[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Proposed Rules]
[Pages 3742-3750]
[FR Doc No: 2014-01224]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 25

[Docket No. FDA-2013-N-1282]

National Environmental Policy Act; Environmental Assessments for
Tobacco Products; Categorical Exclusions

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: In accordance with the National Environmental Policy Act of
1969 (NEPA) and the Council on Environmental Quality (CEQ) Regulations
Implementing NEPA (CEQ Regulations), the Food and Drug Administration
(FDA) is proposing to revise its NEPA implementing regulations to
provide categorical exclusions for certain actions related to
substantial equivalence (SE) reports, SE exemption requests, and
tobacco product applications, and the rescission (order withdrawing an
order) or suspension of orders regarding the marketing of tobacco
products under the Family Smoking Prevention and Tobacco Control Act
(Tobacco Control Act). FDA is also proposing to amend its NEPA
implementing regulations to include tobacco products, where
appropriate, in light of its new authority under the Tobacco Control
Act.

DATES: Submit either electronic or written comments on the proposed
rule by April 8, 2014.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-1282, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions):

Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2013-N-1282 for this rulemaking. All comments
received may be posted without change to http://www.regulations.gov,
including any personal information provided. For additional information
on submitting comments, see the ``Comments'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://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 Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Gerie A. Voss, Center for Tobacco
Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 1-877-287-1373<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background and Legal Authority
II. Overview of the Proposed Rule
    A. Classes of Tobacco Product-Related Actions Subject to
Proposed Categorical Exclusions
    B. Extraordinary Circumstances for Tobacco Product-Related
Actions
    C. Proposed Categorical Exclusions Would Benefit the Public
Interest
III. Description of the Proposed Rule
    A. General Procedures (Sec.  25.15)
    B. Actions Requiring Preparation of an Environmental Assessment
(Sec.  25.20)
    C. General (Sec.  25.30)
    D. Tobacco Product Applications (Sec.  25.35)
    E. Environmental Assessments (Sec.  25.40)
    F. General Information (Sec.  25.50)
    G. Environmental Impact Statements (Sec.  25.52)
IV. Paperwork Reduction Act of 1995
V. Federalism
VI. Environmental Impact
VII. Analysis of Impacts
VIII. Comments
IX. References

I. Background and Legal Authority

    NEPA and the CEQ Regulations require each Federal Agency to assess,
as an integral part of its decisionmaking process, the environmental
impacts of any proposed Federal action to ascertain the environmental
consequences of that action on the quality of the human environment and
to ensure that the interested and affected public is appropriately
informed (42 U.S.C. 4332(2); 40 CFR 1506.6). The CEQ is responsible for
the CEQ Regulations and for overseeing Federal efforts to comply with
NEPA. Both FDA and CEQ have issued regulations governing Agency
obligations and responsibilities under NEPA. The FDA regulations are
included at 21 CFR part 25 and the CEQ regulations are at 40 CFR parts
1500 to 1508.
    The CEQ regulations, which are binding on all Federal executive
Agencies, establish procedures for implementing NEPA. Agencies may
adopt procedures to supplement CEQ's regulations. In adopting NEPA-
implementing procedures, Federal Agencies are directed by CEQ to reduce
paperwork (40 CFR 1500.4 and 1500.2(b)) and to reduce delay (40 CFR
1500.5) by using several means, including the use of categorical
exclusions. The CEQ regulations also state that Agencies shall continue
to review their policies and procedures and, in consultation with CEQ,
revise them as necessary to ensure full compliance with the purpose and
provisions of NEPA (40 CFR 1507.3).
    The FDA regulations state that for major Federal actions that may
``significantly affect the quality of the human environment,'' FDA must
prepare an environmental impact statement (EIS) (21 CFR 25.22; see also
40 CFR 1501.4). The term ``significantly,'' as used in NEPA, requires
considerations of both ``context'' (i.e., analyzed in several contexts)
and ``intensity'' (i.e., severity of impact) (40 CFR 1508.27(a), (b)).
If the action may have a significant environmental impact, FDA can
either prepare an EIS or prepare an Environmental Assessment (EA). An
EA provides sufficient information and analysis for FDA to determine
whether to prepare an EIS or issue a finding of no significant impact
(FONSI) (21 CFR 25.20; 40 CFR 1501.3). FDA is responsible for the scope
and content of an EA and generally requires an applicant to prepare an
EA and make necessary corrections to it (21 CFR 25.40(b)).
    Categorically excluded actions refer to a category of actions that
have been found not to individually or cumulatively have a significant
effect on the quality of the human environment and which do not
ordinarily require the preparation of an EA or EIS (40 CFR 1508.4).
However, as required under 21 CFR 25.21 and 40 CFR 1508.4, FDA will
require at least an EA for any specific action that ordinarily would be
excluded if extraordinary circumstances indicate that the specific
proposed action may significantly affect the quality of the human
environment.
    If a submitter elects to request a categorical exclusion for a
proposed action, a claim of categorical exclusion must be submitted in
accordance with 21 CFR 25.15. Section 25.15 requires that the claim of
categorical exclusion include: (1) A statement of compliance with the
categorical exclusion criteria and (2) a statement that, to the
submitter's knowledge, no extraordinary circumstances exist.
    In November 2010, CEQ issued a final guidance on categorical
exclusions including the process Agencies should use to establish new
categorical exclusions. The guidance states that Agencies can establish
new categorical exclusions to reduce paperwork and delay where the
Agency has developed a record illustrating that the proposed
categorical exclusion covers a category of action that, on the basis of
past experience, does not normally have the potential to cause
significant environmental effects (Ref. 1 at pp. 2 and 16). In
addition, ``[w]hen agencies acquire new responsibilities through
legislation or administrative restructuring, they should propose new
categorical exclusions after they, or other agencies, gain sufficient
experience with the new activities to make a reasoned determination
that any resulting environmental impacts are not significant'' (Ref. 1
at p. 18).
    FDA is proposing new categorical exclusions in accordance with
NEPA, FDA, and CEQ regulations, and the CEQ November 2010 categorical
exclusion guidance.

II. Overview of the Proposed Rule

    Since FDA's NEPA policies and supplemental procedures were
published in 1985 and prior to Congress giving FDA authority to
regulate tobacco products in 2009, the Agency has prepared EAs for many
Agency-initiated actions and has reviewed hundreds of EAs for a variety
of industry requests for Agency action on foods, drugs, and medical
devices for human consumption and use, and foods and drugs given to
animals. In accordance with Sec.  25.40(a) (21 CFR 25.40(a)), these EAs
have focused on the potential environmental effects related to the use
and disposal from use of the FDA-regulated articles. Based on FDA's
experience reviewing EAs for actions involving foods, drugs, and
medical devices for human consumption and use, and food and drugs given
to animals, and its evaluation and knowledge of other relevant
environmental science, FDA has determined that certain classes of

actions related to tobacco products normally do not cause significant
environmental effects and, therefore, should be added to the list of
actions that are excluded from the requirement to prepare an EA or an
EIS. In addition, FDA has gained sufficient experience from its
responsibilities under the Tobacco Control Act to determine that
certain actions on tobacco-related applications do not result in
significant environmental impacts to the quality of the human
environment. Accordingly, FDA is proposing several new categorical
exclusions for tobacco product-related actions. See the ``Statement of
RADM David Ashley, Ph.D. and Hoshing Chang, Ph.D.'' (Ref. 2).

A. Classes of Tobacco Product-Related Actions Subject to Proposed
Categorical Exclusions

    FDA is proposing that the following classes of tobacco product-
related actions qualify for categorical exclusions: (1) Issuance of an
order finding a tobacco product substantially equivalent to a tobacco
product commercially marketed in the United States as of February 15,
2007, under section 910(a)(2)(B) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 387j(a)(2)(B)); (2) issuance of
an order finding a tobacco product not substantially equivalent under
section 910(a) of the FD&C Act, an order under section 910(c) of the
FD&C Act that a new tobacco product may not be introduced or delivered
for introduction into interstate commerce, or an order under section
911 of the FD&C Act (21 U.S.C. 387k) that a modified risk tobacco
product (MRTP) may not be introduced or delivered for introduction into
interstate commerce (a modified risk tobacco product is any tobacco
product that is sold or distributed for use to reduce harm or the risk
of tobacco-related disease associated with commercially marketed
tobacco products); (3) rescission (order withdrawing an order) or
temporary suspension of an order authorizing the marketing of a new
tobacco product under section 910 of the FD&C Act; (4) rescission of an
order authorizing the marketing of a MRTP under section 911 of the FD&C
Act; and (5) rescission of an order granting an exemption request under
21 CFR 1107.1.
    For each proposed categorical exclusion, the environmental effect
from the use and disposal from use of the tobacco product is
negligible, if any, and would not individually or cumulatively have a
significant effect on the quality of the human environment. Therefore,
FDA believes that absent extraordinary circumstances, such actions
should not require the preparation of any further analysis such as an
EIS or an EA, which is intended to focus on ``relevant environmental
issues relating to the use and disposal from use of FDA-regulated
articles'' (Sec.  25.40(a)).
    FDA also is proposing to amend several paragraphs of its existing
environmental impact regulations in order to include tobacco products,
where appropriate, in light of its new authority under the Tobacco
Control Act.
1. SE Order Under Section 910(a)(2)(B) of the FD&C Act
    FDA proposes that the Agency's issuance of an order finding a
product to be substantially equivalent under section 910(a)(2)(B) of
the FD&C Act qualifies for a categorical exclusion. Section
910(a)(2)(B) allows manufacturers of tobacco products that were first
introduced or delivered for introduction into interstate commerce after
February 15, 2007, and before March 22, 2011, and who submit a report
by March 22, 2011, to continue to market the tobacco product unless the
Agency issues an order that the tobacco product is not substantially
equivalent and therefore must be removed from the market.
    The estimated environmental effects that encompass all FDA-
regulated tobacco products on the market, including products marketed
after February 15, 2007, and before March 22, 2011, and grandfathered
products (defined here as those products on the market as of February
15, 2007), are as follows:
    a. Effects due to the manufacture of the tobacco products:
    According to the 2011 Toxics Release Inventory (TRI) National
Analysis, FDA estimates that 46,308 pounds of toxic chemicals (ammonia)
were released to the land in the United States in 2011 without recycle
and treatment; 3,702 pounds of toxic chemicals (including ammonia,
nicotine and salts, and nitrate compounds) to the water; 719,451 pounds
of toxic chemicals (including ammonia, chlorine, lead compounds, as
well as nicotine and salts) to the air; 252,931 pounds of toxic
chemicals (including ammonia, lead compounds, as well as nicotine and
salts) recycled; and 1,563,193 pounds of toxic chemicals (including
ammonia, nitrate compounds, as well as nicotine and salts) treated
(Ref. 3). Compared to toxic waste released due to other manufacture
activities estimated by the Environmental Protection Agency (EPA) using
the same EPA database, the amount of waste released, recycled, and
treated due to the manufacture of all tobacco products on the market is
a fraction of the total toxic waste released from and managed in
industrial facilities in the United States (as reported in 2011 TRI
National Analysis Report).

                                       Table 1--Release of Toxic Chemicals
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                                   Chemicals in Pounds Released Due to Manufacture    Total Toxic Released from
                                    of Tobacco Products in 2011 (Derived from 2011  and Managed in Industrial
                                          TRI National Analysis Report, EPA)        Facilities in the United
                                                                                States in 2011 (2011 TRI
                                                                                National Analysis Report,
                                                                                EPA) in Pounds
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Land Total Release..............  Ammonia...........                        46,308                 1,255,558,266
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Water Total Release.............  Ammonia...........                           185                   212,990,079
                                  Nicotine and Salts                           285
                                  Nitrate compounds.                         3,232
                                 --------------------------------------------------
                                     Subtotal.......                         3,702
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Air Total Release...............  Ammonia...........                       467,181                   799,250,733
                                  Chlorine..........                           294
                                  Lead Compounds....                            38
                                  Nicotine and Salts                       251,938
                                 --------------------------------------------------
                                     Subtotal.......                       719,451
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Total Recycled..................  Ammonia...........                           775                 8,601,489,350
                                  Lead Compounds....                           621
                                  Nicotine and Salts                       251,535
                                 --------------------------------------------------
                                     Subtotal.......                       252,931
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Total Treated...................  Ammonia...........                        30,385                 7,397,857,287
                                  Nicotine and Salts                       369,130
                                  Nitrate compounds.                     1,163,678
                                 --------------------------------------------------
                                     Subtotal.......                     1,563,193
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    b. Effects due to use of the tobacco products:
    As reported in the U.S. Department of Agriculture's 2007 Tobacco
Outlook, the United States consumed 2.9 pounds of cigarettes per capita
and 0.38 pounds of snuff per capita (adults age 18 and over) (Ref. 4).
From 1996 to 2006, tobacco product consumption dropped by about 24
percent, chewing tobacco use decreased 41 percent, snuff use increased
23 percent, and cigarette smoking decreased 29 percent (Ref. 4).
    The existing environmental impact resulting from cigarette and
roll-your-own use is tobacco smoke, which is one of the causes of poor
indoor air quality (Ref. 5). Environmental Tobacco Smoke (secondhand
smoke) is classified as a Class A carcinogen by EPA (Ref. 6). Studies
on outdoor tobacco smoke have shown that during periods of active
smoking, peak and average outdoor tobacco smoke levels near smokers are
equivalent to indoor tobacco smoke concentrations levels. However,
outdoor tobacco smoke levels approached zero at distances greater than
approximately 2 meters from a single cigarette and dropped almost
instantly after smoking activity ceased (Ref. 7). The existing
environmental impact resulting from use of smokeless tobacco products
is not as substantial as that for cigarettes or roll-your-own tobacco.
FDA expects that any new tobacco products that receive marketing
authorization through the available pathways would have less or no more
environmental impact than that of tobacco products currently on the
market.
    c. Effects due to the disposal from use of the tobacco products:
    The existing environmental consequence resulting from disposal from
use of cigarettes is from the discarded cigarette filters. Cigarette
filters are primarily composed of cellulose acetate (Ref. 8) and may
persist under normal environmental conditions for 18 months to 10 years
(Ref. 9). As much as 766,571 metric tons of cigarette filters are
discarded as litter worldwide each year (Ref. 10). Discarded cigarette
filters are carried as runoff from streets to drains and rivers and,
ultimately, to the ocean and its beaches and are found to be the most
collected item in beach clean-ups and litter surveys (Ref. 10).
Evidence has shown that cigarette butts are the most prevalent items
discarded in urban areas (Ref. 11). Cigarette filters were found to be
a point source for metal contamination litter, based on a study
performed to assess the gradual release of multiple metals from the
cigarette filter over the 34-day study period (Ref. 12). Scientists
evaluating the ecotoxicity of discarded cigarette filters also have
shown the potential existing environmental consequences that result
from disposal of cigarette filters. Scientists found that the solution
made as a result of soaking smoked cigarette butts (smoked filter +
tobacco) in water was toxic to both marine and fresh water fish used in
the study (Ref. 13).
    The existing environmental consequence resulting from disposal from
use of smokeless tobacco is the impact on landfills. About 126 million
pounds of smokeless tobacco were consumed in the United States in 2006,
which resulted in an approximately equal amount of spent smokeless
tobacco in the country's landfills (Ref. 14).\1\
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    \1\ The consumption of smokeless tobacco in 2006 is estimated as
follows: 225,662,922 (U.S. population for age 18 years old and over
in 2006) x 0.38 (snuff consumption per capita 18 years and over in
pounds, 2007) + 109,777,445 (U.S. population for male age 18 years
old and over in 2006) x 0.37 (chewing tobacco consumption per capita
male 18 years and over in pounds, 2007) = 126,369,565 pounds.
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    The Agency estimates that there are currently about 5,000 brands
and subbrands of tobacco products on the market that are subject to
FDA's tobacco product authorities. The majority of them are on the
market under section 910(a)(2)(B) of the FD&C Act. The effects of
keeping tobacco products on the market are individually and
cumulatively trivial compared to the existing environmental effects due
to toxic waste released from and managed

in industrial facilities in the United States and the existing
environmental effects due to the use and disposal from use of the
tobacco products in the country. Therefore, the action should qualify
for a categorical exclusion under proposed Sec.  25.35(a).
2. Orders Under Sections 910(a), 910(c), and 911 of the FD&C Act
    FDA proposes that the Agency's issuance of any of the following
orders qualifies for a categorical exclusion: (1) An order finding a
tobacco product not substantially equivalent under section 910(a) of
the FD&C Act; (2) an order finding that a new tobacco product may not
be introduced or delivered for introduction into interstate commerce
under section 910(c) of the FD&C Act; or (3) an order finding that a
modified risk tobacco product may not be introduced or delivered for
introduction into interstate commerce under section 911. No use or
disposal from use exists as a result of these actions. Generally, the
effect of a denial for a new product application is to prevent the
entry or continued entry of a product into the market. With regard to
products that entered the market after February 15, 2007, and before
March 22, 2011, and for which a report was submitted by March 22, 2011,
the effect of a finding of not substantially equivalent would be to
remove that product from the market. Such a removal would not result in
the production or distribution of any substances and, therefore, would
not result in the introduction of any substance into the environment.
Therefore, FDA believes these actions would not individually or
cumulatively have an effect on the quality of the human environment and
should qualify for categorical exclusions under proposed Sec.
25.35(b).
3. Rescission or Temporary Suspension of an Order Issued Under Section
910 of the FD&C Act
    FDA proposes that the Agency's rescission or temporary suspension
of an order authorizing the marketing of a new tobacco product under
section 910 of the FD&C Act qualifies for a categorical exclusion. This
action stops or suspends the use of a new tobacco product under section
910. The Agency is proposing that these rescissions or temporary
suspensions of authorization, whether requested by industry or
initiated by the Agency, be categorically excluded because these types
of actions would not result in the production or distribution of any
substances and, therefore, would not result in the introduction of any
substance into the environment. Furthermore, assuming that users of the
product continued to use tobacco, they would be expected to continue
use by changing their use to products already on the market. These
products would have been part of the baseline market that existed prior
to passage of the Tobacco Control Act or would have already been
subject to a categorical exclusion or an EA. The discontinuation of use
and disposal from use of the tobacco product would not individually or
cumulatively have a significant impact on the quality of the human
environment. Therefore, the action should qualify for a categorical
exclusion under proposed Sec.  25.35(c).
4. Rescission of an Order Issued Under Section 911 of the FD&C Act
    FDA proposes that the Agency's rescission of an order authorizing
the marketing of an MRTP under section 911 of the FD&C Act qualifies
for a categorical exclusion. This action would prohibit a tobacco
product manufacturer from the use of advertisements, labels, or
labeling indicating that the product somehow reduces harm or the risk
of tobacco-related diseases associated with other tobacco products. The
Agency is proposing that these rescissions of authorization, whether
requested by industry or initiated by the Agency, be categorically
excluded because these types of actions would not result in the
production or distribution of any substances and, therefore, would not
result in the introduction of any substance into the environment.
Accordingly, FDA believes the action would not individually or
cumulatively have a significant effect on the quality of the human
environment and should qualify for a categorical exclusion under
proposed Sec.  25.35(d).
5. Rescission of an Order Issued Under Section 905(j)(1)(A)(ii) of the
FD&C Act and Sec.  1107.1
    FDA proposes that the Agency's rescission of an order authorizing
the marketing of a new tobacco product under section 905(j)(1)(A)(ii)
of the FD&C Act (21 U.S.C. 387e(j)(1)(A)(ii)) and Sec.  1107.1
qualifies for a categorical exclusion. Section 1107.1 allows the Agency
to rescind an exemption from the requirements relating to the
demonstration of substantial equivalence where the tobacco product is
modified by adding or deleting a tobacco additive, or increasing or
decreasing the quantity of an existing tobacco additive, if it finds
that the exemption is not appropriate for the protection of public
health (Sec.  1107.1(d)). The action stops the use of a new tobacco
product under these provisions. The Agency is proposing that these
rescissions of authorization, whether requested by industry or
initiated by the Agency, be categorically excluded because these types
of actions would not result in the production or distribution of any
substances and, therefore, would not result in the introduction of any
substance into the environment. The discontinuation of use and disposal
from use of the tobacco product would not individually or cumulatively
have a significant effect on the quality of the human environment.
Therefore, the action should qualify for a categorical exclusion under
proposed Sec.  25.35(e).

B. Extraordinary Circumstances for Tobacco Product-Related Actions

    The current regulations state that FDA will require further
analysis, at least an EA, for any specific action that ordinarily would
be categorically excluded if extraordinary circumstances indicate that
the specific proposed action may significantly affect the quality of
the human environment (Sec.  25.21). The regulations also state that
examples of actions where extraordinary circumstances would preclude
using a categorical exclusion include ``[a]ctions for which available
data establish that, at the expected level of exposure, there is the
potential for serious harm to the environment'' and ``[a]ctions that
adversely affect a species or the critical habitat of a [protected]
species'' (Sec.  25.21(a) and (b)).
    These examples are applicable to tobacco products. If any tobacco
product submission indicates that the action could result in the
exposure of substances harmful to some biological mechanisms or systems
in the environment or that the action may cause harm to a protected or
endangered species, this would be considered an extraordinary
circumstance that would warrant at least the preparation of an EA. FDA
will continue to rely upon considerations of the intensity and context
as set out at 40 CFR 1508.27 for determining whether an extraordinary
circumstance will result in the potential for a proposed action to
significantly affect the environment.

C. Proposed Categorical Exclusions Would Benefit the Public Interest

    FDA believes that this proposal would benefit FDA, regulated
industry, and the public as a whole. The proposal would substantially
reduce the numbers of EAs required to be submitted by industry and
reviewed by FDA and, consequently, reduce the number of FONSIs the
Agency would be required to prepare for such applications. This would
enable FDA to focus its

environmental resources on situations likely to have an effect on the
environment--a key goal of NEPA and CEQ (see 40 CFR 1500.4(b),
1500.5(k)). As CEQ noted in 2010, the ``use of categorical exclusions
can reduce paperwork and delay, so that EAs and EISs are targeted
toward proposed actions that truly have the potential to cause
significant environmental effects'' (Ref. 1 at p. 16). The proposal
also would allow tobacco product manufacturers to focus on other key
portions of their applications, which is particularly necessary given
that this industry has not been previously subject to Federal
regulations. In addition, the proposal would benefit the tobacco
product industry by alleviating otherwise necessary burdens given that
``[g]enerally, FDA requires an applicant to prepare an EA and make
necessary corrections to it'' (21 CFR 25.40(b)). Furthermore, this rule
would benefit the public health by allowing both FDA and industry to
better focus their resources on other matters that could have a direct
impact on the public health. Finally, Sec.  25.21 provides a safeguard
that allows the Agency to prepare or require industry to prepare an EA
if there are extraordinary circumstances such that an action that
ordinarily would be categorically excluded may significantly affect the
quality of the human environment.

III. Description of the Proposed Rule

    FDA proposes to amend Title 21 of the Code of Federal Regulations
in order to:
     Clarify that part 25 applies to tobacco products subject
to FDA's authority under Chapter IX of the FD&C Act (U.S.C. 387 through
U.S.C. 387u); and
     Establish categorical exclusions specific to tobacco
products.
    Specifically, the proposed regulations would: (1) Amend Sec.
25.15(a), (c), and (d) to indicate the availability of categorical
exclusions under Sec.  25.35; (2) amend Sec.  25.20 by adding language
to the introductory paragraph and adding paragraphs (p) and (q) to
identify the tobacco-related actions that normally would require at
least the preparation of an EA, unless the specific classes of actions
are categorically excluded by the proposed exclusions in Sec.  25.35;
(3) revise the introductory paragraph of Sec.  25.30 to reflect the new
proposed categorical exclusions in Sec.  25.35; (4) add Sec.  25.35 to
outline the categorical exclusions that apply solely to certain actions
on tobacco product applications; (5) amend Sec.  25.40(a) to indicate
the availability of categorical exclusions under Sec.  25.35; and (6)
amend Sec. Sec.  25.50(b) and 25.52(a), (b), and (c) to ensure that the
public has an opportunity to participate in the development of
environmental documents regarding tobacco products and that it receives
notification of these documents.

A. General Procedures (Sec.  25.15)

    The proposed rule would revise paragraphs (a), (c), and (d) of
Sec.  25.15 to add a reference to new proposed Sec.  25.35, which would
provide categorical exclusions for actions associated with various
tobacco product submissions. Specifically, the addition to Sec.
25.15(a) would explain that failure to submit an adequate EA with a
tobacco application constitutes sufficient grounds for FDA to refuse to
file or approve the application or petition, unless the action
qualifies for a categorical exclusion under proposed Sec.  25.35. The
addition to Sec.  25.15(c) would add the categorical exclusions under
proposed Sec.  25.35 to the classes of actions that qualify for
categorical exclusions. Finally, the addition to Sec.  25.15(d) would
provide that a person submitting a tobacco application or petition
identified in proposed Sec.  25.35 would not be required to submit an
EA if the person's application states that: (1) The action requested
qualifies for a categorical exclusion and (2) no extraordinary
circumstances exist that would prevent the use of the categorical
exclusion. For the purposes of tobacco products, the term
``application'' includes any application or submission to FDA
(including SE reports and exemption requests) related to the marketing
of tobacco products.

B. Actions Requiring Preparation of an Environmental Assessment (Sec.
25.20)

    FDA proposes to revise Sec.  25.20 to change the introductory
paragraph to indicate the existence of tobacco-specific categorical
exclusions under proposed Sec.  25.35. In addition, FDA proposes to add
to Sec.  25.20 paragraphs (p) and (q) to state that the following
Agency actions on tobacco applications require the preparation of an EA
unless it is an action in a specific class that is categorically
excluded: (1) Issuance of an order finding a tobacco product to be
substantially equivalent under the FD&C Act, unless categorically
excluded in Sec.  25.35 and (2) issuance of an order authorizing the
marketing of a new tobacco product under section 910 or an MRTP under
section 911 of the FD&C Act, unless categorically excluded in Sec.
25.35.
    These revisions are necessary to make clear that certain types of
actions on tobacco-related submissions could result in the requirement
to prepare an EA, but manufacturers may be exempted from this
requirement for certain classes of actions if the action qualifies for
the use of a categorical exclusion.

C. General (Sec.  25.30)

    The proposed rule would revise the introductory sentence to reflect
the fact that we are proposing to add categorical exclusions in Sec.
25.35. Therefore, those actions listed in Sec.  25.30 and in Sec. Sec.
25.30 through 25.35 would not ordinarily require the preparation of an
EA or EIS.

D. Tobacco Product Applications (Sec.  25.35)

    The proposed rule would add new Sec.  25.35, which would provide
additional categorical exclusions from the requirement to prepare at
least an EA for certain actions on tobacco product submissions.
    Specifically, proposed Sec.  25.35(a) would provide for a
categorical exclusion from preparing an EA for the issuance of an order
finding that a product is substantially equivalent to a predicate
product under section 910(a)(2)(B) of the FD&C Act.
    Proposed Sec.  25.35(b) would provide for a categorical exclusion
regarding FDA's issuance of orders stating that: (1) A tobacco product
is not substantially equivalent under section 910(a) of the FD&C Act;
(2) a new tobacco product may not be introduced or delivered for
introduction into interstate commerce under section 910(c) of the FD&C
Act; or (3) a modified risk tobacco product may not be introduced or
delivered into interstate commerce under section 911 of the FD&C Act.
    Proposed Sec.  25.35(c) would allow for a categorical exclusion
where FDA rescinds or temporarily suspends an order authorizing the
marketing of a new tobacco product under section 910 of the FD&C Act.
Proposed Sec.  25.35(d) would provide a categorical exclusion where FDA
rescinds an order authorizing the marketing of a modified risk tobacco
product under section 911 of the FD&C Act. Similarly, proposed Sec.
25.35(e) would provide a categorical exclusion where FDA rescinds an
order authorizing the marketing of a new tobacco product under section
905(j)(1)(A)(ii) of the FD&C Act and under Sec.  1107.1. The term ``new
tobacco product'' is defined in section 910(a)(1)(A) and (a)(1)(B) of
the FD&C Act.

E. Environmental Assessments (Sec.  25.40)

    The proposed rule would amend Sec.  25.40(a), which currently
indicates that an EA shall be prepared for each action not
categorically excluded in Sec.  25.30, 25.31, 25.32, 25.33, or 25.34.

The proposed rule would delete ``or 25.34'' and replace with it with
``25.34, or 25.35'' to indicate the availability of additional
categorical exclusions in proposed Sec.  25.35.

F. General Information (Sec.  25.50)

    The proposed rule would amend Sec.  25.50(b), which relates to
information protected from disclosure by law. By adding tobacco
products to this regulation, FDA seeks to make clear that any
environmental impact documentation regarding tobacco product
applications (including SE reports and requests for exemptions from the
requirements to demonstrate substantial equivalence) would not be
released prior to issuance of an FDA order, unless the existence of
such application has been made publicly available.

G. Environmental Impact Statements (Sec.  25.52)

    Section 25.52 explains the process and requirements for public
participation and notification regarding the preparation of an EIS for
FDA-regulated products. Similar to other FDA-regulated products, FDA
may determine that forthcoming actions involving tobacco products
should require the preparation of an EIS. Therefore, the proposed rule
would add ``tobacco products'' to paragraphs (a), (b), and (c) of Sec.
25.52, where the regulation refers to actions on other FDA-regulated
products that may require preparation of an EIS.
    Specifically, the proposed rule would amend Sec.  25.52(a) to
explain that if an EIS is necessary for an action involving tobacco
products, it would become available for review by the public only at
the time of the issuance of an order authorizing commercial marketing
of the product in the United States. In addition, the proposed rule
would amend Sec.  25.52(b) to indicate that comments on the EIS may be
submitted after the issuance of an order authorizing commercial
marketing of the tobacco product in the United States and that these
comments can form the basis for beginning the process of rescinding the
marketing authorization. The proposed rule also would amend Sec.
25.52(c) to state that where the existence of an application for a
tobacco product has been disclosed before the Agency action, FDA will
involve the public in preparing an EA or an EIS while continuing to
adhere to the Agency's disclosure regulations with regard to
confidential commercial information that has not been disclosed.
    Further, the proposed rule would amend Sec.  25.52(a) and (b) to
add references to ``market authorizations.'' As currently written,
Sec.  25.52(a) and (b) do not identify all the types of actions that
could be taken with regard to tobacco products, including market
authorizations. Not only can FDA engage in review and assessment of
investigations with respect to tobacco products, but the Agency also
may provide market authorizations in response to applications regarding
tobacco products (see, e.g., section 911(g)(1) of the FD&C Act).

IV. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.

V. Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed rule, if finalized, would not contain policies that would
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 tentatively concludes that the proposed 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.

VI. Environmental Impact

    The proposed amendment of the FDA NEPA Regulations (21 CFR part 25)
concerns NEPA documentation for certain actions on tobacco product
submission. CEQ does not direct Agencies to prepare a NEPA analysis or
document before establishing Agency procedures that supplement the CEQ
regulations for implementing NEPA. Agencies are required to adopt NEPA
procedures that establish specific criteria for, and identification of,
three classes of actions: Those that require preparation of an EIS;
those that require preparation of an EA; and those that are
categorically excluded from further NEPA review (40 CFR 1507.3(b)).
Categorical exclusions are one part of those Agency procedures, and
therefore establishing categorical exclusions does not require
preparation of a NEPA analysis or document. Agency NEPA procedures,
such as the FDA NEPA regulations assist FDA in the fulfillment of
Agency responsibilities under NEPA, but are not FDA's final
determination of what level of NEPA analysis is required for a
particular proposed action on a tobacco product submission. The
requirements for establishing Agency NEPA procedures are set forth at
40 CFR 1505.1 and 1507.3. Furthermore, the Agency has also determined
under 21 CFR 25.30(h) that this rulemaking does not individually or
cumulatively have a significant effect on the quality of the human
environment.

VII. Analysis of Impacts

    The analysis of economic impacts is available as Reference 15 in
Docket No. FDA-2013-N-1282 and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

VIII. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). As noted previously, if
you have comments on specific provisions of the proposed regulation, we
request that you identify these provisions in your comments. In
addition, if you have concerns that would be addressed by alternative
text for the regulation, we request that you provide this alternative
text in your comments. It is only necessary to send one set of
comments. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at http://www.regulations.gov.

IX. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m. Monday through Friday, and
are available electronically at http://www.regulations.gov. (FDA has
verified all the Web site addresses in this reference section, but FDA
is not responsible for any subsequent changes to the Web sites after
this document publishes in the Federal Register.)

    1. Council on Environmental Quality, ``Final Guidance for
Federal Departments and Agencies on Establishing, Applying, and
Revising Categorical Exclusions Under the National Environmental
Policy Act,'' 76 FR 3843, January 21, 2011.
    2. Statement of RADM David Ashley, Ph.D. and Hoshing Chang,
Ph.D., ``Impact of Tobacco Products on the Environment.''
    3. 2011 Toxic Release Inventory (TRI) National Analysis.
Available at http://

www.epa.gov/tri/tridata/tri11/nationalanalysis/overview/2011_TRI_
NA_Overview.pdf.
    4. U.S. Department of Agriculture. ``Tobacco Outlook Report,''
Economic Research Service, 2007. http://usda01.library.cornell.edu/usda/ers/TBS//2000s/2007/TBS-10-24-2007.pdf. Accessed on August 29,
2012.
    5. Poor Air Quality, available at http://www.epa.gov/iaq/pubs/insidestory.html.
    6. U.S. Environmental Protection Agency, ``Respiratory Health
Effects of Passive Smoking: Lung Cancer and Other Disorders,'' EPA/
600/6-90/006F, December 1992.
    7. Klepeis, NE., W.R. Ott, and P. Switzer, ``Real-Time
Measurement of Outdoor Tobacco Smoke Particles,'' Journal of the Air
& Waste Management Association, 57:5, 522-534, 2007.
    8. U.S. Department of Health and Human Services, ``Reducing the
Health Consequences of Smoking: 25 Years of Progress.'' A Report of
the Surgeon General, 1989. Rockville, MD: Public Health Service,
Centers for Disease Control, Office on Smoking and Health, 1989.
(DHHS Publication No (CDC) 89-8411.)
    9. Ach, A. Biodegradable Plastics Based on Cellulose Acetate.
Journal of Macromolecular Science: Pure and Applied Chemistry.
A30:733-740, 1993.
    10. Smith, E.A. and T.E. Novotny, ``Whose Butt Is It? Tobacco
Industry Research About Smokers and Cigarette Butt Waste.'' Tobacco
Control, 20:I2-I9, 2011. DOI: 10.1136/tc.2010.040105.
    11. Department for the Environment, Food and Rural Affairs of
the U.K. ``Preventing Cigarette Litter in England: Guidelines for
Local Authorities,'' DEFRA 2007.
    12. Moerman, J.W. and G.E. Potts, ``Analysis of Metals Leached
From Smoked Cigarette Litter.'' Tobacco Control, 20:I30-I35, 2011.
DOI: 10.1136/tc.2010.040196.
    13. Slaughter, E.; R.M. Gersberg, K. Watanabe, et al.,
``Toxicity of Cigarette Butts, and Their Chemical Components, to
Marine and Freshwater Fish,'' Tobacco Control, 20: I25-I29 2011.
    14. United States Census Bureau, Vintage 2006: National Tables,
available at http://www.census.gov/popest/data/historical/2000s/vintage_2006/index.html; accessed October 20, 2012.
    15. Preliminary Regulatory Impact Analysis.

List of Subjects in 21 CFR Part 25

    Environmental impact statements, Foreign relations, Reporting and
recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR Chapter I be amended as follows:

PART 25--ENVIRONMENTAL IMPACT CONSIDERATIONS

0
1. The authority citation for part 25 continues to read as follows:

    Authority: 21 U.S.C. 321-393; 42 U.S.C. 262, 263b-264; 42 U.S.C.
4321, 4332; 40 CFR parts 1500-1508; E.O. 11514, 35 FR 4247, 3 CFR,
1971 Comp., p. 531-533 as amended by E.O. 11991, 42 FR 26967, 3 CFR,
1978 Comp., p. 123-124 and E.O. 12114, 44 FR 1957, 3 CFR, 1980
Comp., p. 356-360.

Sec.  25.15  [Amended]

0
2. Amend Sec.  25.15 as follows:
0
a. Remove from paragraph (a) ``or 25.34,'' and add in its place
``25.34, or 25.35,'';
0
b. Remove from paragraph (c) ``or 25.34''and add in its place ``25.34,
or 25.35''; and
0
c. Remove from paragraph (d) ``or 25.34,'' and add in its place
``25.34, or 25.35,''.
0
3. Amend Sec.  25.20 by revising the introductory text and by adding
paragraphs (p) and (q) to read as follows:

Sec.  25.20  Actions requiring preparation of an environmental
assessment.

    Any proposed action of a type specified in this section ordinarily
requires at least the preparation of an EA, unless it is an action in a
specific class that qualifies for exclusion under Sec. Sec.  25.30,
25.31, 25.32, 25.33, 25.34, or 25.35:
* * * * *
    (p) Issuance of an order finding a tobacco product substantially
equivalent under Federal Food, Drug, and Cosmetic Act, unless
categorically excluded under Sec.  25.35.
    (q) Issuance of an order authorizing marketing of a new tobacco
product under section 910 of the Federal Food, Drug, and Cosmetic Act
or an order authorizing marketing of a modified risk tobacco product
under section 911 of the Federal Food, Drug, and Cosmetic Act, unless
categorically excluded under Sec.  25.35.
0
4. Amend the introductory text of Sec.  25.30 by removing ``25.34'' and
adding in its place ``25.35''.
0
5. Add new Sec.  25.35 to subpart C to read as follows:

Sec.  25.35  Tobacco product applications.

    The classes of actions listed in this section are categorically
excluded and, therefore, ordinarily do not require the preparation of
an EA or an EIS:
    (a) Issuance of an order finding a tobacco product substantially
equivalent under section 910(a)(2)(B) of the Federal Food, Drug, and
Cosmetic Act;
    (b) Issuance of an order finding a tobacco product not
substantially equivalent under section 910(a) of the Federal Food,
Drug, and Cosmetic Act, issuance of an order under section 910(c) of
the Federal Food, Drug, and Cosmetic Act that a new tobacco product may
not be introduced or delivered for introduction into interstate
commerce, or issuance of an order under section 911 of the Federal
Food, Drug, and Cosmetic Act that a modified risk tobacco product may
not be introduced or delivered for introduction into interstate
commerce;
    (c) Rescission or temporary suspension of an order authorizing the
marketing of a new tobacco product under section 910 of the Federal
Food, Drug, and Cosmetic Act;
    (d) Rescission of an order authorizing the marketing of a modified
risk tobacco product under section 911 of the Federal Food, Drug, and
Cosmetic Act; and
    (e) Rescission of an order granting an exemption request under
Sec.  1107.1 of this chapter.
0
6. Amend Sec.  25.40 by removing from paragraph (a) ``or Sec.  25.34''
and adding in its place, ``Sec.  25.34, or Sec.  25.35.''
0
7. Amend Sec.  25.50 by revising the first, third, fourth, and fifth
sentences of paragraph (b) to read as follows:

Sec.  25.50  General information.

* * * * *
    (b) Many FDA actions involving investigations, review, and approval
or market authorization of applications, and premarket notifications
for human drugs, animal drugs, biologic products, devices, and tobacco
products are protected from disclosure under the Trade Secret Act, 18
U.S.C. 1905, and section 301(j) of the Federal Food, Drug, and Cosmetic
Act. * * * Even the existence of applications for human drugs, animal
drugs, biologic products, devices, and tobacco products is protected
from disclosure under these regulations. Therefore, unless the
existence of applications for human drugs, animal drugs, biologic
products, tobacco products, or premarket notification for devices has
been made publicly available, the release of the environmental document
before approval or authorization of human drugs, animal drugs, biologic
products, devices and tobacco products is inconsistent with statutory
requirements imposed on FDA. Appropriate environmental documents,
comments, and responses will be included in the administrative record
to the extent allowed by applicable laws.
0
8. Amend Sec.  25.52 by revising the first sentence of paragraph (a),
and paragraphs (b) and (c) to read as follows:

Sec.  25.52  Environmental impact statements.

    (a) If FDA determines that an EIS is necessary for an action
involving investigations, approvals, or market authorizations for
drugs, animal drugs, biologic products, devices, or tobacco products,
an EIS will be prepared but

will become available only at the time of the approval or market
authorization of the product. * * *
    (b) Comments on the EIS may be submitted after the approval or
market authorization of the drug, animal drug, biologic product,
device, or tobacco product. Those comments can form the basis for the
Agency to consider beginning an action to withdraw the approval or
market authorization of applications for a drug, animal drug, biologic
product, or tobacco product, or to withdraw premarket notifications or
premarket approval applications for devices.
    (c) In those cases where the existence of applications and
premarket notifications for drugs, animal drugs, biologic products,
devices, or tobacco products has already been disclosed before the
Agency approves the action, the Agency will ensure appropriate public
involvement consistent with 40 CFR 1506.6 and part 1503 in preparing
and implementing the NEPA procedures related to preparing EIS's while
following its own disclosure requirements including those listed in
part 20 and Sec. Sec.  312.130(b), 314.430(d), 514.11(d), 514.12(b),
601.51(d), 807.95(e), 812.38(b), and 814.9(d) of this chapter.
* * * * *

    Dated: January 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01224 Filed 1-22-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: October 20, 2010 (Volume 75, Number 202)]
[Notices]
[Page 64710]
[DOCID:fr20oc10-38]

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COMMODITY FUTURES TRADING COMMISSION

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63112, File No. 4-615]

Joint Public Roundtable on Issues Related to the Clearing of
Credit Default Swaps

AGENCIES: Commodity Futures Trading Commission (``CFTC'') and
Securities and Exchange Commission (``SEC'') (each, an ``Agency,'' and
collectively, the ``Agencies'').

ACTION: Notice of roundtable discussion; request for comment.

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

SUMMARY: On October 22, 2010, commencing at 9 a.m. and ending at 12
p.m., staff of the Agencies will hold a public roundtable discussion at
which invited participants will discuss certain issues related to the
clearing of Credit Default Swaps in the context of the Agencies
rulemaking efforts pursuant to the Dodd-Frank Wall Street Reform and
Consumer Protection Act (the ``Act''). The discussion will be open to
the public with seating on a first-come, first-served basis. Members of
the public may also listen by telephone. Call-in participants should be
prepared to provide their first name, last name, and affiliation. The
information for the conference call is set forth below.
     US Toll-Free:<PHONE_NUMBER>.
     International Toll: 1-203-369-5026.
     Passcode: 8693978.
    A transcript of the public roundtable discussion will be published
on the CFTC's Web site at http://www.cftc.gov/LawRegulation/
DoddFrankAct/OTC_7_DCORules.html. The roundtable discussion will take
place in Lobby Level Hearing Room (Room 1000) at the CFTC's
headquarters at Three Lafayette Centre, 1155 21st Street, NW.,
Washington, DC.

FOR FURTHER INFORMATION CONTACT: the CFTC's Office of Public Affairs at
(202) 418-5080 or the SEC's Office of Public Affairs at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The roundtable discussion will take place on
Friday, October 22, 2010, commencing at 9 a.m. and ending at 12 p.m.
Members of the public who wish to comment on the topics addressed at
the discussion may do so via:
     Paper submission to David Stawick, Secretary, Commodity
Futures Trading Commission, Three Lafayette Centre, 1155 21st Street,
NW., Washington, DC 20581, or Elizabeth M. Murphy, Secretary,
Securities and Exchange Commission, 100 F Street, NE., Washington, DC
20549-1090; or
     E-mail to<EMAIL_ADDRESS>(all emails must reference
``Dodd-Frank CDS Roundtable'' in the subject field); and/or rule-
<EMAIL_ADDRESS>or through the comment form available at: http://
www.sec.gov/rules/other.shtml.
    All submissions will be reviewed jointly by the Agencies. All
comments must be in English or be accompanied by an English
translation. All submissions provided to either Agency in any
electronic form or on paper may be published on the website of the
respective Agency, without review and without removal of personally
identifying information. Please submit only information that you wish
to make publicly available.

    By the Securities and Exchange Commission.
    Dated: October 15, 2010.
Elizabeth M. Murphy,
Secretary.
    By the Commodity Futures Trading Commission.
David A. Stawick,
Secretary.
[FR Doc. 2010-26430 Filed 10-19-10; 8:45 am]
BILLING CODE P


TRP Letter of Intent ( LOI) Submissions to EPA 30 June 2003 Date Title / Description Submitted by EPA Reference #

14 Mar 03 TRP Letter of Intent ( LOI) TRP Docket # OPPT 2003 0012 0013;

AR226 1305 24 Mar 03 TRP Database List ( LOI Commitment Item) TRP AR226 1292, 1293, 1294 28 Mar 03 General Description of Telomer Process ( LOI Commitment Item 3) TRP AR226 1266 31 Mar 03 Umbrella Letter of Intent ( APFO Users, Telomer Companies, 3M) FMG/ SPI, TRP, 3M Docket # OPPT 2003 0012 0016;

AR226 1306 31 Mar 03 Biodegradation Research ( 8 2 Telomer B Alcohol)  Scope & Rationale ( LOI Commitment Item) TRP AR226 1283 31 Mar 03 Product & Article Analysis  Scope & Rationale ( LOI Commitment Item 1) TRP Docket # OPPT 2003 0012 0053 31 Mar 03 LC/ MS/ MS Analysis of Articles and Products: Samples and Suggested Sampling Procedures ( LOI 1) TRP Docket # OPPT 2003 0012 0054;

AR226 1274 9 May 03 " Aging" & " In Use" Analysis  Draft Study Plan & Rationale ( LOI Commitment Item 2) TRP Docket # OPPT 2003 0012 0050 9 May 03 Biodegradation Analysis ( Polymeric Products)  Study Plan & Rationale ( LOI Commitment Item 5) TRP Docket # OPPT 2003 0012 0051 9 May 03 Study Protocol: Inherent Biodegradation Test ( Polymeric Products) ( LOI Commitment Item 5) TRP Docket # OPPT 2003 0012 0052 9 May 03 TRP's Response to EPA's Follow up Questions regarding TRP LOI Commitments TRP Docket # OPPT 2003 0012 0049 6 June 03 TRP Opening Statement  June 6 Public Meeting TRP Docket # OPPT 2003 0012 0117 26 June 03 TRP Presentation to ECA Monitoring Work Group ( 23 June 03) TRP Docket # OPPT 2003 0012 0126 26 June 03 TRP Presentation to ECA Telomers Work Group ( 24 June 03) TRP Docket # OPPT 2003 0012 0128 March 03 Company specific information on LOI test products ( LOI Commitment Item 1)  CBI Submissions;

includes chemical identity, 2002 use and volume data, market coverage, etc. TRP companies ( Asahi, Clariant,

Daikin, DuPont) numerous listings in AR226 ( see Index)

March 03 Air monitoring data for PFOA from DuPont operations at Chambers Works ( LOI Appendix 1) DuPont AR 226 (?)

March 03 Employee blood monitoring data from telomer manufacturing + PFOA recycle operations ( LOI App. 1) DuPont AR 226 (?)

May 03 Company information on all fluorinated products ( LOI Commitment Item 1)  CBI Submissions;

includes chemical identity, 2002 use and volume data, market coverage, etc. TRP companies ( Asahi, Clariant,

Daikin, DuPont) numerous listings in AR226 ( see Index)

EPA Docket: www. epa. gov/ edocket ( Docket ID# OPPT 2003 0012)

AR 226: request copy of AR 226 Index from < oppt. ncic@ epa. gov> ( Tel: 202 566 0280)

Information provided by TRP Member Companies directly to EPA


[Federal Register Volume 80, Number 158 (Monday, August 17, 2015)]
[Notices]
[Pages 49299-49301]
[FR Doc No: 2015-20188]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2015-0060]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

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

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA confirms its decision to exempt 49 individuals from its
rule prohibiting persons with insulin-treated diabetes mellitus (ITDM)
from operating commercial motor vehicles (CMVs) in interstate commerce.
The exemptions enable these individuals to operate CMVs in interstate
commerce.

DATES: The exemptions were effective on July 7, 2015. The exemptions
expire on July 7, 2017.

FOR FURTHER INFORMATION CONTACT: Charles A. Horan, III, Director,
Carrier, Driver and Vehicle Safety Standards,<PHONE_NUMBER>,
<EMAIL_ADDRESS>FMCSA, Room W64-224, Department of
Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
Office hours are from 8:30 a.m. to 5 p.m., Monday through Friday,
except Federal holidays.

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue

SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    On June 4, 2015, FMCSA published a notice of receipt of Federal
diabetes exemption applications from 49 individuals and requested
comments from the public (80 FR 31949). The public comment period
closed on July 6, 2015, and no comments were received.
    FMCSA has evaluated the eligibility of the 49 applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to or greater than the level that
would be achieved by complying with the current regulation 49 CFR
391.41(b)(3).

Diabetes Mellitus and Driving Experience of the Applicants

    The Agency established the current requirement for diabetes in 1970
because several risk studies indicated that drivers with diabetes had a
higher rate of crash involvement than the general population. The
diabetes rule provides that ``A person is physically qualified to drive
a commercial motor vehicle if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control'' (49 CFR 391.41(b)(3)).
    FMCSA established its diabetes exemption program, based on the
Agency's July 2000 study entitled ``A Report to Congress on the
Feasibility of a Program to Qualify Individuals with Insulin-Treated
Diabetes Mellitus to Operate in Interstate Commerce as Directed by the
Transportation Act for the 21st Century.'' The report concluded that a
safe and practicable protocol to allow some drivers with ITDM to
operate CMVs is feasible. The September 3, 2003 (68 FR 52441), Federal
Register notice in conjunction with the November 8, 2005 (70 FR 67777),
Federal Register notice provides the current protocol for allowing such
drivers to operate CMVs in interstate commerce.
    These 49 applicants have had ITDM over a range of one to 43 years.
These applicants report no severe hypoglycemic reactions resulting in
loss of consciousness or seizure, requiring the assistance of another
person, or resulting in impaired cognitive function that occurred
without warning symptoms, in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the past 5 years. In each case,
an endocrinologist verified that the driver has demonstrated a
willingness to properly monitor and manage his/her diabetes mellitus,
received education related to diabetes management, and is on a stable
insulin regimen. These drivers report no other disqualifying
conditions, including diabetes-related complications. Each meets the
vision requirement at 49 CFR 391.41(b)(10).
    The qualifications and medical condition of each applicant were
stated and discussed in detail in the June 4, 2015, Federal Register
notice and they will not be repeated in this notice.

III. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the diabetes requirement in 49 CFR 391.41(b)(3) if the exemption
is likely to achieve an equivalent or greater level of safety than
would be achieved without the exemption. The exemption allows the
applicants to operate CMVs in interstate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered medical reports about the applicants' ITDM and vision, and
reviewed the treating endocrinologists' medical opinion related to the
ability of the driver to safely operate a CMV while using insulin.
    Consequently, FMCSA finds that in each case exempting these
applicants from the diabetes requirement in 49 CFR 391.41(b)(3) is
likely to achieve a level of safety equal to that existing without the
exemption.

V. Conditions and Requirements

    The terms and conditions of the exemption will be provided to the
applicants in the exemption document and they include the following:
(1) That each individual submit a quarterly monitoring checklist
completed by the treating endocrinologist as well as an annual
checklist with a comprehensive medical evaluation; (2) that each
individual reports within 2 business days of occurrence, all episodes
of severe hypoglycemia, significant complications, or inability to
manage diabetes; also, any involvement in an accident or any other
adverse event in a CMV or personal vehicle, whether or not it is
related to an episode of hypoglycemia; (3) that each individual provide
a copy of the ophthalmologist's or optometrist's report to the medical
examiner at the time of the annual medical examination; and (4) that
each individual provide a copy of the annual medical certification to
the employer for retention in the driver's qualification file, or keep
a copy in his/her driver's qualification file if he/she is self-
employed. The driver must also have a copy of the certification when
driving, for presentation to a duly authorized Federal, State, or local
enforcement official.

VI. Conclusion

    Based upon its evaluation of the 49 exemption applications, FMCSA
exempts the following drivers from the diabetes requirement in 49 CFR
391.41(b)(10), subject to the requirements cited above 949 CFR
391.64(b)):

Craig S. Barton (UT)
Kevin H. Bennerson (NY)
Eugene Butler (AR)
Dominick M. Ciuffreda (MA)
Allen D. Clise (MD)
John W. Dillard (TX)
Derek P. Elkins (AZ)
Joshua J. Ellett (IN)
Raymond C. Erschen (PA)
Dominic C. Frisina (PA)
David D. Gambill (NC)
Dennis T. Gannon (NJ)
Arnold W. Geske (MN)
Alan G. Gladhill (MD)
Richard A. Hall (IL)
Dwight L. Hawkins (NC)
Craig L. Jackson (WY)
Wayne A. Jadezuk (NY)
Lee L. Kropp (WI)
Douglas B. Lampela (MI)
David E. Lawton (MA)
Babe A. Lisai (NY)
Adrian Martinez-Alba (TX)
Robert S. Medberry (OH)
Daniel Mendolia (NY)
Gary L. Mjoness (ND)
Marty G. Niles (MT)
Timothy W. Olden (NJ)
John Palermo (NJ)
Dennis P. Pantone (NY)
John N. Peterson (WI)
Robert L. Potter, Jr. (NH)
Todd M. Raether (NE)
Michael A. Ramsey (CT)
Gene P. Rhodes Sr. (PA)
Peter B. Rzadkowski, Jr. (IL)
Jeffrey J. Salvador (MI)
Michael A. Scavotto (MA)
Michael Schmidt (PA)
Steven J. Schmitt (MN)
Carl J. Schneider (PA)
John R. Sherbondy (PA)
Douglas J. Smith (NY)

Johnathan C. Steffes (CA)
Carmen M. Stellitano (PA)
Andy L. Strommenger (CO)
Jared Villa (ND)
Robert T. Warriner (NJ)
Ellis E. Wilkins (MA)
    In accordance with 49 U.S.C. 31136(e) and 31315 each exemption is
valid for two years unless revoked earlier by FMCSA. The exemption will
be revoked if the following occurs: (1) The person fails to comply with
the terms and conditions of the exemption; (2) the exemption has
resulted in a lower level of safety than was maintained before it was
granted; or (3) continuation of the exemption would not be consistent
with the goals and objectives of 49 U.S.C. 31136(e) and 31315. If the
exemption is still effective at the end of the 2-year period, the
person may apply to FMCSA for a renewal under procedures in effect at
that time.

    Issued on: August 7, 2015.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2015-20188 Filed 8-14-15; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register: October 21, 2010 (Volume 75, Number 203)]
[Notices]
[Page 65053-65054]
[DOCID:fr21oc10-97]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2010-0141; Notice 1]

Mazda North American Operations, Receipt of Petition for Decision
of Inconsequential Noncompliance

    Mazda North American Operations (MNAO),\1\ on behalf of Mazda Motor
Corporation of Hiroshima, Japan (Mazda), has determined the lens of the
headlamps equipped on certain 2004 through 2009 Mazda RX-8 model
passenger cars, manufactured from April 1, 2003, to May 29, 2009, and
certain 2006 through 2008 MX-5 model passenger cars, built from May 17,
2005, to November 27, 2008, failed to meet the requirements of
paragraph S7.2(b) of Federal Motor Vehicle Safety Standard (FMVSS) No.
108 Lamps, Reflective Devices, and Associated Equipment. Mazda has
filed an appropriate report pursuant to 49 CFR part 573, Defect and
Noncompliance Responsibility and Reports, dated December 18, 2009.
---------------------------------------------------------------------------

    \1\ Mazda Motor Corporation of Hiroshima, Japan (Mazda) is the
manufacturer of the subject vehicles and Mazda North American
Operations (MNAO) is the importer of the vehicles as well as the
registered agent for Mazda.
---------------------------------------------------------------------------

    Pursuant to 49 U.S.C. 30118(d) and 30120(h) (see implementing rule
at 49 CFR part 556), Mazda has petitioned for an exemption from the
notification and remedy requirements of 49 U.S.C. chapter 301 on the
basis that this noncompliance is inconsequential to motor vehicle
safety.
    This notice of receipt of Mazda's petition is published under 49
U.S.C. 30118 and 30120 and does not represent any agency decision or
other exercise of judgment concerning the merits of the petition.
    Mazda estimates approximately 123,000 2004 through 2009 Mazda RX-8
model passenger cars, manufactured from April 1, 2003 to May 29, 2009,
and 2006 through 2008 MX-5 model passenger cars, built from May 17,
2005 to November 27, 2008, are affected. All of the affected vehicles
were built at Mazda's plant in Hiroshima Japan.
    Paragraph 7.2(b) of FMVSS No. 108 requires:

    S7.2(b) The lens of each headlamp and of each beam contributor
manufactured on or after December 1, 1989, to which paragraph (a) of
this section applies shall be marked with the name and/or trademark
registered with the U.S. Patent and Trademark Office of the
manufacturer of such headlamp or beam contributor, or its importer,
or any manufacturer of a vehicle equipped with such headlamp or beam
contributor. Nothing in this paragraph shall be construed to
authorize the marking of any such name and/or trademark by one who
is not the owner, unless the owner has consented to it.

    Mazda states that the noncompliance is that the lenses of the
headlamps on the affected vehicles are not marked with the name or
trademark of the manufacturer of the headlamp, the manufacturer of the
vehicle, or the importer of the vehicle.
    Mazda was notified by its headlamp manufacturer, Koito
Manufacturing Company, Ltd. (Koito) of the apparent

noncompliance. Mazda then concluded that the vehicles equipped with the
affected headlamps failed to comply with paragraph S7.2(b) of FMVSS No.
108.
    Mazda stated the following reasons why they believe the
noncompliance is inconsequential to vehicle safety and does not present
a risk to motor vehicle safety:

    The affected headlamps fulfill all the relevant performance
requirements of FMVSS No. 108, except that trade name and/or
trademark of the manufacturer or importer is missing on the lens.
However, the affected headlamps have the trademark of the headlamp
manufacturer on the rim of the headlamp housing. Thus, Mazda
contends that this marking on the rim is visible with the vehicle's
front hood open and states that it believes that the rim marking
could assist the easy identification of the headlamp manufacturer by
the users of the vehicles.
    Mazda has not received any complaints or claims related to the
noncompliance nor is it aware of any known reports of accidents or
injuries attributed to the noncompliance.

    In summary, Mazda states that it believes the noncompliance is
inconsequential to motor vehicle safety because the affected headlamps
fulfill all other relevant requirements of FMVSS No. 108.
    The company also states that it has taken steps to correct the
noncompliance in future production.
    Supported by the above stated reasons, Mazda believes that the
subject noncompliance is inconsequential to motor vehicle safety, and
that its petition, to exempt it from providing recall notification of
noncompliance as required by 49 U.S.C. 30118 and remedying the recall
noncompliance as required by 49 U.S.C. 30120, should be granted.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance.
    Interested persons are invited to submit written data, views, and
arguments on this petition. Comments must refer to the docket and
notice number cited at the beginning of this notice and be submitted by
any of the following methods:
    a. By mail addressed to: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
    b. By hand delivery to U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590. The Docket Section is open on
weekdays from 10 am to 5 pm except Federal Holidays.
    c. Electronically: By logging onto the Federal Docket Management
System (FDMS) Web site at http://www.regulations.gov/. Follow the
online instructions for submitting comments. Comments may also be faxed
to 1-202-493-2251.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that your comments were received, please
enclose a stamped, self-addressed postcard with the comments. Note that
all comments received will be posted without change to http://
www.regulations.gov, including any personal information provided.
    Documents submitted to a docket may be viewed by anyone at the
address and times given above. The documents may also be viewed on the
Internet at http: //www.regulations.gov by following the online
instructions for accessing the dockets. DOT's complete Privacy Act
Statement is available for review in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    The petition, supporting materials, and all comments received
before the close of business on the closing date indicated below will
be filed and will be considered. All comments and supporting materials
received after the closing date will also be filed and will be
considered to the extent possible. When the petition is granted or
denied, notice of the decision will be published in the Federal
Register pursuant to the authority indicated below.
    Comment Closing Date: November 22, 2010.

    Authority:  (49 U.S.C. 30118, 30120: Delegations of authority at
CFR 1.50 and 501.8)

    Issued on: October 15, 2010.
Claude H. Harris,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2010-26425 Filed 10-20-10; 8:45 am]
BILLING CODE 4910-59-P