[Federal Register Volume 80, Number 152 (Friday, August 7, 2015)]
[Proposed Rules]
[Pages 47441-47448]
[FR Doc No: 2015-19348]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2014-0697; FRL-9930-33]
RIN 2070-AK50

Trichloroethylene (TCE); Significant New Use Rule; TCE in Certain
Consumer Products

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: Under the Toxic Substance Control Act (TSCA), EPA is proposing
a significant new use rule (SNUR) for trichloroethylene (TCE). The
proposed significant new use is manufacture or processing for use in a
consumer product, with a proposed exception for use of TCE in cleaners
and solvent degreasers, film cleaners, hoof polishes, lubricants,
mirror edge sealants, and pepper spray. Persons subject to the SNUR
would be required to notify EPA at least 90 days before commencing any
manufacturing or processing of TCE for a significant new use. The
required notification would provide EPA with the opportunity to
evaluate the intended use and, if necessary based on the information
available at that time, an opportunity to protect against potential
unreasonable risks, if any, from that activity before it occurs.

DATES: Comments must be received on or before October 6, 2015.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2014-0697, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Katherine Sleasman, Chemical Control Division (7405M), Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-7716; email address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture,
process, or distribute in commerce chemical substances and mixtures.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Textile Product Mills (NAICS code 314).
     Wood Product Manufacturing (NAICS code 321).
     Printing and Related Support Activities (NAICS code 323).
     Chemical Manufacturing (NAICS code 325).
     Plastics and Rubber Product Manufacturing (NAICS code
326).
     Primary Metal Manufacturing (NAICS code 331).
     Fabricated Metal Product Manufacturing (NAICS code 332).
     Machinery Manufacturing (NAICS code 333).
     Computer and Electronic Product Manufacturing (NAICS code
334).
     Electrical Equipment, Appliance, and Component
Manufacturing (NAICS code 335).
     Transportation Equipment Manufacturing (NAICS code 336).
     Furniture and Product Related Manufacturing (NAICS code
337).
     Miscellaneous Manufacturing (NAICS code 339).
     Clothing and Clothing Accessory Stores (NAICS code 488).
     Warehousing and Storage (NAICS code 493).
     Repair and Maintenance (NAICS code 811).
     National Security and International Affairs (NAICS code
928).
    This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Persons
who import any chemical substance governed by a final SNUR are subject
to the TSCA section 13 (15 U.S.C. 2612) import certification
requirements and the corresponding regulations at 19 CFR 12.118 through
12.127; see also 19 CFR 127.28. Those persons must certify that the
shipment of the chemical substance complies with all applicable rules
and orders under TSCA, including any SNUR requirements. The EPA policy
in support of import certification appears at 40 CFR part 707, subpart
B. In addition, any persons who export or intend to export a chemical
substance that is the subject of this proposed rule on or after
September 8, 2015 are subject to the export notification provisions of
TSCA section 12(b) (15 U.S.C. 2611(b)), (see 40 CFR 721.20), and must
comply with the export notification requirements in 40 CFR part 707,
subpart D.
    If you have any questions regarding the applicability of this
action to a particular entity, consult the technical information
contact listed under FOR FURTHER INFORMATION CONTACT.

B. What is the agency's authority for taking this action?

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including those listed in TSCA section 5(a)(2). Once
EPA determines that a use of a chemical substance is a significant new
use, TSCA section 5(a)(1)(B) requires persons to submit a significant
new use notice (SNUN) to EPA at least 90 days before they manufacture
(including import) or process the chemical substance for that use (15
U.S.C. 2604(a)(1)(B)). As described in Unit V., the general SNUR
provisions are found at 40 CFR part 721, subpart A.

C. What action is the agency taking?

    EPA is proposing a SNUR for trichloroethylene (TCE). The proposed
significant new use is: Manufacturing and processing for any use in a
consumer product of TCE except for use in cleaners and solvent
degreasers, film cleaners, hoof polishes, lubricants, mirror edge
sealants, and pepper spray.
    The proposed significant use EPA has identified in this unit is a
use that EPA believes is not ongoing at the time of this proposed rule.
EPA is requesting public comment on this proposal, and specifically on
the Agency's understanding of ongoing uses for the chemical identified.
EPA is particularly interested in whether there are any ongoing uses of
this chemical in consumer products of which the Agency is currently
unaware. EPA would welcome specific documentation of any such ongoing
uses. A consumer product is defined at 40 CFR 721.3 as ``a chemical
substance that is directly, or as part of a mixture, sold or made
available to consumers for their use in or around a permanent or
temporary household or residence, in or around a school, or in
recreation.''
    This proposed SNUR would require persons that manufacture
(including import) or process any of the chemicals for a significant
new use, consistent with the requirements at 40 CFR 721.25, to notify
EPA at least 90 days before commencing such manufacture or process of
the chemical substance for a significant new use.

D. Why is the agency taking this action?

    This SNUR is necessary to ensure that EPA receives timely advance
notice of any future manufacturing and processing of TCE for new uses
that may produce changes in human and environmental exposures. The
rationale and objectives for this SNUR are explained in Unit III.

E. What are the estimated incremental impacts of this action?

    EPA has evaluated the potential costs of establishing SNUR
reporting requirements for potential manufacturers and processors of
the chemical substance included in this proposed rule. This analysis,
which is available in the docket, is discussed in Unit IX., and is
briefly summarized here. In the event that a SNUN is submitted, costs
are estimated to be less than $8,900 per SNUN submission for large
business submitters and $6,500 for small business submitters. These
estimates include the cost to prepare and submit the SNUN and the
payment of a user fee. The proposed SNUR would require first-time
submitters of any TSCA section 5 notice to register their company and
key users with the CDX reporting tool, deliver a CDX electronic
signature to EPA, and establish and use a Pay.gov E-payment account
before they may submit a SNUN, for a cost of $203 per firm. However,
these activities are only required of first time submitters of

section 5 notices. In addition, for persons exporting a substance that
is the subject of a SNUR, a one-time notice to EPA must be provided for
the first export or intended export to a particular country, which is
estimated to be $83 per notification.

II. Chemical Substance Subject to This Proposed Rule

A. What chemical is included in the proposed SNUR?

    This proposed SNUR would apply to TCE (Chemical Abstract Services
Registry Number (CASRN 79-01-6) manufactured or processed for use in a
consumer product except for use in cleaners and solvent degreasers,
film cleaners, hoof polishes, lubricants, mirror edge sealants, and
pepper spray. TCE is a volatile organic compound (VOC) that is produced
and imported into the United States, with use estimated to be around
250 million pounds per year. It is a clear, colorless liquid that has a
sweet odor and evaporates quickly (Ref. 1).
    To ascertain if TCE is used in consumer products, EPA reviewed
published literature, the National Institute of Health's (NIH)
Household Product Database (HPD), Safety Data Sheets (SDSs), data
submitted under EPA's Chemical Data Reporting (CDR) rule, and data
submitted under EPA's Toxics Release Inventory (TRI) and communicated
directly with domestic manufacturers and processors (Refs. 1 and 2).
From review of these resources it was confirmed that the following
consumer products containing TCE are available in retail outlets and e-
commerce sites: Cleaners and solvent degreasers, film cleaners, hoof
polishes, lubricants, mirror edge sealants, and pepper spray. Cleaners
and solvents can be used to clean automotive parts, fabrics, and
carpets. EPA does not believe that there are any other types of
consumer products containing TCE (Ref. 1).
    Following the release of the final risk assessment, EPA received a
letter from PLZ Aeroscience Corporation on March 5, 2015, indicating
their intent to reformulate their spray fixative product for consumers.
Their letter states that they will no longer manufacture or process
spray fixatives with TCE by September 1, 2015 (Ref. 3). EPA's review of
the resources indicates this is the only TCE-containing spray fixative
that is still used in a consumer product.

B. What are the production volumes and uses of TCE?

    The majority (>80%) of TCE is used as an intermediate for
manufacturing refrigerant chemicals. Much of the remainder, less than
14 percent, is used as a solvent for metals degreasing, leaving a
relatively small percentage to account for all other uses, including
its use in consumer products. In 2011, global consumption of TCE was
945 million pounds (lbs) and U.S. consumption was 255 million lbs. Nine
companies, including domestic manufacturers and importers, reported a
total production of 224.7 million lbs of TCE in 2011 to the CDR
database. Based on the TRI data for 2012, 38 companies use TCE as a
formulation component, 33 companies process TCE by repackaging the
chemical, 28 companies use TCE as a manufacturing aid, and 1,113
companies use TCE for ancillary uses, such as degreasing. Overall, most
U.S. consumption is attributable to two specific uses: As an
intermediate for manufacturing the refrigerant (closed system) HFC-134a
(a major alternative to CFC-12), and as a solvent for metal degreasing
(Ref. 1).

C. What are the potential health effects of TCE?

    A broad set of relevant studies including epidemiologic studies,
animal bioassays, metabolism studies and mechanistic studies show that
TCE exposure is associated with a wide array of adverse health effects.
TCE has the potential to induce neurotoxicity, immunotoxicity,
developmental toxicity, liver toxicity, kidney toxicity, endocrine
effects, and several forms of cancer (Ref. 1).
    TCE is fat soluble (lipophilic) and easily crosses biological
membranes. It is readily absorbed into the body following oral, dermal,
or inhalation exposure. Following oral ingestion TCE is rapidly
absorbed from the gastrointestinal tract into the systemic circulation
(i.e., blood), and its absorption rate is highly influenced by dose of
the chemical, dosing vehicle, and stomach content. Absorption through
the skin has been shown by both vapor and liquid TCE contact. Likewise,
absorption following inhalation of TCE is also rapid and the inhaled
absorbed dose is proportional to the exposure concentration, duration
of exposure, and lung ventilation rate. Regardless of the route of
exposure, TCE is widely distributed throughout the body. TCE levels can
be found in many different tissues including: Brain, muscle, heart,
kidney, lung, liver, and adipose tissues. Due to its lipophilicity, TCE
has been found in human maternal and fetal blood and in the breast milk
of lactating women (Ref. 1).
    The metabolism of TCE has been extensively studied in humans and
experimental rodent models. Both humans and animals metabolize TCE to
numerous toxicologically active metabolites to varying degrees. These
metabolites are generated from and transported across multiple tissues
and play a key role in causing TCE[hyphen]associated toxic effects that
target the liver and kidney (Ref. 1).
    TCE is characterized as carcinogenic to humans by all routes of
exposure as documented in EPA's TCE Integrated Risk Information System
(IRIS) assessment (Ref. 4). This conclusion is based on strong cancer
epidemiological data that reported an association between TCE exposure
and the onset of various cancers, primarily in the kidney, liver and
the immune system (i.e., non[hyphen]Hodgkin lymphoma or NHL). Further
support for TCE's carcinogenic characterization comes from positive
results in multiple rodent cancer bioassays in rats and mice of both
sexes, similar toxicokinetics between rodents and humans, mechanistic
data supporting a mutagenic mode of action for kidney tumors, and the
lack of mechanistic data supporting the conclusion that any of the
mode(s) of action for TCE[hyphen]induced rodent tumors are irrelevant
to humans. Additional support comes from the recent evaluation of TCE's
carcinogenic effects by the International Agency for Research on Cancer
(IARC). IARC classifies TCE as carcinogenic to humans (Ref. 5).
    EPA's IRIS assessment also concluded that TCE poses a potential
human health hazard for non-cancer toxicity including neurotoxicity,
liver and kidney effects, immunotoxicity, reproductive, and
developmental effects. Also evaluated in the IRIS assessment were TCE's
and its metabolites genotoxic effects. As shown through the results of
in vitro and in vivo tests, TCE has the potential to bind or induce
damage to the structure of DNA or chromosomes (Ref. 4).
    Neurotoxicity has been demonstrated in animal and human studies
under both acute and chronic exposure conditions. Evaluation of the
human studies revealed TCE[hyphen]induced neurotoxic effects including
alterations in trigeminal nerve and vestibular function, auditory
effects, changes in vision, alterations in cognitive function, changes
in psychomotor effects, and neurodevelopmental outcomes. The strongest
neurological evidence of human toxicological hazard is for changes in
trigeminal nerve function or morphology and impairment of vestibular
function. Multiple epidemiological studies in different populations
have reported TCE[hyphen]induced abnormalities in trigeminal nerve

function in humans, and various human studies have consistently
reported vestibular system[hyphen]related symptoms such as headaches,
dizziness, and nausea following TCE exposure (Ref. 1).
    Animals and humans exposed to TCE consistently experience liver
toxicity. Specific effects include the following structural changes:
Increased liver weight, increase in deoxyribonucleic acid (DNA)
synthesis (transient), enlarged hepatocytes, enlarged nuclei, and
peroxisome proliferation. Several human studies reported an association
between TCE exposure and significant changes in serum liver function
tests used in diagnosing liver disease, or changes in plasma or serum
bile acids. There was also human evidence for hepatitis accompanying
immune[hyphen]related generalized skin diseases, jaundice,
hepatomegaly, hepatosplenomegaly, and liver failure in
TCE[hyphen]exposed workers. For kidney effects, studies in both humans
and animals have shown changes in the proximate tubules of the kidney
following exposure to TCE. TCE metabolites also appear to be the
causative agents that induce renal toxicity (Ref. 1).
    Immune[hyphen]related effects following TCE exposures have been
observed in both animal and human studies. In general, these effects
were associated with inducing enhanced immune responses as opposed to
immunosuppressive effects. Human studies have reported a relationship
between systemic autoimmune diseases, such as scleroderma with
occupational exposure to TCE. There have also been a large number of
case reports in TCE[hyphen]exposed workers developing a severe
hypersensitivity skin disorder, often accompanied by systemic effects
to the lymph nodes and other organs, such as hepatitis (Ref. 1).
    The toxicological literature provides support for male and female
reproductive toxicity following TCE exposure. Both the epidemiological
and animal studies provide evidence of adverse outcomes to female
reproductive outcomes. However, much more extensive evidence exists in
support of an association between TCE exposures and male reproductive
toxicity. There is evidence that the metabolism of TCE in male
reproductive tract tissues is associated with adverse effects on sperm
measures in both humans and animals. Furthermore, human studies support
an association between TCE exposure and alterations in sperm density
and quality, as well as changes in sexual drive or function and altered
serum endocrine levels (Ref. 1).
    An evaluation of the overall weight and strength of the evidence of
the human and animal developmental toxicity data suggests an
association between pre[hyphen] and/or post-natal TCE exposures and
potential adverse developmental outcomes. TCE[hyphen]induced heart
malformations in animals have been identified as the most sensitive
developmental toxicity endpoint for TCE. Human studies examined the
possible association of TCE with various prenatal effects. These
adverse effects of developmental TCE exposure could include death
(spontaneous abortion, perinatal death, pre- or post-implantation loss,
resorptions), decreased growth (low birth weight, small for gestational
age), and congenital malformations, in particular cardiac defects, and
postnatal effects such as growth, survival, developmental
neurotoxicity, developmental immunotoxicity, and childhood cancers.
There have also been some epidemiological studies that have
consistently reported an increased incidence of birth defects in
TCE[hyphen]exposed populations from exposure to contaminated water. As
for human developmental neurotoxicity, studies collectively suggest
that the developing brain is susceptible to TCE toxicity. These studies
have reported an association with TCE exposure and central nervous
system birth defects and postnatal effects such as delayed newborn
reflexes, impaired learning or memory, aggressive behavior, hearing
impairment, speech impairment, encephalopathy, impaired executive and
motor function and attention deficit (Ref. 1).

D. What are the potential routes and sources of exposure to TCE?

    The main route of exposure for TCE is inhalation due to its
chemical properties and the nature of the consumer products. However,
EPA recognizes that highly volatile compounds such as TCE may also be
absorbed through the skin. (Ref. 1).
    In EPA's final risk assessment for TCE, EPA examined acute risks
for consumer exposures in residential settings. The assessment
identified risks to consumers and residential bystanders from use of
solvent degreasers and protective spray coatings, also referred to as
spray fixatives, because of either their high TCE content or high
potential for human exposure. TCE is also present in film cleaners, and
mirror edge sealants, but these products were not evaluated because of
either their low TCE content, less frequent use, or low exposure
potential. The final risk assessment calculated indoor air
concentrations using the Exposure and Fast Assessment Screening Tool
Version 2 (E-FAST2) Consumer Exposure Model (CEM) for the consumer
exposure. EPA used E-FAST2 CEM because of the lack of available
emissions and monitoring data for the TCE containing consumer products
(Ref. 1).
    For the spray fixatives and solvent degreasers used by consumers
who experience exposures, there is the potential for acute risks that
could result from even one improper use of these products containing
TCE. Most consumers would be unaware of the potential toxicity of
consumer products containing TCE. Consequently, insufficient and
inadequate hazard communication may lead to incorrect use and increased
consumer and bystander exposures. Even if consumers are aware of such
potential hazards, they may not take appropriate precautions or
research the appropriate resources in which these precautions are
addressed. Of particular concern is that TCE has harmful effects that
occur below the odor threshold, meaning that smelling the chemical in
the home environment is not a sufficient approach to avoid hazardous
effects (Ref. 1).

III. Rationale and Objectives

A. Rationale

    EPA is concerned about the adverse health effects of TCE resulting
from commercial and consumer uses of the chemical substance identified
for a risk assessment as part of EPA's Existing Chemicals Management
Program. EPA identified a work plan of 83 chemicals including TCE for
further assessment under the TSCA Work Plan for Chemical Assessments in
March 2012, to help focus and direct the activities of its Existing
Chemicals Management Program. EPA reviewed readily available
information on TCE including uses, physical and chemical properties,
fate, exposure potential, and associated hazards to humans and the
environment. TCE was selected based on concerns for its human health
hazard (e.g., human carcinogen) and its exposure profile (i.e., widely
used in consumer products and detected in drinking water, indoor
environments, surface water, ambient air, groundwater, and soil) using
OPPT's TSCA Work Plan screening methodology (Ref. 6). In EPA's final
risk assessment released on June 25, 2014, the Agency identified risks
to workers using TCE and non-workers for degreasers and a spot-cleaner
in dry cleaning uses, and EPA also identified health risks to consumers
using spray aerosol degreasers and spray fixatives (Ref. 1).
    EPA believes that any additional use of this chemical substance in
consumer

products could significantly increase human exposure, and that such
exposures should not occur without an opportunity for EPA review and
control as appropriate. However, as discussed in Unit II, based on
review of SDSs and the NIH's HPD, EPA believes that cleaners and
solvent degreasers, film cleaners, hoof polishes, lubricants, mirror
edge sealants, and pepper spray contain TCE. EPA believes that other
consumer products do not presently contain TCE, other than spray
fixative product use which will be discontinued by September 1, 2015 as
described in Unit II.A.
    Consistent with EPA's past practice for issuing SNURs under TSCA
section 5(a)(2), EPA's decision to propose a SNUR for a particular
chemical use need not be based on an extensive evaluation of the
hazard, exposure, or potential risk associated with that use. Rather,
the Agency action is based on EPA's determination that if the use
begins or resumes, it may present a risk that EPA should evaluate under
TSCA before the manufacturing or processing for that use begins. Since
the new use does not currently exist, deferring a detailed
consideration of potential risks or hazards related to that use is an
effective use of resources. If a person decides to begin manufacturing
or processing the chemical for the use, the notice to EPA allows EPA to
evaluate the use according to the specific parameters and circumstances
surrounding that intended use.

B. Objectives

    Based on the considerations in Unit III.A., EPA wants to achieve
the following objectives with regard to the significant new use(s) that
are designated in this proposed rule:
    1. EPA would receive notice of any person's intent to manufacture
or process TCE for the described significant new use before that
activity begins.
    2. EPA would have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing TCE for the described significant new use.
    3. EPA would be able to regulate prospective manufacturers or
processors of TCE before the described significant new use of the
chemical substance occurs, provided that regulation is warranted
pursuant to TSCA section 5(e), 5(f), 6 or 7.

IV. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors including:
    1. The projected volume of manufacturing and processing of a
chemical substance.
    2. The extent to which a use changes the type or form of exposure
of human beings or the environment to a chemical substance.
    3. The extent to which a use increases the magnitude and duration
of exposure of human beings or the environment to a chemical substance.
    4. The reasonably anticipated manner and methods of manufacturing,
processing, distribution in commerce, and disposal of a chemical
substance.
    In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorizes EPA to consider any other relevant factors.
    To determine what would constitute a significant new use of TCE
compounds subject to this proposed rule, as discussed in this unit, EPA
considered relevant information about the toxicity of the substance,
likely human exposures and environmental releases associated with
possible uses, and the four factors listed in section 5(a)(2) of TSCA.
EPA has preliminarily determined as the significant new use:
Manufacture or processing for any use in a consumer product except for
use in cleaners and solvent degreasers, film cleaners, hoof polishes,
lubricants, mirror edge sealants, and pepper spray. Because TCE is not
used in consumer products (with the limited exceptions of use in
cleaners and solvent degreasers, film cleaners, hoof polishes,
lubricants, mirror edge sealants, pepper spray, and (before September
1, 2015) spray fixatives), EPA believes new use in consumer products
could increase the magnitude and duration of human exposure to TCE.
Exposure to TCE through inhalation may lead to a wide array of adverse
health effects, such as neurotoxicity, immunotoxicity, developmental
toxicity, liver toxicity, kidney toxicity, endocrine effects, and
several forms of cancer, as further explained in Unit II.C., and
because of these adverse effects EPA would like the opportunity to
evaluate such potential uses in consumer products for any associated
risks or hazards that might exist before those uses would begin.

V. Applicability of General Provisions

    General provisions for SNURs appear under 40 CFR part 721, subpart
A. These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the final
rule.
    Provisions relating to user fees appear at 40 CFR part 700.
According to 40 CFR 721.1(c), persons subject to SNURs must comply with
the same notice requirements and EPA regulatory procedures as
submitters of Premanufacture Notices (PMNs) under TSCA section
5(a)(1)(A). In particular, these requirements include the information
submissions requirements of TSCA section 5(b) and 5(d)(1), the
exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and
(h)(5), and the regulations at 40 CFR part 720. Once EPA receives a
SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6
or 7 to control the activities on which it has received the SNUN. If
EPA does not take action, EPA is required under TSCA section 5(g) to
explain in the Federal Register its reasons for not taking action.
    Persons who export or intend to export a chemical substance
identified in a proposed or final SNUR are subject to the export
notification provisions of TSCA section 12(b). The regulations that
interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D. In
accordance with 40 CFR 707.60(b) this proposed SNUR does not trigger
export notification for articles. Persons who import a chemical
substance identified in a final SNUR are subject to the TSCA section 13
import certification requirements, codified at 19 CFR 12.118 through
12.127; see also 19 CFR 127.28. Those persons must certify that the
shipment of the chemical substance complies with all applicable rules
and orders under TSCA, including any SNUR requirements. The EPA policy
in support of import certification appears at 40 CFR part 707, subpart
B.

VI. Applicability of Rule to Uses Occurring Before Effective Date of
the Final Rule

    As discussed in the Federal Register of April 24, 1990 (55 FR
17376; FRL-3658-5) (Ref. 7), EPA has decided that the intent of section
5(a)(1)(B) of TSCA is best served by designating a use as a significant
new use as of the date of publication of the proposed rule rather than
as of the effective date of the final rule. If uses begun after
publication of the proposed rule were considered ongoing rather than
new, it would be difficult for EPA to establish SNUR notice
requirements, because a person could defeat the SNUR by initiating the
proposed significant new use before the rule became final, and then
argue that the use was ongoing as of the effective date of the final
rule. Thus, persons who begin commercial manufacture or processing of
the chemical substance(s) that would be regulated through this

proposed rule, if finalized, would have to cease any such activity
before the effective date of the rule if and when finalized. To resume
their activities, these persons would have to comply with all
applicable SNUR notice requirements and wait until the notice review
period, including all extensions, expires. Uses arising after the
publication of the proposed rule are distinguished from uses that exist
at publication of the proposed rule. The former would be new uses, the
latter ongoing uses, except that uses that are ongoing as of the
publication of the proposed rule would not be considered ongoing uses
if they have ceased by the date of issuance of a final rule. However,
recognizing the use in a consumer product of TCE in spray fixatives
will cease by September 1, 2015 as described in Unit II.A., EPA
considers September 1, 2015 as the date from which the significant new
use with respect only to such spray fixatives would be designated. To
the extent that additional ongoing uses are found in the course of
rulemaking, EPA would exclude those specific uses from the final SNUR.
EPA has promulgated provisions to allow persons to comply with the
final SNUR before the effective date. If a person were to meet the
conditions of advance compliance under 40 CFR 721.45(h), that person
would be considered to have met the requirements of the final SNUR for
those activities.

VII. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not usually require
developing any particular test data before submission of a SNUN. There
are two exceptions:
    1. Development of test data is required where the chemical
substance subject to the SNUR is also subject to a test rule under TSCA
section 4 (see TSCA section 5(b)(1)); and
    2. Development of test data may be necessary where the chemical
substance has been listed under TSCA section 5(b)(4) (see TSCA section
5(b)(2)).

In the absence of a section 4 test rule or a section 5(b)(4) listing
covering the chemical substance, persons are required to submit only
test data in their possession or control and to describe any other data
known to or reasonably ascertainable by them (15 U.S.C. 2604(d); 40 CFR
721.25, and 40 CFR 720.50). However, as a general matter, EPA
recommends that SNUN submitters include data that would permit a
reasoned evaluation of risks posed by the chemical substance during its
manufacture, processing, use, distribution in commerce, or disposal.
EPA encourages persons to consult with the agency before submitting a
SNUN. As part of this optional pre-notice consultation, EPA would
discuss specific data it believes may be useful in evaluating a
significant new use. SNUNs submitted for significant new uses without
any test data may increase the likelihood that EPA will take action
under TSCA section 5(e) to prohibit or limit activities associated with
this chemical.

    SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs that provide detailed information on:
     Human exposure and environmental releases that may result
from the significant new uses of the chemical substance;
     Potential benefits of the chemical substance; and
     Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.

VIII. SNUN Submissions

    EPA recommends that submitters consult with the Agency prior to
submitting a SNUN to discuss what data may be useful in evaluating a
significant new use. Discussions with the Agency prior to submission
can afford ample time to conduct any tests that might be helpful in
evaluating risks posed by the substance. According to 40 CFR 721.1(c),
persons submitting a SNUN must comply with the same notice requirements
and EPA regulatory procedures as persons submitting a PMN, including
submission of test data on health and environmental effects as
described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No.
7710-25, generated using e-PMN software, and submitted to the Agency in
accordance with the procedures set forth in 40 CFR[emsp14]721.25 and 40
CFR 720.40. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems.

IX. Economic Analysis

A. SNUNs

    EPA has evaluated the potential costs of establishing SNUR
reporting requirements for potential manufacturers and processors of
the chemical substance included in this proposed rule (Ref. 2). In the
event that a SNUN is submitted, costs are estimated at approximately
$8,900 per SNUN submission for large business submitters and $6,500 for
small business submitters. These estimates include the cost to prepare
and submit the SNUN, and the payment of a user fee. Businesses that
submit a SNUN would be subject to either a $2,500 user fee required by
40 CFR 700.45(b)(2)(iii), or, if they are a small business with annual
sales of less than $40 million when combined with those of the parent
company (if any), a reduced user fee of $100 (40 CFR 700.45(b)(1)).
EPA's complete economic analysis is available in the public docket for
this proposed rule (Ref. 2).

B. Export Notification

    Under section 12(b) of TSCA and the implementing regulations at 40
CFR part 707, subpart D, exporters must notify EPA if they export or
intend to export a chemical substance or mixture for which, among other
things, a rule has been proposed or promulgated under TSCA section 5.
For persons exporting a substance that is the subject of a SNUR, a one-
time notice to EPA must be provided for the first export or intended
export to a particular country. The total costs of export notification
will vary by chemical, depending on the number of required
notifications (i.e., the number of countries to which the chemical is
exported). While EPA is unable to make any estimate of the likely
number of export notifications for the chemical covered in this
proposed SNUR, as stated in the accompanying economic analysis of this
proposed SNUR, the estimated cost of the export notification
requirement on a per unit basis is $83.

X. Alternatives

    Before proposing this SNUR, EPA considered the following
alternative regulatory action: Promulgate a TSCA Section 8(a) Reporting
Rule.
    Under a TSCA section 8(a) rule, EPA could, among other things,
generally require persons to report information to the agency when they
intend to manufacture or process a listed chemical for a specific use
or any use. However, for TCE, the use of TSCA section 8(a) rather than
SNUR authority would have several limitations. First, if EPA were to
require reporting under TSCA section 8(a) instead of TSCA section 5(a),
EPA would not have the opportunity to review human and environmental
hazards and exposures associated with the proposed significant new use
and, if necessary, take immediate follow-up regulatory action under
TSCA section 5(e) or 5(f) to prohibit or limit the activity before it
begins. In addition, EPA may not receive important information from
small businesses, because such firms generally are exempt from TSCA
section 8(a) reporting requirements (see TSCA sections 8(a)(1)(A) and
8(a)(1)(B)). In view of the level of health concerns about TCE if used
for the proposed significant new use, EPA believes that a

TSCA section 8(a) rule for this substance would not meet EPA's
regulatory objectives.

XI. Request for Comment

A. Do you have comments or information about ongoing uses?

    EPA welcomes comment on all aspects of this proposed rule. EPA
based its understanding of the use profile of these chemicals on the
published literature, the 2012 CDR submissions, market research,
discussions with manufacturers, and review of SDSs. To confirm EPA's
understanding, the Agency is requesting public comment on the EPA's
understanding that cleaners and solvent degreasers, film cleaners, hoof
polishes, lubricants, mirror edge sealants, and pepper spray contain
TCE. The Agency is also requesting public comment if any of the listed
uses that contain TCE are no longer available to consumers. EPA
believes that other consumer products do not contain TCE, however, EPA
is interested in information indicating that there are other ongoing
uses of TCE in consumer products. In providing comments on an ongoing
use of TCE in a consumer product, it would be helpful if you provide
sufficient information for EPA to substantiate any assertions of use.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. It is EPA's policy to include all comments
received in the public docket without change or further notice to the
commenter and to make the comments available on-line at
www.regulations.gov, including any personal information provided,
unless a comment includes information claimed to be CBI or other
information whose disclosure is restricted by statute. Do not submit
this information to EPA through regulations.gov or email. Clearly mark
the part or all of the information that you claim to be CBI. For CBI
information in a disk or CD ROM that you mail to EPA, mark the outside
of the disk or CD ROM that you mail to EPA as CBI and then identify
electronically within the disk or CD ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2, subpart B.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date, and page number).
    ii. Follow directions. The agency may ask you to respond to
specific questions or organize comments by referencing a CFR part or
section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

XII. References

    The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.

1. U.S. EPA. Final Risk Assessment on Trichloroethylene (TCE). June
25, 2014.
2. U.S. EPA. Economic Analysis of the Significant New Use Rule for
Trichloroethylene. February 19, 2015.
3. Letter from PLZ Aeroscience Corporation. March 5, 2015.
4. U.S. EPA. (2011). Toxicological Review of Trichloroethylene (CAS
No. 79-01-6). EPA/635/R-09/011F. Integrated Risk Information System,
Washington, DC.
5. IARC (2014). International Agency for Research on Cancer.
Monographs on the Evaluation of Carcinogenic Risks to Humans:
Cadmium, Trichloroethylene, Tetrachloroethylene, and Some
Chlorinated Agents, Volume 106. World Health Organization, Lyon,
France.
6. U.S. EPA. (2014). TSCA Work Plan for Chemical Assessments: 2014
Update. Washington. DC.
7. U.S. EPA. Significant New Uses of Certain Chemical Substances.
Federal Register of April 24, 1990, (55 FR 173776) (FRL-3658-5).

XIII. Statutory and Executive Order Reviews

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

    This proposed SNUR is not a ``significant regulatory action'' under
the terms of the Executive Order 12866 (58 FR 51735, October 4, 1993)
and is therefore not subject to review under Executive Order 12866 and
13563, entitled ``Improving Regulation and Regulatory Review'' (76 FR
3821, January 21, 2011).

B. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden
under the PRA, 44 U.S.C. 3501 et seq. Burden is defined in 5 CFR
1320.3(b). The information collection activities associated with
existing chemical SNURs are already approved by OMB under OMB control
number 2070-0038 (EPA ICR No. 1188); and the information collection
activities associated with export notifications are already approved by
OMB under OMB control number 2070-0030 (EPA ICR No. 0795). If an entity
were to submit a SNUN to the Agency, the annual burden is estimated to
be less than 100 hours per response, and the estimated burden for
export notifications is less than 1.5 hours per notification. In both
cases, burden is estimated to be reduced for submitters who have
already registered to use the electronic submission system.
    An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information that requires OMB approval
under the PRA, unless it has been approved by OMB and displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register, are listed in 40 CFR part 9, and included on the related
collection instrument, or form, if applicable.

C. Regulatory Flexibility Act (RFA)

    Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., I
hereby certify that promulgation of this SNUR would not have a
significant economic impact on a substantial number of small entities.
The rationale supporting this conclusion is as follows.
    A SNUR applies to any person (including small or large entities)
who intends to engage in any activity described in the rule as a
``significant new use.'' By definition of the word ``new'' and based on
all information currently available to EPA, it appears

that no small or large entities presently engage in such activities.
Since this SNUR will require a person who intends to engage in such
activity in the future to first notify EPA by submitting a SNUN, no
economic impact will occur unless someone files a SNUN to pursue a
significant new use in the future or forgoes profits by avoiding or
delaying the significant new use. Although some small entities may
decide to conduct such activities in the future, EPA cannot presently
determine how many, if any, there may be. However, EPA's experience to
date is that, in response to the promulgation of SNURs covering over
1,000 chemical substances, the Agency receives only a handful of
notices per year. During the six year period from 2005-2010, only three
submitters self-identified as small in their SNUN submission (Ref. 2).
EPA believes the cost of submitting a SNUN is relatively small compared
to the cost of developing and marketing a chemical new to a firm or
marketing a new use of the chemical and that the requirement to submit
a SNUN generally does not have a significant economic impact.
    Therefore, EPA believes that the potential economic impact of
complying with this proposed SNUR is not expected to be significant or
adversely impact a substantial number of small entities. In a SNUR that
published as a final rule on August 8, 1997 (62 FR 42690) (FRL-5735-4),
the Agency presented its general determination that proposed and final
SNURs are not expected to have a significant economic impact on a
substantial number of small entities, which was provided to the Chief
Counsel for Advocacy of the Small Business Administration.

D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reason to believe that any
State, local, or Tribal government would be impacted by this
rulemaking. As such, the requirements of sections 202, 203, 204, or 205
of UMRA, 2 U.S.C. 1531-1538, do not apply to this action.

E. Executive Order 13132: Federalism

    This action will not have a substantial direct effect on 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, as specified in Executive Order 13132 (64 FR 43255,
August 10, 1999).

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

    This proposed rule does not have Tribal implications because it is
not expected to have any effect (i.e., there will be no increase or
decrease in authority or jurisdiction) on Tribal governments, on the
relationship between the Federal government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
government and Indian tribes. Thus, Executive Order 13175 (65 FR 67249,
November 9, 2000) does not apply to this action.

G. Executive Order 13045: Protection of Children from Environmental
Health Risks and Safety Risks

    This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because this action is not intended to address
environmental health or safety risks for children.

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

    This proposed rule is not subject to Executive Order 13211 (66 FR
28355, May 22, 2001), because this action is not expected to affect
energy supply, distribution, or use.

I. National Technology Transfer and Advancement Act (NTTAA)

    Since this action does not involve any technical standards, section
12(d) of NTTAA, 15 U.S.C. 272 note, does not apply to this action.

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

    This proposed rule does not invoke special consideration of
environmental justice related issues as delineated by Executive Order
12898 (59 FR 7629, February 16, 1994), because EPA has determined that
this action will not have disproportionately high and adverse human
health or environmental effects on minority or low-income populations.
This action does not affect the level of protection provided to human
health or the environment.

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.

    Dated: July 30, 2015.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.

    Therefore, it is proposed that 40 CFR chapter I be amended as
follows:

PART 721--[AMENDED]

0
1. The authority citation for part 721 continues to read as follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).

0
2. Add Sec.  721.10851 to subpart E to read as follows:

Sec.  721.10851  Trichloroethylene.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance trichloroethylene (CAS 79-01-6)
is subject to reporting under this section for the significant new use
described in paragraph (a)(2) of this section.
    (2) Manufacture or processing for use in a consumer product except
for use in cleaners and solvent degreasers, film cleaners, hoof
polishes, lubricants, mirror edge sealants, and pepper spray.
    (b) [Reserved]

[FR Doc. 2015-19348 Filed 8-6-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 66 (Friday, April 7, 2017)]
[Notices]
[Pages 17074-17075]
[FR Doc No: 2017-06958]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2016-0128; Notice 1]

Harley-Davidson Motor Company, Inc., Receipt of Petition for
Decision of Inconsequential Noncompliance

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

ACTION: Receipt of petition.

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

SUMMARY: Harley-Davidson Motor Company, Inc. (Harley-Davidson), has
determined that certain model year (MY) 2016-2017 Harley-Davidson XL
1200XC Roadster motorcycles do not fully comply with Federal Motor
Vehicle Safety Standard (FMVSS) No. 120, Tire selection and rims and
motor home/recreation vehicle trailer load carrying capacity
information for motor vehicles with a GVWR of more than 4,536 kilograms
(10,000 pounds). Harley-Davidson filed a noncompliance information
report dated November 4, 2016. Harley-Davidson also petitioned NHTSA on
November 28, 2016, for a decision that the subject noncompliance is
inconsequential as it relates to motor vehicle safety.

DATES: The closing date for comments on the petition is May 8, 2017.

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

SUPPLEMENTARY INFORMATION:
    I. Overview: Harley-Davidson Motor Company, Inc. (Harley-Davidson),
has determined that certain model year (MY) 2016-2017 Harley-Davidson
XL 1200XC Roadster motorcycles do not fully comply with paragraph
S5.3.2 of Federal Motor Vehicle Safety Standard (FMVSS) No. 120, Tire
selection and rims and motor home/recreation vehicle trailer load
carrying capacity information for motor vehicles with a GVWR of more
than 4,536 kilograms (10,000 pounds). Harley-Davidson filed a report
dated November 4, 2016, pursuant to 49 CFR part 573, Defect and
Noncompliance Responsibility and Reports. Harley-Davidson also
petitioned NHTSA on November 28, 2016, pursuant to 49 U.S.C. 30118(d)
and 30120(h) and 49 CFR part 556, for an exemption from the
notification and remedy requirements of 49 U.S.C. Chapter 301 on the
basis that this noncompliance is inconsequential as it relates to motor
vehicle safety.
    This notice of receipt of Harley-Davidson's petition is published
under 49 U.S.C. 30118 and 30120 and does not represent any agency
decision or other exercise of judgment concerning the merits of the
petition.
    II. Vehicles Involved: Approximately 2,352 MY 2016-2017 Harley-
Davidson XL 1200XC Roadster motorcycles manufactured between March 8,
2016 and August 23, 2016 are potentially involved.
    III. Noncompliance: Harley-Davidson explains that the noncompliance
is that the certification label on the subject vehicles incorrectly
identifies the rear wheel rim size as 18 x 4.50 instead of 18 x 4.25,
and therefore does not meet the requirements of paragraph S5.3.2 of
FMVSS No. 120.
    IV. Rule Text: paragraph 5.3 of FMVSS No. 120 states:

    Each vehicle shall show the information specified in S5.3.1. and
S5.3.2 . . . in the English language, lettered in block capitals and
numerals not less than 2.4 millimeters high and in the format set
forth following this paragraph. This information shall appear
either:
    (a) After each GAWR listed on the certification label required
by Sec.  567.4 or Sec.  567.5 of this chapter; or at the option of
the manufacturer,
    (b) On the tire information label affixed to the vehicle in the
manner, location, and form described in Sec.  567.4(b) through (f)
of this chapter as appropriate of each GVWR-GAWR combination listed
on the certification label.

    Paragraph S5.3.2 of FMVSS No. 120 states:

    S5.3.2 Rims. The size designation and, if applicable, the type
designation of Rims (not necessarily those on the vehicle)
appropriate for those tires.

    V. Summary of Harley-Davidson's Petition: Harley-Davidson described
the subject noncompliance and stated its belief that the noncompliance
is inconsequential as it relates to motor vehicle safety.
    In support of its petition, Harley-Davidson submitted the following
reasoning:
    1. Harley-Davidson believes this labeling noncompliance is
inconsequential to motor vehicle safety because consumers have the
following sources to reliably identify the correct tire and rim
combination:
    a. The correct tire size is listed on the sidewall of the tire
originally installed on the rim;
    b. The correct tire, including tire size, is listed in the Owner's
Manual;
    c. The correct wheel size is shown in the Original Equipment &
Recommended Replacement Tires table in the Harley-Davidson Genuine
Motor Parts and Accessories catalog; and

    d. The correct wheel size is imprinted in the wheel.
    Harley-Davidson believes these sources, particularly the tire size
information listed on the rear tire's sidewall, are the most likely
places for consumers to look when replacing tires and rims.
    2. Harley-Davidson states that NHTSA has granted petitions for
inconsequential noncompliance for similar labeling errors regarding the
rim size or the omission of the rim size. (Please see Harley-Davidson's
petition for a complete list of referenced petitions.)
    In these cases Harley-Davidson stated that the agency reasoned that
consumers were unlikely to mismatch tires and rims because ``the rim
size information can be found in the vehicle's owner's manual or on the
rim itself, and the tire size information is available from multiple
sources including the owner's manual, the sidewalls of the tires on the
vehicle and on the tire placard or information label located on the
door or door opening. The rim size can be derived using this tire
information.
    3. The incorrect rim size on the subject motorcycles' certification
label is unlikely to expose operators to a significantly greater risk
than an operator riding a compliant motorcycle. Operators have several
reliable sources to assist them in correctly matching the rims and
tires.
    4. Lastly, Harley-Davidson is not aware of any warranty claims,
field reports, customer complaints, legal claims, or any incidents or
injuries related to the subject condition.
    Harley-Davidson concluded by expressing the belief that the subject
noncompliance is inconsequential as it relates to motor vehicle safety,
and that its petition to be exempted from providing notification of the
noncompliance, as required by 49 U.S.C. 30118, and a remedy for the
noncompliance, as required by 49 U.S.C. 30120, should be granted.
    To view Harley-Davidson's petition analyses in its entirety you can
visit https://www.regulations.gov by following the online instructions
for accessing the dockets and by using the docket ID number for this
petition shown in the heading of this notice.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, any decision on
this petition only applies to the subject motorcycles that Harley-
Davidson no longer controlled at the time it determined that the
noncompliance existed. However, any decision on this petition does not
relieve vehicle distributors and dealers of the prohibitions on the
sale, offer for sale, or introduction or delivery for introduction into
interstate commerce of the noncompliant vehicles under their control
after Harley-Davidson notified them that the subject noncompliance
existed.

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

Jeffrey M. Giuseppe,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2017-06958 Filed 4-6-17; 8:45 am]
 BILLING CODE 4910-59-P


Appendix B

Organizational Charts

Existing Organizational Chart

Proposed FY 2009 Organizational Chart

Proposed FY 2010 Organizational Chart

Proposed FY 2011 Organizational Chart

Illinois Central Management Systems Job Descriptions

Industrial Services Hygienist Technician

Industrial Services Hygienist

Public Safety Inspector Trainee

Public Safety Inspector

Industrial Services Consultant II

Office Associate

Public Service Administrator

Senior Public Service Administrator

Personnel Policy Statement


[Federal Register: June 12, 2009 (Volume 74, Number 112)]
[Notices]
[Page 28050]
[DOCID:fr12jn09-68]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-N-0377] (formerly Docket No. 2007N-0299)

Allyn M. Norman; Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (the act) debarring Dr.
Allyn M. Norman for 5 years from providing services in any capacity to
a person that has an approved or pending drug product application. FDA
bases this order on a finding that Dr. Norman was convicted of a
misdemeanor under Federal law for conduct relating to the development
or approval, including the process for development or approval, of a
drug product or otherwise relating to the regulation of drug products
under the act, and that the type of conduct that served as the basis
for the conviction undermines the process for the regulation of drugs.
Dr. Norman failed to request a hearing and, therefore, has waived his
opportunity for a hearing concerning this action.

DATES:  This order is effective June 12, 2009.

ADDRESSES:  Submit applications for termination of debarment to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Robert L. Hummel, Sr., Division of
Compliance Policy (HFC-230), Office of Enforcement, Office of
Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On October 28, 2002, the U.S. District Court for the Western
District of New York accepted Dr. Norman's plea of guilty to one count
of failure to maintain adequate and accurate records relating to the
use of investigational new drugs, a Federal misdemeanor offense under
21 U.S.C. 331(e) and 333(a)(1). On February 5, 2003, the U.S. District
Court for the Western District of New York entered a judgment of
conviction against Dr. Norman for this offense.
    The basis of this conviction was Dr. Norman's creation and
submission of falsified study data in required reports to the sponsor
of an investigational new drug application (IND) study, in violation of
section 505(i) of the act (21 U.S.C. 355(i)) and 21 CFR 312.62(a) and
(b). Dr. Norman failed to conduct the study according to the approved
protocol, reported the enrollment of nonexistent subjects in the study,
and fabricated all of the pertinent study records associated with these
subjects. Dr. Norman's failure to comply with the requirements of the
act and FDA regulations concerning the conduct of an IND study is the
type of conduct that undermines confidence in the results of clinical
studies that are relied on in the approval process for drug products.
    As a result of Dr. Norman's conviction, FDA sent to Dr. Norman, by
certified letter on October 10, 2007, a proposal to debar Dr. Norman
for 5 years from providing services in any capacity to a person that
has an approved or pending drug product application. The letter also
offered Dr. Norman notice of an opportunity for a hearing on the
proposal in accordance with section 306 of the act (21 U.S.C. 335a) and
21 CFR part 12. FDA based the debarment proposal on the findings, under
section 306(b)(2)(B)(i)(I) of the act, that Dr. Norman was convicted of
a misdemeanor under Federal law for conduct relating to the development
or approval, including the process for development or approval, of a
drug product or otherwise relating to the regulation of drug products
under the act, and that the type of conduct which served as the basis
for the conviction undermines the process for the regulation of drugs.
The letter notified Dr. Norman that he had 30 days from the date of
receipt of the letter to request a hearing. Dr. Norman did not request
a hearing. His failure to request a hearing constitutes a waiver of his
opportunity for a hearing and a waiver of any contentions concerning
his debarment.

II. Findings and Order

    Therefore, the Acting Director, Office of Enforcement, Office of
Regulatory Affairs, under section 306(b)(2)(B)(i)(I) of the act and
under authority delegated to the Acting Director (Staff Manual Guide
1410.35), finds that Dr. Allyn M. Norman has been convicted of a
misdemeanor under Federal law for failure to maintain adequate and
accurate records relating to the use of investigational new drugs, that
Dr. Norman's conduct relates to the development or approval, including
the process for development or approval, of a drug product or otherwise
relates to the regulation of drug products under the act, and that Dr.
Norman's conduct, which served as the basis for his conviction, is the
type of conduct that undermines the process for the regulation of
drugs.
    As a result of the foregoing findings, Dr. Norman is debarred for 5
years from providing services in any capacity to a person with an
approved or pending drug product application under sections 505, 512,
or 802 of the act (21 U.S.C. 355, 360b, or 382), or under section 351
of the Public Health Service Act (42 U.S.C. 262), effective (see DATES)
(see sections 306(c)(1)(B) and (c)(2)(A)(iii) and 201(dd) of the act
(21 U.S.C. 321(dd)). Any person with an approved or pending drug
product application who knowingly uses the services of Dr. Norman, in
any capacity, during his period of debarment, will be subject to civil
money penalties (section 307(a)(6) of the act (21 U.S.C. 355b(a)(6))).
If Dr. Norman, during his period of debarment, provides services in any
capacity to a person with an approved or pending drug product
application, he will be subject to civil money penalties (section
307(a)(7) of the act). In addition, FDA will not accept or review any
abbreviated new drug applications submitted by or with the assistance
of Dr. Norman during his period of debarment.
    Any application by Dr. Norman for termination of debarment under
section 306(d)(4) of the act should be identified with Docket No. FDA-
2007-N-0377 (formerly Docket No. 2007N-0299) and sent to the Division
of Dockets Management (see ADDRESSES). All such submissions are to be
filed in four copies. The public availability of information in these
submissions is governed by 21 CFR 10.20(j). Publicly available
submissions may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.

    Dated: June 4, 2009.
Alyson L. Saben,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. E9-13766 Filed 6-11-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: August 18, 2010 (Volume 75, Number 159)]
[Notices]
[Page 51077-51079]
[DOCID:fr18au10-112]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0422]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Information From United States Processors That Export
to the European Community

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on reporting requirements in
implementing the lists of U.S. firms/processors exporting shell eggs,
dairy products, game meat, game meat products, animal casings, gelatin,
and collagen to the European Community (the EC).

DATES:  Submit either electronic or written comments on the collection
of information by October 18, 2010.

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

FOR FURTHER INFORMATION CONTACT:  Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:  Under the PRA (44 U.S.C. 3501-3520),
Federal agencies must obtain approval from the Office of Management and
Budget (OMB) for each collection of information they conduct or
sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3)
and 5 CFR 1320.3(c) and includes agency requests or requirements that
members of the public submit reports, keep records, or provide

information to a third party. Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day
notice in the Federal Register concerning each proposed collection of
information, including each proposed extension of an existing
collection of information, before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Information From U.S. Processors That Export to the European Community
(OMB Control Number 0910-0320)--Extension

    The EC is a group of 27 European countries that have agreed to
harmonize their commodity requirements to facilitate commerce among
member States. EC legislation for intra-EC trade has been extended to
trade with non-EC countries, including the United States. For certain
food products, including those listed in this document, EC legislation
requires assurances from the responsible authority of the country of
origin that the processor of the food is in compliance with applicable
regulatory requirements.
    FDA requests information from processors that export certain
animal-derived products (e.g., shell eggs, dairy products, game meat,
game meat products, animal casings, and gelatin) to the EC. FDA uses
the information to maintain lists of processors that have demonstrated
current compliance with U.S. requirements and provides the lists to the
EC quarterly. Inclusion on the list is voluntary. EC member countries
refer to the lists at ports of entry to verify that products offered
for importation to the EC from the United States are from processors
that meet U.S. regulatory requirements. Products processed by firms not
on the lists are subject to detention and possible refusal at the port.
FDA requests the following information from each processor seeking to
be included on the lists:
     Business name and address;
     Name and telephone number of person designated as business
contact;
     Lists of products presently being shipped to the EC and
those intended to be shipped in the next 6 months;
     Name and address of manufacturing plants for each product;
and
     Names and affiliations of any Federal, State, or local
governmental agencies that inspect the plant, government-assigned plant
identifier such as plant number, and last date of inspection.
    Description of Respondents: The respondents to this collection of
information include U.S. producers of shell eggs, dairy products, game
meat, game meat products, animal casings, gelatin, and collagen.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                        No. of        Annual Frequency     Total Annual         Hours per
    Products         Respondents        per Response        Responses           Response          Total Hours
----------------------------------------------------------------------------------------------------------------
Shell Eggs                       10                  1                 10                0.25                  3
----------------------------------------------------------------------------------------------------------------
Dairy                           120                  1                120                0.25                 30
----------------------------------------------------------------------------------------------------------------
Game Meat and                     5                  1                  5                0.25                  1
 Game Meat
 Products
----------------------------------------------------------------------------------------------------------------
Animal Casings                    5                  1                  5                0.25                  1
----------------------------------------------------------------------------------------------------------------
Gelatin                           3                  1                  3                0.25                  1
----------------------------------------------------------------------------------------------------------------
Collagen                          3                  1                  3                0.25                  1
----------------------------------------------------------------------------------------------------------------
Total             .................  .................  .................  ..................                 37
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA bases its estimates of the number of respondents and total
annual responses on the submissions that the agency has received in the
past 3 years for each product type. To calculate the estimate for the
hours per response values, we assumed that the information requested is
readily available to the submitter. We expect that submitter will need
to gather information from appropriate persons in the submitter's
company and to prepare this information for submission. We believe that
this effort should take no longer than 15 minutes (0.25 hour) per
response. FDA estimates that it will receive 1 submission from 10 shell
egg producers annually, for a total of 10 annual responses. Each
submission is estimated to take 0.25 hour per response for a total of
2.5 hours, rounded to 3 hours. FDA estimates that it will receive 1
submission from 120 dairy product producers annually, for a total of
120 annual responses. Each submission is estimated to take 0.25 hour
per response for a total of 30 hours. FDA estimates that it will
receive 1 submission from 5 game meat and game meat product producers
annually, for a total of 5 annual responses. Each submission is
estimated to take 0.25 hour per response for a total of 1.25 hours,
rounded to 1 hour. FDA estimates that it will receive 1 submission from
5 animal casings producers annually, for a total of 5 annual responses.
Each submission is estimated to take 0.25 hour per response for a total
of 1.25 hours, rounded to 1 hour. FDA estimates that it will receive 1
submission from 3 gelatin producers annually, for a total of 3 annual
responses. Each submission is estimated to take 0.25 hour per response
for a total of 0.75 hour, rounded to 1 hour. FDA estimates that it will
receive 1 submission from 3 collagen producers annually, for a total of
3 annual

responses. Each submission is estimated to take 0.25 hour per response
for a total of 0.75 hour, rounded to 1 hour.
    Therefore, the proposed annual burden for this information
collection is 37 hours.

    Dated: August 12, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-20379 Filed 8-17-10; 8:45 am]
BILLING CODE 4160-01-S


Data Standard Change Log

October 17, 2008

Well Information Data Standard

Updated Version to EX000025.2

Updated Date to October 17, 2008

Update the Introductory Material

Updated Version and Date Headers and Footers to reflect changed date and version

Updated the web address for accessing data standards

Updated Revision History

Corrected an error in the original version—ESAR: Method Standard number was incorrect.

Deleted Aquifer Name and renumbered data elements as appropriate.  Aquifer name now is included in Monitoring Location

Updated Appendix A Data Structure Diagram

ESAR Project Data Standard

Updated Version to EX000002.2

Updated Date to October 17, 2008

Update the Introductory Material

Updated Version and Date Headers and Footers to reflect changed date and version

Updated the web address for accessing data standards

Updated Revision History

Added 2 data elements: 4.3 and 7.4 and  made any necessary numbering changes

Updated Appendix A Data Structure Diagram

Quality Assurance and Quality Control Data Standard

Updated Version to EX000012.2

Updated Date to October 17, 2008

Update the Introductory Material

Updated Version and Date Headers and Footers to reflect changed date and version

Updated the web address for accessing data standards

Updated Revision History

Added 1 data element 1.2 and made any necessary numbering changes

Updated Appendix A Data Structure Diagram

ESAR Monitoring Location Data Standard

Updated Version to EX000003.2

Updated Date to October 17, 2008

Update the Introductory Material

Updated Version and Date Headers and Footers to reflect changed date and version

Updated the web address for accessing data standards

Updated Revision History

Added a new section 8.0 Waterbody Identification with 3 new data elements 8.1, 8.2, and 8.2.1and made any necessary numbering changes

Added a reference to the FDGC NHD Reach Standard

Updated Appendix A Data Structure Diagram

Updated Section 9.0 Notes to reference the Well Information Data Standard

ESAR Analysis and Results Data Standard

Updated Version to EX000005.2

Updated Date to October 17, 2008

Update the Introductory Material

Updated Version and Date Headers and Footers to reflect changed date and version

Updated the web address for accessing data standards

Updated Revision History

Added a new Test Result Type example to Data Element 8.1

Added a new section 11.- Toxicology Analysis Results Information with 14 new data elements 11.1-11.14 .

Updated Appendix A Data Structure Diagram

ESAR Field Activity Data Standard

Updated Version to EX000004.2

Updated Date to October 17, 2008

Update the Introductory Material

Updated Version and Date Headers and Footers to reflect changed date and version

Updated the web address for accessing data standards

Updated Revision History

Changed a data element 7.7 to clarify and added a new data element 7.8 to complete the description

Added a new section 13.- Biological Habitat Collection Information with 8 new data elements 13.1-13.8 .

Updated Appendix A Data Structure Diagram