[Federal Register Volume 79, Number 125 (Monday, June 30, 2014)]
[Proposed Rules]
[Pages 36675-36678]
[FR Doc No: 2014-15246]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0345; Directorate Identifier 2013-NM-230-AD]
RIN 2120-AA64

Airworthiness Directives; Beechcraft Corporation (Type
Certificate Previously Held by Hawker Beechcraft Corporation; Raytheon
Aircraft Company; Beech Aircraft Corporation) Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Beechcraft Corporation (Type Certificate Previously Held by
Hawker Beechcraft Corporation; Raytheon Aircraft Company; Beech
Aircraft Corporation) Model 400, 400A, 400T, and MU-300 airplanes. This
proposed AD was prompted by a report of a failure of the Acme nut
threads in a pitch trim actuator (PTA). This proposed AD would require
an inspection to determine if PTAs having a certain serial number and
part number are installed, and replacement if they are installed. This
proposed AD would also require repetitive replacements of PTAs with new
PTAs or certain overhauled PTAs. We are proposing this AD to prevent
failure of the Acme nut threads in the PTA, which could lead to loss of
control of pitch trim and reduced controllability of the airplane.

DATES: We must receive comments on this proposed AD by August 29, 2014.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room

W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Beechcraft Corporation, TMDC, P.O. Box 85, Wichita, KS 67201-0085;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
Internet http://pubs.beechcraft.com. You may view this referenced
service information at the FAA, Transport Airplane Directorate, 1601
Lind Avenue SW., Renton, WA. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0345; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (phone:<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Ann Johnson, Aerospace Engineer,
Systems and Propulsion Branch, ACE-116W, FAA, Wichita Aircraft
Certification Office (ACO), 1801 Airport Road, Room 100, Mid-Continent
Airport, Wichita, KS 67209; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2014-0345;
Directorate Identifier 2013-NM-230-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We have received a report of a failure of the Acme nut threads in a
PTA, due to accelerated thread wear on the Acme nut that mates with the
jackscrew. This condition, if not corrected, could result in failure of
the Acme nut threads in the PTA, which could lead to loss of control of
pitch trim and reduced controllability of the airplane.

Relevant Service Information

    We reviewed Hawker Beechcraft Mandatory Service Bulletin 27-4100,
dated March 2012. This service bulletin describes procedures for an
inspection to determine if PTAs having a certain serial number and part
number are installed, and replacing those PTAs having specific serial
numbers listed in the service bulletin.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of these same type
designs.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in the service information described previously, except as discussed
under ``Differences Between This Proposed AD and the Service
Information.''

Differences Between This Proposed AD and the Service Information

    Although Hawker Beechcraft Mandatory Service Bulletin 27-4100,
dated March 2012, does not require repetitive replacements, this
proposed AD would require repetitive replacements of PTAs with new PTAs
or with overhauled PTAs having an Acme nut and jackscrew replaced with
a new Acme nut and jackscrew every 1,800 flight hours or at the next
PTA overhaul, whichever occurs first.
    While the effectivity of Hawker Beechcraft Mandatory Service
Bulletin 27-4100, dated March 2012, does not include Model MU-300
airplanes, those airplanes are included in the applicability of this
proposed AD since the affected PTAs can also be used on these
airplanes.

Costs of Compliance

    We estimate that this proposed AD affects 735 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
             Action                   Labor cost          Parts cost       Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Identification of serial/part     1 work-hour x $85   $0................  $85...............  $62,475.
 numbers (735 airplanes).          per hour = $85.
Replacement of PTA (26            10 work-hours x     $17,334 per         $18,184 per         $472,784 per
 airplanes).                       $85 per hour =      replacement.        replacement.        replacement.
                                   $850 per
                                   replacement.
Repetitive replacement of         10 work-hours x     $17,334 per         $18,184 per         $13,365,240 per
 jackscrew and Acme nut on PTAs    $85 per hour =      replacement.        replacement.        replacement.
 (735 airplanes).                  $850 per
                                   replacement.
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, the costs of this proposed AD
associated with Hawker Beechcraft Mandatory Service Bulletin 27-4100,
dated March 2012, may be covered under warranty, thereby reducing the
cost impact on affected owners/operators. We do not control warranty
coverage for affected individuals. As a result, we have included all
costs in our cost estimate. The costs of the repetitive replacement are
not covered under warranty. However, the PTA manufacturer states that
it is already replacing the Acme nut and jackscrew at every overhaul,
so the owners/operators should not see a cost increase due to this
repetitive replacement requirement.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This proposed regulation is
within the scope of that authority because it addresses an unsafe
condition that is likely to exist or develop on products identified in
this rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Beechcraft Corporation (Type Certificate Previously Held by Hawker
Beechcraft Corporation; Raytheon Aircraft Company; Beech Aircraft
Corporation): Docket No. FAA-2014-0345; Directorate Identifier 2013-
NM-230-AD.

(a) Comments Due Date

    We must receive comments by August 29, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the airplanes identified in paragraphs (c)(1)
and (c)(2) of this AD, certificated in any category.
    (1) Beechcraft Corporation (Type Certificate Previously Held by
Hawker Beechcraft Corporation; Raytheon Aircraft Company; Beech
Aircraft Corporation) airplanes identified in paragraphs (c)(1)(i),
(c)(1)(ii), and (c)(1)(iii) of this AD.
    (i) Model 400 Beechjet airplanes having serial numbers RJ-1
through RJ-65, inclusive.
    (ii) Model 400A Beechjet airplanes having serial numbers RK-1
through RK-604, inclusive.
    (iii) Model 400T Beechjet airplanes having serial numbers TT-1
through TT-180, inclusive, and TX-1 through TX-13, inclusive.
    (2) Beechcraft Corporation (Type Certificate Previously Held by
Hawker Beechcraft Corporation; Raytheon Aircraft Company; Mitsubishi
Heavy Industries, Inc. Ltd.) Model MU-300 airplanes, having serial
numbers A003SA through A093SA, inclusive.

(d) Subject

    Air Transport Association (ATA) of America Code 27, Flight
Controls.

(e) Unsafe Condition

    This AD was prompted by a report of a failure of the Acme nut
threads in a pitch trim actuator (PTA). We are issuing this AD to
prevent failure of the Acme nut threads in the PTA, which could lead
to loss of control of pitch trim and reduced controllability of the
airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Determination of Serial Number and Part Number

    Within 200 flight hours or 6 months after the effective date of
this AD, whichever occurs first, inspect to determine the serial
number and part number of the PTA, in accordance with the
Accomplishment Instructions of Hawker Beechcraft Mandatory Service
Bulletin 27-4100, dated March 2012. A review of manufacturer
delivery and operator maintenance records is acceptable, in lieu of
the inspection, if the serial number and part number of the PTA can
be conclusively determined from that review.

(h) Replacement

    If any serial number and part number found during an inspection
required by paragraph (g) of this AD is one listed in Table 1 or
Table 2 of Hawker Beechcraft Mandatory Service Bulletin 27-4100,
dated March 2012: Within 200 flight hours or 6 months after the
effective date of this AD, whichever occurs first, replace the PTA
with a serviceable PTA or an overhauled PTA having an Acme nut and
jackscrew replaced with a new Acme nut and jackscrew, in accordance
with the Accomplishment Instructions of Hawker Beechcraft Mandatory
Service Bulletin 27-4100, dated March 2012.

(i) Repetitive Replacements

    Within 1,800 flight hours after the effective date of this AD,
or at the next PTA overhaul, whichever occurs first, replace the PTA
with a new PTA or an overhauled PTA having the Acme nut and
jackscrew replaced with a new Acme nut and jackscrew, in accordance
with sections 3.A.(2), (3), and (5) through (10) of Hawker
Beechcraft Mandatory Service Bulletin 27-4100, dated March 2012.
Repeat the replacement thereafter at intervals not to exceed 1,800
flight hours, or at every PTA overhaul, whichever occurs first.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Wichita Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (k)(1) of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(k) Related Information

    (1) For more information about this AD, contact Ann Johnson,
Aerospace Engineer, Systems and Propulsion Branch, ACE-116W, FAA,
Wichita Aircraft Certification Office (ACO), 1801 Airport Road, Room
100, Mid-Continent Airport, Wichita, KS 67209; phone: (316) 946-
4105; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Beechcraft Corporation, TMDC, P.O. Box 85, Wichita, KS 67201-0085;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
Internet http://pubs.beechcraft.com. You may view this referenced
service information at the FAA, Transport Airplane Directorate, 1601
Lind Avenue SW., Renton, WA. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on June 10, 2014.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-15246 Filed 6-27-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 211 (Thursday, October 31, 2019)]
[Notices]
[Pages 58446-58447]
[FR Doc No: 2019-23755]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2015-0385]

Qualification of Drivers; Exemption Applications; Hearing

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

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to renew exemptions for three
individuals from the hearing requirement in the Federal Motor Carrier
Safety Regulations (FMCSRs) for interstate commercial motor vehicle
(CMV) drivers. The exemptions enable these hard of hearing and deaf
individuals to continue to operate CMVs in interstate commerce.

DATES: The exemptions were applicable on August 13, 2019. The
exemptions expire on August 13, 2021.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
ET, Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov/docket?D=FMCSA-2015-0385 and choose the document to review. If you do
not have access to the internet, you may view the docket online by
visiting the Docket Operations in Room W12-140 on the ground floor of
the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590,
between 9

a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays.

B. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    On September 3, 2019, FMCSA published a notice announcing its
decision to renew exemptions for three number individuals from the
hearing standard in 49 CFR 391.41(b)(11) to operate a CMV in interstate
commerce and requested comments from the public (84 FR 46092). The
public comment period ended on October 3, 2019, and no comments were
received.
    FMCSA has evaluated the eligibility of these applicants and
determined that renewing these exemptions would achieve a level of
safety equivalent to, or greater than, the level that would be achieved
by complying with Sec.  391.41(b)(11).
    The physical qualification standard for drivers regarding hearing
found in Sec.  391.41(b)(11) states that a person is physically
qualified to drive a CMV if that person first perceives a forced
whispered voice in the better ear at not less than 5 feet with or
without the use of a hearing aid or, if tested by use of an audiometric
device, does not have an average hearing loss in the better ear greater
than 40 decibels at 500 Hz, 1,000 Hz, and 2,000 Hz with or without a
hearing aid when the audiometric device is calibrated to American
National Standard (formerly ASA Standard) Z24.5--1951.
    This standard was adopted in 1970 and was revised in 1971 to allow
drivers to be qualified under this standard while wearing a hearing
aid, 35 FR 6458, 6463 (April 22, 1970) and 36 FR 12857 (July 3, 1971).

III. Discussion of Comments

    FMCSA received insert number comments in this proceeding.

IV. Conclusion

    Based upon its evaluation of the three renewal exemption
applications FMCSA announces its decision to exempt the following
drivers from the hearing requirement in Sec.  391.41(b)(11).
    As of August 13, 2019, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following insert three individuals have satisfied the
renewal conditions for obtaining an exemption from the hearing
requirement in the FMCSRs for interstate CMV drivers (84 FR 46092):
    Jerrell M. McCrary (NC); David A. Pressley (TX); and Jason D.
Swearington (WA).
    The drivers were included in docket number FMCSA-2015-0385. Their
exemptions are applicable as of August 13, 2019, and will expire on
August 13, 2021.
    In accordance with 49 U.S.C. 31315(b), each exemption will be valid
for 2 years from the effective date unless revoked earlier by FMCSA.
The exemption will be revoked if the following occurs: (1) The person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
prior to being granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315(b).

    Issued on: October 24, 2019.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2019-23755 Filed 10-30-19; 8:45 am]
 BILLING CODE 4910-EX-P


FILE NAME: company. wpt ( 1/ 1/ 2005) ( xml) Template Number P25 ATTENTION:

All commodity terms must comply with the Food and Feed Commodity Vocabulary database ( http:// www. epa. gov/ pesticides/ foodfeed/).

All text in blue font ( instructions for preparing the document), should be removed prior to sending the document to the Federal Register Staff. Instructional text and prompts in green font should also be removed.

COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE ( 1/ 1/ 2005)

EPA Registration Division contact:

[ Tony Kish, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW. Washington, DC 20460  0001; Telephone number: ( 703) 308  9943; e mail address: kish. tony@ epa. gov.]

INSTRUCTIONS: Please utilize this outline in preparing tolerance petition documents. In cases where the outline element does not apply please insert " NA Remove" and maintain the outline. The comment notes that appear on the left margin represent hidden typesetting codes designed to expedite the processing of the Federal Register document. Please do not remove or alter these comment notes or change the margins, font, or format in your document. Simply replace the instructions that appear in italics and brackets, i. e., "[ insert company name]," with the information specific to your action. TEMPLATE:

[ BASF Corporation] use existing docket # 2003 0246 [ REVISED PP# 1F6313] EPA has received a REVISED pesticide petition ([ PP# 1F6313]) from [ BASF Corporation], [ Research Triangle Park, NC 27709] proposing, pursuant to section 408( d) of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a( d), to amend 40 CFR part 180 by lowering the established 1.0 ppm tolerances to 0.1 ppm for indirect or inadvertent residues of [ Boscalid ( BAS 510F); [ 3 pyridinecarboxamide, 2 chloro N( 4' chloro( 1,1' biphenyl) 2 yl]] in or on the raw agricultural commodities [ Beet, garden, roots, 0.1 parts per million ( ppm), Beet, sugar, roots,. 0.1 parts per million ( ppm), Radish, roots, 0.1 parts per million ( ppm), Turnip, roots, 0.1 parts per million ( ppm), and Vegetable, root and tuber, leaves, group 2, 0.1 parts per million ( ppm)],

The original notice of filing for petition 1F6313 was published February 14, 2003 ( 68FR7542), and the resultant final rule was published July 30, 2003 ( 68FR44640). As per that final rule and associated notice of pesticide registration, the registrant was conditionally required to submit more extensive field data on the vegetable, root, subgroup 1B. Because the conditional data will result in lowering the 1.0 ppm tolerances established in the final rule to 0.1 ppm, a revised petition, revised final rule, and public comment period are required.

EPA has determined that the petition contains data or information regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry 1. Plant metabolism. [ Nature of the residue studies ( OPPTS Harmonized Guideline860.1300) were conducted in grapes, lettuce and beans as representative crops in order to characterize the fate of boscalid ( BAS 510F) in all crop matrices. In all three crops the boscalid ( BAS 510F) Residues of Concern ( ROC) were characterized as parent boscalid ( BAS 510F). A confined rotational crop study also determined that parent was the residue of concern in the representative crops of radish, lettuce and wheat.]

2. Analytical method. [ In plants the parent residue is extracted using an aqueous organic solvent mixture followed by liquid/ liquid partitioning and a column clean up. Quantitation is by gas chromatography using mass spectrometry ( GC/ MS). In livestock the residues are extracted with methanol. The extract is treated with enzymes in order to release the conjugated glucuronic acid metabolite. The residues are then isolated by liquid/ liquid partition followed by column chromatography. The hydroxylated metabolite is acetylated followed by a column clean up. The parent and acetylated metabolite are quantitated by gas chromatography with electron capture detection.] 3. Magnitude of residues. [ Tier III field rotational crop studies were conducted in the United States to support rotational crop tolerances for Sugarbeet, Garden Beet, and Turnips. Field trials were carried out using the maximum label rate, the maximum number of applications, and the minimum pre plant interval for each crop. Residue levels of boscalid ( BAS 510F) were determined in Sugarbeet, Garden Beet, and Turnips roots and leaves. The number and locations of field trials are in accordance with OPPTS Guideline 860.1500.]

B. Toxicological Profile 1. Acute toxicity. [ Based on available acute toxicity data BAS 510F and its formulated products do not pose acute toxicity risks. The acute toxicity studies place technical Boscalid ( BAS 510F) in toxicity category IV for acute oral; category III for acute dermal and category IV for acute inhalation. BAS 510F is category IV for both eye and skin irritation, and it is not a dermal sensitizer. The formulated end use products proposed are as follows: a water dispersible granule ( WG) termed Endura ® ( BAS 510 02/ 04F) containing 70% boscalid ( BAS 510F510F) and a water dispersible granule ( WG) termed Pristine ® ( BAS 516 02/ 04F) containing a 2: 1 mixture of boscalid ( BAS 510F510F) and pyraclostrobin ( BAS 500F). BAS 510 02F has an acute oral toxicity category of III, acute dermal of category III, acute inhalation of category IV, eye irritation of category III, skin irritation of category IV, and is not a dermal sensitizer. BAS 516 02F has an acute oral toxicity category of III, acute dermal of category III, acute inhalation of category IV, eye irritation of category III, skin irritation of category IV, and is not a dermal sensitizer.]

2. Genotoxicty. [ Ames Test ( 1 Study; gene point mutation): Negative; In Vitro CHO/ HGPRT Locus Mammalian Cell Mutation Assay ( 1 Study; point gene mutation): Negative; In Vitro V79 Cell Cytogenetic Assay ( 1 Study; Chromosome Damage): Negative; In Vivo Mouse Micronucleus ( 1 Study; Chromosome Damage): Negative; In Vitro Rat Hepatocyte ( 1 Study; DNA damage and repair): Negative. BAS 510F has been tested in a total of 5 genetic toxicology assays consisting of in vitro and in vivo studies. It can be stated that BAS 510F did not show any mutagenic, clastogenic or other genotoxic activity when tested under the conditions of the studies mentioned above. Therefore, BAS 510F does not pose a genotoxic hazard to humans.]

3. Reproductive and developmental toxicity. [ The reproductive and developmental toxicity of BAS 510F was investigated in a two generation rat reproduction study as well as in rat and rabbit teratology studies. There were no adverse effects on reproduction in the two generation study at any dose tested. The reproductive NOAEL is 10,000 ppm ( 1165 and 1181 for males and females, respectively), the highest dose tested. Pup effects were observed, at the highest dose tested only. In males of the F1 generation, reduced body weight and reduced body weight gain were observed at 10,000 ppm. Additionally, hepatocyte degeneration was observed in males in animals of both the F0 and F1 generations at 10,000 ppm. The parental systemic NOAEL is 1000 and 10,000 ( 113 and 1181 mg/ kg b. w./ day) for males and females, respectively. Toxicity to the offspring was seen at 1,000 ppm in the form of decreased pup weights in the F2 males, and at 10,000 ppm in the form of decreased pup weights for both males and females of both the F1 and F2 generations. The offspring NOAEL is 100 and 1000 ppm ( 12 and 116 mg/ kg b. w./ day) for males and females, respectively.

The Agency concluded that there are no residual uncertainties for pre and postnatal toxicity as the degree of concern is low for the susceptibility seen in the above studies, and the dose and endpoints selected for the overall risk assessments will address the concerns for the body weight effects seen in the offspring. Although the dose selected for overall risk assessments ( 21.8 mg/ kg b. w./ day) is higher than the NOAELs in the 2 generation reproduction study ( 10.1 mg/ kg b. w./ day) and the developmental neurotoxicity study ( 14 mg/ kg b. w./ day), these differences are considered to be an artifact of the dose selection process in these studies. For example, there is a 10 fold difference between the LOAEL. ( 106.8 mg/ kg b. w./ day) and the NOAEL ( 10.1 mg/ kg b. w./ day) in the two generation reproduction study. A similar pattern was seen with regard to the developmental neurotoxicity study, where there is also a 10 fold difference between the LOAEL ( 147 mg/ kg b. w./ day) and the NOAEL ( 14 mg/ kg b. w./ day). There is only a 2 3 fold difference between the LOAEL ( 57 mg/ kg b. w./ day) and the NOAEL ( 21.8 mg/ kg b. w./ day) in the critical study used for risk assessment. Because the gap between the NOAEL and LOAEL in the 2 generation reproduction and developmental neurotoxicity studies was large and the effects at the LOAELs were minimal, the true no observedadverse effect level was probably considerably higher. Therefore, the selection of the NOAEL of 21.8 mg/ kg b. w./ day from the 1 year dog study is conservative and appropriate for the overall risk assessments. In addition, the endpoints for risk assessment are based on thyroid effects seen in multiple species ( mice, rats and dogs) and after various exposure durations ( subchronic and chronic exposures) which were not observed at the LOAELs in either the 2 generation reproduction or the developmental neurotoxicity studies. Based on these data, the Agency concluded that there are no residual uncertainties for pre and postnatal toxicity.

No teratogenic effects were noted in either the rat or rabbit developmental studies. In the rat study, evidence of maternal or developmental toxicity was not observed at any dose ( highest dose tested of 1,000 mg/ kg b. w./ day). Neither a maternal nor developmental LOAEL were found since the highest dose tested was the NOAEL in both studies. In the rabbit teratology study, maternal toxicity observed at the mid dose of 300 milligrams/ kilogram of body weight ( mg/ kg b. w./ day) consisted of discolored/ reduced feces in one dam and an abortion in one dam. This finding is not necessarily indicative of a definitive test substance related adverse effect. The dam which displayed the fecal alterations and abortion also displayed decreased body weight and body weight gain  compared to the group mean  during gestation. These decreases occurred even prior to compound administration. Food consumption was also dramatically decreased in this dam compared to the other animals in the group. Every day from gestation day ( GD) 1  12, this dam had food consumption values which were less than half the mean for the group ( compound administration began on GD 7). From GD 13 to 26 ( when the animal aborted and was sacrificed) this dam ate essentially nothing ( food consumption during this time period was less than or equal to 1.5 grams food/ day). These decreases in body weight, body weight gain, and food consumption, prior to compound administration, all indicate an animal in poor health and this poor state of health, rather than compound exposure, was likely the reason for the fecal alterations and abortion.

At the high dose of 1,000 mg/ kg b. w./ day a maternal body weight gain decrease compared to controls of 81% was observed during the treatment period. Reduced food consumption, reduced body weight and abortions in three dams, were also seen at 1,000 mg/ kg b. w./ day. Evidence of developmental toxicity was not seen at any dose tested.

Developmental neurotoxicity was not observed at any dose in the developmental neurotoxicity study. No maternal toxic effects were noted at any dose in this study. No developmental toxicity was seen at the low dose of 12 mg/ kg b. w./ day ( 100 ppm). Reduced body weights and body weight gains were seen at 118 mg/ kg b. w./ day ( 1,000 ppm) during post natal day ( PND) 1 4. Reduced body weights and body weight gains were seen at 1,183 mg/ kg b. w./ day ( 10,000 ppm) as well as decreased absolute pup brain weight at day PND 11 ( both sexes) and decreased brain length ( males only) at PND. The reduced pup brain weights and decreased brain length go hand in hand and both are due to the decreased pup weights seen at this dose. In this respect, it should be noted that pup brain weights relative to body weight at PND 11 were not significantly different from controls at this dose. Though no maternal toxicity was seen in this study, other studies using similar doses of BAS 510F resulted in maternal toxicity. A dose of 118 mg/ kg b. w./ day in female rats of the same strain in the multigeneration study, resulted in an increased incidence of hepatic centrilobular hypertrophy  a parameter which could not have been detected in the developmental neurotoxicity ( DNT) study as liver histopathology on parental animals was not performed in the DNT study .]

4. Subchronic toxicity. [ The subchronic toxicity of BAS 510F was investigated in a 90  day feeding studies with rats, mice and dogs, and in a 28  day dermal administration study in rats. Additonally a 90  day neurotoxicity study in rats was performed. Generally, mild toxicity was observed. At high dose levels ( doses above the LOAELs) in feeding studies, allall three species displayed alterations in various clinical chemistry parameters. These clinical chemistry alterations were likely secondary to general toxicity. Statistically significant increased absolute and relative thyroid weights were observed in male rats only at doses at and above the LOAEL. Increased absolute and relative liver weights were observed in both sexes at doses above the LOAEL in rats and dogs. Increased absolute and relative liver weights were seen in both sexes of the mouse at lower doses. However, the increases in liver weights at these lower doses in the mouse were not deemed to be compound related due to the unusually low concurrent control liver weight values. At doses above the LOAELs, liver weight increases were supported by histopathology alterations in the rat and mouse, but not in the dog. Overall, only mild toxicity was observed in oral subchronic testing. In the 28  day repeat dose dermal study, no systemic effects were noted up to the highest dose tested of 1,000 mg/ kg b. w./ day. In a 90  day rat neurotoxicity study, there was no mortality, signs of clinical toxicity, or adverse effects on food consumption or body weight at any dose level in either sex. No signs of neurotoxicity were observed during clinical observations, functional observation batteries, motor activity measurements of neuropathology. Therefore, there were no selective neurotoxic effects. Adverse effects were not seen even at the highest dose level tested. A LOAEL was not found and the NOAEL is the highest tested of 15,000 ppm ( 1,050 mg/ kg b. w./ day in males; 1,272 mg/ kg b. w./ day in females).]

5. Chronic toxicity. [ Based on review of the available data, the Reference Dose ( RfD) forBAS 510F will be based on a a 1 year feeding study in dogs with a NOAEL of 21.8 mg/ kg b. w./ day. Using an uncertainty factor of 100, the RfD is calculated to be 0.218 mg/ kg b. w./ day. The following are summaries of chronic toxicity studies submitted to EPA. The chronic toxicity/ oncogenicity studies with BAS 510F include a 12  month feeding study with Beagle dogs, an 18  month B63CF1 mouse feeding study, a 24  month Wistar rat chronic feeding study and a 24  month Wistar rat oncogenicity study. At the highest dose tested in dogs, effects observed consisted primarily of increased liver and thyroid weights and some serum clinical chemistry changes. The NOAEL was 800 ppm ( 21.8 mg/ kg b. w./ day males; 22.1 mg/ kg b. w./ day females). Decreased body weights were seen in males in the mouse chronic study at doses of 8000 ppm ( 1804 mg/ kg b. w./ day) and above. Decreased female body weight was seen at doses of 2,000 ppm ( 331 mg/ kg b. w./ day) and above. The target organ in this study was the liver. The NOAEL was 65 and 443 mg/ kg b. w./ day ( 8000 and 2000 ppm) for male and female mice, respectively. In both the rat chronic and oncogenicity studies, the highest dose tested of 15,000 ppm exceeded a maximum tolerated dose ( MTD) and was discontinued after 17 months. Effects observed at the next highest dose of 2,500 ppm primarily centered around the thyroid and liver. The NOAEL was 23 and 30 mg/ kg b. w./ day ( 2500 ppm) for male and female rats, respectively. Overall, mild toxicity was observed with chronic exposure to BAS 510F. No evidence of treatment induced oncogenicity was observed in the mouse or dog studies. A slight increase in thyroid follicular cell adenomas was seen in both sexes at the high dose when the data from both rat bioassays are combined. A mode of action ( MOA) for the thyroid follicular cell adenomas has been proposed. This MOA is based on the EPA publication " Assessment of Thyroid Follicular Cell Tumors," March 1998, EPA/ 630/ R  97/ 002. This document describes the criteria which must be met in order for a compound to be considered under the MOA described in that publication. BASF Corporation believes that BAS 510F has met the cited criteria. Threshold effects. Based on a review of the available chronic toxicity data, BASF believes EPA will establish the RfD for BAS 510F at 0.281 mg/ kg b. w./ day. This RfD for BAS 510F is based on the 2  year chronic and 2  year oncogenicity studies in rats and the 1 year dog study with a the lowest threshold NOAEL of 21.8 mg/ kg b. w./ day for males. Using an uncertainty factor of 100, the RfD is calculated to be 0.218 mg/ kg b. w./ day. Based on the acute toxicity data, BASF believes that BAS 510F does not pose any acute dietary risks. BAS 510F was shown to be noncarcinogenic in mice and dogs. There was a slight increase in thyroid follicular cell ademonas at the high dose in both sexes in the rat. A threshold based MOA for these tumors based on the EPA publication " Assessment of Thyroid Follicular Cell Tumors" ( EPA/ 630/ R  97/ 002, March, 1998), has been proposed. BASF believes the data to support this proposed mode of action are strong, and that the thyroid tumors seen in the rat following BAS 510F exposure have a threshold. In addition, a battery of genotoxicity studies demonstrated that BAS 510F has no genotoxic or clastogenic potential. Therefore, BASF believes that the threshold approach to regulating BAS 510F is appropriate. Also, it should be noted that, while the Agency has in the past considered tumors of this type to be potential human carcinogens, the European Union has published a policy which considers these tumor types, when they occur at low incidence rates in the rat, to not be relevant to man. ( The publication: European Commission, European Chemicals Bureau, ECBI/ 49/ 99   Add. 1 Rev. 2; " Draft Summary Record, Commission Group of Specialized Experts in the fields of Carcinogenicity, Mutagenicity and Reprotoxicity" Meeting at Arona, 1  2 September 1999), Therefore, BASF believes that these tumors are not likely relevant to humans and, if these tumors are to be considered relevant to humans, the threshold approach to cancer risk assessment is appropriate.]

6. Animal metabolism. [ In the rat, the predominant route of excretion of BAS 510F is fecal with urinary excretion being minor. The half life of BAS 510F is less than 24 hours. Saturation of absorption appears to be occurring at the high dose level. BAS 510F is rapidly and intensively metabolized to a large number of biotransformation products. The hydroxylation of the diphenyl moiety was the quantitatively most important pathway. Second most important was the substitution of the Cl of the 2 chloropyridine part against SH by conjugation with glutathione. No major differences were observed. In hens and goats the residues of concern were determined to be parent, the hydroxylated metabolite M510 F01 ( 2 chloro N( 4' chloro 5 hydroxy biphenyl 2 yl) nicotinamide), and the glucuronic acid of the metabolite M510 F02.]

7. Metabolite toxicology. [ In the rat, the predominat route of excretion of BAS 510F510F is fecal with urinary excretion being minor. The half life of BAS 510F510F is less than 24 hours. Saturation of absorption appears to be occurring at the high dose level. BAS 510F510F is rapidly and intensively metabolized to a large number of biotransformation products. The hydroxylation of the diphenyl moiety was the quantitatively most important pathway. Second most important was the substitution of the Cl of the 2 chloropyridine part against SH by conjugation with glutathione. No major differences were observed. In hens and goats the residues of concern were determined to be parent, the hydroxylated metabolite M510 F01 ( 2 chloro N( 4' chloro 5 hydroxy biphenyl 2 yl) nicotinamide), and the glucuronic acid of the metabolite M510 F02.]

8. Endocrine disruption. [ No specific tests have been conducted with BAS 510Fto determine whether the chemical may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects. However, there were no significant findings in other relevant toxicity studies ( i. e., subchronic and chronic toxicity, teratology and multi generation reproductive studies) which would suggest that BAS 510F produces endocrine related effects.]

C. Aggregate Exposure 1. Dietary exposure. [ An assessment was conducted to evaluate the potential risk due to chronic dietary exposure of the U. S. population and sub populations to residues of boscalid. Tolerance values for boscalid ( BAS 510F) have previously been established and are listed in U. S. 40 CFR § 180.589.

This analysis included all crops with established boscalid tolerance values and considering a decreased tolerance of 0.1 ppm from 1.0 ppm for garden beet roots, sugar beet roots, radish roots, turnip roots, and leaves of roots and tuber vegetables ( Group 2).

i. Food. Acute Dietary Exposure Assessment An acute assessment was not needed since the U. S. EPA Toxicological Endpoint Selection ( TES) Committees had previously evaluated the boscalid toxicity data and determined there were no toxic effects attributable to a single dose. Therefore, a quantitative acute dietary exposure and risk assessment were not required.

Chronic Dietary Exposure Assessment A Tier 1 chronic dietary exposure assessment was conducted assuming tolerance level residues, default processing factors, 100% crop treated factors for all crops and consumption data from the USDA Continuing Survey of Food Intake by Individuals ( CSFII 1994  1996, 1998) and the EPA Food Commodity Ingredient Database ( FCID) using Exponent's Dietary Exposure Evaluation Module ( DEEM FCID) software. Residues in animal commodities ( i. e. meat, meat byproducts, fat, milk, eggs) were included at the tolerance levels currently established and listed in U. S. 40 CFR § 180.589.

Dietary exposure estimates were compared against the established boscalid chronic Population Adjusted Dose ( cPAD) of 0.218 mg/ kg b. w./ day for all populations. Results of the chronic dietary assessments are listed in the Table 1. The estimated chronic dietary exposure from crops and animal commodities was less than 27 % of the cPAD for all subpopulations. Additional refinements such as the use of anticipated residues and adjusted crop treated factors would further reduce the estimated chronic dietary exposure. The results in Table 1 demonstrate there are no safety concerns for any subpopulation based on established and new uses, and the results clearly meet the FQPA standard of reasonable certainty of no harm.

Table 1. Summary of Chronic Dietary Exposure Assessment for Boscalid Population Subgroups Exposure Estimate ( mg/ kg b. w./ day) % cPAD U. S. Population 0.014236 6.5 All Infants 0.034676 15.9 Children 1 2 years 0.056165 25.8 Children 3 5 years 0.038275 17.6 Children 6 12 years 0.018424 8.5 Youth 13 19 years 0.010037 4.6 Females 13 49 years 0.010061 4.6 Adults 20 49 years 0.010065 4.6 Adults 50+ years 0.010745 4.9 % cPAD = percent of chronic population adjusted dose Exposure estimates based on tolerance values, default processing factors, and 100% CT for all crops/ commodities ii. Drinking water.

Based on PRZM/ EXAMS and SCI GROW models, the estimated drinking water exposure concentrations of boscalid for chronic exposure were 26 ppb for surface water and 0.63 ppb for ground water. Drinking water contributions were assessed based on the maximum estimated boscalid water concentrations ( 26 ug/ L), and water consumption and body weights reported in CSFII, using DEEM FCID software. The chronic estimated water exposure values are summarized in Table 2. Minimal exposure of boscalid occurs through drinking water with < 1.0% cPAD for all subpopulations.

Table 2. Results for Boscalid Chronic Water Exposure Analysis Considering the Maximum Estimated Chronic Drinking Water Concentration using DEEM FCID Population Water Exposure Estimate % aPAD Subgroups ( mg/ kg b. w./ day) U. S. Population 0.000548 0.3 All Infants (< 1 year old) 0.001797 0.8 Children ( 1 2 years old) 0.000814 0.4 Children ( 3 5 years old) 0.000762 0.3 Children ( 6 12 years old) 0.000525 0.2 Youth ( 13 19 years old) 0.000396 0.2 Females ( 13 49 years old) 0.000510 0.2 Adults ( 20 49 years old) 0.000512 0.2 Adults ( 50+ years old) 0.000538 0.2 cPAD = chronic population adjusted dose Based on estimated chronic surface water value of 26 ug/ L Acute Aggregate Exposure and Risk ( Food and water) Since the U. S. EPA Toxicological Endpoint Selection ( TES) Committees has evaluated the Boscalid toxicity data and determined there was no toxicological endpoints for acute dietary exposure, the determination of an acute aggregate exposure and risk evaluation was not required.

Short and Intermediate Term Aggregate Exposure and Risk ( food, water, and residential) Short and intermediate term aggregate exposure takes into account residential exposure plus chronic exposure from food and water. Residential exposure is used to refer to nonoccupational and non dietary exposure. No new residential uses are currently being registered for boscalid that would increase non dietary exposure. The residential exposure value used in this risk assessment was previously determined by the EPA ( Federal Register, Volume 68, No 146, July 30, 2003) and considers dermal exposure to adults from the golf course use. The MOE presented in the Table 3 is considered to be representative for youth playing golf because youth and adults possess similar body surface area to weight rations and because the dietary exposure for youth ( 13 19 years old) is less than that of the general US population.

Table 3. Estimated Short/ Intermediate Term Aggregate Exposure and Risk of Boscalid Population NOAEL ( mg/ kg/ day) Target MOE1 Food Exposure ( mg/ kg/ day) Water Exposure ( mg/ kg/ day) Residential Exposure2 ( mg/ kg/ day) Total Exposure ( mg/ kg/ day) MOE3 US 21.8 100 0.014236 0.000548 0.0008 0.015584 1399 1 Target MOE is 100. 2 Residential Exposure = Exposure to adult while playing golf. 3 Aggregate MOE = ( NOAEL / ( Food + Water + Residential Exposure)

Chronic Aggregate Exposure and Risk ( food and water) The aggregate chronic risk includes residues of boscalid from food and water ( Table 4). Exposures from residential uses are not included in the chronic aggregate assessment. The results demonstrate there are no safety concerns for any subpopulation based on established and new uses, and that the results clearly meet the FQPA standard of reasonable certainty of no harm.

Table 4. Estimated Chronic Aggregate Exposure and Risk of Boscalid Population Subgroup cPAD ( mg/ kg/ day) Food Exposure ( mg/ kg/ day) Water Exposure ( mg/ kg/ day) Total Exposure ( mg/ kg/ day) % cPAD U. S. Population 0.218 0.014236 0.000548 0.014784 6.78 All Infants (< 1 yr old) 0.218 0.034676 0.001797 0.036473 16.73 Children 1 2 years 0.218 0.056165 0.000814 0.056979 26.14 Children 3 5 years 0.218 0.038275 0.000762 0.039037 17.91 Children 6   12 years 0.218 0.018424 0.000525 0.018949 8.69 Youth 13 19 years 0.218 0.010037 0.000396 0.010433 4.79 Females 13 49 years 0.218 0.010061 0.00051 0.010571 4.85 Adults 20 49 years 0.218 0.010065 0.000512 0.010577 4.85 Adults + 50 0.218 0.010745 0.000538 0.011283 5.18 2. Non dietary exposure. [ No new residential uses are currently being registered for boscalid that would increase non dietary exposure. A non occupational dermal post application exposure/ risk assessment for individuals golfing and harvesting fruit at " U Pick" farms and orchards was previously conducted by EPA ( Federal Register, Volume 68, No 146, July 30, 2003). Because U Pick is a one time event ( duration < 1 day) and the EPA found that the oral studies indicated there were no endpoints appropriate to quantitate acute risk. Therefore, only the golfing scenario was evaluated with respect to non occupational, non dietary exposure. The dermal MOE's for adults playing golf were 27,000   74,000. Although specific MOE's were not calculated for youths playing golf, the adult MOEs are considered representative since the body surface area to weight ratios for adolescents do not vary significantly from those of adults.]

D. Cumulative Effects [ Section 408( b)( 2)( D)( v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider " available information" concerning the cumulative effects of a particular pesticide's residues and " other substances that have a common mechanism of toxicity." Boscalid is a foliar fungicide chemically belonging to the carboxin class of fungicides. Boscalid acts in the fungal cell by inhibiting mitochondrial respiration through inhibition of the succinate ubiquinone oxidase reductase system in Complex II of the mitochondrial electron transport chain. Boscalid shares this mode of action with only one other currently registered U. S. pesticide  carboxin. The EPA is currently developing methodology to perform cumulative risk assessments. At this time, there is no available data to determine whether boscalid has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, boscalid does not appear to produce a toxic metabolite produced by other substances.] E. Safety Determination 1. U. S. population. [ Based on this risk assessment, BASF concludes that there is a reasonable certainty that no harm will result to the general population from the aggregate exposure to boscalid residues.]

2. Infants and children. [ Based on this risk assessment, BASF concludes that there is a reasonable certainty that no harm will result to infants or children from the aggregate exposure to boscalid residues.]

F. International Tolerances [ A maximum residue level ( MRL) has not been established for Boscalid ( BAS 510F510F) in any crop by the Codex Alimentarius Commission.]