[Federal Register Volume 84, Number 92 (Monday, May 13, 2019)]
[Notices]
[Pages 20875-20876]
[FR Doc No: 2019-09705]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER19-1778-000]

Glen Ullin Energy Center, LLC.; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Glen Ullin Energy Center, LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is May 28, 2019.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor

must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: May 6, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-09705 Filed 5-10-19; 8:45 am]
 BILLING CODE 6717-01-P


Page of 3 1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES December 8, 2005 MEMORANDUM SUBJECT: Imazapyr. The Health Effects Division's ( HED's) Response to Comments Submitted During Phase One of the Public Participation Process. PC Code 128821. CAS Reg. No. 81334 34 1. Case No. 3078. DP Barcode D324105.

FROM: Christina M. Jarvis, Risk Assessor Reregistration Branch 2 Health Effects Division ( 7509C)

THROUGH: Alan Nielsen, Branch Senior Scientist Reregistration Branch 2 Health Effects Division ( 7509C)

TO: Sherrie Kinard, Chemical Review Manager Special Review Branch Special Review and Reregistration Division ( 7508C)

Summary:

The attached document has been generated to address comments submitted by the registrant ( BASF Corporation) to the Agency on the preliminary HED risk assessment for imazapyr ( HED document D320583, 9/ 20/ 2005). The attached document represents HED's response to these comments, and includes input from David Anderson, Ph. D., ( toxicology), Charles Smith ( occupational/ residential exposure assessment), and Christina Jarvis ( risk assessment).

Introduction: Page of 3 2 The following represents HED's response to the comments submitted by BASF Corporation during Phase 1 of the reregistration process for imazapyr. Comments made by BASF are summarized by discipline ( toxicology, occupational/ residential exposure, and drinking water) with HED's response immediately following.

Toxicology:

BASF Comment: The summary of the combined chronic toxicity/ carcinogenicity study in rats ( page 25 of HED's preliminary risk assessment document) does not reflect the conclusions stated in other parts of the document. The 3rd paragraph states that the study is unacceptable and does not satisfy the guideline requirement for a chronic/ carcinogenicity study. In contrast, the conclusion in table 4.1b, page 17, is that the study is acceptable, with a footnote explaining that the study is acceptable based on additional documentation. The 5th paragraph reinforces that the dosing was not adequate, but there is no mention that the policy that stated the limit dose was published after the study was completed. This is stated in the dose selection discussion on the last bullet point on page 28.

HED Response: BASF's comment is accepted. The combined chronic toxicity/ carcinogenicity study was unacceptable to the reviewer, but was later upgraded to acceptable by the Cancer Assessment Review Committee. The HED chapter of the imazapyr RED ( 9/ 20/ 2005, D320583) will be modified appropriately.

BASF Comment: The toxicological data requirements table lists 90 day dermal and inhalation studies as satisfied. Is that appropriate since we have not performed these studies?

HED Response: The sub chronic dermal and inhalation studies are not required by the use pattern of imazapyr and do not need to be satisfied. The table will be updated accordingly ( i. e., " yes" will be changed to " no" in the " Satisfied" column).

BASF Comment: Page 47, Section 9.1.4, Imazapyr Non Cancer Risk Summary. The first sentence states that the total MOE was calculated from a neurotoxicity endpoint, when in fact, the endpoint was selected based on skeletal muscle effects seen in dogs with the structural analog Imazapic.

HED Response: BASF's comment is accepted. Although skeletal muscle effects are frequently associated with neurotoxicity, in this case the microscopic examination of tissue from the spinal cord and peripheral nerves from the analogue showed no effects. " Skeletal muscle endpoint" will be substituted for " neurotoxicity endpoint" in the sentence. The HED chapter of the imazapyr RED ( 9/ 20/ 2005, D320583) will be modified appropriately.

Occupational/ Residential Exposure: Page of 3 3 BASF Comments: BASF notes that on pages 39 and 40 of the risk assessment document, the application rates in Tables 6.3b, 6.3c, and 6.3d should be changed from ` 1.5 lb ai/ acre' to ` 1.5 lb ae/ acre'.

HED Response: BASF's comment is accepted. The HED chapter of the RED ( 9/ 20/ 2005, D320583) will be modified appropriately.

BASF Comment: Page 45, Section 9.1, Occupational Exposure. The last sentence states that the toxicological endpoint used for inhalation exposures was from an inhalation study, when in fact, it is from an oral study.

HED Response: BASF's comment is accepted. The HED chapter of the imazapyr RED ( 9/ 20/ 2005, D320583) will be modified appropriately.

BASF Comment: Page 47 and 49, Sections 9.1.5 and 10.2. These sections identify a data gap for estimating the exposure to workers during helicopter applications to aquatic sites. PHED scenario # 9 is available for estimating the exposure to applicators using closed cab rotary wing aircraft. The gap should be limited to the use for " open cab helicopters" at aquatic sites.

HED Response: The dataset currently available for estimating exposure to applicators using rotary wing aircraft contains only three replicates. HED believes this data is of poor quality and should not be utilized in the risk assessment. As a result, the rotary wing aircraft scenario was considered to be a data gap. HED will consider any data BASF can provide regarding this particular scenario.

Drinking Water Assessment:

BASF Comment: The data presented in Table 6.2b of the HED chapter of the imazapyr RED ( 9/ 20/ 2005, D320583) are wrong since the information was not correctly transferred from the EFED chapter. BASF suggests the table be corrected.

HED Response: BASF's comment is accepted. The HED chapter of the imazapyr RED ( 9/ 20/ 2005, D320583) will be modified appropriately.

BASF Comment: The Agency chose to use FIRST as the aquatic exposure estimation model. EPA has a suitable Forestry/ Non crop Tier II scenario that BASF has used to estimate aquatic exposure. BASF supports the use of these corrected PRZM/ EXAMS concentrations.

HED Response: HED's acknowledges BASF's comment; however, this comment does not fall within the scope of " error only" and rather will be addressed in a forthcoming Phase of the Reregistration Eligibility Decision ( RED) process for imazapyr.


[Federal Register Volume 83, Number 233 (Tuesday, December 4, 2018)]
[Rules and Regulations]
[Pages 62479-62485]
[FR Doc No: 2018-26348]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0538; FRL-9982-42]

Bixafen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of bixafen
in or on multiple commodities which are identified and discussed later
in this document. FMC Corporation requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 4, 2018. Objections and
requests for hearings must be received on or before February 4, 2019
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2016-0538, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP

Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:  Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2016-0538 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
February 4, 2019. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2016-0538, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of November 30, 2016 (81 FR 86312) (FRL-
9954-06), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
6F8475) by FMC Corporation. The petition requested that 40 CFR part 180
be amended by establishing tolerances for residues of the fungicide
bixafen, N-(3',4'-dichloro-5-fluoro[1,1'-biphenyl]-2-yl)-3-
(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide, in or on cattle,
fat at 0.5 parts per million (ppm); cattle, kidney at 0.3 ppm; cattle,
liver at 1.5 ppm; cattle, muscle at 0.15 ppm; grain, aspirated
fractions at 80 ppm; grain, cereal, forage, fodder and straw, group 16
(except rice), forage at 4.0 ppm; grain, cereal, forage, fodder and
straw, group 16 (except rice), hay at 5.0 ppm; grain, cereal, forage,
fodder and straw, group 16 (except rice), stover at 6.0 ppm; grain,
cereal, forage, fodder and straw, group 16 (except rice), straw at 7.0
ppm; grain, cereal, group 15 (except rice and sorghum) at 0.15 ppm;
milk at 0.1 ppm; oilseed, rapeseed subgroup 20A at 0.15 ppm; peanut,
hay at 10.0 ppm; peanut, nutmeat at 0.02 ppm; peanut, refined oil at
0.04 ppm; poultry, eggs at 0.02 ppm; poultry, fat at 0.02 ppm; poultry,
liver at 0.02 ppm; poultry, muscle at 0.02 ppm; sorghum, grain at 3.0
ppm; soybean, hulls at 0.15 ppm; soybean, seed at 0.06 ppm; sugar beet,
dried pulp at 1.0 ppm; vegetable, root subgroup 1A at 0.2 ppm and
vegetable, tuberous and corm subgroup 1C at 0.02 ppm. That document
referenced a summary of the petition prepared by FMC Corporation, the
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
    Based upon review of the data supporting the petition, EPA is
establishing tolerances that vary from those proposed. The reason for
these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for bixafen including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with bixafen follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable

subgroups of consumers, including infants and children.
    Following repeated oral administration of bixafen, the liver was
the primary target organ in mice, rats and dogs. Increased liver
weights and hepatocellular hypertrophy were observed in all species
tested and were considered to reflect hepatic microsomal enzyme
induction. Also, in several studies, there was evidence for liver
toxicity based on clinical chemistry changes (increased serum alkaline
phosphatase and cholesterol, decreased serum albumin) and
histopathological changes (hepatocellular pigmentation, degeneration
and necrosis). In mice and rats, the thyroid was an additional target
in the subchronic and chronic studies, with effects such as increased
thyroid weight, follicular cell hypertrophy and follicular cell
hyperplasia observed. Thyroid toxicity was seen only in the presence of
liver effects, either adverse effects (such as hepatocellular single-
cell degeneration/necrosis) or adaptive effects (such as increased
liver weights with enzyme changes, hepatocellular hypertrophy). This
correlation suggested they thyroid effects are secondary to the liver
effects via enhanced hepatic clearance of thyroid hormones. This
suggestion was supported by a 14-day mechanistic study in rats in which
a marked induction of phase I and II hepatic enzymes, a slight
reduction of thyroid hormone (T3, T4) levels and a significant increase
of TSH levels were observed at 150 mg/kg bodyweight per day, the only
dose tested. Since thyroid toxicity was seen in the absence of adverse
liver effects in studies such as the subchronic and chronic rat
studies, a primary adverse effect on the thyroid cannot be ruled out.
However, no studies are available to address potential susceptibility
in the young to potential thyroid toxicity. As a result, the need for a
Comparative Thyroid Assay (CTA) was considered. However, given risk
estimates are well below the Agency's level of concern (LOC) even when
using conservative exposure assumptions, the Agency concluded that a
CTA is not required at this time. This conclusion, however, may be
revisited should the use pattern change or if updated risk estimates
reach a point where the PODs used in the risk assessment are no longer
protective of potential life-stage susceptibility.
    From the prenatal developmental studies, it is apparent that
evidence of increased quantitative susceptibility in offspring was
observed in the database. The prenatal developmental study in the rat
showed decreased fetal body weights at a dose that produced no adverse
effects in the dam. Similarly, the prenatal developmental study in the
rabbit showed decreased fetal body weight in the absence of maternal
toxicity. In the rat 2-generation reproduction study, however, parental
toxicity (decreased body weight and increased liver weight with
centrilobular and diffuse hypertrophy) and offspring toxicity
(decreased F1 and F2 pup body weights) occurred
at the same dose level.
    An acute neurotoxicity study in the adult rat indicated decreased
motor activity in both sexes and decreased rearing counts in females at
a high dose level (1,000 mg/kg/day). A subchronic neurotoxicity study
was not available, and no evidence of neurotoxicity was observed in
other studies in the database.
    Bixafen did not produce evidence of mutagenicity or clastogenicity
in the required battery of studies. The available mouse carcinogenicity
study produced no treatment-related tumors in the presence of other
toxicity such as organ weight changes with histopathology in both the
liver and thyroid. Thus, bixafen is classified as ``not likely to be
carcinogenic to humans.''
    Bixafen has low acute oral, dermal, and inhalation toxicity.
Bixafen is not an acute eye irritant and is neither a dermal irritant
nor a dermal sensitizer. Specific information on the studies received
and the nature of the adverse effects caused by bixafen as well as the
no-observed-adverse-effect-level (NOAEL) and the lowest-observed-
adverse-effect-level (LOAEL) from the toxicity studies can be found at
http://www.regulations.gov in the document Bixafen. Human Health Risk
Assessment for Section 3 Registration and Tolerance Requests for a New
Active Ingredient Proposed for Use on Cereal Grains, Group 15 (Except
Rice); Forage, Fodder and Straw of Cereal Grains, Group 16 (Except
Rice); Peanut; Soybean; Root Vegetable Subgroup 1A; and Tuberous and
Corm Vegetable Subgroup 1C at pages 14--23 in docket ID number EPA-HQ-
OPP-2016-0538.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for bixafen used for human
risk assessment is shown in Table 1 of this unit.

    Table 1--Summary of Toxicological Doses and Endpoints for Bixafen for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population  NOAEL = 250 mg/kg/    Acute RfD = 2.5 mg/  Acute Neurotoxicity Study in rats;
 including infants and children).   day.                  kg/day.              MRID 49877279.
                                   UFA = 10x...........  aPAD = 2.5 mg/kg/    LOAEL = 1,000 mg/kg/day based on
                                   UFH = 10x...........   day.                 statistically significant
                                   FQPA SF = 1x........                        decreases in motor activity in
                                                                               both sexes and decreased rearing
                                                                               counts in females approximately 4
                                                                               hours following a single oral
                                                                               dose.

Chronic dietary (All populations)  NOAEL = 2.8 mg/kg/    Chronic RfD = 0.03   Chronic/Carcinogenicity Studies in
                                    day.                  mg/kg/day.           Rats; MRIDs 49877272, 49877273.
                                   UFA = 10x...........  cPAD = 0.03 mg/kg/   LOAEL = 17.4 mg/kg/day based on
                                   UFH = 10x...........   day.                 thyroid effects (follicular cell
                                   FQPA SF = 1x........                        hypertrophy, alteration of the
                                                                               thyroid colloid at interim and
                                                                               terminal sacrifice).
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)     Classification: ``Not likely to be carcinogenic to humans'' based on an
                                     absence of tumors in the rat chronic/oncogenicity and mouse carcinogenicity
                                                                      studies.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. mg/kg/day = milligram/kilogram/day. PAD = population
  adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation
  from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human
  population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to bixafen, EPA considered exposure under the petitioned-for
tolerances. EPA assessed dietary exposures from bixafen in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    Such effects were identified for bixafen. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture (USDA) Nationwide Health and Nutrition
Examination Survey, What We Eat in America (NHANES/WWEIA) conducted
from 2003-2008. As to residue levels in food, the acute dietary
analysis was obtained from the Dietary Exposure Evaluation Model using
the Food Commodity Intake Database (DEEM-FCID; version 3.16). The
assessment is based on tolerance-level residues and 100% crop treated
(100 PCT) estimates for all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA conducted from 2003-2008. As to residue levels in food, the
chronic dietary analysis was obtained from the Dietary Exposure
Evaluation Model using the Food Commodity Intake Database (DEEM-FCID;
version 3.16). The assessment is based on tolerance-level residues and
100 PCT estimates for all commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that bixafen does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for bixafen. Tolerance-level residues and 100 PCT
were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk
assessment for bixafen in drinking water. These simulation models take
into account data on the physical, chemical, and fate/transport
characteristics of bixafen. Further information regarding EPA drinking
water models used in pesticide exposure assessment can be found at
http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    The Tier II Pesticide in Water Calculator (PWC version 1.52) and
Tier I Pesticide Root Zone Model Ground Water (PRZM GW) was used for
calculating surface water and ground water EDWCs respectively. The
driver for drinking water exposure is from surface water and the EDWC
of bixafen for acute exposure is estimated to be 16.3 parts per billion
(ppb). For chronic exposure for non-cancer assessment, it is estimated
to be 15.2 ppb for surface water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 16.3 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 15.2 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Bixafen is not proposed nor is it registered for any specific use
patterns that would result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found bixafen to share a common mechanism of toxicity
with any other substances, and bixafen does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that bixafen does not have
a common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see EPA's website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the

FQPA Safety Factor (SF). In applying this provision, EPA either retains
the default value of 10X, or uses a different additional safety factor
when reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. The prenatal developmental
toxicity studies showed effects in the fetus (decreased body weights)
at dose levels that were lower than that of the observed maternal
toxicity (decreased body weights). However, concerns for potential pre-
and postnatal susceptibility from the developmental and reproduction
studies are low because clear NOAELs and LOAELs exist for these
developmental effects, and the PODs and endpoints selected for risk
assessment are protective of potential toxicity in offspring.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for bixafen is considered complete at this
time. The following acceptable studies are available to support this
determination: A prenatal developmental toxicity study in rabbits, a
prenatal developmental toxicity study in rats, a two-generation
reproduction study in rats and an acute neurotoxicity study. The
following study waivers were accepted, and it was determined that these
studies are not required at this time: subchronic inhalation,
subchronic neurotoxicity, and an immunotoxicity study. As summarized in
Unit III.A., EPA determined that the CTA study is not required at this
time.
    ii. An acute neurotoxicity study in the adult rat indicated
decreased motor activity in both sexes and decreased rearing counts in
females at a high dose level (1,000 mg/kg/day). A subchronic
neurotoxicity study was not available, and no evidence of neurotoxicity
was observed in other studies in the database. Concern for
neurotoxicity is low, and thus no developmental neurotoxicity study or
FQPA 10X SF is necessary, because (1) signs of neurotoxicity in the
database occur only at a high dose level, do not include
neuropathology; (2) a clear and well-defined NOAEL has been
established; and (3) the PODs used for risk assessment are protective
of neurotoxicity seen in the database.
    iii. There is evidence of increased prenatal quantitative
susceptibility of the developing offspring in the toxicology database
for bixafen. Developmental toxicity (reduced fetal body weight) was
seen at doses that caused no maternal toxicity in both rats and
rabbits. However, clear NOAELs and LOAELs exist for these developmental
effects, and the endpoints and PODs selected for risk assessment are
protective of these effects. In the 2-generation reproduction toxicity
study, toxicity in the offspring (decreased F1 and
F2 pup body weights) occurred at the same level where
parental toxicity (decreased body weight) was observed, and
susceptibility was not demonstrated. The subchronic and chronic rat
studies in the database indicate thyroid toxicity (epithelial cell
hypertrophy) at the LOAELs, and no studies are available to address
potential susceptibility in the young to potential thyroid toxicity. As
a result, the need for a CTA was considered. However, given risk
estimates are well below the Agency's level of concern even when using
conservative exposure assumptions and that further refinement of
exposure estimates would yield even greater margins of safety, the
Agency concluded that a CTA is not required at this time.
    iv. There are no residual uncertainties identified in the exposure
databases. The unrefined dietary risk assessments are based on high-end
assumptions such as tolerance-level residues, 100PCT assumptions, and
modeled, high-end estimates of residues in drinking water. EPA made
conservative (protective) assumptions in the ground and surface water
modeling used to assess exposure to bixafen in drinking water. These
assessments will not underestimate the exposure and risks posed by
bixafen.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to bixafen will occupy <1% of the aPAD for children 1-2 years of age,
the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
bixafen from food and water will utilize 20% of the cPAD for children
1-2 years of age the population group receiving the greatest exposure.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). A short-term
adverse effect was identified; however, bixafen is not proposed for any
use patterns that would result in short-term residential exposure.
Short-term risk is assessed based on short-term residential exposure
plus chronic dietary exposure. Because there is no short-term
residential exposure and chronic dietary exposure has already been
assessed under the appropriately protective cPAD (which is at least as
protective as the POD used to assess short-term risk), no further
assessment of short-term risk is necessary, and EPA relies on the
chronic dietary risk assessment for evaluating short-term risk for
bixafen.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    An intermediate-term adverse effect was identified; however,
bixafen is not proposed for any use patterns that would result in
intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for
bixafen.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, bixafen is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to bixafen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Analytical Methods 00983 and
01063, high- performance liquid chromatography methods with tandem mass
spectrometry detection (LC/MS/MS)) is available as an enforcement
method for determination of residues of bixafen and its metabolite
bixafen-desmethyl.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has established MRLs for bixafen in or on barley and oats
at 0.4 ppm; the U.S. tolerance for grain, cereal, group 15, except rice
and grain sorghum at 0.40 ppm is harmonized with those MRLs. Codex has
also established MRLs for rye, wheat, and wheat bran at 0.05 ppm, which
is not harmonized with the U.S. tolerances for group 15 because use
consistent with approved labeling could result in exceedances. Codex
has also established MRLs for barley straw and fodder, dry at 20 ppm;
oat straw and fodder, dry at 20 ppm; rye straw and fodder, dry at 20
ppm; and wheat straw and fodder, dry at 20 ppm. The U.S. tolerance for
grain, cereal, forage, fodder and straw, group 16, except rice at 20
ppm is harmonized with those Codex MRLs.
    Additionally, the Codex has established MRLs for bixafen in or on
cattle, fat at 2 ppm; cattle, meat byproducts at 4 ppm; cattle, muscle
at 2 ppm; goat, fat at 2 ppm; goat, meat byproducts at 4 ppm; goat,
muscle at 2 ppm; horse, fat at 2 ppm; horse, meat byproducts at 4 ppm;
horse, muscle at 2 ppm; milk at 0.2 ppm; sheep, fat at 2 ppm; sheep,
meat byproducts at 4 ppm; and sheep, muscle at 2 ppm. These MRLs are
significantly higher than the tolerances being established for bixafen
on the same commodities in the United States. The U.S. tolerances are
based on calculated dietary burden that supports a lower residue level
in fat, muscle, and meat byproducts commodities. Therefore, these
tolerances are not harmonized because such high tolerances could mask
instances of misuse by U.S. growers. As noted in the next section, the
Agency is not establishing tolerances for milk fats and poultry
commodities in harmony with Codex MRLs for milk fats, poultry, edible
offal, poultry fats, and poultry meat because the Agency has determined
that use consistent with the approved pesticide will not result in
residues in milk fats and poultry commodities.

C. Revisions to Petitioned-For Tolerances

    Several proposed tolerances requested by the petitioner are
different from those being established by EPA. For soybean seed;
peanut; peanut, hay; vegetable, tuberous and corm (subgroup 1C); and
vegetable, root, subgroup 1A, tolerance values were calculated using
the Organization for Economic Cooperation and Development (OECD)
tolerance calculation procedures and field trial residue data. The
combination provided a different tolerance value than the proposed
values. EPA is establishing a tolerance for grain, cereal, group 15,
except rice and grain sorghum at 0.40 ppm instead of 0.15 ppm and for
grain, cereal, forage, fodder and straw, group 16, except rice at 20
ppm, rather than the requested tolerances for forage at 4.0 ppm, hay at
5.0 ppm, stover at 6.0 ppm, straw at 7.0 ppm in order to harmonize with
Codex MRLs. Since the tolerance of 20 ppm for group 16 covers the
residues on forage, hay, stover, and straw forms of the group 16
commodities, EPA has determined that separate tolerances are
unnecessary.
    Additionally, while tolerances were proposed on liver and kidney
for livestock commodities, EPA is establishing tolerances on meat
byproducts, which are inclusive of kidney and liver. EPA is further
establishing lower tolerances for residues in fat, muscle and meat
byproducts in cattle, based on the calculated dietary burdens paired
with low residue transfer rates into ruminant commodities. The
tolerance on milk is also established at a lower level (0.04 ppm versus
the 0.10 ppm proposed tolerance). This recommendation is also based on
the calculated dietary burdens paired with low residue transfer rates
into ruminant commodities.
    Under EPA's regulations (40 CFR 180.6), EPA assessed whether
residues on raw agricultural commodities would result in possible
residues entering the diet of man through the ingestion of milk, eggs,
meat, and/or poultry produced by animals fed agricultural products
bearing such residues. As a result of that assessment, EPA determined
that quantifiable residues are expected in commodities from cattle,
horses, goats, and sheep and is establishing tolerances for residues in
fat, muscle and meat byproducts in horse, goat and sheep. EPA also
determined that there is no reasonable expectation of residues in or on
milk fats and poultry products; therefore, no tolerances on milk fats
and poultry commodities are needed.
    Additionally, the proposed use and associated tolerance on Rapeseed
subgroup 20A (canola) was subsequently withdrawn by the petitioner;
therefore, the Agency is not establishing a tolerance on that subgroup
because it is not needed.
    The Agency is not establishing a tolerance for peanut, refined oil
as requested because the residue data indicate that anticipated
residues in the peanut, refined oil are lower than, and will be covered
by, the tolerance for peanut.
    Finally, the Agency is establishing a tolerance for radish, tops,
even though it was not requested by the petitioner. Under EPA's
regulations (40 CFR 180.40(f)(1)(i)(B)), EPA will not establish a crop
group tolerance unless all necessary tolerances are established,
including tolerances for raw commodities not covered by the crop group
and derivative of commodities in the group. In this case, EPA is
establishing a tolerance for root vegetables, subgroup 1A, which
includes radish. Due to the presence of residues on radish tops, EPA is
establishing a necessary tolerance on radish tops to facilitate the
establishment of the subgroup 1A tolerance.

V. Conclusion

    Therefore, tolerances are established for residues of bixafen in or
on beet, sugar, dried pulp at 1.0 ppm; cattle, fat at 0.08 ppm; cattle,
meat byproducts at 0.40 ppm; cattle, muscle at 0.08 ppm; goat, fat at
0.08 ppm; goat, meat byproducts at 0.40 ppm; goat, muscle at 0.08 ppm;
grain, aspirated grain fractions at 80 ppm; grain, cereal, forage,
fodder, and straw, group 16, except rice at 20 ppm; grain, cereal,
group 15, except rice and grain sorghum at 0.40 ppm; horse, fat at 0.08
ppm; horse, meat byproducts at 0.40 ppm; horse, muscle

at 0.08 ppm; milk at 0.04 ppm; peanut at 0.01 ppm; peanut, hay at 8.0
ppm; radish, tops at 3.0 ppm; sheep, fat at 0.08 ppm; sheep, meat
byproducts at 0.40 ppm; sheep, muscle at 0.08 ppm; sorghum, grain,
grain at 3.0 ppm; soybean, hulls at 0.15 ppm; soybean, seed at 0.04
ppm; vegetable, root subgroup 1A at 0.30 ppm; and vegetable, tuberous
and corm subgroup 1C at 0.01 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). This action does not contain any information collections subject
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
et seq.), nor does it require any special considerations under
Executive Order 12898, entitled ``Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule 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. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: November 13, 2018.
Donna Davis,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Add Sec.  180.702 to subpart C to read as follows:

Sec.  180.702  Bixafen; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the
fungicide bixafen, including its metabolites and degradates, in or on
the commodities in the table below. Compliance with the tolerance
levels specified below is to be determined by measuring only bixafen,
N-(3,4-dichloro-5-fluorobiphenyl-2-yl)-3-(difluoromethyl)-1-
methylpyrazole-4-carboxamide, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Beet, sugar, dried pulp.....................................         1.0
Grain, aspirated grain fractions............................          80
Grain, cereal, forage, fodder, and straw, group 16, except            20
 rice.......................................................
Grain, cereal, group 15, except rice and grain sorghum......        0.40
Peanut......................................................        0.01
Peanut, hay.................................................         8.0
Radish, tops................................................         3.0
Sorghum, grain, grain.......................................         3.0
Soybean, hulls..............................................        0.15
Soybean, seed...............................................        0.04
Vegetable, root, subgroup 1A................................        0.30
Vegetable, tuberous and corm, subgroup 1C...................        0.01
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the fungicide
bixafen, including its metabolites and degradates, in or on the
commodities in the table below. Compliance with the tolerance levels
specified below is to be determined by measuring only the sum of
bixafen, N-(3,4-dichloro-5-fluorobiphenyl-2-yl)-3-(difluoromethyl)-1-
methylpyrazole-4-carboxamide, and its desmethyl metabolite, N-(3',4'-
dichloro-5-fluoro[1,1'-biphenyl]-2-yl)-3-(difluoromethyl)-1H-pyrazole-
4-carboxamide, calculated as the stoichiometric equivalent of bixafen,
in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.08
Cattle, meat byproducts.....................................        0.40
Cattle, muscle..............................................        0.08
Goat, fat...................................................        0.08
Goat, meat byproducts.......................................        0.40
Goat, muscle................................................        0.08
Horse, fat..................................................        0.08
Horse, meat byproducts......................................        0.40
Horse, muscle...............................................        0.08
Milk........................................................        0.04
Sheep, fat..................................................        0.08
Sheep, meat byproducts......................................        0.40
Sheep, muscle...............................................        0.08
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2018-26348 Filed 12-3-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 236 (Friday, December 7, 2012)]
[Notices]
[Page 73114]
[FR Doc No: 2012-29744]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Draft Written Re-Evaluation for Environmental Impact Statement:
T.F. Green Airport, Warwick, RI

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of availability and notice of comment period.

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

SUMMARY: The FAA is issuing this notice to advise the public that a
Draft Written Re-Evaluation for an Environmental Impact Statement (EIS)
has been prepared for Theodore Francis Green Airport in Warwick, Rhode
Island.

DATES: Comments must be received by January 7, 2013.

ADDRESSES: Send comments by any of the following methods: Email:
<EMAIL_ADDRESS>Include ``Comment to T.F. Green Draft Written
Re-Evaluation'' in the subject line Mail: Richard Doucette,
Environmental Program Manager, Federal Aviation Administration New
England, 12 New England Executive Park, Burlington, MA 01803.

FOR FURTHER INFORMATION CONTACT: Richard Doucette, Environmental
Program Manager, Federal Aviation Administration New England, 12 New
England Executive Park, Burlington, MA 01803,<PHONE_NUMBER>, or at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The FAA is making available a Draft Written
Re-Evaluation document, which evaluates the impacts of Runway Safety
Areas and other airfield improvements at Theodore Francis Green Airport
in Warwick, Rhode Island. The document will assist the FAA in
determining the suitability of the July 2011 EIS and September 2011
Record of Decision (ROD). The Re-Evaluation document is available for
review during normal business hours at the following locations:

FAA New England, 16 New England Executive Park, Burlington, MA, 781-
238-7613;
Warwick Central Library, 600 Sandy Lane, Warwick, RI,<PHONE_NUMBER>;
Warwick Library, Apponaug Branch, 3267 Post Road, Warwick, RI, 401-
739-6411;
Warwick Library, Norwood Branch, 328 Pawtuxet Ave., Warwick, RI,
401-941-7545.

    Copies of the document can be obtained by contacting Richard
Doucette at<EMAIL_ADDRESS>or<PHONE_NUMBER>. It is also
available at http://www.faa.gov/airports/new_england/
    Public comments will be accepted through January 7, 2013.

    Issued on: November 26, 2012.
Richard Doucette,
Environmental Program Manager, Airports Division, FAA New England
Region.
[FR Doc. 2012-29744 Filed 12-5-12; 4:15 pm]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 153 (Tuesday, August 9, 2011)]
[Notices]
[Pages 48869-48870]
[FR Doc No: 2011-20181]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0064]

Ray Nathan; Denial of Hearing; Final Debarment Order

Agency: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is denying Ray Nathan's
request for a hearing and is issuing an order under the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) permanently debarring Nathan from
providing services in any capacity to a person that has an approved or
pending drug product application. FDA bases this order on a finding
that Nathan was convicted of a felony under Federal law for conduct
relating to the development or approval, including the process for
development or approval, of any drug product. Nathan has failed to file
with the Agency information and analysis sufficient to create a basis
for a hearing concerning this action.

DATES: This order is effective August 9, 2011.

ADDRESSES: Submit applications for termination of debarment to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: G. Matthew Warren, Office of
Scientific Integrity, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 4210, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On May 3, 2007, the U.S. District Court for the District of
Massachusetts entered a criminal judgment against Nathan pursuant to
his guilty plea for wire fraud under 18 U.S.C. 1343 and 1342. The basis
for this conviction was Nathan's scheme to obtain from Lyne
Laboratories (Lyne) a copy of a certificate of analysis for the drug
PhosLo to determine how to manufacture a generic version of the drug.
Nathan, a founder of a startup drug company named Argus Therapeutics
(Argus), admitted that he created a fake email account for a senior
employee at Nabi Biopharmaceuticals (Nabi), a Florida company. In an
effort to obtain the certificate of analysis, he then sent an email
from that account to an employee at Lyne, which manufactured PhosLo as
a subcontractor for Nabi. When the Lyne employee requested a physical
address to which the certificate should be sent, Nathan provided the
address of another principal at Argus via email. Nathan subsequently
sent a third email from the fraudulent email account to inquire about
the status of his request.
    Nathan is subject to debarment based on a finding, under section
306(a)(2)(A) of the FD&C Act (21 U.S.C. 335a(a)(2)(A)), that he was
convicted of a felony under Federal law for conduct relating to the
development or approval, including the process for development or
approval, of any drug product. By a letter dated March 2, 2010, FDA
served Nathan a notice proposing to permanently debar him from
providing services in any capacity to a person having an approved or
pending drug product application. In a letter dated April 6, 2010,
Nathan requested a hearing on the proposal, and he submitted materials
in support of that request on May 10, 2010. In his request for a
hearing, Nathan acknowledges his conviction for wire fraud under
Federal law, as alleged by FDA. However, he argues that the conduct
underlying the conviction does not relate to the development or
approval, including the

process for development or approval, of any drug product or otherwise
relate to the regulation of drugs under the FD&C Act.
    We reviewed Nathan's request for a hearing, as well as the
materials submitted in support of that request, and find that Nathan
has not created a basis for a hearing because hearings will be granted
only if there is a genuine and substantial issue of fact. Hearings will
not be granted on issues of policy or law, on mere allegations,
denials, or general descriptions of positions and contentions, or on
data and information insufficient to justify the factual determination
urged (see 21 CFR 12.24(b)).
    The Chief Scientist and Deputy Commissioner for Science and Public
Health has considered Nathan's arguments and concludes that they are
unpersuasive and fail to raise a genuine and substantial issue of fact
requiring a hearing.

II. Argument

    In support of his hearing request, Nathan argues that the conduct
underlying his conviction for wire fraud does not relate to the
development or approval of a drug product or otherwise relate to the
regulation of drugs under the FD&C Act. We need not address whether the
conduct relates to the regulation of drugs under the FD&C Act because
it clearly relates to the development of a drug product. Nathan argues
that the ``development or approval'' of a drug product subject to FDA's
premarket review begins with preclinical testing in animals and ends
with postmarket studies. He contends that his actions in attempting to
obtain a certificate of analysis for PhosLo do not relate to that
process but instead relate to ``pre-development'' market research.
Nathan maintains that he and Argus were attempting to evaluate
production costs for a generic version of PhosLo and that Argus did not
possess the funding necessary to pursue the steps that he asserts are
associated with the actual development or approval of a drug product.
    Nathan's narrow reading of section 306(a)(2)(A) is not convincing.
In analyzing the scope of a statute, the first step is to ``determine
whether the language at issue has a plain and unambiguous meaning.''
(Robinson v. Shell Oil Co., 519 U.S. 337, 340 (1997)) Statutory
interpretation turns on ``the language itself, the specific context in
which that language is used, and the broader context of the statute as
a whole'' (id. at 341). Here, as FDA has held in denying a hearing in a
debarment proceeding in the past, ``[t]he statutory language, `relating
to the development or approval * * *,' by definition encompasses all
things that are logically connected to the development or approval of a
drug product.'' (59 FR 62399, December 5, 1994) As defined by
``Merriam-Webster's Collegiate Dictionary,'' ``develop'' means, inter
alia, ``to explore the possibilities of'' and ``to make suitable for
commercial * * * purposes.'' (see ``Merriam-Webster's Collegiate
Dictionary,'' 10th Edition (2002)). Although Nathan argues that
researching manufacturing techniques and the commercial viability of
those techniques is not part of the drug development process, it is
clearly a necessary step in that process. At the very least, such
research relates to that development process for a drug product.
Indeed, the information that Nathan attempted to obtain through his
illegal conduct would have enabled Argus to begin compiling the
chemistry, manufacturing, and controls section for an abbreviated new
drug application (see 21 CFR 314.94(a)(9), 314.50(d)(1)). Debarring
individuals who have been convicted of a felony for attempting to
obtain such key information through fraudulent means is consistent with
the clear remedial goals of section 306 of the FD&C Act.

III. Findings And Order

    Therefore, the Chief Scientist and Deputy Commissioner for Science
and Public Health, under section 306(a)(2)(A) of the FD&C Act and under
authority delegated to him, finds that Nathan has been convicted a of a
felony under Federal law for conduct relating to the development or
approval, including the process for development or approval, of a drug
product.
    As a result of the foregoing findings, Nathan is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application under section 505, 512, or
802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section 351
of the Public Health Service Act (42 U.S.C. 262), effective August 9,
2011 (21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(ii) and 21 U.S.C. 321(dd)).
Any person with an approved or pending drug product application who
knowingly uses the services of Nathan, in any capacity during his
period of debarment, will be subject to civil money penalties. If
Nathan, during his period of debarment, provides services in any
capacity to a person with an approved or pending drug product
application, he will be subject to civil money penalties. In addition,
FDA will not accept or review any abbreviated new drug applications
submitted by or with the assistance of Nathan during his period of
debarment.
    Any application by Nathan for termination of debarment under
section 306(d) of the FD&C Act (21 U.S.C. 335a(d)) should be identified
with Docket No. FDA-2010-N-0064 and sent to the Division of Dockets
Management (see ADDRESSES). All such submissions are to be filed in
four copies. The public availability of information in these
submissions is governed by 21 CFR 10.20(j). Publicly available
submissions may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.

    Dated: July 7, 2011.
Jesse L. Goodman,
Chief Scientist and Deputy Commissioner for Science and Public Health.
[FR Doc. 2011-20181 Filed 8-8-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 83, Number 165 (Friday, August 24, 2018)]
[Notices]
[Pages 42969-42970]
[FR Doc No: 2018-18412]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Rule on Disposal of Aeronautical Property at
McGhee Tyson Airport, Alcoa, TN (TYS)

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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

SUMMARY: The Federal Aviation Administration is requesting public
comment on a request by the Metropolitan Knoxville Airport Authority
(MKAA), to release approximately 59.093 acres of land at McGhee Tyson
Airport from federal obligations. This release is being issued for the
relocation of the existing alignment of State Route 115 (U.S. 129/Alcoa
Highway) at the location commonly referred to as the Hunt Road
interchange.

DATES: Comments must be received on or before September 24, 2018.

ADDRESSES: Comments on this notice may be mailed or delivered in
triplicate to the FAA at the following address: Memphis Airports
District Office, Attn: Jamal Stovall, Community Planner, 2600 Thousand
Oaks Boulevard, Suite 2250, Memphis, TN 38118.
    In addition, one copy of any comments submitted to the FAA must

be mailed or delivered to Mr. William F. Marrison, Executive Director,
Metropolitan Knoxville Airport Authority at the following address: 2055
Alcoa Highway, Alcoa, TN 37701.

FOR FURTHER INFORMATION CONTACT: Mr. Jamal Stovall, Community Planner,
Federal Aviation Administration, Memphis Airports District Office,
2600, Thousand Oaks Boulevard, Suite 2250, Memphis, TN 38118-2482. The
application may be reviewed in person at this same location, by
appointment.

SUPPLEMENTARY INFORMATION: The FAA proposes to rule and invites public
comment on the request to release property for disposal at McGhee Tyson
Airport, 2055 Alcoa Hwy., Alcoa, TN 37701, under the provisions of 49
U.S.C. 47107(h)(2). The FAA determined that the request to release
property at McGhee Tyson Airport (TYS) submitted by the Sponsor meets
the procedural requirements of the Federal Aviation Administration and
the release of the property does not and will not impact future
aviation needs at the airport. The FAA may approve the request, in
whole or in part, no sooner than thirty days after the publication of
this notice.
    The following is a brief overview of the request:
    The Metropolitan Knoxville Airport Authority is releasing
approximately 59.093 acres of airport property. This release is
necessary for the relocation of the existing alignment of State Route
115 (US 129/Alcoa Highway) at the Hunt Road Interchange. This request
will release this property from federal obligations.
    The request consists of the following:
    Total land area and portions of 18 federally obligated parcels
currently owned by MKAA. The total amount of land to be released is
59.093 acres. The parcels in whole or portions thereof being released
are referenced on the approved airport property map. The following are
the effected parcels as they appear on the Approved Exhibit A and the
amount of total land to be released versus the parcels total land area:
A-1 (2.545ac. of 1,401.72ac.), A-3 (1.752ac. of 97.63 ac.), A-31
(49.03ac. of 70.88 ac.), A-191 (0.071ac. of 0.89ac.), A-192 (0.162ac.
of 0.86ac.), A-193 (0.25ac. of 0.86ac.), A-194 (0.216ac. of 0.57ac.),
A-195 (0.37ac. of 0.86ac.), A-196 (0.391 ac. of 0.86ac.), A-197
(0.454ac. of 0.83ac.), A-198 (0.608ac. of 0.91ac.), A-199 (0.756ac. of
0.75ac.), A-200 (0.59ac. of 0.59ac.), A-201 (1.107ac. of 1.107ac.), A-
202 (0.232ac. of 0.232ac.), A-203 (0.21ac. of 0.21ac.), A-204 (0.185ac.
of 0.185ac.), A-205 (0.162ac. of 0.162ac.). This property is bounded by
Terminal Loop Drive to the west, North Wright Road to the east and
Ambrose Street to the South. Parcels A-191 to A-205 were acquired in
1989. These parcels are all vacant with scattered trees and mowed
grass. Parcel A-1 was purchased from the City of Knoxville in 1979,
which included 1,401 acres of the original airport. Parcel A-3 was
purchased from a private land owner in 1969. Parcel A-31 was purchased
from the Aluminum Company of America in 1986.
    This request will release this property from federal obligations.
This action is taken under the provisions of 49 U.S.C. 47107(h)(2).
    Any person may inspect the request in person at the FAA office
listed above under FOR FURTHER INFORMATION CONTACT.
    In addition, any person may, upon request, inspect the request,
notice and other documents germane to the request in person at the
Metropolitan Knoxville Airport Authority.

    Issued in Memphis, Tennessee, on August 17, 2018.
Phillip J. Braden,
Manager, Memphis Airports District Office, Southern Region.
[FR Doc. 2018-18412 Filed 8-23-18; 8:45 am]
BILLING CODE 4910-13-P


                         Plant-Incorporated Protectant                                                                    Y9 late blight protection                     OECD Unique Identifier: SPS-ØØØY9-7

Active Ingredient:

The VNT1 protein product of the Rpi-vnt1 gene from plasmid pSIM1678...................<1.0x10[-][5] %* *Percent VNT1 protein expressed in fresh potato tubers.

KEEP OUT OF REACH OF CHILDREN

CAUTION

EPA Registration Number: 8917-3

EPA Establishment Number: 8917-ID-35

J.R. Simplot Company 5369 W. Irving St. Boise, ID 83706

                              DIRECTIONS FOR USE

It is a violation of Federal law to use this product in any manner inconsistent with its labeling.

Potatoes with Y9 late blight protection have been transformed to express the Rpi-vnt1 gene product, the VNT1 protein, for protection against foliar late blight caused by Phytophthora infestans. Controlled P. infestans strains include US-8, US-22, US-23, and US-24.

Under this registration, Y9 late blight protection may be used for conventional breeding with non-PIP potatoes not regulated by EPA to develop new potato varieties containing VNT1 and the genetic material necessary for its production (pSIM1678 T-DNA).

Under this registration, this plant-incorporated protectant may be re-transformed with additional non-pesticidal traits not regulated by EPA.

This plant-incorporated protectant may be re-transformed with additional pesticidal traits. Products of this re-transformation must be registered with EPA.

This plant-incorporated protectant may be combined through conventional breeding with registered PIPs that are similarly approved for use in combination with registered PIPs to produce new potato varieties with combined pesticidal traits.

                          INTEGRATED PEST MANAGEMENT

Best management practices are recommended when using Y9 late blight protection. Examples of appropriate BMPs include:  using certified seed;  crop rotation, including avoidance of planting to fields with infected potato volunteers;  sanitizing seed-cutting equipment;  monitoring late blight alerts;  scouting for late blight lesions;  killing vines prior to harvest if the crop will be stored; and  destroying cull piles.

In order to prolong trait durability, late blight fungicide use may be recommended. Read and follow the Innate(R) Generation 2 Late Blight Integrated Pest Management Guide for the recommended number of fungicide applications.

Y9 late blight protection is a patent-protected* product of the J.R. Simplot Company, Simplot Plant Sciences with unique genetic elements (*United States Patent No. 8,889,964).


[Federal Register: October 3, 2006 (Volume 71, Number 191)]
[Notices]
[Page 58388-58389]
[DOCID:fr03oc06-65]

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

[EPA-HQ-OW-2006-0394; FRL-8226-9]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Approval of State Coastal
Nonpoint Pollution Control Programs; EPA ICR No. 1569.06, OMB Control
No. 2040-0153 (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that an Information
Collection Request (ICR) has been forwarded to the Office of Management
and Budget (OMB) for review and approval. This is a request to renew an
existing approved collection. The ICR, which is abstracted below,
describes the nature of the information collection and its estimated
burden and cost.

DATES: Additional comments may be submitted on or before November 2,
2006.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OW-
2006-0394, to (1) EPA online using http://www.regulations.gov (our preferred method), by e-mail to<EMAIL_ADDRESS>or by mail to: EPA Docket

Center, Environmental Protection Agency, Water Docket--Mail Code 4101T,
1200 Pennsylvania Ave., NW., Washington, DC 20460, and (2) OMB by mail
to: Office of Information and Regulatory Affairs, Office of Management
and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street,
NW., Washington, DC 20503.

    Note: The EPA Docket Center suffered damage due to flooding
during the last week of June 2006. The Docket Center is continuing
to operate. However, during the cleanup, there will be temporary
changes to Docket Center telephone numbers, addresses, and hours of
operation for people who wish to make hand deliveries or visit the
Public Reading Room to view documents. Consult EPA's Federal
Register notice at 71 FR 38147 (July 5, 2006) or the EPA Web site at
http://www.epa.gov/[fxsp0]epahome/dockets.htm for current

information on docket operations, locations and telephone numbers.
The Docket Center's mailing address for U.S. mail and the procedure
for submitting comments to http://www.regulations.gov are not affected by

the flooding and will remain the same.

FOR FURTHER INFORMATION CONTACT: Don Waye, Assessment and Watershed
Protection Division, Office of Wetlands Oceans and Watersheds, Mail
Code

4503T, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 566-1333; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On May 16, 2006 (71 FR 28319), EPA sought comments on this ICR
pursuant to 5 CFR 1320.8(d). EPA received no comments. Any additional
comments on this ICR should be submitted to EPA and OMB within 30 days
of this notice.
    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OW-2006-0394, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the Water Docket in the

EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC Public Reading Room is open from
8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.
The telephone number for the Reading Room is<PHONE_NUMBER>, and the
telephone number for the Water Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at
http://www.regulations.gov, to submit or view public comments, access the

index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov as EPA receives

them and without change, unless the comment contains copyrighted
material, Confidential Business Information (CBI), or other information
whose public disclosure is restricted by statute. For further
information about the electronic docket, go to http://www.regulations.gov.

    Title: Approval of State Coastal Nonpoint Pollution Control
Programs (Renewal).
    ICR numbers: EPA ICR No. 1569.06, OMB Control No. 2040-0153.
    ICR Status: This ICR is scheduled to expire on October 31, 2006.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information, unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, are displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: Under the provisions of national Program Development and
Approval Guidance implementing section 6217 of the Coastal Zone Act
Reauthorization Amendments of 1990 (CZARA) which was jointly developed
and published by EPA and the National Oceanic and Atmospheric
Administration (NOAA), 29 coastal States and 5 coastal Territories with
Federally approved Coastal Zone Management Programs have developed and
submitted to EPA and NOAA Coastal Nonpoint Pollution Programs. EPA and
NOAA have approved 13 States and 4 Territories, and conditionally
approved 16 States and 1 Territory. The conditional approvals will
require States and Territories to submit additional information in
order to obtain final program approval. CZARA section 6217 requires
States and Territories to obtain final approval of their Coastal
Nonpoint Pollution Programs in order to retain their full share of
funding available to them under section 319 of the Clean Water Act and
section 306 of the Coastal Zone Management Act.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 125
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: 16 States and 1 Territory with
approved coastal zone management programs.
    Estimated Number of Respondents: 17.
    Frequency of Response: Once.
    Estimated Total Annual Hour Burden: 2,125 hours.
    Estimated Total Annual Cost: $76,500, which includes $0 annualized
Capital Startup costs, $0 annualized O&M costs, and $76,500 annualized
Labor Costs.
    Changes in the Estimates: There is a decrease of 1125 hours in the
total estimated burden currently identified in the OMB Inventory of
Approved ICR Burdens. This decrease is the result of EPA and NOAA
having fully approved 17 of the 34 State Coastal Nonpoint Programs.

    Dated: September 22, 2006.
Oscar Morales,
Director, Collection Strategies Division.
 [FR Doc. E6-16297 Filed 10-2-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 182 (Thursday, September 19, 2019)]
[Notices]
[Pages 49377-49378]
[FR Doc No: 2019-20238]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2019-0031]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

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

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA announces its decision to exempt ten individuals from
the requirement in the Federal Motor Carrier Safety Regulations
(FMCSRs) that interstate commercial motor vehicle (CMV) drivers have
``no established medical history or clinical diagnosis of epilepsy or
any other condition which is likely to cause loss of consciousness or
any loss of ability to control a CMV.'' The exemptions enable these
individuals who have had one or more seizures and are taking anti-
seizure medication to operate CMVs in interstate commerce.

DATES: The exemptions were applicable on August 21, 2019. The
exemptions expire on August 21, 2021.

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

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov/docket?D=FMCSA-2019-0031 and choose the document to review. If you do
not have access to the internet, you may view the docket online by
visiting the Docket Management Facility in Room W12-140 on the ground
floor of the DOT West Building, 1200 New Jersey Avenue SE, Washington,
DC 20590, between 9 a.m. and 5 p.m., ET, Monday through Friday, except
Federal holidays.

B. Privacy Act

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

II. Background

    On July 15, 2019, FMCSA published a notice announcing receipt of
applications from ten individuals requesting an exemption from the
epilepsy and seizure disorders prohibition in 49 CFR 391.41(b)(8) and
requested comments from the public (84 FR 33805). The public comment
period ended on August 14, 2019, and one comment was received.
    FMCSA has evaluated the eligibility of these applicants and
determined that granting exemptions to these individuals would achieve
a level of safety equivalent to, or greater than, the level that would
be achieved by complying with Sec.  391.41(b)(8).
    The physical qualification standard for drivers regarding epilepsy
found in Sec.  391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of epilepsy

or any other condition which is likely to cause the loss of
consciousness or any loss of ability to control a CMV.
    In addition to the regulations, FMCSA has published advisory
criteria \1\ to assist medical examiners (MEs) in determining whether
drivers with certain medical conditions are qualified to operate a CMV
in interstate commerce.
---------------------------------------------------------------------------

    \1\ These criteria may be found in APPENDIX A TO PART 391--
MEDICAL ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8),
paragraphs 3, 4, and 5, which is available on the internet at
https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
---------------------------------------------------------------------------

III. Discussion of Comments

    FMCSA received one comment in this proceeding. This comment
supported granting the exemptions.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. The statute also allows the Agency to renew exemptions at
the end of the 5-year period. FMCSA grants medical exemptions from the
FMCSRs for a 2-year period to align with the maximum duration of a
driver's medical certification.
    The Agency's decision regarding these exemption applications is
based on the 2007 recommendations of the Agency's Medical Expert Panel
(MEP). The Agency conducted an individualized assessment of each
applicant's medical information, including the root cause of the
respective seizure(s) and medical information about the applicant's
seizure history, the length of time that has elapsed since the
individual's last seizure, the stability of each individual's treatment
regimen and the duration of time on or off of anti-seizure medication.
In addition, the Agency reviewed the treating clinician's medical
opinion related to the ability of the driver to safely operate a CMV
with a history of seizure and each applicant's driving record found in
the Commercial Driver's License Information System for commercial
driver's license (CDL) holders, and interstate and intrastate
inspections recorded in the Motor Carrier Management Information
System. For non-CDL holders, the Agency reviewed the driving records
from the State Driver's Licensing Agency (SDLA). A summary of each
applicant's seizure history was discussed in the July 15, 2019, Federal
Register notice (84 FR 33805) and will not be repeated in this notice.
    These ten applicants have been seizure-free over a range of 15
years while taking anti-seizure medication and maintained a stable
medication treatment regimen for the last 2 years. In each case, the
applicant's treating physician verified his or her seizure history and
supports the ability to drive commercially.
    The Agency acknowledges the potential consequences of a driver
experiencing a seizure while operating a CMV. However, the Agency
believes the drivers granted this exemption have demonstrated that they
are unlikely to have a seizure and their medical condition does not
pose a risk to public safety.
    Consequently, FMCSA finds that in each case exempting these
applicants from the epilepsy and seizure disorder prohibition in Sec.
391.41(b)(8) is likely to achieve a level of safety equal to that
existing without the exemption.

V. Conditions and Requirements

    The terms and conditions of the exemption are provided to the
applicants in the exemption document and includes the following: (1)
Each driver must remain seizure-free and maintain a stable treatment
during the 2-year exemption period; (2) each driver must submit annual
reports from their treating physicians attesting to the stability of
treatment and that the driver has remained seizure-free; (3) each
driver must undergo an annual medical examination by a certified ME, as
defined by Sec.  390.5; and (4) each driver must provide a copy of the
annual medical certification to the employer for retention in the
driver's qualification file, or keep a copy of his/her driver's
qualification file if he/she is self-employed. The driver must also
have a copy of the exemption when driving, for presentation to a duly
authorized Federal, State, or local enforcement official.

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VII. Conclusion

    Based upon its evaluation of the ten exemption applications, FMCSA
exempts the following drivers from the epilepsy and seizure disorder
prohibition, Sec.  391.41(b)(8), subject to the requirements cited
above:

Aaron Ashford (MI)
Elton Behnken (MN)
Tina Farmer (PA)
Elizabeth Galvin (GA)
Roderick Haslip (NY)
Brian Kinkade (MO)
Barbara Miller (TX)
Ryan Moore (NC)
Roger Prynn (NY)
Jerel Sayers (ID)

    In accordance with 49 U.S.C. 31315(b), each exemption will be valid
for 2 years from the effective date unless revoked earlier by FMCSA.
The exemption will be revoked if the following occurs: (1) The person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
prior to being granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315(b).

    Issued on: August 29, 2019.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2019-20238 Filed 9-18-19; 8:45 am]
 BILLING CODE 4910-EX-P