[Federal Register Volume 83, Number 237 (Tuesday, December 11, 2018)]
[Rules and Regulations]
[Pages 63569-63574]
[FR Doc No: 2018-26712]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 216

[Docket No. FDA-2016-N-2462]
RIN 0910-AH35

List of Drug Products That Have Been Withdrawn or Removed From
the Market for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
amending its regulations to revise the list of drug products that have
been withdrawn or removed from the market because such drug products or
components of such drug products have been found to be unsafe or not
effective. Drug products appearing on this list may not be compounded
under the exemptions provided by sections 503A and 503B of the Federal
Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the final rule
adds two entries to this list of drug products.

DATES: This rule is effective January 10, 2019.

ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number found in brackets in the heading of this final rule into
the ``Search'' box and follow the prompts, and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Alexandria Fujisaki, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5169, Silver Spring, MD 20993-0002, 301-
796-3110.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Regulatory Action
    B. Summary of the Major Provisions of the Regulatory Action
    C. Legal Authority
    D. Costs and Benefits
II. Background
    A. Relevant Provisions of the Statute
    B. The List of Drug Products in Sec.  216.24
    C. Regulatory History of the List
III. Proposed Rule and Final Rule
    A. Presentation to the Advisory Committee
    B. The Proposed Rule
    C. The Final Rule
IV. Comments on the Proposed Rule and FDA's Responses
    A. Comments on Proposed Entries for Inclusion on the List
    B. Miscellaneous Comments
V. Legal Authority
VI. Analysis of Environmental Impact
VII. Economic Analysis of Impacts
VIII. Paperwork Reduction Act of 1995
IX. Consultation and Coordination With Indian Tribal Governments
X. Federalism
XI. References

I. Executive Summary

A. Purpose of the Regulatory Action

    FDA is amending its regulations to revise the list of drug products
that have been withdrawn or removed from the market because such drug
products or components of such drug products have been found to be
unsafe or not effective (referred to as ``the withdrawn or removed
list'' or ``the list'') (Sec.  216.24 (21 CFR 216.24)). Drug products
appearing on the withdrawn or removed list may not be compounded under
the exemptions provided by sections 503A and 503B of the FD&C Act (21
U.S.C. 353a and 353b). In this final rule, the Agency is finalizing in
part the proposed amendments to Sec.  216.24 set forth in the proposed
rule published in the Federal Register of October 18, 2016 (81 FR
71648).

B. Summary of the Major Provisions of the Regulatory Action

    After soliciting public comments and consulting with the FDA
Pharmacy Compounding Advisory Committee (the Committee), we are adding
the following entries to the list in Sec.  216.24 of drug products that
have been withdrawn or removed from the market because such drug
products or

components of such drug products have been found to be unsafe or not
effective:
    Bromocriptine mesylate: All drug products containing bromocriptine
mesylate for prevention of physiological lactation.
    Ondansetron hydrochloride: All intravenous drug products containing
greater than a 16 milligram (mg) single dose of ondansetron
hydrochloride.

C. Legal Authority

    Sections 503A, 503B, and 701(a) of the FD&C Act (21 U.S.C. 353a,
353b, and 371(a)) provide the principal legal authority for this final
rule.

D. Costs and Benefits

    The Agency is not aware of routine compounding of the drug products
that are the subject of this final rule. Therefore, we do not estimate
any compliance costs or loss of sales as a result of the prohibition
against compounding these drug products for human use. The Agency has
determined that this rulemaking is not a significant regulatory action
as defined by Executive Order 12866.

II. Background

A. Relevant Provisions of the Statute

    Section 503A of the FD&C Act describes the conditions that must be
satisfied for human drug products compounded by a licensed pharmacist
or licensed physician to be exempt from the following three sections of
the FD&C Act: (1) Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B))
(concerning current good manufacturing practice); (2) section 502(f)(1)
(21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate
directions for use); and (3) section 505 (21 U.S.C. 355) (concerning
the approval of new drugs under new drug applications (NDAs) or
abbreviated new drug applications (ANDAs)).
    In addition, section 503B of the FD&C Act describes the conditions
that must be satisfied for a drug compounded for human use by or under
the direct supervision of a licensed pharmacist in an outsourcing
facility to be exempt from three sections of the FD&C Act: (1) Section
502(f)(1), (2) section 505, and (3) section 582 (21 U.S.C. 360eee-1)
(concerning drug supply chain security).
    One of the conditions that must be satisfied for a drug product to
qualify for the exemptions under sections 503A or 503B of the FD&C Act
is that the compounder does not compound a drug product that appears on
a list published by the Secretary of Health and Human Services (the
Secretary) (delegated to FDA) of drug products that have been withdrawn
or removed from the market because such drug products or components of
such drug products have been found to be unsafe or not effective (the
withdrawn or removed list) (see sections 503A(b)(1)(C), 503B(a)(4), and
503B(a)(11) of the FD&C Act).

B. The List of Drug Products in Sec.  216.24

    The drug products listed in the withdrawn or removed list codified
at Sec.  216.24 have been withdrawn or removed from the market because
they have been found to be unsafe or not effective. A drug product that
is included in the withdrawn or removed list is not eligible for the
exemptions provided in section 503A(a) from sections 501(a)(2)(B),
502(f)(1), and 505 of the FD&C Act. In addition, a drug that is
included in the withdrawn or removed list is not eligible for the
exemptions provided in section 503B(a) from sections 502(f)(1), 505,
and 582 of the FD&C Act.

C. Regulatory History of the List

    The Food and Drug Modernization Act of 1997 (Pub. L. 105-115) added
section 503A to the FD&C Act. On October 8, 1998, FDA proposed a rule
in the Federal Register (63 FR 54082) to establish the original
withdrawn or removed list. On March 8, 1999, FDA finalized this rule
(64 FR 10944), prohibiting the products described on the original list
from being compounded under the exemptions provided by section 503A(a)
of the FD&C Act.
    Following the addition of section 503B to the FD&C Act on November
27, 2013, through the enactment of the Drug Quality and Security Act
(Pub. L. 113-54), FDA published a proposed rule to revise and update
the list in Sec.  216.24 on July 2, 2014 (79 FR 37687); FDA published
the final rule to amend Sec.  216.24 in the Federal Register of October
7, 2016 (81 FR 69668) (2016 final rule). Given that nearly identical
criteria apply for a drug to be included on the list referred to in
section 503A(b)(1)(C) and the list referred to in section 503B(a)(4) of
the FD&C Act, the 2016 final rule added language to Sec.  216.24
clarifying that it applies for purposes of both sections 503A and 503B.

III. Proposed Rule and Final Rule

A. Presentation to the Advisory Committee

    At a meeting held on June 17 and 18, 2015 (see the Federal Register
of May 22, 2015 (80 FR 29717)), FDA presented to the Committee FDA's
proposal to add to the withdrawn or removed list all drug products
containing more than 325 mg of acetaminophen per dosage unit, all drug
products containing aprotinin, all drug products containing
bromocriptine mesylate for the prevention of physiological lactation,
and all intravenous drug products containing greater than a 16 mg
single dose of ondansetron hydrochloride. The Committee voted in favor
of including each drug product entry on the list as proposed by FDA.\1\
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    \1\ A transcript of the June 2015 Committee meeting (Ref. 1) and
briefing information that includes reviews and background on the
proposed entries (Ref. 2) may be found at the Dockets Management
Staff (see ADDRESSES) and at https://wayback.archive-it.org/7993/20170111202622/http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PharmacyCompoundingAdvisoryCommittee/ucm431285.htm.
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B. The Proposed Rule

    In the Federal Register of October 18, 2016, FDA proposed to revise
the withdrawn or removed list to add all drug products containing
aprotinin, all drug products containing bromocriptine mesylate for the
prevention of physiological lactation, and all intravenous drug
products containing greater than a 16 mg single dose of ondansetron
hydrochloride (October 2016 proposed rule). The addition of all drug
products containing more than 325 mg of acetaminophen per dosage unit
to the list was not included in the October 2016 proposed rule and
remains under consideration by the Agency.

C. The Final Rule

    The Agency has considered the public discussion and the advice
provided by the Committee regarding these matters at the June 2015
meeting, as well as the October 2016 proposed rule, including the
comments submitted on the proposed rule (see section IV). Based on the
information before FDA and its own knowledge and expertise, FDA is
adding two entries from the proposed rule to the withdrawn or removed
list in Sec.  216.24.
    The two entries FDA is adding to Sec.  216.24 are as follows:
    Bromocriptine mesylate: All drug products containing bromocriptine
mesylate for prevention of physiological lactation.
    Ondansetron hydrochloride: All intravenous drug products containing
greater than a 16 mg single dose of ondansetron hydrochloride.
    At this time, FDA is not finalizing the entry in the proposed rule
for all drug products containing aprotinin. The addition of an entry to
the withdrawn or removed list for drug products containing aprotinin
remains under consideration by FDA.

IV. Comments on the Proposed Rule and FDA's Responses

    Four comments, all from individuals, were submitted on the October
2016 proposed rule. FDA has summarized and responded to the relevant
comments in the following paragraphs. A comment about ``hernia repair
with mesh and plug'' has not been answered because it was not relevant
to this rulemaking. Comments regarding the proposed addition of an
entry to the withdrawn or removed list for aprotinin will not be
answered at this time because the entry remains under consideration by
FDA.
    To make it easier to identify the comments and FDA's responses, the
word ``Comment,'' in parentheses, appears before the comment's
description, and the word ``Response,'' in parentheses, appears before
the Agency's response. We have numbered each comment to help
distinguish between different comments. Similar comments are grouped
together under the same number, and, in some cases, different subjects
discussed in the same comment are separated and designated as distinct
comments for purposes of FDA's response. The number assigned to each
comment or comment topic is purely for organizational purposes and does
not signify the comment's value or importance or the order in which the
comments were received.

A. Comments on Proposed Entries for Inclusion on the List

1. Bromocriptine Mesylate
    (Comment 1) One comment supported the proposal to include all drug
products containing bromocriptine mesylate for prevention of
physiological lactation on the withdrawn or removed list.
    (Response 1) FDA agrees with the comment.
    (Comment 2) FDA received one comment opposing the proposal to
include all drug products containing bromocriptine mesylate for
prevention of physiological lactation on the withdrawn or removed list.
The comment asserts that bromocriptine mesylate offers ``significant
improvements in the quantity and quality of life,'' and, although it
has ``serious adverse effects,'' the benefits of bromocriptine mesylate
compared to its risks ``should warrant continuous approvability.''
    (Response 2) FDA disagrees with the comment. For the reasons that
follow, FDA will add all drug products containing bromocriptine
mesylate for prevention of physiological lactation to the list in Sec.
216.24.
    As a preliminary matter, the issue in this rulemaking is whether
all drug products containing bromocriptine mesylate for the indication
of prevention of physiological lactation were withdrawn or removed from
the market because they were found to be unsafe or not effective for
this indication. The criteria that must be met to place a drug product
on the withdrawn or removed list are laid out in the FD&C Act. Under
sections 503A and 503B of the FD&C Act, to be placed on the withdrawn
or removed list, drug products must have been withdrawn or removed from
the market because such drug products or components of such drug
products have been found to be unsafe or not effective.
    As FDA previously explained in the October 2016 proposed rule, FDA
withdrew approval of PARLODEL (bromocriptine mesylate, NDA 17962) for
the indication of prevention of physiological lactation in a document
published in the Federal Register of January 17, 1995 (60 FR 3404). At
the time, PARLODEL was the only marketed drug product containing
bromocriptine mesylate labeled with this indication. FDA's 2015
``Review of Bromocriptine Mesylate for the Withdrawn or Removed List''
indicates that the 1995 withdrawal of PARLODEL for prevention of
physiological lactation was based on the unfavorable benefit-risk
balance of this product for this indication. See ``Review of
Bromocriptine Mesylate for the Withdrawn or Removed List'' in the FDA
Briefing Document for the June 17 and 18, 2015 Pharmacy Compounding
Advisory Committee Meeting, available at https://wayback.archive-it.org/7993/20170113060809/http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PharmacyCompoundingAdvisoryCommittee/ucm449533.htm. In particular, in a notice published in the Federal
Register on August 23, 1994 (59 FR 43347), FDA concluded that
bromocriptine mesylate's risks of hypertension, seizures, and
cardiovascular accidents outweighed the product's marginal benefit in
preventing postpartum lactation, which can be suppressed without risk
by using more conservative, nonpharmacological treatments. Withdrawal
of PARLODEL's indication for the prevention of physiological lactation
became effective on February 16, 1995 (60 FR 3404). FDA has determined
that all drug products containing bromocriptine mesylate for prevention
of physiological lactation were withdrawn or removed from the market
because such products have been found to be unsafe or not effective. We
note that FDA-approved drug products containing bromocriptine mesylate
for other indications, such as treatment of Parkinson's disease,
acromegaly, and prolactin-secreting adenomas, remain marketed.
    FDA's 2015 review, which included a discussion of the withdrawal of
PARLODEL's indication for the prevention of physiological lactation,
was presented to the Committee at the meeting held on June 17 and 18,
2015, and the Committee voted in favor of the Agency's proposal to
include all drug products containing bromocriptine mesylate for the
prevention of physiological lactation on the list. For these reasons,
FDA proposed in the October 2016 proposed rule to include all drug
products containing bromocriptine mesylate for the prevention of
physiological lactation on the withdrawn or removed list.
    The comment offered no scientific rationale or support for its
position that this drug product should not be on the list; therefore,
FDA is including bromocriptine mesylate for prevention of physiological
lactation on the withdrawn or removed list.
2. Ondansetron Hydrochloride
    (Comment 3) One comment supported the proposal to include all
intravenous drug products containing greater than a 16 mg single dose
of ondansetron hydrochloride on the withdrawn or removed list.
    (Response 3) FDA agrees with the comment.
    (Comment 4) FDA received one comment on the proposal to include all
intravenous drug products containing greater than a 16 mg single dose
of ondansetron hydrochloride suggesting ``perhaps there is more to
investigate and stricter regulation of the administration of IV
ondansetron hydrochloride is warranted in the future.''
    (Response 4) FDA intends to monitor future approvals, withdrawals,
or removals of drugs, to consider other relevant information that may
suggest the need to revise the withdrawn or removed list, and to
propose modifications as appropriate. In addition, members of the
public can submit a citizen petition at any time under 21 CFR 10.25 and
10.30 requesting that FDA add, modify, or remove an entry on the list
(with data to support their request), and FDA will consider and respond
to the petition.
    (Comment 5) FDA received one comment opposing the proposal to
include all intravenous drug products containing greater than a 16 mg
single dose of ondansetron hydrochloride on

the withdrawn or removed list. The comment asserts that ondansetron
hydrochloride offers ``significant improvements in the quantity and
quality of life,'' and, although it has ``serious adverse effects,''
the benefits of ondansetron hydrochloride compared to its risks
``should warrant continuous approvability.''
    (Response 5) FDA disagrees with the comment. For the reasons that
follow, FDA will add all intravenous drug products containing greater
than a 16 mg single dose of ondansetron hydrochloride to the list in
Sec.  216.24.
    As noted earlier, the issue in this rulemaking is whether drug
products containing greater than a 16 mg single dose of ondansetron
hydrochloride were withdrawn or removed from the market because they
were found to be unsafe or not effective.
    As FDA previously explained in the October 2016 proposed rule, in
the Federal Register of June 10, 2015 (80 FR 32962), FDA announced its
determination under 21 CFR 314.161 and 314.162(a)(2) that the NDA for
Ondansetron (ondansetron hydrochloride) Injection, USP, 32 mg/50 mL,
single IV dose was withdrawn from sale for reasons of safety. In
particular, this product was associated with a specific type of
irregular heart rhythm called QT interval prolongation, and the data
suggest that any dose above the maximum recommendation of 16 mg per
dose intravenously has the potential for increased risk of QT
prolongation. FDA made this determination after holders of one NDA and
four ANDAs voluntarily removed such products from the market and
requested that FDA withdraw approval of their respective applications
under 21 CFR 314.150(d). Thus, all drug products containing greater
than a 16 mg single dose of ondansetron hydrochloride have been
withdrawn or removed from the market because such drug products have
been found to be unsafe or not effective. We note that FDA-approved
drug products containing lower single doses of ondansetron
hydrochloride remain marketed.
    FDA's review of intravenous drug products containing greater than a
16 mg single dose of ondansetron hydrochloride was presented to the
Committee at the meeting held on June 17 and 18, 2015, and the
Committee voted in favor of the Agency's proposal to include all
intravenous drug products containing greater than a 16 mg single dose
of ondansetron hydrochloride on the list. For these reasons, FDA
proposed in the October 2016 proposed rule to include all intravenous
drug products containing greater than a 16 mg single dose of
ondansetron hydrochloride on the withdrawn or removed list.
    (Comment 6) FDA received one comment asserting that ondansetron
hydrochloride should not be recommended for use by pregnant women
because it was not approved by FDA for pregnant women.
    (Response 6) This comment is outside the scope of this rulemaking.
Compounded drugs are not FDA approved and this rulemaking addresses the
placement of certain drug products on the withdrawn or removed list,
including all intravenous drug products containing greater than a 16 mg
single dose of ondansetron hydrochloride. As previously noted, drugs
appearing on this list may not be compounded under the exemptions
provided by sections 503A and 503B of the FD&C Act. Therefore, to the
extent the commenter believes that intravenous drug products containing
greater than a 16 mg single dose of ondansetron hydrochloride should
not be compounded for pregnant women under the exemptions provided by
sections 503A and 503B of the FD&C Act, we agree. The addition of the
entry FDA is finalizing regarding ondansetron hydrochloride through
this rulemaking for the list in Sec.  216.24 will prohibit compounding
of intravenous drug products containing greater than a 16 mg single
dose of ondansetron hydrochloride under the exemptions provided by
sections 503A and 503B of the FD&C Act for all patients, including
pregnant women.

V. Legal Authority

    Sections 503A and 503B of the FD&C Act provide the principal legal
authority for this final rule. As described previously in section II,
section 503A of the FD&C Act describes the conditions that must be
satisfied for human drug products compounded by a licensed pharmacist
or licensed physician to be exempt from three sections of the FD&C Act
(sections 501(a)(2)(B), 502(f)(1), and 505). One of the conditions that
must be satisfied to qualify for the exemptions under section 503A of
the FD&C Act is that the licensed pharmacist or licensed physician does
not compound a drug product that appears on a list published by FDA in
the Federal Register of drug products that have been withdrawn or
removed from the market because such drug products or components of
such drug products have been found to be unsafe or not effective (see
section 503A(b)(1)(C) of the FD&C Act). Section 503A(c)(1) of the FD&C
Act also states that the Secretary shall issue regulations to implement
section 503A, and that before issuing regulations to implement section
503A(b)(1)(C) pertaining to the withdrawn or removed list, among other
sections, the Secretary shall convene and consult an advisory committee
on compounding unless the Secretary determines that the issuance of
such regulations before consultation is necessary to protect the public
health.\2\
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    \2\ Note: The functions of the Secretary described herein have
been delegated to FDA.
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    Section 503B of the FD&C Act describes the conditions that must be
satisfied for a drug compounded for human use by or under the direct
supervision of a licensed pharmacist in an outsourcing facility to be
exempt from three sections of the FD&C Act (sections 502(f)(1), 505,
and 582). One of the conditions in section 503B of the FD&C Act that
must be satisfied to qualify for the exemptions is that the drug does
not appear on a list published by FDA of drugs that have been withdrawn
or removed from the market because such drugs or components of such
drugs have been found to be unsafe or not effective (see section
503B(a)(4)). To be eligible for the exemptions in section 503B, a drug
must be compounded in an outsourcing facility in which the compounding
of drugs occurs only in accordance with section 503B, including as
provided in section 503B(a)(4) of the FD&C Act.
    Thus, sections 503A and 503B of the FD&C Act, in conjunction with
our general rulemaking authority in section 701(a) of the FD&C Act (21
U.S.C. 371(a)), serve as our principal legal authority for this final
rule revising FDA's regulation on the list of drug products withdrawn
or removed from the market because such drug products or components of
such drug products have been found to be unsafe or not effective in
Sec.  216.24.

VI. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VII. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, Executive Order 13771, the
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and
13563 direct us to assess all costs and benefits of available
regulatory alternatives and, when regulation is

necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety,
and other advantages; distributive impacts; and equity). Executive
Order 13771 requires that the costs associated with significant new
regulations ``shall, to the extent permitted by law, be offset by the
elimination of existing costs associated with at least two prior
regulations.'' This final rule is not a significant regulatory action
as defined by Executive Order 12866 and is not subject to Executive
Order 13771.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because small businesses are not expected to incur any
compliance costs or loss of sales due to this regulation, we certify
that the final rule will not have a significant economic impact on a
substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $150
million, using the most current (2017) Implicit Price Deflator for the
Gross Domestic Product. This final rule is not expected to result in an
expenditure in any year that would meet or exceed this amount.
    This final rule amends Sec.  216.24 concerning human drug
compounding. Specifically, the final rule adds to the list of drug
products that may not be compounded under the exemptions provided by
sections 503A and 503B of the FD&C Act because the drug products have
been withdrawn or removed from the market because such drug products or
components of such drug products have been found to be unsafe or not
effective (see section II). We are adding two entries to the list: Drug
products containing bromocriptine mesylate for prevention of
physiological lactation and intravenous drug products containing
greater than a 16 mg single dose of ondansetron hydrochloride. The
Agency is not aware of routine compounding of these drug products;
therefore, we do not estimate any compliance costs or loss of sales as
a result of the prohibition against compounding these drugs for human
use.
    Unless we certify that a rule will not have a significant economic
impact on a substantial number of small entities, the Regulatory
Flexibility Act requires us to analyze regulatory options to minimize
any significant economic impact of a regulation on small entities. Most
pharmacies meet the Small Business Administration definition of a small
entity, which is defined as having annual sales less than $27.5 million
for this industry. We are not aware of any routine compounding of the
drug products that are the subject of this final rule and do not
estimate any compliance costs or loss of sales to small businesses as a
result of the prohibition against compounding these drug products.
Therefore, we certify that this final rule will not have a significant
economic impact on a substantial number of small entities.

VIII. Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.

IX. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set
forth in Executive Order 13175. We have determined that the rule does
not contain policies that have substantial direct effects on one or
more Indian Tribes, on the relationship between the Federal Government
and Indian Tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian Tribes. Accordingly, we
conclude that the rule does not contain policies that have tribal
implications as defined in the Executive Order and, consequently, a
tribal summary impact statement is not required.

X. Federalism

    We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the final
rule does not contain policies that have substantial direct effects 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. Accordingly, the Agency concludes that
the rule does not contain policies that have federalism implications as
defined in the Executive order and, consequently, a federalism summary
impact statement is not required.

XI. References

    The following references are on display in the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.

    1. Transcript for the June 17-18, 2015, Meeting of the Pharmacy
Compounding Advisory Committee, available at https://wayback.archive-it.org/7993/20170111202622/http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PharmacyCompoundingAdvisoryCommittee/ucm431285.htm.
    2. Briefing Information for the June 17-18, 2015, Meeting of the
Pharmacy Compounding Advisory Committee, available at https://wayback.archive-it.org/7993/20170111202622/http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PharmacyCompoundingAdvisoryCommittee/ucm431285.htm.

List of Subjects in 21 CFR Part 216

    Drugs, Prescription drugs.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
216 is amended as follows:

PART 216--HUMAN DRUG COMPOUNDING

0
1. The authority citation for part 216 continues to read as follows:

    Authority:  21 U.S.C. 351, 352, 353a, 353b, 355, and 371.

0
2. Amend Sec.  216.24 by adding, in alphabetical order, to the list of
drugs ``Bromocriptine mesylate'' and ``Ondansetron hydrochloride'' to
read as follows:

Sec.  216.24  Drug products withdrawn or removed from the market for
reasons of safety or effectiveness.

* * * * *
    Bromocriptine mesylate: All drug products containing bromocriptine
mesylate for prevention of physiological lactation.
* * * * *
    Ondansetron hydrochloride: All intravenous drug products containing
greater than a 16 milligram single dose of ondansetron hydrochloride.
* * * * *

    Dated: December 4, 2018.
Scott Gottlieb,
Commissioner of Food and Drugs.
[FR Doc. 2018-26712 Filed 12-10-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 229 (Wednesday, November 28, 2018)]
[Rules and Regulations]
[Pages 61127-61134]
[FR Doc No: 2018-25891]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 51

[EPA-HQ-OAR-2017-0175; FRL-9987-02-OAR]
RIN 2060-AT52

Air Quality: Revision to the Regulatory Definition of Volatile
Organic Compounds--Exclusion of cis-1,1,1,4,4,4-hexafluorobut-2-ene
(HFO-1336mzz-Z)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: On May 1, 2018, the U.S. Environmental Protection Agency (EPA)
published a proposed rule seeking comments in response to a petition
requesting the revision of the EPA's regulatory definition of volatile
organic compounds (VOC) to exempt cis-1,1,1,4,4,4-hexafluorobut-2-ene
(also known as HFO-1336mzz-Z; CAS number 692-49-9). The EPA is now
taking final action to revise the regulatory definition of VOC under
the Clean Air Act (CAA). This final action adds HFO-1336mzz-Z to the
list of compounds excluded from the regulatory definition of VOC on the
basis that this compound makes a negligible contribution to
tropospheric ozone (O3) formation.

DATES: This final rule is effective on January 28, 2019.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-HQ-OAR-2017-0175. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
materials, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available electronically through https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Souad Benromdhane, Office of Air
Quality Planning and Standards, Health and Environmental Impacts
Division, Mail Code C539-07, Environmental Protection Agency, Research
Triangle Park, NC 27711; telephone:<PHONE_NUMBER>; fax number: (919)
541-5315; email address: [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Does this action apply to me?
II. Background
    A. The EPA's VOC Exemption Policy
    B. Petition To List HFO-1336mzz-Z as an Exempt Compound
III. The EPA's Assessment of the Petition
    A. Contribution to Tropospheric Ozone Formation
    B. Potential Impacts on Other Environmental Endpoints
    1. Contribution to Stratospheric Ozone Depletion
    2. The Significant New Alternatives Policy (SNAP) Program
Acceptability Findings
    3. Toxicity
    4. Contribution to Climate Change
    C. Response to Comments and Conclusion
IV. Final Action
V. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs
    C. Paperwork Reduction Act (PRA)
    D. Regulatory Flexibility Act (RFA)
    E. Unfunded Mandates Reform Act (UMRA)
    F. Executive Order 13132: Federalism
    G. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    H. Executive Order 13045: Protection of Children From
Environmental Health and Safety Risks
    I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use
    J. National Technology Transfer and Advancement Act (NTTAA)
    K. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
    L. Congressional Review Act (CRA)
    M. Judicial Review

I. Does this action apply to me?

    Entities potentially affected by this final rule include, but are
not necessarily limited to, the following: State and local air
pollution control agencies that adopt and implement regulations to
control air emissions of VOC; and industries manufacturing and/or using
HFO-1336mzz-Z for use in polyurethane rigid insulating foams,
refrigeration, and air conditioning. Potential entities that may be
affected by this action include:

   Table 1--Potentially Affected Entities by North American Industrial
                   Classification System (NAICS) Code
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                                                      Description of
            Category               NAICS code       regulated entities
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Industry.......................          326140  Polystyrene Foam
                                                  Product Manufacturing.
Industry.......................          326150  Urethane and Other Foam
                                                  Product (except
                                                  Polystyrene)
                                                  Manufacturing.
Industry.......................          333415  Air-Conditioning and
                                                  Warm Air Heating
                                                  Equipment and
                                                  Commercial and
                                                  Industrial
                                                  Refrigeration
                                                  Equipment
                                                  Manufacturing.
Industry.......................            3363  Motor Vehicle Parts
                                                  Manufacturing.
Industry.......................          336611  Ship Building and
                                                  Repairing.
Industry.......................          336612  Boat Building.
Industry.......................          339999  All other Miscellaneous
                                                  Manufacturing.
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    This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities that might be affected by this
deregulatory action. This table lists the types of entities that the
EPA is now aware of that could potentially be affected to some extent
by this action. Other types of entities not listed in the table could
also be affected to some extent. To determine whether your entity is
directly or indirectly affected by this action, you should consult your
state or local air pollution control and/or air quality management
agencies.

II. Background

A. The EPA's VOC Exemption Policy

    Tropospheric O3, commonly known as smog, is formed when VOC and
nitrogen oxides (NOX) react in the atmosphere in the presence of
sunlight. Because of the harmful health effects of O3, the EPA and
state governments limit the amount of VOC that can be released into the
atmosphere. VOC form O3 through atmospheric photochemical reactions,
and different VOC have different levels of reactivity. That is,
different VOC do not react to form O3 at the same speed or do not form
O3 to the same extent. Some VOC react slowly or form less O3;
therefore, changes in their emissions have limited effects on local or
regional O3 pollution episodes. It has been the EPA's policy since
1971, that certain organic compounds with a negligible level of
reactivity should be excluded from the regulatory definition of VOC in
order to focus VOC control efforts on compounds that significantly
affect O3 concentrations. The EPA also believes that exempting such
compounds creates an incentive for industry to use negligibly reactive
compounds in place of more highly reactive compounds that are regulated
as VOC. The EPA lists compounds that it has determined to be negligibly
reactive in its regulations as being excluded from the regulatory
definition of VOC (40 CFR 51.100(s)).
    The CAA requires the regulation of VOC for various purposes.
Section 302(s) of the CAA specifies that the EPA has the authority to
define the meaning of ``VOC'' and, hence, what compounds shall be
treated as VOC for regulatory purposes. The policy of excluding
negligibly reactive compounds from the regulatory definition of VOC was
first laid out in the ``Recommended Policy on Control of Volatile
Organic Compounds'' (42 FR 35314, July 8, 1977) (from here forward
referred to as the 1977 Recommended Policy) and was supplemented
subsequently with the ``Interim Guidance on Control of Volatile Organic
Compounds in Ozone State Implementation Plans'' (70 FR 54046, September
13, 2005) (from here forward referred to as the 2005 Interim Guidance).
The EPA uses the reactivity of ethane as the threshold for determining
whether a compound has negligible reactivity. Compounds that are less
reactive than, or equally reactive to, ethane under certain assumed
conditions may be deemed negligibly reactive and, therefore, suitable
for exemption from the regulatory definition of VOC. Compounds that are
more reactive than ethane continue to be considered VOC for regulatory
purposes and, therefore, are subject to control requirements. The
selection of ethane as the threshold compound was based on a series of
smog chamber experiments that underlay the 1977 Recommended Policy.
    The EPA has used three different metrics to compare the reactivity
of a specific compound to that of ethane: (i) The rate constant for
reaction with the hydroxyl radical (OH) (known as kOH); (ii)
the maximum incremental reactivity (MIR) on a reactivity per unit mass
basis; and (iii) the MIR expressed on a reactivity per mole basis.
Differences between these three metrics are discussed below.
    The kOH is the rate constant of the reaction of the
compound with the OH radical in the air. This reaction is often, but
not always, the first and rate-limiting step in a series of chemical
reactions by which a compound breaks down in the air and contributes to
O3 formation. If this step is slow, the compound will likely
not form O3 at a very fast rate. The kOH values
have long been used by the EPA as metrics of photochemical reactivity
and O3-forming activity, and they were the basis for most of
the EPA's early exemptions of negligibly reactive compounds from the
regulatory definition of VOC. The kOH metric is inherently a
molar-based comparison, i.e., it measures the rate at which molecules
react.
    The MIR, both by mole and by mass, is a more updated metric of
photochemical reactivity derived from a computer-based photochemical
model, and it has been used as a metric of reactivity since 1995. This
metric considers the complete O3-forming activity of a
compound over multiple hours and through multiple reaction pathways,
not merely the first reaction step with OH. Further explanation of the
MIR metric can be found in Carter (1994).
    The EPA has considered the choice between MIRs with a molar or mass
basis for the comparison to ethane in past rulemakings and guidance. In
the 2005 Interim Guidance, the EPA stated:

    [A] comparison to ethane on a mass basis strikes the right
balance between a threshold that is low enough to capture compounds
that significantly affect ozone concentrations and a threshold that
is high enough to exempt some compounds that may usefully substitute
for more highly reactive compounds.
    When reviewing compounds that have been suggested for VOC-exempt
status, EPA will continue to compare them to ethane using
kOH expressed on a molar basis and MIR values expressed
on a mass basis.

    The 2005 Interim Guidance notes that the EPA will consider a
compound to be negligibly reactive if it is equally as or less reactive
than ethane based on either kOH expressed on a molar basis
or MIR values expressed on a mass basis.
    The molar comparison of MIR is more consistent with the original
smog chamber experiments, which compared equal molar concentrations of
individual VOCs, supporting the selection of ethane as the threshold,
while the mass-based comparison of MIR is consistent with how MIR
values and other reactivity metrics are applied

in reactivity-based emission limits. It is, however, important to note
that the mass-based comparison is slightly less restrictive than the
molar-based comparison in that a few more compounds would qualify as
negligibly reactive.
    Given the two goals of the exemption policy articulated in the 2005
Interim Guidance, the EPA believes that ethane continues to be an
appropriate threshold for defining negligible reactivity. And, to
encourage the use of environmentally beneficial substitutions, the EPA
believes that a comparison to ethane on a mass basis strikes the right
balance between a threshold that is low enough to capture compounds
that significantly affect O3 concentrations and a threshold
that is high enough to exempt some compounds that may usefully
substitute for more highly reactive compounds.
    The 2005 Interim Guidance also noted that concerns have sometimes
been raised about the potential impact of a VOC exemption on
environmental endpoints other than O3 concentrations,
including fine particle formation, air toxics exposures, stratospheric
O3 depletion, and climate change. The EPA has recognized,
however, that there are existing regulatory or non-regulatory programs
that are specifically designed to address these issues, and the EPA
continues to believe in general that the impacts of VOC exemptions on
environmental endpoints other than O3 formation can be
adequately addressed by these programs. The VOC exemption policy is
intended to facilitate attainment of the O3 National Ambient
Air Quality Standards (NAAQS) and VOC exemption decisions will continue
to be based primarily on consideration of a compound's contribution to
O3 formation. However, if the EPA determines that a
particular VOC exemption is likely to result in a significant increase
in the use of a compound and that the increased use would pose a
significant risk to human health or the environment that would not be
addressed adequately by existing programs or policies, then the EPA may
exercise its judgment accordingly in deciding whether to grant an
exemption.

B. Petition To List HFO-1336mzz-Z as an Exempt Compound

    DuPont Chemicals & Fluoroproducts (DuPont) submitted a petition to
the EPA on February 14, 2014, requesting that cis-1,1,1,4,4,4-
hexafluorobut-2-ene (HFO-1336mzz-Z; CAS number 692-49-9) be exempted
from the regulatory definition of VOC. The petition was based on the
argument that HFO-1336mzz-Z has low reactivity relative to ethane. The
petitioner indicated that HFO-1336mzz-Z may be used in a variety of
applications as a replacement for foam expansion or blowing agents with
higher global warming potential (GWP) (>700 GWP) for use in
polyurethane rigid insulating foams, among others. It is also a new
developmental refrigerant as a potential working fluid for Organic
Rankine Cycles (ORC).\1\
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    \1\ Konstantinos Kontomaris, 2014, HFO-1336mzz-Z High
Temperature Chemical Stability and Use as a Working Fluid in Organic
Rankine Cycles. International Refrigeration and Air Conditioning
Conference. Purdue University: https://www.chemours.com/Refrigerants/en_US/products/Opteon/Stationary_Refrigeration/assets/downloads/2014_Purdue-Paper-Opteon-MZ.pdf.
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    To support its petition, DuPont referenced several documents,
including one peer-reviewed journal article on HFO-1336mzz-Z reaction
rates (Baasandorj, M. et al., 2011). DuPont also provided a
supplemental technical report on the MIR of HFO-1336mzz-Z (Carter,
2011a). Per this report, the MIR of HFO-1336mzz-Z is 0.04 gram (g)
O3/g HFO-1336mzz-Z on the mass-based MIR scale. This
reactivity rate is 86 percent lower than that of ethane (0.28 g
O3/g ethane). The reactivity rate kOH for the
gas-phase reaction of OH radicals with HFO-1336mzz-Z (kOH)
has been measured to be 4.91 x 10-13 centimeter (cm)\3\/
molecule-seconds at ~296 degrees Kelvin (K) (Pitts et al., 1983,
Baasandorj et al., 2011). This kOH rate is twice as high as
that of ethane (kOH of ethane = 2.4 x 10-13
cm\3\/molecule-sec at ~298 K) and, therefore, suggests that HFO-
1336mzz-Z is twice as reactive as ethane. In most cases, chemicals with
high kOH values also have high MIR values, but for HFO-
1336mzz-Z, the products that are formed in subsequent reactions are
expected to be poly fluorinated compounds, which do not contribute to
O3 formation (Baasandorj et al., 2011). Based on the current
scientific understanding of tetrafluoroalkene reactions in the
atmosphere, it is unlikely that the actual O3 impact on a
mass basis would equal or exceed that of ethane in the scenarios used
to calculate VOC reactivity (Baasandorj et al., 2011; Carter, 2011a).
    To address the potential for stratospheric O3 impacts,
the petitioner contended that, because the atmospheric lifetime of HFO-
1336mzz-Z due to loss by OH reaction was estimated to be ~20 days and
it does not contain chlorine or bromine, it is not expected to
contribute to the depletion of the stratospheric O3 layer.

III. The EPA's Assessment of the Petition

    On May 1, 2018, the EPA published a proposed rulemaking (83 FR
19026) seeking comments in response to the petition to revise the EPA's
regulatory definition of VOC for exemption of HFO-1336mzz-Z. The EPA is
taking final action to respond to the petition by exempting HFO-
1336mzz-Z from the regulatory definition of VOC. This action is based
on consideration of the compound's low contribution to tropospheric
O3 and the low likelihood of risk to human health or the
environment, including stratospheric O3 depletion, toxicity,
and climate change. Additional information on these topics is provided
in the following sections.

A. Contribution to Tropospheric Ozone Formation

    As noted in studies cited by the petitioner, HFO-1336mzz-Z has a
MIR value of 0.04 g O3/g VOC for ``averaged conditions,''
versus 0.28 g O3/g VOC for ethane (Carter, 2011). Therefore,
the EPA considers HFO-1336mzz-Z to be negligibly reactive and eligible
for VOC-exempt status in accordance with the Agency's long-standing
policy that compounds should so qualify where either reactivity metric
(kOH expressed on a molar basis or MIR expressed on a mass
basis) indicates that the compound is less reactive than ethane. While
the overall atmospheric reactivity of HFO-1336mzz-Z was not studied in
an experimental smog chamber, the chemical mechanism derived from other
chamber studies (Carter, 2011) was used to model the complete formation
of O3 for an entire single day under realistic atmospheric
conditions (Carter, 2011a). Therefore, the EPA believes that the MIR
value calculated in the Carter study submitted by the petitioner is
reliable.
    Table 2 presents three reactivity metrics for HFO-1336mzz-Z as they
compare to ethane.

                                Table 2--Reactivities of Ethane and HFO-1336mzz-Z
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                                                                                Maximum
                                                                                incremental       Maximum
                                                                    kOH (cm\3\/     reactivity      incremental
                            Compound                               molecule-sec)   (MIR) (g O3/     reactivity
                                                                                mole VOC)     (MIR) (g O3/g
                                                                                VOC)
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Ethane..........................................................     2.4 x 10-13             8.4            0.28
HFO-1336mzz-Z...................................................    4.91 x 10-13             6.6            0.04
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Notes:
\1.\ kOH value at 298 K for ethane is from Atkinson et al., 2006 (page 3626).
\2.\ kOH value at 296 K for HFO-1336mzz-Z is from Baasandorj, 2011.
\3.\ Mass-based MIR value (g O3/g VOC) of ethane is from Carter, 2011.
\4.\ Mass-based MIR value (g O3/g VOC) of HFO-1336mzz-Z is from a supplemental report by Carter, 2011a.
\5.\ Molar-based MIR (g O3/mole VOC) values were calculated from the mass-based MIR (g O3/g VOC) values using
  the number of moles per gram of the relevant organic compound.

    The reaction rate of HFO-1336mzz-Z with the OH radical
(kOH) has been measured to be 4.91 x 10-13 cm\3\/
molecule-sec (Baasandorj et al., 2011); other reactions with
O3 and the nitrate radical were negligibly small. The
corresponding reaction rate of ethane with OH is 2.4 x
10-13cm\3\/molecule-sec (Atkinson et al., 2006). The data in
Table 2 show that HFO-1336mzz-Z has a higher kOH value than
ethane, meaning that it initially reacts twice as fast in the
atmosphere as ethane. However, the resulting unsaturated fluorinated
compounds in the atmosphere are short lived and react more slowly to
form O3 (Baasandorj et al., 2011). The mass based MIR is
0.04 g O3/g VOC and much lower than that of ethane.
    A molecule of HFO-1336mzz-Z is less reactive than a molecule of
ethane in terms of complete O3-forming activity as shown by
the molar-based MIR (g O3/mole VOC) values. One gram of HFO-
1336mzz-Z has a lower capacity than one gram of ethane to form
O3 in terms of a mass-based MIR. Thus, following the 2005
Interim Guidance in striking a balance between reactivity on a molar
basis as well as a gram basis, the EPA finds HFO-1336mzz-Z to be
eligible for exemption from the regulatory definition of VOC based on
both the molar- and mass-based MIR.

B. Potential Impacts on Other Environmental Endpoints

    The EPA's decision to exempt HFO-1336mzz-Z from the regulatory
definition of VOC is based on our findings above. However, as noted in
the 2005 Interim Guidance, the EPA reserves the right to exercise its
judgment in certain cases where an exemption is likely to result in a
significant increase in the use of a compound and a subsequent
significantly increased risk to human health or the environment. In
this case, the EPA does not find that exemption of HFO-1336mzz-Z would
result in an increase of risk to human health or the environment, with
regard to stratospheric O3 depletion, toxicity and climate
change. Additional information on these topics is provided in the
following sections.
1. Contribution to Stratospheric Ozone Depletion
    HFO-1336mzz-Z is unlikely to contribute to the depletion of the
stratospheric O3 layer. The O3 depletion
potential (ODP) of HFO-1336mzz-Z is expected to be negligible based on
several lines of evidence: The absence of chlorine or bromine in the
compound and the atmospheric reactions described in Carter (2008).
Because HFO-1336mzz-Z has a kOH value that is twice as high
as that of ethane (see section III.A ``Contribution to Tropospheric
Ozone Formation''), it will decay before it has a chance to reach the
stratosphere and, thus, will not participate in O3
destruction.
2. The Significant New Alternatives Policy (SNAP) Program Acceptability
Findings
    The SNAP program is the EPA's program to evaluate and regulate
substitutes for end-uses historically using O3-depleting
chemicals. Under section 612(c) of the CAA, the EPA is required to
identify and publish lists of acceptable and unacceptable substitutes
for class I or class II O3-depleting substances. Per the
SNAP program findings, the ODP of HFO-1336mzz-Z is zero. The SNAP
program has listed HFO-1336mzz-Z as an acceptable substitute for a
number of foam blowing end-uses provided in 79 FR 62863, October 21,
2014 (USEPA, 2014), and as an acceptable substitute in the
refrigeration and air conditioning sector in heat transfer, as well as
in chillers and industrial process air conditioning provided in 81 FR
32241, May 23, 2016 (USEPA, 2016).
3. Toxicity
    Based on screening assessments of the health and environmental
risks of HFO-1336mzz-Z, the SNAP program anticipated that users will be
able to use the compound without significantly greater health risks
than presented by use of other available substitutes for the same uses
(USEPA, 2014, 2016).
    The EPA anticipates that HFO-1336mzz-Z will be used consistent with
the recommendations specified in the material safety data sheet (SDS)
(DuPont, 2011). According to the SDS, potential health effects from
inhalation of HFO-1336mzz-Z include skin or eye irritation or
frostbite. Exposure to high concentrations of HFO-1336mzz-Z from misuse
or intentional inhalation abuse may cause irregular heartbeat. In
addition, HFO-1336mzz-Z could cause asphyxiation if air is displaced by
vapors in a confined space. The Workplace Environmental Exposure Limit
(WEEL) committee of the Occupational Alliance for Risk Science (OARS)
reviewed available animal toxicity data and recommends a WEEL for the
workplace of 500 parts per million (ppm) (3350 mg/m\3\) time-weighted
average (TWA) for an 8-hour workday as provided in the OARS (OARS,
2014).\2\ This WEEL was derived based on reduced male body weight in
the 13-week rat inhalation toxicity study (Dupont, 2011). The WEEL is
also protective against skeletal fluorosis, which may occur at higher
exposures because of metabolism. The EPA anticipates that users will be
able to meet the WEEL and address potential health risks by following
requirements and recommendations in the SDS and other safety
precautions common to the refrigeration and air conditioning industry.
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    \2\ Occupational Alliance for Risk Science (OARS-WEELs)--HFO-
1336mzz-Z, 2014: https://www.tera.org/OARS/HFO-1336mzz-Z%20WEEL%20FINAL.pdf.

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    HFO-1336mzz-Z is not regulated as a hazardous air pollutant (HAP)
under title I of the CAA. Also, it is not listed as a toxic chemical
under section 313 of the Emergency Planning and Community Right-to-Know
Act (EPCRA).
    The Toxic Substances Control Act (TSCA) gives the EPA authority to
assess and prevent potential unreasonable risks to human health and the
environment before a new chemical substance is introduced into
commerce. Section 5 of TSCA requires manufacturers and importers to
notify the EPA before manufacturing or importing a new chemical
substance by submitting a Premanufacture Notice (PMN) prior to the
manufacture (including import) of the chemical. Under the TSCA New
Chemicals Program, the EPA then assesses whether an unreasonable risk
may, or will, be presented by the expected manufacturing, processing,
distribution in commerce, use, and disposal of the new substance. The
EPA has determined, however, that domestic manufacturing, use in non-
industrial products, or use other than as described in the PMN may
cause serious chronic health effects. To mitigate risks identified
during the PMN review of HFO-1336mzz-Z, the EPA issued a Significant
New Use Rule (SNUR) under TSCA on June 5, 2015, to require persons to
submit a Significant New Use Notice (SNUN) to the EPA at least 90 days
before they manufacture or process HFO-1336mzz-Z for uses other than
those described in the PMN (80 FR 32003, 32005, June 5, 2015). The
required notification will provide the EPA with the opportunity to
evaluate the intended use and, if necessary, to prohibit or limit that
activity before it occurs. The EPA, therefore, believes that existing
programs address the risk of toxicity associated with the use of HFO-
1336mzz-Z.
4. Contribution to Climate Change
    The Intergovernmental Panel on Climate Change (IPCC) Fifth
Assessment Report (IPCC AR5) estimated the lifetime of HFO-1336mzz-Z to
be approximately 22 days (Baasandorj et al., 2011), and the gas-phase
degradation of HFO-1336-mzz-Z is not expected to lead to a significant
formation of atmospherically long-lived species. The radiative
efficiency of HFO-1336-mzz-Z was calculated to be 0.38 watts per square
meter at the earth's surface per part per billion concentration of the
material (W m-2 ppb-1) based on Baasandorj et
al., 2011. The report estimated the resulting 100-year GWP to be 9,
meaning that, over a 100-year period, one ton of HFO-1336mzz-Z traps 9
times as much warming energy as one ton of carbon dioxide
(CO2) (IPCC, 2013). HFO-1336mzz-Z's GWP of 9 is lower than
those of some of the substitutes in a variety of foam blowing end-uses
and in centrifugal and positive displacement chillers, heat transfer,
and industrial process air conditioning. HFO-1336mzz-Z was developed to
replace other chemicals used for similar end-uses with GWP ranging from
725 to 5,750 such as CFC-11, CFC-113, HCFC-141b and HCFC-22. The
petitioner claims that HFO-1336mzz-Z is a better alternative to other
substitutes in foam expansion or blowing agents for use in polyurethane
rigid insulating foams. Thermal test data and energy efficiency trials
indicate that HFO-1336mzz-Z will provide superior insulating value and,
thus, reduces climate change impacts both directly by its relatively
low GWP and indirectly by decreasing energy consumption throughout the
lifecycle of insulated foams in appliances, buildings, refrigerated
storage and transportation.

C. Response to Comments and Conclusion

    The EPA received five comments on the May 1, 2018, notice of
proposed rulemaking. One commenter supported the proposed action to
exempt HFO-1336mzz-Z from the EPA's definition of VOC in 40 CFR
51.100(s), one opposed the proposed action, and three raised issues
that were outside the scope of this rulemaking including a discussion
about air and water quality in Asia and Mexico, and climate change.
These three anonymous comments failed to identify any specific issue
that is germane to our proposal to exempt HFO-1336mzz-Z. Substantial
comments and the EPA's responses are provided below.
    Comment: One commenter (ID: EPA-HQ-OAR-2017-0175-0010) expressed
concern that ``the EPA should not exempt HFO-1336mzz-Z . . . [and that]
. . . surely there is a reason it was . . . [regulated as a VOC] in the
first place.'' The commenter expressed skepticism that ``other
regulatory groups outside of the EPA'' would prevent the compound from
being used, if there were other environmental impacts than
O3, once the EPA exempted this compound. This commenter also
expressed concern that the petitioner's data ``could potentially be
biased'' and they ``. . . would like to read a proposal that gets its
information from a more unbiased source and considers how it will deal
with possible drawbacks of deregulating HFO-1336mzz-Z.''
    Response: The commenter appears to state that HFO-1336mzz-Z should
not be exempted from the definition of VOC simply because it is
currently included in the definition of VOC. This is a circular
argument, and, if followed, the EPA would never be able to exempt any
substances from the definition of VOC, even where, as here, scientific
data supported such an exemption. The commenter does not provide any
scientific evidence that rebuts the petitioner's data supporting the
demonstration that HFO-1336mzz-Z is eligible for this exemption.
    The reason HFO-1336mzz-Z is currently regulated as a VOC is because
it meets the EPA's definition of VOC in 40 CFR 51.100(s) as ``any
compound of carbon, excluding carbon monoxide, carbon dioxide, carbonic
acid . . . which participates in atmospheric photochemical reactions.''
[emphasis added] The petitioner submitted data to the EPA that show
HFO-1336mzz-Z negligibly participates in atmospheric photochemical
reactions, presenting a better environmental alternative for similar
industrial applications, and therefore should be excluded from the
definition of VOC. As explained above, our approval would allow states
to encourage VOC substitutions with negligibly reactive compounds that
would reduce O3 formation.
    The EPA would like to clarify the statement in the proposal which
referred to ``existing regulatory or non-regulatory programs that are
specifically designed to address'' other environmental issues besides
tropospheric O3 formation, such as fine particle formation,
air toxics exposures, stratospheric O3 depletion, and
climate change. When referring to existing regulatory or non-regulatory
programs, the EPA was not referring to ``other regulatory groups
outside of the EPA,'' as the commenter suggested. Rather, Congress has
granted the EPA with other authorities under the CAA that allow the
Agency to address these issues specifically (e.g., NAAQS program for
fine particle pollution; section 112 for air toxics). As stated in the
2005 Interim Guidance, where an exemption is likely to result in a
significant increase in the use of a compound and a subsequent
significantly increased risk to human health or the environment, the
EPA reserves the right to exercise its judgment and choose not to grant
a petition for an exemption from the definition of VOC, even where the
substance meets the reactivity metrics. However, as explained in
section III.B. of this final rule, the EPA does not believe an
exemption of HFO-1336mzz-

Z will lead to significant environmental impacts.
    To the extent the commenter is raising concerns that the EPA's
action will result in non-EPA organizations treating HFO-1336mzz-Z
differently, we note that this action does not prohibit state and local
air pollution regulatory agencies from regulating HFO-1336mzz-Z. Some
local agencies continue restrictions on the use of certain compounds
that have been excluded from the definition of VOC by the EPA.
    With respect to the comment that the petitioner's data could
potentially be biased, the EPA uses credible, peer-reviewed information
in its review of VOC exemption petitions. In this regard, and as
discussed in our proposed rule and in this action, we note that the
journal article submitted by DuPont on HFO-1336mzz-Z reaction rates was
performed by the National Oceanic and Atmospheric Administration and
published in The Journal of Physical Chemistry, a peer-reviewed
journal. The other primary document relied on to support the exemption
petition was authored by the researcher who developed the MIR scale
(Carter, 2011a). Staff in the EPA's Office of Research and Development
reviewed these documents as part of the petition assessment process and
find that they are consistent with current understanding of atmospheric
chemistry. We are not aware of information that would indicate they are
biased.
    Therefore, for reasons discussed above, the EPA is finalizing this
rule with no changes. The EPA finds that HFO-1336mzz-Z is negligibly
reactive with respect to its contribution to tropospheric O3
formation and, thus, may be exempted from the EPA's definition of VOC
in 40 CFR 51.100(s). HFO-1336mzz-Z has been listed as acceptable for
use in several industrial and commercial refrigeration and air
conditioning end-uses, as well as for use as a blowing agent under the
SNAP program (USEPA, 2014, 2016). The EPA has also determined that
exemption of HFO-1336mzz-Z from the regulatory definition of VOC will
not result in an increase of risk to human health and the environment,
and, to the extent that use of this compound does have impacts on other
environmental endpoints, those impacts are adequately managed by
existing programs. For example, HFO-1336mzz-Z has a similar or lower
stratospheric O3 depletion potential than available
substitutes in those end-uses, and the toxicity risk from using HFO-
1336mzz-Z is not significantly greater than the risk from using other
available alternatives for the same uses. The EPA has concluded that
non-tropospheric O3-related risks associated with potential
increased use of HFO-1336mzz-Z are adequately managed by SNAP. The EPA
does not expect significant use of HFO-1336mzz-Z in applications not
covered by the SNAP program. To the extent that the compound is used in
other applications not already reviewed under SNAP or under the New
Chemicals Program under TSCA, the SNUR in place under TSCA requires
that any significant new use of a chemical be reported to the EPA using
a SNUN. Any significant new use of HFO-1336mzz-Z would, thus, need to
be evaluated by the EPA, and the EPA will continually review the
availability of acceptable substitute chemicals under the SNAP program.

IV. Final Action

    The EPA is responding to the petition by revising its regulatory
definition of VOC at 40 CFR 51.100(s) to add HFO-1336mzz-Z to the list
of compounds that are exempt from the regulatory definition of VOC
because it is less reactive than ethane based on a comparison of mass-
based MIR and molar-based MIR metrics and is, therefore, considered
negligibly reactive. As a result of this action, if an entity which
uses or produces this compound and is subject to the EPA regulations
limiting the use of VOC in a product, limiting the VOC emissions from a
facility, or otherwise controlling the use of VOC for purposes related
to attaining the O3 NAAQS, this compound will not be counted
as a VOC in determining whether these regulatory obligations have been
met. This action would affect whether this compound is considered a VOC
for state regulatory purposes to reduce O3 formation, if a
state relies on the EPA's regulatory definition of VOC. States are not
obligated to exclude from control as a VOC those compounds that the EPA
has found to be negligibly reactive. However, no state may take credit
for controlling this compound in its O3 control strategy.
Consequently, reductions in emissions for this compound will not be
considered or counted in determining whether states have met the rate
of progress requirements for VOC in State Implementation Plans or in
demonstrating attainment of the O3 NAAQS.

V. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at https://www2.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was,
therefore, not submitted to the Office of Management and Budget (OMB)
for review.

B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs

    This action is considered an Executive Order 13771 deregulatory
action. This final rule provides meaningful burden reduction by
exempting HFO-1336mzz-Z from the VOC regulatory definition and
relieving manufacturers, distributers, and users from recordkeeping or
reporting requirements. This action is voluntary in nature and has non-
quantifiable cost savings given the unpredictability in who or how much
of it will be used.

C. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under
the PRA. It does not contain any recordkeeping or reporting
requirements.

D. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This
action will not impose any requirements on small entities. This action
removes HFO-1336mzz-Z from the regulatory definition of VOC and,
thereby, relieves manufacturers, distributers, and users of the
compound from tropospheric O3 requirements to control
emissions of the compound.

E. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. This action imposes no enforceable duty on any
state, local or tribal governments, or the private sector.

F. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects 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.

G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175. This final rule removes HFO-1336mzz-Z from the
regulatory definition of VOC and, thereby, relieves manufacturers,
distributers and users from tropospheric O3 requirements to
control emissions of the compound. Thus, Executive Order 13175 does not
apply to this action.

H. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    This action is not subject to Executive Order 13045, because it is
not economically significant as defined in Executive Order 12866, and
because the EPA does not believe the environmental health or safety
risks addressed by this action present a disproportionate risk to
children. Since HFO-1336mzz-Z is utilized in specific industrial
applications where children are not present and dissipates quickly
(e.g., lifetime of 22 days) with short-lived end products, there is no
exposure or disproportionate risk to children. This action removes HFO-
1336mzz-Z from the regulatory definition of VOC and, thereby, relieves
manufacturers, distributers and users from tropospheric O3
requirements to control emissions of the compound.

I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

J. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards.

K. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    The EPA believes that this action does not have disproportionately
high and adverse human health or environmental effects on minority
populations, low-income populations and/or indigenous peoples, as
specified in Executive Order 12898 (59 FR 7629 February 16, 1994). This
action removes HFO-1336mzz-Z from the regulatory definition of VOC and,
thereby, relieves manufacturers, distributers, and users of the
compound from tropospheric O3 requirements to control
emissions of the compound.

L. Congressional Review Act (CRA)

    This action is subject to the CRA, and the EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. This action is not a ``major rule'' as defined by 5
U.S.C. 804(2).

M. Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the District of Columbia Circuit Court within 60 days from the date the
final action is published in the Federal Register. Filing a petition
for review by the Administrator of this final action does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review
must be filed, and shall not postpone the effectiveness of such action.
Thus, any petitions for review of this action related to the exemption
of HFO-1336mzz-Z from the regulatory definition of VOC must be filed in
the Court of Appeals for the District of Columbia Circuit within 60
days from the date the final action is published in the Federal
Register.

References

Atkinson, R., Baulch, D.L., Cox, R.A., Crowley, J.N., Hampson, Jr.,
R.F., Hynes, R.G., Jenkin, M.E., Kerr, J.A., Rossi, M.J., and Troe,
J. (2006) Evaluated kinetic and photochemical data for atmospheric
chemistry: Volume II--gas phase reactions of organic species. Atmos.
Chem. Phys. 6: 3625-4055.
Baasandorj, M., Ravishankara, A.R., Burkholder, J.B. (2011)
Atmospheric chemistry of (Z)-CF3CH[boxH]CHCF3: OH radical reaction
rate coefficient and global warming potential. J Phys Chem A. 2011
Sep 29; 115(38):10539-49. doi: 10.1021/jp206195g.
Carter, W.P.L. (1994) Development of ozone reactivity scales for
volatile organic compounds. J. Air Waste Manage, 44: 881-899.
Carter, W.P.L. (2008) Reactivity Estimates for Selected Consumer
Product Compounds, Final Report to California Air Resources Board
Contract No. 06-408, February 19, 2008. http://www.arb.ca.gov/research/reactivity/consumer_products.pdf.
Carter, W.P.L. (2011) SAPRC Atmospheric Chemical Mechanisms and VOC
Reactivity Scales, at http://www.engr.ucr.edu/~carter/SAPRC/. Last
updated in Sept. 14, 2013. Tables of Maximum Incremental Reactivity
(MIR) Values available at http://www.arb.ca.gov/regact/2009/mir2009/mir2009.htm. May 11, 2011.
Carter, W.P.L. (2011a) Estimation of the ground-level atmospheric
ozone formation potentials of Cis 1,1,1,4,4,4-HexaFluoro-2-Butene,
August 8, 2011.
DuPont Haskell. FEA-1100: 90-day inhalation toxicity study in rats;
Unpublished Report DuPont-17453-785-1; Haskell Laboratory of
Industrial Toxicology: Newark, DE, 2011.
IPCC, 2007: Climate Change 2007: The Physical Science Basis.
Contribution of Working Group I to the Fourth Assessment Report of
the Intergovernmental Panel on Climate Change [Solomon, S., D. Qin,
M. Manning, Z. Chen, M. Marquis, K.B. Averyt, M. Tignor and H.L.
Miller (eds.)]. Cambridge University Press, Cambridge, United
Kingdom and New York, NY, USA, 996 pp.
IPCC, 2013: Climate Change 2013: The Physical Science Basis.
Contribution of Working Group I to the Fifth Assessment Report of
the Intergovernmental Panel on Climate Change [Stocker, T.F., D.
Qin, G.-K. Plattner, M. Tignor, S.K. Allen, J. Boschung, A. Nauels,
Y. Xia, V. Bex and P.M. Midgley (eds.)]. Cambridge University Press,
Cambridge, United Kingdom and New York, NY, USA, 1535 pp.
Pitts, J.N. Jr., Winer, A.M., Aschmann, S.M., Carter, W.P.L., and
Atkinson, K. (1983), Experimental Protocol for Determining Hydroxyl
Radical Reaction Rate Constants Environmental Science Research
Laboratory, ORD, USEPA. EPA600/3-82-038.
USEPA, 2014. Significant New Alternatives Policy Program; Foam
Blowing Sector; Risk Screen on Substitutes in Rigid Polyurethane
Appliance Foam; Rigid Polyurethane and Polyisocyanurate Laminated
Boardstock; Rigid Polyurethane Commercial Refrigeration and Sandwich
Panels; Rigid Polyurethane Slabstock and Other; Flexible
Polyurethane; Integral Skin Polyurethane; and Phenolic Insulation
Board and Bunstock. Substitute: HFO-1336mzz(Z) (Formacel[supreg]
1100); October 10, 2014. Available online at: https://www.gpo.gov/fdsys/pkg/FR-2014-10-21/pdf/2014-24989.pdf.
USEPA, 2016. Significant New Alternatives Policy Program;
Refrigeration and Air Conditioning Sector; Risk Screen on
Substitutes for Use in Chillers and Industrial Process Air
Conditioning Substitute: HFO-1336mzz(Z) (Opteon[supreg] MZ); May 23,
2016. Available online at: https://www.gpo.gov/fdsys/pkg/FR2016-05-23/pdf/2016-12117.pdf.

List of Subjects in 40 CFR Part 51

    Environmental protection, Administrative practice and procedure,
Air pollution control, Ozone, Reporting and recordkeeping requirements,
Volatile organic compounds.

    Dated: November 16, 2018.
Andrew R. Wheeler,
Acting Administrator.

    For reasons stated in the preamble, part 51 of chapter I of title
40 of the Code of Federal Regulations is amended as follows:

PART 51--REQUIREMENTS FOR PREPARATION, ADOPTION, AND SUBMITTAL OF
IMPLEMENTATION PLANS

0
1. The authority citation for part 51 continues to read as follows:

    Authority:  23 U.S.C. 101; 42 U.S.C. 7401-7671q.

Subpart F--Procedural Requirements

0
2. Section 51.100 is amended by revising paragraph (s)(1) introductory
text to read as follows:

Sec.  51.100   Definitions.

* * * * *
    (s) * * *
    (1) This includes any such organic compound other than the
following, which have been determined to have negligible photochemical
reactivity: Methane; ethane; methylene chloride (dichloromethane);
1,1,1-trichloroethane (methyl chloroform); 1,1,2-trichloro-1,2,2-
trifluoroethane (CFC-113); trichlorofluoromethane (CFC-11);
dichlorodifluoromethane (CFC-12); chlorodifluoromethane (HCFC-22);
trifluoromethane (HFC-23); 1,2-dichloro 1,1,2,2-tetrafluoroethane (CFC-
114); chloropentafluoroethane (CFC-115); 1,1,1-trifluoro 2,2-
dichloroethane (HCFC-123); 1,1,1,2-tetrafluoroethane (HFC-134a); 1,1-
dichloro 1-fluoroethane (HCFC-141b); 1-chloro 1,1-difluoroethane (HCFC-
142b); 2-chloro-1,1,1,2-tetrafluoroethane (HCFC-124); pentafluoroethane
(HFC-125); 1,1,2,2-tetrafluoroethane (HFC-134); 1,1,1-trifluoroethane
(HFC-143a); 1,1-difluoroethane (HFC-152a); parachlorobenzotrifluoride
(PCBTF); cyclic, branched, or linear completely methylated siloxanes;
acetone; perchloroethylene (tetrachloroethylene); 3,3-dichloro-
1,1,1,2,2-pentafluoropropane (HCFC-225ca); 1,3-dichloro-1,1,2,2,3-
pentafluoropropane (HCFC-225cb); 1,1,1,2,3,4,4,5,5,5-decafluoropentane
(HFC 43-10mee); difluoromethane (HFC-32); ethylfluoride (HFC-161);
1,1,1,3,3,3-hexafluoropropane (HFC-236fa); 1,1,2,2,3-pentafluoropropane
(HFC-245ca); 1,1,2,3,3-pentafluoropropane (HFC-245ea); 1,1,1,2,3-
pentafluoropropane (HFC-245eb); 1,1,1,3,3-pentafluoropropane (HFC-
245fa); 1,1,1,2,3,3-hexafluoropropane (HFC-236ea); 1,1,1,3,3-
pentafluorobutane (HFC-365mfc); chlorofluoromethane (HCFC-31); 1
chloro-1-fluoroethane (HCFC-151a); 1,2-dichloro-1,1,2-trifluoroethane
(HCFC-123a); 1,1,1,2,2,3,3,4,4-nonafluoro-4-methoxy-butane
(C4F9OCH3 or HFE-7100); 2-
(difluoromethoxymethyl)-1,1,1,2,3,3,3-heptafluoropropane
((CF3)2CFCF2OCH3); 1-
ethoxy-1,1,2,2,3,3,4,4,4-nonafluorobutane
(C4F9OC2H5 or HFE-7200); 2-
(ethoxydifluoromethyl)-1,1,1,2,3,3,3-heptafluoropropane
((CF3)2CFCF2OC2H5
); methyl acetate; 1,1,1,2,2,3,3-heptafluoro-3-methoxy-propane (n-
C3F7OCH3, HFE-7000); 3-ethoxy- 1,1,1,2,3,4,4,5,5,6,6,6-dodecafluoro-2-
(trifluoromethyl) hexane (HFE-7500); 1,1,1,2,3,3,3-heptafluoropropane
(HFC 227ea); methyl formate (HCOOCH3); 1,1,1,2,2,3,4,5,5,5-decafluoro-
3-methoxy-4-trifluoromethyl-pentane (HFE-7300); propylene carbonate;
dimethyl carbonate; trans-1,3,3,3-tetrafluoropropene;
HCF2OCF2H (HFE-134);
HCF2OCF2OCF2H (HFE-236cal2);
HCF2OCF2CF2OCF2H (HFE-
338pcc13);
HCF2OCF2OCF2CF2OCF2
H (H-Galden 1040x or H-Galden ZT 130 (or 150 or 180)); trans 1-chloro-
3,3,3-trifluoroprop-1-ene; 2,3,3,3-tetrafluoropropene; 2-amino-2-
methyl-1-propanol; t-butyl acetate; 1,1,2,2- Tetrafluoro -1-(2,2,2-
trifluoroethoxy) ethane; cis-1,1,1,4,4,4-hexafluorobut-2-ene (HFO-
1336mzz-Z); and perfluorocarbon compounds which fall into these
classes:
* * * * *
[FR Doc. 2018-25891 Filed 11-27-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: October 19, 2006 (Volume 71, Number 202)]
[Notices]
[Page 61749]
[DOCID:fr19oc06-65]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER06-1143-000, ER06-1143-001]

MATEP LLC.; Notice of Issuance of Order

October 13, 2006.
    MATEP LLC filed an application for market-based rate authority,
with an accompanying tariff. The proposed market-based rate tariff
provides for the sale of energy, capacity and ancillary services at
market-based rates. MATEP LLC also requested waivers of various
Commission regulations. In particular, MATEP LLC requested that the
Commission grant blanket approval under 18 C.F.R. Part 34 of all future
issuances of securities and assumptions of liability by MATEP LLC.
    On August 11, 2006, pursuant to delegated authority, the Director,
Division of Tariffs and Market Development--West, granted the requests
for blanket approval under Part 34. The Director's order also stated
that the Commission would publish a separate notice in the Federal
Register establishing a period of time for the filing of protests.
Accordingly, any person desiring to be heard or to protest the blanket
approvals of issuances of securities or assumptions of liability by
MATEP LLC should file a motion to intervene or protest with the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426, in accordance with Rules 211 and 214 of the Commission's Rules
of Practice and Procedure. 18 CFR 385.211, 385.214 (2004).
    Notice is hereby given that the deadline for filing motions to
intervene or protest is November 17, 2006.
    Absent a request to be heard in opposition by the deadline above,
MATEP LLC is authorized to issue securities and assume obligations or
liabilities as a guarantor, indorser, surety, or otherwise in respect
of any security of another person; provided that such issuance or
assumption is for some lawful object within the corporate purposes of
MATEP LLC, compatible with the public interest, and is reasonably
necessary or appropriate for such purposes.
    The Commission reserves the right to require a further showing that
neither public nor private interests will be adversely affected by
continued approvals of MATEP LLC's issuance of securities or
assumptions of liability.
    Copies of the full text of the Director's Order are available from
the Commission's Public Reference Room, 888 First Street, NE.,
Washington, DC 20426. The Order may also be viewed on the Commission's
Web site at http://www.ferc.gov, using the eLibrary link. Enter the

docket number excluding the last three digits in the docket number
filed to access the document. Comments, protests, and interventions may
be filed electronically via the internet in lieu of paper. See, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-17477 Filed 10-18-06; 8:45 am]

BILLING CODE 6717-01-P