[Federal Register Volume 79, Number 186 (Thursday, September 25, 2014)]
[Notices]
[Page 57654]
[FR Doc No: 2014-22143]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Notice of Applications for Certificates of Public Convenience and
Necessity and Foreign Air Carrier Permits Filed Under Subpart B
(Formerly Subpart Q) During the Week Ending August 23, 2014

    The following Applications for Certificates of Public Convenience
and Necessity and Foreign Air Carrier Permits were filed under Subpart
B (formerly Subpart Q) of the Department of Transportation's Procedural
Regulations (See 14 CFR 302.201 et. seq.). The due date for Answers,
Conforming Applications, or Motions to Modify Scope are set forth below
for each application. Following the Answer period DOT may process the
application by expedited procedures. Such procedures may consist of the
adoption of a show-cause order, a tentative order, or in appropriate
cases a final order without further proceedings.
    Docket Number: DOT-OST-2014-0139.
    Date Filed: August 18, 2014.
    Due Date for Answers, Conforming Applications, or Motion to Modify
Scope: September 8, 2014.
    Description: Application of London Executive Aviation Limited
(``LEA'') requesting a foreign air carrier permit and an exemption
authorizing LEA to engage in: (i) Foreign charter air transportation of
persons, property, and mail from any point or points behind any Member
State of the European Union, via any point or points in any EU Member
State and via intermediate points, to any point or points in the United
States and beyond; (ii) foreign charter air transportation of persons,
property, and mail between any point or points in the United States and
any point or points in any member of the European Common Aviation Area;
(iii) foreign charter air transportation of cargo between any point or
points in the United States and any other point or points; (iv) other
charters pursuant to the prior approval requirements; and (v) charter
transportation authorized by any additional route rights made available
to European Union carriers in the future.

Barbara J. Hairston,
Supervisory Dockets Officer, Docket Operations, Federal Register
Liaison.
[FR Doc. 2014-22143 Filed 9-24-14; 8:45 am]
BILLING CODE 4910-9X-P


From:
Jones, DonnaLee<EMAIL_ADDRESS>Sent:
Monday, April 4, 2016 5:15 PM
To:
<EMAIL_ADDRESS><EMAIL_ADDRESS>Cc:
David Ailor<EMAIL_ADDRESS><EMAIL_ADDRESS>Raymond, Gabrielle<EMAIL_ADDRESS>Subject:
Your coke ICR letter and attachments - U.S. Steel

Hello  -  Attached you will find a pdf of your signed cover letter for the Coke ICR. Also attached are Enclosures 1&2 as pdf files. Enclosures #3 through #8 are attached in a combined pdf file; these are standard enclosures we include with all ICRs. Please visit the Coke ICR website at: https://icr2010.rti.org/  for the latest versions of the data tables (Excel files) to use for your answers to Enclosures 1 and 2 as well as Word versions of both Enclosures 1&2. Your packages which include hard copies of all of the attached enclosures as well as a disc with Word versions of Enclosures 1&2 and the Excel data tables. Feel free to use this disc for your first submission, but you can also send a USB/flash drive with the files, or alternatively upload the files to a password protected area of the ICR website. Note that discs and flash drives will not be returned until the end of the ICR process.
_____________________________________________________________
Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D 243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

<< Coke114_cover_letter_04-04-16_USS_signed.PDF >>
<< Coke ICR-Enclosure 1-04-01-16P.pdf >>
<< Coke ICR-Enclosure 2-04-04B-16.pdf >>
<< Enclosure 3 - 8-2016-RTI.pdf >>


Reviewed Studies Pertaining to

High-efficiency Particulate Air Filter Shroud Effectiveness

Akbar-Khanzadeh, Farhang and Randall L. Brillhart.  Respirable
Crystalline Silica Dust Exposure During Concrete Finishing (Grinding)
Using Hand-held Grinders in the Construction Industry.  Annals of
Occupational Hygiene 46(3):341-346 (2002).

Akbar-Khanzadeh, Farhang, Sheryl Milz, April Ames, Pamela P. Susi,
Michael Bisesi, Sadik A. Khuder, and Mahboubeh Akbar-Khanzadeh.
Crystalline Silica Dust and Respirable Particulate Matter During Indoor
Concrete Grinding—Wet Grinding and Ventilated Grinding Compared with
Uncontrolled Conventional Grinding.  Journal of Occupational and
Environmental Hygiene 4:770-779 (2007).

Centers for Disease Control and Prevention: National Institute of
Occupational Safety and Health.  In-depth Survey Report of Control of
Respirable Dust and Crystalline Silica from Grinding Concrete at Messer
Construction, Newport, Kentucky, and Baker Concrete Construction,
Dayton, Ohio.  August 2002.

Chisholm, Jim.  Respirable Dust and Respirable Silica Concentrations
from Construction Activities.  Indoor and Built Environment 8:94 (1999).

Collingwood, Scott Charles.  Research to Practice: Evaluations and
Recommendations for Local Exhaust Ventilation Designed to Reduce
Respirable Crystalline Silica and Dust Exposures Experienced During
Mortar Removal.  Doctoral Dissertation, University of Iowa (2006).

Croteau, Gerry A., Mary Ellen Flanagan, Janice E. Camp, and Noah S.
Seixas.  The Efficacy of Local Exhaust Ventilation for Controlling Dust
Exposures During Concrete Surface Grinding.  Annals of Occupational
Hygiene 48(6):509-518 (2004).

Croteau, Gerry A., Steven E. Guffey, Mary Ellen Flanagan, and Noah S.
Seixas.  The Effect of Local Exhaust Ventilation Controls on Dust
Exposures During Concrete Cutting and Grinding Activities.  American
Industrial Hygiene Association Journal 63(4):458-467 (2002).

Heitbrink, William A., Thomas C. Cooper, and Marjorie A. Edmonds.
Evaluation of Ventilated Sanders in the Autobody Repair Industry.
American Industrial Hygiene Association Journal 55(8):756-759 (1994).

Nij, Evelyn Tjoe, Simone Hilhorst, Ton Spee, Judith Spierings, Friso
Steffens, Mieke Lumens, and Dick Heederik.  Dust Control Measures in the
Construction Industry.  Annals of Occupational Hygiene 47(3):211-218
(2003).

Ojima, Jun.  Efficiency of a Tool-mounted Local Exhaust Ventilation
System for Controlling Dust Exposure during Metal Grinding Operations.
Industrial Health 45(6):817-819 (2007).

Seixas, Noah S., Janice Camp, Mary Ellen Flanagan, and Gerry A. Croteau.
 Evaluation of Dust Control Technologies in Construction Tasks.
University of Washington Department of Environmental Health (2004).

Shepherd, S., S.R. Woskie, C. Holcroft, and M. Ellenbecker.  Reducing
Silica and Dust Exposures in Construction During Use of Powered
Concrete-cutting Hand Tools: Efficacy of Local Exhaust Ventilation on
Hammer Drills.  Journal of Occupational and Environmental Hygiene
6:42-51 (2009).

Teitsworth, Jan Edward and Maura J. Sheehan.  The Effectiveness of Local
Exhaust-Ventilated (Shrouded) Hand Power Tools Used for Grinding/Sanding
Composite Materials.  American Industrial Hygiene Association Journal
59:689-693 (1998).

Thorpe, A., A.S. Ritchie, M.J. Gibson, and R.C. Brown.  Measurements of
the Effectiveness of Dust Control on Cut-off Saws Used in the
Construction Industry.  Annals of Occupational Hygiene 43(7):443-456
(1999).


OAQPS staff BART meetings with outside groups, 2005 to date:

Feb. 15, 2005: National Environmental Development Association's Clean Air Project ( NEDA/ CAP)   Leslie Ritts, et. al.

April 25, April 27, May 4: Western Regional Air Partnership ( WRAP) Stationary Source Joint Forum / Pat Cummins May 5: American Forest and Paper Association May 17: WRAP Board


[Federal Register: August 6, 2010 (Volume 75, Number 151)]
[Rules and Regulations]
[Page 47465-47475]
[DOCID:fr06au10-10]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0190; FRL-8836-8]

Pymetrozine; Regulation Denying NRDC's Objections on Remand

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final Regulation.

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SUMMARY: In this regulation, EPA again denies objections by the Natural
Resources Defense Council (NRDC) to an action establishing tolerance
regulations for the pesticide pymetrozine under section 408 of the
Federal Food, Drug, and Cosmetic Act (FFDCA). EPA's previous denial of
NRDC's objections, published in the Federal Register on August 10,
2005, was remanded to EPA by the U.S. Court of Appeals, Ninth Circuit,
for further explanation of EPA's decision on the application of the
FFDCA's requirement concerning an additional tenfold safety factor for
the protection of infants and children to these pesticide tolerances.
In the challenged action, EPA had applied a reduced additional safety
factor to several risk assessments for pymetrozine. EPA has reviewed
its decision on the children's safety factor in light of the current
data on pymetrozine and now determined that the full additional
children's safety factor should be applied in assessing the risk of the
pymetrozine tolerances. However, EPA still denies NRDC's objections
because the increase in the children's safety factor does not change
EPA's conclusion that the tolerances are safe. EPA's explanation for
its decisions on the children's safety factor and the safety of
pymetrozine tolerances are included in this regulation.

DATES: This regulation is effective August 6, 2010. Objections and
requests for hearings must be received on or before October 5, 2010,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2004-0190. To access the
electronic docket, go to http://www.regulations.gov, and search for the
docket number. Follow the instructions on the regulations.gov website
to view the docket index or access available documents. All documents
in the docket are listed in the docket index available in
regulations.gov. Although listed in the index, some information is not
publicly available, e.g., Confidential Business Information (CBI) or
other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Meredith Laws, Registration Division
(7510P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    In this document EPA denies objections by the NRDC to EPA's
establishment of certain pesticide tolerances. This action may also be
of interest to agricultural producers, food manufacturers, or pesticide
manufacturers. Potentially affected entities may include, but are not
limited to those engaged in the following activities:
     Crop production (NAICS) code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection

or request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2005-0190 in the
subject line on the first page of your submission. All requests must be
in writing, and must be received by the Hearing Clerk as required by 40
CFR part 178 on or before October 5, 2010.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2005-0190, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Introduction

A. What Action Is the Agency Taking?

    This action is being taken in response to a remand to EPA of a
final order denying objections filed by the NRDC to regulations
establishing pesticide tolerances for pymetrozine under section 408 of
the FFDCA, 21 U.S.C. 346a. (70 FR 46706, August 10, 2005); (Ref. 1).
The order was remanded to EPA by the U.S. Court of Appeals, Ninth
Circuit, for an explanation of the basis for EPA's decision on the
FFDCA's provision requiring a presumptive additional tenfold (10X)
safety factor for the protection of infants and children. (NCAP v. EPA,
544 F.3d 1043, 1052 (9th Cir. 2008)). Specifically, the court held that
EPA did not provide ``enough information'' on why in evaluating the
risk of pymetrozine it chose to deviate from this presumptive safety
factor. (Id.). In response to the remand, EPA is again denying the
objections. In light of new data received on pymetrozine, EPA has now
determined that the presumptive safety factor for infants and children
should be retained; however, the objections are denied because
retention of this additional safety factor does not show the
pymetrozine tolerances to be unsafe.
    Because EPA has taken new information into account in issuing this
decision upon remand, EPA is issuing the remand decision as a
regulation under FFDCA section 408(d)(4)(i). Any person may file
objections to a FFDCA section 408(d)(4)(i) regulation with EPA and
request a hearing on those objections. (Id.). If this decision was
issued as a revised final order on NRDC's objections under FFDCA
section 408(g)(2)(C), (21 U.S.C. 346a(g)(2)(C)), then any party who
wished to contest EPA's determination would have no opportunity to
submit factual contentions to the record concerning the new information
prior to seeking judicial review.

B. What Is the Agency's Authority for Taking This Action?

    EPA's authority for issuing pesticide tolerances is contained in
FFDCA section 408(d) and the statutory provisions governing the
administrative review process for tolerances is in FFDCA section
408(g)(2). (21 U.S.C. 346a(d) and (g)(2)).

III. Statutory and Regulatory Background

    In this Unit, EPA provides background on the relevant statutes and
regulations governing NRDC's objections as well as on pertinent Agency
policies and practices. Unit III.A. summarizes the requirements and
procedures in section 408 of the FFDCA and applicable regulations
pertaining to pesticide tolerances. Unit III.B. provides an overview of
EPA's risk assessment process. It contains an explanation of how EPA
identifies the hazards posed by pesticides, how EPA determines the
level of exposure to pesticides that pose a concern (``level of
concern''), how EPA measures human exposure to pesticides, and how
hazard, level of concern conclusions, and human exposure estimates are
combined to evaluate risk. Further, this unit presents background
information on the EPA's policy with regard to the statutory safety
factor for the protection of infants and children.

A. FFDCA

    1. In general. EPA establishes maximum residue limits, or
``tolerances,'' for pesticide residues in food under section 408 of the
FFDCA. (21 U.S.C. 346a). Without such a tolerance or an exemption from
the requirement of a tolerance, a food containing a pesticide residue
is ``adulterated'' under section 402 of the FFDCA and may not be
legally moved in interstate commerce. (21 U.S.C. 331, 342). Monitoring
and enforcement of pesticide tolerances are carried out by the U.S.
Food and Drug Administration and the U.S. Department of Agriculture
(USDA). Section 408 was substantially rewritten by the Food Quality
Protection Act of 1996 (FQPA), which added the provisions discussed
below establishing a detailed safety standard for pesticides and
additional protections for infants and children. (Public Law 104-170,
110 Stat. 1489 (1996)).
    2. Safety standard for pesticide tolerances. A pesticide tolerance
may only be promulgated by EPA if the tolerance is ``safe.'' (21 U.S.C.
346a(b)(2)(A)(i)). ``Safe'' is defined by the statute to mean that
``there is a reasonable certainty that no harm will result from
aggregate exposure to the pesticide chemical residue, including all
anticipated dietary exposures and all other exposures for which there
is reliable information.'' (21 U.S.C. 346a(b)(2)(A)(ii)). The statute
explains that aggregate exposure to a pesticide includes ``dietary
exposure under the tolerance and all other tolerances in effect for the
pesticide chemical residue, and exposure from other non-occupational
sources.'' (21 U.S.C. 346a(b)(2)(D)(vi)).
    In making the safety determination for a tolerance, risks to
infants and children are given special consideration. Specifically,
section 408(b)(2)(C) creates a presumptive additional safety factor for
the protection of infants and children. It directs that ``[i]n the case
of threshold effects, ... an additional tenfold margin of safety for
the pesticide chemical residue and other sources of exposure shall be
applied for infants and children to take into account potential pre-
and post-natal toxicity and completeness of the data with respect to
exposure and toxicity to infants and children.'' (21 U.S.C.
346a(b)(2)(C)). EPA is permitted to ``use a different margin of safety
for the pesticide chemical residue only if, on the basis of reliable
data, such margin will be safe for infants and children.'' (Id.). The
additional safety margin for infants and children is referred to
throughout this document as the ``children's safety factor.''
    3. Procedures for establishing, amending, or revoking tolerances.
Tolerances are established, amended, or revoked by rulemaking under the

unique procedural framework set forth in the FFDCA. Generally, a
tolerance rulemaking is initiated by the party seeking to establish,
amend, or revoke a tolerance by means of filing a petition with EPA.
(See 21 U.S.C. 346a(d)(1)). EPA publishes in the Federal Register a
notice of the petition filing and requests public comment. (21 U.S.C.
346a(d)(3)). After reviewing the petition, and any comments received on
it, EPA may issue a final rule establishing, amending, or revoking the
tolerance, issue a proposed rule to do the same, or deny the petition.
(21 U.S.C. 346a(d)(4)).
    Once EPA takes final action on the petition by establishing,
amending, or revoking the tolerance or denying the petition, any person
may file objections with EPA and seek an evidentiary hearing on those
objections. (21 U.S.C. 346a(g)(2)). Objections and hearing requests
must be filed within 60 days after date of publication in the Federal
Register. (Id.). EPA's final order on the objections is subject to
judicial review. (21 U.S.C. 346a(h)(1)).

B. EPA Risk Assessment for Tolerances - Policy and Practice

    1. The safety determination-risk assessment. To assess risk of a
pesticide tolerance, EPA combines information on pesticide toxicity
with information regarding the route, magnitude, and duration of
exposure to the pesticide. The risk assessment process involves four
distinct steps:
     Identification of the toxicological hazards posed by a
pesticide;
     Determination of the ``level of concern'' with respect to
human exposure to the pesticide;
     Estimation of human exposure to the pesticide; and
     Characterization of the risk posed to humans by the
pesticide based on comparison of human exposure to the level of
concern.
    a. Hazard identification. In evaluating toxicity or hazard, EPA
reviews toxicity studies, primarily in laboratory animals, to identify
any adverse effects on the test subjects. Animal studies typically
involve investigating a broad range of endpoints including gross and
microscopic effects on organs and tissues, functional effects on body
organs and systems, effects on blood parameters (such as red blood cell
count, hemoglobin concentration, hematocrit, and a measure of clotting
potential), effects on the concentrations of normal blood chemicals
(including glucose, total cholesterol, urea nitrogen, creatinine, total
protein, total bilirubin, albumin, hormones, and enzymes such as
alkaline phosphatase, alanine aminotransfersase and cholinesterases),
and behavioral or other gross effects identified through clinical
observation and measurement. EPA examines whether adverse effects are
caused by either short-term (e.g., acute) or longer-term (e.g.,
chronic) pesticide exposure and the effects of pre-natal and post-natal
exposure in animals.
    EPA also considers whether the adverse effect has a threshold -- a
level below which exposure has no appreciable chance of causing the
effect. For non-threshold effects, EPA assumes that any exposure to the
substance increases the risk that the adverse effect may occur. At
present, EPA only considers one adverse effect, the chronic effect of
cancer, to potentially be a non-threshold effect. (Ref. 2 at 4-9). Not
all carcinogens, however, pose a risk at any exposure level (i.e., ``a
non-threshold effect or risk''). Advances in the understanding of the
mode of action of carcinogenesis have increasingly led EPA to conclude
that some pesticides that cause carcinogenic effects in animal studies
only cause such effects above a certain threshold of exposure.
    b. Level of concern/dose-response analysis. Once a pesticide's
potential hazards are identified, EPA determines a toxicological level
of concern for evaluating the risk posed by human exposure to the
pesticide. In this step of the risk assessment process, EPA essentially
evaluates the levels of exposure to the pesticide at which effects
might occur. An important aspect of this determination is assessing the
relationship between exposure (dose) and response. The assessment of
this relationship is often referred to as the dose-response analysis.
EPA follows differing approaches to identifying a level of concern for
threshold and non-threshold hazards.
    i. Threshold effects. In examining the dose-response relationship
for a pesticide's threshold effects, EPA evaluates an array of toxicity
studies on the pesticide. In each of these studies, EPA attempts to
identify the lowest observed adverse effect level (LOAEL) and the next
lower dose at which there are no observed adverse effect levels
(NOAEL). Generally, EPA will use the lowest NOAEL from the available
studies as a starting point (called the Point of Departure) in
estimating the level of concern for humans. (Ref. 2 at 9 (The Point of
Departure ``is simply the toxic dose that serves as the `starting
point' in extrapolating a risk to the human population.'')). At times,
however, EPA will use a LOAEL from a study as the Point of Departure
when no NOAEL is identified in that study and the LOAEL is close to, or
lower than, other relevant NOAELs. The Point of Departure is in turn
used in choosing a level of concern. EPA will make separate
determinations as to the Points of Departure, and correspondingly
levels of concern, for both short and long exposure periods as well as
for the different routes of exposure (oral, dermal, and inhalation).
    In estimating and describing the level of concern, the Point of
Departure is at times used differently depending on whether the risk
assessment addresses dietary or non-dietary exposures. (Pymetrozine is
not expected to result in any meaningful non-dietary exposure and thus
risk assessment of non-dietary exposure is not further discussed in
this document.) For dietary risks, EPA uses the Point of Departure to
calculate an safe or acceptable level of exposure designated as the
reference dose (RfD). The RfD is calculated by dividing the Point of
Departure by applicable safety or uncertainty factors. Typically, EPA
uses a baseline safety/uncertainty factor of 100X. That value includes
a factor of ten (10X) where EPA is using data from laboratory animals
to reflect potentially greater sensitivity in humans than animals and a
factor of 10X to account for potential variations in sensitivity among
members of the human population as well as other unknowns. Additional
safety factors may be added to address data deficiencies or concerns
raised by the existing data. Under the FQPA, an additional safety
factor of 10X is presumptively applied to protect infants and children,
unless reliable data support selection of a different factor. This FQPA
additional safety factor largely replaces pre-FQPA EPA practice
regarding additional safety factors. (Ref. 3 at 4-11).
    In implementing FFDCA section 408, EPA's Office of Pesticide
Programs, also calculates a variant of the RfD referred to as a
Population Adjusted Dose (PAD). A PAD is the RfD divided by any portion
of the FQPA safety factor that does not correspond to one of the
traditional additional safety factors used in general Agency risk
assessments. (Ref. 3 at 13-16). The reason for calculating PADs is so
that other parts of the Agency, which are not governed by FFDCA section
408, can, when evaluating the same or similar substances, easily
identify which aspects of a pesticide risk assessment are a function of
the particular statutory commands in FFDCA section 408. Today, RfDs and
PADs are generally calculated for both acute and chronic dietary risks
although traditionally a RfD or PAD was only calculated for chronic
dietary risks. Throughout this document general references to EPA's

calculated safe dose are denoted as a RfD/PAD.
    ii. Non-threshold effects. For risk assessments for non-threshold
effects, EPA does not use the RfD/PAD approach to choose a level of
concern if quantification of the risk is deemed appropriate. Rather,
EPA calculates the slope of the dose-response curve for the non-
threshold effects from relevant studies using a linear, low-dose
extrapolation model that assumes that any amount of exposure will lead
to some degree of risk. This dose-response analysis will be used in the
risk characterization stage to estimate the risk to humans of the non-
threshold effect. Linear, low-dose extrapolation is typically used as
the default approach for estimating the risk to carcinogens, unless
there are mode of action data indicating a threshold response (or
nonlinearity).
    c. Estimating human exposure. Risk is a function of both hazard and
exposure. Thus, equally important to the risk assessment process as
determining the hazards posed by a pesticide and the toxicological
level of concern for those hazards is estimating human exposure. Under
FFDCA section 408, EPA is concerned not only with exposure to pesticide
residues in food but also exposure resulting from pesticide
contamination of drinking water supplies and from use of pesticides in
the home or other non-occupational settings. (See 21 U.S.C.
346a(b)(2)(D)(vi)).
    i. Exposure from food. There are two critical variables in
estimating exposure in food: (1) The types and amount of food that is
consumed; and (2) the residue level in that food. Consumption is
estimated by EPA based on scientific surveys of individuals' food
consumption in the United States conducted by the USDA. (Ref. 2 at 12).
Information on residue values comes from a range of sources including
crop field trials, data on pesticide reduction (or concentration) due
to processing, cooking, and other practices, information on the extent
of usage of the pesticide, and monitoring of the food supply. (Id. at
17).
    In assessing exposure from pesticide residues in food, EPA, for
efficiency's sake, follows a tiered approach in which it, in the first
instance (i.e., Tier 1), assesses exposure using the worst case
assumptions that 100 percent of the crops for which tolerances exist or
are proposed are treated with the pesticide and 100 percent of the food
from those crops contain pesticide residues at the tolerance level.
(Id. at 11). When such an assessment shows no risks of concern, a more
complex risk assessment is unnecessary. By avoiding a more complex risk
assessment, EPA's resources are conserved and regulated parties are
spared the cost of any additional studies that may be needed. If,
however, a Tier 1 assessment suggests there could be a risk of concern,
EPA then attempts to refine its exposure assumptions to yield a more
realistic picture of residue values through use of data on the percent
of the crop actually treated with the pesticide and data on the level
of residues that may be present on the treated crop. These latter data
are used to estimate what has been traditionally referred to by EPA as
``anticipated residues.'' EPA refinement of an exposure assessment
``can have dramatic effects on the level of exposure predicted,
reducing worst case estimates by 1 or 2 orders of magnitude or more.''
(73 FR 42683, 42687, July 23, 2008). More information on how EPA
refines estimates of exposure from pesticides in food can be found in
the following EPA publication, ``A User's Guide to Available EPA
Information on Assessing Exposure to Pesticides in Food.'' (Ref. 2; see
also 73 FR at 42687).
    ii. Exposure from water. EPA may use either or both field
monitoring data and mathematical water exposure models to generate
pesticide exposure estimates in drinking water. Monitoring and modeling
are both important tools for estimating pesticide concentrations in
water and can provide different types of information. Monitoring data
can provide estimates of pesticide concentrations in water that are
representative of specific agricultural or residential pesticide
practices and under environmental conditions associated with a sampling
design. Although monitoring data can provide a direct measure of the
concentration of a pesticide in water, it does not always provide a
reliable estimate of exposure because sampling may not occur in areas
with the highest pesticide use, and/or the sampling may not occur when
the pesticides are being used.
    In estimating pesticide exposure levels in drinking water, EPA most
frequently uses mathematical water exposure models. EPA's models are
based on extensive monitoring data and detailed information on soil
properties, crop characteristics, and weather patterns. (69 FR 30042,
30054-30065 (May 26, 2004)). These models calculate estimated
environmental concentrations of pesticides using laboratory data that
describe how fast the pesticide breaks down to other chemicals and how
it moves in the environment. These concentrations can be estimated
continuously over long periods of time, and for places that are of most
interest for any particular pesticide. Modeling is a useful tool for
characterizing vulnerable sites, and can be used to estimate peak
concentrations from infrequent, large storms.
    Typically EPA uses a two-tiered approach to modeling pesticide
concentrations in surface and ground water. The first tier model uses
high-end and worst-case assumptions as a screen to identify pesticides
that will not result in residues in water that pose a concern. If the
first tier model suggests that pesticide levels in water may be
unacceptably high, a more refined model is used as a second tier
assessment. Second tier models substitute more detailed information for
the high-end or worst-case assumptions used in first tier models. For
example, a second tier model may incorporate information on the maximum
percentage of acreage surrounding a drinking water reservoir that may
be devoted to agriculture instead of assuming that 100 percent of the
watershed is, in fact, farmland.
    iii. Residential exposures. Generally, in assessing residential
exposure to pesticides EPA relies on its Residential Standard Operating
Procedures (SOPs). (Ref. 4). The SOPs establish models for estimating
application and post-application exposures in a residential setting
where pesticide-specific monitoring data are not available. SOPs have
been developed for many common exposure scenarios including pesticide
treatment of lawns, garden plants, trees, swimming pools, pets, and
indoor surfaces including crack and crevice treatments. The SOPs are
based on existing monitoring and survey data including information on
activity patterns, particularly for children. Where available, EPA
relies on pesticide-specific data in estimating residential exposures.
    d. Risk characterization. The final step in the risk assessment is
risk characterization. In this step, EPA combines information from the
first three steps (hazard identification, level of concern/dose-
response analysis, and human exposure assessment) to quantitatively
estimate the risks posed by a pesticide. Separate characterizations of
risk are conducted for different durations of exposure. Additionally,
separate and, where appropriate, aggregate characterizations of risk
are conducted for the different routes of exposure (dietary and non-
dietary).
    For threshold dietary risks, EPA typically estimates risk by
expressing human exposure as a percentage of the RfD/PAD. Exposures
lower than 100 percent of the RfD/PAD are generally

not of concern. Under current procedures, EPA aggregates pesticide
exposure from food and drinking water prior to comparing exposure to
the RfD/PAD.
    2. EPA policy on the children's safety factor. As the above brief
summary of EPA's risk assessment practice indicates, the use of safety
factors plays a critical role in the process. This is true for the use
of traditional 10X safety factors to account for potential differences
between animals and humans when relying on studies in animals (inter-
species safety factor) and potential differences among humans (intra-
species safety factor) as well as the use of FQPA's additional 10X
children's safety factor.
    In applying the children's safety factor provision, EPA has
interpreted it as imposing a presumption in favor of applying an
additional 10X safety factor. (Ref. 3 at 4, 11). Thus, EPA generally
refers to the additional 10X factor as a presumptive or default 10X
factor. EPA has also made clear, however, that this presumption or
default in favor of the additional 10X is only a presumption. The
presumption can be overcome if reliable data demonstrate that a
different factor is safe for children. (Id.). In determining whether a
different factor is safe for children, EPA focuses on the three factors
listed in section 408(b)(2)(C) -- the completeness of the toxicity
database, the completeness of the exposure database, and potential pre-
and post-natal toxicity. In examining these factors, EPA strives to
make sure that its choice of a safety factor, based on a weight-of-the-
evidence evaluation, does not understate the risk to children. (Id. at
24-25, 35).

IV. Challenged Tolerance Regulation for Pymetrozine

    1.  In general. NRDC challenged a December 27, 2001, action
establishing tolerances for pymetrozine on cotton seed; cotton gin
byproducts; fruiting, cucurbit, leafy, and Brassica vegetables; turnip
greens; hops; and pecans. (66 FR 66786, December 27, 2001). Given
pymetrozine's exposure pattern and toxicological characteristics, EPA
determined that pymetrozine potentially presented acute, short-term,
chronic, and cancer risks and EPA quantitatively assessed these risks
in making its safety determination. (Id. at 66791-66792). All of these
risks were found to be below the Agency's level of concern. (Id.).
    2. Children's safety factor determination. For pymetrozine, EPA
concluded there was uncertainty regarding its effects on the young
because a DNT was outstanding and a NOAEL had not been identified in an
acute neurotoxicity study. (66 FR at 66791; 64 FR 52438, 52444,
September 29, 1999). EPA determined, however, that these uncertainties
were partially offset by a number of factors. First, EPA noted that
there was no increased sensitivity in young animals observed in the
pre- and post-natal studies conducted with pymetrozine, and that these
studies showed no evidence of abnormalities in the fetal nervous
system. (Ref. 5 at 5). Second, the evidence on pymetrozine's
neurotoxicity was mixed. Although the acute neurotoxicity study had
identified behavioral effects at 125 milligrams per kilogram of body
weight per day (mg/kg bw/day), the subchronic neurotoxicity only showed
``indefinite evidence'' of neurotoxicity at significantly higher doses
(201 mg/kg/day for males, 228 mg/kg/day for females). (Id. at 2).
Third, exposure data were deemed adequate not to underestimate
exposure. (Id. at 5). Weighing all of this evidence, EPA determined
that the safety of infants and children would be protected by an
additional 3X safety factor applied to all risk assessments; (66 FR at
55791) and a second additional 3X safety factor for assessing acute
risks to the general population, including infants and children. The
second additional safety factor was only applied to the acute
assessment because it was only in an acute neurotoxicity study that a
NOAEL had not been identified. (64 FR at 52444). Given the two 3X
safety factors for acute risk, EPA essentially retained the full 10X
FQPA safety factor for the acute risk assessment. The second additional
3X safety factor was not retained as to the acute assessment for women
of child-bearing age because this assessment was based on an acute
study in which a NOAEL was obtained. (Id.).

V. Subsequent Tolerance Action for Pymetrozine

    Since December 2001, EPA has established an additional tolerance
for pymetrozine on asparagus. (70 FR 43292, July 27, 2005). Because
section 408 requires EPA, in setting a pesticide tolerance, to consider
aggregate exposure to the pesticide, ``including dietary exposure under
. . . all other tolerances for the pesticide chemical residue,'' in
this subsequent action EPA took into account exposure to pymetrozine
under challenged tolerances established on December 27, 2001 (cotton
seed; cotton gin byproducts; fruiting, cucurbit, leafy, and Brassica
vegetables; turnip greens; hops; and pecans). In its action on the
asparagus tolerance in 2005, EPA concluded that the additional exposure
from the new tolerance, when aggregated with exposure under existing
tolerances, was safe. (70 FR at 43297).
    With regard to the children's safety factor in this subsequent
action, EPA relied on a revised analysis taking into account its
Children's Safety Factor Policy, which had not been released at the
time of the December 27, 2001 tolerance action. This revised analysis
focused on how the expected dose level in the requested DNT study
compared to the existing Points of Departure for acute and chronic
risks. The dose levels in the DNT study are generally guided by the
results of the two-generation study in rats because it is a study
involving the young and is conducted in the same species as the DNT
study. Noting that the Points of Departure for acute risk were
generally in the same order of magnitude of the NOAEL in the
reproduction study, EPA concluded that full additional 10X safety
factor should be retained for acute risk assessments because the DNT
study could potentially lower the existing Point of Departure
significantly and thus EPA lacked reliable data to choose a factor
other than the default value. EPA reasoned that if the DNT study showed
adverse effects at the lowest dose tested (presumably a dose in the
range of the current Point of Departure), then a revised Point of
Departure would be tenfold lower than the existing Point of Departure
once EPA compensated for a lack of NOAEL in the DNT study. The opposite
conclusion was reached for chronic risks because the Point of Departure
for chronic risk assessment was already 30X lower than the expected low
dose in the DNT study. Due to this significant difference in the
chronic Point of Departure and the expected low dose in the DNT study,
the results of the DNT study were unlikely to affect the chronic Point
of Departure and thus an additional safety factor was not needed to
protect infants and children in the absence of the DNT study. (Ref. 6).

VI. Summary of NRDC Objections, Administrative Review of the
Objections, and Judicial Review of EPA's Order Denying the Objections

A. NRDC's Objections

    On four occasions in the first half of 2002, the NRDC and various
other parties filed objections with EPA to final rules under section
408 of the FFDCA, (21 U.S.C. 346a), establishing pesticide tolerances
for various pesticides. The objections applied to 14 pesticides and 112
separate pesticide tolerances. The challenged tolerances included the
tolerances for pymetrozine addressed in

today's regulation. The objections to the pymetrozine tolerances were
filed on February 25, 2002, and grouped with objections to tolerances
for halosulfuron-methyl.
    Although NRDC's petitions raised dozens of issues, most of the
issues related to two main claims: (1) That EPA had not properly
applied the additional 10X safety factor for the protection of infants
and children in section 408(b)(2)(C); and (2) that EPA had not
accurately assessed the aggregate exposure of farm children to
pesticide residues. Many of the issues were not fact-specific to the
challenged tolerances but rather represented a generic challenge to
EPA's implementation of the FQPA.
    Two specific issues raised by NRDC are worthy of greater
description because they later figured in the judicial review of EPA's
disposition of the objections. First, as to several of the pesticides,
NRDC argued that EPA had unlawfully removed the 10X children's safety
factor because EPA had required that a DNT study be submitted for the
pesticides but such study had not yet been completed. Specifically as
to pymetrozine, NRDC asserted that:
     Even though . . . DNT results are required and overdue, EPA has
established new tolerances for pymetrozine. In doing so, EPA failed to
apply the required 10X safety factor for children that is intended to
compensate for just such data gaps.
(Ref. 1 at 4). Second, NRDC argued that EPA could not lawfully remove
the children's safety factor as to all of the challenged pesticides
because EPA relied on drinking water exposure models to estimate
pesticide exposure levels in water instead of ``collect[ing] pesticide-
specific data on water-based exposure.'' (Ref. 7 at 5; Ref. 8 at 6).
According to NRDC, drinking water models, as a definitional matter,
could not supply the ``reliable data'' needed to choose a children's
safety factor differing from the presumptive value. (Ref. 7 at 4-6;
Ref. 8 at 6).

B. EPA's Denial of the Objections

    EPA denied NRDC's objections in two separate orders. The first was
issued on May 26, 2004, and addressed only the tolerances for
imidacloprid. (69 FR 30042, May 26, 2004). The second was released on
August 10, 2005 and addressed the tolerances for the remaining 14
pesticides. (70 FR 46706, August 10, 2005). The second order relied
heavily on the imidacloprid order because in the process of resolving
the claims pertaining to imidacloprid, EPA resolved many of NRDC's
generic attacks on EPA's interpretation of the FQPA. (70 FR at 46711,
46716, 46725, 46726, 46730).
    As to the DNT study and the children's safety factor, EPA rejected
``NRDC's contention that an EPA finding that a DNT study is needed in
evaluating the risks posed by the pesticide is outcome-determinative as
regards to retaining the children's safety factor until such time as
the DNT study is submitted and reviewed.'' (70 FR at 46724). EPA
carefully reviewed all of the evidence cited by NRDC regarding the DNT
study and concluded that NRDC had not shown that the DNT was so
critical to the protection of children that in the absence of that
study EPA was conclusively precluded from exercising its statutory
authority to make a case-by-case determination regarding the
appropriate children's safety factor. EPA specifically did not address
the specific factual considerations relating to its individual
children's safety factor decisions as to pymetrozine (and the other
pesticides), noting that ``NRDC has offered no pesticide-specific
arguments as to the pesticides in this proceeding as to why the absence
of a DNT study requires the retention of the default 10X additional
factor.'' (Id.)
    With regard to whether reliance on drinking water models precluded
lowering of the children's safety factor, EPA exhaustively reviewed the
underlying factual basis for its models, the scientific peer review
they had received, and how the models had worked in practice. EPA
concluded that ``they are based on reliable data and have produced
estimates that EPA can reliably conclude will not underestimate
exposure to pesticides in drinking water.'' (70 FR at 46726).
Accordingly, NRDC's claim that only actual pesticide-specific water
monitoring data could provide ``reliable data'' on the levels of
pesticides in drinking water was rejected.

C. Judicial Review

    1. NRDC's petition for review. In August, 2005, NRDC and the
Northwest Coalition for Alternatives to Pesticides (NCAP) filed
petitions for review of EPA's August 10, 2005 order. NRDC had not
challenged the May 26, 2004 imidacloprid order. The petitions were
filed in the Second and Ninth Circuits and the matter was assigned to
the Ninth Circuit. The consolidated petitions sought review as to EPA's
denial of NRDC's objections as they pertained to the tolerances of the
following seven pesticides: acetamiprid, fenhexamid, halosulfuron-
methyl, isoxadifen-ethyl, mepiquat, pymetrozine, and zeta-cypermethrin.
    NRDC/NCAP's brief argued that EPA had unlawfully removed or lowered
the children's safety factor as to these seven pesticides and that
EPA's establishment of tolerances for the seven pesticides was
arbitrary and capricious. (Ref. 9). As to the contentions regarding the
children's safety factor, NRDC/NCAP made several independent claims as
to why EPA's action was unlawful. These claims were:
     a. As to acetamiprid, halosulfuron-methyl, mepiquat, pymetrozine,
and zeta-cypermethrin, EPA had no discretion to alter the children's
safety factor because it had determined that a DNT study was
specifically needed to address concerns regarding these pesticides (DNT
studies were not required on fenhexamid and isoxadifen-ethyl);
     b. EPA's decision on the children's safety factor could not be
upheld because EPA provided ``no pesticide-specific response to NRDC's
objections with respect to the missing DNT studies, and does not offer
any explanation or justification for the agency's departure from the
tenfold children's safety factor for these five pesticides;''
     c. EPA lacked the reliable data on pesticide exposure levels in
drinking water for each of the pesticides and such data are necessary
to justify altering the children's safety factor; and
     d. EPA must retain the children's safety factor for each of the
pesticides because data showed that they resulted in pre- or post-natal
toxicity.
NRDC/NCAP argued that EPA's decision was arbitrary and capricious
because EPA determined that additional data were needed on the
pesticides but had not waited for submission of that data before
establishing the pesticide tolerances and because EPA had not offered a
sufficient explanation of its decisions on the children's safety
factor.
    2. The Ninth Circuit's decision. On September 19, 2008, the Ninth
Circuit unanimously determined that:
     a. It was not arbitrary and capricious for EPA to have established
the tolerances for acetamiprid, mepiquat, and pymetrozine without
waiting for DNT studies for these pesticides;
     b. EPA had offered a reasoned explanation for why, as a general
matter, the children's safety factor could be reduced in the absence of
a DNT study; and
     c. It was reasonable for EPA to rely

in drinking water models in estimating pesticide levels in water in
making children's safety factor determinations.
(NCAP v. EPA, 544 F.3d 1043, 1044-1051 (9th Cir. 2008)). Additionally,
by a 2-to-1 vote, the court remanded to EPA its decision on the
children's safety factor for acetamiprid, mepiquat, and pymetrozine.
The majority found that EPA's order on NRDC's objections had not
adequately explained the pesticide-specific reasons for removing or
reducing the children's safety factor as to these pesticides in the
absence of a required DNT study. (Id. at 1052). Without elaborating,
the court dismissed all other issues raised by NRDC/NCAP. (Id. at
1053).
    Although NRDC/NCAP's petition for review concerned seven
pesticides, the court only remanded to EPA the tolerance decisions on
acetamiprid, mepiquat, and pymetrozine. The petition for review was
denied as to the other four pesticides because the remand only
pertained to pesticides for which there was a question concerning EPA's
pesticide-specific choice of a children's safety factor in the absence
of a required DNT study. As to fenhexamid and isoxadifen-ethyl, a DNT
study had not been required by EPA. For halosulfuron-methyl and zeta-
cypermethrin tolerances, a DNT study had been required and had not been
submitted at the time of the tolerance action; however, by the time of
the oral argument, the circumstances had changed. As to zeta-
cypermethrin, the DNT study had been submitted and reviewed by EPA and
EPA had established further tolerances in reliance on the DNT study. As
to halosulfuron-methyl, EPA had withdrawn the requirement for a DNT
study. EPA notified the court that there was no longer a live
controversy as to the tolerances for halosulfuron-methyl and zeta-
cypermethrin and NRDC/NCAP and the court agreed the petition was moot
as to these pesticides. (544 F.3d at 1048 n.4; Refs. 10 and 11).

VII. Revised Regulation on Remand

    On remand, EPA has determined that NRDC's objections should again
be denied because the remanded objections do not show that the
pymetrozine tolerances are not safe. EPA has now received and reviewed
a DNT study on pymetrozine. The results of the DNT study, when
considered in combination with the rest of the pymetrozine database,
convince EPA that the 10X children's safety factor should be retained
for pymetrozine. EPA evaluated the risk of pymetrozine, taking into
account the additional 10X children's safety factor and has concluded
that pymetrozine tolerances are safe. A summary of EPA's reasons for
retaining the 10X children's safety factor and of EPA's risk assessment
is provided below.

A. DNT Study for Pymetrozine

    A DNT study with pymetrozine was performed in Wistar-derived rats.
(Ref. 12). Dose levels in the study were 0 (control), 100, 500, or
2,500 parts per million (ppm). To translate these doses to humans they
are expressed in terms of the daily dose in milligrams of pymetrozine
per kilogram of body weight of the experimental animals. Additionally,
because of significant body weight changes between fetuses during the
period of gestation and post-natal animals during lactation, that
weight change is incorporated into the expression of dose by using
separate dose calculations for gestation and lactation. Expressed in
these terms, the doses in the pymetrozine DNT study were 0/0
(gestation/lactation), 8.1/16.8, 38.7/82.6, and 173.1 milligrams/
kilogram of body weight/day (mg/kg/day). No dose is provided for the
high dose group of lactation animals because higher than expected
mortality was observed during littering, resulting in an insufficient
number of litters. Therefore, the study was terminated for the high
dose group prior to lactation.
    Effects in pups, as well as maternal animals, were evaluated
through both in-life and post-mortem observations. To investigate
potential neurotoxic effects, the in-life observations included
monitoring of motor activity, testing of acoustic startle response,
learning and memory evaluation, and use of a functional observation
battery (FOB). The FOB is a noninvasive procedure designed to detect
gross functional deficits resulting from exposure to chemicals and to
better quantify neurotoxic effects detected in other studies. The FOB
consists of six types of observations: home cage, handling, open field,
sensory, neuromuscular, and physiological responses. Post-mortem
evaluation included examination of the major portions of the central
and peripheral nervous system for any sign of neuropathology.
    The primary effect seen in the maternal animals was loss of the
litter. At the 38.7 mg/kg/day dose, total litter loss was experienced
between birth and post-natal-day 5 by 5 out of 29 treated maternal
animals (17.2%) compared to 2 out of 30 controls (6.7%). On gestation
day 24, one maternal animal with staining around the nose was
sacrificed due to difficult parturition, and another animal was pale.
Food consumption was decreased ([darr]21%; statistical significance of
p<=0.01) during lactation days 1-5. However, body weights at this dose
were comparable to controls throughout treatment. At the 8.1/16.8 mg/
kg/day dose, no treatment-related effects were seen on litter loss,
survival, clinical signs, body weight, body weight gain, food
consumption, or reproductive performances. EPA determined that the
maternal LOAEL is 38.7 mg/kg/day and the maternal NOAEL is 8.1 mg/kg/
day.
    Pymetrozine caused a dose-dependent increase in the number of pups
dying during post-natal-days 1-5; 57 pups at 8.1/16.8 mg/kg/day, 95
pups at 38.7/82.6 mg/kg/day, and 151 pups at 173.1 mg/kg/day, compared
to 48 pups in the controls. This was due to the increase in the number
of whole litter losses at 8.1/16.8 mg/kg/day (3 litters), 38.7/82.6 mg/
kg/day (5 litters), and 173.1 mg/kg/day (4 litters) compared to
controls (2 litters). When whole litter losses are excluded, no
treatment-related findings were observed on litter size or viability.
    Treatment had no adverse effects on pup body weight, body weight
gain, food consumption, developmental landmarks, clinical signs, FOB,
motor activity, auditory startle reflex, learning and memory, or brain
weights. However, measurement of brain morphometry showed the following
differences (p<=0.05) from controls: (i) Increased thickness of the
corpus callosum in the 38.7/82.6 mg/kg/day males on post-natal-day 12
([uarr]15%) and in the 8.1/16.8 mg/kg/day males on post-natal-day 63
([uarr]4-13%); (ii) increased thickness of the inner granular and
molecular layers of the pre-pyramidal fissure in the cerebellum in the
38.7/82.6 mg/kg/day males on post-natal-day 63 ([uarr]4-19%); and (iii)
increased thickness of the dorsal cortex in the 8.1/16.8 mg/kg/day
females on post-natal-day 12 ([uarr]4-10%).
    EPA determined that the offspring LOAEL is 8.1 mg/kg/day, the
lowest dose tested, based on morphometric changes in the brains of
female pups on post-natal-day 12 and male pups on post-natal-day 63.
The offspring NOAEL was not established.

B. Children's Safety Factor Decision for Pymetrozine

    In evaluating the children's safety factor for pymetrozine, EPA
considered the completeness of the toxicity and exposure databases as
well as the potential for pymetrozine to cause pre- or post-natal
toxicity, particularly where such toxicity indicates increased
sensitivity in juvenile animals compared to adult animals. (Ref. 13)
    1. Toxicity database. With the receipt of the DNT study, the
toxicity database

for pymetrozine is complete in terms of the requirements in place at
the time of the challenged pymetrozine tolerance action in 2001.
However, since that time, EPA has amended data requirements pertaining
to registration of pesticides under the Federal Insecticide, Fungicide,
and Rodenticide Act, (7 U.S.C. 136 et seq.), and establishment of
tolerances under the FFDCA. (72 FR 60934, October 26, 2007). Several
new requirements apply to agricultural pesticides such as pymetrozine
but the only new data requirement for pymetrozine that has not yet been
fulfilled is the requirement for an immunotoxicity study.
    In the absence of this study, EPA examined the pymetrozine database
to evaluate pymetrozine's immunotoxic potential. EPA concluded that the
liver is the primary target organ of pymetrozine and that apparent
immunotoxic effects are the result of exceedingly high doses.
    Potential immune organ effects include atrophy of the thymus in the
subchronic rat and dog studies at 360 and 54 mg/kg/day, respectively;
decreased thymus weight in the chronic mouse study at 675 mg/kg/day;
increased leucocytes in the subchronic rat study at 360 mg/kg/day; and
hyperplasia of the splenic lymphocyte follicles in the reproduction
study at 136.9 mg/kg/day. Clear NOAELs were identified for these
potential immunotoxic effects at higher doses than the endpoint that
was selected for risk assessment, i.e., the 8.1 mg/kg/day LOAEL from
the DNT study based on brain morphometric changes in the offspring.
Lymphocytic infiltration in the prostrate and thyroid was observed at
14 mg/kg/day in the subchronic dog study but these organs are not a
primary part of the immune system and the lymphocytic infiltration is
considered an immune system reaction to other toxic effects on these
organs and not an immunotoxic effect.
    The Agency does not believe that conducting a functional
immunotoxicity study will result in a lower Point of Departure than the
endpoint currently selected for overall risk assessment (i.e. the
extrapolated NOAEL from the DNT study--see discussion below in Unit
VII.C.1.a.) based on:
     a. The only potential immunotoxic responses occurred at doses
greater than the endpoint selected for risk assessment,
     b. Clear NOAELs were identified for the potential immunotoxic
effects, again at doses greater the endpoint selected for risk
assessment; and
     c. The lymphohistocytic effects were determined not to be
immunotoxic effects but a reaction to other toxic effects.
    The other concern with the toxicity database is that a NOAEL was
not identified for juvenile animals in the DNT study. The LOAEL in that
study was based on differences from controls in the measurement of
brain morphometrics. The concern with this effect, however, is lessened
somewhat here in that no effects were seen in other barometers of
effects on developmental neurology such as developmental landmarks,
clinical signs, FOB, motor activity, auditory startle reflex, learning
and memory, or brain weights.
    2. Potential pre- and post-natal toxicity. No indications of
qualitative or quantitative sensitivity in the young were seen in the
developmental studies in rats and rabbits or in the two generation
reproduction study in rats. NOAELs were identified for all effects in
the young seen in these studies. On the other hand, EPA has assumed
that quantitative sensitivity was detected in the DNT study in rats
given that toxicity was observed in the juveniles (brain morphometric
changes) in the absence of maternal toxicity. This is a conservative
assumption on EPA's part in that the maternal animals' brains were not
examined for morphometric changes.
    3. Exposure database. EPA's exposure estimate is based mainly on a
2005 exposure assessment performed for the last pymetrozine tolerance
action. (70 FR 43292, July 27, 2005). For the acute exposure
assessment, EPA used the very conservative approach of assuming
pymetrozine was used on all foods with a tolerance and residues were at
the tolerance level. The chronic exposure assessment is more refined in
that for most crops EPA relied on average values from pesticide residue
field trials for all commodities and data on the percentage of crops
that are treated with pymetrozine for most of the more heavily-consumed
commodities. Because several years have passed since the 2005
pymetrozine tolerance action, EPA updated the percent crop treated data
in assessing exposure. Although pymetrozine is licensed for use on
ornamentals, EPA expects exposure to the public, including children,
from this use to be negligible because pymetrozine may only be applied
by commercial applicators (hence, no applicator exposure for the
public) and post-application contact with ornamentals is infrequent and
brief compared with, for example, turf.
    4. Conclusion. The primary factor of concern from the above is the
weakness in the toxicity database due to the failure to identify a
NOAEL in the DNT study. This deficiency is heightened by the fact that,
although pre- and post-natal animals were generally not more sensitive
than adults, the DNT study showed quantitative sensitivity in rat pups
due to the identification of adverse brain morphometric changes in rat
pups at a dose that did not cause maternal toxicity. Although the brain
morphometric effects seen at the LOAEL in the DNT study were not
confirmed by other barometers of developmental neurotoxicity, the
absence of a NOAEL for these effects creates sufficient uncertainty
that reliable data are not available to revise the default 10X
children's safety factor. Therefore, EPA is retaining the full 10X
children's safety factor in assessing risk based on the DNT study. As
discussed in Unit VII.C.1. below, the DNT study provides the Point of
Departure for both acute and chronic risk assessments. Retention of the
full children's safety factor reduces any concerns from lack of an
immunotoxicity study as the NOAELs from the potential immunotoxic organ
effects are all greater than 1000X higher than the level of concern
(aPAD and cPAD) when the 10X children's safety factor is taken into
account. Despite the lack of a NOAEL in the DNT study and the increased
sensitivity in juveniles shown in that study, EPA does not believe that
the weight of the evidence supports an additional safety factor higher
than 10X given that the brain morphometric effects seen at the LOAEL in
the DNT study were not confirmed by any other measures of neurological
effect.

C. Risk Assessment and Safety Determination for Pymetrozine

    Given the new data on developmental neurotoxicity and EPA's revised
children's safety factor determination, EPA has recalculated the risks
of pymetrozine taking this information into account. EPA last assessed
the risks of pymetrozine in connection with a tolerance rulemaking for
pymetrozine on asparagus in 2005. (70 FR 43292, July 27, 2005). The new
information affects the hazard identification and dose-response aspects
of the risk assessment for acute and chronic non-cancer risk. EPA has
also updated the exposure assessment performed for the 2005 assessment
because exposure information is needed in completing a revised acute
and chronic risk assessment.
    1. Hazard identification/dose response--a. Point of Departure. As
previously explained, EPA chooses a Point of Departure from toxicology
studies for use in calculating a safe level of exposure to humans. This
safe level

of exposure is called a Reference Dose (RfD) or Population-Adjusted
Dose (PAD). In the 2002 tolerance rulemaking, EPA used the following
Points of Departure: for acute risk to the general population
(including infants and children) a LOAEL of 125 mg/kg/day from the
acute neurotoxicity study in rats; for acute risk to pre-natal infants
(focusing on exposure to females of child-bearing age) a NOAEL of 10
mg/kg/day from the rabbit developmental study; and for chronic risk to
the general population (including infants and children) a NOAEL of
0.377 from the chronic toxicity study in rats. The same Points of
Departure were used in risk assessment for the 2005 rulemaking.
    The Points of Departure have been changed based on a review of the
DNT study. EPA determined that the LOAEL of 8.1 mg/kg/day from the DNT
study (no NOAEL was established) would be used as the Point of
Departure for both acute risk (all population groups including infants
and children and women of child-bearing age) and chronic risk (again,
all population groups). As described above, the effect seen at the
LOAEL was changes in brain morphometrics in the offspring. The LOAEL
from the DNT study was chosen for the Point of Departure for assessing
acute risk because it is lower than either of the two doses previously
used (the LOAEL from the acute neurotoxicity study and the NOAEL from
the rabbit developmental study). Selection of this LOAEL for the Point
of Departure for acute risk assessment is conservative because the
brain morphometric changes were observed in the absence of impacts on
other parameters, including developmental landmarks, clinical signs,
FOB, motor activity, acoustic startle response, learning and memory, or
brain weight. It is additionally conservative because EPA has assumed
that these brain changes could occur from a single dose.
    The Agency is using the LOAEL from the DNT study as the Point of
Departure for chronic risk because brain morphometric changes may be
the result of single or multiple doses and this LOAEL produces the most
protective cPAD. Previously, EPA used the NOAEL from the chronic rat
study as the Point of Departure but the LOAEL from that study is based
on hepatic hypertrophy and EPA no longer considers hepatic hypertrophy
in the absence of liver pathology or changes in relevant clinical
chemistry parameters to be an adverse effect. Hepatocellular
hypertrophy is often an adaptive and reversible effect in response to
the presence of a chemical (i.e. induction of microsomal enzymes in the
liver). Although there are other NOAELs in the pymtrozine database at
or slightly below the LOAEL from the DNT study, once an additional
safety factor (see above) is retained to address the lack of a NOAEL in
the DNT study, reliance on the LOAEL from this study produces the most
protective cPAD.
    b. Dose response. To calculate both the aPAD and cPAD, EPA divided
the LOAEL from the DNT study by 1,000, representing a 10X factor to
account for inter-species variability, a 10X factor to account for
intra-species variability, and an additional 10X safety factor for the
protection of infants and children due to the lack of a NOAEL in the
DNT study. As noted above, the retention of the full 10X children's
safety factor is conservative given the fact that the brain
morphometric changes were noted in the absence of any confirming
clinical or neuropathological signs.
    2. Exposure. As explained in Unit VII.B. above, EPA relied on the
exposure assessment for the 2005 pymetrozine tolerance rulemaking
updated to incorporate more recent percent crop treated information.
Residue levels in drinking water were estimated for that exposure
assessment based upon EPA's screening level drinking water models. This
assessment is very conservative with regard to acute exposure, and,
while more refined for chronic exposure, still retains significant
conservatisms. (Refs. 13 and 14).
    3. Safety Determination. Table 1 below shows how exposure to
pymetrozine residues in food and drinking water compared to the aPAD
and cPAD for the general population and major population subgroups
based on age. The highest subgroups for acute and chronic exposure are
shown in bold.

    Table 1--Summary of Combined Dietary (Food + Drinking Water) Exposure and Risk Estimates for Pymetrozine
----------------------------------------------------------------------------------------------------------------
                                                           Acute (95th Percentile)              Chronic
                                                      ----------------------------------------------------------
                 Population Subgroup                    Exposure (mg/                  Exposure(mg/kg/
                                                           kg/day)         % aPAD           day)         % cPAD
----------------------------------------------------------------------------------------------------------------
General U.S. Population                                      0.002831              35        0.000237        2.9
----------------------------------------------------------------------------------------------------------------
All Infants (1 year old)                                     0.003882              48        0.000707        8.7
----------------------------------------------------------------------------------------------------------------
Children 1-2 years old                                       0.004368              54        0.000350        4.3
----------------------------------------------------------------------------------------------------------------
Children 3-5 years old                                       0.004034              50        0.000329        4.1
----------------------------------------------------------------------------------------------------------------
Children 4-12 years old                                      0.003027              37        0.000224        2.8
----------------------------------------------------------------------------------------------------------------
Youth 13-19 years old                                        0.002312              28        0.000174        2.2
----------------------------------------------------------------------------------------------------------------
Adults 24-49 years old                                       0.002698              33        0.000222        2.7
----------------------------------------------------------------------------------------------------------------
Adults 50+ years old                                         0.002669              33        0.000235        2.9
----------------------------------------------------------------------------------------------------------------
Females 13-49 years old                                      0.002625              32        0.000217        2.7
----------------------------------------------------------------------------------------------------------------

    Given the data and analysis underlying the derivation of the
pymetrozine aPAD and cPAD and the pymetrozine exposure assessment, EPA
concludes that its finding that exposure for the highest exposed
population subgroup is below the aPAD and cPAD shows that there is a
reasonable certainty of no harm from aggregate exposure to pymetrozine
for all population subgroups including infants and children. (Refs. 13
and 14).

D. Conclusion

    Because EPA's revised risk assessment - which incorporates both the
DNT study and the 10X children's safety factor - shows pymetrozine
exposure to be safe, NRDC's objection to the establishment of the
pymterozine tolerances is denied.

VIII. Regulatory Assessment Requirements

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

IX. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. Here, the underlying rule
establishing pymetrozine tolerances is currently in effect. (See 66 FR
66786, December 27, 2001). The EPA order denying objections to that
rule, however, has been remanded to EPA for a further explanation of
the basis for EPA's decision on the objections. Importantly, the court
remanded the matter to EPA without vacating the underlying rule.
Today's action reaffirming the prior rule responds to the judicial
remand and does not affect the status of the underlying rule. EPA will
submit a report containing today's action reaffirming the pymetrozine
tolerance regulation and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. The reaffirmed pymetrozine tolerance regulation is not a
``major rule'' as defined by 5 U.S.C. 804(2).

X. References

    1. Objections to the Establishment of Tolerances for Pesticide
Chemical Residues: Halosulfuron-methyl and Pymetrozine Tolerances
(filed February 25, 2002).
    2. USEPA, A User's Guide to Available EPA Information on Assessing
Exposure to Pesticides in Food (June 21, 2000).
    3. Office of Pesticide Programs, USEPA, Office of Pesticide
Programs' Policy on the Determination of the Appropriate FQPA Safety
Factor(s) For Use in the Tolerance Setting Process (February 28, 2002).
    4. Office of Pesticide Programs, USEPA, Standard Operating
Procedures (SOPs) for Residential Exposure Assessments (Draft December
19, 1997).
    5. Office Of Prevention, Pesticides and Toxic Substances, USEPA,
Memorandum from Brenda Tarplee to Michael Doherty, Pymetrozine - Report
of the FQPA Safety Factor Committee (July 21, 1999).
    6. Office Of Prevention, Pesticides and Toxic Substances, USEPA,
Memorandum from Brenda Tarplee to Michael Doherty, Pymetrozine - 3rd
Report of the Hazard Identification Assessment Review Committee
(February 9, 2003).
    7. NRDC, Objections to the Establishment of Tolerances for
Pesticide Chemical Residues: Isoxadifen-ethyl, Acetamiprid,
Propiconazole, Furilazole, Fenhexamid, and Fluazinam Tolerances (filed
May 20, 2002).
    8. NRDC, Objections to the Establishment of Tolerances for
Pesticide Chemical Residues: Imidacloprid, Mepiquat, Bifenazate, Zeta-
cypermethrin, and Diflubenzuron Tolerances (filed March 19, 2002).
    9. Petitioners' Brief, NCAP v. EPA, Case Nos. 75255, 76807 (9th
Cir. March 6, 2006).
    10. Letter from Kent E. Hanson, U.S. Department of Justice to Cathy
Catterson, Clerk of the Court, United States Court of Appeals, Ninth
Circuit, Notice of Supplemental Authority in Northwest Coalition for
Alternatives to Pesticides v. EPA, Nos. 04-75255 & 04-76807 (May 25,
2007).
    11. Letter from Aaron Colangelo, U.S. Department of Justice to
Cathy Catterson, Clerk of the Court, United States Court of Appeals,
Ninth Circuit, Response to EPA's Notice of Supplemental Authority in
Northwest Coalition for Alternatives to Pesticides v. EPA, Nos. 04-
75255 & 04-76807 (May 29, 2007).
    12. Office Of Prevention, Pesticides and Toxic Substances, USEPA,
Memorandum from Robert J. Mitkus to Daniel Peacock, Pymetrozine -
Review of Developmental Neurotoxicity Study in Rats (July 13, 2005).
    13. Office Of Prevention, Pesticides and Toxic Substances, USEPA,
Memorandum from Christina Swartz to Daniel B. Peacock and Meredith F.
Laws, Pymetrozine. Updated Aggregate Human Health Risk Assessment
(April 2, 2010).
    14. Office Of Prevention, Pesticides and Toxic Substances, USEPA,
Memorandum from Christina Swartz to Daniel B. Peacock and Meredith F.

Laws, Pymetrozine - Acute, Chronic and Cancer Combined Dietary (Food +
Drinking Water) Exposure and Risk Assessments (April 2, 2010).

List of Subjects in 40 CFR Part 180

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

    Dated: July 27, 2010.
Steven Bradbury,
Director, Office of Pesticide Programs.

[FR Doc. 2010-19423 Filed 8-5-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register: June 14, 2010 (Volume 75, Number 113)]
[Notices]
[Page 33666-33667]
[DOCID:fr14jn10-96]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2010-0166]

Parts and Accessories Necessary for Safe Operation; Applications
for an Exemption From Con-Way Freight, TK Holdings, Inc., and Iteris,
Inc.

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

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

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

SUMMARY: FMCSA requests public comment on applications for exemption
from Con-way Freight (Con-way), TK Holdings, Inc. (Takata), and Iteris,
Inc. (Iteris) regarding the placement of lane departure warning system
sensors at the top of the windshields of commercial motor vehicles
(CMVs). Each applicant requests that FMCSA permit the mounting of the
lane departure warning system sensors near the top of the windshield,
and within the swept area of the windshield wipers, which is currently
prohibited by the Agency's regulations. The lane departure warning
system would be used to alert a driver when he or she unintentionally
drifts out of their lane of travel, thus promoting improved safety
performance of CMV drivers. Each applicant contends that this mounting
position does not adversely impact driver visibility.

DATES: Comments must be received on or before July 14, 2010.

ADDRESSES: You may submit comments identified by DOT DMS Docket Number
FMCSA-2010-0166 by any of the following methods:
     Web site: http://www.regulations.gov. Follow the
instructions for submitting comments on the Federal electronic docket
site.
     Fax: 1-202-493-2251.
     Mail: Docket Management Facility, U.S. Department of
Transportation, Room W12-140, 1200 New Jersey Avenue, SE., Washington,
DC 20590-0001.
     Hand Delivery: Ground Floor, Room W12-140, DOT Building,
1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m.
e.t., Monday through Friday, except Federal holidays.
    Instructions: All submissions must include the Agency name and
docket number for this notice. For detailed instructions on submitting
comments and additional information on the exemption process, see the
``Public Participation'' heading below. 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 for further information.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov or to Room W12-140,
DOT Building, New Jersey Avenue, SE., Washington, DC, between 9 a.m.
and 5 p.m., Monday through Friday, except Federal holidays.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19476) or you may visit http://
www.regulations.gov.
    Public participation: The http://www.regulations.gov Web site is
generally available 24 hours each day, 365 days each year. You can get
electronic submission and retrieval help and guidelines under the
``help'' section of the http://www.regulations.gov Web site and also at
the DOT's http://docketsinfo.dot.gov Web site. If you want us to notify
you that we received your comments, please include a self addressed,
stamped envelope or postcard or print the acknowledgement page that
appears after submitting comments online.

FOR FURTHER INFORMATION CONTACT: Mr. Luke W. Loy, Vehicle and Roadside
Operations Division, Office of Bus and Truck Standards and Operations,
MC-PSV,<PHONE_NUMBER>; Federal Motor Carrier Safety Administration,
1200 New Jersey Avenue, SE., Washington, DC 20590-0001.

SUPPLEMENTARY INFORMATION:

Background

    Section 4007 of the Transportation Equity Act for the 21st Century
(TEA- 21) [Pub. L. 105-178, June 9, 1998, 112 Stat. 401] amended 49
U.S.C. 31315 and 31136(e) to provide authority to grant exemptions from
the Federal Motor Carrier Safety Regulations (FMCSRs). On August 20,
2004, FMCSA published a final rule (69 FR 51589) implementing section
4007. Under this rule, FMCSA must publish a notice of each exemption
request in the Federal Register (49 CFR 381.315(a)). The Agency must
provide the public with an opportunity to inspect the information
relevant to the application, including any safety analyses that have
been conducted. The Agency must also provide an opportunity for public
comment on the request.
    The Agency reviews the safety analyses and the public comments and
determines whether granting the exemption would likely achieve a level
of safety equivalent to or greater than the level that would be
achieved by the current regulation (49 CFR 381.305). The decision of
the Agency must be published in the Federal Register (49 CFR
381.315(b)). If the Agency denies the request, it must state the reason
for doing so. If the decision is to grant the exemption, the notice
must specify the person or class of persons receiving the exemption and
the regulatory provision or provisions from which an exemption is
granted. The notice must also specify the effective period of the
exemption (up to 2 years) and explain the terms and conditions of the
exemption. The exemption may be renewed (49 CFR 381.315(c) and 49 CFR
381.300(b)).

Applications for Exemption

    On November 11, 2009, Con-way applied for an exemption from 49 CFR
393.60(e)(1) to allow it to install lane departure waning system
sensors on 1,272 of its newly purchased power units. Takata and Iteris
submitted nearly identical exemption applications on December 15, 2009
and on February 25, 2010, respectively. Copies of each of the
applications are included in the docket referenced at the beginning of
this notice.
    Section 393.60(e)(1) of the FMCSRs prohibits the obstruction of the
driver's field of view by devices mounted at the top of the windshield.
Antennas, transponders and similar devices (devices) must not be
mounted more than 152 mm (6 inches) below the upper edge of the
windshield. These devices must be located outside the area swept by the
windshield wipers and outside the driver's sight lines to the road and
highway signs and signals.
    Each of the applicants note that over the past several years, FMCSA
has collaborated with the trucking industry to test, evaluate, and
encourage the deployment of several promising onboard safety systems
for CMVs in an effort to enhance the safety of all roadway users. From
a motor carrier perspective, Con-way states that it would like to make
an investment in

three of these safety systems--forward collision waning systems, roll
stability control systems, and lane departure warning systems, on its
newly purchased power units. From a supplier perspective, both Takata
and Iteris would like to ensure that motor carriers are able to utilize
the safety systems that they manufacture, to enhance highway safety,
while maintaining compliance with the applicable FMCSRs.
    The applicants note that the lane departure warning system
requires, as a necessary element, a lane departure warning sensor to be
installed to the inside of the tractor windshield. For the warning
sensor to be effective, it must be mounted inside the area swept by the
windshield to insure maximum visibility.
    The applicants state that over the last several years, truck
manufacturers have increased the windshield area to maximize driver
visibility. As a result, manufacturers have voluntarily installed
larger windshield wipers on these windshields that increase the swept
area beyond that which is minimally required by Federal Motor Vehicle
Safety Standard (FMVSS) No. 104, ``Windshield Wiping and Washing
Systems.'' FMVSS No. 104 establishes the requirements applicable to
vehicle and equipment manufacturers for windshield wiper system
coverage for passenger cars, multi-purpose passenger vehicles, trucks
and buses.
    In the exemption applications, the applicants provided diagrams and
photos showing the sensor dimensions and mounting location on the
windshield. Specifically, the sensor device itself measures 2 inches by
3.5 inches, and it is mounted approximately 2 inches below the top of
the windshield--within the 6-inch limit specified in 49 CFR
393.60(e)(1). The applicants state that this mounting position does not
adversely impact the driver's visibility.
    In support of the exemption applications, each applicant cited the
findings of a report published by FMCSA's Office of Analysis, Research
and Technology titled ``Benefit-Cost Analyses of Onboard Safety
Systems,'' that summarizes the projected safety benefits for various
CMV onboard safety systems, including lane departure warning systems.
Using low and high estimates of efficacy rates ranging from 23 percent
to 53 percent, the report estimated that, based on industry-wide use of
lane departure warning systems, these systems have the potential to
reduce approximately 1,609-2,463 single-vehicle roadway departure
collisions, 627-1,307 single-vehicle roadway departure rollovers,
1,111-2,223 same-direction lane departure sideswipes, 997-1,992
opposite-direction lane departure sideswipes, and 59-118 opposite-
direction lane departure head-on collisions. The applicants state that
without the exemption, motor carriers will be unable to (1) implement
the lane departure warning system, and (2) realize the potential safety
benefits that can be expected with the utilization of this technology
as estimated in the report described above.

Request for Comments

    In accordance with 49 U.S.C. 31315 and 31136(e), FMCSA requests
public comment from all interested persons on the applications for an
exemption from 49 CFR 393.116(a)(3) submitted by Con-way, Takata, and
Iteris. All comments received before the close of business on the
comment closing date indicated at the beginning of this notice will be
considered and will be available for examination in the docket at the
location listed under the ADDRESSES section of this notice. Comments
received after the comment closing date will be filed in the public
docket and will be considered to the extent practicable. In addition to
late comments, FMCSA will also continue to file, in the public docket,
relevant information that becomes available after the comment closing
date. Interested persons should continue to examine the public docket
for new material.

    Issued on: June 4, 2010.
Larry W. Minor,
Associate Administrator for Policy and Program Development.
[FR Doc. 2010-14222 Filed 6-11-10; 8:45 am]
BILLING CODE 4910-EX-P