM since 2010. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Tillman understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Tillman meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2016 and certified that he has stable
nonproliferative diabetic retinopathy. He holds an operator's license
from Florida.

William C. Tomlinson

    Mr. Tomlinson, 27, has had ITDM since 1992. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Tomlinson understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Tomlinson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Georgia.

David E. Walters

    Mr. Walters, 62, has had ITDM since 2015. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Walters understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Walters meets the

requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class B CDL from New Mexico.

Brennan S. Watkins

    Mr. Watkins, 26, has had ITDM since 1994. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Watkins understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Watkins meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2016 and certified that he does not
have diabetic retinopathy. He holds a Class B CDL from Vermont.

Julius Williams

    Mr. Williams, 53, has had ITDM since 2011. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Williams understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Williams meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2016 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Mississippi.

Kevin A. Wilson

    Mr. Wilson, 34, has had ITDM since 2007. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Wilson understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Wilson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2016 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from West Virginia.

Jeffrey S. Wine

    Mr. Wine, 57, has had ITDM since 2016. His endocrinologist examined
him in 2016 and certified that he has had no severe hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the last 5 years. His
endocrinologist certifies that Mr. Wine understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Wine meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His optometrist examined him
in 2016 and certified that he does not have diabetic retinopathy. He
holds a Class A CDL from Iowa.

John T. Witcraft

    Mr. Witcraft, 51, has had ITDM since 2015. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Witcraft understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Witcraft meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2016 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from South Dakota.

William B. Witzel

    Mr. Witzel, 33, has had ITDM since 2010. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Witzel understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Witzel meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2016 and certified that he has stable
nonproliferative diabetic retinopathy. He holds an operator's license
from South Carolina.

P. Wayne Woodward, Jr.

    Mr. Woodward, 53, has had ITDM since 1990. His endocrinologist
examined him in 2016 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Woodward understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Woodward meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2016 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from New York.

Richard Wynn

    Mr. Wynn, 29, has had ITDM since 2014. His endocrinologist examined
him in 2016 and certified that he has had no severe hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the last 5 years. His
endocrinologist certifies that Mr. Wynn understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Wynn meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His optometrist examined him
in 2016 and certified that he does not have diabetic retinopathy. He
holds an operator's license from Texas.

III. Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests
public comment from all interested persons on the exemption petitions
described in this notice. We will consider all comments received before
the close of

business on the closing date indicated in the date section of the
notice.
    FMCSA notes that section 4129 of the Safe, Accountable, Flexible
and Efficient Transportation Equity Act: A Legacy for Users requires
the Secretary to revise its diabetes exemption program established on
September 3, 2003 (68 FR 52441).\1\ The revision must provide for
individual assessment of drivers with diabetes mellitus, and be
consistent with the criteria described in section 4018 of the
Transportation Equity Act for the 21st Century (49 U.S.C. 31305).
---------------------------------------------------------------------------

    \1\ Section 4129(a) refers to the 2003 notice as a ``final
rule.'' However, the 2003 notice did not issue a ``final rule'' but
did establish the procedures and standards for issuing exemptions
for drivers with ITDM.
---------------------------------------------------------------------------

    Section 4129 requires: (1) Elimination of the requirement for 3
years of experience operating CMVs while being treated with insulin;
and (2) establishment of a specified minimum period of insulin use to
demonstrate stable control of diabetes before being allowed to operate
a CMV.
    In response to section 4129, FMCSA made immediate revisions to the
diabetes exemption program established by the September 3, 2003 notice.
FMCSA discontinued use of the 3-year driving experience and fulfilled
the requirements of section 4129 while continuing to ensure that
operation of CMVs by drivers with ITDM will achieve the requisite level
of safety required of all exemptions granted under 49 U.S.C.. 31136
(e).
    Section 4129(d) also directed FMCSA to ensure that drivers of CMVs
with ITDM are not held to a higher standard than other drivers, with
the exception of limited operating, monitoring and medical requirements
that are deemed medically necessary.
    The FMCSA concluded that all of the operating, monitoring and
medical requirements set out in the September 3, 2003 notice, except as
modified, were in compliance with section 4129(d). Therefore, all of
the requirements set out in the September 3, 2003 notice, except as
modified by the notice in the Federal Register on November 8, 2005 (70
FR 67777), remain in effect.

IV. Submitting Comments

    You may submit your comments and material online or by fax, mail,
or hand delivery, but please use only one of these means. FMCSA
recommends that you include your name and a mailing address, an email
address, or a phone number in the body of your document so that FMCSA
can contact you if there are questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov and
in the search box insert the docket number FMCSA-2016-0220 and click
the search button. When the new screen appears, click on the blue
``Comment Now!'' button on the right hand side of the page. On the new
page, enter information required including the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. 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. FMCSA may issue a final determination at any time after
the close of the comment period.

V. Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this
preamble, go to http://www.regulations.gov and in the search box insert
the docket number FMCSA-2016-0220 and click ``Search.'' Next, click
``Open Docket Folder'' and you will find all documents and comments
related to this notice.

    Issued on: September 2, 2016.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2016-22452 Filed 9-16-16; 8:45 am]
BILLING CODE 4910-EX-P


Notes from the November 6, 2013 Imazalil Cancer Risk Concern Meeting with EPA and Janssen PMF

           Imazalil Cancer Risk Meeting with Registrant Janssen PMF
               Wednesday, November 6[th] at 3-4pm (Eastern Time)
                 Location: Potomac Yards South, Room PYS 9261

Purpose of Meeting:
The upcoming meeting is intended as an opportunity for the EPA science divisions to ask registrant Janssen PMF questions relating to potential cancer risks from imazalil.
EPA Attendees:
HED: Jaime D'Agostino, Dennis McNeilly, Karlyn Middleton, Christina Swartz, Jess Rowland, Charles Wood (calling in)
PRD: Kevin Costello, Meg Hathaway (Chemical Review Manager), Tom Myers
RD: Tony Kish

Registrants (Calling In):
Janssen PMF
Bill Goodwine; Dr. Vince Picirillo (Toxicologist)

Agenda:
   I. Introductions

   II. Upcoming regulatory milestones
         a. December 2013 = Docket opening & Preliminary Work Plan (PWP) publication
         b. February 2014 = Close of public comment period on Imazalil PWP
         c. May 2014 = Final Work Plan (FWP) publishes
   III. Discussion of EPA science team questions and available MoA data
         a. HED discussion of options for registrant to move forward on addressing imazalil cancer risk concerns
         b. Other concerns?

   IV. Questions from the Registrants

   V. Conclusion (Next Steps/Repetition of Action Items)

Meeting Summary:
On November 6, 2013, staff from HED, PRD, and RD held a teleconference with representatives from Janssen PMP, a technical registrant for imazalil and imazalil sulfate.  Imazalil and imazalil sulfate are imidazole systemic fungicides used for a wide range of applications such as postharvest citrus treatments, equipment sterilization in poultry hatcheries, seed treatments, and greenhouse foggers.  Registrants provided EPA with an overview of available and proposed cancer-related studies on imazalil and addressed questions from HED regarding various data gaps.  The discussion focused on the type of data EPA would need to establish a mitogenic Mode of Action (MoA).  Janssen PMP is interested in establishing a MoA in anticipation of submitting a cancer reclassification package for imazalil.  EPA provided clarification on submission details for a cancer reclassification petition.  The registrant agreed to respond to questions from HED after reviewing data available from their imazalil study archives.  While a cancer reclassification is not necessary for registration review to proceed, Janssen PMF is interested in submitting their cancer reclassification petition before EPA's registration review process for imazalil is complete.

Discussion Topics:
(EPA Concerns in Black; Meeting Outcomes in Red)

The registrant plans to request a re-classification of Imazalil in the near future. However, the Agency currently believes that there is not enough data to support the proposed MoA for liver or thyroid tumors in either species. Instead, the Agency recommends the following options to address the tumors observed in each species:
*         Liver tumors in male mice. Previously, the registrant conducted a 4-day study with imazalil at 1200 ppm which showed an increased BrdU labeling index in the liver indicative of an early mitogenic burst. This study was conducted at a dose higher than those that caused tumors (200 ppm) and is not useful to support a mitogenic MoA. The Agency suggests conducting a cellular proliferation study in mice with doses at and below the dose (200 ppm) that induced liver tumors.  The results of this proposed study when taken together with the existing data in mice may provide the appropriate data for evaluating a potential MoA for liver tumors in mice.
*        MEETING RESULTS: Registrant responds that they have a completed study that will address EPA's concerns.  They plan to submit this study along with the cancer reclassification petition package.

*         Thyroid tumors in male rats. A previous study in rats (MRID 45160101) was conducted investigating thyroid hormones (T4 and TSH) following treatment with Imazalil. The study was conducted at doses both below (1200 ppm) and above (3200 ppm) the dose that induced tumors (2400 ppm). The data is suggestive of hormone changes but the data is not robust for reaching a decision on thyroid hormone perturbation. Consequently, the Agency recommends conducting a new study using doses at and below the dose that induced tumors; the treatment period should be for 90 days with thyroid hormone (T4 and TSH) measurements at appropriate time periods.
*        MEETING RESULTS: Registrant responds that they need to review their old studies and will get back to EPA on this topic. Also, EPA's Jess Rowland agreed to look through the thyroid MOA data EPA has in-house to see if any received submissions were short-term studies (e.g., 28 days vs. the 90-day study EPA was recommending) and inform Janssen of his findings.  After both parties report back to each other, a meeting/teleconference may be needed.

*         Liver tumors in male rats. The cellular proliferation study recently reviewed by the Agency was not supportive of the mitogenic MoA proposed by the registrant. The study was conducted at the appropriate time points and with the appropriate doses; however, there was no evidence of cellular proliferation.  Since the study was conducted adequately, repeating the study is not likely to provide different results.  Therefore, the Agency proposes a peer review of the original slides to confirm the diagnosis of the observed tumors (e.g, the  adenomas).
*         MEETING RESULTS: EPA informs the registrants that this item will not be of concern if acceptable studies are submitted for items A and B.  After the registrant addresses the liver (mouse) and thyroid (rat) tumor issues, a meeting may be needed to confirm this possible outcome.