                United States	EPA 745B18002 April 2021
                Environmental Protection Agency	Office of Chemical
                                                Safety and Pollution Prevention

   Access to Toxic Substances Control Act Confidential Business Information:

A guide for access to TSCA CBI for medical and environmental professionals in non-emergency situations

                                        April 2021
Disclaimer:
This Guidance does not constitute rulemaking by the United States Environmental Protection Agency, and cannot be relied on to create a substantive or procedural right enforceable by any party in litigation with the United States.  Non-mandatory language such as "should" provides recommendations and does not impose any legally binding requirements.
The Toxic Substances Control Act statutory provisions and EPA regulations described in this document contain legally binding requirements for access to TSCA Confidential Business Information.  This document is not a regulation itself, nor does it change or substitute those provisions and regulations. While EPA has made every effort to ensure the accuracy of the discussion in this guidance, the obligations of EPA and the regulated community are determined by statutes, regulations, or other legally binding requirements, which supersede this guidance document.
Interested persons are free to raise questions and objections about the substance of this guidance and the appropriateness of the application of this guidance to a particular situation.  EPA may make changes in this document at any time without prior public notice.

Paperwork Reduction Act Notice:
This collection of information is approved by OMB under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. (OMB Control No. 2070-0209). Responses to this collection of information are mandatory for certain persons, as specified in TSCA Section 14(d). An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The public reporting and recordkeeping burden for this collection of information is estimated to be 14.8 hours per response. Send comments on the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to the Regulatory Support Division Director, U.S. Environmental Protection Agency (2821T), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. Include the OMB control number in any correspondence. Do not send the completed form to this address.

Preface:
The Toxic Substances Control Act of 1976 (TSCA) was amended in June of 2016.  The amendments, known as the Frank R. Lautenberg Chemical Safety for the 21st Century Act, changed and expanded many parts of TSCA.  Among these changes, under TSCA section 14(d) (15 U.S.C. 2613(d)), is an expansion of the categories of people who may now access TSCA confidential business information (CBI).  TSCA CBI is information submitted to EPA under TSCA for which a business has made a claim of business confidentiality.  This information is protected from disclosure until the business withdraws the CBI claim, until the CBI claim expires, until EPA determines that the claim is not entitled to confidential treatment, or as authorized under TSCA and EPA regulations.  Under section 14(d)(5) (15 U.S.C. 2613(d)(5)), TSCA authorizes disclosure to environmental, health, and medical professionals, if the requester provides a written statement of need and agrees to sign a written confidentiality agreement.  TSCA section 14(c)(4)(B) (15 U.S.C. 2613(c)(4)(B)) requires that EPA develop guidance concerning the "content and form of the statements of need and agreements required" under section 14(d)(4), (5), and (6).  Section 14(d)(5) requires that the statement of need and confidentiality agreement be consistent with this guidance.  Disclosure is further conditioned that the person requesting the information will not use it for any purpose other than the needs asserted in the statement of need, except as otherwise authorized by the confidentiality agreement, or by the person who made the CBI claim.
This document provides guidance for access to TSCA CBI under section 14(d)(5) in a nonemergency situation by the following categories of requesters:
 Health professional employed by a Federal or State agency or Tribal government;
 Environmental professional employed by a Federal or State agency or Tribal government;
      or
 Treating physician or nurse.
This document also provides guidance on how to determine whether the information is necessary for or will assist with nonemergency medical diagnosis or treatment, or response to an environmental release under section 14(d)(5), and addresses the following issues:
 Determining whether you are eligible for access to TSCA CBI under section 14(d)(5);
 How to request access to CBI; and
 What information to provide in the required written statement of need and the confidentiality agreement.
Guidance for states, tribes, subdivisions of states, as well as for medical and environmental professionals and other first responders in an emergency situation, are addressed in separate documents:
Access to Toxic Substances Control Act Confidential Business Information:
A guide for access to TSCA CBI in emergency situations
(Available at: https://www.epa.gov/tsca-cbi/requesting-access-cbi-under-tsca)

Access to Toxic Substances Control Act Confidential Business Information:
A guide for access to TSCA CBI for state, local, and tribal governments
(Available at: https://www.epa.gov/tsca-cbi/requesting-access-cbi-under-tsca)

Table of Contents

 Definitions

 Eligibility for Accessing TSCA CBI in a Nonemergency Situation
 Who may request TSCA CBI in a nonemergency event
 Disclosure in a "nonemergency situation"
 Justification: identifying the reasonable basis

 How to Request and Access CBI
 Where to request CBI
 Verification of eligibility
 Describing the information sought and circumstances of the request
 Written statement of need
 Confidentiality agreement
 Notice and waiting period
 Handling CBI information received from EPA

 Definitions
Environment:  includes water, air, and land and the interrelationship which exists among and between water, air, and land and all living things.
Environmental professional: a Federal, State, or tribal government employee assigned to an agency or other government subdivision principally concerned with protection of the environment, natural resources, wildlife, and/or human health (for example, a state department of environmental quality or environmental protection, or a state department of health).
Health professional: a Federal, State, or tribal government employee assigned to an agency or other government subdivision principally concerned with health matters, such as a state department of health or the federal Department of Health and Human Services.
Nurse: a nurse (e.g., a nurse practitioner, clinical nurse specialist, licensed practical nurse, certified-nurse midwife, registered nurse, or physician's assistant) who is licensed or otherwise legally authorized to provide medical consultation or nursing care to an individual in the State where such services are performed.

Physician: a physician (e.g., a doctor of medicine or osteopathy) who is licensed or otherwise legally authorized to practice medicine and furnish medical treatment to an individual in the State where such services are performed.
Environmental release: any spilling, leaking, pumping, pouring, emitting, emptying, discharging, injecting, escaping, leaching, dumping, or disposing into the environment (including the abandonment or discarding of barrels, containers, and other closed receptacles containing any hazardous substance or pollutant or contaminant).
State: any State of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Canal Zone, American Samoa, the Northern Mariana Islands, or any other territory or possession of the United States.
Tribal government:  any Indian Tribe, band, nation, or community recognized by the United States Secretary of the Interior and exercising substantial governmental duties and powers.

TSCA: the Toxic Substances Control Act, 15 U.S.C. 2601, et seq.
TSCA confidential business information (TSCA CBI): information submitted to EPA under TSCA, for which a business has made a claim of business confidentiality that EPA has not denied, that has not otherwise expired, or that the business has not waived or withdrawn.

 Eligibility for Accessing TSCA CBI in a Nonemergency Situation
Summary

According to TSCA section 14(d)(5), you must meet the following requirements to access TSCA CBI in a nonemergency situation:

Who:  You must be one of the following:

 A health professional employed by a Federal or State agency or tribal government,
 An environmental professional employed by a Federal or State agency or tribal government,
      OR
 A treating physician or nurse.

Justification:  You assert in a statement of need that you have a reasonable basis to suspect that:

  The information is necessary for, or will assist in, either:
 The diagnosis or treatment of 1 or more individuals; or
 Responding to an environmental release or exposure; and
 One or more individuals being diagnosed or treated have been exposed to the chemical substance or mixture concerned or an environmental release of or exposure to the chemical substance or mixture concerned has occurred.

Purpose:  You must agree to use the information exclusively for the health or environmental needs asserted in the statement of need, and to sign a written confidentiality agreement.

Note that EPA cannot disclose the information until after a 15-day notice to the entity that made the CBI claim.

 Who may request TSCA CBI in a nonemergency event

Under TSCA section 14(d)(5), the following persons may request CBI in a nonemergency situation:

 Health professional employed by a Federal or State agency or tribal government;
 Environmental professional employed by a Federal or State agency or tribal government; or
 Treating physician or nurse.

Contractors of State or tribal governments are not considered to be persons "employed by" a State agency or tribal government, and therefore may not be given access as a health or environmental professional.  However, a treating physician or nurse is not required to be employed by a Federal or State agency or tribal government, so a treating physician or nurse who is a contractor may be given access under this section.  In addition, contractors might be eligible to access CBI pursuant to section 14(d)(4) or section 14(d)(6).  For more information, please consult the guidance documents pertaining to those sections, listed in the Preface to this document.

 Disclosure under section 14(d)(5) limited to "nonemergency situations"

Among other conditions, section 14(d)(5) applies in "nonemergency situations" (i.e., any situation that does not qualify as a medical, public health, or environmental emergency within the meaning of section 14(d)(6)(i) or otherwise require the requested information for the purposes set forth in section 14(d)(6)(ii)-(iii)).  For access to CBI in "emergency situations," eligible requesters should consult the procedures set forth in section 14(d)(6), and which are further explained in another guidance document, "Access to Toxic Substances Control Act Confidential Business Information: A guide for access to TSCA CBI in emergency situations."  (Available at: https://www.epa.gov/tsca-cbi/requesting-access-cbi-under-tsca)

In addition, health or environmental professionals employed by a State, political subdivision of a state, or by a tribal government may use the access provisions described in TSCA section 14(d)(4) when requesting access to the CBI for the purposes of administering or enforcing a law.  For more information on section 14(d)(4), please refer to another guidance document, "Access to Toxic Substances Control Act Confidential Business Information: A guide for access to TSCA CBI for state, local, and tribal governments."  (Available at: https://www.epa.gov/tsca-cbi/requesting-access-cbi-under-tsca)

Federal employees seeking to gain access to TSCA CBI should note that TSCA section 14(d)(1) provides for CBI access for federal employees more generally, and may wish to look into whether their agency already has made arrangements with EPA for access to TSCA CBI.

 Justification: identifying the reasonable basis
In order to justify a request for access to TSCA CBI in a nonemergency situation, requesters must attest in a written statement of need that they have a reasonable basis to suspect that:
             The information is necessary for, or will assist in, the diagnosis or treatment of one or more individuals who have been exposed to the chemical substance or mixture concerned
OR
             The information is necessary for, or will assist in, responding to an environmental release or exposure which has occurred with respect to the chemical substance or mixture concerned.
At the time that the request is made, EPA will ask the requester to confirm his/her understanding that the information disclosed to him/her can only be used for the purpose asserted in the written statement of need, except as may be authorized by the terms of the confidentiality agreement, or by the person who made the CBI claim.

 How to Request and Access CBI

 Requesting CBI
To request access to CBI information, contact by mail, fax, or delivery service:
Director, Information Management Division
Office of Pollution Prevention and Toxics
Office of Chemical Safety and Pollution Prevention
William Jefferson Clinton Building
1200 Pennsylvania Avenue, N. W.
Mail Code: 7407M
Washington, DC 20460
      Phone:<PHONE_NUMBER>
      Fax:<PHONE_NUMBER>

Requests may also be emailed.  A current list of staff contacts is maintained on EPA's website, at: https://www.epa.gov/tsca-cbi/requesting-access-cbi-under-tsca.

Requests for access will be evaluated by the EPA Office of Chemical Safety and Pollution Prevention, in consultation with the EPA Office of General Counsel.  Requests will be acknowledged in writing, and a staff point of contact will be provided in the acknowledgement.

EPA is also considering developing an electronic request and access system for TSCA CBI information, using EPA's Central Data Exchange (CDX) platform.  Prospective TSCA CBI requesters will first register for CDX (https://cdx.epa.gov/).  Registering for CDX will provide a means for EPA to verify the requester's identity, and provide an efficient, electronic means of making the request for information.  Instructions for registering with CDX and making electronic requests for CBI access will be made available when such system is developed.
If the request for disclosure is granted, EPA will provide instructions for accessing the data.  In some circumstances, it might be most efficient for EPA to simply provide the information orally, over the phone, and in other circumstances, the information may be provided in writing, and/or via electronic access.
 Verification of eligibility
   When the CBI is requested, EPA must verify that the requester falls within one of the above-mentioned categories of requesters eligible for access to CBI under section 14(d)(5).  To do this, requesters should provide the following information:
 The requester's first and last name
 The requester's position
 The requester's employer and/or affiliation
 The requester's contact information (email address, phone number and/or mailing address)
EPA reserves the right to request further information at the time of the request for the TSCA CBI, or after the TSCA CBI has been released.  Any false statements or misrepresentations made to EPA at the time of the request may result in liability under 18 U.S.C. 1001.
 Describing the information sought and circumstances of the request
Requesters should provide a description of the information requested and the circumstances of the request.  For example, one might request the specific chemical identity information for a chemical publicly identified only by trade name, or health and safety data for a particular substance or class of substances.  The requester should also explain the facts or circumstances surrounding his request (e.g., describe the environmental release or exposure event).  Such details may help EPA to identify information relevant to a particular request, and help to support the assertions in the statement of need.  On reviewing a request for information, EPA may also contact the requester to request further information, or to clarify the request.
In addition, TSCA requires that the requester provide a written statement of need, as well as agree to a written confidentiality agreement.  Note that according to section 14(d)(5)(A), these statements of need and confidentiality agreements must be consistent with this guidance document.
   Written statement of need
According to section 14(d)(5), the written statement of need shall be a statement that the person has a reasonable basis to suspect that:
 the information is necessary for, or will assist in --
 the diagnosis or treatment of one or more individuals; or
 responding to an environmental release or exposure; and
 One or more individuals being diagnosed or treated have been exposed to the chemical substance or mixture concerned, or an environmental release of or exposure to the chemical substance or mixture concerned has occurred.
In their request for information, the requester must include the relevant part of this statement of need.
For a human exposure, the statement of need should be as follows:
      I have a reasonable basis to suspect that the requested information is necessary for, or will assist in, the diagnosis or treatment of one or more individuals, and one or more individuals being diagnosed or treated have been exposed to the chemical substance or mixture concerned.
For an environmental release, the statement of need should be as follows:
      I have a reasonable basis to suspect that the requested information is necessary for, or will assist in, responding to an environmental release or exposure, and an environmental release of or exposure to the chemical substance or mixture concerned has occurred.
            2.  Confidentiality agreement
Prior to disclosure of the information, and as required by section 14(d)(5), persons requesting access to TSCA CBI under these circumstances must also sign a written confidentiality agreement.  The following is a model agreement EPA has developed that fulfills this requirement:
      The undersigned hereby agrees to the following terms and conditions associated with this request for access to and use of confidential business information pursuant to section 14(d)(5) of TSCA:
            I will have access to certain confidential business information (CBI) submitted under the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601, et seq. This access has been granted in accordance with TSCA section 14(d)(5), for the purposes established in that section, and in the statement of need pertaining to this disclosure of TSCA CBI to me.
            The TSCA CBI may be used only for the purposes stated in my statement of need, except as otherwise authorized by the terms of this agreement or by the person who has a CBI claim under TSCA section 14 with respect to this information.  Use of this information for any other purpose than that included in the statement of need will not be undertaken until a separate written statement of need for access to the information has been submitted and access pursuant to that need is granted.
            I understand that under TSCA section 14(h), 15 U.S.C. 2613(h), I am liable for a possible fine and/or imprisonment for up to one year if I willfully disclose TSCA CBI to any person not authorized to receive it.  I further understand that disclosure of CBI is limited by TSCA section 14, and by this agreement, except that medical professionals may disclose the information to their patient or to persons authorized to make medical or health care decisions on behalf of the patient, as set out in section 14(h)(1)(C).
            I understand that I have an obligation to protect any TSCA CBI information provided to me from further disclosure by taking appropriate precautions against loss, theft, or unauthorized disclosure.  For example, physical documents and portable electronic media should be stored in a locked cabinet when not in use, and TSCA CBI should not be duplicated more than is necessary for the purpose of meeting the health or environmental need specified in the request.
      I certify that, to the best of my knowledge, the statements I have made in this agreement and all attachments thereto are true, accurate, and complete.  I acknowledge that any knowingly false or misleading statement may be punishable by fine or imprisonment or both under 18 U.S.C. 1001.
         D.  Notice and waiting period
Once EPA determines that the above requirements have been met, TSCA section 14(g)(2) requires that EPA provide 15 days' notice to the submitter before disclosing the information.
             Handling CBI information received from EPA
The requester should be especially aware that the CBI is only to be disclosed to those who are authorized to receive it.  Persons that willfully disclose such CBI to unauthorized persons are liable for a possible fine and/or imprisonment for up to one year, under section 14(h) of TSCA (except that medical professionals may disclose the information to their patient or to persons authorized to make medical or health care decisions on behalf of the patient, as set out in section 14(h)(1)(C)).
In cases where the CBI information has been provided in written or electronic form, the requester should ensure that the information is secured and stored in such a manner as to prevent disclosure to unauthorized persons.  For example, requesters should consider the following practices:
 Store physical documents and portable electronic media in a locked cabinet when not in use;
 Avoid duplicating TSCA CBI more than is necessary for the purpose of meeting the health or environmental need specified in the request;
 Consistent with applicable legal requirements, destroy written or electronic copies once the need for the information subsides (by, for example, shredding, burning, or degaussing);
 Report to EPA the loss of documents or possible disclosure to unauthorized persons.

Medical professionals who disclose CBI to their patient or to persons authorized to make medical or health care decisions on behalf of their patient should also consider documenting the fact and circumstances of this disclosure.  At the time of disclosure, medical professionals making such disclosure should communicate the fact that the information has been claimed as confidential by a business to their patient or other person authorized to make medical or health care decisions on behalf of the patient.


[Federal Register Volume 85, Number 140 (Tuesday, July 21, 2020)]
[Notices]
[Pages 44098-44099]
[FR Doc No: 2020-15729]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1529]

Independent Third-Party Assessment of Investigational New Drug
Food and Drug Administration-Sponsor Communication Practices in
Prescription Drug User Fee Act VI; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
hosting a public meeting entitled ``Independent Third-Party Assessment
of IND FDA-Sponsor Communication Practices in PDUFA VI,'' and an
opportunity for public comment. The meeting will include a presentation
from an independent third-party contractor about its assessment of FDA-
sponsor communications during the investigational new drug (IND) stage
of drug/biologic development in the Prescription Drug User Fee Act
(PDUFA) VI; a series of presentations by and a panel discussion with
invited regulatory and industry representatives, and an open public
comment period. This meeting is intended to satisfy FDA's commitment to
host a public meeting about the assessment no later than March 2021.

DATES: The public meeting will be held on August 11, 2020, from 9:30
a.m. to 12:30 p.m. and will take place virtually by webcast only.
Registration to attend the meeting and other information can be found
at https://indassessmentmeeting.eventbrite.com. See the SUPPLEMENTARY
INFORMATION section for registration date and information.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before September 11, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 11, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact

information, or other information that identifies you in the body of
your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-N-1529 for ``Independent Third-Party Assessment of IND FDA-
Sponsor Communication Practices in PDUFA VI; Public Meeting; Request
for Comments.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Kimberly Taylor,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    This public meeting is intended to meet performance commitments
included in PDUFA VI. This user fee program was reauthorized as part of
the FDA Reauthorization Act of 2017 (FDARA), signed by the President on
August 18, 2017. The complete set of performance goals for PDUFA is
available at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf.
    Section I.I of the PDUFA VI goals (``PDUFA Reauthorization
Performance Goals and Procedures Fiscal Years 2018 Through 2022'' (p.
21)), entitled ``Enhancing Regulatory Science and Expediting Drug
Development,'' details FDA's commitments to promote innovation through
enhanced communication between FDA and sponsors during drug
development; it also describes FDA's commitment to contract with an
independent third party to assess FDA-sponsor communication practices
during the IND stage of drug/biologic development in PDUFA VI and
identify best practices and areas for improvement. An independent
third-party contractor, Eastern Research Group, Inc., has completed the
assessment of FDA-sponsor communication practices during the IND stage
of drug/biologic development in PDUFA VI. FDA has published the report
to its website at https://www.fda.gov/media/138379/download.

II. Topics for Discussion at the Public Meeting

    This meeting will provide FDA with the opportunity to share the
independent third-party assessment of FDA-sponsor communications during
the IND stage of drug/biologic development in PDUFA VI. This meeting
will also be an opportunity to share any challenges and lessons learned
relating to communications between FDA and IND sponsors. The format of
the meeting will consist of a presentation of assessment results,
followed by a series of presentations by and a panel discussion with
invited regulatory and industry representatives regarding their
experiences with and approaches to communications during the IND stage
of drug development. The meeting will conclude with an open public
comment period.

III. Attending the Public Meeting

    Registration: To register for the public meeting, please visit the
following website: https://indassessmentmeeting.eventbrite.com. Please
provide complete contact information for each attendee, including name,
title, affiliation, address, email, and telephone.
    Persons interested in attending this public meeting must register
by August 10, 2020, at 11:59 p.m. Eastern Time. Registrants will
receive confirmation once they have been accepted.
    Streaming Webcast of the Public Meeting: The webcast for this
meeting will be available to registrants. If you have never attended a
Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a
quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview. FDA has verified the website addresses in this
document, as of the date this document publishes in the Federal
Register, but websites are subject to change over time.
    Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff,
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852,<PHONE_NUMBER>.

    Dated: July 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15729 Filed 7-20-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 207 (Monday, October 26, 2020)]
[Proposed Rules]
[Pages 67694-67696]
[FR Doc No: 2020-23446]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0967; Product Identifier 2018-SW-013-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters Deutschland GmbH
Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for Airbus Helicopters Deutschland GmbH Model MBB-BK117 A-1, MBB-BK117
A-3, MBB-BK117 A-4, MBB-BK117 B-1, MBB-BK117 B-2, MBB-BK117 C-1, and
MBB-BK117 C-2 helicopters. This proposed AD would require inspecting
the tail gearbox (TGB) bellcrank attachment arm (arm) for a crack. This
proposed AD was prompted by a report of a cracked TGB arm. The actions
of this proposed AD are intended to address an unsafe condition on
these products.

DATES: The FAA must receive comments on this proposed AD by December
10, 2020.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to https://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments 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 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0967; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this proposed AD, the European Aviation Safety Agency (now European
Union Aviation Safety Agency) (EASA) AD, any comments received, and
other information. The street address for Docket Operations is listed
above. Comments will be available in the AD docket shortly after
receipt.
    For service information identified in this proposed rule, contact
Airbus Helicopters, 2701 N Forum Drive, Grand Prairie, TX 75052;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at https://www.airbus.com/helicopters/services/technical-support.html. You may
view the referenced service information at the FAA, Office of the
Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321,
Fort Worth, TX 76177.

FOR FURTHER INFORMATION CONTACT: David Hatfield, Aviation Safety
Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA,
10101 Hillwood Pkwy., Fort Worth, TX

76177; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2020-0967; Product Identifier
2018-SW-013-AD'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this proposal.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to David
Hatfield, Aviation Safety Engineer, Safety Management Section,
Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX
76177; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>Any
commentary that the FAA receives which is not specifically designated
as CBI will be placed in the public docket for this rulemaking.

Discussion

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD No. 2018-0046, dated February 19,
2018, to correct an unsafe condition for Airbus Helicopters Deutschland
GmbH (AHD) (formerly Eurocopter Deutschland GmbH, Eurocopter
Hubschrauber GmbH, Messerschmitt-B[ouml]lkow-Blohm GmbH), Airbus
Helicopters Inc. (formerly American Eurocopter LLC) Model MBB-BK117 A-
1, MBB-BK117 A-3, MBB-BK117 A-4, MBB-BK117 B-1, MBB-BK117 B-2, MBB-
BK117 C-1, and MBB-BK117 C-2 helicopters. The EASA AD advises that a
crack was detected on a Model MBB-BK117 A-4 TGB arm and that this
condition, if not corrected, could result in disconnection of the arm
from the TGB and possible loss of control of the helicopter. To address
this unsafe condition, the EASA AD requires an inspection of the TGB
arm for a crack and for surface anomalies.

FAA's Determination

    These helicopters have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA about the
unsafe condition described in its AD. The FAA is proposing this AD
after evaluating all known relevant information and determining that an
unsafe condition is likely to exist or develop on other products of the
same type design.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Airbus Helicopters Alert Service Bulletin (ASB)
MBB-BK117 C-2-65A-008 for Model MBB-BK117 C-2 helicopters and ASB MBB-
BK117-30A-120 for Model MBB-BK117 A-1, MBB-BK117 A-3, MBB-BK117 A-4,
MBB-BK117 B-1, MBB-BK117 B-2, and MBB-BK117 C-1 helicopters, each
Revision 0 and dated January 31, 2018. The service information contains
procedures for inspecting the TGB arm for a crack and surface
anomalies.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Proposed AD Requirements

    This proposed AD would require the following:
     Within 100 hours time-in-service, removing the surface
coating from the TGB bellcrank attachment arm and using a 5X or higher
power magnifying glass, dye-penetrant inspecting the TGB arm for a
crack and for any dent, nick, and scratch.
     If there is a crack, before further flight, replacing the
TGB.
     If there is a dent, nick, or scratch, before further
flight, removing the surface material up to 0.2 mm using 80-grit
abrasive paper and repeating the dye penetrant inspection. If there is
a crack or if the damage cannot be removed, before further flight,
replacing the TGB.
     If there is no crack and no dent, nick, or scratch, before
further flight, finishing the surface with 600-grit or finer abrasive
paper.

Differences Between This Proposed AD and the EASA AD

    The EASA AD requires operators to contact Airbus Helicopters if
there is a crack or if there is damage that cannot be repaired by
removing surface material. This proposed AD would require replacing the
TGB instead.

Costs of Compliance

    The FAA estimates that this proposed AD would affect 177
helicopters of U.S. Registry. Labor rates are estimated at $85 per
work-hour. Based on these numbers, the FAA estimates that operators may
incur the following costs in order to comply with this proposed AD.
    Removing the surface protection and inspecting the TGB arm for a
crack would take about 2 work-hours and the cost of materials would be
minimal, for an estimated cost of $170 per helicopter and $30,090 for
the U.S. fleet.
    If required, reworking the TGB arm would take about 1 work-hour and
the cost of materials would be minimal, for an estimated cost of $85
per helicopter. Replacing a TGB with a cracked arm would take about 4.5
work-hours and cost about $69,000 for required parts, for an estimated
cost of $69,383 per helicopter.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or

develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed, I certify this proposed regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866,
    2. Will not affect intrastate aviation in Alaska, and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

Airbus Helicopters Deutschland GmbH: Docket No. FAA-2020-0967;
Product Identifier 2018-SW-013-AD.

(a) Applicability

    This airworthiness directive (AD) applies to Airbus Helicopters
Deutschland GmbH Model MBB-BK117 A-1, MBB-BK117 A-3, MBB-BK117 A-4,
MBB-BK117 B-1, MBB-BK117 B-2, MBB-BK117 C-1, and MBB-BK117 C-2
helicopters, certificated in any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as a crack in a tail
gearbox (TGB) bellcrank attachment arm. This condition could result
in disconnection of the bellcrank attachment arm from the TGB and
subsequent loss of control of the helicopter.

(c) Comments Due Date

    The FAA must receive comments by December 10, 2020.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    Within 100 hours time-in-service:
    (1) Remove the surface coating from the TGB bellcrank attachment
arm and using a 5X or higher power magnifying glass, dye-penetrant
inspect the TGB arm for a crack and for any dent, nick, and scratch
in the area shown in Figure 1 of Airbus Helicopters Alert Service
Bulletin (ASB) MBB-BK117 C-2-65A-008 or ASB MBB-BK117-30A-120, each
Revision 0 and dated January 31, 2018, as applicable to your model
helicopter.
    (2) If there is a crack, before further flight, replace the TGB.
    (3) If there is a dent, a nick, or a scratch, before further
flight, remove the surface material up to 0.2 mm using 80-grit
abrasive paper and repeat the dye penetrant inspection. If there is
a crack or if the damage cannot be removed, before further flight,
replace the TGB.
    (4) If there is no crack and no dent, nick, or scratch, before
further flight, finish the surface with 600-grit or finer abrasive
paper.

(f) Special Flight Permits

    Special flight permits are prohibited.

(g) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Rotorcraft Standards Branch, FAA, may approve
AMOCs for this AD. Send your proposal to: David Hatfield, Aviation
Safety Engineer, Safety Management Section, Rotorcraft Standards
Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone
817-222-5110; email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, the FAA suggests
that you notify your principal inspector, or lacking a principal
inspector, the manager of the local flight standards district office
or certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(h) Additional Information

    The subject of this AD is addressed in European Aviation Safety
Agency (now European Union Aviation Safety Agency) (EASA) AD No.
2018-0046, dated February 19, 2018. You may view the EASA AD on the
internet at https://www.regulations.gov in the AD Docket.

 (i) Subject

    Joint Aircraft Service Component (JASC) Code: 6520, Tail Rotor
Gearbox.

    Issued on October 19, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-23446 Filed 10-23-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 83 (Thursday, April 30, 2015)]
[Rules and Regulations]
[Pages 24213-24216]
[FR Doc No: 2015-10122]

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

40 CFR Parts 52

[EPA-R06-OAR-2014-0846; FRL-9927-10-Region 6]

Approval and Promulgation of Implementation Plans; Texas;
Revisions to the State Implementation Plan; Stage I Regulations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is taking a direct
final action to approve revisions to the Texas State Implementation
Plan (SIP) related to Stage I Regulations that were submitted by the
State of Texas on November 12, 2014. The EPA evaluated the SIP
submittal from Texas and determined these revisions are consistent with
the requirements of the Clean Air Act (Act or CAA). The EPA is
approving this action under the federal CAA.

DATES: This direct final rule is effective on June 29, 2015 without
further notice, unless the EPA receives relevant adverse comment by
June 1, 2015. If the EPA receives such comment, the EPA will publish a
timely withdrawal in the Federal Register informing the public that
this rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R06-
OAR-2014-0846, by one of the following methods:
    (1) www.regulations.gov: Follow the on-line instructions.
    (2) Email: Ms. Tracie Donaldson at<EMAIL_ADDRESS>    (3) Mail or Delivery: Ms. Tracie Donaldson, Air Permits Section
(6PD-R), Environmental Protection Agency, 1445 Ross Avenue, Suite 1200,
Dallas, Texas 75202-2733.
    Instructions: Direct your comments to Docket ID No. EPA-R06-OAR-
2014-0846. 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 the
disclosure of which is restricted by statute. Do not submit information
through http://www.regulations.gov or email, if you believe that it is
CBI or otherwise protected from disclosure. The http://www.regulations.gov Web site is an ``anonymous access'' system, which
means that the EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an email
comment directly to the EPA without going through http://www.regulations.gov, your email 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, the EPA recommends that you include your name and other
contact information in the body of your comment along with any disk or
CD-ROM submitted. If the EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, the EPA may not
be able to consider your comment. Electronic files should avoid the use
of special characters and any form of encryption and should be free of
any defects or viruses. For additional information about the EPA's
public docket, visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: The index to the docket for this action is available
electronically at www.regulations.gov and in hard copy at EPA Region 6,
1445 Ross Avenue, Suite 700, Dallas, Texas. While all documents in the
docket are listed in the index, some information may be publicly
available only at the hard copy location (e.g., copyrighted material),
and some may not be publicly available at either location (e.g., CBI).

FOR FURTHER INFORMATION CONTACT:  Ms. Tracie Donaldson,<PHONE_NUMBER>,
<EMAIL_ADDRESS>To inspect the hard copy materials, please
schedule an appointment with Ms. Donaldson or Mr. Bill Deese at (214)
665-7253.

SUPPLEMENTARY INFORMATION: Throughout this document wherever ``we,''
``us,'' or ``our'' is used, we mean the EPA.

Table of Contents

I. Background
    A. CAA and SIPs
    B. Why do we regulate VOCs?
    C. What is Stage I Vapor Recovery?
    D. SIP Revision Submitted on November 12, 2014
II. EPA's Evaluation
III. Final Action
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. Background

A. CAA and SIPs

    Section 110 of the CAA requires states to develop and submit to the
EPA a SIP to ensure that state air quality meets National Ambient Air
Quality Standards (NAAQS). The NAAQS currently address six criteria
pollutants: Carbon monoxide, nitrogen dioxide, ozone, lead, particulate
matter, and sulfur dioxide. Each federally-approved SIP protects air
quality primarily by addressing air pollution at its point of origin
through air pollution regulations and control strategies. The EPA-
approved SIP provisions and control strategies are federally
enforceable. States revise the SIP as needed and submit revisions to
the EPA for review and approval.

B. Why do we regulate VOCs?

    Volatile Organic Compound is a term used to describe a class of
chemicals that react in the atmosphere in the presence of sunlight to
form ozone. Sources include vehicle exhaust, gasoline vapors, oil-based
paints and industrial operations. A regulatory definition of Volatile
Organic Compounds can be found at 40 CFR 51.100(s). The definition in
Texas can be found in 30 TAC 115.10. Oxygen in the atmosphere reacts
with VOCs and Oxides of Nitrogen to form ozone, a key component of
urban smog. Inhaling even low levels of ozone can trigger a variety of
health problems including chest pains, coughing, nausea, throat
irritation, and congestion. It also can worsen bronchitis and asthma.
Exposure to ozone can also reduce lung capacity in healthy adults.

C. What is Stage I Vapor Recovery?

    Capturing the vapors from the gasoline station storage tanks as
tank-trucks fill these tanks, and returning the vapors to the tank-
truck is commonly known as Stage I vapor recovery. The tank-truck then
carries the vapors back to the bulk gasoline plant or terminal. To
insure the vapors are not lost in transit, the Texas rules also include
requirements that the gasoline tank-trucks be tested for vapor
tightness. We are approving the vapor recovery requirements and the
vapor tightness requirements.

D. SIP Revision Submitted on November 12, 2014

    On September 10, 2014, Texas Commission on Environmental Quality
(TCEQ) adopted revisions to 30 Texas Administrative Code (TAC) Chapter
115, Control of Air Pollution from Volatile Organic Compounds,

Subchapter A. Definitions and Subchapter C. Volatile Organic Compound
Transfer Operations. This review will determine if the changes to the
Texas SIP are consistent with the requirements of the Clean Air Act and
EPA's policy and guidance.

II. EPA's Evaluation

    As detailed in the Technical Support Document (TSD) accompanying
this action, the TCEQ submitted a SIP revision to the Stage I
regulations found in 30 TAC 115, Subchapter A. Definitions and
Subchapter C. Volatile Organic Compound Transfer Operations. The TCEQ
adopted amended sections 115.10, 115.221, 115.222, 115.224-115.227 and
115.229 of 30 TAC Chapter 115, Control of Air Pollution from Volatile
Organic Compounds and corresponding revisions to the state
implementation plan. The revisions preserve existing Stage I testing
requirements in the 1997 ozone nonattainment counties and specify Stage
I testing requirements for gasoline dispensing facilities located in
the 12 ozone nonattainment counties and 4 ozone maintenance counties
that will be affected by the decommissioning of the Stage II vapor
recovery equipment rule revision and in the 95 counties that are
subject to the state Stage I rule but not Stage II requirements. The
adopted revisions also establish testing requirements that are more
consistent with federal Stage I testing in 40 CFR part 63, subpart
CCCCCC and are more appropriate for Stage I facilities.
    Previously, in separate actions, we found that Texas' Stage I
regulations meet Reasonably Available Control Technology (RACT)
requirements for the 1997 ozone standard in Dallas-Fort Worth area
(January 14, 2009, 74 FR 1903) and for the Houston-Galveston-Brazoria
area (April 2, 2013, 63 FR 19599). The current revisions update RACT
where applicable for 1997 ozone nonattainment counties in Texas.
    The revisions will enhance the EPA-approved SIP because they will
not result in any loss in emission reductions, will become more
enforceable with the test methods in place and will be more consistent
with the federal Stage I testing requirements; therefore, we are
approving them into the Texas SIP.

III. Final Action

    For the reasons stated above and in the TSD, the EPA is taking
direct final action to approve revisions to the Texas SIP pertaining to
Stage I regulations at 30 TAC, Chapter 115, Subchapter A: Definitions,
Section 115.10 and Subchapter C, Division 2: Filling of Gasoline
Storage Vessels (Stage I) for Motor Vehicle Fuel Dispensing Facilities,
Sections 115.221, 115.222, 115.224-115.227 and 115.229, adopted on
September 10, 2014, and submitted as revisions to the Texas SIP on
November 12, 2014.
    We are approving the revisions to the Texas SIP under section 110
of the Act. We are publishing this rule without prior proposal because
we view this as a noncontroversial amendment and anticipate no relevant
adverse comments. However, in the proposed rules section of this
Federal Register publication, we are publishing a separate document
that will serve as the proposal to approve the SIP revision if relevant
adverse comments are received. This rule will be effective on June 29,
2015 without further notice unless we receive relevant adverse comment
by June 1, 2015. If we receive relevant adverse comments, we will
publish a timely withdrawal in the Federal Register informing the
public that the rule will not take effect. We will address all public
comments in a subsequent final rule based on the proposed rule. We will
not institute a second comment period on this action. Any parties
interested in commenting must do so now. Please note that if we receive
adverse comment on an amendment, paragraph, or section of this rule and
if that provision may be severed from the remainder of the rule, we may
adopt as final those provisions of the rule that are not the subject of
an adverse comment.

IV. Incorporation by Reference

    In this direct final rule, the EPA is finalizing regulatory text
that includes incorporation by reference. In accordance with
requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by
reference of the Texas Stage I requirements described in the Final
Action section above. The EPA has made, and will continue to make,
these documents generally available electronically through
www.regulations.gov and/or in hard copy at the appropriate EPA office
(see the ADDRESSES section of this preamble for more information).

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the Clean Air Act. Accordingly,
this action merely approves state law as meeting Federal requirements
and does not impose additional requirements beyond those imposed by
state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

The SIP is not approved to apply on any Indian reservation land or in
any other area where the EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications and will not impose substantial direct
costs on tribal governments or preempt tribal law as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the

Congress and to the Comptroller General of the United States. The EPA
will submit a report containing this action and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. A major rule cannot take effect until
60 days after it is published in the Federal Register. This action is
not a ``major rule'' as defined by 5 U.S.C. 804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by June 29, 2015. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposed of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

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

    Dated: April 22, 2015.
Ron Curry,
Regional Administrator, Region 6.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart SS--Texas

0
2. In Sec.  52.2270(c), the table titled ``EPA Approved Regulations in
the Texas SIP'' is amended by adding, in sequential order, the entry
for section 115.221; and revising the entries for sections 115.10,
115.222, 115.224 through 115.227, and 115.229 to read as follows:

Sec.  52.2270  Identification of plan.

* * * * *
    (c) * * *

                                    EPA-Approved Regulations in the Texas SIP
----------------------------------------------------------------------------------------------------------------
                                                       State
     State citation            Title/subject         approval/       EPA approval date          Explanation
                                                  submittal date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                  Chapter 115 (Reg 5)--Control of Air Pollution From Volatile Organic Compounds
                                            Subchapter A--Definitions
----------------------------------------------------------------------------------------------------------------
115.10..................  Definitions...........       9/10/2014  4/30/2015 [Insert FR
                                                                   citation].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                           Subchapter C--Volatile Organic Compound Transfer Operations
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
     Division 2: Filling of Gasoline Storage Vessels (Stage I) for Motor Vehicle Fuel Dispensing Facilities
----------------------------------------------------------------------------------------------------------------
115.221.................  Emission                     9/10/2014  4/30/2015 [Insert FR
                           Specifications.                         citation].
115.222.................  Control Requirements..       9/10/2014  4/30/2015 [Insert FR
                                                                   citation].

                                                  * * * * * * *
115.224.................  Inspection                   9/10/2014  4/30/2015 [Insert FR
                           Requirements.                           citation].
115.225.................  Testing Requirements..       9/10/2014  4/30/2015 [Insert FR
                                                                   citation].
115.226.................  Recordkeeping                9/10/2014  4/30/2015 [Insert FR
                           Requirements.                           citation].
115.227.................  Exemptions............       9/10/2014  4/30/2015 [Insert FR
                                                                   citation].
115.229.................  Counties and                 9/10/2014  4/30/2015 [Insert FR
                           Compliance Schedules.                   citation].

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

* * * * *

[FR Doc. 2015-10122 Filed 4-29-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: April 12, 2010 (Volume 75, Number 69)]
[Notices]
[Page 18497]
[DOCID:fr12ap10-49]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR10-13-000; PR03-17-000]

Chevron Keystone Gas Storage, LLC; Notice of Notification of
Change in Market Power Analysis and Request for Renewed Approval of
Market-Based Rates

April 5, 2010.
    Take notice that on March 31, 2010, Chevron Keystone Gas Storage,
LLC (Keystone) filed pursuant to section 284.504 of the Commission's
regulations and the January 23, 2004 Commission order in Docket No.
PR03-17-000, a notification of change in market power analysis and
request for renewed approval of market-based rates for its storage and
hub services, including wheeling services, provided under its limited
jurisdiction certificate.
    Any person desiring to participate in this rate proceeding must
file a motion to intervene or a protest in accordance with Rules 211
and 214 of the Commission's Rules of Practice and Procedure (18 CFR
385.211 and 385.214). Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Any person wishing to
become a party must file a notice of intervention or motion to
intervene, as appropriate. Such notices, motions, or protests must be
filed on or before the date as indicated below. Anyone filing an
intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern time April 19, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-8215 Filed 4-9-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: April 4, 2007 (Volume 72, Number 64)]
[Notices]
[Page 16352-16356]
[DOCID:fr04ap07-61]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0936; FRL-8119-2]

Notice of Filing of Pesticide Petitions for Residues of Pesticide
Chemicals in or on Various Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of pesticide
petitions proposing the establishment or modification of regulations
for residues

of pesticide chemicals in or on various commodities.

DATES: Comments must be received on or before May 4, 2007.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the pesticide petition number (PP) of interest, 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'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>.
    Instructions: Direct your comments to the assigned docket ID number
and the pesticide petition number of interest. EPA's policy is that all
comments received will be included in the docket without change and may
be made available on-line 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
regulations.gov or e-mail. The regulations.gov website 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 regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the 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.
    Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket

Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
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, is not placed on the Internet and will be publicly available
only in hard copy. Publicly available docket materials are available
electronically 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
hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: The person listed at the end of the
pesticide petition summary of interest.

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 at the end of the pesticide petition
summary of interest.

B. What Should I Consider as I Prepare My Comments for EPA?

     1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
     2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Docket ID Numbers

    When submitting comments, please use the docket ID number and the
pesticide petition number of interest, as shown in the table.

------------------------------------------------------------------------
                 PP number                        Docket ID number
------------------------------------------------------------------------
PP 3E6562                                   EPA-HQ-OPP-2007-0107
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PP 6E7138                                   EPA-HQ-OPP-2007-0107
------------------------------------------------------------------------

PP 6E7129                                   EPA-HQ-OPP-2007-0106
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PP 6E7152                                   EPA-HQ-OPP-2007-0116
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PP 6E7163                                   EPA-HQ-OPP-2007-0105
------------------------------------------------------------------------
PP 6E7165                                   EPA-HQ-OPP-2007-0117
------------------------------------------------------------------------
PP 5E6962                                   EPA-HQ-OPP-2005-0305
------------------------------------------------------------------------
PP 5E7007                                   EPA-HQ-OPP-2005-0305
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PP 6E7164                                   EPA-HQ-OPP-2007-0115
------------------------------------------------------------------------
PP 6E7168                                   EPA-HQ-OPP-2007-0114
------------------------------------------------------------------------
PP 5E6996                                   EPA-HQ-OPP-2005-0306
------------------------------------------------------------------------

III. What Action is the Agency Taking?

    EPA is printing notice of the filing of pesticide petitions
received under section 408 of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a, proposing the establishment or modification of
regulations in 40 CFR part 180 for residues of pesticide chemicals in
or on various food commodities. EPA has determined that the pesticide
petitions described in this notice contain data or information
regarding the elements set forth in FFDCA section 408(d)(2); however,
EPA has not fully evaluated the sufficiency of the submitted data at
this time or whether the data support granting of the pesticide
petitions. Additional data may be needed before EPA rules on these
pesticide petitions.
    Pursuant to 40 CFR 180.7(f), a summary of each of the petitions
included in this notice, prepared by the petitioner, is included in a
docket EPA has created for each rulemaking. The docket for each of the
petitions is available on-line at http://www.regulations.gov.

Amendment to Existing Tolerances

    1. PPs 3E6562 and 6E7138. (Docket ID number EPA-HQ-OPP-2007-0107).
Interregional Research Project Number 4 (IR-4), 500 College Road East,
Suite 201 W, Princeton, NJ 08540, proposes to amend 40 CFR 180.443 by
establishing tolerances for residues of the fungicide myclobutanil in
or on the food commodities in PP 3E6562: Black sapote, canistel, mamey
sapote, mango, papaya, sapodilla, and star apple at 3.0 parts per
million (ppm); and in PP 6E7138: Fruiting vegetables, crop group 8,
except tomato at 4.5 ppm; leafy vegetables, crop subgroup 4A, except
spinach at 11.0 ppm; globe artichoke at 0.9 ppm; cilantro at 11.0 ppm;
and okra at 4.5 ppm. The residue analytical method used was Rohm and
Haas Company method 34S-88-10, ``RH-3866 total residue analytical
method for apple, and grape'' for artichokes, lettuce, pepper, and
tropical fruits; and Rohm and Haas method TR34S-88-21, ``Analytical
method for the measure of RH-3866 in various crops, soil, meat, milk
and eggs''. The lowest level of method validation (LLMV) in this study
was 0.01 ppm for each analyte. Based on recoveries of samples fortified
at the LLMV, the limit of detection (LOD) and the limit of quantitation
(LOQ) were estimated as 0.0036 ppm and 0.011 ppm; respectively, for
myclobutanil as 0.018 ppm and 0.054 ppm; respectively, for RH-9090.
Contact: Barbara Madden, telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>    2. PP 6E7129. (Docket ID number EPA-HQ-OPP-2007-0106).
Interregional Research Project Number 4 (IR-4), 500 College Road East,
Suite 201 W, Princeton, NJ 08540, proposes to amend 40 CFR 180.361 by
establishing tolerances for residues of the herbicide pendimethalin,
[N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine] and its
metabolite 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl alcohol
in or on the food commodities Brassica, head and stem, subgroup 5A at
0.05 ppm; grape at 0.05 ppm; artichoke, globe at 0.05 ppm; and
asparagus at 0.1 ppm. The analytical method in plants is aqueous
organic solvent extraction, column clean-up, and quantitation by gas
chromatography (GC). The method has a LOQ of 0.05 ppm for pendimethalin
and the alcohol metabolite. Contact: Barbara Madden, telephone number:
(703) 305-6463; e-mail address<EMAIL_ADDRESS>    3. PP 6E7152. (Docket ID number EPA-HQ-OPP-2007-0116).
Interregional Research Project Number 4 (IR-4), 500 College Road East,
Suite 201 W, Princeton, NJ 08540, proposes to amend 40 CFR 180.361 by
establishing tolerances for residues of the herbicide dimethenamid,
(R,S)-2-chloro-N-[(1-methyl-2-methoxy) ethyl]-N-(2,4-dimethyl-thien-3-
yl)-acetamide in or on the food commodities squash, winter at 0.01 ppm;
pumpkin at 0.01 ppm; radish, roots at 0.01 ppm; radish, tops at 0.01
ppm; turnip, roots at 0.01 ppm; turnip, tops at 0.01 ppm; rutabaga,
roots at 0.01 ppm; rutabaga, tops at 0.01 ppm; and hops, dried cones
0.05 ppm. The proposed analytical method uses extraction and clean-up
followed by quantification with capillary column GC using thermionic
nitrogen specific detector. A gas spectrometry/mass spectrometry (GS/
MS) method for identification is also available. This method is not
selective towards the dimethenamid isomer and is therefore valid for
residues from both racemic dimethenamid and the enriched isomer
dimethenamid-P. Tolerances are proposed based on a non-isomer specific
basis. Contact: Shaja Brothers, telephone number:<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>    4. PP 6E7163. (Docket ID number EPA-HQ-OPP-2007-0105).
Interregional Research Project Number 4 (IR-4), 500 College Road East,
Suite 201 W, Princeton, NJ 08540, proposes to amend 40 CFR 180.578 by
establishing tolerances for residues of the insecticide acetamiprid,
N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-methylacetamidine in or on
the food commodities strawberry, bearberry, bilberry, lowbush
blueberry, cloudberry, cranberry, ligonberry, muntries, and
partridgeberry at 0.60 ppm. Based upon the metabolism of acetamiprid in
plants and the toxicology of the parent, and metabolites quantification
of the parent acetamiprid is sufficient to determine toxic residues. As
a result, a method has been developed which involves extraction of
acetamiprid from crops with methanol and analysis by liquid
chromatography/tandem mass spectrometry (LC/MS/MS) methods. The LOQ and
the LOD for the method are calculated to be 0.002 ppm and 0.0008 ppm
for strawberries, respectively. The LLMV for strawberries was 0.01 ppm
for acetamiprid. Contact: Barbara Madden, telephone number: (703) 305-
6463; e-mail address<EMAIL_ADDRESS>    5. PP 6E7165. (Docket ID number EPA-HQ-OPP-2007-0117).
Interregional Research Project Number 4 (IR-4), 500 College Road East,
Suite 201 W, Princeton, NJ 08540, proposes to amend 40 CFR 180.582 by
establishing tolerances for residues of the fungicide pyraclostrobin,
(carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]
phenyl]methoxy-, methyl ester) and its metabolite (methyl-N-[[[1-(4-
chlorophenyl) pyrazol-3-yl]oxy]o-tolyl] carbamate) (BF 500-3) expressed
as parent compound in or on the food commodities herbs, fresh at 30.0
ppm; avocado at 0.7 ppm; mango at 0.7 ppm; papaya at 0.7 ppm; sapote,
black at 0.7 ppm; sapote, mamey at 0.7 ppm; canistel at 0.7 ppm;
sapodilla at 0.7 ppm; and star apple at 0.7 ppm. In plants the method
of analysis is aqueous organic solvent extraction, column clean-up and
quantitation by LC/MS/MS. In animals the method of analysis

involves base hydrolysis, organic extraction, column clean up and
quantitation by LC/MS/MS or derivatization (methylation) followed by
quantitation by GC/MS. Contact: Shaja R. Brothers, telephone number:
(703) 308-3194; e-mail address<EMAIL_ADDRESS>    6. PP 5E6962. (Docket ID number EPA-HQ-OPP-2005-0305).
Interregional Research Project Number 4 (IR-4), 681 U.S. Highway
1 South, North Brunswick, NJ 08902-3390; and Bayer
CropScience, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709,
proposes to amend the tolerances in 40 CFR 180.570 for residues of the
isoxadifen-ethyl (ethyl 5,5-diphenyl-2-isoxazoline -3-carboxylate) and
its metabolite 4,5-dihydro-5,5,diphenyl-3-isoxazolecarboxylic acid when
used as an inert ingredient (safener) in or on the food commodities
corn, field, forage at 0.20 ppm (increased from existing tolerance of
0.10 ppm), and corn, field, stover at 0.40 ppm (increased from existing
tolerance of 0.20 ppm); (request removal of the specified limitation in
seasonal application rate from the existing tolerances); and
isoxadifen-ethyl and its metabolites 4,5-dihydro-5,5,diphenyl -3-
isoxazolecarboxylic acid and [beta]-hydroxy-[beta]-
benzenepropanenitrile when used as an inert ingredient (safener) in or
on the following raw agricultural commodities: Rice, grain at 0.10 ppm;
rice, hulls at 0.50 ppm; and rice, straw at 0.25 ppm (request removal
of the specified limitation in seasonal application rate from the
existing tolerances). The analytical targets selected were the parent
compound, isoxadifen-ethyl and the major metabolite isoxadifen acid (AE
F129431). In rice, AE C637375 and AE F162241 are also determined. After
extraction and cleanup, the analytes are determined by either GC/MS or
HPLC/MS. The LOQ are 0.02 ppm in corn grain, 0.05 ppm in corn forage
and stover, and 0.02 ppm in rice. Contact: Shaja R. Brothers, telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
New Tolerances

    1. PP 5E7007. (Docket ID number EPA-HQ-OPP-2005-0305).
Interregional Research Project Number 4 (IR-4), 681 U.S. Highway
1 South, North Brunswick, NJ 08902-3390; and Bayer
CropScience, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709,
proposing 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 by
establishing a tolerance for residues of isoxadifen-ethyl, (ethyl 5,5-
diphenyl-2-isoxazoline-3-carboxylate) and its metabolite 4,5-dihydro-
5,5,diphenyl-3-isoxazolecarboxylic acid when used as an inert
ingredient (safener) in or on the food commodities corn, sweet, kernel
plus cob with husks removed at 0.05 ppm; corn, sweet, forage at 0.40
ppm; corn, sweet, stover at 0.40 ppm; corn, pop, grain at 0.02 ppm; and
corn, pop, stover at 0.40 ppm. The analytical targets selected were the
parent compound, isoxadifen-ethyl and the major metabolite isoxadifen
acid (AE F129431). In rice, AE C637375 and AE F162241 are also
determined. After extraction and clean-up, the analytes are determined
by either GC/MS or HPLC/MS. The LOQ are 0.02 ppm in corn grain, 0.05
ppm in corn forage and stover, and 0.02 ppm in rice. Contact: Shaja R.
Brothers, telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
    2. PP 6E7164. (Docket ID number EPA-HQ-OPP-2007-0115).
Interregional Research Project Number 4 (IR-4), 500 College Road East,
Suite 201 W, Princeton, NJ 08540, proposes to establish a tolerance for
residues of the fungicide boscalid, (BAS 510F), 3-pyridinecarboxamide,
2-chloro-N-(4'-chloro(1,1'-biphenyl)-2-yl) in or on food commodities
avocado at 1.5 ppm; sapote, black at 1.5 ppm; canistel at 1.5 ppm;
sopote, mamey at 1.5 ppm; mango at 1.5 ppm; papaya at 1.5 ppm;
sapodilla at 1.5 ppm; star apple at 1.5 ppm; and herbs, fresh, subgroup
19A at 60.0 ppm. In plants the parent residue is extracted using an
aqueous organic solvent mixture followed by liquid/liquid partitioning
and a column clean-up. Quantitation is by GC using MS. In livestock the
residues are extracted with methanol. The extract is treated with
enzymes in order to release the conjugated glucuronic acid metabolite.
The residues are then isolated by liquid/liquid partition followed by
column chromatography. The hydroxylated metabolite is acetylated
followed by a column clean-up. The parent and acetylated metabolite are
quantitated by GC with electron capture detection. Contact: Shaja R.
Brothers, telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
    3. PP 6E7168. (Docket ID number EPA-HQ-OPP-2007-0114).
Interregional Research Project Number 4 (IR-4), 500 College Road East,
Suite 201 W, Princeton, NJ 08540, proposes to establish a tolerance for
residues of fluroxypyr MHE, and its metabolite fluroxypyr (expressed as
combined residues of total fluroxypyr) in or on food commodities pome,
fruit, group 11 at 0.02 ppm; millet, grain at 0.5 ppm; millet, forage
at 12.0 ppm; grass, hay at 20.0 ppm; millet, proso, grain at 0.5 ppm;
millet, proso, straw at 12.0 ppm; millet, proso, forage at 12.0 ppm;
millet, proso, hay at 20.0 ppm; millet, pearl, grain at 0.5 ppm;
millet, pearl, forage at 12.0 ppm; and millet, pearl, hay at 20.0 ppm.
Adequate enforcement method for the combined residues of total
fluroxypyr is available to enforce the tolerance expression in or on
food. The analytical method uses capillary GC and mass selective
detection (MSD) with LOQ of 0.01 ppm. Fluroxypyr has also been tested
through the Food and Drug Administration (FDA), Multi-residue
Methodology, Protocols C, D, and E. The results have been published in
the FDA Pesticide Analytical Manual, volume 1. Contact: Shaja R.
Brothers, telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

Amended Exemption from Tolerance

    PP 5E6996. (Docket ID number EPA-HQ-OPP-2005-0306). BASF
Corporation, 100 Campus Drive, Florham Park, NJ 07932, proposes to
amend an exemption from the requirement of a tolerance for residues of
vitamin E (CAS no. 1406-18-4) by including the form of vitamin E
alcohol (d-alpha tocopherol, CAS no. 59-02-9 and dl-alpha tocopherol,
CAS no. 10191-41-0), and vitamin E Acetate (d-alpha tocopheryl acetate,
CAS no. 58-95-7 and dl-alpha tocopheryl acetate, CAS no. 7695-91-2), in
or on raw agricultural commodities when used as an ingredient in
pesticide formulations used in accordance with good agricultural
practices. Vitamin E is a chemical complex that includes eight
naturally occurring homologues having a chromanol ring and a twelve-
carbon aliphatic side chain containing two methyl groups in the middle
and two or more methyl groups on the end. Vitamin E is found in many
plant-derived foods and is believed to be necessary for human health.
Vitamin E alcohol in the form of d-alpha tocopherol has the highest
biological activity of the compounds in the vitamin E complex. Vitamin
E alcohol and its ester, vitamin E acetate, are commonly consumed as
dietary supplements. Vitamin E alcohol and vitamin E acetate are common
food additives. Vitamin E alcohol is used as an antioxidant for foods
or food chemicals. Vitamin E acetate is a common animal feed additive
and is used widely in topical skin care products.
    EPA has determined that the petition contains data or information
regarding the elements set forth in section 408 (d)(2) of the FFDCA;
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. Because this petition is a
request for an exemption from the requirement of a tolerance without
numerical limitations, no analytical method is required. Contact:
Kathleen Martin, telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: March 22, 2007.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.

[FR Doc. E7-6047 Filed 4-3-07; 8:45 am]

BILLING CODE 6560-50-S