[Federal Register Volume 84, Number 75 (Thursday, April 18, 2019)]
[Notices]
[Pages 16322-16324]
[FR Doc No: 2019-07783]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Dockets No. FMCSA-2007-28043; FMCSA-2018-0140]

Hours of Service (HOS) of Drivers; American Pyrotechnics Assn.
(APA); Request To Add New Members to Current APA Exemptions; Request
for Comments

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

ACTION: Notice of application for exemptions; request for comments.

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

SUMMARY: FMCSA announces that it has received an application from the
American Pyrotechnics Association (APA) requesting exemptions from the
Agency's hours-of-service (HOS) regulations for four new members:
Celebration Fireworks, Inc., International Fireworks Mfg. Company,
Inc., Johnny Rockets Display Company, and the Wald & Company All
American Display Fireworks Company. The first exemption request is from
the prohibition on driving commercial motor vehicles (CMVs) after the
14th hour after the driver comes on duty. APA requests this exemption
to allow drivers employed by the four member companies to exclude off-
duty and sleeper-berth time of any length from the calculation of the
14-hour limit. The second exemption request is from the HOS regulations
that require a motor carrier to install and require each of its drivers
to use an electronic logging device (ELD) to record the driver's HOS.
APA requests this exemption to allow these same drivers employed by the
four members to continue to use paper records of duty status (RODS) in
lieu of an ELD during the designated Independence Day periods. If
granted, these exemptions would terminate at the same time as the other
53 exempted APA member carriers. The original terms and conditions of
the limited exemptions, that ensure a level of safety equivalent to, or
greater than, the level of safety achieved without the exemption, will
be upheld by the four new members.

DATES: Comments are due no later than May 20, 2019.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket ID FMCSA-2007-28043 and FMCSA-2018-0140
using any of the following methods:
     Federal eRulemaking Portal: www.regulations.gov. Follow
the online instructions for submitting comments.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building, Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building, Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: 1-202-493-2251.
    Each submission must include the Agency name and the docket number
for this notice. Note that DOT posts all comments received without
change to www.regulations.gov, including any personal information
included in a comment. Please see the Privacy Act heading below.
    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, 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through Friday,
except Federal holidays. The on-line FDMS is available 24 hours each
day, 365 days each year. 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 on-line.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Ms. Pearlie Robinson, FMCSA Driver and
Carrier Operations Division; Office of Carrier, Driver and Vehicle
Safety Standards; Telephone:<PHONE_NUMBER>.

Email: [email protected]. If you have questions on viewing or submitting
material to the docket, contact Docket Services, telephone (202) 366-
9826.

SUPPLEMENTARY INFORMATION:

I. Public Participation and Request for Comments

    FMCSA encourages you to participate by submitting comments and
related materials.

Submitting Comments

    If you submit a comment, please include the docket numbers for this
notice (FMCSA-2007-28043 and FMCSA-2018-0140), indicate the specific
section of this document to which the comment applies, and provide a
reason for suggestions or recommendations. 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 the Agency can contact you if it has questions
regarding your submission.
    To submit your comment online, go to www.regulations.gov and put
the respective docket number, ``FMCSA-2007-28043'' or ``FMCSA-2018-
0140'' in the ``Keyword'' box, and click ``Search.'' When the new
screen appears, click on ``Comment Now!'' button and type your comment
into the text box in the following screen. Choose whether you are
submitting your comment as an individual or on behalf of a third party
and then submit. 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.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to www.regulations.gov and insert
the docket number, ``FMCSA-2007-28043'' or ``FMCSA-2018-0140'' in the
``Keyword'' box and click ``Search.'' Next, click ``Open Docket
Folder'' button and choose the document listed to review. If you do not
have access to the internet, you may view the docket online by visiting
the Docket Management Facility in Room W12-140 on the ground floor of
the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590,
between 9 a.m. and 5 p.m., e.t., Monday through Friday, except Federal
holidays.

II. Legal Basis

    FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant
exemptions from certain parts of the Federal Motor Carrier Safety
Regulations. FMCSA must publish a notice of each exemption request in
the Federal Register (49 CFR 381.315(a)). The Agency must provide the
public an opportunity to inspect the information relevant to the
application, including any safety analyses that have been conducted.
The Agency must also provide an opportunity for public comment on the
request.
    The Agency reviews the safety analyses and the public comments, and
determines whether granting the exemption would likely achieve a level
of safety equivalent to, or greater than, the level that would be
achieved by the current regulation (49 CFR 381.305). The decision of
the Agency must be published in the Federal Register (49 CFR
381.315(b)) with the reason for the grant or denial, and, if granted,
the specific person or class of persons receiving the exemption, and
the regulatory provision or provisions from which exemption is granted.
The notice must also specify the effective period of the exemption (up
to 5 years), and explain the terms and conditions of the exemption. The
exemption may be renewed (49 CFR 381.300(b)).

Request for Exemptions

    The APA reports that it is a national safety and trade association
of the U.S. fireworks industry, representing manufacturers, importers,
distributors, wholesalers, retailers, suppliers and professional
display companies. APA has over 250 member companies. Along with their
subsidiaries, APA's member-companies are responsible for nearly 90
percent of the fireworks manufactured, imported, distributed and
professionally displayed in the United States.
    APA requested HOS exemptions from the 14-hour rule and the ELD rule
for four new members: Celebration Fireworks, Inc., DOT #1527687,
International Fireworks Mfg. Company, Inc., DOT #385065, Johnny Rockets
Display Company, DOT #1263181, and the Wald & Company All American
Display Fireworks Company, DOT #87079. The exemptions for these APA
carriers, if granted, would expire on July 8, 2020. Although this is
less than the 5-year exemption period authorized by 49 U.S.C.
31315(b)(2), as amended by section 5206(a)(3) of the Fixing America's
Surface Transportation (FAST) Act (Pub. L. 114-94, 129 Stat. 1312,
1537, Dec. 4, 2015), FMCSA believes that the interests of the APA
members and the Agency would best be served by synchronizing the
expiration dates of all such fireworks-related exemptions. The four new
members would be subject to all of the terms and conditions in the
original exemptions.
    The CMV drivers employed by APA members are trained pyro-
technicians who hold commercial driver's licenses (CDLs) with hazardous
materials (HM) endorsements. They transport fireworks and related
equipment by CMVs on a very demanding schedule during a brief
Independence Day period, often to remote locations. After they arrive,
the drivers are responsible for set-up and staging of the fireworks
shows.
    The APA has requested exemptions for the four new member companies
because compliance with the current 14-hour rule in 49 CFR 395.3(a)(2)
would impose a substantial economic hardship on numerous cities, towns
and municipalities, as well as its members. To meet the demand for
fireworks without the exemptions, APA states that its members would be
required to hire a second driver for most trips. The APA advises that
the result would be a substantial increase in the cost of the fireworks
shows--beyond the means of many of its members' customers--and that
many Americans would be denied this important component of the
celebration of Independence Day.
    Additionally, APA is seeking exemptions from the ELD rule in 49 CFR
395.8(a)(1)(i) for these same members. APA asserts that granting this
exemption is appropriate because there is no basis to believe that
continuing to allow paper record keeping for this limited subset of the
regulated community, and for a limited period of time, would impact
operational safety in any regard. In addition, due to the unique nature
of the fireworks industry, requiring the use of ELDs for this limited
seasonal delivery period would impose a substantial financial burden on
members because it would require them to purchase/lease systems for use
for only a short period every year.
    APA explained that members rely upon intermittent casual drivers
periodically throughout the year and particularly during the busy
Independence Day season when industry depends upon short-term rental
trucks. The fireworks industry is unique in that it rents or leases
approximately 90% of its vehicles throughout the year for fewer than 30
days at a time. However, most rental companies require a minimum rental
period of 14 to 21 days when APA members may only use the trucks in
commerce for up to 11 days. The mix of

vehicles rented includes pick-up trucks, cargo vans, city vans and
straight trucks less than 26,000 GVW. The industry relies heavily upon
short-term rental trucks to transport and deliver 98% of the 16,000
Independence Day fireworks displays nationwide.
    The APA believes that the exemptions would not adversely affect the
safety of the fireworks transportation provided by these motor
carriers. APA's members have operated under the exemption from the 14-
hour rule for 12 previous Independence Day periods without incident.
Moreover, it asserts, without the extra time provided by the exemption
from the 14-hour rule, safety would decline because APA drivers would
be unable to return to their home base after each show. They would be
forced to park the CMVs carrying HM 1.1G, 1.3G and 1.4G products in
areas less secure than the motor carrier's home base. Without the
exemption from the ELD rule, these companies would be required to
purchase/lease ELD systems for a limited period of 11 days.
    APA asserts that the operational demands of this unique industry
minimize the risks of CMV crashes. In the last few days before July 4,
these drivers transport fireworks over relatively short routes from
distribution points to the site of the fireworks display, and normally
do so in the early morning when traffic is light. At the site, they
spend considerable time installing, wiring, and safety-checking the
fireworks displays, followed by several hours off duty in the late
afternoon and early evening prior to the event. During this time, the
drivers are able to rest and nap, thereby reducing or eliminating the
fatigue accumulated during the day.

Method To Ensure an Equivalent or Greater Level of Safety

    Before beginning another duty day, drivers must take 10 consecutive
hours off duty. Drivers are off duty for several hours in the late
afternoon and early evenings, prior to an event. Additionally, these
members would continue to use paper RODS in lieu of an ELD during the
designated Independence Day periods.

Terms and Conditions of the Exemption

Period of the Exemption

    The requested HOS exemptions from 49 CFR 395.3(a)(2) and 49 CFR
395.8(a)(1)(i) would be effective from June 28 through July 8, at 11:59
p.m. local time, each year through 2020.

Terms and Conditions of the Exemptions

    During the 2019 Independence Day period, the exemptions from 49 CFR
395.3(a)(2) and 49 CFR 395.8(a)(1)(i) would be limited to drivers
employed by the 53 motor carriers already covered by the exemptions,
plus (if approved) the four carriers now seeking these exemptions.
Section 395.3(a)(2) prohibits a driver from driving a CMV after the
14th hour after coming on duty and does not permit off-duty periods to
extend the 14-hour limit. Section 395.8(a)(1)(i) requires drivers of
motor carriers subject to the rule to use ELDs to record their HOS.
Drivers covered by these exemptions would be able to exclude off-duty
and sleeper-berth time of any length from the calculation of the 14-
hour limit. The exemptions would be contingent on the following:
     Drivers do not drive more than 11 hours in the 14-hour
period after coming on duty, as extended by any off-duty or sleeper-
berth time in accordance with this exception.
     Drivers must have 10 consecutive hours off duty following
14 hours on duty prior to beginning a new driving period.
     Drivers must use paper RODs
     The carriers and drivers must comply with all other
requirements of the Federal Motor Carrier Safety Regulations (49 CFR
parts 350-399) and Hazardous Materials Regulations (49 CFR parts 105-
180).

Preemption

    In accordance with 49 U.S.C. 31315(d), as implemented by 49 CFR
381.600, during the period these exemptions would be in effect, no
State shall enforce any law or regulation applicable to interstate
commerce that conflicts with or is inconsistent with the exemptions
with respect to a firm or person operating under the exemptions. States
may, but are not required to, adopt the same exemptions with respect to
operations in intrastate commerce.

FMCSA Notification

    Exempt motor carriers would be required to notify FMCSA within 5
business days of any accidents (as defined by 49 CFR 390.5) involving
the operation of any of their CMVs while under these exemptions. The
notification must be by email to [email protected] and include the
following information:
    a. Name of the Exemption: ``APA''
    b. Date of the accident,
    c. City or town, and State, in which the accident occurred, or
which is closest to the scene of the accident,
    d. Driver's name and driver's license State, number, and class,
    e. Co-Driver's name and driver's license State, number, and class,
    f. Vehicle company number and power unit license plate State and
number,
    g. Number of individuals suffering physical injury,
    h. Number of fatalities,
    i. The police-reported cause of the accident,
    j. Whether the driver was cited for violation of any traffic laws,
or motor carrier safety regulations, and
    k. The total driving time and the total on-duty time of the CMV
driver at the time of the accident.
    In addition, if there are any injuries or fatalities, the carrier
must forward the police accident report to [email protected] as soon as
available.

    Issued on: April 11, 2019.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2019-07783 Filed 4-17-19; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 75, Number 44 (Monday, March 8, 2010)]
[Notices]
[Page 10550]
[FR Doc No: 2010-4872]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Request Revision From the Office of
Management and Budget of a Currently Approved Information Collection
Activity, Request for Comments; Certification and Operation FAR 125

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: The FAA invites public comments about our intention to request
the Office of Management and Budget (OMB) to approve a current
information collection. Part A of Subtitle VII of the Revised Title 49
United States Code authorizes the issuance of regulations governing the
use of navigable airspace. 14 CFR Part 125 prescribes requirements for
leased aircraft, Aviation Service Firms, and Air Travel.

DATES: Please submit comments by May 7, 2010.

FOR FURTHER INFORMATION CONTACT: Carla Mauney on<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Federal Aviation Administration (FAA)

    Title: Certification and Operation FAR 125.
    Type of Request: Extension without change of an approved
collection.
    OMB Control Number: 2120-0085.
    Forms(s): There are no FAA forms associated with this collection.
    Affected Public: A total of 163 respondents.
    Frequency: The information is collected on occasion.
    Estimated Average Burden per Response: Approximately 1.33 hours per
response.
    Estimated Annual Burden Hours: An estimated 61,388 hours annually.
    Abstract: Part A of Subtitle VII of the Revised Title 49 United
States Code authorizes the issuance of regulations governing the use of
navigable airspace. 14 CFR Part 125 prescribes requirements for leased
aircraft, Aviation Service Firms, and Air Travel. A letter of
application and related documents which set forth an applicant's
ability to conduct operations in compliance with the provisions of FAR
Part 125 are submitted to the appropriate Flight Standards District
Office (FSDO). Inspectors in FAA FSDO's review the submitted
information to determine certificate eligibility.

ADDRESSES: Send comments to the FAA at the following address: Ms. Carla
Mauney, Room 712, Federal Aviation Administration, IT Enterprises
Business Services Division, AES-200, 800 Independence Ave., SW.,
Washington, DC 20591.
    Comments are invited on: 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; the accuracy of the Department's estimates of the burden of
the proposed information collection; ways to enhance the quality,
utility and clarity of the information to be collected; and 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.

    Issued in Washington, DC, on February 25, 2010.
Carla Mauney,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
[FR Doc. 2010-4872 Filed 3-5-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 221 (Wednesday, November 16, 2011)]
[Rules and Regulations]
[Pages 70896-70899]
[FR Doc No: 2011-29587]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[[EPA-HQ-OPP-2011-0606; FRL-8892-1]

Polyethylene Glycol; Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of [alpha]-Hydro-[omega]-
hydroxypoly(oxyethylene), minimum number average molecular weight (in
amu), 17,000; also known as polyethylene glycol, when used as an inert
ingredient in a pesticide chemical formulation. Clariant Corporation
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), requesting an exemption from the requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of [alpha]-Hydro-[omega]-
hydroxypoly(oxyethylene), minimum number average molecular weight (in
amu), 17,000 on food or feed commodities.

DATES: This regulation is effective November 16, 2011. Objections and
requests for hearings must be received on or before January 17, 2012,
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: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2011-0606. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Elizabeth Fertich, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; 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.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

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

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. 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-2011-0606 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
January 17, 2012. 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 that does not contain any 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 a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2011-0606, by one of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries

are only accepted during the Docket Facility's normal hours of
operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays). Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of August 26, 2011 (76 FR 53372) (FRL-8884-
9), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C.
346a, announcing the receipt of a pesticide petition (PP 1E7880) filed
by Clariant Corporation, 4000 Monroe Road, Charlotte, NC 28205. The
petition requested that 40 CFR 180.960 be amended by establishing an
exemption from the requirement of a tolerance for residues of Poly(oxy-
1,2-ethanediyl), [alpha]-Hydro-[omega]-hydroxy-, Mn 17000 amu; (CAS
Reg. No. 25322-68-3) when used as a pesticide inert ingredient in
pesticide formulations as a solubilizer without limitations. That
notice included a summary of the petition prepared by the petitioner
and solicited comments on the petitioner's request. The Agency did not
receive any comments in response to this notice. This regulation
establishes an exemption from the requirement of a tolerance for
residues of the chemical [alpha]-hydro-[omega]-hydroxypoly(oxyethylene,
minimum number average molecular weight (in amu), 17,000; also known as
polyethylene glycol.
    Section 408(c)(2)(A)(i) of FFDCA allows 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 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 use 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 an exemption from the
requirement of 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.* * *'' and
specifies factors EPA is to consider in establishing an exemption.

III. Risk Assessment and Statutory Findings

    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be shown that the risks from aggregate
exposure to pesticide chemical residues under reasonably foreseeable
circumstances will pose no appreciable risks to human health. In order
to determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a finite tolerance is not necessary to ensure that there
is a reasonable certainty that no harm will result from aggregate
exposure to the inert ingredient, an exemption from the requirement of
a tolerance may be established.
    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information 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. In the case of certain chemical substances that
are defined as polymers, the Agency has established a set of criteria
to identify categories of polymers expected to present minimal or no
risk. The definition of a polymer is given in 40 CFR 723.250(b) and the
exclusion criteria for identifying these low-risk polymers are
described in 40 CFR 723.250(d). Polyethylene glycol conforms to the
definition of a polymer given in 40 CFR 723.250(b) and meets the
following criteria that are used to identify low-risk polymers.
    1. The polymer is not a cationic polymer nor is it reasonably
anticipated to become a cationic polymer in a natural aquatic
environment.
    2. The polymer does contain as an integral part of its composition
the atomic elements carbon, hydrogen, and oxygen.
    3. The polymer does not contain as an integral part of its
composition, except as impurities, any element other than those listed
in 40 CFR 723.250(d)(2)(ii).
    4. The polymer is neither designed nor can it be reasonably
anticipated to substantially degrade, decompose, or depolymerize.
    5. The polymer is manufactured or imported from monomers and/or
reactants that are already included on the TSCA Chemical Substance
Inventory or manufactured under an applicable TSCA section 5 exemption.
    6. The polymer is not a water absorbing polymer with a number
average molecular weight (MW) greater than or equal to 10,000 daltons.
    Additionally, the polymer also meets as required the following
exemption criteria specified in 40 CFR 723.250(e).
    7. The polymer's number average MW of 17,000 is greater than or
equal to 10,000 daltons. The polymer contains less than 2% oligomeric
material below MW 500 and less than 5% oligomeric material below MW
1,000.
    Thus, polyethylene glycol meets the criteria for a polymer to be
considered low risk under 40 CFR 723.250. Based on its conformance to
the criteria in this unit, no mammalian toxicity is anticipated from
dietary, inhalation, or dermal exposure to polyethylene glycol.

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this
exemption, EPA considered that polyethylene glycol could be present in
all raw and processed agricultural commodities and drinking water, and
that non-occupational non-dietary exposure was possible. The number
average MW of polyethylene glycol is 17,000 daltons. Generally, a
polymer of this size would be poorly absorbed through the intact
gastrointestinal tract or through intact human skin. Since polyethylene
glycol conforms to the criteria that identify a low-risk polymer, there
are no concerns for risks associated with any potential exposure
scenarios that are reasonably foreseeable. The Agency has determined
that a tolerance is not necessary to protect the public health.

V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
    EPA has not found polyethylene glycol to share a common mechanism
of toxicity with any other substances, and polyethylene glycol does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
polyethylene glycol does

not have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

VI. Additional Safety Factor for the Protection of Infants and Children

    Section 408(b)(2)(C) of FFDCA 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 concludes
that a different margin of safety will be safe for infants and
children. Due to the expected low toxicity of polyethylene glycol, EPA
has not used a safety factor analysis to assess the risk. For the same
reasons the additional tenfold safety factor is unnecessary.

VII. Determination of Safety

    Based on the conformance to the criteria used to identify a low-
risk polymer, EPA concludes that there is a reasonable certainty of no
harm to the U.S. population, including infants and children, from
aggregate exposure to residues of polyethylene glycol.

VIII. Other Considerations

A. Existing Exemptions From a Tolerance

    [alpha]-Hydro-[omega]-hydroxypoly(oxyethylene), minimum molecular
weight (in amu), 100,000 is exempted from the requirement of a
tolerance under 40 CFR 180.960 when used as an inert ingredient in
pesticide chemical formulations.

B. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

C. 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 U.N. 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 polyethylene glycol.

IX. Conclusion

    Accordingly, EPA finds that exempting residues of polyethylene
glycol from the requirement of a tolerance will be safe.

X. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the requirement of a
tolerance under section 408(d) of FFDCA in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these rules from review under Executive Order 12866, entitled
Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because
this final rule has been exempted from review under Executive Order
12866, this final rule 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 final rule 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 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 of 1995 (NTTAA), Public Law 104-113, section 12(d) (15
U.S.C. 272 note).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, 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 final rule 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 section 408(n)(4) of FFDCA. 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, or otherwise have any unique
impacts on local governments. 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 final rule. In addition, this final rule does not impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L.
104-4).
    Although this action does not 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), EPA seeks to achieve
environmental justice, the fair treatment and meaningful involvement of
any group, including minority and/or low-income populations, in the
development, implementation, and enforcement of environmental laws,
regulations, and policies. As such, to the extent that information is
publicly available or was submitted in comments to EPA, the Agency
considered whether groups or segments of the population, as a result of
their location, cultural practices, or other factors, may have atypical
or disproportionately high and adverse human health impacts or
environmental effects from exposure to the pesticide discussed in this
document, compared to the general population.

XI. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. 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 this rule in the Federal
Register. This rule 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: October 31, 2011.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.960, the table is amended by revising the polymer
``[alpha]-Hydro-[omega]-hydroxypoly(oxyethylene), minimum molecular
weight (in amu), 100,000'' to read as follows:

Sec.  [emsp14]180.960  Polymers; exemptions from the requirement of a
tolerance.

* * * * *

------------------------------------------------------------------------
                        Polymer                              CAS No.
------------------------------------------------------------------------

                                * * * * *
[alpha]-Hydro-[omega]-hydroxypoly(oxyethylene),               25322-68-3
 minimum number average molecular weight (in amu),
 17,000...............................................

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

[FR Doc. 2011-29587 Filed 11-15-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 75, Number 11 (Tuesday, January 19, 2010)]
[Notices]
[Pages 2861-2862]
[FR Doc No: 2010-827]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2010-0013; FRL-9104-5]

Board of Scientific Counselors, Executive Committee Meeting--
February 2010

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of meeting.

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

SUMMARY: Pursuant to the Federal Advisory Committee Act, Public Law 92-
463, the Environmental Protection Agency, Office of Research and
Development (ORD), gives notice of a meeting of the Board of Scientific
Counselors (BOSC) Executive Committee.

DATES: The meeting will be held on Thursday, February 4, 2010, from 9
a.m. to 5 p.m., and will continue on Friday, February 5, 2010, from
8:30 a.m. until 12 noon. All times noted are Eastern Standard Time. The
meeting may adjourn early if all business is finished. Requests for the
draft agenda or for making oral presentations at the meeting will be
accepted up to one business day before the meeting.

ADDRESSES: The meeting will be held at the Marriott at Metro Center
hotel, 775 12th Street, NW., Washington, DC 20005. Submit your
comments, identified by Docket ID No. EPA-HQ-ORD-2010-0013, by one of
the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     E-mail: Send comments by electronic mail (e-mail) to:
<EMAIL_ADDRESS>Attention Docket ID No. EPA-HQ-ORD-2010-0013.
     Fax: Fax comments to:<PHONE_NUMBER>, Attention Docket ID
No. EPA-HQ-ORD-2010-0013.
     Mail: Send comments by mail to: Board of Scientific
Counselors, Executive Committee Meeting--February 2010 Docket,
Mailcode: 2822T, 1301 Constitution Avenue, NW., Washington, DC 20004,
Attention Docket ID No. EPA-HQ-ORD-2010-0013.
     Hand Delivery or Courier. Deliver comments to: EPA Docket
Center (EPA/DC), Room 3334, EPA West Building, 1301 Constitution
Avenue, NW., Washington, DC, Attention Docket ID No. EPA-HQ-ORD-2010-
0013. Deliveries are only accepted during the docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2010-0013. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/dockets.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at

the Board of Scientific Counselors, Executive Committee Meeting--
February 2010 Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution
Ave., NW., Washington, DC. 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 ORD Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: The Designated Federal Officer via
mail at: Greg Susanke, Mail Code 8104-R, Office of Science Policy,
Office of Research and Development, Environmental Protection Agency,
1200 Pennsylvania Avenue, NW., Washington, DC 20460; via phone/voice
mail at:<PHONE_NUMBER>; via fax at:<PHONE_NUMBER>; or via e-mail at:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

General Information

    Any member of the public interested in receiving a draft BOSC
agenda or making a presentation at the meeting may contact Greg
Susanke, the Designated Federal Officer, via any of the contact methods
listed in the FOR FURTHER INFORMATION CONTACT section above. In
general, each individual making an oral presentation will be limited to
a total of three minutes.
    Proposed agenda items for the meeting include, but are not limited
to: Executive Committee review of the BOSC Computational Toxicology
Letter report; update on BOSC program review subcommittees (Drinking
Water, Global Change); an ORD briefing on revisions to the program
review process; a briefing from the BOSC Decision Analysis Workgroup
and discussion of draft workgroup product; an ORD update; and future
issues and plans. The meeting is open to the public.
    Information on Services for Individuals with Disabilities: For
information on access or services for individuals with disabilities,
please contact Greg Susanke<PHONE_NUMBER> or<EMAIL_ADDRESS>To
request accommodation of a disability, please contact Greg Susanke,
preferably at least 10 days prior to the meeting, to give EPA as much
time as possible to process your request.

    Dated: January 5, 2010.
Fred Hauchman,
Director, Office of Science Policy.
[FR Doc. 2010-827 Filed 1-15-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 149 (Monday, August 3, 2020)]
[Notices]
[Pages 46657-46658]
[FR Doc No: 2020-16784]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3723]

Watson Laboratories, Inc.; Withdrawal of Approval of an
Abbreviated New Drug Application for Oxycodone Hydrochloride and
Ibuprofen Tablets

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration's (FDA) Center for Drug
Evaluation and Research (CDER) is withdrawing approval of an
abbreviated new drug application (ANDA) for oxycodone hydrochloride and
ibuprofen tablets. The basis for the withdrawal is that the holder of
the ANDA has repeatedly failed to submit the required data to support a
finding of bioequivalence for this ANDA. The holder of the ANDA has
waived its opportunity for a hearing.

DATES: Approval is withdrawn as of August 3, 2020.

FOR FURTHER INFORMATION CONTACT: Jennifer Forde, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6228, Silver Spring, MD 20993-0002, 301-
348-3035.

SUPPLEMENTARY INFORMATION: FDA's Office of Generic Drugs (OGD) approved
ANDA 078394, held by Watson Laboratories, Inc. (Watson),\1\ for a
generic version of oxycodone hydrochloride and ibuprofen tablets, 5
milligrams (mg)/400 mg, under the requirements of section 505(j) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) and
FDA's implementing regulations. The OGD approved ANDA 078394 on
November 26, 2007. In a notice of opportunity for a hearing (NOOH)
published in the Federal Register of October 28, 2019 (84 FR 57739),
CDER notified Watson of CDER's proposal to issue an order, under
section 505(e) of the FD&C Act and Sec.  314.150 (21 CFR 314.150),
withdrawing approval of ANDA 078394 and all amendments and supplements
to it on the grounds that Watson has failed to submit the required
bioequivalence data necessary to demonstrate the bioequivalence of its
drug product.
---------------------------------------------------------------------------

    \1\ In correspondence dated February 23, 2017, Watson notified
FDA that Watson is an indirect, wholly-owned subsidiary of Teva
Pharmaceuticals USA, Inc.
---------------------------------------------------------------------------

    As noted in the October 28, 2019, NOOH, FDA issued a letter to
Watson on August 9, 2011, regarding ANDA 078394 because this drug
product application was supported by bioequivalence studies with the
bioanalytical analysis conducted by Cetero Research at the Houston, TX,
site between April 1, 2005, and June 15, 2010. As FDA noted in its
August 9, 2011 correspondence, inspection findings regarding Cetero
Research's bioequivalence studies raised significant concerns about the
validity of the reported results of the analytical studies conducted
between April 2005 and June 2010 in support of drug applications.
Accordingly, FDA informed Watson that ANDA 078394 needed to be
supplemented by conducting new bioequivalence studies or re-assaying

the samples from the original bioequivalence study. FDA recommended to
Watson that the results of the requested bioequivalence studies or re-
assays be submitted to ANDA 078394 within 6 months of the date of the
August 9, 2011, letter.
    In its October 28, 2019, notice of opportunity for a hearing, CDER
provided Watson with an opportunity to request a hearing to show why
approval of ANDA 078394 should not be withdrawn. No request for a
hearing on this matter was received following publication of the notice
for an opportunity for a hearing in the Federal Register. Failure to
file a written notice of participation and request for a hearing as
required by Sec.  314.200 (21 CFR 314.200) constitutes an election by
Watson not to make use of the opportunity for a hearing concerning the
proposal to withdraw approval of ANDA 078394 and a waiver of any
contentions concerning the legal status of the drug product. We note
that in correspondence dated November 1, 2019, Watson requested
withdrawal of the approval of ANDA 078394 under Sec.  314.150(c) (21
CFR 314.150(c)). Because this application withdrawal is effectuated
through the notice-of-opportunity-for-a-hearing process (see 84 FR
57739), Watson's request to withdraw approval under Sec.  314.150(c) is
moot.
    FDA finds that Watson has repeatedly failed to submit the required
data to support a finding of bioequivalence for ANDA 078394. In
addition, under Sec.  314.200, FDA finds that Watson has waived any
contentions concerning the legal status of the drug product. Therefore,
under section 505(e) of the FD&C Act, approval of ANDA 078394, and all
amendments and supplements thereto, is withdrawn (see DATES).
Introduction or delivery for introduction of this drug product into
interstate commerce without an approved application is illegal and
subject to regulatory action (see sections 505(a) and 301(d) of the
FD&C Act (21 U.S.C. 355(a), 331(d))).

    Dated: July 28, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-16784 Filed 7-31-20; 8:45 am]
BILLING CODE 4164-01-P