Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for VNT 1 Protein in Potato

                    Docket ID Number: EPA-HQ-OPP-2014-0457
                            Date: December 6, 2016

Section 408(c)(2)(A)(i) of FFDCA allows the U.S. Environmental Protection Agency (EPA) to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if the EPA determines that the exemption is "safe." Section 408(c)(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. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, the EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require the EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance or tolerance exemption, 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 . . . ." Additionally, FFDCA section 408(b)(2)(D) requires that the EPA consider "available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity."
The EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, the EPA determines the toxicity of the pesticide. Second, the EPA examines exposure to the pesticide through food, drinking water, and other exposures that occur as a result of pesticide use in residential settings.
I.  Summary of Petitioned-for Tolerance Exemption
In the Federal Register of April 25, 2016 (Vol. 81, No. 79 FR 24047), the EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 5F8425) by J.R. Simplot Co., 5369 W. Irving St., Boise, ID 83706. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of VNT-1 protein in potatoes. That document referenced a summary of the petition prepared by the petitioner J.R. Simplot, which is available in Docket ID Number EPA-HQ-OPP-2014-0457 via http://www.regulations.gov.
II.  Toxicological Profile
Consistent with FFDCA section 408(b)(2)(D), the EPA reviewed the available scientific data and other relevant information on the VNT-1 protein, and considered its validity, completeness, and reliability, as well as the relationship of this information to human risk. The EPA also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
Expression of Rpi-vnt1 in wild and cultivated potato confers broad-spectrum resistance to late blight strains caused by Phytophthora infestans.  Resistant potato parts include leaves, stems and tubers.  This resistance is based on the recognition of a pathogen-specific protein (effector protein) by a host-specific protein (resistance or R-protein).  Upon infection, AVR-VNT1, an effector protein produced by Phytophthora infestans, is recognized by the R-protein VNT1 expressed in potato (Pel, 2010).  Consequently, VNT1 activates a signal transduction pathway that leads to localized plant cell death or the hypersensitive response.  Death is restricted to a few plant cells and limits the growth and spread of P. infestans throughout the rest of the plant. Using Simplot Innate[TM] Technology, the Rpi-vnt1 gene has been transformed into several commercially important potato varieties successfully conferring late blight resistance.
The VNT1 protein is not detectable by current methodologies and attempts to isolate or produce the VNT1 protein were not successful.  Therefore, no toxicity testing was performed with either plant purified protein or protein produced in a surrogate organism. Rather, the Agency has reviewed a bioinformatics analysis of the allergenic and toxic potential of the VNT1 protein and on similar proteins to which humans are currently and regularly exposed through ingestion of edible plants.  Allergens were analyzed based upon searching for sequence identity with a curated database of allergens hosted by the Food Allergy Research and Resource Program (FARRP). A database of toxin-related proteins was generated using the Universal Protein Resource (uniprot). The databases used for all queries were the latest available resources on May 18, 2015.  The bioinformatics analyses showed that no significant similarity between VNT1 and known allergens or toxins was identified.
The Rpi-vnt1 resistance gene introduced into potato is similar to genes that have been bred into tomato (Solanum lycopersicum; a species closely related to potato) for resistance to tomato mosaic virus (ToMV).  Submitted data, including a nucleotide BLAST search, show that the Rpi-vnt1 gene shares greater than 90% genetic sequence identity with ToMV resistance genes (referred to as Tm-2 or Tm2[2]).  Also, the VNT1 protein is greater than 75% homologous to the Tm-2 To-MV protein from tomato at the amino acid level. Taken together, results from the bioinformatics analyses suggest that genes highly similar to Rpi-vnt1 at both the nucleic acid and protein levels are constituents of tomato.
Given the large per capita consumption of fresh market tomato consumption in the United States, consumers are very likely to have been exposed to ToMV resistant tomatoes in their diet. ToMV-resistant tomato varieties are readily available and grown in the U.S. for fresh market tomato production. Some examples of tomatoes with the ToMV resistance gene are Amai (STM 7704) grape, Arbason F1, Atomic, and Big Beef F1 cultivars. Since the Rpi-vnt1 gene is substantially similar to the ToMV resistance genes (approximately 90% homologous), it is reasonable to conclude that U.S. consumers have dietary exposure to proteins that are substantially similar to the VNT1 protein without negative impacts to human health.
III.  Aggregate Exposure

In examining aggregate exposure, FFDCA section 408 directs the EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

The Agency has considered available information on the aggregate exposure levels of consumers (and major identifiable subgroups of consumers) to the pesticide chemical residue and to other related substances. These considerations include dietary exposure under the tolerance exemption and all other tolerances or exemptions in effect for the plant-incorporated protectant chemical residue, and exposure from non-occupational sources. Exposure via the skin or inhalation is not likely since the plant-incorporated protectant is contained within plant cells, which essentially eliminates these exposure routes or reduces these exposure routes to negligible.

As discussed above, bioinformatics analyses and the similarity of the Rpi vntl gene with the tomato mosaic virus disease resistance gene (ToMV) has been used to demonstrate that it is unlikely that introduction of VNT1 potatoes would represent a safety risk related to toxicity.

IV.  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 EPA consider available information concerning the cumulative effects of a particular pesticide's residues and other substances that have a common mechanism of toxicity.

The Rpi-vnt1 gene that expresses the VNT1 protein is not toxic and does not have a common mechanism of toxicity with other substances. Consequently, section 408(b)(2)(D)(v) does not apply. 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://www.epa.gov/pesticides/cumulative.

V.  Determination of Safety for the U.S. Population, Infants and Children

A.  U.S. Population

As discussed in section II above, the data submitted and cited regarding potential health effects for the VNT1 protein include the characterization that the Rpi-vnt1 gene shares greater than 90% sequence identity with tomato mosaic virus (ToMV) resistance genes.  Also, the VNT1 protein is greater than 75% homologous to Tm-2 ToMV proteins from Solanum lycopersicum (tomato) at the amino acid level. Taken together, results from the bioinformatics analyses suggest that genes highly similar to Rpi-vnt1 at both the nucleic acid and protein levels are already present in food as constituents of tomato.  Since, ToMV resistant tomato varieties are readily available and grown in the US for fresh market tomato production, it is reasonable to conclude that proteins similar to the VNT1 protein (as expressed by the Rpi-vnt1 gene) have already been consumed as part of the U.S. human diet.

B.  Infants and Children

FFDCA section 408(b)(2)(C) provides that EPA shall assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity.
In addition, FFDCA section 408(b)(2)(C) also provides that EPA shall apply an additional tenfold 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 data base unless EPA determines that a different margin of safety will be safe for infants and children.
In this instance, based on the available information discussed in section II above, the Agency concludes that there is a finding of no toxicity for the VNT1 protein. Thus, there are no threshold effects of concern and, as a result, the provision requiring an additional margin of safety does not apply. Further, the provisions of consumption patterns, special susceptibility, and cumulative effects do not apply.

VI.  Conclusions
The Agency concludes, there is reasonable certainty that no harm will result from aggregate exposure of the U.S. population, including infants and children, to the VNT1 protein produced from the Rpi-vnt1 gene. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The Agency has arrived at this conclusion because, as previously discussed, there is no indication of toxicity or allergenicity potential for the plant-incorporated protectant.


[Federal Register: July 18, 2007 (Volume 72, Number 137)]
[Notices]
[Page 39396-39397]
[DOCID:fr18jy07-49]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. RP01-245-024; RP06-569-003]

Transcontinental Gas Pipe Line Corporation; Notice of Compliance
Filing

July 10, 2007.
    Take notice that on July 3, 2007, Transcontinental Gas Pipe Line
Corporation (Transco) tendered for filing as part of its FERC Gas
Tariff, Third Revised Volume No. 1, the tariff sheets listed on
Appendix A to the filing.
    Transco states that the filing is being made in compliance with the
Commission's order issued on June 7, 2007, in Docket Nos. RP01-245-019,
RP01-245-021, RP01-245-022, and RP06-569-001.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Such protests
must be filed in accordance with the provisions of Sec.  154.210 of the
Commission's regulations (18 CFR 154.210). Anyone filing a protest must
serve a copy of that document on all the parties to the proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

unable to file electronically should submit an original and 14 copies
of the protest to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public

Reference Room in Washington, DC. There is an ``eSubscription'' link on
the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-13859 Filed 7-17-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 100 (Thursday, May 25, 2017)]
[Rules and Regulations]
[Pages 24062-24067]
[FR Doc No: 2017-10763]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0112; FRL-9961-54]

Flazasulfuron; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
flazasulfuron in or on olives. ISK Biosciences Corporation requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).

DATES: This regulation is effective May 25, 2017. Objections and
requests for hearings must be received on or before July 24, 2017, 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-2016-0112, 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_ADDRESS>
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-2016-0112 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 July 24, 2017. 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-2016-0112, 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 April 25, 2016 (81 FR 24044) (FRL-9944-
86), 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
6F8447) by ISK Biosciences Corporation, 7470 Auburn Road, Suite A,
Concord, Ohio 44077. The petition requested that 40 CFR part 180 be
amended by establishing tolerances for residues of the herbicide,
flazasulfuron (N-[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]-3-
(trifluoromethyl)-2-pyridinesulfonamide), in or on olive at 0.01 parts
per million (ppm). That document referenced a summary of the petition
prepared by ISK Biosciences 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.

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 flazasulfuron including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with flazasulfuron
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.
    The risk assessment for flazasulfuron is based on a well-
characterized and complete toxicology database. After oral
administration to rats, more than 84% of the dose of flazasulfuron was
excreted within 72 hours, mostly as parent compound. Urinary
elimination accounted for about 80-90% of the dose and fecal
elimination for about 10-20%. Females tended to eliminate more in the
urine, and slightly more rapidly, than males. Tissue distribution was
rapid but incomplete. While levels in tissue were generally low, the
tissues with highest concentrations were the blood, liver, and muscle.
    The liver was the main target organ of flazasulfuron in most
species tested, with effects ranging from non-adverse liver hypertrophy
to more severe histopathological findings like inflammatory cell
infiltration, hepatocellular necrosis and swelling, and bile duct
proliferation. Rats also showed kidney toxicity (nephropathy) after
chronic exposure. No adverse effects were observed in most short and
intermediate duration (<=90 days) studies; only reduced body weight
gain and non-adverse liver effects (increased weight and hepatocellular
hypertrophy) were observed in some of the subchronic toxicity studies.
    Developmental toxicity was observed in rats and abortions in
rabbits; however, findings in rats were not consistent across strains.
A small increase in the incidence of intraventricular septal defect was
observed in Wistar rats but not in Sprague-Dawley rats. Significant
decreases in mean fetal body weight were observed in both rat strains
at the limit dose. In these same studies in the rat, the maternal
animals showed no adverse effects. A high incidence of abortion and
decreased food consumption, but no specific fetal effects, were
observed in rabbits. While the developmental studies indicate there is
offspring susceptibility in rats, both rat studies provide clear no-
observed-adverse-effect levels (NOAELs) for the adverse fetal effects.
Furthermore, the points of departure (PODs) used for risk assessment
are lower than doses associated with fetal effects; therefore, the
assessments are protective of the observed offspring effects.
    No increase in tumor incidence was seen in rats or mice.
Flazasulfuron is not genotoxic. There was no evidence of neurotoxicity
in the database. The acute toxicity data indicate that flazasulfuron
has low acute oral, dermal, and inhalation toxicity. It was not found
to be a skin irritant, but was a moderate eye irritant. Flazasulfuron
was not a dermal sensitizer. Flazasulfuron is classified as ``not
likely to be carcinogenic in humans'' based on the lack of carcinogenic
effects in the rat and mouse carcinogenicity studies, and lack of a
mutagenicity concern.
    Specific information on the studies received and the nature of the
adverse effects caused by flazasulfuron as well as the NOAEL and the
lowest-observed-

adverse-effect-level (LOAEL) from the toxicity studies can be found at
http://www.regulations.gov in document titled ``Flazasulfuron.
Aggregate Human Health Risk Assessment for the Proposed New Use on
Olives'' at page 23 in docket ID number EPA-HQ-OPP-2016-0112.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological 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 flazasulfuron used for
human risk assessment is discussed in Unit II. B. of the final rule
published in the Federal Register of September 5, 2014 (79 FR 52985)
(FRL-9915-32).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to flazasulfuron, EPA considered exposure under the
petitioned-for tolerances as well as all existing flazasulfuron
tolerances in 40 CFR 180.655. EPA assessed dietary exposures from
flazasulfuron 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 flazasulfuron. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture (USDA) under the Continuing Survey of
Food Intake by Individuals (CSFII) and the CDC under the National
Health and Nutrition Examination Survey/What We Eat in America (NHANES/
WEIA) 2003-2008. The acute dietary exposure analyses incorporate
tolerance-level residues of the currently registered and proposed crops
combined with 100% crop treated (%CT) to determine the exposure and
risk estimates. Residues of flazasulfuron were all http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Root Zone Model Ground Water (PRZM GW) for
ground water and the Pesticide Root Zone Model/Exposure Analysis
Modeling System (PRZM/EXAMS) for surface water, the estimated drinking
water concentrations (EDWCs) of flazasulfuron for acute exposures are
estimated to be 26.9 parts per billion (ppb) for surface water and 90.8
ppb for ground water.
    For chronic exposures for non-cancer assessments EDWCs are
estimated to be 4.67 ppb for surface water and 55.6 ppb for ground
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
90.8 ppb was used to assess the contribution to drinking water.
    For chronic dietary risk assessment, the water concentration of
value 55.6 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).
    Flazasulfuron is currently registered for use on turf that could
result in residential exposures. Residential exposure may occur by the
dermal, oral, and inhalation routes of exposures. Flazasulfuron does
not pose a dermal hazard; therefore, only inhalation (handler exposure
for adults) and oral (post-application incidental oral for children)
were assessed. Non-occupational exposures to flazasulfuron are expected
to be for short-term durations only. The recommended residential
exposure for use in the adult aggregate assessment reflects inhalation
exposure from applications to turf via backpack or manually pressurized
handwand. The recommended residential exposure for use in the children
1 to <2 years old aggregate assessment reflects hand-to-mouth exposures
from post-application exposure to turf treatments. A turf transferable
residues (TTR) study is not required for flazasulfuron at this time
since there was no dermal hazard

identified and the hand-to-mouth MOE is greater than 1,000 based on
default values for the fraction of application rate available for
transfer after a turf application. Further information regarding EPA
standard assumptions and generic inputs for residential exposures may
be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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.''
    In 2016, EPA's Office of Pesticide Programs released a guidance
document entitled, ``Pesticide Cumulative Risk Assessment: Framework
for Screening Analysis'' https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework. This document provides guidance on how to screen groups of
pesticides for cumulative evaluation using a two-step approach
beginning with the evaluation of available toxicological information
and if necessary, followed by a risk-based screening approach. This
framework supplements the existing guidance documents for establishing
common mechanism groups (CMGs) and conducting cumulative risk
assessments (CRA). The Agency has utilized this framework for
flazasulfuron and determined that although flazasulfuron shares some
chemical and/or toxicological characteristics (e.g., chemical structure
or apical endpoint) with other pesticides, the toxicological database
does not support a testable hypothesis for a common mechanism of
action. No further data is required to determine that no common
mechanism of toxicity exists for flazasulfuron and other pesticides and
no further cumulative evaluation is necessary for flazasulfuron.

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 available data indicate
that flazasulfuron produced developmental effects in the rabbit
(increased abortions), and reproductive effects in the rat (decreased
pup body weight), only at maternally/parentally toxic dose levels, and
these developmental/offspring effects were not more severe than
maternal/parental effects (increased abortions the rabbit, increased
nephropathy and decreased pup body weight in the rat). While
developmental effects (increased incidence of interventricular septal
defect and reduced fetal weights) were seen in rats in the absence of
maternal toxicity, an indication of quantitative and qualitative
susceptibility, clear NOAELs and LOAELs have been established for these
adverse fetal effects. Furthermore, the PODs used for risk assessment
are lower than doses associated with these developmental effects.
Therefore, the assessments are protective of the observed offspring
effects, and the Agency has no concerns for quantitative or qualitative
susceptibility.
    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 flazasulfuron is complete.
    ii. An acute neurotoxicity study was conducted with flazasulfuron
at dose levels up to 2,000 mg/kg. Mean motor activity measurements at
dose levels of 1,000 and 2,000 mg/kg for males and females were
statistically significantly decreased from the respective control
groups five hours post-dosing. Animals were less active with more
resting time than controls. The effect was reversed by the next
scheduled observation (Day 7). Neurohistopathologic evaluation did not
demonstrate any test material related neurotoxic lesions following the
examination of tissues from the central and peripheral nervous systems
of high dose and control animals. The NOAEL was 50 mg/kg. A subchronic
neurotoxicity study was conducted with flazasulfuron at up to 732 mg/kg
bw/day in the diet for 90 days. No biologically relevant neurotoxic
effects were observed at the dose levels tested. The available
neurotoxicity battery, therefore, did not raise concern for
neurotoxicity. Similarly, the subchronic and chronic data in the
database did not show any adverse effects that could be considered as
neurotoxicity.
    iii. While there is evidence of increased qualitative and
quantitative susceptibility in the young based on rat malformations and
decreased fetal weight in two rat developmental toxicity studies, the
FQPA Safety Factor is reduced to 1X and is protective of the observed
offspring susceptibility because there are clear NOAELs for the
developmental effects in the two rat studies developmental toxicity
studies and the PODs selected for risk assessment are protective of
those effects.
    iv. There are no residual uncertainties identified in the exposure
databases. The exposure databases are complete or are estimated based
on data that reasonably account for potential exposures. The acute and
chronic dietary food exposure assessment were conservatively based on
tolerance-level residues on the currently registered and proposed
crops, 100% CT assumptions, and conservative ground water drinking
water modeling estimates. The Agency does not believe that the non-
dietary residential exposures are underestimated because they are also
based on conservative assumptions. All of the exposure estimates are
based on conservative assumptions and are not likely to result in
underestimated risk.

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 flazasulfuron will occupy 3.1% of the aPAD for infants less than
one-year old, 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
flazasulfuron from food and water will utilize 23% of

the cPAD for infants less than one-year old, the population group
receiving the greatest exposure. Based on the explanation in Unit
III.C.3., regarding residential use patterns, chronic residential
exposure to residues of flazasulfuron is not expected.
    3. Short- and intermediate-term aggregate risk. There is potential
short-term aggregate exposure to flazasulfuron via the dietary pathway
(which is considered background exposure) and the residential pathway
(which is considered the primary pathway). Since intermediate-term
residential exposures are not likely to occur, intermediate-term
aggregate risks were not assessed. Since there is no dermal endpoint,
the short-term aggregate exposure assessment for adults includes
dietary (food and drinking water) and inhalation handler exposures and
results in an aggregate MOE of 1,600. The short-term aggregate exposure
assessment for children 1-2 years old includes dietary (food and
drinking water) and post-application hand-to-mouth exposure from
treated turf and results in an aggregate MOE of 810. Because EPA's
level of concern for flazasulfuron is a MOE of 100 or below, these MOEs
are not of concern.
    4. Aggregate cancer risk for U.S. population. A cancer aggregate
risk assessment was not conducted because there was no evidence of
carcinogenicity to humans based on lack of carcinogenic effects in the
rat and mouse carcinogenicity studies.
    5. 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 flazasulfuron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate enforcement method is available. The method uses high
performance liquid chromatography/tandem mass spectrometry with
multiple reaction monitoring (HPLC/MS-MS/MRM). The LOQ is 0.01 ppm.

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 not established a MRL for flazasulfuron.

V. Conclusion

    Therefore, tolerances are established for residues of
flazasulfuron, herbicide, in or on olive 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). 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 tolerance 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: April 26, 2017.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

0
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. In Sec.  180.655, add alphabetically the entry ``Olive'' to the
table in paragraph (a) to read as follows:

Sec.  180.655  Flazasulfuron; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Olive...................................................            0.01

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2017-10763 Filed 5-24-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 206 (Thursday, October 26, 2023)]
[Notices]
[Pages 73636-73640]
[FR Doc No: 2023-23639]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[U.S. DOT Docket Number NHTSA-2016-0065]

Defect and Noncompliance Notification and Reporting

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

ACTION: Notice and request for comment on the reinstatement of a
previously approved collection of information.

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

SUMMARY: The National Highway Traffic Safety Administration (NHTSA)
invites public comments about our intention to request approval from
the Office of Management and Budget (OMB) for the reinstatement of a
previously approved information collection. Before a Federal agency can
collect certain information from the public, it must receive approval
from OMB. Under procedures established by the Paperwork Reduction Act
of 1995, before seeking OMB approval, Federal agencies must solicit
public comment on proposed collections of information, including
extensions and reinstatement of previously approved collections. This
document describes a collection of information for which NHTSA intends
to seek OMB approval.

DATES: Comments must be submitted on or before December 26, 2023.

ADDRESSES: You may submit comments identified by the Docket No. NHTSA-
2016-0065 through any of the following methods:
     Electronic submissions: Go to the Federal eRulemaking
Portal at http://www.regulations.gov. Follow the online instructions
for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail or Hand Delivery: Docket Management, U.S. Department
of Transportation, 1200 New Jersey Avenue SE, West Building, Room W12-
140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through
Friday, except on Federal holidays.
    Instructions: All submissions must include the agency name and
docket number for this notice. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading
below.
    Privacy Act: Anyone is able to search the electronic form of all
comments 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 DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78) or you may visit https://www.transportation.gov/privacy.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov or the street
address listed above. Follow the online instructions for accessing the
dockets via internet.

FOR FURTHER INFORMATION CONTACT: For additional information or access
to background documents, contact Jeremy Gunderson, Recall Management
Division (NEF-107), [email protected], National Highway Traffic
Safety Administration, U.S. Department of Transportation, 1200

New Jersey Avenue SE, Washington, DC 20590.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.), before an agency submits a proposed
collection of information to OMB for approval, it must first publish a
document in the Federal Register providing a 60-day comment period and
otherwise consult with members of the public and affected agencies
concerning each proposed collection of information. The OMB has
promulgated regulations describing what must be included in such a
document. Under OMB's regulation (at 5 CFR 1320.8(d)), an agency must
ask for public comment on the following: (a) whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (c) how to enhance
the quality, utility, and clarity of the information to be collected;
and (d) how to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In compliance with these requirements, NHTSA
asks for public comments on the following proposed collection of
information for which the agency is seeking approval from OMB.
    Title: Defect and Noncompliance Notification and Reporting.
    OMB Control Number: 2127-0004.
    Form Number(s): N/A.
    Type of Request: Reinstatement of a previously approved information
collection.
    Type of Review Requested: Regular.
    Requested Expiration Date of Approval: 3 years from date of
approval.
    Summary of the Collection of Information: This notice requests
comment on NHTSA's proposed reinstatement of a previously approved
collection of information, designated as OMB No. 2127-0004. This
collection covers the information collection requirements found within
various statutory provisions of the Motor Vehicle Safety Act of 1966
(Act), 49 U.S.C. 30101, et seq., that address and require manufacturer
notifications to NHTSA of safety-related defects and failures to comply
with Federal Motor Vehicle Safety Standards (FMVSS) in motor vehicles
and motor vehicle equipment, as well as the provision of particular
information related to the ensuing owner and dealer notifications and
free remedy campaigns that follow those notifications. The sections of
the Act imposing these requirements include 49 U.S.C. 30118, 30119,
30120, and 30166. Many of these requirements are implemented through,
and addressed with more specificity in, 49 CFR part 573, Defect and
Noncompliance Responsibility and Reports (Part 573) and 49 CFR 577,
Defect and Noncompliance Notification (Part 577).
    Pursuant to the Act, motor vehicle and motor vehicle equipment
manufacturers are obligated to notify, and then provide various
information and documents to, NHTSA when a safety defect or
noncompliance with FMVSS is identified in products they manufactured.
See 49 U.S.C. 30118(b) and 49 CFR 573.6. Manufacturers are further
required to notify owners, purchasers, dealers, and distributors about
the safety defect or noncompliance. See 49 U.S.C. 30118(b), 30120(a);
49 CFR 577.7, 577.13. Manufacturers are required to provide to NHTSA
copies of communications pertaining to recall campaigns that they issue
to owners, purchasers, dealers, and distributors. See 49 U.S.C.
30166(f); 49 CFR 573.6(c)(10).
    Manufacturers are also required to file with NHTSA a plan
explaining how they intend to reimburse owners and purchasers who paid
to have their products remedied before being notified of the safety
defect or noncompliance and explain that plan in the notifications they
issue to owners and purchasers about the safety defect or
noncompliance. See 49 U.S.C. 30120(d) and 49 CFR 573.13. Manufacturers
are further required to keep lists of the respective owners,
purchasers, dealers, distributors, lessors, and lessees of the products
determined to be defective or noncompliant and involved in a recall
campaign, and are required to provide NHTSA with a minimum of eight
quarterly reports and three annual reports reporting on the progress of
their recall campaigns. See 49 U.S.C. 30118and 49 CFR 573.7.
    The Act and part 573 also contain numerous information collection
requirements specific to tire recall and remedy campaigns. These
requirements relate to the proper disposal of recalled tires, including
a requirement that the manufacturer conducting the tire recall submit a
plan and provide specific instructions to certain persons (such as
dealers and distributors) addressing that disposal, and a requirement
that those persons report back to the manufacturer certain deviations
from the plan. See 49 U.S.C. 30120(d) and 49 CFR 573.6(c)(9). The
regulations also require that manufacturers report to NHTSA intentional
and knowing sales or leases of defective or noncompliant tires.
    49 U.S.C. 30166(n) and its implementing regulation found at 49 CFR
573.10 mandate that anyone who knowingly and willfully sells or leases
for use on a motor vehicle a defective tire or a tire that is not
compliant with FMVSS, and with actual knowledge that the tire
manufacturer has notified its dealers of the defect or noncompliance as
required under the Act, is required to report that sale or lease to
NHTSA no more than five working days after the person to whom the tire
was sold or leased takes possession of it.
    Description of the Need for the Information and Proposed Use of the
Information: This information is necessary to enable NHTSA to
administer, monitor, and enforce the legal, statutory, and regulatory
requirements identified above. These requirements are intended to
ensure the safety of the motoring public through the proper and timely
notification and remedy of defective or noncompliant motor vehicles and
motor vehicle equipment.
    Affected Public: Businesses or individuals.
    Estimated Number of Respondents: NHTSA receives reports of defect
or noncompliance from roughly 240 manufacturers per year. Accordingly,
we estimate that there will be approximately 240 manufacturers per year
filing defect or noncompliance reports and completing the other
information collection responsibilities associated with those filings.
    In summary, we estimate that there will be a total of 240
respondents per year associated with OMB No. 2127-0004.
    Frequency: As circumstances necessitate.
    Estimated Burden: NHTSA previously estimated an annual burden of
64,966 hours associated with this collection (of which 456 hours was
contemplated for conducting supplemental recall communications under
administrative activities. We continue to estimate a small burden of 2
hours annually in order to set up a manufacturer's online recalls
portal account with the pertinent contact information and maintaining/
updating their account information as needed. We estimate this will
require a total of 480 hours annually (2 hours x 240 MFRs).
    Our prior estimates of the burden hours and cost associated with
the requirements currently covered by this

information collection require adjustment as follows.
    Based on current information, we estimate 240 distinct
manufacturers filing an average of 976 part 573 Safety Recall Reports
each year. This is a change from our previous estimate of 988 part 573
Safety Recall Reports filed by 249 manufacturers each year. In
addition, with reference to the metric associated with NHTSA's Vehicle
Identification Number (VIN) Look-up Tool regulation, see 49 CFR 573.15,
we continue to estimate it takes the 17 major passenger vehicle
manufacturers (those that produce more than 25,000 vehicles annually)
additional burden hours to complete these Reports to NHTSA, as explored
in more detail below. See 82 FR 60789 (December 22, 2017). Between 2017
and 2021, the major passenger vehicle manufacturers conducted an
average of 355 recalls annually.
    We continue to estimate that maintenance of the required owner,
purchaser, dealer, and distributors lists requires 8 hours a year per
manufacturer. We also continue to estimate it takes a major passenger
vehicle manufacturer 40 hours to complete each part 573 Safety Recall
notification report to NHTSA, and it takes all other manufacturers 4
hours. Accordingly, we estimate the annual burden hours related to the
reporting to NHTSA of a safety defect or noncompliance for the 17 major
passenger vehicle-manufacturers to be 14,200 hours annually (355
notices x 40 hours/report), and that all other manufacturers require a
total of 2,484 hours annually (621 notices x 4 hours/report) to file
their notices. Thus, the estimated annual burden hours related to the
reporting to NHTSA of a safety defect or noncompliance is 17,164 hours
(14,200 hours + 2,484 hours) + (240 MFRs x 8 hours to maintain
purchaser lists).\1\
---------------------------------------------------------------------------

    \1\ For more information about how we derived these and certain
other estimates, please see 81 FR 70269 (October 11, 2016).
---------------------------------------------------------------------------

    We continue to estimate that an additional 40 hours will be needed
to account for major passenger vehicle manufacturers adding details to
Part 573 Safety Recall Reports relating to the intended schedule for
notifying its dealers and distributors and tailoring its notifications
to dealers and distributors in accordance with the requirements of 49
CFR 577.13. An additional 2 hours will be needed to account for this
obligation in other manufacturers' Safety Recall Reports. This burden
is estimated at 15,442 hours annually (621 notices x 2 hours/
notification) + (355 notices x 40 hours/notification).
    49 U.S.C. 30166(f) requires manufacturers to provide to the Agency
copies of all communications regarding defects and noncompliances sent
to owners, purchasers, and dealerships. Manufacturers must index these
communications by the year, make, and model of the vehicle as well as
provide a concise summary of the subject of the communication. We
continue to estimate this burden requires 3 hours for each vehicle
recall for the 17 major passenger vehicle manufacturers, and 30 minutes
for all other manufacturers for each vehicle recall. This totals an
estimated 1,375.5 hours annually (355 recalls x 3 hours for the 17
major passenger vehicle manufacturers) + (621 recalls x .5 for all
other manufacturers).
    In the event a manufacturer supplied the defective or noncompliant
product to independent dealers through independent distributors, that
manufacturer is required to include in its notifications to those
distributors an instruction that the distributors are then to provide
copies of the manufacturer's notification of the defect or
noncompliance to all known distributors or retail outlets further down
the distribution chain within five working days. See 49 CFR
577.7(c)(2)(iv). As a practical matter, this requirement would only
apply to equipment manufacturers, since vehicle manufacturers generally
sell and lease vehicles through a dealer network, and not through
independent distributors. We have estimated the burden associated with
these notifications (identifying retail outlets, making copies of the
manufacturer's notice, and mailing) to be 5 hours per recall campaign.
Assuming an average of 3 distributors per equipment item, which is a
liberal estimate given that many equipment manufacturers do not use
independent distributors, the total number of burden hours associated
with this third-party notification requirement is approximately 1,290
hours per year (86 recalls x 3 distributors x 5 hours).
    As for the burden linked with a manufacturer's preparation of and
notification concerning its reimbursement for pre-notification
remedies, we continue to estimate that the preparation of a
reimbursement plan takes approximately 4 hours annually. We also
continue to estimate that an additional 1.5 hours per year is spent by
the 17 major passenger vehicle manufacturers adapting the plan to
particular defect and noncompliance notifications to NHTSA and adding
tailored language about the plan to a particular safety recall's owner
notification letters, whereas an additional .5 hours per year is spent
on this task by all other manufacturers. And we continue to estimate
that an additional 12 hours annually is spent disseminating plan
information, for a total of 4,827 annual burden hours ((249 MFRs x 4
hours to prepare plan) + (355 recalls x 1.5 hours tailoring plan for
each recall) + (621 recalls x .5 hours) + (249 MFRs x 12 hours to
disseminate plan information)).
    The Safety Act and 49 CFR part 573 also contain numerous
information collection requirements specific to tire recall and remedy
campaigns, as well as a statutory and regulatory reporting requirement
that anyone who knowingly and intentionally sells or leases a defective
or noncompliant tire notify NHTSA of that activity.
    Manufacturers are required to include specific information related
to tire disposal in the notifications they provide NHTSA concerning
identification of a safety defect or noncompliance with FMVSS in their
tires, as well as in the notifications they issue to their dealers or
other tire outlets participating in the recall campaign. See 49 CFR
573.6(c)(9). We believe our previous estimate of 12 tire recalls per
year needs to be adjusted to 11 tire recalls per year to better reflect
recent data. We continue to estimate that the inclusion of this
additional information will require an additional two hours of effort
beyond the subtotal above associated with non-tire recall campaigns.
This additional effort consists of one hour for the NHTSA notification
and one hour for the dealer notification for a total of 22 burden hours
(11 tire recalls a year x 2 hours per recall).
    Manufacturer-owned or controlled dealers are required to notify the
manufacturer and provide certain information should they deviate from
the manufacturer's disposal plan. Consistent with our previous
analysis, we continue to ascribe zero burden hours to this requirement
since to date no such reports have been provided, and our original
expectation that dealers would comply with manufacturers' plans has
proven accurate.
    Accordingly, we estimate 22 burden hours a year will be spent
complying with the tire recall campaign requirements found in 49 CFR
573.6(c)(9).
    The agency continues to estimate 1 burden hour annually will be
spent preparing and submitting reports of a defective or noncompliant
tire being intentionally sold or leased under 49 U.S.C. 30166(n) and
its implementing regulation at 49 CFR 573.10.

    We continue to expect that nine vehicle manufacturers, who did not
operate VIN-based recalls lookup systems prior to August 2013, incur
certain recurring burdens on an annual basis. We continue to estimate
that 100 burden hours will be spent on system and database
administrator support. These 100 burden hours include: Backup data
management and monitoring; database management, updates, and log
management; and data transfer, archiving, quality assurance, and
cleanup procedures. We continue to estimate another 100 burden hours
will be incurred on web/application developer support. These burdens
include: Operating system and security patch management; application/
web server management; and application server system and log files
management. We continue to estimate these burdens will total 1,800
hours each year (9 MFRs x 200 hours). We also continue to estimate the
recurring costs of these burden hours will be $30,000 per
manufacturer.\2\ Furthermore, we continue to estimate that the total
cost to the industry from these recurring expenses will total $270,000,
on an annual basis (9 MFRs x $30,000).
---------------------------------------------------------------------------

    \2\ $8,000 (for data center hosting for the physical server) +
$12,000 (for web/application developer support) = $30,000.
---------------------------------------------------------------------------

    Changes to 49 CFR part 573 in 2013 required 27 manufacturers to
update each recalled vehicle's repair status no less than every 7 days,
for 15 years from the date the VIN is known to be included in the
recall. This ongoing requirement to update the status of a VIN for 15
years continues to add a recurring burden on top of the one-time burden
to implement and operate these online search tools. We continue to
estimate that 8 affected motorcycle manufacturers will make recalled
VINs available for an average of 2 recalls each year and 19 affected
passenger vehicle manufacturers will make recalled VINs available for
an average of 8 recalls each year. We believe it will take no more than
1 hour, and potentially less with automated systems, to update the VIN
status of vehicles that have been remedied under the manufacturer's
remedy program. We continue to estimate this will require 8,736 burden
hours per year (1 hour x 2 recalls x 52 weeks x 8 MFRs + 1 hour x 8
recalls x 52 weeks x 19 MFRs) to support the requirement to update the
recalls completion status of each VIN in a recall at least weekly for
15 years.
    Due to a congressionally-mandated increase in the required number
of quarterly reports for each recall, the number of quarterly reports
that track the completion of safety recalls has also increased. Our
previous estimate of 4,498 quarterly reports received annually is now
revised upwards to 5,875 quarter reports received annually. We continue
to estimate it takes manufacturers 1 hour to gather the pertinent
information for each quarterly report, and 10 additional hours for the
17 major passenger vehicle manufacturers to submit electronic reports.
We therefore now estimate that the quarterly reporting burden pursuant
to 49 U.S.C.A. 30118 totals 6,045 hours ((5,875 quarterly reports x 1
hour/report) + (17 MFRs x 10 hours for electronic submission)).
    We continue to estimate that 20 percent of part 573 reports will
involve a change or addition regarding recall components, and that at
two hours per amended report, this totals 390 burden hours per year
(976 recalls x .20 = 195 recalls; 195 x 2 = 390 hours).
    Additionally, per the Bipartisan Infrastructure Law (Pub. L. 117-
58, title IV, subtitle B, section 24202), manufacturers are now
required to submit three (3) annual recall completion rate reports.
NHTSA estimates that it will receive and average of 316 reports yearly
from manufacturers. We estimate it takes manufacturers 2 hours to
complete annual reports, including 1.5 hours to gather pertinent
information for each report, and .5 hours for the 17 major passenger
vehicle manufacturers to submit the electronic reports. We therefore
estimate that the annual reporting burden pursuant to 49 U.S.C. 30118
totals 632 hours ((316 annual reports x 1.5 hours) + (17 MFRs x .5
hours for electronic submission)). We continue to estimate that 20
percent of Part 573 reports will involve a change or addition regarding
recall components, and that at two hours per amended report, this
totals 390 burden hours per year (976 recalls x .20 = 195 recalls; 195
x 2 = 390 hours).
    As to the requirement that manufacturers notify NHTSA in the event
of a bankruptcy, we expect this notification to take an estimated 2
hours to draft and submit to NHTSA. We continue to estimate that only
10 manufacturers might submit such a notice to NHTSA each year, so we
calculate the total burden at 20 hours (10 MFRs x 2 hours).
    We continue to estimate that it takes the 17 major passenger
vehicle manufacturers an average of 11 hours to draft their
notification letters, submit them to NHTSA for review, and then
finalize them for mailing to their affected owners and purchasers. We
also continue to estimate it takes 8 hours for all other manufacturers
to perform this task. Accordingly, we estimate that the 49 CFR part 577
requirements result in 8,873 burden hours annually (11 hours per recall
x 355 recalls per year) + (8 hours per recall x 621 recalls per year).
    We previously calculated that about 12 percent of past recalls
require an interim notification mailing, but recent trends show that 3
percent of recalls require an interim owner notification mailing. We
continue to estimate the preparation of an interim notification can
take up to 10 hours. We therefore estimate that 1,250 burden hours are
associated with the 60-day interim notification requirement (976
recalls x .03 = 34 recalls; 34 recalls times 10 hours per recall = 340
hours).
    As for costs associated with notifying owners and purchasers of
recalls, to reflect an increase in postage rates, we are revising our
estimate of the cost of first-class mail notification to $1.53 per
notification, on average. This cost estimate includes the costs of
printing and mailing, as well as the costs vehicle manufacturers may
pay to third-party vendors to acquire the names and addresses of the
current registered owners from state and territory departments of motor
vehicles. In reviewing recent recall figures, we determined that an
estimated 51.4 million letters are mailed yearly totaling $78,642,000
($1.53 per letter x 51,400,000 letters). The requirement in 49 CFR part
577 for a manufacturer to notify their affected customers within 60
days would add an additional $10,223,460 (51,400,000 letters x .03
requiring interim owner notifications = 1,542,000 letters; 1,542,000 x
$1.53 = $2,359,260). In total, we estimate that the current 49 CFR part
577 requirements cost manufacturers a total of $81,001,260 annually
($78,642,000 for owner notification letters + $2,359,260 for interim
notification letters = $81,001,260).
    Utilizing these variables, we now estimate an initial annualized
cost over the next three years of $81,271,260 per year.
    Because of the forgoing burden estimates, we are revising the
burden estimate associated with this collection. The 49 CFR part 573
and 49 CFR part 577 requirements found in today's notice will require
68,837.5 hours each year. Additionally, manufacturers impacted by 49
CFR part 573 and 49 CFR part 577 requirements will incur a recurring
annual cost estimated at $81,271,260 total. NHTSA welcomes further
comment and data on these estimates.
    Public Comments Invited: You are asked to comment on any aspects of
this

information collection, including (a) whether the proposed collection
of information is necessary for the proper performance of the functions
of the Department, including whether the information will have
practical utility; (b) the accuracy of the Department's estimate of the
burden of the proposed information collection; (c) ways to enhance the
quality, utility and clarity of the information to be collected; and
(d) ways to minimize the burden of the collection of information on
respondents, including the use of automated collection techniques or
other forms of information technology.
    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. chapter
35, as amended; 49 CFR 1.49; and DOT Order 1351.29.

Cem Hatipoglu,
Acting Associate Administrator for Enforcement.
[FR Doc. 2023-23639 Filed 10-25-23; 8:45 am]
BILLING CODE 4910-59-P