UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES Date: 21 JUN 2006 MEMORANDUM SUBJECT: AMENDMENT TO: Bifenthrin: Human Health Risk Assessment for Proposed Uses on Cilantro, Leafy Brassica Greens, Tuberous and Corm Vegetables, Dried Shelled Peas and Beans and Tobacco. Date: 06 April 2006. PC Code: 128825. DP Barcodes: DP313817, DP313818, DP310089, DP313738, DP310088, DP310874.

Regulatory Action: Section 3 Registration Action Risk Assessment Type: Single Chemical Aggregate FROM: Mary Clock Rust, Biologist Registration Action Branch 1 ( RAB1) Health Effects Division ( HED) ( 7509C)

THROUGH: Felecia Fort, Acting Branch Chief And PV Shah, Ph. D., Branch Senior Scientist RAB1 HED ( 7509C)

TO: Barbara Madden, Minor Use Team Registration Division ( RD, 7505C) 2 The most recent human health risk assessment for bifenthrin ( memo, M. Clock Rust. DP313817. 4/ 6/ 06.) has been updated with the addition of new information on the percent of crops projected to be treated with bifenthrin. In the previous assessment, projections of bifenthrin percent crop treated for uses on collards, kale, mustard greens, dried beans/ peas, okra, and sweet potatoes were used. BEAD recently provided updated information for four crops: collards, kale, mustard greens and sweet potatoes. A new dietary assessment was performed using the new information from BEAD, assuming 100% projected percent of crop treated. No other changes have been made to the human health risk assessment. The updated risk estimates for dietary and aggregate risk are summarized in the tables below. These updated tables replace the corresponding tables in the April 6, 2004 risk assessment.

Updated Table 4.2.2: Summary of Dietary Exposure and Risk for Bifenthrin Assuming 100 PCT for Collards, Kale, Mustard Greens and Sweet Potatoes Acute Dietary ( 99.9th Percentile) Chronic Dietary Population Subgroup Dietary Exposure ( mg/ kg/ day) % aPAD Dietary Exposure ( mg/ kg/ day) % cPAD General U. S. Population 0.007985 24 0.000384 10 All Infants (< 1 year old) 0.012467 38 0.000468 12 Children 1 2 years old 0.014044 43 0.001036 26 Children 3 5 years old 0.014204 43 0.000767 19 Children 6 12 years old 0.005499 17 0.000441 11 Youth 13 19 years old 0.007038 21 0.000295 7 Adults 20 49 years old 0.006971 21 0.000347 9 Adults 50+ years old 0.006040 18 0.000304 8 Females 13 49 years old 0.005838 18 0.000258 6 3 Updated Table 6.2.1. Short and Intermediate Term Aggregate Risk for Bifenthrin Assuming 100 PCT for Collards, Kale, Mustard Greens and Sweet Potatoes Population Dietary MOE1 Nondietary Oral MOE2 Dermal MOE3 Inhalation MOE4 Aggregate MOE5 General US population 5,800 N/ A 600 23,000 530 All infants (< 1 yr old) 4,700 590 1400 380 Children 1 2 yrs. Old 2,100 590 1400 350 Children 3 5 yrs. Old 2,900 590 1400 360 Children 6 12 yrs. Old 5,000 1400 1,100 Youth 13 19 yrs. Old 7,500 1400 N/ A 1,200 Adults 20 49 yrs. Old 6,400 600 540 Adults 50+ yrs. Old 7,300 600 540 Females 13 49 yrs. Old 8,600 N/ A 510 23,000 470 1 Dietary MOE = [( short or intermediate term oral NOAEL) ÷ ( chronic dietary exposure)]; NOAEL= 2.21 mg/ kg/ day; chronic dietary ( food + water) exposures were utilized as surrogates for short and intermediate term exposures 2 Non dietary oral MOE = [( short or intermediate term oral NOAEL) ÷ ( sum of all high end incidental oral residential exposure)]; NOAEL= 2.21 mg/ kg/ day; chronic dietary ( food + water) exposures ( see Table 4.2.2) were utilized as surrogates for short and intermediate term exposures. 3 Dermal MOE = [( short or intermediate term dermal NOAEL) ÷ ( high end dermal residential exposure)]; NOAEL= 47 mg/ kg/ day; structural wood treatment ( paintbrush application) used for adult estimates 4 Inhalation MOE = [( short or intermediate term inhalation NOAEL) ÷ ( high end dermal residential exposure)]; NOAEL= 2.21 mg/ kg/ day 5 Aggregate MOE ( dietary and residential) = 1 ÷ [ ( 1 ÷ Dietary MOE) + ( 1 ÷ Non dietary oral MOE) + ( 1 ÷ Dermal MOE) + ( 1 ÷ Inhalation MOE)]; values expressed to 2 significant figures; Inhalation MOE based on adult residential handler exposure ( intermediate term not likely).


[Federal Register Volume 77, Number 204 (Monday, October 22, 2012)]
[Notices]
[Pages 64588-64590]
[FR Doc No: 2012-25915]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2012-0063]

Highway Safety Programs; Conforming Products List of Calibrating
Units for Breath Alcohol Testers

AGENCY: National Highway Traffic Safety Administration, Department of
Transportation.

ACTION: Notice.

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

SUMMARY: This notice updates the Conforming Products List (CPL)
published in the Federal Register on June 25, 2007 (72 FR 34747) for
devices that conform to the Model Specifications for Calibrating Units
for Breath Alcohol Tester (CUs) dated, June 25, 2007 (72 FR 34742).
This update to the CPL includes 44 new listings--3 wet bath units and
41 dry gas units.

DATES: Effective Date: October 22, 2012.

FOR FURTHER INFORMATION CONTACT: For technical issues: Ms. De Carlo
Ciccel, Behavioral Research Division, NTI-131, National Highway Traffic
Safety Administration, 1200 New Jersey Avenue SE., Washington, DC
20590; Telephone:<PHONE_NUMBER>. For legal issues: Mr. David Bonelli,
Office of Chief Counsel, NCC-113, National Highway Traffic Safety
Administration, 1200 New Jersey Avenue SE., Washington, DC 20590;
Telephone number<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: On August 18, 1975 (40 FR 36167), the
National Highway Traffic Safety Administration (NHTSA) published a
standard for Calibrating Units for Breath Alcohol Testers. A Qualified
Products List of calibrating units for breath alcohol testers that met
the standard was first issued on November 30, 1976 (41 FR 53389).
    On December 14, 1984, NHTSA issued a notice to convert the
mandatory standards for calibrating units for breath alcohol testers to
Model Specifications for such devices (49 FR 48865) and to establish a
Conforming Products List (CPL) of calibrating units meeting the Model
Specifications. Calibrating units provide known concentrations of
ethanol vapor for the calibration or calibration checks of instruments
that measure breath alcohol (BrAC).
    On December 29, 1994, NHTSA published a notice amending the Model
Specifications and updated the CPL for calibrating units (59 FR 67377).
That notice also proposed and sought comments about an alternate test
procedure using National Institute for Standards and Technology (NIST)
Reference Gas Mixtures for evaluating the accuracy and precision of
dry-gas ethanol calibrating units. In Appendix A of that notice, NHTSA
identified the calibrating units with an asterisk that had been tested
and found to conform to the 1984 Model Specifications (49 FR 48864),
when tested at alcohol concentrations 0.050, 0.100, and 0.150. All the
other calibrating units listed had been tested and found to conform to
the 1994 amended Model Specifications (59 FR 67377) when tested at
alcohol concentrations 0.000, 0.020, 0.040, 0.080 and 0.160.
    The agency amended the Model Specifications on August 13, 1997 by
incorporating the NIST test procedure (62 FR 43416). In that same
notice, NHTSA updated the CPL and proposed an alternate test procedure
for evaluating the accuracy and precision for wet bath and dry gas
calibrating units using infra-red spectroscopy. On June 25, 2007, NHTSA
adopted an alternate procedure for evaluating wet bath and dry gas
calibrating units using infra-red spectroscopy (72 FR 34742). That
notice also adds references to the dry gas standards by fixed
concentration of ethanol in terms of parts per million (ppm) and tank
size in terms of liters (L). In that same notice, NHTSA updated the CPL
to include 22 new listings (8 wet bath and 14 dry gas units).
    The CPL that appears in today's notice lists calibrating units that
have been determined to conform to the current Model Specifications and
continues to identify those units found to conform to the 1984 Model
Specifications.
    The updated CPL includes 44 new calibrating units (3 wet bath and
41 dry gas units). The wet bath units include:
    (1) Alcosim, submitted by Alcohol Countermeasure Systems, Toronto,
Ontario, Canada;
    (2) Model 12V500 submitted by Guth Laboratories, Inc Harrisburg,
Pennsylvania; and
    (3) Model 3402C-Tandem submitted by RepCo Marketing, Inc., Raleigh,
North Carolina.
    The dry gas units \1\ include:
---------------------------------------------------------------------------

    \1\ The naming convention of the dry gas units added to the CPL
today is illustrative of the ethanol concentration in the volume of
nitrogen dry gas. Concentration is expressed in parts per million
(ppm) or marketed as breath alcohol concentrations (BAC) and volume
is expressed in Liters (L).
---------------------------------------------------------------------------

    (4) 105.1 ppm/30 L, 225.8 ppm/30 L, 104 ppm/55 L, 226 ppm/55 L, 274
ppm/55 L, 53.5 ppm/108 L, 224.9 ppm/108 L, 273.8 ppm/108 L, and 316.2
ppm/108 L totaling nine (9) tanks submitted by Airgas, Mid-America, St.
Louis, Missouri.
    (5) 65.1 ppm/15 L, 130.3 ppm/15 L, 195.4 ppm/15 L, 208.4 ppm/15 L,
390.8 ppm/15 L, 65.1 ppm/34 L, 130.3 ppm/34 L, 195.4 ppm/34 L, 208.4
ppm/34 L, 260.5 ppm/34 L, 390.8 ppm/34 L, 260.5 ppm/105 L, and 260.5
ppm/116 L totaling 13 tanks submitted by Air Liquide CALGAZ, Cambridge,
Maryland.
    (6) 104 ppm/34 L, 208 ppm/34 L, 223 ppm/34 L, 260 ppm/34 L, 52 ppm/
67 L, 103.5 ppm/67 L, 209 ppm/67 L, 260 ppm/67 L, 103.5 ppm/105 L, 208
ppm/105 L, 223 ppm/105 L, 260 ppm/105 L, 273 ppm/105 L, 52 ppm/108 L,
209 ppm/108 L, 103.5 ppm/110 L, 208 ppm/110 L, 223 ppm/110 L, and 260
ppm/110 L totaling 19 tanks submitted by ILMO Specialty Gas Products,
Jacksonville, Illinois.
    This notice also removes nine (9) manufacturers of fourteen (14)
CUs from the CPL whose products are discontinued or no longer sold or
supported by the manufacturer. In some cases, the manufacturer no
longer exists or expressed an interest in removing their unit(s) from
the CPL. In one case, a unit was previously produced by one
manufacturer and is now being supported by another manufacturer. This
unit will not be removed from the CPL, but it will be listed only under
the manufacturer that is currently supporting it. The manufacturers and
units being removed include:
    (1) Davtech Analytical Services, Canada, and its CALWAVE dT-100
unit;
    (2) Intoximeters, Inc., St. Louis, Missouri, and its Alco Breath
Alcohol Standards unit;
    (3) Luckey Laboratories, San Bernardino, California, and its
Simulator unit;
    (4) PLD of Florida, Inc., Rockledge, Florida, and its BA 500 unit;
    (5) Protection Devices, Inc., U.S. Alcohol Testing, Inc., Rancho
Cucamonga, California, and its LS34 Model 6100 unit;
    (6) Scott Specialty Gases, Inc., Plumsteadville, Pennsylvania, and
its Model EBSTM Gaseous Ethanol Breath Standard, Scotty 28
0.040 BAC/28L, Scotty 28 0.045 BAC/28L, Scotty 28 0.080 BAC/28L, Scotty
28 0.100 BAC/28L and Scotty 28 0.105 BAC/28L units;
    (7) Smith & Wesson Electronic Co., Springfield, Massachusetts is
being removed from the CPL. However, its Mark II-A Simulator continues
to be supported and maintained by National Draeger, Inc., Colorado.
This unit will continue to be listed under National Draeger.

    (8) Systems Innovation, Inc., Hallstead, Pennsylvania and its True-
Test MD 901 unit; and
    (9) U.S. Alcohol Testing, Cucamonga, California and its Alco-
Simulator 2000 and Alco-Simulator 61000 units.
    The other change today is an update to the listing for Liquid
Technology Corp., Orlando, Florida, which expands Ethanol-in-Nitrogen
to specify that the unit includes a 105 Liter tank with alcohol
concentrations of 104.3 to 219 ppm.
    Consistent with the paragraphs above, NHTSA updates the Conforming
Products List of Calibrating Units for Breath Alcohol Testers
(Manufacturer and Calibrating Unit) \2\ to read as follows:
---------------------------------------------------------------------------

    \2\ Infra-red (IR) and fuel cell breath testers may be
calibrated with either wet-bath or dry-gas CUs. However, it is
inadvisable to use dry gas CUs when calibrating gas chromatograph
EBTs.

Conforming Products List of Calibrating Units for Breath Alcohol Testers
------------------------------------------------------------------------
                                                    Type of device
         Manufacturers/Name of units         ---------------------------
                                                 Dry gas      Wet bath
------------------------------------------------------------------------
1. Airgas, Inc. (Formerly known as: Gateway
 Airgas, AG Specialty Gas, or Acetylene Gas
 Co.), St. Louis, MO
    Ethanol in Nitrogen Breath Alcohol        ............  ............
     Standards
         105.1 ppm/30 liters (L)....            X   ............
         225.8 ppm/30 L.............            X   ............
         270 ppm/30 L...............            X   ............
         104 ppm/55 liters L........            X   ............
         226 ppm/55 liters L........            X   ............
         274 ppm/55 liters L........            X   ............
         53.5 ppm/108 L.............            X   ............
         103 ppm/108 L..............            X   ............
         224.9 ppm/108 L............            X   ............
         273.8 ppm/108 L............            X   ............
         316.2 ppm/108 L............            X   ............
2. Air Liquide CALGAZ, Cambridge, MD
    Ethanol in Nitrogen Breath Alcohol
     Standards
         65.1 ppm/15 L..............            X   ............
         130.3 ppm/15 L.............            X   ............
         195.4 ppm/15 L.............            X   ............
         208.4 ppm/15 L.............            X   ............
         260.5 ppm/15 L.............            X   ............
         390.8 ppm/15 L.............            X   ............
         65.1 ppm/34 L..............            X   ............
         115 ppm/34 L...............            X   ............
         130.3 ppm/34 L.............            X   ............
         195.4 ppm/34 L.............            X   ............
         208.4 ppm/34 L.............            X   ............
         230 ppm/34 L...............            X   ............
         260.5 ppm/34 L.............            X   ............
         390.8 ppm/34 L.............            X   ............
         260.5 ppm/58 L.............            X   ............
         115 ppm/105 L..............            X   ............
         230 ppm/105 L..............            X   ............
         260.5 ppm/105 L............            X   ............
         260.5 ppm/116 L............            X   ............
         260.5 ppm/537 L............            X   ............
3. Alcohol Countermeasure Systems, Toronto,
 Ontario, Canada
         Alcosim....................  ............            X
4. CMI, Inc., Owensboro, KY                   ............  ............
         Toxitest II................  ............            X
5. Guth Laboratories, Inc., Harrisburg, PA
         Model 34C Simulator........  ............            X
        (variations: Model 34C Cal DOJ, 34-C- ............            X
         FM, and 34C-NPAS)..................
         Model 3412.................  ............            X
         Model 10-4 and 10-4D.......  ............            X
         Model 10-4D Revision A.....  ............            X
         Model 1214.................  ............            X
         Model 2100 (formerly Model   ............            X
         210021)............................
         Model 2100 Revision A......  ............            X
         590........................  ............            X
         12V500.....................  ............            X
6. ILMO Specialty Gas Products,
 Jacksonville, IL
    Ethanol in Nitrogen Standards
         104 ppm/34 L...............            X   ............
         208 ppm/34 L...............            X   ............
         223 ppm/34 L...............            X   ............
         260 ppm/34 L...............            X   ............
         52 ppm/67 L................            X   ............
         103.5 ppm/67 L.............            X   ............
         209 ppm/67 L...............            X   ............

         260 ppm/67 L...............            X   ............
         103.5 ppm/105 L............            X   ............
         208 ppm/105 L..............            X   ............
         223 ppm/105 L..............            X   ............
         260 ppm/105 L..............            X   ............
         273 ppm/105 L..............            X   ............
         52 ppm/108 L...............            X   ............
         209 ppm/108 L..............            X   ............
         103.5 ppm/110 L............            X   ............
         208 ppm/110 L..............            X   ............
         223 ppm/110 L..............            X   ............
         260 ppm/110 L..............            X   ............
7. Lion Laboratories, Cardiff, Wales, UK
(a subsidiary of CMI, Inc.)
         AlcoCal Breath Alcohol                 X   ............
         Standard...........................
8. Liquid Technology Corp., Orlando, FL
         Ethanol-in-Nitrogen                    X   ............
         Standards 104.3 to 219 ppm/105 L...
9. National Draeger, Inc., Durango, CO
         Mark II-A Simulator*         ............            X
         (formerly Smith & Wesson)..........
         Alcotest CU 34.............  ............            X
10. RepCo Marketing, Inc., Raleigh, NC
         AS-1.......................  ............            X
         Model 3402C................  ............            X
         Model 3402C-2K.............  ............            X
         3402C-Tandem...............  ............            X
------------------------------------------------------------------------
\*\ (This instrument met the Model Specifications in 49 FR 48864
  (December 14, 1984), i.e. tested at 0.050, 0.100, and 0.150).
  Instruments not marked with an asterisk meet the Model Specifications
  in 72 FR 32742 (June 25, 2007), tested at 0.020, 0.040, 0.080, and
  0.160 BrAC.

    Authority: 23 U.S.C. 403; 49 CFR 1.50; 49 CFR part 501.

    Issued on: October 17, 2012.
Jeff Michael,
Associate Administrator, Research and Program Development, National
Highway Traffic Safety Administration.
[FR Doc. 2012-25915 Filed 10-19-12; 8:45 am]
BILLING CODE 4910-59-P