[Federal Register Volume 78, Number 131 (Tuesday, July 9, 2013)]
[Notices]
[Pages 41185-41187]
[FR Doc No: 2013-16460]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2006-24278; FMCSA-2006-25854; FMCSA 2008-0355; FMCSA
2010-0203; FMCSA-2011-0089]

Denial of Exemption Applications; Epilepsy and Seizure Disorders

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of denial for exemptions from the provisions of 49 CFR
391.41(b)(8).

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SUMMARY: FMCSA announces denial of applications from seven individuals
for an exemption from the prohibition against persons with a clinical
diagnosis of epilepsy or any other condition which is likely to cause a
loss of consciousness or any loss of ability to operate a commercial
motor vehicle (CMV), from operating CMVs in interstate commerce.
Reasons for denial are listed after each name entry.

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Director, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Room
W64-224, Department of Transportation, 1200 New Jersey Avenue SE.,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31315 and 31136(e), FMCSA may grant an exemption
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 statutes also allow the
Agency to renew exemptions at the end of the 2-year period. The 7
individuals listed in this notice have recently requested an exemption
from the epilepsy and seizure disorder standard in 49 CFR 391.41(b)(8),
which applies to drivers who operate CMVs, as defined in 49 CFR 390.5,
in interstate commerce. Section 391.41(b)(8) states that a person is
physically qualified to drive a CMV if that person has no established
medical history or clinical diagnosis of epilepsy or any other
condition which is likely to cause the loss of consciousness or any
loss of ability to control a commercial motor vehicle.
    In order to make an evidence-based decision, FMCSA conducted a
comprehensive review of scientific literature and convened a panel of
medical experts in the field of neurology to evaluate key questions
regarding seizure and anti-seizure medication related to the safe
operation of a commercial motor vehicle. In reaching the determination
to grant or deny exemption requests for individuals who have
experienced a seizure, the Agency considered both current medical
literature and information and the 2007 recommendations of the Agency's
Medical Expert Panel (MEP). The Agency previously gathered evidence for
decision-making concerning potential changes to the regulation, by
conducting a comprehensive review of scientific literature that was
compiled into a report entitled, ``Evidence Report on Seizure Disorders
and Commercial Vehicle Driving'' (Evidence Report) [CD-ROM HD TL230.3
.E95 2007]. The Agency then convened an MEP in the field of neurology
on May 14-15, 2007, to review: 49 CFR 391.41(b)(8) and the advisory
criteria regarding individuals who have experienced a seizure; and the
2007 Evidence Report. The Evidence Report and the MEP recommendations
are published on-line at http://www.fmcsa.dot.gov/rules-regulations/topics/mep/mep-reports.htm, under Seizure Disorders, and are in the
docket for this notice.

MEP Criteria for Evaluation

    On October 15, 2007, the MEP issued the following recommended
criteria for evaluating whether an individual with epilepsy or a
seizure disorder should be allowed to operate a CMV.\1\ The MEP
recommendations are included in an appendix at the end of this notice
and in each of the previously published dockets.
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    \1\ Engel, J., Fisher, R.S., Krauss, G.L., Krumholz, A., and
Quigg, M.S., ``Expert Panel Recommendations: Seizure Disorders and
Commercial Motor Vehicle Driver Safety,'' FMCSA, October 15, 2007.
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    Epilepsy diagnosis. If there is an epilepsy diagnosis, the
applicant should be seizure-free for 8 years, on or off medication. If
the individual is taking anti-seizure medication(s), the plan for
medication should be stable for 2 years. Stable means no changes in
medication, dosage, or frequency of medication administration.
Recertification for drivers with an epilepsy diagnosis should be
performed every year.
    Single unprovoked seizure. If there is a single unprovoked seizure
(i.e., there is no known trigger for the seizure), the individual
should be seizure-free for 4 years, on or off medication. If the
individual is taking anti-seizure medication(s), the plan for
medication should be stable for 2 years. Stable means no changes in
medication, dosage, or frequency of medication administration.
Recertification for drivers with a single unprovoked seizure should be
performed every 2 years.
    Single provoked seizure. If there is a single provoked seizure
(i.e., there is a known reason for the seizure), the Agency should
consider specific criteria that fall into the following two categories:
Low-risk factors for recurrence and moderate-to-high risk factors for
recurrence.
     Examples of low-risk factors for recurrence include
seizures that were caused by a medication; by non-penetrating head
injury with loss of consciousness less than or equal to 30 minutes; by
a brief loss of consciousness not likely to recur while driving; by
metabolic derangement not likely to recur; and by alcohol or illicit
drug withdrawal.
     Examples of moderate-to-high-risk factors for recurrence
include seizures caused by non-penetrating head injury with loss of
consciousness or amnesia greater than 30 minutes, or penetrating head
injury; intracerebral hemorrhage associated with a stroke or trauma;
infections; intracranial hemorrhage; post-operative complications from
brain surgery with significant brain hemorrhage; brain tumor; or
stroke.

The MEP report indicates individuals with moderate to high-risk
conditions should not be certified. Drivers with a history of a single
provoked seizure with low risk factors for recurrence should be
recertified every year.

Medical Review Board Recommendations and Agency Decision

    FMCSA presented the MEP's findings and the Evidence Report to the
Medical Review Board (MRB) for consideration. The MRB reviewed and
considered the 2007 ``Seizure Disorders and Commercial Driver Safety''
evidence report and the 2007 MEP recommendations. The MRB recommended
maintaining the current advisory criteria, which provide that ``drivers
with a history of epilepsy/seizures off anti-seizure medication and
seizure-free for 10 years may be qualified to drive a CMV in interstate
commerce. Interstate drivers with a history of a single unprovoked
seizure may be qualified to drive a CMV in interstate commerce if
seizure-free and off anti-seizure medication for a 5 year period or
more'' [Advisory criteria to 49 CFR 391.43(f)].
    The Agency acknowledges the MRB's position on the issue but
believes relevant current medical evidence supports a less conservative
approach. The medical advisory criteria for epilepsy and other seizure
or loss of consciousness episodes was based on the 1988 ``Conference of
Neurological Disorders and Commercial Driving'' (NITS Accession No.
PB89-158950/AS). A copy of the report can be found in the docket
referenced in this notice.
    The MRB's recommendation treats all drivers who have experienced a
seizure the same, regardless of individual medical conditions and
circumstances. In addition, the recommendation to continue prohibiting
drivers who are taking anti-seizure medication from operating a CMV in
interstate commerce does not consider a driver's actual seizure history
and time since the last seizure. The Agency has decided to use the 2007
MEP recommendations as the basis for evaluating applications for an
exemption from the seizure regulation on an individual, case-by-case
basis. The disposition of applications announced in this notice applies
the 2007 MEP recommendations.

Public Comments

    Patty Cantagallo, MD, expressed her concern that applicant John
Morris had indications of alcohol abuse in his medical data. The Agency
did not include Mr. Morris in the final disposition. Dr. Cantagallo
also indicated uncertainty with applicant Anthony Besch having
unresolved ``nighttime seizures.'' Mr. Besch was excluded from final
disposition.

Denials and Reasons

     The following drivers were listed previously in Federal
Register Notice FMCSA-2006-24278:
    Anthony Besch--We are unable to contact Mr. Besch by phone or
through his former employer to ascertain his status.
    Charles Gant--Mr. Gant's records indicated that he had suffered
transient ischemic attacks (stroke), not epilepsy.
    John Morris--Mr. Morris' file indicated that his seizure was
induced by alcohol.
     The following driver was previously listed in Federal
Register Notice FMCSA-2006-25854:
    Daniel L. Pulse--Mr. Pulse may meet the criteria, but he has been
unresponsive in attempts to certify the date of his last seizure and/or
any anti-seizure medication he is taking.
     The following driver was previously listed in Federal
Register FMCSA-2008-0355:
    Travis Williams--Mr. Williams has a diagnosis of epilepsy, and his
last seizure was in 2008. He will have been seizure-free for 8 years,
as required by the MEP guidelines, in 2016. He may reapply at that
time.
     The following driver was listed previously in Federal
Register FMCSA 2010-0203:
    Leo Lombardio--Mr. Lombadrio had a loss of consciousness event
related to a diagnosis of complex partial seizures in 2009. He does not
meet the exemption criteria at this time.
     The following driver was listed previously in Federal
Register FMCSA 2011-0089:
    Richard Laqua--Mr. Laqua had a seizure in 2009 and does not
currently meet the exemption criteria.

    Issued on: June 27, 2013.
T.F. Scott Darling, III,
Chief Counsel.
[FR Doc. 2013-16460 Filed 7-8-13; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 82, Number 197 (Friday, October 13, 2017)]
[Notices]
[Pages 47750-47752]
[FR Doc No: 2017-22172]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-5991]

Agricultural Biotechnology Education and Outreach Initiative;
Public Meetings; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meetings; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
following public meetings entitled ``Agricultural Biotechnology
Education and Outreach Initiative.'' The purpose of the public meetings
is to provide the public with an opportunity to share information,
experiences, and suggestions to help inform the development of this
education and outreach initiative.

DATES: The public meetings will be held on November 7, 2017, in
Charlotte, North Carolina, and on November 14, 2017, in San Francisco,
California. Submit either electronic or written comments by November
17, 2017. See the SUPPLEMENTARY INFORMATION section for registration
date and information.

ADDRESSES: The public meetings will be held at:
     The Omni Charlotte, 132 East Trade St., Charlotte, NC
28202 on November 7, 2017, and
     The San Francisco Marriott Marquis, 780 Mission St., San
Francisco, CA 94103 on November 14, 2017.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before November 17, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of November 17, 2017. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your

comment will be made public, you are solely responsible for ensuring
that your comment does not include any confidential information that
you or a third party may not wish to be posted, such as medical
information, your or anyone else's Social Security number, or
confidential business information, such as a manufacturing process.
Please note that if you include your name, contact information, or
other information that identifies you in the body of your comments,
that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-N-5991 for ``Agricultural Biotechnology Education and Outreach
Initiative; Public Meetings; Request for Comments.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: For questions regarding registration
to attend a meeting: Simone Katz, Strategic Results, 101 Lakeforest
Blvd., Suite 390, Gaithersburg, MD 20877,<PHONE_NUMBER>,
<EMAIL_ADDRESS>For all other questions: Juanita
Yates, Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The Consolidated Appropriations Act, 2017 (Pub. L. 115-31)
stipulates that the Commissioner of Food and Drugs, in coordination
with the Secretary of Agriculture, will use appropriated funds to
provide consumer outreach and education regarding agricultural
biotechnology and biotechnology-derived food products and animal feed,
including through publication and distribution of science-based
educational information on the environmental, nutritional, food safety,
economic, and humanitarian impacts of such biotechnology.
    FDA is responsible for promoting and protecting the public health,
including by ensuring that the nation's food supply is safe and
nutritious. FDA provides information and outreach to a variety of
audiences along with extensive, hands-on food safety and nutrition
education programs for educators, health professionals, and consumers.
Educational materials are targeted to consumers in general, as well as
to specific groups such as children/youth, older Americans, underserved
populations, individuals with weakened immune systems (related to food
safety), pregnant women, and other subpopulations.
    To further our public health mission, we develop food safety and
nutrition outreach initiatives in conjunction with non-Federal
organizations and individuals, including teachers, community leaders,
health educators, animal owners, and private and public health
professionals, to increase awareness of and provide education on food
safety and nutrition.
    In developing and implementing the Agricultural Biotechnology
Education and Outreach Initiative, FDA will coordinate with the U.S.
Department of Agriculture (USDA). We also will collaborate with other
U.S. Federal Government Agencies, and public and private organizations
as needed. These interactions will help us to develop a comprehensive
and thorough framework for consumer education and awareness of the
environmental, nutritional, food safety, economic, and humanitarian
impacts of agricultural biotechnology. We believe public comment will
be helpful to inform the development of this education and outreach
initiative.

II. Topics for Discussion at the Public Meetings

    FDA is holding two public meetings, one in North Carolina and one
in California, to provide the public with an opportunity to provide
comments related to FDA's Agricultural Biotechnology Education and
Outreach Initiative. We invite the public to share information,
experiences, and suggestions that can help inform the development of
the education and outreach initiative. We invite interested persons,
including those participating in the public meetings, to respond to the
following questions specifically regarding agricultural biotechnology
and biotechnology-derived food products and animal feed:
    1. What are the specific topics, questions, or other information
that consumers would find most useful, and why?
    2. Currently, how and from where do consumers most often receive
information on this subject?
    3. How can FDA (in coordination with USDA) best reach consumers
with science-based educational information on this subject?
    The comments received will help FDA identify education goals,
messaging, and dissemination strategies

for FDA's Agricultural Biotechnology Education and Outreach Initiative.

III. Participating in the Public Meeting

    Registration: To register for a public meeting, please include your
name, title, firm name, address, and phone and fax numbers in your
registration information and send to: Simone Katz, Strategic Results,
101 Lakeforest Blvd., Suite 390, Gaithersburg, MD 20877,<PHONE_NUMBER>,
Fax:<PHONE_NUMBER>, email<EMAIL_ADDRESS>You can
register for one or both meetings.
    Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
meeting must register by October 30, 2017, for the Charlotte, NC,
meeting and must register by November 6, 2017, for the San Francisco,
CA, meeting. Early registration is recommended because seating is
limited; therefore, FDA may limit the number of participants from each
organization. Registrants will receive confirmation when they have been
accepted.
    If you need special accommodations due to a disability, please
contact Simone Katz, Strategic Results, 101 Lakeforest Blvd., Suite
390, Gaithersburg, MD 20877,<PHONE_NUMBER>, Fax:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>no later than October 20, 2017, for
the Charlotte, NC, meeting and no later than October 27, 2017, for the
San Francisco, CA, meeting.
    Requests for Oral Presentations: During online registration you may
indicate if you wish to present during a public comment session or
participate in a specific session, and which topic(s) you wish to
address. We will do our best to accommodate requests to make public
comments. Individuals and organizations with common interests are urged
to consolidate or coordinate their presentations, and request time for
a joint presentation, or submit requests for designated representatives
to participate in the focused sessions. Following the close of
registration, we will determine the amount of time allotted to each
presenter and the approximate time each oral presentation is to begin,
and will select and notify participants by October 24, 2017, for the
meeting in Charlotte, NC, and by November 1, 2017, for the meeting in
San Francisco, CA. All requests to make oral presentations must be
received by October 20, 2017, for the meeting in Charlotte, NC, and by
October 27, 2017, for the meeting in San Francisco, CA.
    Streaming Webcast of the Public Meeting: Each public meeting will
also be webcast. Individuals who wish to participate by webcast are
asked to preregister at: https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm
    If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the Web site addresses in this document, as of the date this document
publishes in the Federal Register, but Web sites are subject to change
over time.
    Transcripts: Please be advised that as soon as a transcript of each
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.
    Other Issues for Consideration: A summary of key information on
participating in a meeting follows:

                                                  Table 1--Information on Participation in the Meeting
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Request to make                         Submit either
             Date                    Address          Preregister       Electronic address         an oral            Special          electronic or
                                                                                presentation     accommodations      written comments
--------------------------------------------------------------------------------------------------------------------------------------------------------
November 7, 2017, from 8:30     Omni Charlotte     October 30, 2017:  Please preregister at   October 20, 2017.  October 20,       Submit Comments by
 a.m. to 1 p.m. EST.             Hotel, 132 E       Closing date for   https://www.fda.gov/                       2017: Closing     November 17, 2017,
                                 Trade St.,         registration.      Food/NewsEvents/                           date to request   to: https://
                                 Charlotte, NC                         WorkshopsMeetingsConf                      special           www.regulations.gov,
                                 28202.                                erences/default.htm.                       accommodations    or Dockets
                                                                                due to a          Management Staff
                                                                                disability.       (HFA-305), Food and
                                                                                Drug Administration,
                                                                                5630 Fishers Lane,
                                                                                Rm. 1061, Rockville,
                                                                                MD 20852.
November 14, 2017, from 8:30    San Francisco      November 6, 2017:  Please preregister at   October 27, 2017.  October 27,       Same as above.
 a.m. to 1 p.m. PST.             Marriott           Closing date for   https://www.fda.gov/                       2017: closing
                                 Marquis, 780       registration.      Food/NewsEvents/                           date to request
                                 Mission St., San                      WorkshopsMeetingsConf                      special
                                 Francisco, CA                         erences/default.htm.                       accommodations
                                 94103.                                                                           due to a
                                                                                disability.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    You may also register via email, mail, or fax. Please include your
name, title, firm name, address, and phone and Fax numbers in your
registration information and send to: Simone Katz, Strategic Results,
101 Lakeforest Blvd., Suite 390, Gaithersburg, MD 20877,<PHONE_NUMBER>,
Fax:<PHONE_NUMBER>, email<EMAIL_ADDRESS>    Individuals who wish to participate by webcast are asked to
preregister at: https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.

    Dated: October 6, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22172 Filed 10-12-17; 8:45 am]
 BILLING CODE 4164-01-P


DRAFT - Confidential, Internal and Deliberative Material

5/17/06

MEMORANDUM

SUBJECT:	Minutes of 4/19/06 ChemSAC meeting

TO:		HED’s Chemistry Interest Group

FROM:	HED’s Chemistry Science Advisory Council

Attendees: Chris Olinger (Minutes), Will Donovan, George Kramer, Tom
Bloem, P. Yvonne Barnes, Bernie Schneider, Leung Cheng, Rick Loranger,
Dave Soderberg, Mike Doherty (Chair), Doug Dotson, Toiya Goodlow, Rame
Cromwell, Steve Funk, and Hong Chen (IR-4, via phone)

[Note:  This is the last ChemSAC meeting held at Crystal Mall II.]

1.  Revision of Berry Crop Group (B. Schneider and H. Chen).   Bernie
provided a brief history of the berry crop group and outlined the
proposed changes developed by the EPA/IR-4 workgroup. Fresh fruit and
jam samples were provided as well. The new group will be called the
Berries and Small Fruits Group and will include several subgroups and
fruits that were previously excluded from any groups.  Details of the
proposal may be found in a memo from B. Schneider to B. Madden dated
3/28/06, entitled “Crop Grouping – Part II:  Analysis of the USDA
IR-4 Petition to Amend the Crop Group Regulation 40 CFR § 180.41
(c)(13) and Commodity Definitions [40 CFR § 180.1(h)] Related to Crop
Group 13 Berry”.  The ChemSAC concurred with the proposal and
recommended that the changes be adopted.

2.  Thiabendazole Mushroom Nutrient Supplement Use (W. Donovan).  Will
Donovan presented a proposal from IR-4 regarding the use of
thiabendazole (TBZ) in mushroom houses, using thiophanate-methyl residue
data to support the tolerance proposal.  Currently there are Section 24
(c) registrations for this use but IR-4 would like to extend the
registration for a national Section 3 use.  The ChemSAC decided there
was insufficient information to support IR-4’s proposal to translate
data from thiophanate-methyl to TBZ.  IR-4 should provide a more
detailed rationale in their Section 3 amended registration request to
justify the requested data translation and provide more detailed use
information.  Lacking a convincing rationale for translating from
thiophanate-methyl to TBZ, the request should be supported by field
trial data similar to what IR-4 has provided for thiophanate-methyl.

3.  Non-food-use Request for Applications with Shielded Sprayers (W.
Donovan).  Nichino America, Inc., submitted a rationale for considering
application of pyraflufen-ethyl using a hooded sprayer to row middles
between vegetable crops as a non-food use.  The rationale was based on
the cited 1) low probability of chemical drift from the hooded sprayer
to the vegetable crops, 2)  low probability of absorption from the soil
as demonstrated by confined accumulation in rotational crop studies, and
3) lack of translocation of pyraflufen-ethyl within plants as
demonstrated by nature of the residue studies in/on cotton, potato, and
wheat.  Applications to fields of crops well into the growing season are
virtually always considered food uses.  The ChemSAC did not consider the
use of hooded or shielded spray equipment for weed control in row
middles of vegetable crops to be sufficient to ensure that residues will
not occur in the harvested commodities.  However, a reduced data set may
be considered if the registrant conducts exaggerated rate, worst case
studies on representative crops from the crop groups proposed.

4.  Follow-up on Prothioconazole Issues (S. Funk).  Steve Funk updated
the ChemSAC on the issues raised when ChemSAC reviewed the draft Residue
Chemistry Chapter for the new chemical prothioconazole on March 29,
2006.  The ChemSAC recommended the team review the ruminant metabolism
and feeding studies for the metabolite desthio-prothioconazole.  The
transfer factor is greater for the metabolite than the parent compound
in the metabolism study, but is about the same or somewhat less in the
feeding studies.  The ChemSAC concluded that the results of the
supplementary studies when considered together do not alter the values
for the total levels of residue of concern in ruminant commodities,
i.e., the primary studies on parent metabolism and feeding in ruminants
adequately define the situation.  The outputs from the MRL calculator
were added to the chemistry summary document.  In general, the outputs
were used with the exception of the commodities for which there were
high levels of non-detectable residues.

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