[Federal Register Volume 82, Number 66 (Friday, April 7, 2017)]
[Proposed Rules]
[Pages 16962-16963]
[FR Doc No: 2017-06754]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2016-9496; Airspace Docket No. 16-AEA-16]

Proposed Establishment of Class E Airspace; Finleyville, PA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to establish Class E airspace at
Finleyville, PA, to accommodate new Area Navigation (RNAV) Global
Positioning System (GPS) Standard Instrument Approach Procedures
(SIAPs) serving Finleyville Airpark. Controlled airspace is necessary
for the safety and management of instrument flight rules (IFR)
operations at the airport.

DATES: Comments must be received on or before May 22, 2017.

ADDRESSES: Send comments on this rule to: U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE., West
Bldg Ground Floor, Rm. W12-140, Washington, DC 20590; Telephone: 1-800-
647-5527, or<PHONE_NUMBER>.You must identify the Docket No. FAA-2016-
9496; Airspace Docket No. 16-AEA-16, at the beginning of your comments.
You may also submit and review received comments through the Internet
at http://www.regulations.gov. You may review the public docket
containing the proposal, any comments received, and any final
disposition in person in the Dockets Office between 9:00 a.m. and 5:00
p.m., Monday through Friday, except Federal holidays.
    FAA Order 7400.11A, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed on line at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue, SW., Washington, DC, 20591; telephone: 202-267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11A at NARA, call<PHONE_NUMBER>, or go to
http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This proposed rulemaking is promulgated under the authority
described in Subtitle VII, Part, A, Subpart I, Section 40103. Under
that section, the FAA is charged with prescribing regulations to assign
the use of airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it would establish Class E airspace at Finleyville
Airpark, Finleyville, PA.

Comments Invited

    Interested persons are invited to comment on this proposed rule by
submitting such written data, views, or arguments, as they may desire.
Comments that provide the factual basis supporting the views and
suggestions presented are particularly helpful in developing reasoned
regulatory decisions on the proposal. Comments are specifically invited
on the overall regulatory, aeronautical, economic, environmental, and
energy-related aspects of the proposal.
    Communications should identify both docket numbers and be submitted
in triplicate to the address listed above. You may also submit comments
through the Internet at http://www.regulations.gov.
    Persons wishing the FAA to acknowledge receipt of their comments on
this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to Docket
No. FAA-2016-9496; Airspace Docket No. 16-AEA-16.'' The postcard will
be date/time stamped and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see the ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
Holidays. An informal docket may also be examined between 8:00 a.m. and
4:30 p.m., Monday through Friday, except Federal Holidays at the office
of the Eastern Service Center, Federal Aviation Administration, Room
350, 1701 Columbia Avenue, College Park, Georgia 30337.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11A, Airspace
Designations and Reporting Points, dated August 3, 2016, and effective
September 15, 2016. FAA Order 7400.11A is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11A lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to establish Class E airspace at
Finleyville, PA, providing the controlled airspace required to support
the new RNAV

(GPS) standard instrument approach procedures for Finleyville Airpark.
Controlled airspace extending upward from 700 feet above the surface
within a 7.3-mile radius of the airport would be established for IFR
operations.
    Class E airspace designations are published in Paragraph 6005 of
FAA Order 7400.11A, dated August 3, 2016, and effective September 15,
2016, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, will not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal would be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

Lists of Subjects in 14 CFR part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11A,
Airspace Designations and Reporting Points, dated August 3, 2016,
effective September 15, 2016, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
feet or More Above the Surface of the Earth.

* * * * *

AEA PA E5 Finleyville, PA, [New]

Finleyville Airpark, PA
    (Lat. 40[deg]14'45'' N., long. 80[deg]00'44'' W.)

    That airspace extending upward from 700 feet above the surface
within a 7.3-mile radius of Finleyville Airpark.

    Issued in College Park, Georgia, on March 27, 2017.
Joey L. Medders,
Acting Manager, Operations Support Group, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2017-06754 Filed 4-6-17; 8:45 am]
 BILLING CODE 4910-13-P


00151905 Suter, P. ( 1983) 13 Week Toxicity Study with Trifluralin ( HOE 38474 O H AT210) in Mice following Dietary Administration: Report: Project No. 008842. Unpublished study prepared by Research & Consulting Co., AG. 223 p.

00151906 Schutz; Weigand; Kramer ( 1980) Repeated dose ( 3 Months) Oral Toxicity Study of the Active Substance HOE 38474 ( Code: HOE 38474 O H AT204) Administered in the Feed to Rats: Report No. 618/ 80. Unpublished study prepared by Hoechst Aktiengesellschaft. 422 p.

00151907 Brunk; Weigand; Kramer ( 1981) Toxicology Testing of Trifluralin ( Hoe 38474 OH AT 204) by Repeated Oral Administration to Beagle Dogs for Six Months: Report No. 636/ 81. Unpublished report prepared by Hoechst Aktiengesellschaft. 742 p 00151908 Bathe, R. ( 1984) 12 Month Oral Toxicity ( Feeding) Study in Beagle Dogs: Trifluralin TRIFLURALIN ( 036101) October 2003 TRED Toxicology Chapter 42 Substance Technical Grade ( Code: HOE 38474 O H AT210): Project No. 008864: Report Part 1. Unpublished study prepared by Research & Consulting Co. 439 p 00152419 Byrd, R. ( 1984) A Teratology Study of Trifluralin ( El 152, Compound 36352) Administered Orally to Charles River CD Rats: Study R08484. Unpublished study prepared by Lilly Research Labs. 308 p.

00152421 Byrd, R. ( 1984) A Teratology Study ( II) of Trifluralin ( El 152, Compound 36352) Administered Orally to Dutch Belted Rabbits: Study B01784. Unpublished study prepared by Lilly Research Labs. 223 p.

00153171 Suter, P. ( 1982) 31 Days Dermal Toxicity Study with Hoe 38474 OH AT 210 Active Ingredient ( Technical) in Rats: Project 005490. Unpublished study prepared by Research & Consulting Co., Ltd. 450 p.

00152888 Negilski, D. ( 1985) Subchronic ( 21 day) Dermal Toxicity Study in New Zealand White Rabbits with Technical Trifluralin: Study B00184. Unpublished study prepared by Lilly Research Laboratories. 222 p.

00153173 Engelbart ( 1979) Test for Mutagenicity in Bacteria Strains in the Absence and Presence of a Liver Preparation: Hoe 38474 OH AT204 ( Active Ingredient) Trifluralin: Report No. 74/ 79. Unpublished study prepared by Hoechst AG. 7 p.

00155261 Leist, K. ( 1981) Four Hour LC50 Aerosol Inhalation Toxicity Study in Rats on HOE 38474 OH at 210 Active Ingredient ( Technical): Report: Project 005477. Unpublished study prepared by Research & Consulting Co. Ltd. 37 p.

00157154 Jordan, W. ( 1983) A Preliminary Dietary Study of the Effects of Trifluralin on the Urinary Tract of Male Fischer 344 Rats: Study No. R15083: Report No. 1. Unpublished study prepared by Lilly Research Labs. 89 p.

00157156 Usher, R. ( 1985) A Special Urinalysis Study in Fischer 344 Rats Maintained on Diets Containing Trifluralin ( Compound 36352) for Three Months: Study No. R04785. Unpublished study prepared by Lilly Research Labs. 711 p.

00157482 Vigna, E. ( 1985) Trifluralin Technical: Acute Dermal Toxicity Study in Rats: RBM Exp. No. 2159. Unpublished study prepared by Istituto di Ricerche Biomediche " Antoine Marxer", RBM S. p. A. 13 p.

00157483 Vigna, E. ( 1985) Trifluralin Technical: Acute Eye Irritation Study in Rabbits: RBM Exp. No. 2160. Unpublished study prepared by Istituto di Ricerche Biomediche " Antoine Marxer", RBM S. p. A. 15 p.

00157484 Bassi, L. ( 1985) Trifluralin Technical: Dermal Sensitization Study in Guinea Pigs: RBM TRIFLURALIN ( 036101) October 2003 TRED Toxicology Chapter 43 Exp. No. I 892. Unpublished study prepared by Istituto di Ricerche Biomediche " Antoine Marxer", RBM S. p. A. 15 p.

00157485 Vigna, E. ( 1985) Trifluralin Technical: Acute Dermal Irritation Study in Rabbit: RBM Exp. No. 2161. Unpublished study prepared by Istituto di Ricerche Biomediche " Antoine Marxer", RBM S. p. A. 13 p.

00157486 Vigna, E. ( 1985) Trifluralin Technical: Acute Toxicity Study by Oral Route in Rats: RBM Exp. No. 2162. Unpublished study prepared by Istituto di Ricerche Biomediche " Antoine Marxer", RBM S. p. A. 13 p.

00158935 Suter, P. ( 1986) Oncogenicity Study with Trifluralin Active Ingredient Technical ( HOE 38474 O H AT210) in Mice: Project No. 008853. Unpublished study prepared by Research & Consulting Company AG. 6478 p.

00159616 Ebert, E. ( 1985) Trifluralin Active Ingredient Technical Testing for Acute Delayed Neurotoxicity in White Leghorn Hens: Report No. 85.0742. Unpublished study prepared by Hoechst AG. 38 p.

00159618 Bathe, R. ( 1985) Trifluralin, Substance Technical Grade: 12 Month Oral Toxicity ( Feeding) Study in Beagle Dogs: Concentration of Trifluralin, Substance Technical Grade in Dog Feed ¿ : Project No. 008864: Report No. A32778. Unpublished study prepared by Research & Consulting Co. AG. 4 p.

00159619 Becker, H. ( 1985) Trifluralin, Substance Technical Grade: Multiple Generation Study in the Rat: Diet Preparation, Stability, and Analysis of the Test Article ¿ : 1st Amendment to Report: Project No. 008875: Report No. A32777. Unpublished study prepared by Research & Consulting Co. AG. 4 p 00159620 Baeder; Mayer ( 1986) Testing for Embryotoxicity in Wistar Rats following Oral Administration of Hoe 38474: Incidence of Wavy Ribs in Control Studies and at Dose Levels Toxic to Either Dams or Embryos: Supplement to Report No. 83.0557: Report No. 86.0166. Unpublished study prepared by Hoechst AG. 15 p.

00162458 Donaubauer ( 1986) Carcinogenicity Study in Rats ( 28 month Feeding Study): Trifluralin: Study No. 680: Report No. 85.0087. Unpublished study prepared by Hoechst Aktiengesellschaft, Pharma Forschung Toxikologie. 3126 p.

00162543 Hoyt, J. ( 1986) A One year Two generation Reproduction Study in CD Rats Maintained on Diets Containing Trifluralin ( EL 152, Com pound 36352): Studies R06384 and R13984. Unpublished study prepared by Lilly Research Laboratories. 778 p.

00162457 Donaubauer ( 1986) Chronic Feeding Study ( 24 Months) in Rats: Trifluralin: Study TRIFLURALIN ( 036101) October 2003 TRED Toxicology Chapter 44 No. 680: Report No. 85.0302. Unpublished study prepared by Hoechst Aktiengellschaft, Pharma Forschung Toxikologie. 1837 p.

40138301 Usher, R. ( 1986) A Supplementary Report of a Special Urinalysis Study in Fischer 344 Rats Maintained on Diets Containing Trifluralin ( Compound 36352) for Three Months: Study R04785. Unpublished study prepared by Lilly Research Laboratories. 263 p.

40334707 Loveday, K. ( 1987) Evaluation of Trifluralin in the Ames Mutagenesis Assay: ADL Reference: 88720 68. Unpublished study prepared by Arthur D. Little, Inc. 28 p.

40392310 Leist, K.; Penseler, D.; Mayer ( 1987) Trifluralin Substance Technical Grade ( Code: HOE 38474 OH AT210): Testing for Embryotoxicity in Wistar Rats following Oral Administration: Supplementary Data in Support of Previously Submitted Study Acc. No. 258993: Laboratory Project No. 87.0997, Report No. A 36041. Unpublished study prepared by Hoechst Aktiengesellschaft. 19 p.

40392312 Ullman, L. ( 1987) 30 Day Repeated Dose Inhalation Toxicity Study with HOE 38474 OH at 210 in Rats: Amended Version of Previously Submitted Study Acc. No. 258996: Laboratory Project No. 005488, Report No. A 22688 and A 36084. Unpublished study prepared by Research & Consulting Co. Ag. 711 p.

40392313 Suter, P.; Horst, K.; Vogel, W.; et al. ( 1987) Oncogenicity Study with Trifluralin Active Ingredient Technical ( HOE 38474 OH AT210) in Mice: Supplementary Data in Support of Previously Submitted Study Acc. No. 262516 262520: Laboratory Project No. 008853, Report No. A 36197. Unpublished study prepared by Research & Consulting Co. AG. 47 p.

40405007 Rubin, Y.; et al. ( 1987) Triflurex: Two generation Reproduction Study in theRat: Laboratory Project ID AGN/ 125/ TRI. Unpublished study prepared by Life Science Research Israel Ltd. 1664 p.

40673701 Adams, E.; Glass, S.; Van Lier, R. ( 1988) Percutaneous ( Dermal) Absorption of Carbon 14 Trifluralin in Rhesus Monkeys: Laboratory Project ID: P07487 and P03087. Unpublished study prepared by Lilly Research Laboratories. 55 p.

40765601 Young, R. ( 1988) Mutagenicity Test on Trifluralin Technical Grade: Batch Number 39 in the CHO/ HGPRT Foreward Mutation Assay: Project ID. 10137 0 435. Unpublished study prepared by Hazleton Laboratories America, Inc. 46 p.

40765602 Cifone, M. ( 1988) Mutagenicity Test on Trifluralin, Technical Grade in the Rat Primary Hepatocyte Unscheduled DNA Synthesis Assay: Project ID. 10137 0 447. Unpublished study prepared by Hazleton Laboratories America, Inc. 39 p.

40765603 Ivett, J. ( 1988) Mutagenicity Test on Trifluralin Technical Grade in the Mouse Bone TRIFLURALIN ( 036101) October 2003 TRED Toxicology Chapter 45 Marrow and Spermatogonial Cell Cytogenetics Assay: Project ID. 10137 0 473. Unpublished study prepared by Hazleton Laboratories America, Inc. 51 p.

41086101 Adams, E.; Bendele, R.; Emmerson, J. ( 1989) Reanalysis and Discussion of Urine Protein Electrophoresis Data From a Special Urinalysis Study in Fischer 344 Rats with Trifluralin ( Compound 36352). Unpublished supplemental submission prepared by Lilly Research Laboratories 63p.

41218901 Magnussen, J. ( 1989) Identification of the Urinary Metabolites of carbon 14Trifluralin in Rats: Project ID: Experiment ABC 0433. Unpublished study prepared by Lilly Research Laboratories. 53 p.

41993810 Vedula, U.; Kociba, R.; Bond, D. ( 1991) XRM 5313: A Formulation Containing Trifluralin and XRD 498 21 Day Dermal Study in New Zealand White Rabbits: Lab Project Number: M 005313 003A. Unpublished study prepared by The Dow Chemical Co., Tox. Research Lab. 166 p.

42447001 Adams, E.; Bernhard, N.; Jordon, W. ( 1992) A Chronic Toxicity Study of Trifluralin ( Compound 036352) Administered Orally to Beagle Dogs for One Year ( Supp.): Lab Project Number: D07190. Unpublished study prepared by Lilly Research Labs. 470 p.

42972701 Shapiro, R. ( 1993) EPA Acute Oral Toxicity Defined LD50 in Rats: Trilin 5, Lot # 227284: Lab Project Number: T 2527: 2527: P320. Unpublished study prepared by Product Safety Labs. 34 p.

42972702 Shapiro, R. ( 1993) EPA Acute Dermal Toxicity Limit Test: Rabbits: Trilin 5, Lot 227284: Lab Project Number: T 2530: 2530: P322. Unpublished study prepared by Product Safety Labs. 20 p.

42972703 Shapiro, R. ( 1993) EPA Acute Inhalation Defined LC50: Rats: Trilin 5, Lot # 227284: Lab Project Number: T 2532. Unpublished study prepared by product Safety Labs. 54 p.

42972704 Shapiro, R. ( 1993) EPA Primary Eye Irritation: Rabbit: Trilin 5, Lot # 227284: Lab Project Number: T 2528: P324: E30715 1. Unpublished study prepared by Product Safety Labs. 30 42972705 Shapiro, R. ( 1993) EPA Primary Dermal Irritation Test: Rabbits: trilin 5, Lot 227284: Lab Project Number: T 2529: 2529: P326. Unpublished study prepared by Product Safety Labs 23 p.

42972706 Shapiro, R. ( 1993) EPA Topical Skin Sensitization Test in Guinea Pigs ( Buehler): Trilin 5, Lot # 227284: Lab Project Number: T 2531: 2531. Unpublished study prepared by Product Safety Labs. 33 p. TRIFLURALIN ( 036101) October 2003 TRED Toxicology Chapter 46 43447301 Kuhn, J. ( 1994) Trific 10G: Acute Oral Toxicity Study in Rats: Lab Project Number: 0875 93. Unpublished study prepared by Stillmeadow, Inc. 11 p.

43447302 Kuhn, J. ( 1994) Trific 10G: Acute Dermal Toxicity Study in Rabbits: Lab Project Number: 0876 93. Unpublished study prepared by Stillmeadow, Inc. 11 p.

43447303 Holbert, M. ( 1994) Trific 10G: Acute Inhalation Toxicity Study in Rats: Lab Project Number: 0877 93. Unpublished study prepared by Stillmeadow, Inc. 20 p.

43447304 Kuhn, J. ( 1994) Trific 10G: Primary Eye Irritation in Rabbits: Lab Project Number: 0878 93. Unpublished study prepared by Stillmeadow, Inc. 18 p.

43447305 Kuhn, J. ( 1994) Trific 10G: Primary Dermal Irritation in Rabbits: Lab Project Number: 0879 93. Unpublished study prepared by Stillmeadow, Inc. 12 p.

43447306 Kuhn, J. ( 1994) Trific 10G: Dermal Sensitization Study in Guinea Pigs: Lab Project Number: 0880 93. Unpublished study prepared by Stillmeadow, Inc. 17 p.

44135107 Adams, E.; Markham, J. ( 1996) A One Year Two Generation Reproduction Study in CD Rats Maintained on Diets Containing Trifluralin: Supplement # 1 to MRID No. 00162543: Lab Project Number: R06384: R13984 S1: R13984. Unpublished study prepared by Lilly Research Labs. 16 p 92062028 Environ Corp. ( 1990) Dowelanco Phase 3 Summary of MRID 00132820. Percutaneous Absorption of ( Carbon 14)  Ethalfluralin in Monkeys: M 6162 and P03282. Prepared by LILLY RESEARCH LABS. 7 p IARC ( 1991) IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, Trifluralin, Vol 53, 1991 USEPA ( 1979) Trifluralin ( Treflan ® ) Position Document 1/ 2/ 3, 44 FR 50911, NTIS # PB80 213937, Aug 30, 1979.

USEPA ( 1982) Alpha, alpha, alpha trifluoro 2,6 dinitro N, N dipropyl p toluidine, Trifluralin ( Treflan ® ) Position Document 4, 47 FR 33777, NTIS# PB82 263252, Aug 4, 1982. TRIFLURALIN ( 036101) October 2003 TRED Toxicology Chapter 47 8 APPENDICES Tables for Use in Risk Assessment TRIFLURALIN ( 036101) October 2003 TRED Toxicology Chapter 48 8.1 Toxicity Profile Summary Tables 8.1.1 Acute Toxicity Table  See Section 4.1 8.1.2 Subchronic, Chronic and Other Toxicity Tables Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Comments 870.3100 2 Week R F Feeding  Rats ( male) 00157154 ( 1983)

0, 6500 ppm range finding study for 00157156 ( 1985), 41038301 ( 1986)

Acceptable/ Nonguideline NOAEL = not achieved LOAEL = 6500 ppm based on renal epith damage, urine triple phosphates crystals and urinary sediment 870.3100 90 Day Oral toxicity  Rat 00151906 ( 1980)

0, 800, 2000, or 5000 ppm M: 0, 59, 154, and 392 mg/ kg/ day F: 0, 69, 168, and 421 mg/ kg/ day Acceptable/ Guideline NOAEL = 2000 ppm ( 154/ 168 mg/ kg/ day, M/ F) LOAEL = 5000 ( 392/ 421 mg/ kg/ day, M/ F) Based on minor decreases in overall body weight gains and food consumption in males and females, decreased hemoglobin, alkaline phosphatase, and alanine aminotransferase in the males, and increased absolute and relative ( to body) liver weights in males and females.

870.3200 21/ 28 Day dermal toxicity rabbit 41993810 ( 1991)

0, 100, 500, or 1000 mg/ kg / day, [ formulation containing 35.8% trifluralin and 2.6% XRD 498]

Acceptable/ Guideline Systemic NOAEL = 1000 mg/ kg/ day Systemic LOAEL = Not achieved Dermal NOAEL = Not achieved Dermal LOAEL = 100 mg/ kg/ day, edema, and/ or scaling and fissuring 100 mg/ kg/ day based skin irritation 870.3200 31 Day dermal toxicity rat 00153171 ( 1982)

0, 40, 200, or 1000 mg/ kg/ day Acceptable/ Guideline Systemic NOAEL = 1000 mg/ kg/ day ( limit dose) Systemic LOAEL = not achieved Dermal NOAEL = 40 mg/ kg/ day. Dermal LOAEL = 200 mg/ kg/ day based on subepidermal inflamation and ulcerations in males and females.

870.3200 21/ 28 Day dermal toxicity rat 00152888 ( 1985)

0, 1000 mg/ kg/ day ( limit dose)

Acceptable/ Guideline Systemic NOAEL = 1000 mg/ kg/ day. Systemic LOAEL = Not achieved Dermal NOAEL= Not achieved Dermal LOAEL = 1000 mg/ kg/ day ( limit dose) based on erythema, edema, and desquamination of the treated skin. TRIFLURALIN ( 036101) October 2003 TRED Toxicology Chapter Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Comments 49 870.3465 30 Day inhalation toxicity 40392312 ( 1987) reformat of 00151904 ( 1982)

0, 100, 301, 1006 mg/ m3 ( 6 hours/ day 5 days/ week for up to 30 days)

Acceptable/ Nonguideline NOAEL = 301 mg/ m3 LOAEL = 1006 mg/ m3 based on increased bilirubin in females and incidences of dyspnea and ruffled fur in males and females.

870.3700 [ 83 3( a)]

Developmental Toxicity Study  Rat 00151899 ( 1983), 159620 ( 1986), 40392310 ( 1987)

0, 20, 100, 500 mg/ kg/ day Systemic Maternal NOAEL = 100 mg/ kg/ day Systemic Maternal LOAEL = 500 mg/ kg/ day based on mortality, clinical signs, decreased body weight gains, decreased food consumption, and increased liver and spleen weights,

Developmental NOAEL = 100 mg/ kg/ day. Developmental LOAEL = 500 mg/ kg/ day based on reduced ossification of the vertebrae and ribs and thickened, wavy or bent ribs and increased incidences of resorptions 870.3700 [ 83 3( a)]

Developmental Toxicity Study  Rat 00152419 ( 1984) 0, 100, 225, 470, or 1000 mg/ kg/ day Acceptable/ Guideline Maternal NOAEL = 475 mg/ kg/ day Maternal LOAEL = 1000 mg/ kg/ day based decreased body weights and decreased food consumption.

Offspring NOAEL = 475 mg/ kg/ day Offspring LOAEL = 1000 mg/ kg/ day based on decreased fetal body weights.

Developmental NOAEL = 1000 mg/ kg/ day Developmental LOAEL was not established.

870.3700 [ 83 3( b)]

Developmental Toxicity  Rabbit 00152421 ( 1984)

0, 100, 225, 500 mg/ kg/ day Acceptable/ Guideline Maternal NOAEL = 100 mg/ kg/ day Maternal LOAEL = 225 mg/ kg/ day based on abortions, macroscopic changes in the liver and lungs, and decreased food consumption.

Developmental NOAEL = 100 mg/ kg/ day Developmental LOAEL = 225 mg/ kg based on abortions. TRIFLURALIN ( 036101) October 2003 TRED Toxicology Chapter Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Comments 50 870.3800 [ 83 4] 2 Gen Repro  Rat 00151901 ( 1984) 00151902 ( 1984) Feed analysis 00151903 ( 1984) Path 0, 200, 650, 2000 ppm 0, 20, 32.5, 200 mg/ kg/ day ( 1 ppm = 0.5 mg/ kg/ day)

Acceptable/ Guideline Parental NOAEL = 200 ppm ( 10 mg/ kg/ day). Parental LOAEL = 650 ppm ( 32.5 mg/ kg/ day) based on mortality due to acute renal failure and increased lesions of the renal proximal tubules in the F1 females; increased relative ( to body) weights of the liver, kidney ( males), and testes in both generations.

Offspring NOAEL = 200 ppm ( 10 mg/ kg/ day) Offspring LOAEL = 650 ppm ( 32.5 mg/ kg/ day) based on decreased pup weights in both generations and increased relative to body liver weights in the F2b females Repro NOAEL = 2000 ppm ( 100 mg/ kg/ day) Repro LOAEL = Not established.

870.3800 [ 83 4] 2 Gen Repro  Rat 00162543 ( 1986) 44135107 ( 1996)

0, 200, 630, 2000 ppm 0, 15, 47, 148 mg/ kg/ day Acceptable/ Guideline Parental NOAEL = 200 ppn ( 15 mg/ kg/ day) Parental LOAEL = 630 ppm ( 47 mg/ kg/ day), based on decreased BWG and food consumption Offspring NOAEL = 200 ppm ( 15 mg/ kg/ day) Offspring LOAEL = 630 ppm ( 47 mg/ kg/ day) based on small pup size in 3 litters Repro NOAEL = 2000 ppm ( 148 mg/ kg/ day) Repro LOAEL = Not established TRIFLURALIN ( 036101) October 2003 TRED Toxicology Chapter Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Comments 51 870.3800 [ 83 4] 2 Gen Repro  Rat 40405007 ( 1987)

0, 50, 450, 4000 ppm M: 0, 3.9, 35, 295 mg/ kg/ day F: 0, 4.7, 42, 337 mg/ kg/ day Acceptable/ Guideline Parental NOAEL = 450 ppm [ 35/ 42 mg/ kg/ day M/ F] Parental LOAEL = 4000 ppm [ 295/ 337 mg/ kg/ day M/ F] based on decreased body weights, body weight gains, food consumption, and food efficiency in males and females of both generations; decreased ovary weights in both generations; colon distension in the F1 males; and uterine atrophy in the females of both generations.

Offspring NOAEL = 450 ppm ( 35/ 42 mg/ kg/ day M/ F] Offspring LOAEL = 4000 ppm [ 295/ 337mg/ kg/ day , M/ F] based on decreased pup weight in F1a litters Repro NOAEL = 450 ppm ( 35/ 42 mg/ kg/ day) Repro LOAEL = 4000 ppm [ 295/ 337 mg/ kg/ day , M/ F), based on decreased fetal, neonatal, and litter viability and decreased lactation index in the F1a pups; and decreased number of implantation sites, newborn pups, litter size, and pup weights in both generations.

870.4100 [ 83 1( b)] 1 Year Oral ( capsule) Study  Dog 00151908( 1984), 00159618 ( 1985)

0, 30, 150, or 750 ppm 0.0, 0.8, 3.8, 18.8 mg/ kg / day Acceptable/ guideline NOAEL = 30 ppm ( 0.8 mg/ kg/ day LOAEL = 150 ppm ( 3.8 mg/ kg/ day) based on increased absolute liver weights in males 870.4100 [ 83 1( b)] 1 Year Oral ( capsule) Study  Dog 42447001 ( 1992)

0, 0.75, 2.4, 40 mg/ kg/ day Acceptable/ Guideline Systemic NOAEL = 2.4 mg/ kg/ day Systemic LOAEL = 40 mg/ kg/ day, based on increased frequency of abnormal stool and pigment deposition in the kidney and liver in males and females, decreased body weights and body weight gains, and on decreased erythrocytes and hemoglobin and increased thrombocytes in males. TRIFLURALIN ( 036101) October 2003 TRED Toxicology Chapter Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Comments 52 870.4300 [ 83 5( a)] 24 Month Chronic Toxicity/ Carcinogenicity Study  Rat 00162457 ( 1985), 00162458 ( 1985)

0, 200, 800, or 3200 ppm M: 0, 10, 40, and 169 mg/ kg/ day F: 0, 13, 53, and 219 mg/ kg/ day Acceptable/ guideline NOAEL = 800 ppm ( 40/ 53 mg/ kg/ day M/ F). LOAEL = 3200 ppm ( 169/ 219 mg/ kg/ day M/ F) based on decreases in body weight and body weight gains.

At the doses tested, the carcinogenic potential of trifluralin was negative. Dosing was considered adequate based on differences in body weight and body weight gains 870.4300 [ 83 2( a)] 24 Month Carcinogenicity Study  Mouse 00158935 ( 1986), 40392313 ( 1987)

0, 50, 200, or 800 ppm M: 0, 7.5, 29, and 118 mg/ kg/ day F: 0, 10.5, 41, and 165 mg/ kg/ day Unacceptable/ guideline Sys NOAEL = 800 ppm ( 118/ 165 mg/ kg/ day in males/ females) Sys LOAEL = Not achieved At the doses tested, the carcinogenic potential of trifluralin was negative. Dosing was considered inadequate as a toxic effect was not observed, and the limit dose was not tested 870.5100 Bacterial reverse gene mutation assay MRID 00148345 ( 1984) Acceptable/ Guideline Trifluralin was tested up to the limit of solubility ( 400

g/ plate  S9; 800

g/ plate + S9). No cytotoxicity was observed in any strain at up to 800 (+ S9) or 400 ( S9)

g/ plate. No treatmentrelated increases in revertant colonies were observed at any dose in any strain ( ± S9). The positive controls induced the appropriate responses. There was no evidence of induced mutant colonies over background 870.5100 Bacterial reverse gene mutation assay MRID 40334707 ( 1987) Acceptable/ Guideline In a reverse gene mutation assay in bacteria ( MRID 40334707), Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and TA1538 were exposed to trifluralin ( 96.8% a. i., Lot/ Batch #: 335/ 336) in dimethylsulfoxide ( DMSO) at concentrations of 30, 100, 300, 1000, 3000, or 10,000

g/ plate in the presence and absence of mammalian metabolic activation ( S9). The standard plate incorporation method was used. Standard strain specific mutagens served as positive controls.

Trifluralin was tested up to the limit of solubility ( 3000

g/ plate, +/ S9). No cytotoxicity was observed in any strain at up to 3000

g/ plate (+/ S9). No treatment related increases in revertant colonies were observed at any dose in any strain (+/ S9). The positive controls induced the appropriate responses. There was no evidence of induced mutant colonies over background. TRIFLURALIN ( 036101) October 2003 TRED Toxicology Chapter Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Comments 53 870.5100 Bacterial reverse gene mutation assay MRID 00153173 ( 1979)

Acceptable/ Guideline In a reverse gene mutation assay in bacteria ( MRID 00153173), Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and TA1538 were exposed to HOE 38474 ( trifluralin; purity not reported; Lot/ Batch #: OH AT204) in DMSO at concentrations of 0, 4, 20, 100, 500, 2500, or 10,000

g/ plate (+/ S9). Standard strain specific positive controls were used.

HOE 38474 was tested up to the limit dose ( 10,000

g/ plate, +/ S9). No treatment related increases in revertant colonies were observed at any dose in any strain ( ± S9). The positive controls induced the appropriate responses. There was no evidence of induced mutant colonies over background.

870.5250 Gene Mutation Assay  Yeast MRID 00151898 (( 1982) Acceptable/ Guideline The test material was tested up to the limit of solubility ( 1000 mg/ L); however, no solubility data were provided. No treatment related increases in mutation frequency were observed at any dose with or without S9 activation. The positive controls induced the appropriate response. There was no concentration related positive response of induced mutant colonies over background.

870.5300 In vitro mammalian cell gene mutation assay MRID 00126661 Acceptable/ Guideline In a mammalian cell gene mutation assay at the thymidine kinase ( TK) locus, mouse lymphoma L5178Y cells cultured in vitro were exposed to trifluralin ( 95.0% a. i.; Lot/ Batch #: 00554AP2) in DMSO for 4 hours at 8 concentrations ranging from 0.5 to 20

g/ mL ( individual doses not reported) both in the presence and absence of S9 activation.

Trifluralin was tested up to cytotoxic concentrations ( 20

g/ mL, +/ S9). No treatment related increases in mutation frequency were observed at any dose compared to controls. The positive controls induced the appropriate response. There was no concentration related positive response of induced mutant colonies over background. TRIFLURALIN ( 036101) October 2003 TRED Toxicology Chapter Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Comments 54 870.5450 Dominant Lethal  Rat MRID 00148319 ( 1984) Acceptable/ Guideline In a dominant lethal assay ( MRID 00148319), groups of 20 male Sprague Dawley ( CD) rats/ dose were treated once daily via gavage ( 1.0 mL/ dose) with Triflurex technical ( trifluralin; 97.3% a. i.; Batch #: 5320), in corn oil for 5 consecutive days at doses of 0, 100, 333, or 1000 mg/ kg/ day ( total doses of 0, 500, 1665, or 5000 mg/ kg). Beginning two days after the last exposure, each male was mated sequentially to two untreated female rats per week for seven weeks. At 14 days after the midpoint of each mating week, the females were killed, determined to be pregnant or not pregnant, and the number of corpora lutea, living, dead, and total implantations was determined. On the fifth day of dosing, the positive control males were given a single dose of triethylenemelamine ( TEM; 0.3 mg/ kg, i. p. in 0.9% saline).

One 1000 mg/ kg male (# 8476) was found dead 72 hours after the last treatment. Triflurex technical was tested at the limit dose ( 5000 mg/ kg = 1000 mg/ kg/ day X 5 days). There were no treatment related effects on fertility, number of implants, pre implantation losses, number of dead implants, number of females with  1 or  2 dead implants, or ratio of dead implants to total implants at any dose in the study. The positive control induced the appropriate response. There was no time related positive response of increased pre or post implantation loss compared to controls. TRIFLURALIN ( 036101) October 2003 TRED Toxicology Chapter Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Comments 55 870.5300 Forward Gene Mutation Assay MRID 40765601 ( 1988) Acceptable/ Guideline In a mammalian cell gene mutation assay at the HGPRT locus ( MRID 40765601), Chinese hamster ovary ( CHO) cells cultured in vitro were exposed to trifluralin ( 97.6% a. i.; Lot/ Batch #: 39) in dimethyl sulfoxide for 4 hours at concentrations of 50, 100, 150, 200, 300, 400, or 500

g/ mL ( Trial 1,  S9); 50, 100, 200, 300, 500, 600, or 700

g/ mL ( Trial 2,  S9); 50, 100, 200, 250, 300, 400, or 500

g/ mL ( Trial 1, + S9); and 50, 100, 200, 300, 400, 500, or 600

g/ mL ( Trial 2, + S9).

Trifluralin was tested up to cytotoxic concentrations (>= 200

g/ mL, +/ S9) and the limit of solubility (>= 100

g/ mL, +/ S9). No treatment related increases in mutant frequency were observed in either trial in the presence or absence of S9. The positive controls induced the appropriate response. There was no evidence of induced mutant colonies over background in the presence or absence of S9 activation.

870.5300 Forward Gene Mutation Assay MRID 00148318 ( 1984) Acceptable/ Guideline In a mammalian cell gene mutation assay at the HGPRT locus ( MRID 00148318), Chinese hamster ovary ( CHO) cells cultured in vitro were exposed to triflurex technical ( trifluralin; purity not reported; Lot/ Batch #: not reported) in ethanol for 4 hours at concentrations of 10, 50, 100, 200, 300, 400, or 500

g/ mL ( S9) and 50, 100, 200, 300, 400, 500, or 600

g/ mL (+ S9).

Triflurex technical was tested up to cytotoxic concentrations (>= 200

g/ mL,  S9 and >= 300

g/ mL, + S9) and the limit of solubility (>= 100

g/ mL, +/ S9). No treatment related increases in mutant frequency were observed in either trial in the presence or absence of S9. The positive controls induced the appropriate response. There was no evidence of induced mutant colonies over background in the presence or absence of S9 activation. TRIFLURALIN ( 036101) October 2003 TRED Toxicology Chapter Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Comments 56 870.5385 In Vivo Mammalian Cytogenetics [ Bone Marrow/ Spermatogonial Aberration Test] MRID 40765603 ( 1988) Acceptable/ Guideline In a bone marrow/ spermatogonial chromosome aberration assay ( MRID 40765603), ICR mice ( 10 males/ dose, spermatogonial tissue; and 5/ sex/ dose, bone marrow) were dosed once daily via gavage ( 10 mL/ kg) with trifluralin ( 97.6% a. i., Lot/ BatchNo 39) in corn oil at doses of 0, 62.5, 208, or 625 mg/ kg for 5 consecutive days. Bone marrow and spermatogonial cells were harvested at 4.5 hours after the last treatment.

Mortalities were observed in the 625 mg/ kg females ( 2/ 5 treated vs 1/ 5 controls), and at 62.5 mg/ kg in the males ( 2/ 10 treated vs 1/ 10 controls) and females ( 2/ 5 treated vs 1/ 5 controls). Clinical signs of toxicity ( lethargy, swollen neck, and yellow stains around the mouth and perianal area) were also observed at >= 62.5 mg/ kg. No statistically significant increases in the percent of aberrant cells were observed at any dose in either sex in the bone marrow assay or in the males in the spermatogonial assay. Trifluralin was tested at an adequate dose based on mortalities observed at >= 62.5 mg/ kg. The positive control induced the appropriate response. There was no evidence of chromosome aberration induced over background TRIFLURALIN ( 036101) October 2003 TRED Toxicology Chapter Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Comments 57 870.5385 In Vivo Mammalian Cytogenetics [ Bone Marrow Chromosome Aberration Test] MRID 00148320 Acceptable/ Guideline In a bone marrow chromosome aberration assay ( MRID 00148320), 5 Sprague Dawley ( HSD:([ SD] BR) rats/ sex/ dose/ sacrifice time were treated once via oral gavage with Triflurex technical ( trifluralin; 97.3% a. i.; Batch #: 5320), in corn oil at doses of 0, 500, 1650, or 5000 mg/ kg. Bone marrow cells were harvested at 6, 24, or 48 hours after treatment.

Mortality was observed at 1650 ( 3/ 15 males and 5/ 15 females) and 5000 ( 2/ 15 males and 1/ 15 females) mg/ kg upon initial dosing; however, these animals were replaced and only one replacement 1650 mg/ kg female in the 48 hour group died after dosing. Triflurex technical induced minimal bone marrow toxicity ( as indicated by decreased mitotic index) at  500 mg/ kg in males and  1650 mg/ kg in females. Dosing was considered adequate based on bone marrow toxicity and that the animals were dosed above the limit dose ( 2000 mg/ kg). No statistically significant increases in the percent of aberrant cells were observed at any dose or sampling time compared to concurrent controls. The positive control induced the appropriate response. There was no evidence of chromosome aberration induced over background. TRIFLURALIN ( 036101) October 2003 TRED Toxicology Chapter Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Comments 58 870.5395 In vivo Mouse Erythrocyte Micronucleus assay MRID 00151895 ( 1981) Acceptable/ Guideline In a bone marrow micronucleus assay, 5 NMRI mice/ sex/ dose were treated via oral gavage with HOE 38474 ( Trifluralin; 98.3% a. i., Lot/ Batch #: OH AT208), in sesame oil at doses of 0, 25, 250, or 2500 mg/ kg on two consecutive days ( 24 hours apart). Bone marrow cells were harvested at 6 hours after the last treatment.

No unscheduled deaths occurred during the study. No clinical signs of toxicity were observed. No statistically significant differences in the number of micronucleated polychromatic erythrocytes ( MPCE) or normocytes and no decrease in polychromatic erythrocyte to normocyte ( PCE: NCE) ratios were noted in the treated animals compared to controls; however, only individual data were provided. Additionally, although no evidence of cytotoxicity ( decreased PCE: NCE) was noted in the bone marrow, the animals were sufficiently dosed ( the limit dose was given twice). The test material was absorbed as indicated by the presence of orange urine in the 2500 mg/ kg animals. The positive control induced the appropriate response. There was no significant increase in the frequency of micronucleated polychromatic erythrocytes in bone marrow compared to controls.

870.5450 Dominant Lethal  Mouse MRID 00151896 ( 1984) Acceptable/ Guideline In a dominant lethal assay ( MRID 00151896), 30 male NMRI mice were dosed once daily for 5 consecutive days via oral gavage ( 5 mL/ kg) with HOE 38474 ( trifluralin; 98.3% a. i.; Lot/ Batch #: OHZD99002), in sesame oil at concentrations of 0, 10, 100, or 1000 mg/ kg. After the final treatment, each male was mated with 13 untreated females during separate 4 day intervals over a 52 day period.

No treatment related mortalities were noted during the study. No treatment related effects on clinical signs, body weight, fertilization rate, and pre or post implantation loss were observed; however, no data were provided. The positive control ( cyclophosphamide) increased the number of post implantation fetal losses. There was no time related positive response of increased pre or post implantation loss compared to controls. TRIFLURALIN ( 036101) October 2003 TRED Toxicology Chapter Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Comments 59 870.5550 Unscheduled DNA synthesis in mammalian cell culture MRID 40765602 ( 1988) Acceptable/ Guideline In an unscheduled DNA synthesis assay ( MRID), primary rat hepatocyte cultures were exposed to trifluralin ( 97.6% a. i.; Lot/ Batch #: 39) in DMSO for 18 19 hours at concentrations of 0, 0.032, 0.214, 0.404, 0.917, 2.22, 4.36, 8.52, 21.3, 42.9, 88.0, 448, or 898

g/ mL. Fifteen doses ranging from 0.032 898

g/ mL were used in each assay; however, the three doses between 0.032 and 0.214

g/ mL were not reported.

Trifluralin was tested up to cytotoxic levels ( determined by trypan blue exclusion), 88.0

g/ mL in rat # 1 and 42.9

g/ mL in rat # 2. There were no marked increases observed in the mean NNG or percent cells in repair at any dose in either trial. The positive controls induced marked increases in mean NNG and the percent of cells in repair. There was no evidence that unscheduled DNA synthesis, as determined by radioactive tracer procedures ( nuclear silver grain counts), was induced.

870.5550 Unscheduled DNA synthesis in mammalian cell culture MRID 00151894 ( 1982) Acceptable/ Guideline In an unscheduled DNA synthesis assay ( MRID 00151894), HeLa cell cultures were exposed to HOE 38474 ( trifluralin, 98.3% a. i.; Lot/ Batch #: OH AT 208) in DMSO for 1 hour at concentrations of 0, 50, 100 or 500

g/ mL both in the presence and absence of S9 activation.

HOE 38474 was tested up to cytotoxic concentrations (>= 50

g/ mL, +/ S9). No statistically significant increases in mean counts per minute of the test material with hydroxyurea were noted compared to concurrent solvent controls at any dose level, either in the presence or absence of S9 activation. The positive controls induced the appropriate response. There was no evidence that unscheduled DNA synthesis, as determined by liquid scintillation counting procedures, was induced. TRIFLURALIN ( 036101) October 2003 TRED Toxicology Chapter Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Comments 60 870.5900 In vivo Sister Chromatid Exchange Assay MRID 00133426 ( 1983) Acceptable/ Guideline In a mammalian cell cytogenetics assay [ SCE] using the BrdU tablet method , groups of 3 female Chinese hamsters/ dose were exposed once via gavage ( 10 mL/ kg) to trifluralin ( 95.0% a. i., Lot/ batch No 00554AP2) in DMSO and 10% acacia at concentrations of 200, 300, 400, or 500 mg/ kg at 5 hours following BrdU tablet implantation. Bone marrow was collected at 21 hours after treatment.

Trifluralin was tested up to cytotoxic concentrations (>= 400 mg/ kg). Cytotoxicity ( as indicated by an increase in the number of first division metaphase figures) was observed in all animals at >= 400 mg/ kg. No statistically significant increases in SCE frequency were observed at any dose compared to controls. The positive control induced the appropriate response. There was no evidence of SCE induced over background TRIFLURALIN ( 036101) October 2003 TRED Toxicology Chapter Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Comments 61 870.7845 ( 85 1) Metabolism  Rat Urinary metabolites 41218901 ( 1989) Acceptable/ Guideline There was no sex dependent effect on metabolic profiles. A minimum of 20 30 non conjugated metabolites and an additional 10 20 conjugated metabolites were present in the urine, but no parent compound was detected. Information on the percentage of the administered dose excreted in the urine was not provided. However, no single metabolite accounted for more than 8 10% of the total urinary radioactivity, and the majority of the metabolites were present at 1 2% of the total urinary radioactivity. Thus, almost all of the metabolites were minor (< 5% of the total radioactive dose). Metabolite F1B was found at 8.2 8.9% of the total urinary radioactivity in both sexes, and Metabolite F2, N[( 3( acetylamino) 2 amino 5 ( trifluoromethyl) phenyl] acetamide, was found at 4.0 5.2%. Metabolite F1B was partially characterized as retaining the trifluoromethyl groups, the two equivalent aromatic protons, and the two nitro groups, but the propyl groups were lost. Ten other metabolites were identified (< 0.1 3.7% of total urinary radioactivity, each compound in each sex). Two additional metabolites were partially characterized ( 0.1 2.6% of total urinary radioactivity, each compound in each sex).

Four metabolic pathways were identified as follows: ( i) oxidative N dealkylation of one or both propyl groups and metabolites which were hydroxylated on the propyl side chain; ( ii) reduction of one or both nitro groups to the corresponding amine; ( iii) cyclization reactions to give a variety of substituted and unsubstituted benzimidazole metabolites; and ( iv) conjugation reactions, including acetylation of the reduced nitro groups, sulfate, and glucuronic acid conjugates.

Special study 3 Mo Feeding  Rat with Urinalysis study 00157156 ( 1985), 40138301( 1986) 41086101 ( 1989)

0, 50, 200, 800, 3200, and 6400 ppm 0, 2.6, 10.7, 42.2, 170.2, and 342.1 mg/ kg/ day Acceptable/ Nonguideline NOAEL = 200 ppm ( 10.7 mg/ kg/ day) LOAEL for nephrotoxicity = 800 ppm ( 42.2 mg/ kg/ day), based on the presence of cortical tubular cytoplasmic hyaline droplets; increased total protein, AST, and LDH in the urine; and increased urinary volume upon protein electrophoresis and urinalysis. TRIFLURALIN ( 036101) October 2003 TRED Toxicology Chapter 62 TRIFLURALIN ( 036101) October 2003 TRED Toxicology Chapter 63 8.2 Summary of Toxicological Dose and Endpoints Summary of Toxicological Dose and Endpoints for Trifluralin ( PC Code 036101)

Exposure Scenario Dose Used in Risk Assessment, UF Special FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects Acute Dietary ( Females 13 50 years of age) NOAEL = 100 mg/ kg/ day UF = 100 Acute RfD = 1.0 mg/ kg/ day FQPA SF = 1 aPAD = acute RfD FQPA SF = 1.0 mg/ kg/ day Developmental Toxicity Study  Rat LOAEL = 500 mg/ kg/ day based on increased total liter resorptions.

Acute Dietary ( General population including infants and children) No appropriate single dose endpoint was found for this population sub group Chronic Dietary ( All populations) NOAEL= 2.4 mg/ kg/ day UF = 100 Chronic RfD = 0.024 mg/ kg/ day FQPA SF = 1 cPAD = chronic RfD FQPA SF = 0.024 mg/ kg/ day Chronic Toxicity ( capsule)  Dog LOAEL = 40 mg/ kg/ day based on based on increased frequency of abnormal stool, decreased body weights and body weight gains, and on decreased erythrocytes and hemoglobin and increased thrombocytes in males Short Term Incidental Oral ( 1 30 days) NOAEL= 10 mg/ kg/ day Residential LOC for MOE = 100 Occupational = NA Two generation Reproduction Study  Rat LOAEL = 32.5 mg/ kg/ day based on decreased pup weights in both generations TRIFLURALIN ( 036101) October 2003 TRED Toxicology Chapter Exposure Scenario Dose Used in Risk Assessment, UF Special FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects 64 Intermediate Term Incidental Oral ( 1 6 months) NOAEL= 10 mg/ kg/ day Residential LOC for MOE = 100 Occupational = NA Special Urinalysis Study  Rat LOAEL = 40 mg/ kg/ day based on based on the presence of tubular cytoplasmic hyaline droplets; increased total protein, AST, and LDH in the urine; albumin  1 globulin and  2 globulin observed by urine electrophoresis; and increased urinary volume Short Term Dermal ( 1 to 30 days) No quantification required. since there was no systemic toxicity at the limit dose in the dermal toxicity study. There are no developmental toxicity concerns. Also, because risk can not be quantified, the HIARC also recommends that the products containing trifluralin should be labeled as SENSITIZER and should avoid human contact Intermediate Term Dermal ( 1 to 6 months) Oral study NOAEL = 10 mg/ kg/ day ( dermal absorption rate = 3 % Residential LOC for MOE = 100 Occupational LOC for MOE = 100 Special Urinalysis Study  Rat LOAEL = 40 mg/ kg/ day based on based on the presence of tubular cytoplasmic hyaline droplets; increased total protein, AST, and LDH in the urine; albumin  1 globulin and  2 globulin observed by urine electrophoresis; and increased urinary volume Long Term Dermal (> 6 months) Oral study NOAEL= 2.4 mg/ kg/ day ( dermal absorption rate = 3 % when appropriate) Residential LOC for MOE = 100 Occupational LOC for MOE = 100 Chronic Toxicity ( capsule)  Dog LOAEL = 40 mg/ kg/ day based on based on increased frequency of abnormal stool, decreased body weights and body weight gains, and on decreased erythrocytes and hemoglobin and increased thrombocytes in males TRIFLURALIN ( 036101) October 2003 TRED Toxicology Chapter Exposure Scenario Dose Used in Risk Assessment, UF Special FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects 65 Short Term Inhalation ( 1 to 30 days) Inhalation study NOAEL= 81 mg/ kg/ day Residential LOC for MOE = 100 Occupational LOC for MOE = 100 30 Day Inhalation Study  Rat LOAEL = 270 mg/ kg/ day based on increased methemoglobin and bilirubin in females and incidences of dyspnea and ruffled fur in males and females Intermediate Term Inhalation ( 1 to 6 months) Oral study NOAEL = 10 mg/ kg/ day ( inhalation absorption rate = 100%) Residential LOC for MOE = 100 Occupational LOC for MOE = 100 Special Urinalysis Study  Rat LOAEL = 40 mg/ kg/ day based on based on the presence of tubular cytoplasmic hyaline droplets; increased total protein, AST, and LDH in the urine; albumin  1 globulin and  2 globulin observed by urine electrophoresis; and increased urinary volume Long Term Inhalation (> 6 months) Oral study NOAEL= 2.4 mg/ kg/ day ( inhalation absorption rate = 100%) Residential LOC for MOE = 100 Occupational LOC for MOE = 100 Chronic Toxicity ( capsule)  Dog LOAEL = 40 mg/ kg/ day based on based on increased frequency of abnormal stool, decreased body weights and body weight gains, and on decreased erythrocytes and hemoglobin and increased thrombocytes in males Cancer ( oral, dermal, inhalation) Q1* = 0.00579 ( mg/ kg/ day) 1 " Group C" ( limited evidence of carcinogenicity)

UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD = population adjusted dose ( a = acute, c = chronic) RfD = reference dose, MOE = margin of exposure, LOC = level of concern, NA = Not Applicable NOTE: The Special FQPA Safety Factor recommended by the HIARC assumes that the exposure databases ( dietary food, drinking water, and residential) are complete and that the risk assessment for each TRIFLURALIN ( 036101) October 2003 TRED Toxicology Chapter 66 potential exposure scenario includes all metabolites and/ or degradates of concern and does not underestimate the potential risk for infants and children.


[Federal Register Volume 80, Number 3 (Tuesday, January 6, 2015)]
[Notices]
[Pages 508-509]
[FR Doc No: 2014-30907]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1081]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on Postmarketing Adverse Event Reporting for Medical Products and
Dietary Supplements During an Influenza Pandemic; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by
February 5, 2015.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0701.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Guidance for Industry on Postmarketing Adverse Event Reporting for
Medical Products and Dietary Supplements During an Influenza Pandemic;
Availability (OMB Control Number 0910-0701)--Extension

    The guidance includes recommendations for planning, notification,
and documentation for firms that report postmarketing adverse events.
The guidance recommends that each firm's pandemic influenza continuity
of operations plan (COOP) include instructions for reporting adverse
events, including a plan for the submission of stored reports that were
not submitted within regulatory timeframes. The guidance explains that
firms that are unable to fulfill normal adverse event reporting
requirements during an influenza pandemic should: (1) Maintain
documentation of the conditions that prevent them from meeting normal
reporting requirements; (2) notify the appropriate FDA organizational
unit responsible for adverse event reporting compliance when the
conditions exist and when the reporting process is restored; and (3)
maintain records to identify what reports have been stored.
    Based on the number of manufacturers that would be covered by the
guidance, we estimate that approximately 5,000 firms will add the
following to their COOP: (1) Instructions for reporting adverse events;
and (2) a plan for submitting stored reports that were not submitted
within regulatory timeframes. We estimate that each firm will take
approximately 50 hours to prepare the adverse event reporting plan for
its COOP.
    We estimate that approximately 500 firms will be unable to fulfill
normal adverse event reporting requirements because of conditions
caused by an influenza pandemic and that these firms will notify the
appropriate FDA organizational unit responsible for adverse event
reporting compliance when the conditions exist. Although we do not
anticipate such pandemic influenza conditions to occur every year, for
purposes of the PRA, we estimate that each of these firms will notify
FDA approximately once each year, and that each notification will take
approximately 8 hours to prepare and submit.
    Concerning the recommendation in the guidance that firms unable to
fulfill normal adverse event reporting requirements maintain
documentation of the conditions that prevent them from meeting these
requirements, maintaining records to identify what adverse event
reports have been stored, and when the reporting process is restored.
We estimate that approximately 500 firms will each need approximately 8
hours to maintain the documentation and approximately 500 firms will
each need approximately 8 hours to maintain the records. Therefore, the
total recordkeeping burden that would result from the guidance would be
258,000 hours.
    The guidance also refers to previously approved collections of
information found in FDA's adverse event reporting requirements in 21
CFR 310.305, 314.80, 314.98, 600.80, 606.170, 640.73, 1271.350, and
part 803. These regulations contain collections of information that are
subject to review by OMB under the PRA (44 U.S.C. 3501-3520) and are
approved under OMB control numbers 0910-0116, 0910-0291, 0910-0230,
0910-0308, 0910-0437, and 0910-0543. In addition, the guidance also
refers to adverse event reports for nonprescription human drug products
marketed without an approved application and dietary supplements
required under sections 760 and 761 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379aa and 379aa-1), which include collections
of information approved under OMB control numbers 0910-0636 and 0910-
0635.
    In the Federal Register of August 11, 2014 (79 FR 46839), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received one comment. The comment said
that during an influenza pandemic, FDA should not put forth a policy of
reduced reporting, especially for newly approved drugs and vaccines.
The comment recommended that FDA ask companies to modify their
contingency plans by either leveraging the company's remote call center
locations not affected by the pandemic or by outsourcing their safety
reporting to such locations. The comment stated that at minimum, FDA
should require weekly reporting or establish a threshold number of
reports that a company must report to FDA. The comment added that FDA
should specifically require reporting on newly approved drugs or
vaccines for which there is little safety information.
    FDA response: The Guidance for Industry on Postmarketing Adverse
Event Reporting for Medical Products and Dietary Supplements During an
Influenza Pandemic does not describe an approach of reduced reporting
during an influenza pandemic. Rather, the guidance states that ``normal
adverse event reporting processes should be maintained to the maximum
extent possible'' (see section III.C.1, page 3).

FDA also provides recommendations on how to prioritize reporting when
regulatory timelines cannot be met due to limited resources during a
pandemic, so that FDA continues to receive critical safety information
in a timely manner. For example, table 1 of the guidance outlines how
companies should prioritize their submission of postmarketing safety
reports during an influenza pandemic if normal processes of mandatory
adverse event reporting are not feasible because of high employee
absenteeism: Reports for pandemic influenza vaccines, drugs and
biological products labeled for the treatment of influenza, drugs and
biologics approved for less than three years, and products with special
concerns as specified by FDA. The list includes reporting on newly
approved products as the comment recommended. The guidance provides
resources for companies establishing a COOP plan, but specifying the
content of the COOP plans as suggested by the comment is beyond the
scope of the guidance. Instead, the guidance provides the more general
recommendation that ``each firm's pandemic influenza COOP plan should
include instructions for reporting adverse events and the submission of
any stored reports not submitted in the regulatory timeframes'' (see
section III.B, page 2).
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                         Type of reporting                              Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notify FDA when normal reporting is not feasible...................             500                1              500                8            4,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
      Type of recordkeeping          Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeper
----------------------------------------------------------------------------------------------------------------
Add adverse event reporting plan           5,000               1           5,000              50         250,000
 to COOP........................
Maintain documentation of                    500               1             500               8           4,000
 influenza pandemic conditions
 and resultant high absenteeism.
Maintain records to identify                 500               1             500               8           4,000
 what reports have been stored
 and when the reporting process
 was restored...................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         258,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: December 30, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30907 Filed 1-5-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 65 (Tuesday, April 5, 2022)]
[Notices]
[Pages 19691-19692]
[FR Doc No: 2022-07153]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2022-0202]

Information Collection Request to Office of Management and
Budget; OMB Control Number: 1625-0010

AGENCY: Coast Guard, DHS.

ACTION: Sixty-Day notice requesting comments.

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

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 an extension of
its approval for the following collection of information: 1625-0010,
Defect/Noncompliance Report and Campaign Update Report; without change.
Our ICR describes 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 June 6, 2022.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2022-0202] to the Coast Guard using the Federal
eRulemaking Portal at https://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 https://www.regulations.gov. Additionally, copies are available
from: Commandant (CG-6P), ATTN: Paperwork Reduction Act Manager, U.S.
Coast Guard, 2703 Martin Luther King Jr. Ave SE, Stop 7710, Washington,
DC 20593-7710.

FOR FURTHER INFORMATION CONTACT: A.L. Craig, Office of Privacy
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. 3501 et seq., 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 an extension of approval for 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-2022-0202], and
must be received by June 6, 2022.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at https://www.regulations.gov. If your material cannot be
submitted using https://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 https://www.regulations.gov and
can be viewed by following that website'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 https://www.regulations.gov and will include any
personal information you have provided. For more about privacy and
submissions in response to this document, see DHS's eRulemaking System
of Records notice (85 FR 14226, March 11, 2020).

Information Collection Request

    Title: Defect/Noncompliance Report and Campaign Update Report.
    OMB Control Number: 1625-0010.
    Summary: Manufacturers whose products contain defects which create
a substantial risk of personal injury to the public or which fail to
comply with an applicable U.S. Coast Guard safety standard are required
to conduct defect notification and recall campaigns in accordance with
46 U.S.C. 4310. Regulations in 33 CFR 179 require manufacturers to
submit certain reports to the Coast Guard about progress made in
notifying owners and making repairs.
    Need: According to 46 U.S.C. 4310(d) and (e) and 33 CFR
179.13(a)(2) the manufacturer shall provide the Commandant of the Coast
Guard with an initial report consisting of certain information about
the defect notification and recall campaign being conducted. Upon
receipt of information from a manufacturer indicating the initiation of
a recall, the Recreational Boating Product Assurance Branch assigns a
recall campaign number, and sends the manufacturer a CG-4917 form for
supplying the information. According to 33 CFR 179.15(a), a
manufacturer who makes an initial report required by 33 CFR 179.13
shall send to the Commandant of the Coast Guard a follow-up report
within 60 days after the initial report.
    Forms:
     CG-4917, Defect/Noncompliance Report; and
     CG-4918, Campaign Update Report.
    Respondents: Manufacturers of boats and certain items of
``designated'' associated equipment (inboard engines, outboard motors,
or sterndrive engines).
    Frequency: Quarterly.
    Hour Burden Estimate: The estimated burden has decreased from 166.5
hours to 162 hours a year, due to a decrease in the estimated annual
number of responses and a decrease of recalls.
    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. chapter
35, as amended.

    Dated: March 30, 2022.
Kathleen Claffie,
Chief, Office of Privacy Management, U.S. Coast Guard.
[FR Doc. 2022-07153 Filed 4-4-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 160 (Friday, August 17, 2012)]
[Notices]
[Pages 49859-49860]
[FR Doc No: 2012-20249]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2012-0091]

Proposed Traffic Records Program Assessment Advisory

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Notice.

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

SUMMARY: This notice announces the publication of the Traffic Records
Program Assessment Advisory, DOT HS 811 644, which provides guidance to
States on the collection, management, and analysis of data used to
inform highway and traffic safety decision-making. States need timely,
accurate, complete, and uniform traffic records to identify and
prioritize traffic safety issues and to choose appropriate
countermeasures and evaluate their effectiveness. This document
provides information on the contents, capabilities, and data quality
attributes of an effective traffic records system, and includes
assessment questions that qualified independent assessors can use to
evaluate the capabilities of a State's traffic records system.

DATES: Written comments may be submitted to this agency and must be
received no later than October 16, 2012.

ADDRESSES: You may submit comments identified by DOT Docket ID number
NHTSA-2011-0044 by any of the following methods:
     Electronic Submissions: Go to http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Management Facility, M-30 U.S. Department of
Transportation, West Building, Ground floor, Room W12-140, 1200 New
Jersey Ave. SE., Washington, DC 20590.

     Hand Delivery or Courier: Docket Management Facility, M-30
U.S. Department of Transportation, West Building, Ground floor, Room
W12-140, 1200 New Jersey Ave. SE., Washington, DC 20590, between 9 a.m.
and 5 p.m. Eastern time, Monday through Friday, except Federal
holidays.
    Regardless of how you submit your comments, you should identify the
Docket number of this document.
    Instructions: For detailed instructions on submitting comments and
additional information, see http://www.regulations.gov. Note that all
comments received will be posted without change to http://www.regulations.gov, including any personal information provided.
Please read the ``Privacy Act'' heading below.
    Privacy Act: Anyone is able to search the electronic form of all
contents received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review the
complete User Notice and Privacy Notice for Regulations.gov at http://www.regulations.gov/search/footer/privacyanduse.jsp.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov at any time or to
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Eastern Time, Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: For programmatic issues: John Siegler,
Office of Traffic Records and Analysis, NVS-423, National Highway
Traffic Safety Administration, 1200 New Jersey Avenue SE., Washington,
DC 20590. Telephone<PHONE_NUMBER>. For legal issues: Roland Baumann,
Office of Chief Counsel, NCC-113, National Highway Traffic Safety
Administration, 1200 New Jersey Avenue SE., Washington, DC 20590.
Telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Timely, accurate, complete, and uniform
traffic records data is needed to identify and prioritize traffic
safety issues, and choose appropriate countermeasures and evaluate
their effectiveness. The National Highway Traffic Safety Administration
published the Traffic Records Program Assessment Advisory (DOT HS 811
644) to provides guidance to States on the collection, management and
analysis of data from the crash, driver, vehicle, roadway, citation and
adjudication, and injury surveillance databases.
    This document describes the capabilities of traffic records systems
and includes a set of questions, which are the basis for an in-depth
formal review of State highway safety data and State traffic records
systems. Specifically, these questions examine how the State Traffic
Records Coordinating Committee (TRCC) collects, manages, and integrates
information on the crash, driver, vehicle, roadway, citation and
adjudication, and injury surveillance databases. This assessment
instrument was created in response to the GAO recommendation (GAO-10-
454) that ``NHTSA take steps to ensure state traffic records
assessments are complete and consistent to provide an in-depth
evaluation of all state traffic safety data systems across all
performance measures''.
    During a traffic records assessment, assessors will evaluate the
response to each question. Per the Advisory, the system being evaluated
will be deemed to be: (1) Meeting the description of the ideal traffic
records system, (2) partially meeting the ideal description, or (3) not
meeting the ideal description. These assessments will identify the
strengths and weaknesses of each component of the State's traffic
records systems and provide the State with an overview of the current
status of their traffic records program that can be used to benchmark
improvement efforts. In addition, NHTSA will aggregate this data to
examine the strengths and weaknesses of traffic records systems
nationally. The full text of the Traffic Records Program Assessment
Advisory, DOT HS 811 644, is available at http://www-nrd.nhtsa.dot.gov/Pubs/811644.pdf.

Terry T. Shelton,
Associate Administrator, National Center for Statistics and Analysis.
[FR Doc. 2012-20249 Filed 8-16-12; 8:45 am]
BILLING CODE P


[Federal Register Volume 83, Number 245 (Friday, December 21, 2018)]
[Rules and Regulations]
[Pages 65535-65537]
[FR Doc No: 2018-27607]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R10-OAR-2017-0170; FRL-9988-17-Region 10]

Air Plan Approval; ID, West Silver Valley PM2.5 Clean Data
Determination

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is finalizing a
determination that the West Silver Valley, Idaho nonattainment area has
clean data for the 2012 annual fine particulate matter
(PM2.5) National Ambient Air Quality Standard (NAAQS). This
clean data determination (CDD) is based upon quality-assured, quality-
controlled, and certified ambient air monitoring data showing the area
has attained the 2012 PM2.5 NAAQS based on the 2015-2017
data available in the EPA's Air Quality System (AQS) database. The EPA
also is taking final agency action on the September 2017 wildfire
exceptional event at the Pinehurst monitoring station as having
affected PM2.5 and PM10 values. Based on this
clean data determination, the EPA determines that the obligation for
Idaho to make submissions to meet certain Clean Air Act (CAA or the
Act) requirements related to attainment of the NAAQS for this area is
suspended for as long as the area continues to attain the 2012 annual
PM2.5 NAAQS. Additionally, the sanctions and Federal
Implementation Plan (FIP) clocks triggered by the March 26, 2018
Finding of Failure to Submit action will be suspended. No adverse
comments were received on this action.

DATES: This action is effective on January 22, 2019.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R10-OAR-2017-0170. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information or other information the disclosure
of which is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available through https://www.regulations.gov, or please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section for additional availability information.

FOR FURTHER INFORMATION CONTACT: Justin Spenillo at<PHONE_NUMBER>, or
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, it is intended to refer to the EPA.

Table of Contents

I. Background
II. Response to Comments
III. Final Action
IV. Statutory and Executive Orders Review

I. Background

    On December 14, 2012, the Environmental Protection Agency (EPA)
revised the level of the primary annual PM2.5 standard,
lowering the level from 15.0 micrograms per cubic meter ([micro]g/m\3\)
to 12.0 [micro]g/m\3\. Effective April 15, 2015, the EPA made
designation determinations for the 2012 annual PM2.5
NAAQS.\1\ In that action, EPA designated the West Silver Valley area in
Shoshone County, Idaho (WSV NAA) as moderate nonattainment for the 2012
annual PM2.5 NAAQS. See 40 CFR 81.313.
---------------------------------------------------------------------------

    \1\ 80 FR 2206.
---------------------------------------------------------------------------

    On March 26, 2018, the EPA issued a finding of failure to submit
under section 110(k) of the CAA finding that several states, including
Idaho, failed to submit specific moderate area SIP elements for the
2012 annual PM2.5 NAAQS required under subpart 4 of part D
of Title I of the CAA.\2\ In particular, Idaho failed to submit the
following specific moderate area SIP elements for the WSV NAA: An
attainment demonstration; control strategies, including reasonably
available control measures (``RACM'') and reasonably available control
technologies (``RACT''); a reasonable further progress (RFP) plan;
quantitative milestones; and contingency measures. This finding
triggered the sanctions clock under Section 179 of the CAA, as well as
an obligation under Section 110(c) of the CAA for EPA to promulgate a
FIP no later than 2 years from the effective date of the finding.
---------------------------------------------------------------------------

    \2\ 83 FR 14759.
---------------------------------------------------------------------------

    On October 22, 2018 (83 FR 53201), the EPA proposed to determine,
based on the most recent 3 years (2015-2017) of valid data, that the
WSV NAA has attained the 2012 PM2.5 annual NAAQS. The EPA
also proposed to take final agency action on the September 2017
wildfire exceptional event at the Pinehurst monitoring station as
having affected PM2.5 and PM10 values on
September 4 through September 8, 2017 as described in Table 1.

  Table 1--24-Hr PM2.5 and PM10 Values at the Pinehurst Monitoring Station That Meet the EPA Exceptional Event
                                                    Criteria
----------------------------------------------------------------------------------------------------------------
                                                           24-hr PM2.5 Concentration   24-hr PM10 Concentration
                          Date                              ([micro]g/m\3\) 16-079-     ([micro]g/m\3\) 16-079-
                                                                   0017 POC1                   0017 POC3
----------------------------------------------------------------------------------------------------------------
9/4/2017................................................                      144.9   ..........................
9/5/2017................................................                      222.2   ..........................
9/6/2017................................................                      147.1                       169.6
9/7/2017................................................                      123.8                       149.8
9/8/2017................................................                      116.7                       143.7
----------------------------------------------------------------------------------------------------------------

    Based on the clean data determination (CDD), the EPA also proposed
to determine that the obligation to submit the attainment planning
elements for the PM2.5 NAAQS are not applicable so long as
the area continues to attain the 2012 annual PM2.5 NAAQS.
Additional detail can be found in the October 22, 2018, proposed action
(83 FR 53201). Finally, the action proposed to suspend the sanctions
and FIP clocks triggered by the March 26, 2018, Finding of Failure to
Submit action.

II. Response to Comments

    The comment period for the proposed action closed on November 21,
2018. The EPA received seven supportive comments regarding this action.
The EPA received no adverse comments. All comments can be found in the
docket for this action.

III. Final Action

    The EPA is finalizing this action as proposed. Pursuant to 40 CFR
51.1015(a), the EPA determines that based on 3-years of certified,
valid monitoring data between 2015 and 2017, the WSV NAA has attained
the 2012 annual PM2.5 NAAQS. Pursuant to 50 CFR 50.14, the
EPA is also taking final action excluding the 2017 24-hr
PM2.5 and PM10 values listed in Table 1, above,
at the Pinehurst monitoring station because those NAAQS exceedances
were caused by a wildfire exceptional event. Pursuant to 40 CFR
51.1015(a), and based upon our determination that the WSV NAA has
attained the standard, the EPA determines that the obligation to submit
any attainment-related SIP revisions arising from classification of the
WSV NAA as a moderate nonattainment area under subpart 4 of part D, of
title I of the Act for the 2012 annual PM2.5 NAAQS is not
applicable for so long as the area continues to attain the 2012 annual
PM2.5 NAAQS. In particular, the obligation for Idaho to
submit attainment demonstrations, projected emissions inventories, RACM
(including RACT), RFP plans, motor vehicle emissions budgets,
quantitative milestones, and contingency measures for the WSV NAA are
suspended until such time as: (1) The area is redesignated to
attainment, after which such requirements are permanently discharged;
or (2) the EPA determines that the area has re-violated the
PM2.5 NAAQS, at which time the state shall submit such
attainment plan elements for the Moderate nonattainment area by a
future date to be determined by the EPA and announced through
publication in the Federal Register at the time the EPA determines the
area is violating the PM2.5 NAAQS.
    Although the obligation has been suspended, this action does not
preclude Idaho from submitting, nor the EPA from acting on the
suspended attainment plan elements. As a result of this final action,
the sanctions and FIP clocks triggered by the EPA's March 26, 2018,
Finding of Failure to Submit are suspended. See 83 FR 14759.
    Today's final action does not constitute a redesignation of the WSV
NAA to attainment for the 2012 annual PM2.5 NAAQS under CAA
section 107(d)(3) because we have not yet approved a maintenance plan
for WSV NAA as meeting the requirements of section 175A of the CAA or
determined that the area has met the other CAA requirements for
redesignation. The classification and designation status in 40 CFR part
81 remains Moderate nonattainment for this area until such time as the
EPA determines that Idaho has met the CAA requirements for
redesignation to attainment for the WSV NAA.

IV. Statutory and Executive Orders Review

    This action finalizes a determination of attainment based on air
quality and suspends certain federal requirements, and thus will not
impose additional requirements beyond those imposed by state law. For
this reason, this final action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Is not expected to be an Executive Order 13771 (82 FR
9339, February 2, 2017) regulatory action because this action is not
significant under Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. The EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by February 19, 2019. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Particulate
matter, Reporting and recordkeeping requirements, Sulfur oxides,
Volatile organic compounds.

    Authority: 42 U.S.C. 7401 et seq.

    Dated: December 4, 2018.
Michelle L. Pirzadeh,
Acting Regional Administrator, Region 10.
[FR Doc. 2018-27607 Filed 12-20-18; 8:45 am]
 BILLING CODE 6560-50-P