[Federal Register Volume 79, Number 238 (Thursday, December 11, 2014)]
[Notices]
[Pages 73590-73591]
[FR Doc No: 2014-29046]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0073]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance on Consultation Procedures: Foods Derived
From New Plant Varieties

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment. This notice
solicits comments on the information collection provisions of FDA's
consultation procedures for foods derived from new plant varieties,
including the information collection provisions in the guidance
entitled, ``Guidance on Consultation Procedures: Foods Derived From New
Plant Varieties,'' and in Form FDA 3665 entitled, ``Final Consultation
For Food Derived From a New Plant Variety (Biotechnology Final
Consultation),'' which developers may use to prepare the final
consultation in a standard format.

DATES: Submit either electronic or written comments on the collection
of information by February 9, 2015.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, we are publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, we invite
comments on these topics: (1) Whether the proposed collection of
information is necessary for the proper performance of our functions,
including whether the information will have practical utility; (2) the
accuracy of our estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.

Guidance on Consultation Procedures: Foods Derived From New Plant
Varieties

    Since 1992, when FDA issued its ``Statement of Policy: Foods
Derived From New Plant Varieties'' (the 1992 policy) (57 FR 22984, May
29, 1992), FDA has encouraged developers of new plant varieties,
including those varieties that are developed through biotechnology, to
consult with FDA during the plant development process to discuss
possible scientific and regulatory issues that might arise. In the 1992
policy, FDA explained that, under the Federal Food, Drug, and Cosmetic
Act (the FD&C Act), developers of new foods (in this document food
refers to both human food and animal feed) have a responsibility to
ensure that the foods they offer to consumers are safe and are in
compliance with all requirements of the FD&C Act (57 FR 22984 at
22985).
    FDA recommends that producers who use biotechnology in the
manufacture or development of foods and food ingredients work
cooperatively with FDA to ensure that products derived through
biotechnology are safe and comply with all applicable legal
requirements and has instituted a voluntary consultation process with
industry. To facilitate this process the Agency has issued a guidance
entitled, ``Guidance on Consultation Procedures: Foods Derived From New
Plant Varieties,'' which is available on FDA's Web site at http://www.fda.gov/FoodGuidances. The guidance describes FDA's consultation
process for the evaluation of information on new plant varieties
provided by developers. The Agency believes this consultation process
will help ensure that human food and animal feed safety issues or other
regulatory issues (e.g. labeling) are resolved prior to commercial
distribution. Additionally, such communication will help to ensure that
any potential food safety issues regarding a new plant variety are
resolved during development, and will help to ensure that all market
entry decisions by the industry are made consistently and in full
compliance with the standards of the FD&C Act.
    Description of Respondents: Respondents to this collection of
information include developers of new plant varieties intended for food
use.
    FDA estimates the burden of this collection as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                Number of                        Average
                 Activity                           FDA form No.             Number of     responses per   Total annual     burden per      Total hours
                                                                            respondents     respondent       responses       response
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Initial consultation......................  None........................              20               2              40               4             160
Final consultation........................  FDA 3665....................              12               1              12             150           1,800
                                           -------------------------------------------------------------------------------------------------------------
    Total.................................  ............................  ..............  ..............  ..............  ..............           1,960
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

Initial Consultations

    Initial consultations are generally a one-time burden, although a
developer might return more than once to discuss additional issues
before submitting a final consultation. As noted in the guidance, FDA
encourages developers to consult early in the development phase of
their products, and as often as necessary. Historically, firms
developing a new bioengineered plant variety intended for food use have
generally initiated consultation with FDA early in the process of
developing such a variety, even though there is no legal obligation for
such consultation. These consultations have served to make FDA aware of
foods and food ingredients before these products are distributed
commercially, and have provided FDA with the information necessary to
address any potential questions regarding the safety, labeling, or
regulatory status of the food or food ingredient. As such, these
consultations have provided assistance to both industry and the Agency
in exercising their mutual responsibilities under the FD&C Act.
    FDA estimates that its Center for Veterinary Medicine (CVM) and its
Center for Food Safety and Applied Nutrition (CFSAN) jointly received
an average of 40 initial consultations per year in the last 3 years via
telephone, email or written letter. Based on this information, we
expect to receive no more than 40 annually in the next 3 years.

Final Consultations

    Final consultations are a one-time burden. At some stage in the
process of research and development, a developer will have accumulated
the information that the developer believes is adequate to ensure that
food derived from the new plant variety is safe and that it
demonstrates compliance with the relevant provisions of the FD&C Act.
The developer will then be in a position to conclude any ongoing
consultation with FDA. The developer submits to FDA a summary of the
safety and nutritional assessment that has been conducted about the
bioengineered food that is intended to be introduced into commercial
distribution. FDA evaluates the submission to ensure that all potential
safety and regulatory questions have been addressed. FDA has developed
a form that prompts a developer to include certain elements in the
final consultation in a standard format: Form FDA 3665 entitled,
``Final Consultation for Food Derived From a New Plant Variety
(Biotechnology Final Consultation).'' The form, and elements that would
be prepared as attachments to the form, can be submitted in electronic
format.
    Upon implementation of the collection, FDA contacted five firms
that had made one or more biotechnology consultation submissions. We
asked each of these firms for an estimate of the hourly burden to
prepare a submission under the voluntary biotechnology consultation
process. Based on information provided by the three firms who
responded, we estimate the average time to prepare a submission for
final consultation to be 150 hours.

    Dated: December 8, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-29046 Filed 12-10-14; 8:45 am]
BILLING CODE 4164-01-P


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

General Comment:I believe that e cigs and supplies should be sold to adults only.  I have smoked regular cigarettes for over 45 years, 4 years ago I was diagnosed with breast cancer.  I was able to quit smoking regular cigarettes ONLY because of the e cigs and my doctor is happier with me smoking e cigs than regular tobacco products.  I request that the comment period remain open for 180 days.


[Federal Register Volume 86, Number 69 (Tuesday, April 13, 2021)]
[Notices]
[Pages 19319-19321]
[FR Doc No: 2021-07507]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2020-0090; Notice 1]

Nissan North America, Inc., Receipt of Petition for Decision of
Inconsequential Noncompliance

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

ACTION: Receipt of petition.

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SUMMARY: Nissan North America, Inc. (Nissan) has determined that
certain replacement windshield glass panes manufactured by Central
Glass Co., Ltd., outsourced to Japan Tempered & Laminated Glass Co.,
Ltd., and sold to Nissan as replacement parts for use in certain Nissan
motor vehicles do not

fully comply with Federal Motor Vehicle Safety Standard (FMVSS) No.
205, Glazing Materials. Nissan filed a noncompliance report dated June
29, 2020. Nissan subsequently petitioned NHTSA on July 29, 2020, for a
decision that the subject noncompliance is inconsequential as it
relates to motor vehicle safety. This notice announces receipt of
Nissan's petition.

DATES: Send comments on or before May 13, 2021.

ADDRESSES: Interested persons are invited to submit written data,
views, and arguments on this petition. Comments must refer to the
docket and notice number cited in the title of this notice and
submitted by any of the following methods:
     Mail: Send comments by mail addressed to the U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC
20590.
     Hand Delivery: Deliver comments by hand to the U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC
20590. The Docket Section is open on weekdays from 10 a.m. to 5 p.m.
except for Federal holidays.
     Electronically: Submit comments electronically by logging
onto the Federal Docket Management System (FDMS) website at https://www.regulations.gov/. Follow the online instructions for submitting
comments.
     Comments may also be faxed to<PHONE_NUMBER>.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that comments you have submitted by mail were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to https://www.regulations.gov, including any personal information
provided.
    All comments and supporting materials received before the close of
business on the closing date indicated above will be filed in the
docket and will be considered. All comments and supporting materials
received after the closing date will also be filed and will be
considered to the fullest extent possible.
    When the petition is granted or denied, notice of the decision will
also be published in the Federal Register pursuant to the authority
indicated at the end of this notice.
    All comments, background documentation, and supporting materials
submitted to the docket may be viewed by anyone at the address and
times given above. The documents may also be viewed on the internet at
https://www.regulations.gov by following the online instructions for
accessing the docket. The docket ID number for this petition is shown
in the heading of this notice.
    DOT's complete Privacy Act Statement is available for review in a
Federal Register notice published on April 11, 2000 (65 FR 19477-78).

SUPPLEMENTARY INFORMATION:

I. Overview

    Nissan has determined that certain replacement windshield glass
panes manufactured by Central Glass Co., Ltd., outsourced to Japan
Tempered & Laminated Glass Co., Ltd., and sold to Nissan as replacement
parts for use in certain Nissan motor vehicles do not fully comply with
the requirements of paragraph S6.2 of FMVSS No. 205, Glazing Materials
(49 CFR 571.205). Nissan filed a noncompliance report dated June 29,
2020, pursuant to 49 CFR part 573, Defect and Noncompliance
Responsibility and Reports. Nissan subsequently petitioned NHTSA on
July 29, 2020, for an exemption from the notification and remedy
requirements of 49 U.S.C. chapter 301 on the basis that this
noncompliance is inconsequential as it relates to motor vehicle safety,
pursuant to 49 U.S.C. 30118(d) and 30120(h) and 49 CFR part 556,
Exemption for Inconsequential Defect or Noncompliance.
    This notice of receipt of Nissan's petition is published under 49
U.S.C. 30118 and 30120 and does not represent any Agency decision or
other exercise of judgment concerning the merits of the petition.

II. Windshields Involved

    Approximately 1,934 replacement windshield glass panes sold as
replacement service parts, manufactured between April 1, 2000, and
April 30, 2012, are potentially involved. These replacement windshield
glass panes were manufactured by Central Glass Co., Ltd., who
subsequently outsourced to a subsidiary company, Japan Tempered &
Laminated Glass Co., Ltd., and sold to Nissan as replacement parts for
Nissan motor vehicles.

III. Noncompliance

    Nissan explains that the noncompliance is that subject replacement
windshield glass panes manufactured by Central Glass Co., Ltd., who
subsequently outsourced to a subsidiary company, Japan Tempered &
Laminated Glass Co., Ltd., and sold to Nissan as replacement parts for
use in certain Nissan motor vehicles contain the incorrect
manufacturer's code mark and therefore, do not meet the requirements
set forth in paragraph S6.2 of FMVSS No. 205. Specifically, the subject
replacement windshield glass panes were marked with manufacturer code
DOT44, which applies to Central Glass Co., Ltd., when they should have
been marked, DOT166, which applies to Japan Tempered & Laminated Glass
Co., Ltd. (JTLG).

IV. Rule Requirements

    Paragraph S6.2 of FMVSS No. 205 includes the requirements relevant
to this petition. A prime glazing manufacturer certifies its glazing by
adding to the marks required by section 7 of ANSI/SAE Z26. 1-1996, in
letters and numerals of the same size, the symbol ``DOT'' and a
manufacturer's code mark that NHTSA assigns to the manufacturer. NHTSA
will assign a code mark to a manufacturer after the manufacturer
submits a written request to the Office of Vehicle Safety Compliance,
National Highway Traffic Safety Administration, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590. The
request must include the company name, address, and a statement from
the manufacturer certifying its status as a prime glazing manufacturer
as defined in S4.

V. Summary of Nissan's Petition

    The following views and arguments presented in this section, ``V.
Summary of Nissan's Petition,'' are the views and arguments provided by
Nissan. They have not been evaluated by the Agency and do not reflect
the views of the Agency. Nissan describes the subject noncompliance and
contends that the noncompliance is inconsequential as it relates to
motor vehicle safety.
    In support of its petition, Nissan offers the following reasoning:
    1. Nissan states that although the manufacturer code is incorrect,
the certification mark affixed to the subject parts features the
correct AS Item number and model number (i.e., M number). In addition,
the windshield glass panes were fabricated in full compliance with the
technical requirements of 49 CFR 571.205 applicable to laminated glass
for use in motor vehicles.
    2. Nissan says that many of the 1,934 windshield glass components
that may

contain an incorrect manufacturer's code are located in non-U.S.
markets. For this reason, Nissan believes the actual number of subject
parts is substantially lower than the 1,934 possible windshield glass
panes because only a small number of potentially affected windshield
glass panes were shipped to the U.S. market for use as service parts
between April 1, 2000, and April 30, 2012.
    3. Nissan also states that the part number remains accurate,
despite the manufacturer's code discrepancy. The subject noncompliance,
accordingly, is unlikely to result in the use of an incorrect
replacement part in an OEM application because the part would be
ordered using Nissan's unique part number and not the ``DOT'' number.
In Nissan's ordering system, parts with the incorrect manufacturing
code are indistinguishable from parts with the correct code. In fact,
the parts are traceable to Central Glass Co., Ltd., since the incorrect
code used by their subsidiary, JLTG is the code for the parent company,
Central Glass Co., Ltd.
    4. Nissan believes that there is a low likelihood of a vehicle
requiring this replacement part because the average age of potentially
affected vehicles (MY 1991-1999) is 25+ years old. Currently, only one
replacement windshield glass service part (727120M010) is in stock and
available. However, Nissan instructed the Sagamihara Part Center in
Japan to suspend shipment for this part. Even so, if a vehicle
previously received or were to receive a subject replacement part, the
part fully complies with the technical requirements of 49 CFR 571.205.
In no way is the actual safety aspect of the windshield glass
compromised by the misprinted manufacturer's code.
    5. Nissan contends that in similar situations, NHTSA has granted
the applications of other petitioners. For example, 80 FR 3737 (January
23, 2015) Petition by Custom Glass Solutions Upper Sandusky
Corporation.
     ``Custom Glass explains that the noncompliance is that the
labeling on the subject laminated glass panes does not fully meet the
requirements of paragraph S6 of FMVSS No. 205. The panes were labeled
with the incorrect manufacturer's code mark, incorrect manufacturer's
trademark, and incorrect manufacturer's model number, and were
incorrectly marked as Tempered.''
     Nissan cited NHTSA, saying ``NHTSA believes that the
subject labeling errors are inconsequential to motor vehicle safety
because the marking of glazing as `Tempered' or `Laminated' is not
required by FMVSS No. 205, the probability of anyone in the United
States obtaining the subject incorrectly marked glazing as replacement
glazing is very unlikely since the affected glazing is specifically
designed for use in mining vehicles manufactured by Atlas Copco in
Australia. In addition, there is no concern that the wrong model number
on the subject glazing would result in an incorrect replacement part
being used because replacement parts are ordered by referring to the
glazing part number or by identifying the vehicle for which the
replacement glazing is intended.''
    Nissan concludes by again contending that the subject noncompliance
is inconsequential as it relates to motor vehicle safety, and that its
petition to be exempted from providing notification of the
noncompliance, as required by 49 U.S.C. 30118, and a remedy for the
noncompliance, as required by 49 U.S.C. 30120, should be granted.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, any decision on
this petition only applies to the subject vehicles and equipment that
Nissan no longer controlled at the time it determined that the
noncompliance existed. However, any decision on this petition does not
relieve vehicle and equipment distributors and dealers of the
prohibitions on the sale, offer for sale, or introduction or delivery
for introduction into interstate commerce of the noncompliant vehicles
and replacement windshield glass panes under their control after Nissan
notified them that the subject noncompliance existed.

(Authority: 49 U.S.C. 30118, 30120: Delegations of authority at 49
CFR 1.95 and 501.8)

Otto G. Matheke III,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2021-07507 Filed 4-12-21; 8:45 am]
BILLING CODE 4910-59-P


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: [PV Shah,<PHONE_NUMBER>]

[Morse Enterprises Limited, Inc. d/b/a KeyPlex]

[IN 11093]

	EPA has received a pesticide petition (IN 11093) from [Morse Enterprises Limited, Inc. d/b/a KeyPlex], [PO Box 2515, Winter Park, FL 32790] requesting, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.920 in order to permit trans-anethole as a fragrance in pesticide formulations at rates of 3% of the formulation when applied pre-harvest to crops.

(Options (pick one)        	1. by establishing a tolerance for residues of NA-Remove

	2. to establish an exemption from the requirement of a tolerance for

	[NA-Remove] in or on the raw agricultural commodity [NA-Remove] at [NA-Remove] parts per million (ppm).  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism.

	2. Analytical method. [NA-Remove.]

	3. Magnitude of residues. [NA-Remove.]

B. Toxicological Profile

	1. Acute toxicity.  [The oral acute toxicity of trans-anethole in rats and mice (LD50) has been reported as 1510 and 3050 mg/kg, respectively. The dermal acute toxicity of trans-anethole in rabbits (LD50) has been reported as >5000 mg per kg. In an acute eye irritation study in rabbits, no irritation occurred at up to 72 hours of observation. In a skin irritation test on New Zealand White rabbits, it was determined to be not irritating. In a sensitization (non-LLNA) study with guinea pigs, trans-anethole was noted to be a sensitizer.]

	2. Genotoxicty. [A wide variety of genotoxicity studies have been conducted on trans-anethole including bacterial reverse mutation tests, in vitro mammalian gene mutation tests, in vivo micronucleus tests where most have negative results. A few in vitro studies have been noted to have positive results including 3 reverse mutation studies with S. typhimurium and 2 mouse lymphoma gene mutation studies. The overall assessment considering all studies concludes that trans-anethole is not genotoxic.]

	3. Reproductive and developmental toxicity. [In a combined pre-natal/reproductive toxicity study (equivalent to OECD Guideline 414), groups of 10 pregnant Sprague-Dawley rats received oral (gavage) administration of trans-anethole in corn oil at 0, 35, 175 or 350 mg/kg bw/day for 7 days, then in a 7 day mating period (with untreated males), during gestation, parturition and lactation (up to 4 days). Unmated rats continued to be dosed for 25 days after the 7-day mating period. On day 4 of lactation, pups were examined, sacrificed and discarded. Parameters evaluated included: body weight, body weight gain, food consumption, male and female fertility, gestation index, implantation sites, length of gestation, number of stillborn pups, litter size, pup viability, pup weight, and clinical observations of pups.

Maternal toxicity at the high dose (350 mg/kg bw/day) manifested as significant decreases in body weight and food consumption throughout study. Dams exhibited various types of clinical signs (urine-stained fur, emaciation and pale in appearance). In dams that died necropsy showed, congested lungs, raised yellow area in the liver and hematomas on the vessels supplying the implantation sites). Average gestation duration was increased (number of dams delivering on days 23 and 24 was increased over controls); number of dams with stillborn pups and with all pups dying before postpartum day 4 was significantly increased (P <0.01). At 175 mg/kg bw/day, maternal toxicity was characterized as significant decreases in body weight (GD 6 and 14) and food consumption (premating days 1-8).

Developmental toxicity at the high dose manifested as: significant (p<0.01) decreases in the number of live born pups (75) compared to controls (147); number of stillborn pups (18)  compared to controls (0); number of pups dying on day 1 and days 2-4 (8 and 7 respectively) compared to controls (0 and 0, respectively); viability index (80%) compared to controls (99.3%); number of surviving pups/litter on postpartum day 4 (7.5) compared to controls (14.6); live litter size on postpartum day 4 (12.0) compared to controls (14.6); and pup weight/litter on postpartum day 1 (5.1 g) compared to controls (6.2 g). No other effects were reported at the other doses. External examination of the fetuses revealed no anomalies.

For maternal toxicity, the NOAEL was 35 mg/kg bw/day and the LOAEL was 175 mg/kg bw/day based on decreases in body weight and food consumption.

For developmental toxicity, the NOAEL was 175 mg/kg bw/day and the LOAEL was 350 mg/kg bw/day based on decreases in litter size, pup viability and pup weight.]

	4. Subchronic toxicity. [In a subchronic feeding study, groups of male and female Sprague-Dawley rats (20/sex/dose) were fed diets containing trans-anethole at 0 (control), 150, 300, 600, and 900 mg/kg bw/day for 90-days. Parameters evaluated included: survival, clinical signs of toxicity, body weight, body weight gains, food consumption, food efficiency, ophthalmology, clinical pathology (hematology and clinical chemistry), organ weights, gross and histopathology. No treatment-related effects were seen on survival, clinicals signs, or ophthalmology. Minor changes seen in body weight and food consumptions at the high dose were attributable to palatability. Hematology revealed decreases in the mean cell volume and mean cell hemoglobin in females, and a decrease in platelet counts in both sexes at the high dose. Clinical chemistry showed significant alterations in liver enzymes including increases in gamma glutamyl transferase, alanine aminotransferase and aspartate aminotransferase and decreases in total protein, albumin and glucose levels at 600 mg/kg/day. Relative liver weights were increased at doses above 300 mg/kg/day. Gross necropsy revealed enlarged liver in males and uterine findings in females. Histopathology showed increased incidence of single cell necrosis in males at 600 mg/kg/day. Under the conditions of this study, the NOAEL was 300 mg/kg bw/day and the LOAEL was 600 mg/kg bw/day based on elevation in serum gamma glutamyltranferase in females and single cell necrosis in male rats.]

	5. Chronic toxicity. [In a chronic feeding study, rats were fed daily doses of anethole at 125 or 500 mg/kg for 52 or 16 weeks, respectively. At the higher dose level, slight changes in hepatic cells were observed in males, whereas at the lower dose, no adverse effects were observed.

In a combined chronic and carcinogenicity study, male and female Sprague-Dawley rats were fed trans-anethole at concentrations of 0.25% (100 and 120 mg/body weight day, female and male, respectively), 0.5% (200 and 250 mg/kg body weight/day, female and male, respectively), and 1% (400 and 550 mg/kg body weight/day, female and male, respectively) for ~2 years (117 to 121 weeks).  Rats were weighed weekly for the first 26 weeks and monthly thereafter. Food and water consumption was recorded daily for first 32 weeks and then for 1 day/month for the remainder of the study. Hematology parameters evaluated were: erythrocyte count, hemoglobin concentration, mean corpuscular volume, hematocrit, mean corpuscular hemoglobin concentration, leukocyte count and differential count. Brain, caecum, heart, kidneys, liver, ovaries, spleen and testes were weighed. All the major organs underwent histopathological evaluations. No treatment related effects were seen on survival, body weight, body weight gain, food consumption, hematology, organ weights or gross necropsy. Histopathology revealed non-neoplastic liver lesions including sinusoidal dilation in males in the 1% group, in both sexes of the 0.5% group, nodular hyperplasia in males in the 0.5% group and in both sexes in the 1% group, and hepatocytic hypertrophy in the females of 0.5 and 1% groups. A small but statistically significant (p<0.005) increase in liver tumors (6/52 benign and 6/52 malignant) were seen in females at 1% when compared to controls (1/52 for both tumors). The malignant tumors were characterized as hepatocellular carcinomas and had a late onset (first tumor seen at 98 weeks), had no effect on survival of the rats, and the incidence (6/52; 11.5%) were within the historical control range (0-14%). Under the conditions of this study, the NOAEL was 100 mg/kg bw/day in males and 120 mg/kg bw/day in females. The LOAEL was 200 mg/kg bw/day in males and 250 mg/kg bw/day in females based on non-neoplastic lesions (nodular hyperplasia and hepatocytic hypertrophy) of the liver.

A Pathology Work Group (PWG) evaluated the liver lesions of the rats from the above noted study. The PWG confirmed the results reported by the study authors, and further concluded that the slightly increased incidence of hepatocellular neoplasms in females at 1% is of no significance to human safety, and that trans-anethole does not constitute a carcinogenic risk to humans.

In another study the carcinogenic potential of some naturally occurring and synthetic alkenyl benzene derivatives in two strains of mice. In the first experiment 51 male and 56 female CD-1 mice received post oral administration of anethole at 5 or 2.5 umol/g body weight twice weekly for 10 weeks. Mice were necropsied at 11-14 months. In the second experiment, 53 male CD-1 mice received intraperitoneal injection of trans-anethole on days 1, 8, 15 and 22 for a total dose of 9.45 umol/mouse and were sacrificed at 12 months. In the third experiment, 50 male B6C3F1 mice received intraperitoneal injection of trans-anethole for a total dose of 4.75 umol/mouse. Mice were sacrificed at 12 months. trans-Anethole showed no hepatocarcinogenic activity in the three experiments.]

	6. Animal metabolism. [Metabolism of trans-anethole in vivo has been well characterized in rodents and in humans, with cytochrome P450-catalyzed oxidation, epoxidation and o-demethylation as the major pathways and glycine conjugates of p-methoxyhippuric and p-methoxycinnamic acid carboxylic acids as the major metabolites in the urine.]

	7. Metabolite toxicology. [trans-Anethole is metabolized into metabolites that are not of toxicological significance.]

	8. Endocrine disruption. [In an in vitro test on yeast conducted to assess androgenic activity of essential oils including trans-anethole, no effects were reported. In an in vitro test with human endometrial cells, trans-anethole was negative in stimulating effects in the cells. This test was repeated and the results were also negative in the second round.  In an in vitro test with yeast, trans-anethole was determined to have estrogenic activity at high concentrations.]

C. Aggregate Exposure

	1. Dietary exposure. [trans-Anethole is currently found in a significant number of food and beverage products as a flavoring agent and in animal feeds. In addition, trans-anethole is naturally found in anise, fennel, thyme, cinnamon, clove bud, nutmeg, pepper, coriander seed, and dill seed. Therefore, the potential for aggregate exposure from dietary routes does exist for trans-anethole. While it is difficult to develop a precise estimate of total human exposure to trans-anethole, its low toxicity and metabolism into innocuous compounds that are readily excreted, indicate that expected exposures are likely to be of low toxicological concern.  The addition of trans-anethole in biopesticide products at 3% w/w of the formulation applied to food crops is not expected to significantly increase the dietary exposure potential of humans.]

	i. Food. [trans-Anethole when used as a fragrance in pesticide formulations at 3% w/w of the formulation applied pre-harvest according to 40 CFR 180.920 will come into contact with food crops. trans-Anethole is currently found in a significant number of food and beverage products in addition to being found naturally in several spices. While it is difficult to develop a precise estimate of total human exposure to trans-anethole, its low toxicity and metabolism into innocuous compounds that are readily excreted, indicate that expected exposures are likely to be of low toxicological concern.]

	ii. Drinking water. [trans-Anethole when used as a fragrance in pesticide formulations at 3% w/w of the formulation applied pre-harvest according to 40 CFR 180.920 is not expected to come into contact directly with drinking water. trans-Anethole is slightly soluble in water (111 mg/L at 25°C) and readily biodegradable. Any potential exposure via drinking water is not expected to be of toxicological concern.]

	2. Non-dietary exposure. [trans-Anethole is currently found in non-dietary products including pesticides (nonfood inert, fragrance uses) and occurs naturally in many plants. Therefore, the potential for aggregate exposure from non-dietary routes does exist for trans-anethole. While it is difficult to develop a precise estimate of total human exposure to trans-anethole, its low toxicity and metabolism into innocuous compounds that are readily excreted, indicate that expected exposures are likely to be of low toxicological concern.  The addition of trans-anethole in biopesticide products at 3% w/w of the formulation applied to food crops is not expected to significantly increase the exposure potential of humans.]

D. Cumulative Effects

	[trans-Anethole has no known common mechanism of toxicity with any other toxic substances.]

E. Safety Determination

	1. U.S. population. [The safety of trans-anethole to humans has been previously evaluated based on its use as a flavoring in foods and beverages and its natural occurrence in many foods. Many toxicity studies are available in the public literature for trans-anethole. Though there is a long history of anise and fennel preparations as herbal medicines, specific therapeutic and beneficial effects of trans-anethole have not been especially well documented although this is an area of active research. trans-Anethole is one of the active principles in culinary spices thought to reduce the risk of specific cancers, i.e., it can act as a chemo preventive agent. It also shows anti-thrombatic activity and protects against ethanol-induced gastric lesions in rats. trans-Anethole is approved by the FDA for use as a food additive under 21 CFR 180.60.  It is further classified as GRAS (generally recognized as safe) by the FDA.  Following an exhaustive review, The Flavour and Extract Manufacturers' Association (FEMA) Expert Panel concluded that trans-anethole does not pose a risk to human health when used as a flavoring substance.  The use of trans-anethole as a fragrance in biopesticide formulations at 3% w/w is not expected to significantly increase the exposure to humans.]

	2. Infants and children. [The history of human use and consumption and evaluations of such use do not suggest there will be a safety concern for infants and children with the use of trans-anethole as a fragrance in biopesticide formulations at 3% w/w.]

F. International Tolerances

	[No known tolerances exist for trans-anethole.]


[Federal Register Volume 87, Number 220 (Wednesday, November 16, 2022)]
[Rules and Regulations]
[Pages 68635-68640]
[FR Doc No: 2022-24923]

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

Federal Motor Carrier Safety Administration

49 CFR Part 371

[Docket No. FMCSA-2022-0134]

Definitions of Broker and Bona Fide Agents

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

ACTION: Notification of interim guidance; request for comments.

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

SUMMARY: FMCSA is issuing this interim guidance to inform the public
and regulated entities about FMCSA's interpretation of the definitions
of ``broker'' and ``bona fide agents'' as it relates to all brokers of
transportation by motor vehicle. FMCSA is taking this action to better
define the terms in response to a mandate in the Infrastructure
Investment and Jobs Act (IIJA). After consideration of public comments
received, FMCSA is providing clarification on its interpretation of the
definitions of ``broker'' and ``bona fide agents,'' in addition to
meeting other criteria

required by the IIJA. While this interim guidance is effective
immediately, FMCSA is also seeking comments in response to this interim
guidance and may issue updated guidance if comments demonstrate a need.

DATES:
    Effective date: This updated guidance is effective November 16,
2022.
    Comment date: Comments must be received on or before January 17,
2023.

FOR FURTHER INFORMATION CONTACT: Mr. Jeff Secrist, Registration,
Licensing, and Insurance Division, Office of Registration and Safety
Information, FMCSA, 1200 New Jersey Avenue SE, Washington, DC 20590-
0001,<PHONE_NUMBER>, [email protected]. If you have questions on
viewing or submitting material to the docket, contact Dockets
Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation and Request for Comments

A. Request for Public Comments

    FMCSA requests public comment on its regulatory guidance and the
factors the Agency will use in its interpretation of the definitions of
``broker'' and ``bona fide agents.''
    Docket: For access to the docket to read background documents or
comments, go to www.regulations.gov at any time or visit Room W12-140
on the ground level of the West Building, DOT, 1200 New Jersey Avenue
SE, Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through
Friday, except Federal holidays. If you want acknowledgment that we
received your comments, please include a self-addressed, stamped
envelope or postcard or print the acknowledgement page that appears
after submitting comments online.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its guidance 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.

B. Submitting Comments

    If you submit a comment, please include the docket number for this
notice (FMCSA-2022-0134), indicate the specific section of this
document to which your comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online or by fax, mail, or hand delivery, but please use only one of
these means. FMCSA recommends that you include your name and a mailing
address, an email address, or a phone number in the body of your
document so FMCSA can contact you if there are questions regarding your
submission.
    To submit your comment online, go to https://www.regulations.gov/docket/FMCSA-2022-0134/document, click on this notice, click
``Comment,'' and type your comment into the text box on the following
screen.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the facility, please enclose a stamped,
self-addressed postcard or envelope.

C. Confidential Business Information (CBI)

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (5 U.S.C. 552), CBI is exempt from public disclosure.
If your comments to this notice contain commercial or financial
information that is customarily treated as private, that you actually
treat as private, and that is relevant or responsive to the notice, it
is important that you clearly designate the submitted comments as CBI.
Please mark each page of your submission that constitutes CBI as
``PROPIN'' to indicate it contains proprietary information. FMCSA will
treat such marked submissions as confidential under the Freedom of
Information Act, and they will not be placed in the public docket for
this notice. Submissions containing CBI should be sent to Mr. Brian
Dahlin, Chief, Regulatory Evaluation Division, Office of Policy, FMCSA,
1200 New Jersey Avenue SE, Washington, DC 20590-0001. Any comments
FMCSA receives not specifically designated as CBI will be placed in the
public docket for this proceeding.

D. Viewing Comments and Documents

    To view any documents mentioned as being available in the docket,
go to https://www.regulations.gov/docket/FMCSA-2022-0134/document and
choose the document to review. To view comments, click this notice,
then click ``Browse Comments.'' If you do not have access to the
internet, you may view the docket online by visiting Dockets Operations
in Room W12-140 on the ground floor of the DOT West Building, 1200 New
Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. To be sure someone is
there to help you, please call<PHONE_NUMBER> or<PHONE_NUMBER> before
visiting Dockets Operations.

E. Privacy Act

    In accordance with 49 U.S.C. 31315(b), DOT solicits comments from
the public to better inform its decision-making 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 https://www.transportation.gov/privacy, the comments are searchable by the name
of the submitter.

II. Background

    Broker is defined in 49 U.S.C. 13102(2) as a ``person, other than a
motor carrier or an employee or agent of a motor carrier, that as a
principal or agent sells, offers for sale, negotiates for, or holds
itself out by solicitation, advertisement, or otherwise as selling,
providing, or arranging for, transportation by motor carrier for
compensation.'' It is also defined in 49 CFR 371.2(a) as a ``person
who, for compensation, arranges, or offers to arrange, the
transportation of property by an authorized motor carrier. Motor
carriers, or persons who are employees or bona fide agents of carriers,
are not brokers within the meaning of this section when they arrange or
offer to arrange the transportation of shipments which they are
authorized to transport and which they have accepted and legally bound
themselves to transport.'' In that same section, bona fide agents are
defined as ``persons who are part of the normal organization of a motor
carrier and perform duties under the carrier's directions pursuant to a
preexisting agreement which provides for a continuing relationship,
precluding the exercise of discretion on the part of the agent in
allocating traffic between the carrier and others.'' 49 CFR 371.2(b).
    On November 15, 2021, the President signed the IIJA into law (Pub.
L. 117-58, 135 Stat. 429). Section 23021 of the IIJA \1\ directed the
Secretary (FMCSA) to issue guidance, within one year of the date of
enactment of the IIJA, clarifying the definitions of the terms
``broker'' and ``bona fide agents'' in 49 CFR 371.2. The guidance must
take into consideration the extent to which technology has changed the
nature of freight brokerage, the role of bona fide

agents, and other aspects of the freight transportation industry.
Additionally, when issuing the guidance, FMCSA must, at a minimum: (1)
examine the role of a dispatch service in the transportation industry;
(2) examine the extent to which dispatch services could be considered
brokers or bona fide agents; and (3) clarify the level of financial
penalties for unauthorized brokerage activities under 49 U.S.C. 14916,
applicable to a dispatch service.\2\
---------------------------------------------------------------------------

    \1\ The full text is available at congress.gov/117/plaws/publ58/PLAW-117publ58.pdf.
    \2\ Due to a statutory omission, FMCSA is unable to assess civil
penalties for violations of 49 U.S.C. 14916 and may pursue such
penalties only through the Department of Justice in federal court.
Congress has indicated interest in FMCSA's statutory authority in a
recent House Appropriations Committee Report.
---------------------------------------------------------------------------

    In an effort to obtain and consider stakeholder input in the
development of its guidance, FMCSA issued a Federal Register notice on
June 10, 2022, seeking comment in 13 specific areas. 87 FR 35593.

Stakeholder Comments

    FMCSA appreciates the robust response to our request for comment.
Over 80 stakeholders filed comments in the public docket, including
individuals, trade associations, brokers, and dispatch services.\3\
While the Agency does not specifically reference all comments in this
guidance, the Agency would like to assure stakeholders it has reviewed
and considered all comments filed.
---------------------------------------------------------------------------

    \3\ FMCSA appreciates commenters that provided submissions by
the July 11 deadline for comment submission. A number of commenters
submitted comments after the deadline. While FMCSA reminds
stakeholders of the importance of submitting timely comments, in
this particular proceeding, FMCSA will consider the late-filed
comments in the interest of developing a complete record. While
FMCSA accepted the comments in this proceeding, it may not consider
late-filed comments in future proceedings.
---------------------------------------------------------------------------

III. Compliance With the IIJA

A. Technology

    As an initial matter, commenters were nearly unanimous that while
technology has changed freight brokerage, such changes have not
affected the fundamental nature of freight brokerage, nor are they
relevant for the issuance of this guidance.\4\ One commenter did note
that the technological changes have exacerbated fraud problems.\5\
Accordingly, while the Agency recognizes that brokerage has changed
immeasurably due to technology, including moving from a phone based
system to one based on the internet, such changes do not impact the
fundamental nature of brokerage, which involves arranging
transportation for compensation, and hence do not have a significant
impact on this guidance.
---------------------------------------------------------------------------

    \4\ See comments of Truckstop.com, at 5; Mode Transportation
(Mode), at 8; Transportation Intermediaries Association (TIA), at
10; National Industrial Transportation League (NITL), at 2; Small
business in Transportation Coalition (SBTC), at 14; England
Logistics (England), at 8; and Uship, at 3.
    \5\ See Comments of 13 stakeholders (13 Stakeholder comments),
at 12-13. The 13 stakeholders include the Air & Expedited Motor
Carriers Association, Airforwarders Association, Alliance for Safe,
Efficient, and Competitive Truck Transportation (ASECTT), Auto
Haulers Association of America, American Home Furnishings Alliance,
Apex Capital Corp, National Association of Small Trucking Companies
(NASTC), PFA Transportation Insurance & Surety Services, Sompo
International, Transportation & Logistics Council, Specialized
Furniture Carriers, The Expedite Association of North America,
Transportation Loss Prevention and Security Association.
---------------------------------------------------------------------------

B. Bona Fide Agents

    Stakeholders provided FMCSA with useful information on the role of
bona fide agents. Commenters have described bona fide agents as
advocates or a sales force for a single motor carrier,\6\ an outside
sales force that acquires freight for an employer,\7\ a dispatch
service used in lieu of motor carrier employees,\8\ people who look for
freight for a motor carrier,\9\ a service that allows motor carriers to
outsource operations instead of having employees handle them,\10\ a
sales force from acquired motor carriers that big motor carriers
use,\11\ and an operation where people work for one motor carrier and
have no discretion to allocate traffic.\12\ Based upon stakeholder
comments, it appears that bona fide agents are generally considered
individuals/entities that solicit business for a motor carrier.
---------------------------------------------------------------------------

    \6\ See Mode comments, at 7.
    \7\ See comment of AWM Associates, LLC (AWM), at 4.
    \8\ See TIA comments, at 9.
    \9\ See comments of the Owner-Operator Independent Drivers
Association (OOIDA), at 5.
    \10\ See comments of the Intermodal Association of North America
(IANA), at 5.
    \11\ See 13 Stakeholder comments, at 10-11.
    \12\ See comments of the American Trucking Associations Moving
and Storage Conference (MSC), at 5.
---------------------------------------------------------------------------

C. Other Aspects of the Freight Transportation Industry

    Finally, stakeholders provided input, albeit more limited, on other
aspects of the freight transportation industry. A broker indicated that
other aspects of the transportation industry do not need to be
considered.\13\ A managing general agency and program administrator for
insurance companies focused on transportation indicated that FMCSA
should issue guidance that is consistent with the Motor Carrier Safety
Improvement Act of 1999 and the Moving Ahead for Progress in the 21st
Century Act (MAP-21).\14\ A truck safety advocacy group indicated that
FMCSA must issue a clear definition of broker that enables
enforcement.\15\ And, a coalition of stakeholders noted the significant
ramifications of being considered a broker or not.\16\
---------------------------------------------------------------------------

    \13\ See comments of Mode, at 8.
    \14\ See comments of Greenwich Transportation Underwriters, at
2.
    \15\ See comments of the Truck Safety Coalition (TSC), at 3.
FMCSA reminds stakeholders that guidance is not enforceable, in
contrast to statutes and regulations, which are.
    \16\ See 13 Stakeholder comments, at 4-6.
---------------------------------------------------------------------------

    While stakeholders did not provide FMCSA with specific information
related to the requirement that the Agency must consider ``other
aspects of the freight transportation industry'' in issuing the
guidance, FMCSA recognizes that its guidance is operating in a broader
context and has impacts beyond the immediate focus of this guidance. In
today's notice, FMCSA has worked to avoid creating unintended
consequences, in issuing guidance on its interpretation of its
regulations and related matters. While guidance may be relevant to
stakeholder compliance with FMCSA's regulations, any changes to FMCSA's
regulations and hence compliance responsibilities would need to be
enacted in a separate rulemaking proceeding.\17\
---------------------------------------------------------------------------

    \17\ FMCSA notes and appreciates SBTC's Petition for rulemaking
regarding the definition of ``dispatcher.'' As noted in its response
to SBTC, FMCSA is continuing to review SBTC's petition. Today's
notice is not to be interpreted as a decision on SBTC's petition.
Other stakeholders are free to file petitions for rulemaking related
to the issues covered in today's notice as well.
---------------------------------------------------------------------------

IV. Interim Guidance

    With the aforementioned consideration of factors as background,
FMCSA now turns to the core IIJA mandate: the issuance of guidance
pertaining to the definition of broker and bona fide agents, the
examination of the role of dispatch services in the transportation
industry, the extent to which dispatch services could be considered
brokers or bona fide agents, and the level of financial penalties for
unauthorized brokerage activities under 49 U.S.C. 14916 applicable to a
dispatch service. This document does not have the force and effect of
law and is not meant to bind the public in any way, and the document is
intended only to provide information to the public regarding existing
requirements under the law or agency policies

A. Definition of Broker

    While FMCSA is unable to change the definition of ``broker'' absent
a rulemaking, it is able to provide clarification here. As an initial
matter,

there was a split amongst stakeholders on whether the current
definition of broker was adequate. A majority of stakeholders believed
that the current definition of broker was adequate,\18\ while others
proposed some changes. A safety advocacy group recommended amendment of
the definition of ``broker.'' \19\ A stakeholder representing the
household goods (HHG) motor carrier industry asked FMCSA to clarify
that merely selling leads does not require an entity to obtain broker
authority.\20\ One broker believed that FMCSA should amend the
definition of ``broker'' to comport with changes in MAP-21 that
required motor carriers and hence their agents to obtain broker
operating authority.\21\ Additionally, internet based load matching
services have requested that FMCSA consider electronic load boards to
not be considered brokers.\22\
---------------------------------------------------------------------------

    \18\ See comments of Mode, at 3-4; TIA, at 3; OOIDA, at 2; NITL,
at 2; IANA, at 2; MSC, at 2-3; Agricultural and Food Transporters
Conference of ATA and multiple state trucking associations (AFTC),
at 2; 13 Stakeholder comments, at 4; Larry Walker.
    \19\ TSC comments, at 2. In order for FMCSA to consider such a
change, TSC would need to file a petition for rulemaking.
    \20\ See comments of MSC, at 4. FMCSA appreciates MSC's comments
and recognizes that they have raised the issue with the Agency for
quite some time. In order to give stakeholders a chance to comment
in this area, FMCSA will treat MSC's comments as a request for
guidance on the definition of HHG broker and issue guidance in a
separate proceeding.
    \21\ See Comments of England, at 1-4. FMCSA recognizes this
issue but does not believe that this is the appropriate forum to
resolve it. England would need to file a petition for rulemaking
with the Agency for a change in the definition of ``broker.''
However, as England notes, Congress did not change the definition of
``broker'' in 49 U.S.C. 13102(2). In order for FMCSA to change the
definition of broker in its regulations as England suggests, the
Agency would have to carefully consider its authority to make such a
change given that Congress specifically left the prior definition of
``broker'' in place in MAP-21.
    \22\ See comments of DAT, at 1; Truckstop.com, at 1-5; and
Uship, at 4. Comments filed by representatives of the HHG motor
carrier industry do not believe a carveout from the broker
definition for load boards is appropriate. See comments of Unigroup/
Mayflower/MoveRescue, at 3. While whether an entity requires broker
operating authority must be determined on a case by case basis,
FMCSA does not believe that where entities merely host an electronic
platform for shippers and motor carriers to connect directly that
broker operating authority registration is required. This position
is consistent with a 2000 letter from FMCSA that has been placed in
the docket. See Letter from Judith Rutledge, FMCSA Acting Chief
Counsel, to Andrew K. Light, Esq.
---------------------------------------------------------------------------

    Given the prevailing view among commenters that the current
definition of ``broker'' is adequate, the Agency feels the need to
clarify it in only one area: the relevance of an entity's handling of
funds in a transaction between shippers and motor carrier. FMCSA
appreciates the robust input it received on this issue. Some commenters
believed that whether one handles funds is irrelevant to whether one is
a broker.\23\ A coalition of stakeholders believed the handling of
money is not determinative in the broker determination.\24\ Other
stakeholders felt that the handling of money had at least some
relevance as to whether one is brokering.\25\
---------------------------------------------------------------------------

    \23\ See comments of SBTC, at 6; England, at 5; TSC, at 2.
    \24\ See 13 Stakeholder comments, at 6-7.
    \25\ See comments of TIA, at 7; OOIDA, at 4; MSC, at 4; Cox
Automotive, at 1-2.
---------------------------------------------------------------------------

    After consideration of the stakeholder comments and the important
role of financial responsibility in broker regulation,\26\ FMCSA wishes
to clarify that handling money exchanged between shippers and motor
carriers is a factor that strongly suggests the need for broker
authority, but it is not an absolute requirement for one to be
considered a broker.
---------------------------------------------------------------------------

    \26\ One of the most significant broker regulations is the
requirement that brokers have a $75,000 bond or trust fund to
protect motor carriers from non-payment. Where a shipper pays a fee
to third party that then takes a profit and remits the balance to a
motor carrier, the third party is clearly required to have broker
authority. FMCSA will soon be issuing a Notice of Proposed
Rulemaking on broker and freight forwarder financial responsibility,
which will further clarify related duties.
---------------------------------------------------------------------------

B. Definition of Bona Fide Agent

    Next, FMCSA is mandated to clarify the definition of ``bona fide
agents'' in 49 CFR 371.2. Stakeholders provided feedback on this point.
A HHG motor carrier trade association thought the current definition
was ``clear as to what entities fall within that term.'' \27\ A broker
indicated that the definition should be eliminated due to MAP-21
requiring motor carriers, and hence their agents, to have broker
authority.\28\ And multiple entities believe that in order to be deemed
a ``bona fide agent'' one can represent only one motor carrier.\29\
---------------------------------------------------------------------------

    \27\ See comments of the MSC, at 5.
    \28\ See comments of England, at 1-4. As noted above, any such
change would require rulemaking in accordance with the APA and
statutory authority concerns would need to be addressed.
    \29\ See comments of TIA, at 8; NITL, at 2; SBTC, at 9.
---------------------------------------------------------------------------

    After careful consideration, FMCSA has determined that representing
more than one motor carrier does not necessarily mean one is a broker
rather than a bona fide agent. Any determination will be highly fact
specific and will entail determining whether the person or company is
engaged in the allocation of traffic between motor carriers.

C. Role of Dispatch Services

    Next, the IIJA required the agency to examine the role of dispatch
services in the transportation industry and the extent to which such
services could be considered brokers or bona fide agents.
    Stakeholder comments make clear that there is no universally
accepted definition of ``dispatch service,'' nor did Congress define
the term in the IIJA provision mandating this guidance.\30\ One broker
trade association characterized it is as a vague term,\31\ while a
coalition of stakeholders said it is an invented term.\32\ According to
a self-identified dispatch service, dispatchers represent motor
carriers, they don't connect shippers and motor carriers, they don't
handle money, but they do provide carrier support services.\33\
Additional commenters stated that dispatchers perform back office
operations for motor carriers; \34\ they book freight and perform other
tasks; \35\ they perform many administrative duties and basic
accounting for small carriers; \36\ and they are paid a percentage of
the freight charges from a motor carrier.\37\ Other stakeholders
indicate that dispatch services find loads for motor carriers, handle
administrative tasks and assist with compliance,\38\ source shipments,
and allocate shipments between motor carriers.\39\ According to a
shipper trade association, dispatch services would be expected to be
like an in-house truck dispatcher, but in reality many are operating
more like brokers.\40\ A broker commenter indicated that dispatch
services have multiple motor carriers in their client base, they seek
freight and obtain freight for motor carriers, and they are paid by
motor carriers.\41\
---------------------------------------------------------------------------

    \30\ See comments of England, at 5-7.
    \31\ See TIA comments, at 7.
    \32\ See 13 stakeholder comments, at 7.
    \33\ See comments of Seeley & Sylvester. LLC, at 2-4; See also
comments of A1 Express, at 2 (stating that dispatch services ``are
and should be a carrier support service.'') Note that a number of
individuals submitted identical comments which are cited as A1
Express.
    \34\ See Mode comments, at 5; See also comments from Shelley
Smith (stating that ``a dispatcher should be categorized as a back
office assistant because that is truly a power dispatcher.'').
    \35\ See comments of Quality Dispatching, at 5.
    \36\ See comments of WCF Freight Transport.
    \37\ See comments of AWM Associates LLC, at 2.
    \38\ See comments of OOIDA, at 4.
    \39\ See comments of IANA, at 3-4.
    \40\ See comments of the Transportation and Logistics Council,
Inc., at 2.
    \41\ See comments of England, at 5-7.
---------------------------------------------------------------------------

    After consideration of the public comments, while it is clear that
there is no commonly accepted definition of a dispatch service, such
services appear to have certain common features. First,

they work exclusively for motor carriers, not for shippers. Second,
they source loads for motor carriers. And third, they perform
additional services for motor carriers that are unrelated to sourcing
shipments.

D. Dispatch Service: Broker or Bona Fide Agent

    Further, the IIJA mandated that FMCSA examine when a dispatch
service could be considered a broker and when it could be considered a
bona fide agent. Stakeholders provided significant input on these
points.
    A trade association indicated that when a dispatch service
represents one motor carrier it is a bona fide agent, but when it
represents more than one it is a broker.\42\ A broker thought that when
a dispatch service only performed back office operations, it was not a
broker, but if it arranges loads it is.\43\ A dispatch service
indicated that dispatch services are bona fide agents, as they are
merely agents to locate freight and are paid a flat fee or a
percentage.\44\ Another dispatch service also believes that a dispatch
service is a bona fide agent and not a broker because dispatch services
do not connect shippers with carriers that can transport their loads,
and therefore do not meet the broker business model.\45\ A consulting
firm believes that dispatch services are bona fide agents if they are
employees per IRS regulations, but not if they represent more than one
motor carrier.\46\ Several trade organizations believe that if a
dispatch service represents more than one motor carrier it is a broker,
and that the handling of funds warrants a finding of brokerage.\47\ A
coalition of 13 stakeholders believes that representing more than one
motor carrier renders a dispatch service a broker, and a broker
believes that representing more than one motor carrier takes one
outside of the definition of ``bona fide agent.'' \48\ Finally, a
dispatch service indicated that broker authority should be required
only when arranging transportation on behalf of shippers.\49\
---------------------------------------------------------------------------

    \42\ See comments of IANA, at 4.
    \43\ See comments of Mode, at 5.
    \44\ See comments of Quality Dispatching, at 4-5.
    \45\ See comments of A1 Express, at 2.
    \46\ See comments of AWM, at 4.
    \47\ See comments of TIA, at 7; and OOIDA, at 4.
    \48\ See comments of 13 stakeholders, at 10; England, at 8.
    \49\ See comments of Seeley & Sylvester LLC, at 4.
---------------------------------------------------------------------------

    After careful consideration, FMCSA clarifies that when a dispatch
service does not participate in the arrangement of freight, or when it
represents only one motor carrier, it is not a broker. If a dispatch
service arranges transportation on behalf of multiple motor carriers
and engages in the allocation of traffic, however, then pursuant to 49
CFR 371.2, it is not a bona fide agent and must obtain broker operating
authority registration. Ultimately, the analysis of whether a person or
entity requires broker authority is often highly fact specific and must
be made on a case-by-case basis.
    Regarding whether a dispatch service is a bona fide agent, one must
analyze whether the service falls within the definition of bona fide
agent in 49 CFR 371.2(b). However, if the dispatch service allocates
traffic between two motor carriers, it cannot be a bona fide agent by
definition.

E. Dispatch Services That Would Not Require Broker Authority

    Generally, the factors relevant to whether a dispatch service is
not required to obtain broker authority are stated below:
    (1) The dispatch service has a written legal contractual
relationship with a motor carrier that clearly reflects the motor
carrier is appointing the dispatch service as a licensed agent for the
motor carrier. This is often a long-term contractual relationship;
    (2) The written legal contract specifies the insurance and
liability responsibilities of the dispatch service and motor carrier.
The dispatch service must also meet all state licensing requirements;
    (3) The dispatch service goes through a broker to arrange for the
transportation of shipments for the motor carrier. The dispatch service
may not seek or solicit shippers for freight;
    (4) The dispatch service does not provide billing nor accept
compensation from the broker, 3PL (third-party logistics company), or
factoring company, but instead receives compensation from the motor
carrier(s) based on the pre-determined written legal contractual
agreement;
    (5) The dispatch service is not an intermediary or involved in the
financial transaction between a broker and motor carrier;
    (6) The dispatch service is an IRS 1099 recipient from the motor
carrier, or a W2 employee of the motor carrier as specified in the
legal written contract agreement;
    (7) The dispatch service discloses that they are a dispatch service
operating under the authority of a specific motor carrier, and the
shipment is arranged for that motor carrier only;
    (8) The dispatch service does not subsequently assign or arrange
for the load to be carried/moved by another motor carrier; or
    (9) A dispatch service does not provide their ``services'' for a
motor carrier unless that motor carrier specifically appointed the
dispatch service as their agent in accordance with the aforementioned
requirements.

F. Dispatch Services That Require Broker Authority

    The following factors would indicate the dispatch service should
obtain broker authority:
    (1) The dispatch service interacts or negotiates a shipment of
freight directly with the shipper, or a representative of the shipper;
    (2) The dispatch service accepts or takes compensation for a load
from the broker, or factoring company, or is involved in any part of
the monetary transaction between any of those entities;
    (3) The dispatch service arranges for a shipment of freight for a
motor carrier, with which there is no written legal contract with the
motor carrier that meets the aforementioned criteria;
    (4) The dispatch service accepts a shipment without a truck/
carrier, then attempts to find a truck/carrier to move the shipment;
    (5) The dispatch service is a named party on the shipping contract;
or
    (6) The dispatch service is soliciting to the open market of
carriers for the purposes of transporting a freight shipment.
    It is clear based on feedback from industry that there is a need
and desire for dispatch services, among large and small motor carriers.
A beneficial role that a dispatch service may provide is the
outsourcing of resources for small motor carriers who cannot afford a
full-time employee to perform these functions. The dispatch service can
help to ensure the motor carrier has a steady stream of shipments while
allowing the motor carrier to focus on its core business of safely
transporting freight. FMCSA does not believe it is the intent of
Congress to eliminate the services that dispatch services provide.
    While no single factor is paramount in assessing the business
relationship between a dispatch service and a motor carrier, the extent
of a motor carrier's control over the individual(s) performing the
dispatch services is highly significant, i.e., the dispatch service
works on behalf of the motor carrier and makes decisions based on the
motor carrier's guidance and direction. As noted, FMCSA determines
whether a dispatcher is conducting broker operations on a case-by-case
basis, utilizing factors including those above.

G. Financial Penalties

    Finally, FMCSA must clarify the level of penalties for unauthorized
brokerage applicable to dispatch services. Such an assessment is
straightforward. If the dispatch service is deemed to be providing
unauthorized brokerage services pursuant to 49 U.S.C. 14916, the
service will be subject to applicable penalties.\50\ If no finding of
unauthorized brokerage is made, it will not be subject to such
penalties.
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    \50\ Penalties for violations of section 14916 are provided in
49 U.S.C. 14916(c)(1),(d).
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V. Request for Public Comment

    FMCSA requests public comment on its regulatory guidance and the
factors the Agency will use in its interpretation of the definitions of
``broker'' and ``bona fide agent.'' The Agency welcomes comments from
stakeholders that are relevant to identifying a dispatch service that
engages in actions that would require broker authority compared with
actions that don't require broker authority. Additionally, FMCSA
welcomes comments concerning the potential impact of this guidance on
dispatch services upon which the broker rules would be considered
applicable.

Robin Hutcheson,
Administrator.
[FR Doc. 2022-24923 Filed 11-15-22; 8:45 am]
BILLING CODE 4910-EX-P