[Federal Register: July 15, 2010 (Volume 75, Number 135)]
[Proposed Rules]
[Page 41104-41106]
[DOCID:fr15jy10-20]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0711; Directorate Identifier 2008-SW-25-AD]
RIN 2120-AA64

Airworthiness Directives; Robinson Helicopter Company (Robinson)
Model R22, R22 Alpha, R22 Beta, and R22 Mariner Helicopters, and Model
R44, and R44 II Helicopters

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This document proposes adopting a new airworthiness directive
(AD) for Robinson Model R22, R22 Alpha, R22 Beta, and R22 Mariner
helicopters, and Model R44 and R44 II helicopters. The AD would require
visually inspecting each tail rotor (T/R) control pedal bearing block
support (support) for a crack, measuring the thickness of each
uncracked support, installing support safety tabs on certain supports,
and replacing supports of a certain thickness during overhaul. This
proposal is prompted by two reports of Model R22 helicopters
experiencing broken supports during flight, which resulted in the T/R
control pedals becoming jammed. The actions specified by the proposed
AD are intended to prevent the supports from breaking, which can bind
the T/R control pedals, resulting in a reduction of yaw control and
subsequent loss of control of the helicopter.

DATES: Comments must be received on or before September 13, 2010.

ADDRESSES: Use one of the following addresses to submit comments on
this proposed AD:
     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: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    You may get the service information identified in this proposed AD
from Robinson Helicopter Company, 2901

Airport Drive, Torrance, California 90505, telephone<PHONE_NUMBER>,
fax<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Eric D. Schrieber, Aviation Safety
Engineer, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>, regarding
Robinson Model R22 helicopters, or Fred Guerin, Aviation Safety
Engineer, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>, regarding
Robinson Model R44 helicopters, at the FAA, Los Angeles Aircraft
Certification Office, Airframe Branch, 3960 Paramount Blvd., Lakewood,
California 90712.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to submit any written data, views, or arguments
regarding this proposed AD. Send your comments to the address listed
under the caption ADDRESSES. Include the docket number ``FAA-2010-0711,
Directorate Identifier 2008-SW-25-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of the proposed AD. We will
consider all comments received by the closing date and may amend the
proposed AD in light 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
with FAA personnel concerning this proposed rulemaking. Using the
search function of our docket Web site, you can find and read the
comments to any of our dockets, including the name of the individual
who sent or signed the comment. You may review the DOT's complete
Privacy Act Statement in the Federal Register published on April 11,
2000 (65 FR 19477).

Examining the Docket

    You may examine the docket that contains the proposed AD, any
comments, and other information in person at the Docket Operations
office between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The Docket Operations office (telephone<PHONE_NUMBER>) is
located in Room W12-140 on the ground floor of the West Building at the
street address stated in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.

Discussion

    This document proposes adopting a new AD for Robinson Model R22,
R22 Alpha, R22 Beta, and R22 Mariner helicopters, serial numbers (S/N)
0002 through 3325, that have more than 2,200 hours total time-in-
service (TIS); and Model R44 and R44 II helicopters, S/N 0001 through
1200, that have more than 2,200 hours total TIS. The AD would require,
within 100 hours TIS, visually inspecting both A359-1 and A359-2
supports for a crack and replacing any cracked or broken support before
further flight, and if not cracked, measuring the thickness of both
supports and if less than 0.050-inch thick, installing support safety
tabs, and at the next 2,200 hour TIS overhaul, replacing any support
that is less than 0.050-inch thick with a support that is at least
0.050-inch thick. This proposal is prompted by two reports of Model R22
helicopters with more than 7,000 hours TIS, with supports made from
0.040-inch thick sheet metal, experiencing broken supports during
flight, which led to the T/R control pedals becoming jammed, resulting
in hard landings and damage to the helicopters. The actions specified
by the proposed AD are intended to prevent the supports from breaking,
which can bind the T/R control pedals, resulting in a reduction of yaw
control and subsequent loss of control of the helicopter.
    We have reviewed Robinson Helicopter Company Service Bulletin SB-63
and SB-97, both dated February 22, 2008, which describe procedures for
inspecting both supports for a crack, and if no crack is found,
measuring each support and installing safety tabs on supports that are
less than 0.050-inch thick, and at the next 2,200 hour TIS overhaul,
replacing certain supports.
    This unsafe condition is likely to exist or develop on other
helicopters of the same type design. The actions would be required to
be accomplished by following specified portions of the service
bulletins described previously.
    This proposed AD would affect 4,524 helicopters of U.S. registry,
and proposed actions would take approximately 0.5 work hour to inspect
and measure the supports. We estimate that 2,050 helicopters would
require an additional 1 work hour to install both safety tabs; 6 work
hours to replace both supports if cracked or broken or before overhaul,
or 3 work hours to replace both supports as part of a 2,200 hours TIS
overhaul, at an average labor rate of $85 per work hour. Required parts
would cost approximately $20 per support if replacement is required.
Based on these figures, the total cost impact of the proposed AD on
U.S. operators would be $1,101,830, assuming 1,538 (approximately 75%
of the 2,050 helicopters) have both supports replaced during overhaul,
and 512 helicopters (approximately 25% of the 2,050 helicopters) have
both supports replaced before the next 2,200 hours TIS overhaul.

Regulatory Findings

    We have determined that this proposed AD would not have federalism
implications under Executive Order 13132. Additionally, 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 that the 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); and
    3. 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.
    We prepared a draft economic evaluation of the estimated costs to
comply with this proposed AD. See the AD docket to examine the draft
economic evaluation.

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 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.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the Federal Aviation Administration proposes to amend
part

39 of the Federal Aviation Regulations (14 CFR part 39) as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    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]

    2. Section 39.13 is amended by adding a new airworthiness directive
to read as follows:

Robinson Helicopter Company: Docket No. FAA-2010-0711; Directorate
Identifier 2008-SW-25-AD.
    Applicability: Model R22, R22 Alpha, R22 Beta, and R22 Mariner
helicopters, serial numbers (S/N) 0002 through 3325, that have more
than 2,200 hours total time-in-service (TIS); and Model R44 and R44
II helicopters, S/N 0001 through 1200, that have more than 2,200
hours total TIS, certificated in any category.
    Compliance: Required as indicated, unless accomplished
previously.
    To prevent the tail rotor (T/R) control pedal bearing block
support (support) from breaking, which can bind the T/R control
pedals, resulting in a reduction of yaw control and subsequent loss
of control of the helicopter, accomplish the following:
    (a) Within 100 hours TIS, visually inspect each A359-1 (left)
and A359-2 (right) pedal support for a crack by referring to the
figure in Robinson Helicopter Company (Robinson) Service Bulletin
SB-97, dated February 22, 2008 (SB-97) for all Model R22
helicopters, and Robinson Service Bulletin SB-63, dated February 22,
2008 (SB-63) for all Model R44 helicopters.
    (1) If you find a crack in a support, before further flight,
replace the cracked support with an airworthy support that is at
least 0.050-inch thick.
    (2) For each uncracked support, measure the thickness of the
support. If the support is less than 0.050-inch thick, before
further flight, install a safety tab on the support in accordance
with steps 4 and 5 of the Compliance Procedures section in SB-97 or
SB-63, as appropriate for your model helicopter.
    (b) At the next 2,200 hours TIS overhaul, replace any support
that is less than 0.050-inch thick, with an airworthy support that
is at least 0.050-inch thick.
    (c) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Contact the Manager, Los Angeles Aircraft Certification Office, FAA,
ATTN: Eric D. Schrieber, Aviation Safety Engineer, 3960 Paramount
Blvd., Lakewood, California 90712, telephone<PHONE_NUMBER>, fax
(562) 627-5210 (regarding Model R22 helicopters); or ATTN: Fred
Guerin, Aviation Safety Engineer, telephone<PHONE_NUMBER>, fax
(562) 627-5210 (regarding Model R44 helicopters) for information
about previously approved alternative methods of compliance.

    Issued in Fort Worth, Texas, on July 6, 2010.
Mark R. Schilling,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2010-17283 Filed 7-14-10; 8:45 am]
BILLING CODE 4910-13-P


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

General Comment:Dear Mr. Zeller:

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

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to formulate the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes, and given the fact that I had previously tried every smoking alternative available over a period of many years, I can truthfully state that I absolutely believe that they saved my life, and I know for certain that they greatly improved the quality of my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

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


[Federal Register Volume 80, Number 223 (Thursday, November 19, 2015)]
[Notices]
[Page 72451]
[FR Doc No: 2015-29573]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2015-0756]

Information Collection Request to Office of Management and
Budget; OMB Control Number: 1625-0009

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an Information Collection Request
(ICR) to the Office of Management and Budget (OMB), Office of
Information and Regulatory Affairs (OIRA), requesting approval for
reinstatement, with change, of the following collection of information:
1625-0009, Oil Record Book for Ships. Our ICR describe the information
we seek to collect from the public. Before submitting this ICR to OIRA,
the Coast Guard is inviting comments as described below.

DATES: Comments must reach the Coast Guard on or before January 19,
2016.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2015-0756] to the Coast Guard using the Federal
eRulemaking Portal at http://www.regulations.gov. See the ``Public
participation and request for comments'' portion of the SUPPLEMENTARY
INFORMATION section for further instructions on submitting comments.
    A copy of the ICR is available through the docket on the Internet
at http://www.regulations.gov. Additionally, copies are available from:
Commandant (CG-612), Attn: Paperwork Reduction Act Manager, U.S. Coast
Guard, 2100 2nd Street SW., Stop 7101, Washington, DC 20593-7710.

FOR FURTHER INFORMATION CONTACT: Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology. In response to
your comments, we may revise this ICR or decide not to seek
reinstatement of the Collection. We will consider all comments and
material received during the comment period.
    We encourage you to respond to this request by submitting comments
and related materials. Comments must contain the OMB Control Number of
the ICR and the docket number of this request, [USCG-2015-0756], and
must be received by January 19, 2016.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at http://www.regulations.gov and
can be viewed by following that Web site's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).

Information Collection Request

    1. Title: Oil Record Book for Ships.
    Omb Control Number: 1625-0009.
    Summary: The Act to Prevent Pollution from Ships (APPS) and the
International Convention for Prevention of Pollution from Ships, 1973,
as modified by the 1978 Protocol relating thereto (MARPOL 73/78),
requires that information about oil cargo or fuel operations be entered
into an Oil Record Book (CG-4602A). The requirement is contained in 33
CFR 151.25.
    Need: This information is used to verify sightings of actual
violations of the APPS to determine the level of compliance with MARPOL
73/78 and as a means of reinforcing the discharge provisions.
    Forms: CG-4602A; Oil Record Book for Ships.
    Respondents: Operators of vessels.
    Frequency: On occasion.
    Hour Burden Estimate: The estimated burden has increased from
20,221 hours to 28,536 hours a year due to an increase in the estimated
annual number of responses.

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

    Dated: November 10, 2015.
Thomas P. Michelli,
 Deputy Chief Information Officer, U.S. Coast Guard.
[FR Doc. 2015-29573 Filed 11-18-15; 8:45 am]
BILLING CODE 9110-04-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

MEMORANDUM

Date:		26-April-2006

Subject:	Buprofezin (PC Code 275100) - Human Health Risk Assessment for Establishment of Permanent Almond Hull, Cottonseed, and Cotton Gin Byproduct Tolerances and Extension of the Tomato Time-limited Tolerance.  Registration 71711-16.   DP #:  328804.  Decision #:  359609.

From:		Thomas Bloem, Chemist

P.V. Shah, Ph.D., Toxicologist

Mark Dow, Ph.D., Biologist

Registration Action Branch 1 (RAB1)

Health Effects Division (HED) (7509C)

To:		Richard Gebken/Kevin Sweeney

Risk Management Team 10

Registration Division (RD)

Thru:		Felicia Fort, Acting Branch Chief

P.V. Shah, Ph.D., Branch Senior Scientist

RAB1/HED (7509C)

The HED of the Office of Pesticide Programs (OPP) is charged with estimating the risk to human health from exposure to pesticides.  The RD of OPP has requested that HED evaluate hazard and exposure data and conduct dietary, occupational, residential and aggregate exposure assessments, as needed, to estimate the risk to human health that will result from all registered/proposed buprofezin uses.

A summary of the findings and an assessment of human risk resulting from the registered and proposed buprofezin tolerances is provided in this document.  The risk assessment, residue chemistry data review, and the dietary risk assessment were provided by Tom Bloem (RAB1), the hazard characterization by P.V. Shah  (RAB1), the occupational/residential exposure assessment by Mark Dow (RAB1), and the drinking water assessment by James Wolf of the Environmental

ate and Effects Division (EFED).

 TOC \f

1.0 	EXECUTIVE SUMMARY	Page 3 of  21

2.0	PHYSICAL/CHEMICAL PROPERTIES CHARACTERIZATION	Page 7 of  21

3.0 	HAZARD CHARACTERIZATION	Page 8 of  21

3.1 	Hazard Profile	Page 8 of  21

3.2 	FQPA Considerations	Page 9 of  21

3.3 	Dose-Response Assessment	Page 10 of  21

4.0	EXPOSURE ASSESSMENT	Page 12 of  21

4.1	Summary of Registered Uses	Page 12 of  21

4.2	Summary of Proposed Uses	Page 12 of  21

4.3	Dietary Exposure/Risk Pathway	Page 13 of  21

4.3.1 	Food Residue Profile	Page 13 of  21

4.3.2 	Water Residue Profile Exposure/Risk Pathway	Page 16 of  21

Drinking Water Fate Assessment	Page 16 of  21

4.4  	Dietary Exposure Analyses	Page 17 of  21

4.5	Residential Exposure/Risk Pathway	Page 18 of  21

5.0	AGGREGATE RISK ASSESSMENTS AND RISK CHARACTERIZATION	Page 18 of  21

6.0 	CUMULATIVE RISK	Page 18 of  21

7.0	OCCUPATIONAL EXPOSURE	Page 19 of  21

7.3	Restricted-Entry Interval (REI)	Page 19 of  21

8.0	DATA NEEDS/LABEL REQUIREMENTS	Page 20 of  21

8.1	Toxicology	Page 20 of  21

8.2	Residue Chemistry	Page 20 of  21

8.3	Occupational/Residential	Page 20 of  21

1.0 	EXECUTIVE SUMMARY tc \l1 "1.0 	EXECUTIVE SUMMARY

HED previously recommended for time-limited almond hull, cottonseed, cotton gin byproduct, and tomato tolerances either due to the lack of sufficient field trial data (almond hull) or field trial data which was conducted at an exaggerated rate (cottonseed, cotton gin byproduct, and tomato).  As part of a residue chemistry amendment (D319815, T. Bloem, 14-Dec-2005), HED is now recommending for the establishment of permanent almond hull, cottonseed, and cotton gin byproduct tolerances and extension of the tomato time-limited tolerance.

Background:  Buprofezin (2-[(1,1-dimethylethyl)imino]tetrahydro-3(1-methylethyl)-5-phenyl-4H-1,3 ,5-thiadiazin-4-one) is an insecticide which shows a high level of activity against Homoptera spp (planthoppers, leafhoppers, whiteflies, and scales) and is active through inhibition of chitin biosynthesis and suppression of oviposition and/or egg hatching.  Buprofezin is currently registered for application to numerous crops with tolerances for residues of buprofezin ranging from 0.05 - 60 ppm (40 CFR 180.511).  Tolerances have also been established for residues of buprofezin in/on ruminant fat, liver, and meat byproducts at 0.05 ppm and in milk at 0.01 ppm.    Currently, there are no proposed or registered uses for buprofezin that result in residential exposures.

Hazard Characterization and Dose Response:  Buprofezin falls into Toxicity Category III for acute oral toxicity and Toxicity Category IV for acute dermal toxicity, acute inhalation toxicity, eye irritation, and dermal irritation.  It is not a dermal sensitizer.

In subchronic toxicity studies, the primary effects of concern in the rat were increased microscopic lesions in male and female liver and thyroid, increased liver weights in males and females, and increased thyroid weight in males.  In chronic studies in the rat, an increased incidence of follicular cell hyperplasia and hypertrophy in the thyroid of males was reported.  Increased relative liver weights were reported in female dogs.  Buprofezin was not carcinogenic to male and female rats.  In the mouse, increased absolute liver weights in males and females, along with an increased incidence of hepatocellular adenomas and hepatocellular adenomas plus carcinomas in females were reported.  Based on the increased incidence of liver tumors in female mice only; no evidence of carcinogenicity in rats; and no evidence of genotoxicity in submitted guideline studies using in vitro and in vivo genotoxicity assays, the HED Cancer Assessment Review Committee (CARC) classified buprofezin as having “Suggestive Evidence of Carcinogenicity, but not sufficient to assess human carcinogenic potential.”  No quantification of cancer risk is required.  Although buprofezin was negative in in vitro and in vivo genotoxicity assays, the findings from the published literature indicate that it causes cell transformation and induces micronuclei in vitro.  However, in the absence of a positive response in an in vivo micronucleus assay, the CARC concluded that buprofezin may have aneugenic potential which is not expressed in vivo.

Developmental and reproductive toxicity studies do not raise concern for increased susceptibility in offspring since toxicity in the offspring was found at dose levels that were also toxic to the parent(s) and the effects observed in the offspring were not more severe, qualitatively, than the effects observed in the parent(s).

Dose-Response and Food Quality Protection Act Safety Factor (FQPA SF) Decision:  The HED Hazard Identification Assessment and Review Committee (HIARC) selected endpoints for acute dietary (females 13-50 years old only; no acute endpoint identified for the remaining population subgroups); chronic dietary; short- and intermediate-term incidental oral; and short-, intermediate- and long-term dermal and inhalation exposure assessment.  The CARC classified buprofezin as “Suggestive Evidence of Carcinogenicity, but not sufficient to assess human carcinogenic potential;” therefore, a cancer exposure analysis was not performed.

The table below summarizes the endpoints chosen for the exposure scenarios assessed as part of the current document.  Due to the lack of a comparative 28-day thyroid assay (young -vs- old), a 10x database uncertainty factor was applied to all endpoints which are based on thyroid effects. However, the thyroid effects were seen in rats and since it has been established that rats are more susceptible to thyroid effects than humans, HED concluded that the interspecies uncertainty factor for these assessments may be reduced to 3x.  Based on toxicological considerations, the conservative residue assumptions used in the dietary risk assessment (there are currently no residential exposures), and the completeness of the residue chemistry and environmental fate databases, the FQPA SF was reduced to 1x.  Therefore, the total uncertainty factor for chronic dietary and inhalation assessments is 300x (10x database uncertainty, 3x interspecies variation, and 10x intraspecies variation) and the total uncertainty factor for acute dietary and dermal assessments is 100x (10x interspecies variation and 10x intraspecies variation).

Risk Assessment Scenario

Dose Used in Risk Assessment

 Level of Concern (LOC) for Risk Assessment

Study and Endpoint

Acute Dietary:

females 13-50 yrs old

aPAD1=2.0 mg/kg/day

(100% of

aPAD

developmental toxicity study/rats: incomplete ossification and reduced pup body weight.

Chronic Dietary:

general population

cPAD=0.0033 mg/kg/day

(100% of

cPAD

2-yr chronic feeding study/rats: increased incidence of follicular cell hyperplasia and hypertrophy in the thyroid in males.

Short-term and Intermediate-term Dermal

NOAEL=300 mg/kg/day

MOE1<100

24-day dermal toxicity study in rats: inflammatory infiltrate of the liver in females and an increase in acanthosis and hyperkeratosis in the skin of females.

Short-term and Intermediate-term Inhalation

NOAEL=13 mg/kg/day

MOE<300

90-day oral toxicity in rats: organ weight changes and microscopic findings in the liver and thyroid of males and females and in the kidney of males (enlarged hepatocytes, hepatocellular nuclei, and nucleoli in the liver; thickening and hyperplasia of follicular epithelial cells in the thyroid, hyaline droplets and basophilic bodies in the kidneys).

1	aPAD = acute population adjusted dose; MOE = margin of exposure

Dietary Exposure Estimates:  The acute and chronic dietary risk assessments were conducted using the Dietary Exposure Evaluation Model - Food Consumption Intake Database (DEEM-FCID(, ver. 2.03).  DEEM-FCID incorporates food consumption data from the USDA’s Continuing Surveys of Food Intakes by Individuals (CSFII; 1994-1996 and 1998).  The acute analysis assumed DEEM( (ver. 7.76) default processing factors and 100% crop treated for all commodities.  Tolerance level residues were assumed for all commodities excluding meat and milk.  Since meat and milk (limit of quantitation (LOQ) tolerances) residues were only detected in the feeding study at 6.8-9.3x the maximum theoretical dietary burden (MTDB), residues in these commodities were normalized to 1x the MTDB.  The acute analysis also incorporated the acute PRZM-EXAMS surface drinking water estimate resulting from application of buprofezin to citrus in Florida (highest acute drinking water estimate).  The resulting acute exposure estimate for females 13-49 years old was less than HED’s level of concern (5% aPAD).  No acute endpoint was identified for the remaining population subgroups.

The chronic analysis assumed DEEM( (ver. 7.76) default processing factors for all commodities and incorporated percent crop treated estimates or projected percent crop treated estimates.  Tolerance level or average field trial residues were assumed for all crop commodities and since meat and milk (LOQ tolerances) residues were only detected in the feeding study at 6.8-9.3x the MTDB, residues in these commodities were normalized to 1x the MTDB.  The chronic analysis also incorporated the chronic PRZM-EXAMS surface drinking water estimate resulting from application of buprofezin to citrus in Florida (highest chronic drinking water estimate).  The resulting chronic exposure estimates were less than HED’s level of concern ((87% cPAD; children 1-2 years old were the most highly exposed population).

Aggregate Risk Estimates:  There are no registered/proposed uses which result in residential exposure.  Therefore, the acute and chronic exposure estimates provided in the previous section represent aggregate exposure.

Occupational Estimates:  Based on the proposed use patterns, commercial applicators are anticipated to have short- and intermediate-term dermal and inhalation exposures and grower/applicators are anticipated to have short- and intermediate-term dermal exposures.  No chemical-specific data are available to assess potential exposures to pesticide handlers for the proposed uses; therefore, the exposure assessment was conducted using data available in Pesticide Handler Exposure Database (PHED) Surrogate Table (ver. 1.1; 1998).  The resulting dermal (with the use of gloves as specified on the label) and inhalation MOEs ranged from 1,800-570,000 and are therefore not of concern to HED.

There are no compound-specific data with which to estimate post-application exposure to agricultural workers.  Therefore, estimates of post-application exposure are based upon methodologies similar to the Standard Operating Procedures (SOPs) for Residential Exposure Assessment (18-Dec-1997) with revisions by the Science Advisory Council for Exposure (ExpoSAC).  In addition, transfer coefficients used to calculate post-application exposure are taken from the interim transfer coefficient policy developed by HED’s ExpoSAC using propriety data from the Agricultural Re-entry Task Force (ARTF) database (SOP 003.1).

The memos which assessed occupational exposure to cotton, almond, and tomato also assessed several other crops including fruit trees.  The post-application exposure estimates were based on propping fruit trees on the day of application as this provided the most conservative transfer coefficient (3,000 cm2/hour) and highest application rate.  The resulting MOEs were 250.  However, the application rates for tomato and cotton are significantly lower than that for fruit trees and the highest transfer coefficient for the post-harvest activities in these crops is 1,000 cm2/hour.  Propping of almond trees is unnecessary and the highest applicable transfer coefficient is for scouting or thinning in tree nut orchards is 500 cm2/hour.  Since reduction in transfer coefficients leads to a proportionate increase in the MOE, the post-harvest MOEs following treatment of almond, cotton, and tomato will be >300 and are therefore not of concern to HED.

Recommendations:  Provided the petitioner submits a revised Section F, HED concludes that the toxicology, residue chemistry, and occupational/residential databases are sufficient to support conditional registration, extension of the tomato time-limited tolerance expiration date, and establishment of the following permanent tolerances for residues of buprofezin:

almond, hulls	.	.	.	.	.	.	.	.	.	.	2.0 ppm

cotton, gin byproducts		.	.	.	.	.	.	.	.	20 ppm

cottonseed	.	.	.	.	.	.	.	.	.	.	0.35 ppm

Unconditional registration may be appropriate upon submission of data which adequately addresses the following deficiencies:

A comparative thyroid assay in young and adult rats

radiovalidation of the livestock enforcement method

storage stability data (see page 20)

tomato magnitude of the residue data (see page 20)

2.0	PHYSICAL/CHEMICAL PROPERTIES CHARACTERIZATION tc \l1 "2.0 PHYSICAL/CHEMICAL PROPERTIES CHARACTERIZATION

Buprofezin is a miticide which causes nymphs to die at molting through chitin biosynthesis inhibition and causes suppression of oviposition and/or egg hatching.  Buprofezin shows a high level of activity against Homoptera spp such as planthoppers, leafhoppers, whiteflies, and scales.

Table 1:  Test Compound Nomenclature

Compound

Common name

buprofezin

Company experimental name

BF1

IUPAC name

2-tert-butylimino-3-isopropyl-5-phenyl-1,3,5-thiadiazinan-4-one

CAS name

2-[(1,1-dimethylethyl)imino]tetrahydro-3-(1-methylethyl)-5-phenyl-4H-1,3 ,5-thiadiazin-4-one

CAS #

69327-76-0

End-use product/(EP)

Applaud® 70 WP (EPA Reg. No. 71711-15)

Table 2:  Physicochemical Properties of the Technical Grade Test Compound

Melting point/range

104-106 (C

pH

7.8

Density

1.18 g/cm3

Water solubility

0.382 g/liter at 25 (C

Solvent solubility

520 g/liter - chloroform; 320 g/liter - toluene; 240 g/liter acetone; 20 g/liter hexane

Vapor pressure

9.4 x 10-6 mm Hg at 20 (C

Dissociation constant (pKa)

not available

Octanol/water partition coefficient Log(KOW)

4.31 at 20 (C

UV/visible absorption spectrum

not available

3.0 	HAZARD CHARACTERIZATION tc \l1 "3.0 	HAZARD CHARACTERIZATION

HIARC:  HED Doc. Nos. 014093, 014221, and 051342

FQPA SFC:  HED Doc. No. 014138

CARC:  HED Doc. No. 014045

Conversion of time-limited tolerances to permanent tolerances requires a review of the toxicological database.  HED has reviewed the toxicological database and agreed with all of the previous conclusions except for the total uncertainty factor (interspecies, intraspecies, database uncertainty factors, FQPA SF).  HED previously concluded that a 100x uncertainty factor was appropriate for all assessments; as part of the review associated with the current action, HED concludes that a 300x uncertainty factor is appropriate for chronic dietary, inhalation, and incidental oral assessments and an uncertainty factor of 100x is appropriate for acute dietary and dermal assessments (see following paragraphs for rationale).

The toxicological profile for buprofezin is explained in detail in the November 2001 human health risk assessment (T. Bloem, D284767).  The following is a summary of the information provided in that document as well as an explanation of the uncertainty factors.

3.1 	Hazard Profile tc \l2 "3.1 	Hazard Profile

The toxicological database for buprofezin is complete.  The HIARC requested a 28-day inhalation toxicity study as a condition of registration.  However, based on the low volatility and low inhalation toxicity (Category IV) of buprofezin and inhalation MOEs >1000 for the proposed uses in this risk assessment, buprofezin qualifies for a waiver of the 28-day inhalation toxicity study for the proposed uses [HED SOP 2002.01: Guidance: Waiver Criteria for Multiple-Exposure Inhalation Toxicity Studies, 08/15/02].  The 28-day inhalation toxicity study is waived for this action only.  If in the future, requests for new uses or formulations are submitted that may result in a significant change in either the toxicity profile or exposure scenarios, HED will reconsider this data requirement.

Buprofezin falls into Toxicity Category III for acute oral toxicity and Toxicity Category IV for acute dermal toxicity, acute inhalation toxicity, eye irritation, and dermal irritation.  It is not a dermal sensitizer.

In subchronic toxicity studies, the primary effects of concern in the rat were increased microscopic lesions in male and female liver and thyroid, increased liver weights in males and females, and increased thyroid weight in males.  Increased focal necrosis with an inflammatory infiltrate in the liver was observed in females following dermal subchronic exposure, as was increased acanthosis and hyperkeratosis in skin.

In chronic studies in the rat, an increased incidence of follicular cell hyperplasia and hypertrophy in the thyroid of males was reported.  Increased relative liver weights were reported in female dogs.  Buprofezin was not carcinogenic to male and female rats.  In the mouse, increased absolute liver weights in males and females, along with an increased incidence of hepatocellular adenomas and hepatocellular adenomas plus carcinomas in females were reported.  Based on the increased incidence of liver tumors in female mice only; no evidence of carcinogenicity in rats; and no evidence of genotoxicity in submitted guideline studies using in vitro and in vivo genotoxicity assays, the CARC (HED Doc. No. 014045) ) classified buprofezin as having “Suggestive Evidence of Carcinogenicity, but not sufficient to assess human carcinogenic potential.”  Therefore, no quantification of cancer risk is required.  Although buprofezin was negative in in vitro and in vivo genotoxicity assays, the findings from the published literature indicate that it causes cell transformation and induces micronuclei in vitro.  However, in the absence of a positive response in an in vivo micronucleus assay, the CARC concluded that buprofezin may have aneugenic potential which is not expressed in vivo.

The developmental toxicity study in the rat produced reduced ossification and reduced pup weight at maternally toxic doses (death, decreased pregnancy rates, increased resorption rates).  No developmental toxicity was observed in the rabbit at or below maternally toxic dose levels.  The reproductive toxicity study showed decreased pup body weights at dose levels where liver effects (increased relative and/or absolute liver weights) and decreased body weight gains were observed in the parental generations.  These studies do not raise concern for increased susceptibility in offspring since toxicity in the offspring was found at dose levels that were also toxic to the parent(s) and the effects observed in the offspring were not more severe, qualitatively, than the effects observed in the parent(s).  The data do not indicate a basis for concern for neurotoxicity.  The rat metabolism study indicated that 95% of the administered dose was excreted in urine and feces within 72 hours (feces - 79.1%; urine - 12.9%).  In the feces, about 45% of the radioactivity was recovered as parent compound, with the remainder as several metabolites.

3.2 	FQPA Considerations tc \l2 "3.2 	FQPA Considerations

At a meeting held on October 22, 2002, the HIARC concluded that the toxicology database for buprofezin is complete for FQPA assessment.  It was concluded that developmental toxicity studies in rats and rabbits and the 2-generation reproduction study in rats provided no indication of increased susceptibility of rats or rabbits following in utero exposure or of rats following pre/postnatal exposure to buprofezin.  The data do not indicate a basis for concern for neurotoxicity and acute, subchronic, and developmental neurotoxicity studies are not required.

Based on the evidence of thyroid toxicity following subchronic and chronic exposures to rats (histopathological lesions) and dogs (decreases in serum thyroxine levels and increased thyroid weights), the HIARC requested a comparative thyroid assay study in rats (young versus adults) to determine if the thyroid effects occur at a lower dose in young versus adult animals.

The petitioner has not submitted the requested comparative thyroid assay.  Based on the lack of a comparative 28-day thyroid assay (young -vs- old), HED concludes that a database uncertainty factor of 10x should be applied.  Further, since it has been established that rats are more susceptible to thyroid effects than humans, HED concluded that the interspecies uncertainty factor may be reduced to 3x.  The database uncertainty factor is not applicable to the acute endpoint since a single dose of a chemical would not be expected to perturb thyroid  homeostasis in the adult or the young due to the buffering of thyroid hormone concentrations by homeostatic mechanisms for compounds with short half lives, like buprofezin (half-life = 1 to 2 days).  This database uncertainty factor was not applied to dermal exposure assessments because no thyroid effects were seen in a dermal toxicity study (thyroid effects were monitored).  Based on toxicological considerations, the conservative residue assumptions used in the dietary risk assessment (there are currently no residential exposures), and the completeness of the residue chemistry and environmental fate databases, the FQPA SF was reduced to 1x.  Therefore, the total uncertainty factor for chronic dietary and inhalation assessments is 300x (10x database uncertainty, 3x interspecies variation, and 10x intraspecies variation) and the total uncertainty factor for acute dietary and dermal assessments is 100x (10x interspecies variation and 10x intraspecies variation).

Table 3:  Summary of FQPA SFs for Buprofezin

Factor

Rationale for the Factor

Endpoints the Factor is Applied

LOAEL to NOAEL (UFL)

1x

NA1

all

Subchronic to Chronic  (UFS)

1x

NA

all

Incomplete Database (UFDB)

10x

data gap - comparative thyroid assay in rats (thyroid hormone measurements; adult versus young animals)

all dietary and occupational exposure assessments; whose endpoint is based on thyroid effects.

Inter/Intra species variation

100x

default

all dietary and occupational exposure assessments; whose endpoint is not based on thyroid effects.

Inter/Intra species variation

30x

rats are more susceptible to thyroid effects than humans such that reduction in the interspecies variation from 10x to 3x is appropriate

all dietary and occupational exposure assessments; whose endpoint is based on thyroid effects.

FQPA SF

1x

Based on the establishment of a 10x UFDB, the complete residue chemistry and environmental fate databases, conservative residue assumptions used in the dietary exposure analyses (currently no residential exposures), and no residual uncertainties regarding pre- or post-natal toxicity.

all

1	NA = Not Applicable

3.3 	Dose-Response Assessment tc \l2 "3.3 	Dose-Response Assessment

A summary of decisions made by the HIARC (15-Feb-2000 and 22-Oct-2002 meetings) concerning endpoints for dietary, residential, and occupational risk assessments is provided in Table 4 (see next page).

3.4	Endocrine Disruption

EPA is required under the Federal Food Drug and Cosmetic Act (FFDCA), as amended by FQPA, to develop a screening program to determine whether certain substances (including all pesticide active and other ingredients) "may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate."  Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), EPA determined that there was scientific bases for including, as part of the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone system.  EPA also adopted EDSTAC’s recommendation that the Program include evaluations of potential effects in wildlife.  For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA has authority to require the wildlife evaluations.  As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program (EDSP).

In subchronic toxicity studies in rats, buprofezin caused increased microscopic lesions in male and female liver and thyroid, increased liver weights in males and females, and increased thyroid weight in males.  In chronic studies in the rat, an increased incidence of follicular cell hyperplasia and hypertrophy in the thyroid of males was reported.  In 2-generation reproduction toxicity study in rats, no effects on reproductive parameters were observed due to treatment with buprofezin.  When the appropriate screening and/or testing protocols being considered under the Agency’s EDSP have been developed, buprofezin may be subjected to additional screening and/or testing to better characterize effects related to endocrine disruption.

Table 4:  Summary of Toxicological Dose and Endpoints for Buprofezin

Exposure

Scenario

Dose Used in Risk Assessment, UF

FQPA SF* and Level of Concern for Risk Assessment

Study and Toxicological Effects

Acute Dietary

(females 13-50 years of age)

NOAEL = 200 mg/kg/day

UF = 100

aRfD = 2.0 mg/kg/day

FQPA SF = 1X

aPAD = aRfD ( FQPA SF

= 2.0 mg/kg/day

Developmental Toxicity Study - Rats

LOAEL = 800 mg/kg/day based on incomplete ossification and reduced pup weight.

Acute Dietary

(general population including infants and children)

No appropriate endpoint was identified for the general population which might occur following a single dose or exposure, including maternal toxicity in developmental studies.

Chronic Dietary

(all populations)

NOAEL=1.0 mg/kg/day

UF = 300

cRfD = 0.0033 mg/kg/day

FQPA SF = 1X

cPAD = cRfD ( FQPA SF

= 0.0033 mg/kg/day

Two-Year Chronic/Feeding Study - Rat

LOAEL = 8.7  mg/kg/day based on increased incidence of follicular cell hyperplasia and hypertrophy in the thyroid in males.

Short-Term Incidental oral

(1-30 Days)

NOAEL= 13.0 mg/kg/day

Residential = NA1

90-day Oral Toxicity Study - Rat

LOAEL = 68.6 mg/kg/day based on organ weight changes and microscopic findings in the liver and thyroid of both males and females and in the kidney of males.

Intermediate-Term Incidental oral

(1-6 Months)

NOAEL= 13.0 mg/kg/day

Residential = NA

90-day Oral Toxicity Study - Rat

LOAEL = 68.6 mg/kg/day based on organ weight changes and microscopic findings in the liver and thyroid of both males and females and in the kidney of males.

Short-Term Dermal

(1-30 days)

Dermal NOAEL=

300 mg/kg/day

Occupational LOC for

MOE <100

Residential = NA

24-day Dermal Toxicity Study - Rat

LOAEL = 1000 mg/kg/day based on inflammatory infiltrate of the liver in females and an increase in acanthosis and hyperkeratosis of the skin in females.

Intermediate-Term Dermal

(1-6 Months)

Dermal NOAEL=

300 mg/kg/day

Occupational LOC for

MOE <100

Residential = NA

24-day Dermal Toxicity Study - Rat

LOAEL = 1000 mg/kg/day based on inflammatory infiltrate of the liver in females and an increase in acanthosis and hyperkeratosis of the skin in females.

Long-Term Dermal

(>6 Months)

Oral NOAEL= 1.0 mg/kg/day

10% dermal penetration

Occupational LOC for

MOE <100

Residential = NA

Two-Year Chronic/Feeding Study - Rat

LOAEL = 8.7 mg/kg/day based on increased incidence of follicular cell hyperplasia and hypertrophy in the thyroid in males.

Short-Term Inhalation

(1-30 days)

Oral NOAEL= 13.0 mg/kg/day

Occupational LOC for

MOE <300

Residential = NA

90-day Oral Toxicity Study - Rat

LOAEL = 68.6 mg/kg/day based on organ weight changes and microscopic findings in the liver and thyroid of both males and females and in the kidney of males.

Intermediate-Term Inhalation

(1-6 Months)

Oral NOAEL= 13.0 mg/kg/day

Occupational LOC for

MOE <300

Residential = NA

90-day Oral Toxicity Study - Rat

LOAEL = 68.6 mg/kg/day based on organ weight changes and microscopic findings in the liver and thyroid of both males and females and in the kidney of males.

Long-Term Inhalation

(>6 Months)

Oral NOAEL= 1.0 mg/kg/day

Occupational LOC for

MOE <300

Residential = NA

Two-Year Chronic/Feeding Study - Rat

LOAEL = 8.7 mg/kg/day based on increased incidence of follicular cell hyperplasia and hypertrophy in the thyroid in males.

Cancer

Classification: “Suggestive Evidence of Carcinogenicity, but not sufficient to assess human carcinogenic potential.”

1	NA = Not Applicable; There are no residential uses at this time.

4.0	EXPOSURE ASSESSMENT tc \l1 "4.0	EXPOSURE ASSESSMENT

-D273252, T. Bloem, 20-Mar-2001 (residue chemistry review)

-D296492, T. Bloem, 17-Dec-2003 (residue chemistry review)

-D304845, T. Bloem, 26-Jan-2005 (residue chemistry review)

-D319815, T. Bloem, 14-Dec-2005 (residue chemistry review)

-D328806, T. Bloem, 12-Apr-2006 (dietary exposure analysis)

-EFED memorandum:  Tier II Water Assessment for Buprofezin, including proposed new uses.  J. Wolf. 08-JAN-2003.

4.1	Summary of Registered Uses tc \l2 "4.1	Summary of Registered Uses

Buprofezin is currently-registered for application to almonds, banana, citrus, cotton, cucumbers, grape, lettuce (head and leaf), tomato, melon (cantaloupe, honeydew, watermelon, muskmelon), pumpkins, squash, snap bean, peach, pome fruit, pistachio, avocado, guava, and several types of tropical fruit with tolerances for residues of buprofezin ranging from 0.02 - 60 ppm (40 CFR 180.511; application rate of 0.70 - 3.16 lbs ai/acre/season).  Tolerances have also been established for residues of buprofezin, as a result of secondary residues, in milk (0.01 ppm), ruminant fat (0.05 ppm), liver (0.05 ppm), and meat byproducts (0.05 ppm).  Buprofezin is not currently registered for application in the residential setting.

4.2	Summary of Proposed Uses tc \l2 "4.2	Summary of Proposed Uses

The current risk assessment pertains to the conversion of the time-limited almond hull (1 x 2.0 lb ai/acre; 60-day preharvest interval (PHI)), cotton (gin byproduct and seed; 2 x 0.35 lb ai/acre; 28-day retreatment interval (RTI); 14-day PHI) tolerances to permanent tolerance and extending the expiration date for the tomato (2 x 0.38 lb ai/acre; 28 day RTI; 7-day PHI) tolerance.  Therefore, there are no new uses for this petition.

4.3	Dietary Exposure/Risk Pathway tc \l2 "4.3	Dietary Exposure/Risk Pathway

4.3.1 	Food Residue Profile tc \l3 "4.3.1 	Food Residue Profile

Nature of the Residue - Plants, Livestock, and Rotational Crops:  The HED Metabolism Assessment Review Committee (MARC) reviewed lettuce, tomato, cotton, lemon, ruminant, and  poultry metabolism studies and the confined rotational crop study (D264546, T. Bloem, 20-Apr-2000; D273214, T. Bloem, 13-Mar-2001; TXR No. 0052261, T. Bloem, 10-Dec-2003).  Table 5 is a summary of the residues of concern in primary crops, livestock, and rotational crops.

Table 5:  Summary of MARC decisions for Buprofezin

Matrix

Residues of Concern

For Risk Assessment

For Tolerance Expression

plants

buprofezin1,2

buprofezin

ruminant tissue

buprofezin and  BF2

buprofezin

milk

buprofezin and BF23

buprofezin

poultry and eggs

Due to the limited residues in egg and tissue samples collected from the poultry metabolism study, the MARC determined that a conclusion pertaining to the residues of concern in egg and poultry was not possible.

Rotational crops

buprofezin

buprofezin

1	apple, grape, and orange processing data monitoring for residue of BF4 conjugates are requested; in the absence of these data, the residues of concern in fruit crops and crops with an interval greater than ~50 days from intial application to harvest are buprofezin and BF4 conjugates (see text for procedure for estimating BF4 conjugate residues)

2	residues of concern in grape juice are buprofezin, BF4 conjugates, and BF12; BF12 is a residue of concern in grape juice because the BF12 grape juice processing factor (0.75x) is much greater than the buprofezin grape juice processing factor (0.12x) and residues of BF12 may be significant in grape juice

 Plants: Buprofezin was the major residue identified in the lettuce, cotton, and tomato metabolism studies (all other identified residues were at <10% TRR).  The lemon metabolism study provided data for fruit treated 75 and 14 days prior to harvest and treated only 75 days prior to harvest.  Buprofezin (66% TRR preharvest interval (PHI) = 14 days; 18% TRR PHI = 75 days) and BF 4 conjugates (6% TRR PHI = 14 days; 34% TRR PHI = 75 days) were the major identified residues (all other identified residues were <10% TRR).  Based on the results of these studies, the MARC concluded the following (TXR No. 0052261, T. Bloem, 10-Dec-2003):  (1) tolerance expression for plants will include only buprofezin; (2) for purposes of risk assessment, the residues of concern for all proposed and registered commodities (excluding grape juice) will include only buprofezin; (3) based on the grape processing study, the residues of concern in grape juice are buprofezin and BF12; and (4) residues of BF9 and BF12 should be monitored in all future field trial and processing studies (BF9 and BF12 residue data are requested due to the potential for these compounds to concentrate in processed commodities).

The MARC also requested that the petitioner submit orange, apple, and grape processing studies conducted using the labeled retreatment and preharvest intervals but at 5x the labeled rate.  The processing studies should employ an analytical method which includes a hydrolysis step and monitor for residues of BF9, BF12, and BF26 (BF9, BF12, and BF26 are hydrolysis products of BF4 conjugates).  These data will enable HED to determine the potential magnitude of BF4 conjugates in the RACs (normalized to 1x) and determine if the BF4 conjugates, if present, possess different processing factors than parent.  The need for additional BF4 conjugate magnitude of the residue data will be determined upon submission and review of these data.  In the interim, for risk assessment purposes, residues of BF4 conjugates should be estimated in/on fruit crops and crops with an extended interval between initial application and harvest (greater than ~50 days) using the buprofezin:BF4 conjugate residue ratio from the citrus metabolism study (1.8x) and the buprofezin residues from the field trials.

Ruminants:  BF2 was the major residue identified in liver and kidney (residue in fat and muscle were (0.020 ppm) and BF23 was the major residue identified in milk from the ruminant metabolism study (all other residue were <10% TRR; 3.5x the MTDB).  The petitioner also submitted a poultry metabolism study (131x the MTDB).  Based on these data the MARC concluded the following:  (1) due to the low total radioactive residues (TRRs) in egg and tissue samples collected from the poultry metabolism study, the nature of the residue in poultry could not be determined; (2) the tolerance expression for milk and ruminant tissues will include only buprofezin; (3) for purposes of risk assessment, the residues of concern in milk are buprofezin and BF23; (4) for purposes of risk assessment, the residues of concern in ruminant tissues are buprofezin and BF2.

Rotational Crops:  Buprofezin, BF9, and BF12 were the major residues identified in the confined rotational crop study.  However, the field rotational crop studies resulted in the identification of only buprofezin.  Provided the petitioner can validate the storage intervals used in the field rotational study (validation of buprofezin, BF 9 and BF 12 is necessary), the MARC concluded that buprofezin was the only residue of concern in rotated crops.

Magnitude of the Residue - Plants:  The petitioner submitted and HED has reviewed almond, cotton, and tomato field trial studies and cotton and tomato processing studies.  Based on these data, HED made the following conclusions.

Almond Hull:  The petitioner initially submitted almond shell and nutmeat residue data and HED determined that a time-limited almond hull tolerance, based on the almond shell data, was appropriate provided the petitioner agreed to submit almond hull residue data.  The petitioner has submitted the requested almond hull residue data and based on these data, HED concludes that a permanent tolerance of 2.0 ppm for residues of buprofezin, per se, in/on almond hulls is appropriate.  A revised Section F should be submitted.

Cotton:  The petitioner initially submitted cotton residue data conducted with four applications at the proposed single application rate (5-7-day RTI; 14-day PHI) rather than the proposed two applications (28-day RTI; 14-day PHI).  Provided the petitioner agreed to submit additional cotton residue data, HED concluded that time-limited tolerances were appropriate.  The petitioner submitted the requested data, and based on these data, HED concludes that the following permanent tolerance for residues of buprofezin are appropriate: cotton, undelinted seed - 0.35 ppm; cotton, gin byproducts - 20 ppm.  A revised Section F should be submitted.

Tomato:  The petitioner initially submitted tomato residue data conducted with four applications at the proposed single application rate (4-10-day RTI; 7-day PHI) rather than the proposed two applications (28-day RTI; 7-day PHI).  Provided the petitioner agreed to submit additional tomato residue data, HED concluded that time-limited tolerances were appropriate.  The petitioner has not submitted the requested data but has indicated that they will be submitting in 2006 an amendment to reduce the PHI to 1 day and will be submitting tomato residue data from all suggested regions to support this PHI reduction.  Therefore, HED concludes that the expiration date for the currently established tomato tolerances may be extended.

Magnitude of the Residue - Livestock:  The currently-established milk and ruminant tissue tolerances are sufficient to cover secondary residues in milk and ruminants when taking into account the almond hull and cotton gin byproduct tolerances (these commodities are not fed to poultry or hogs).

Analytical Enforcement Method - Plants:  The methods used in the field trial studies were similar to a method validated by the Analytical Chemistry Branch (ACB; D278950, T. Bloem, 8-Nov-2001).  Since adequate method validation and concurrent recoveries were attained in the field trial studies, HED concludes that the method validated by ACB is appropriate for enforcement of the tolerances associated with this petition.

Analytical Enforcement Method - Livestock:  The ACB has successfully validated method BF/11/97 for enforcement of the livestock tolerances (D278950, T. Bloem, 8-Nov-2001) and the method was forwarded to FDA’s Technical Editing Group for publication in a future revision of the Pesticide Analytical Manual I (PAM I; D278952, T. Bloem, 8-Nov-2001).  Radiovalidation of the livestock enforcement method is requested.

Rotational Crops:  Based on the cotton and tomato application scenarios (2 x 0.38 lbai/acre; RTI =28 days; PHI = 14 days for cotton and 7 days for tomato) and the field rotational crop data (4 x 0.38 lb ai/acre; 4-10 RTI), HED concludes that the plant-back intervals (PBIs) included on the labels are appropriate (0-days for labeled crops, 30-days for cereal grains, and 60 days for all remaining crops).  HED notes that the petitioner is requested to submit buprofezin, BF12, and BF9 storage stability data validating the storage intervals used in the field rotational crop studies (see page 20).

Proposed and Recommended Tolerances:  Table 6 is a summary of the HED recommended tolerances for residues of buprofezin (revised Section F is requested).

Table 6:  Tolerance Summary for Buprofezin

Commodity Definition

Tolerance (ppm)

cotton, undelinted seed

0.35

cotton, gin byproducts

20

almond, hulls

2.0

tomato (time-limited)

0.40

4.3.2 	Water Residue Profile Exposure/Risk Pathway tc \l3 "4.3.2 	Water Residue Profile Exposure/Risk Pathway

The MARC determined that only the parent compound, buprofezin, is of concern in drinking water.

Drinking Water Fate Assessment tc \l3 "Drinking Water Fate Assessment :  Buprofezin may get into surface water via spray drift, in solution in runoff water, or attached to soil particles eroded during runoff events.  If it reaches acidic water (pH(5), buprofezin is expected to slowly hydrolyze.  In neutral or alkaline water (pH(7), buprofezin will likely remain bound to sediment or suspended particles (due to its high soil/water partitioning coefficients), and could persist for several months if the water is deep, static, and/or cloudy.  However, buprofezin persistence may be reduced significantly by photolysis if the water is shallow and clear.  Based on the Henry's Law constant, buprofezin loss to air is expected to be minor.  Although moderately persistent in soils, the use rates and the mobility/leaching data indicated that buprofezin will have low propensity to leach into ground water.

Modeling and Drinking Water Estimates:  The PRZM/EXAMS (surface water) and SCIGROW (groundwater) drinking water exposures assessments for buprofezin are summarized in Table 7.

Buprofezin concentrations in surface water were simulated in an Index Reservoir, with a regional percent cropped area and 30 years of scenario specific weather data, using the linked PRZM/EXAMS.  The maximum concentration estimates are associated with Florida citrus use.  The other scenarios considered were Florida avocados, California pome fruit (plums), Georgia peaches, and Oregon apples.

del estimates a ground water concentration of less than 0.10 μg/L.  These results are supported by the absence of buprofezin residues in the deep soil profiles of the terrestrial field dissipation studies.

Table 7:  Estimated Drinking Water Concentrations for Buprofezin (μg/L or ppb)

Acute

Chronic

Long-term average

Surface1

19.2

4.5

3.5

Ground2

0.1

0.1

0.1

1	Buprofezin concentrations estimated in Index Reservoir by PRZM/EXAMS from use on Florida Citrus, buprofezin applied twice at the rate of 2.0 lb ai/acre with a regional PCA of 0.38

2	SCI-GROW estimate 2 applications at 2.0 lb ai/acre

4.4  	Dietary Exposure Analyses tc \l2 "4.4  	Dietary Exposure Analyses

The acute and chronic dietary risk assessments were conducted using the DEEM-FCID( (ver. 2.03).  DEEM-FCID incorporates food consumption data from the USDA’s CSFII (1994-1996 and 1998).  The acute analysis assumed DEEM( (ver. 7.76) default processing factors and 100% crop treated for all commodities.  Tolerance level residues were assumed for all commodities excluding meat and milk.  Since meat and milk (LOQ tolerances) residues were only detected in the feeding study at 6.8-9.3x the MTDB, residues in these commodities were normalized to 1x the MTDB.  The acute analysis also incorporated the acute PRZM-EXAMS surface drinking water estimate resulting from application of buprofezin to citrus in Florida (highest acute drinking water estimate).  The resulting acute exposure estimate for females 13-49 years old was less than HED’s level of concern (5% aPAD).  No acute endpoint was identified for the remaining population subgroups.

The chronic analysis assumed DEEM( (ver. 7.76) default processing factors for all commodities and incorporated percent crop treated estimates or projected percent crop treated estimates.  Tolerance level or average field trial residues were assumed for all crop commodities and since meat and milk (LOQ tolerances) residues were only detected in the feeding study at 6.8-9.3x the MTDB, residue in these commodities were normalized to 1x the MTDB.  The chronic analysis also incorporated the chronic PRZM-EXAMS surface drinking water estimate resulting from application of buprofezin to citrus in Florida (highest chronic drinking water estimate).  The resulting chronic exposure estimates were less than HED’s level of concern ((87% cPAD; children 1-2 years old were the most highly exposed population).

Table 8:  Summary of Acute Dietary Exposure and Risk

Population Subgroup

aPAD (mg/kg/day)

Acute (95th Percentile)

Exposure (mg/kg/day)

%aPAD

Females 13-49 years old

2.0

0.108328

5

Table 9:  Summary of Chronic Dietary Exposure and Risk

Population Subgroup

cPAD (mg/kg/day)

Chronic

Exposure (mg/kg/day)

%cPAD

General U.S. Population

0.0033

0.001322

40

All Infants (<1 year old)

0.0033

0.001844

56

Children (1-2 years old)

0.0033

0.002872

87

Children (3-5 years old)

0.0033

0.002414

73

Children (6-12 years old)

0.0033

0.001581

48

Youth (13-19 years old)

0.0033

0.001041

32

Adults (20-49 years old)

0.0033

0.001211

37

Adults (50+ years old)

0.0033

0.001101

33

Females 13-49 years old

0.0033

0.001296

39

4.5	Residential Exposure/Risk Pathway tc \l2 "4.5	Residential Exposure/Risk Pathway

There are no registered or proposed residential uses of buprofezin that result in residential exposure.  Spray drift is always a potential source of exposure to residents nearby to spraying operations.  This is particularly the case with aerial application, but, to a lesser extent, could also be a potential source of exposure from groundboom application methods.  The Agency has been working with the Spray Drift Task Force, EPA Regional Offices and State Lead Agencies for pesticide regulation and other parties to develop the best spray drift management practices.  The Agency is now requiring interim mitigation measures for aerial applications that must be placed on product labels/labeling.  The Agency has completed its evaluation of the new data base submitted by the Spray Drift Task Force, a membership of U.S. pesticide registrants, and is developing a policy on how to appropriately apply the data and the AgDRIFT® computer model to its risk assessments for pesticides applied by air, orchard airblast and ground hydraulic methods.  After the policy is in place, the Agency may impose further refinements in spray drift management practices to reduce off-target drift and risks associated with aerial as well as other application types where appropriate.

5.0	AGGREGATE RISK ASSESSMENTS AND RISK CHARACTERIZATION tc \l1 "5.0 AGGREGATE RISK ASSESSMENTS AND RISK CHARACTERIZATION

Since there are no registered/proposed uses which result in residential exposures, only acute and chronic aggregate exposure assessments, considering exposure from food and water, are required.  Since the dietary exposure analysis included the drinking water estimates, the discussion and exposure estimates presented in Section 4.4 represent aggregate acute and chronic exposure.

6.0 	CUMULATIVE RISK tc \l1 "6.0 	CUMULATIVE RISK

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding for buprofezin and any other substances, and buprofezin does not appear to produce a toxic metabolite produced by other substances.  For the purposes of this tolerance action, therefore, EPA assumed that buprofezin does not have a common mechanism of toxicity with other substances.  For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA’s OPP concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA’s website at http://www.epa.gov/pesticides/cumulative/.

7.0	OCCUPATIONAL EXPOSURE tc \l1 "7.0	OCCUPATIONAL EXPOSURE

D273823, T. Swackhammer, 29-Mar-2001

D289514, M. Dow, 19-May-2003

D292034. M. Dow. 09-Oct-2003

HED has previously evaluated occupational exposure resulting from application of buprofezin to almond (D273823, T. Swackhammer, 29-Mar-2001), cotton (D273823, T. Swackhammer, 29-Mar-2001; D292034. M. Dow. 09-Oct-2003), and tomato (D273823, T. Swackhammer, 29-Mar-2001; D289514, M. Dow, 19-May-2003; D292034. M. Dow. 09-Oct-2003).  The application rates assessed in these documents and the current rates are the same.

Handler Exposure:  Based on the proposed use patterns, commercial applicators are anticipated to have short- and intermediate-term dermal and inhalation exposures and grower/applicators are anticipated to have short- and intermediate-term dermal exposures.  No chemical-specific data are available to assess potential exposures to pesticide handlers for the proposed uses; therefore, the exposure assessment was conducted using data available in the PHED Surrogate Table (ver. 1.1; 1998).  The resulting dermal (with the use of gloves as specified on the label) and inhalation MOEs ranged from 1,800-570,000 and are therefore not of concern to HED.

Post-Application:  There are no compound-specific data with which to estimate post-application exposure to agricultural workers.  Therefore, estimates of post-application exposure are based upon methodologies similar to the SOPs for Residential Exposure Assessment (18-Dec-1997) with revisions by the ExpoSAC.  In addition, transfer coefficients used to calculate post-application exposure are taken from the interim transfer coefficient policy developed by HED’s ExpoSAC using propriety data from the Agricultural Re-entry Task Force (ARTF) database (SOP 003.1).

The memos which assessed occupational exposure to cotton, almond, and tomato also assessed several other crops including fruit trees.  The post-application exposure estimates were based on propping fruit trees on the day of application as this provided the most conservative transfer coefficient (3,000 cm2/hour) and highest application rate.  The resulting MOEs were 250.  However, the application rates for tomato and cotton are significantly lower than that for fruit trees and the highest transfer coefficient for the post-harvest activities in these crops is 1,000 cm2/hour.  Propping of almond trees is unnecessary and the highest applicable transfer coefficient is for scouting or thinning in tree nut orchards is 500 cm2/hour.  Since reduction in transfer coefficients leads to a proportionate increase in the MOE, the post-harvest MOEs following treatment of almond, cotton, and tomato will be >300 and are therefore not of concern to HED.

7.3	Restricted-Entry Interval (REI) tc \l2 "7.3	Restricted-Entry Interval (REI)

Buprofezin is classified as Toxicity Category IV for Acute Dermal, Acute Inhalation, Eye Irritation and Dermal Irritation.  It is not a Dermal Sensitizer.  Therefore the interim Worker Protection Standard (WPS) REI of 12 hours is sufficient to protect agricultural workers.

8.0	DATA NEEDS/LABEL REQUIREMENTS tc \l1 "8.0	DATA NEEDS/LABEL REQUIREMENTS

8.1	Toxicology tc \l2 "8.1	Toxicology

A comparative thyroid assay in young and adult rats

The HIARC has required a 28-day inhalation toxicity study in rats with thyroid hormone measurements (T3, T4, and Thyroxin) because of the concern for exposure via this route.  However, per HED SOP 2002.01, this study is not required for these uses only.

8.2	Residue Chemistry tc \l2 "8.2	Residue Chemistry

revised Section F

radiovalidation of the livestock enforcement method

tomato residue data; Extension of the time-limited tomato tolerance is based on information submitted by the petitioner indicating that they will be submitting tomato field trial data as specified in OPPTS 860.1500 to support a reduction in the tomato PHI to 1-day.

The table below is a summary of the requested storage stability data.  The adequacy of these data to validate the storage intervals for the samples collected from the field trial, processing, feeding, and rotational crop studies will be determined upon submission and review.

matrix

interval (days)

analytes

comments

almond nutmeat

870

buprofezin, BF9, BF12

--

almond hull

870

buprofezin, BF9, BF12

--

potato tuber

870

buprofezin, BF9, BF12

--

wheat grain

870

buprofezin, BF9, BF12

--

wheat forage

870

buprofezin, BF9, BF12

--

wheat hay

870

buprofezin, BF9, BF12

--

wheat straw

870

buprofezin, BF9, BF12

--

grape juice

319

buprofezin, BF12

--

grape raisins

319

buprofezin

--

citrus oil

455

buprofezin

--

whole milk

210

BF12, BF23

buprofezin storage stability data already submitted (45694202.der.wpd)

ruminant liver

210

BF2, BF12

buprofezin storage stability data already submitted (45694202.der.wpd)

ruminant fat

210

BF2, BF12

buprofezin storage stability data already submitted (45694202.der.wpd)

8.3	Occupational/Residential tc \l2 "8.3	Occupational/Residential

none

RDI: RAB1 (26-Apr-2006)

T. Bloem:S10945:Potamc yard:(703)605-0217:7590C

Attachment 1:  Chemical Structures

Attachment 1: Attachment 1: Chemical Structures

compound

structure

buprofezin;

@

@

@

„@

`„@

$a$

„

옍

옍

옍

@

@

$

@

$

@

@

@

@

@

@

$

@

@

B*

$

@

@

@

@

@

@

@

@

@

@

@

@

@

2-[(1,1-dimethylethyl)imino]tetrahydro-3(1-methylethyl)-5-phenyl-4H-1,3, 5-thiadiazin-4-one

BF2

2-tert-butylimino-5-(4-hydroxyphenyl)-3-isopropyl-1,3,5-thiadiazinan-4-o ne

BF4

2-(2-hydroxy-1,1-dimethylethylimino)-3-isopropyl-5-phenyl-1,3,5-thiadiaz inan-4-one

BF9

3-isopropyl-5-phenyl-1,3,5-thiadiazinan-2,4-dione

BF12

1-isopropyl-3-phenylurea

BF23

N-(4-hydroxyphenyl)acetamide

((((( PAGE  21 ((((( NUMPAGES  1


[Federal Register Volume 76, Number 8 (Wednesday, January 12, 2011)]
[Notices]
[Pages 2190-2192]
[FR Doc No: 2011-241]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2010-0354]

Qualification of Drivers; Exemption Applications; Vision

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

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA announces its decision to exempt 46 individuals from the
vision requirement in the Federal Motor Carrier Safety Regulations
(FMCSRs). The exemptions will enable these individuals to operate
commercial motor vehicles (CMVs) in interstate commerce without meeting
the prescribed vision standard. The Agency has concluded that granting
these exemptions will provide a level of safety that is equivalent to,
or greater than, the level of safety maintained without the exemptions
for these CMV drivers.

DATES: The exemptions are effective January 12, 2011. The exemptions
expire on January 12, 2012.

FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Director, Medical
Programs,<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. Monday through
Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Electronic Access

    You may see all the comments on-line through the Federal Document
Management System (FDMS) at http://www.regulations.gov.

    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue, SE.,
Washington, DC between 9 a.m. and 5 p.m., Monday through Friday, except
Federal holidays. The FDMS is available 24 hours each day, 365 days
each year. If you want acknowledgment that we received your comments,
please include a self-addressed, stamped envelope or postcard or print
the acknowledgement page that appears after submitting comments on-
line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the FDMS published in
the Federal Register on January 17, 2008 (73 FR 3316), or you may visit
http://edocket.access.gpo.gov/2008/pdf/E8-785.pdf.

Background

    On November 26, 2010, FMCSA published a notice of receipt of
exemption applications from certain individuals, and requested comments
from the public (75 FR 72863). That notice listed 46 applicants' case
histories. The 46 individuals applied for exemptions from the vision
requirement in 49 CFR 391.41(b)(10), for drivers who operate CMVs in
interstate commerce.
    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
for a 2-year period if it finds ``such exemption would likely achieve a
level of safety that is equivalent to, or greater than, the level that
would be achieved absent such exemption.'' The statute also allows the
Agency to renew exemptions at the end of the 2-year period.
Accordingly, FMCSA has evaluated the 46 applications on their merits
and made a determination to grant exemptions to each of them.

Vision and Driving Experience of the Applicants

    The vision requirement in the FMCSRs provides:
    A person is physically qualified to drive a commercial motor
vehicle if that person has distant visual acuity of at least 20/40
(Snellen) in each eye without corrective lenses or visual acuity
separately corrected to 20/40 (Snellen) or better with corrective
lenses, distant binocular acuity of a least 20/40 (Snellen) in both
eyes with or without corrective lenses, field of vision of at least
70[deg] in the horizontal meridian in each eye, and the ability to
recognize the colors of traffic signals and devices showing standard
red, green, and amber (49 CFR 391.41(b)(10)).
    FMCSA recognizes that some drivers do not meet the vision standard,
but have adapted their driving to accommodate their vision limitation
and demonstrated their ability to drive safely. The 46 exemption
applicants listed in this notice are in this category. They are unable
to meet the vision standard in one eye for various reasons, including
amblyopia, complete loss of vision, macular scarring, keratoconus,
cataracts and prosthesis. In most cases, their eye conditions were not
recently developed. 32 of the applicants were either born with their
vision impairments or have had them since childhood. The 14 individuals
who sustained their vision conditions as adults have had them for
periods ranging from 3 to 36 years.
    Although each applicant has one eye which does not meet the vision
standard in 49 CFR 391.41(b)(10), each has at least 20/40 corrected
vision in the other eye, and in a doctor's opinion, has sufficient
vision to perform all the tasks necessary to operate a CMV. Doctors'
opinions are supported by the applicants' possession of valid
commercial driver's licenses (CDLs) or non-CDLs to operate CMVs. Before
issuing CDLs, States subject drivers to knowledge and skills tests
designed to evaluate their qualifications to operate a CMV.
    All of these applicants satisfied the testing standards for their
State of residence. By meeting State licensing requirements, the
applicants demonstrated their ability to operate a commercial vehicle,
with their limited vision, to the satisfaction of the State. While
possessing a valid CDL or non-CDL, these 46 drivers have been
authorized to drive a CMV in intrastate commerce, even though their
vision disqualified them from driving in interstate commerce. They have
driven CMVs with their limited vision for careers ranging from 2 to 43
years. In the past 3 years, 9 of the drivers were involved in crashes
or convicted of moving violations in a CMV.
    The qualifications, experience, and medical condition of each
applicant were stated and discussed in detail in the November 26, 2010
notice (75 FR 72863).

Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the vision standard in 49 CFR 391.41(b)(10) if the exemption is
likely to achieve an equivalent or greater level of safety than would
be achieved without the exemption. Without the exemption, applicants
will continue to be restricted to intrastate driving. With the
exemption, applicants can drive in interstate commerce. Thus, our
analysis focuses on whether an equal or greater level of safety is
likely to be achieved by permitting each of these drivers to drive in
interstate commerce as opposed to restricting him or her to driving in
intrastate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered not only the medical reports about the applicants' vision,
but also their driving records and experience with the vision
deficiency.
    To qualify for an exemption from the vision standard, FMCSA
requires a person to present verifiable evidence that he/she has driven
a commercial vehicle safely with the vision deficiency for the past 3
years. Recent driving performance is especially important in evaluating
future safety, according to several research studies designed to
correlate past and future driving performance. Results of these studies
support the principle that the best predictor of future performance by
a driver is his/her past record of crashes and traffic violations.
Copies of the studies may be found at Docket Number FMCSA-1998-3637.
    We believe we can properly apply the principle to monocular
drivers, because data from the Federal Highway Administration's (FHWA)
former waiver study program clearly demonstrate the driving performance
of experienced monocular drivers in the program is better than that of
all CMV drivers collectively (See 61 FR 13338, 13345, March 26, 1996).
The fact that experienced monocular drivers demonstrated safe driving
records in the waiver program supports a conclusion that other
monocular drivers, meeting the same qualifying conditions as those
required by the waiver program, are also likely to have adapted to
their vision deficiency and will continue to operate safely.
    The first major research correlating past and future performance
was done in England by Greenwood and Yule in 1920. Subsequent studies,
building on that model, concluded that crash rates for the same
individual exposed to certain risks for two different time periods vary
only slightly (See Bates and Neyman, University of California
Publications in Statistics, April 1952). Other studies demonstrated
theories of predicting crash proneness from crash history coupled with
other factors.

These factors--such as age, sex, geographic location, mileage driven
and conviction history--are used every day by insurance companies and
motor vehicle bureaus to predict the probability of an individual
experiencing future crashes (See Weber, Donald C., ``Accident Rate
Potential: An Application of Multiple Regression Analysis of a Poisson
Process,'' Journal of American Statistical Association, June 1971). A
1964 California Driver Record Study prepared by the California
Department of Motor Vehicles concluded that the best overall crash
predictor for both concurrent and nonconcurrent events is the number of
single convictions. This study used 3 consecutive years of data,
comparing the experiences of drivers in the first 2 years with their
experiences in the final year.
    Applying principles from these studies to the past 3-year record of
the 46 applicants, four of the applicants were convicted for a moving
violation and five of the applicants were involved in a crash. All the
applicants achieved a record of safety while driving with their vision
impairment, demonstrating the likelihood that they have adapted their
driving skills to accommodate their condition. As the applicants' ample
driving histories with their vision deficiencies are good predictors of
future performance, FMCSA concludes their ability to drive safely can
be projected into the future.
    We believe that the applicants' intrastate driving experience and
history provide an adequate basis for predicting their ability to drive
safely in interstate commerce. Intrastate driving, like interstate
operations, involves substantial driving on highways on the interstate
system and on other roads built to interstate standards. Moreover,
driving in congested urban areas exposes the driver to more pedestrian
and vehicular traffic than exists on interstate highways. Faster
reaction to traffic and traffic signals is generally required because
distances between them are more compact. These conditions tax visual
capacity and driver response just as intensely as interstate driving
conditions. The veteran drivers in this proceeding have operated CMVs
safely under those conditions for at least 3 years, most for much
longer. Their experience and driving records lead us to believe that
each applicant is capable of operating in interstate commerce as safely
as he/she has been performing in intrastate commerce. Consequently,
FMCSA finds that exempting these applicants from the vision standard in
49 CFR 391.41(b)(10) is likely to achieve a level of safety equal to
that existing without the exemption. For this reason, the Agency is
granting the exemptions for the 2-year period allowed by 49 U.S.C.
31136(e) and 31315 to the 46 applicants listed in the notice of
November 26, 2010 (75 FR 72863).
    We recognize that the vision of an applicant may change and affect
his/her ability to operate a CMV as safely as in the past. As a
condition of the exemption, therefore, FMCSA will impose requirements
on the 46 individuals consistent with the grandfathering provisions
applied to drivers who participated in the Agency's vision waiver
program.
    Those requirements are found at 49 CFR 391.64(b) and include the
following: (1) That each individual be physically examined every year
(a) by an ophthalmologist or optometrist who attests that the vision in
the better eye continues to meet the standard in 49 CFR 391.41(b)(10),
and (b) by a medical examiner who attests that the individual is
otherwise physically qualified under 49 CFR 391.41; (2) that each
individual provide a copy of the ophthalmologist's or optometrist's
report to the medical examiner at the time of the annual medical
examination; and (3) that each individual provide a copy of the annual
medical certification to the employer for retention in the driver's
qualification file, or keep a copy in his/her driver's qualification
file if he/she is self-employed. The driver must also have a copy of
the certification when driving, for presentation to a duly authorized
Federal, State, or local enforcement official.

Discussion of Comments

    FMCSA received one comment in this proceeding. The comment was
considered and discussed below.
    The Pennsylvania Department of Transportation stated that it was in
favor of granting Federal vision exemptions to Terry L. Anderson and
Scott C. Geiter.

Conclusion

    Based upon its evaluation of the 46 exemption applications, FMCSA
exempts, Charles H. Akers, Jr., David B. Albers, Sr., Kurtis A.
Anderson, Terry L. Anderson, Grover h. Baelz, Sammy J. Barada, Kenneth
L. Bowers, Jr., Timothy Bradford, Donald G. Brock, Jr., Anthony D.
Buck, Cody W. Cook, Marvin R. Daly, Douglas R. Duncan, Douglas K. Esp,
Roger C. Evans, II, Jevont D. Fells, Steven C. Fox, Scott C. Geiter,
Gary Golson, Donald L. Hamrick, Eugene W. Harnisch, Ronnie E.
Henderson, Clinton L. Hines, Jr., Steve D. James, Matthew C. Kalebaugh,
Keith A. Larson, Brent E. Lewis, Timothy R. McCullugh, Marcus McMillin,
George C. Milks, Daniel R. Murphy, Joseph M. Palmer, Garrick D. Pitts,
Gary W. Robey, Jonathan C. Rollings, Preston S. Salisbury, Victor M.
Santana, Kevin W. Schaffer, Gerald E. Skalitzky, Allen W. Smith, Robert
B. Steinmetz, George A. Teti, Calvin J. Wallace, II, David W. Ward,
Ralph W. York, Richard L. Zacher from the vision requirement in 49 CFR
391.41(b)(10), subject to the requirements cited above (49 CFR
391.64(b)).
    In accordance with 49 U.S.C. 31136(e) and 31315, each exemption
will be valid for 2 years unless revoked earlier by FMCSA. The
exemption will be revoked if: (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 before it was granted;
or (3) continuation of the exemption would not be consistent with the
goals and objectives of 49 U.S.C. 31136 and 31315.
    If the exemption is still effective at the end of the 2-year
period, the person may apply to FMCSA for a renewal under procedures in
effect at that time.

    Issued on: December 30, 2010.
Larry W. Minor,
Associate Administrator, Office of Policy.
[FR Doc. 2011-241 Filed 1-11-11; 8:45 am]
BILLING CODE 4910-EX-P