Proposed Clarification for Chemical Identification Describing Activated Phosphors for TSCA Inventory Purposes, 2854-2859 [E8-681]
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evidence of a causal association satisfies
the standard for inclusion in the
labeling under § 201.57(c) of this
chapter;
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(5) For purposes of paragraph (f)(2) of
this section, information will be
considered newly acquired if it consists
of data, analyses, or other information
not previously submitted to the agency,
which may include (but are not limited
to) data derived from new clinical
studies, reports of adverse events of a
different type or greater severity or
frequency than previously included in
submissions to FDA, or new analyses of
previously submitted data (e.g., metaanalyses).
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Dated: December 4, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8–702 Filed 1–15–08; 8:45 am]
PART 814—PREMARKET APPROVAL
OF MEDICAL DEVICES
AGENCY:
6. The authority citation for 21 CFR
part 814 continues to read as follows:
Authority: 21 U.S.C. 351, 352, 353, 360,
360c–360j, 371, 372, 373, 374, 375, 379, 379e,
381.
7. Section 814.3 is amended by
adding paragraph (o) to read as follows:
§ 814.3
Definitions.
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(o) Newly acquired information means
data, analyses, or other information not
previously submitted to the agency,
which may include (but are not limited
to) data derived from new clinical
studies, reports of adverse events of a
different type or greater severity or
frequency than previously included in
submissions to FDA, or new analyses of
previously submitted data (e.g., metaanalyses).
8. Section 814.39 is amended by
revising paragraphs (d)(1) introductory
text and (d)(2)(i) to read as follows:
§ 814.39
PMA supplements.
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(d)(1) After FDA approves a PMA, any
change described in paragraph (d)(2) of
this section to reflect newly acquired
information that enhances the safety of
the device or the safety in the use of the
device may be placed into effect by the
applicant prior to the receipt under
§ 814.17 of a written FDA order
approving the PMA supplement
provided that:
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(2) * * *
(i) Labeling changes that add or
strengthen a contraindication, warning,
precaution, or information about an
adverse reaction for which there is
reasonable evidence of a causal
association.
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BILLING CODE 4160–01–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 704, 720, 721, and 723
[EPA–HQ–OPPT–2007–0392; FRL–8131–8]
RIN 2070–AJ21
Proposed Clarification for Chemical
Identification Describing Activated
Phosphors for TSCA Inventory
Purposes
Environmental Protection
Agency (EPA).
ACTION: Proposed clarification.
SUMMARY: This document proposes a
clarification under which activated
phosphors that are not on the Toxic
Substances Control Act (TSCA) section
8(b) Chemical Substance Inventory
(TSCA Inventory) would be considered
to be new chemical substances under
TSCA section 5, thus would be subject
to the notification requirements under
TSCA section 5(a) new chemical
notification requirements. In certain
letters and other interpretations issued
by EPA from 1978 to 2003, it appears
that the Agency erroneously indicated
that activated phosphors constitute
solid mixtures for purposes of the TSCA
Inventory, and thus that they were not
separately reportable as chemical
substances under TSCA section 5(a)
new chemical notification requirements.
This proposed clarification is necessary
because EPA’s interpretations in this
area have not been consistent. Given
this past inconsistency, EPA is seeking
comment on its proposed clarfication.
DATES: Comments must be received on
or before March 17, 2008.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2007–0392, by
one of the following methods:
• Federal eRulemaking Portal: http://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• 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: OPPT Document
Control Office (DCO), EPA East Bldg.,
Rm. 6428, 1201 Constitution Ave., NW.,
Washington, DC. Attention: Docket ID
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Number EPA–HQ–OPPT–2007–0392.
The DCO is open from 8 a.m. to 4 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
DCO is (202) 564–8930. Such deliveries
are only accepted during the DCO’s
normal hours of operation, and special
arrangements should be made for
deliveries of boxed information.
Instructions: Direct your comments to
docket ID number EPA–HQ–OPPT–
2007–0392. EPA’s policy is that all
comments received will be included in
the docket without change and may be
made available on-line at http://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through regulations.gov or email. The regulations.gov website is an
‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an e-mail comment directly
to EPA without going through
regulations.gov, your e-mail address
will be automatically captured and
included as part of the comment that is
placed in the docket and made available
on the Internet. If you submit an
electronic comment, EPA recommends
that you include your name and other
contact information in the body of your
comment and with any disk or CD-ROM
you submit. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
EPA may not be able to consider your
comment. Electronic files should avoid
the use of special characters, any form
of encryption, and be free of any defects
or viruses. For additional information
about EPA’s public docket, visit the EPA
Docket Center homepage at http://
www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket
are listed in the docket index available
in regulations.gov. To access the
electronic docket, go to http://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
website to view the docket index or
access available documents. Although
listed in the index, some information is
not publicly available, e.g., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
will be publicly available only in hard
copy. Publicly available docket
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materials are available electronically at
http://www.regulations.gov, or, if only
available in hard copy, at the OPPT
Docket. The OPPT Docket is located in
the EPA Docket Center (EPA/DC) at Rm.
3334, EPA West Bldg., 1301
Constitution Ave., NW., Washington,
DC. The EPA/DC Public Reading Room
hours of operation are 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding
Federal holidays. The telephone number
of the EPA/DC Public Reading Room is
(202) 566–1744, and the telephone
number for the OPPT Docket is (202)
566–0280. Docket visitors are required
to show photographic identification,
pass through a metal detector, and sign
the EPA visitor log. All visitor bags are
processed through an X-ray machine
and subject to search. Visitors will be
provided an EPA/DC badge that must be
visible at all times in the building and
returned upon departure.
FOR FURTHER INFORMATION CONTACT: For
general information contact: Colby
Lintner, Regulatory Coordinator,
Environmental Assistance Division
(7408M), Office of Pollution Prevention
and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001; telephone
number: (202) 554–1404; e-mail address:
TSCA-Hotline@epa.gov.
For technical information contact:
David Schutz, 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–
9262; e-mail address:
schutz.david@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
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A. Does this Action Apply to Me?
You may be affected by this action if
you are, or may in the future be, a
manufacturer or importer of an activated
phosphor that requires submission of a
premanufacture notification (PMN) or
exemption request under TSCA section
5. Special procedures would apply to
persons who manufactured these
chemicals after the publication of the
Initial TSCA Inventory and before a date
12 months following the publication of
a final chemical identification
clarification document in the Federal
Register. Potentially affected entities
may include, but are not limited to:
• Chemical manufacturers or
importers (NAICS codes 325, 3251), e.g.,
anyone who manufactures or imports, or
who plans to manufacture or import, an
activated phosphor for a non-exempt
commercial purpose.
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• Electric Lighting Equipment
Manufacturing, Electric Lamp Bulb and
Part Manufacturing (NAICS codes 3351,
33511), e.g., anyone who manufactures
or imports, or who plans to manufacture
or import, lighting equipment
containing an activated phosphor for a
non-exempt commercial purpose.
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the technical person listed under FOR
FURTHER INFORMATION CONTACT.
B. What Should I Consider as I Prepare
My Comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through
regulations.gov or e-mail. Clearly mark
the part or all of the information that
you claim to be CBI. For CBI
information in a disk or CD-ROM that
you mail to EPA, mark the outside of the
disk or CD-ROM that you mail to EPA,
mark the outside of the disk or CD-ROM
as CBI and then identify electronically
within the disk or CD-ROM the specific
information that is claimed as CBI. In
addition to one complete version of the
comment that includes information
claimed as CBI, a copy of the comment
that does not contain the information
claimed as CBI must be submitted for
inclusion in the public docket.
Information so marked will not be
disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments.
When submitting comments, remember
to:
i. Identify the document by docket ID
number and other identifying
information (subject heading, Federal
Register date and page number).
ii. Follow directions. The Agency may
ask you to respond to specific questions
or organize comments by referencing a
Code of Federal Regulations (CFR) part
or section number.
iii. Explain why you agree or disagree;
suggest alternatives and substitute
language for your requested changes.
iv. Describe any assumptions and
provide any technical information and/
or data that you used.
v. If you estimate potential costs or
burdens, explain how you arrived at
your estimate in sufficient detail to
allow for it to be reproduced.
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vi. Provide specific examples to
illustrate your concerns and suggest
alternatives.
vii. Explain your views as clearly as
possible, avoiding the use of profanity
or personal threats.
viii. Make sure to submit your
comments by the comment period
deadline identified.
II. Background
A. What Action is the Agency Taking?
This action proposes a clarification in
the approach used for the chemical
identification of activated (doped)
phosphors for purposes of listing on the
TSCA Inventory. A doped or activated
phosphor is a substance resulting from
the chemical combination of a mixture
of metal oxides, carbonates, phosphates
or acid phosphates, chlorides, and/or
fluorides, most frequently by sintering,
along with a small amount of one or
more dopants. Dopants can include
such chemical substances as antimony,
europium, gallium, germanium,
magnesium, manganese, strontium, or
yttrium. When this material is
electrically excited, it emits light. The
color and electrical efficiency of light
emission is a function of the parent
phosphor and of the dopant which is
present.
EPA is required under TSCA section
8(b), 15 U.S.C. 2607(b), to compile and
keep current an inventory of chemical
substances manufactured, imported, or
processed for commercial purposes in
the United States. This inventory is
known as the TSCA Chemical
Substances Inventory (TSCA Inventory).
In 1977, EPA promulgated a rule
published in the Federal Register issue
of December 23, 1977 (42 FR 64572)
under TSCA section 8(a), 15 U.S.C.
2607(a), to compile an inventory of
chemical substances in commerce at
that time. In 1983, and building on
several earlier interim policies, EPA
promulgated a rule published in the
Federal Register issue of May 13, 1983
(48 FR 21722) under TSCA section 5, 15
U.S.C. 2604, to keep the TSCA
Inventory up-to-date through a
procedure for the submission, receipt,
and health and safety review of PMNs
covering chemical substances not yet in
commerce from their intending
manufacturers and importers.
Manufacturing, importing, or
processing of a new chemical is illegal
prior to the expiration of the PMN
review period. Once EPA receives a
PMN, the Agency has 90 days to review
the notice (unless for good cause EPA
extends the review period). During the
review period, EPA may act under
TSCA section 5(e) or 5(f) to regulate the
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new chemical substance. If EPA has not
prohibited manufacture or import of the
chemical substance during the review
period, these activities may begin
subject to any restrictions or testing
requirements imposed upon the
submitter during the review period
(these restrictions may be imposed upon
others via a Significant New Use Rule
(SNUR) and subsequent action under
TSCA section 5(e) or 5(f) taken in
follow-up to a significant new use
notification (SNUN)). When
manufacture or import begins, the
notice submitter must provide a notice
of commencement, after which EPA
adds the chemical substance to the
TSCA Inventory. If the Agency receives
a PMN submission for a chemical
substance which EPA determines is
excluded from consideration as a
chemical substance under TSCA
(generally because it meets the criteria
for one of the excepted categories at
TSCA section 3(2)(B), which include
mixtures, pesticides, tobacco, food,
drugs, etc.) it will not accept the PMN.
A similar practice was followed as well
during the period 1978–1979, when the
EPA was accepting submissions for the
Initial TSCA Inventory, and during
1979–1983, prior to promulgation of the
May 13, 1983 PMN rule.
Partly as a result of the Agency’s
incomplete information and
understanding of the chemistry
involved in manufacturing activated
phosphors, from 1978 through 2003
EPA has been inconsistent in its
interpretation to potential submitters
and in its actions regarding whether
activated phosphors are considered
distinct chemical substances for
purposes of the TSCA Inventory. During
the period 1978–1979, when EPA
received submissions for the Initial
TSCA Inventory, it accepted a number
of doped phosphors for listing, but in
other cases it sent ‘‘problem letters’’ to
the manufacturers of doped phosphors
indicating that they were mixtures.
In October 1979, the Agency wrote to
a lighting manufacturer and stated that
such listings could be ‘‘unnecessary’’
and that their continued inclusion on
the TSCA Inventory would be ‘‘closely
examined.’’ In January 1980, a lighting
manufacturer wrote to the Agency to
challenge problem letters it had
received. The manufacturer stated that
the materials it manufactured should be
excluded from mixture status because
they had characteristic crystal structures
and that volatile reaction products given
off during their manufacture showed
that chemical synthesis was occurring.
In March 1982, the Agency wrote to a
lighting manufacturer and suggested
that activated phosphors could be
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regarded either as physically altered
chlorophosphates or as mixtures, thus
not subject to PMN. In August 1983, the
Agency wrote to the lighting
manufacturer which had challenged the
problem letters and informed it that the
materials had, in fact, been placed on
the TSCA Inventory, and in addition
that a PMN was appropriate for another
activated phosphor but that ‘‘low
levels’’ of an activator would not require
separate PMN.
In January 1993, a lighting
manufacturer submitted a Low Volume
Exemption (LVE) Application for an
activated phosphor with a letter
referencing much of the history as
described in this unit and asserting that,
based on Agency positions, no
submission should be necessary, but the
Agency did accept the application and
granted the LVE. After that LVE was
granted, the manufacturer submitted a
letter making the case that activated
phosphors should, in fact, be considered
to be mixtures and requesting that the
Agency issue a clarifying statement. In
response, the Agency met with the
manufacturer on the issue and indicated
that activated phosphors should be
considered chemical substances instead
of mixtures, but did not issue a written
clarification.
In 1995, EPA issued the publication
entitled Toxic Substances Control Act
Inventory Representation for Products
Containing Two or More Substances:
Formulated and Statutory Mixtures
(Formulated and Statutory Mixtures),
available at http://www.epa.gov/
opptintr/newchems/pubs/mixtures.txt),
which interpreted the mixture
definition given at 40 CFR 710.3(d) and
720.3(u):
Mixture means any combination of two or
more chemical substances if the combination
does not occur in nature and is not, in whole
or in part, the result of a chemical reaction;
except ‘‘mixture’’ does include (1) any
combination which occurs, in whole or in
part, as a result of a chemical reaction if the
combination could have been manufactured
for commercial purposes without a chemical
reaction at the time the chemical substances
comprising the combination were combined,
and if all of the chemical substances
comprising the combination are not new
chemical substances, and (2) hydrates of a
chemical substance or hydrated ions formed
by association of a chemical substance with
water, so long as the nonhydrated form is
itself not a new chemical substance.
Formulated and Statutory Mixtures
discusses common examples of
mixtures, including paints, blended
fuels, and solvent combinations.
‘‘Mixture’’ can include, as well, solid
solutions—homogeneous crystalline
phases composed of several distinct
chemical species. Alloys are solid
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solutions, and are considered mixtures.
For the purposes of TSCA, multicomponent blends or formulations of
chemical substances, or certain reaction
product combinations which can be
completely characterized as consistently
formed sets of their constituent
chemical substances, are considered to
be mixtures of chemical substances.
Mixtures are not reportable, although
their constituent chemical substances
are. Most important in the context of
this clarification, a mixture can often
provide its function over some range of
constituent ratios, consequently it is
unusual if the ratios of chemical
substances which comprise a mixture
are necessarily definite or
stoichiometric, and if the mixture
components are deliberately reacted
together to manufacture a chemical
substance, this reaction product cannot
be considered a mixture for TSCA
purposes except in very specialized
circumstances which are not present in
the case of the activated phosphors.
In June 1998, a lighting manufacturer
wrote to the Agency and stated that, in
the absence of any negative response by
the Agency within 60 days of the letter,
it intended to rely on the interpretation
in Formulated and Statutory Mixtures,
and that it believed that that
interpretation precluded TSCA
Inventory listing for activated
phosphors. The Agency did not respond
to that letter. Based on a 2003 request
from a lighting manufacturer, and
cognizant of the history described in
this unit, EPA held a meeting with the
manufacturer in September 2003 and as
a result has reexamined some earlier
assumptions—particularly about nonstoichiometry and non-reaction between
chemical substances used to make
activated phosphors—which may have
led it to believe that activated
phosphors could be considered
mixtures.
The result of this reexamination is
this clarification that individual
activated phosphors should be
considered to be distinct chemical
substances under TSCA. EPA’s
clarification on the potential need to
report activated phosphor materials is
based on its updated understanding
about reactions and stoichiometry in
activated phosphors, as follows:
Activated phosphors are in general
synthesized by means of a solid state
reaction at high temperature and using
precise quantities of the precursor
chemical substances, both for the base
materials and for the dopants which
control the quality of light emitted.
Precise ratios of component materials
are used to maintain strict stoichiometry
in the end product, and component
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materials are thoroughly blended before
reaction for uniformity of the product.
Heat may be absorbed or released by the
reactant mixture at certain temperatures,
typically by the release of water: This is
generally an indication of chemical
substance synthesis. During the
manufacture of activated phosphors,
other volatile reaction products are
often emitted, another indication that
chemical substances are being formed.
The phosphor and the amount of dopant
added need to be controlled with high
precision, and during sintering the
doped phosphor undergoes oxidation
state changes. Consequently, EPA
believes that activated phosphors
cannot be manufactured for commercial
purposes without chemical reaction.
Additionally, activated phosphor
products have a different function from
the material which would be produced
by the same synthetic process in the
absence of dopant, and which would
not emit the characteristic light, which
is the primary property sought. Because
dopants provide the primary property
sought from these materials, small or
even trace amounts of dopant must be
considered to be reactants which must
be included in the chemical identity.
These factors preclude these materials
from being considered as ‘‘mixtures.’’
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B. What is the Agency’s Authority for
Taking this Action?
Section 5 of TSCA requires any
person who intends to manufacture
(defined by statute to include import) a
new chemical substance (i.e., a chemical
substance not on the TSCA Inventory) to
notify EPA at least 90 days in advance
and comply with the statutory
provisions pertaining to the
manufacture of new chemical
substances for non-exempt commercial
purposes. Section 8(b) of TSCA requires
EPA to compile, keep current, and
publish a list of each chemical
substance which is manufactured or
processed in the United States (the
TSCA Inventory). This requirement
includes defining the scope of the
listings on the TSCA Inventory.
C. Why is this Proposed Chemical
Identity Clarification Necessary?
Because activated phosphors are
precluded by the factors identified in
the last paragraph of Unit II.A. from
being considered to be formulated or
statutory mixtures, some previous EPA
interpretations that such materials need
not be reviewed through the new
chemicals process were incorrect. As a
result of certain past EPA
interpretations, some manufacturers of
activated phosphors have not submitted
new chemical notifications under TSCA
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section 5 because those interpretations
incorrectly indicated that activated
phosphors were covered for TSCA
purposes if the substances used in their
manufacture were already on the TSCA
Inventory. Other manufacturers have
submitted notices for these materials,
and they have been given TSCA
Inventory listings in some cases. Several
industry representatives have asked
EPA to clarify the Agency’s chemical
identity policy for activated phosphors.
EPA now agrees that it is necessary to
add listings to the TSCA Inventory for
activated phosphors which have been
manufactured but not listed, and that it
is possible that some existing listings
should be altered to describe certain
metal components as dopants. This
document proposes a clarification to
previous interpretations on chemical
identity for activated phosphors. With
this proposed clarification, activated
phosphors that are not on the TSCA
Inventory would be considered new
chemical substances under TSCA
section 5.
Because some of the interpretations
provided by the agency prior to 2003 led
some manufacturers to believe that the
products they manufactured were
already on the TSCA Inventory if their
precursor substances were on the TSCA
Inventory, some manufacturers of
activated phosphor products have not
submitted PMNs required under TSCA
section 5. This chemical identification
problem is similar to one involving
monomer acid and its derivatives,
which was resolved through Agencyindustry dialog and a period for
submission of new notices (Correction
to Chemical Nomenclature for Monomer
Acid and Derivatives for TSCA
Inventory Purpose published in the
Federal Register issue of June 27, 2001
(66 FR 34193) (FRL–6784–6). The
Agency is proposing to address this
activated phosphor situation in a similar
manner.
III. Proposed TSCA New Chemicals
Program Policy for Activated Phosphor
Chemical Identity
EPA is proposing that the portion of
EPA’s earlier interpretations indicating
that activated phosphors are mixtures
rather than chemical substances in their
own right was erroneous, and that TSCA
Inventory listing would be required for
these materials. Under this proposal,
PMNs would be required for activated
phosphors not on the TSCA Inventory
(and for which a TSCA section 5(h)(4)
exemption has not been granted) and
which are manufactured on or after the
effective date of the final clarification.
In accordance with TSCA Inventory
correction guidelines published in the
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Federal Register issue of July 29, 1980
(45 FR 50544), activated phosphors that
were never reported for the Initial TSCA
Inventory are not eligible for TSCA
Inventory correction as an alternative to
PMN submission.
A. What is the Basis for and Scope of
this Proposed Chemical Identification
Clarification?
EPA no longer considers to be valid
the chemical identity interpretation that
activated phosphors are mixtures rather
than chemical substances in their own
right. Thus listing on the TSCA
Inventory established at TSCA section
8(b) is required for these chemical
substances. The proposed chemical
identity clarification would affect
anyone who manufactures or imports, or
who plans to manufacture or import, an
activated phosphor not now listed on
the TSCA Inventory.
B. What Are the Key Dates and
Provisions of this Proposed Chemical
Identification Clarification?
The effective date for this proposed
new chemical identity clarification,
described in Unit II.B. would be 12
months following the date of
publication of the final chemical
identification clarification document in
the Federal Register. Prior to this
effective date, companies would be
allowed to continue commercial
production of non-TSCA Inventory
listed activated phosphors under the
old, incorrect chemical identity
interpretation. After the effective date,
any manufacturer making non-TSCA
Inventory listed activated phosphors for
non-exempt commercial purposes
would no longer be in compliance with
TSCA section 5. Therefore, companies
would need to submit PMNs or
exemption applications at least 90 days
before the effective date to ensure that
Agency review is completed before this
chemical identification clarification
takes effect. Continued commercial
production prior to expiration of the
applicable review period would be
allowed if it were during the year
following the date of publication of the
final chemical identification
clarification document in the Federal
Register and applies only to activated
phosphor materials already being made.
EPA will work closely with chemical
manufacturers and importers to resolve
chemical identity issues for any specific
material for which the manufacturer
believes the incorrect activated
phosphor interpretations may still have
applicability.
To facilitate the PMN process for
activated phosphors currently using the
incorrect chemical identification, EPA
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Federal Register / Vol. 73, No. 11 / Wednesday, January 16, 2008 / Proposed Rules
would allow an exception to its TSCA
new chemicals program policy of a limit
of six chemical substances per
consolidation notice for these chemical
substances. However, consistent with
the Agency’s chemical identification
requirements for consolidated notices,
submitters must use the Chemical
Abstracts Service (CAS) Inventory
Expert Service to develop correct
Chemical Abstracts (CA) names for all of
their reported chemical substances, in
accordance with Method 1 as described
in the Premanufacture Notification
regulations, 40 CFR 720.45(a)(3)(i). EPA
encourages persons intending to
manufacture activated phosphors to file
PMNs using the proper chemical
identity immediately instead of delaying
their submissions to near the effective
date of this proposed document.
PMNs filed in response to this
chemical identification clarification
should, as specified in 40 CFR 720.50,
include all information normally
included with a PMN submission, such
as toxicity data on the PMN chemical
substance that are in the possession or
control of the PMN submitter, or known
to or reasonably ascertainable by the
PMN submitter.
ebenthall on PRODPC61 with PROPOSALS
C. What Are the Consequences of Not
Submitting a PMN and Completing PMN
Review on an Activated Phosphor
Before the Effective Date of this
Proposed Chemical Identification
Clarification?
Starting on the effective date of the
final chemical identification
clarification document, anyone
manufacturing (includes import) for a
non–exempt commercial purpose an
activated phosphor that is not
specifically listed on the TSCA
Inventory would be in violation of
TSCA. Penalties of $32,500 per violation
per day are possible.
D. Would a PMN Be Required for
Persons Who Did Not Submit One Due
to an Incorrect EPA Interpretation,
Regardless of Whether They Still
Manufacture the Chemical Substance?
A PMN would have to be submitted
by any person who intends to
manufacture or import an activated
phosphor not on the TSCA Inventory for
a non–exempt commercial purpose on
or after the effective date of the final
chemical identification clarification
document. If future manufacture is not
intended, no PMN need be submitted.
For example, if you manufactured such
a phosphor in 1986 but are not currently
manufacturing nor intending to resume
manufacture, you would not be required
to submit a PMN at this time. However,
if you later form an intention to
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manufacture the activated phosphor
after the effective date of the final
chemical identification clarification
document, you would need to submit a
PMN 90 days before commencing
manufacture.
IV. Do Certain Statutory and Executive
Order Reviews Apply to this Action?
No. This document presents the
Agency’s clarification of the TSCA
Inventory chemical identification
principles. This action is not a
regulatory action or significant guidance
document under Executive Order 12866,
entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993),
as amended by Executive Order 13422
(72 FR 2763, January 23, 2007). As such,
this action does not require review by
the Office of Management and Budget
(OMB) under Executive Order 12866. In
addition, Executive Orders 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997) and
13211, entitled Actions Concerning
Regulations that Significantly Affect
Energy Supply, Distribution, or Use (66
FR 28355, May 22, 2001), do not apply
to this action because it is not
‘‘economically significant’’ as defined
by section 3(f) of Executive Order
12866. Nor does this action establish an
environmental standard that may have a
negatively disproportionate effect on
children, or otherwise have any
significant adverse effect on the supply,
distribution, or use of energy.
This document does not contain any
new information collection
requirements that would require
additional review and approval by OMB
under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.). The
information collection activities related
to the submission of information
pursuant to TSCA section 5 are already
approved by OMB under OMB Control
No. 2070–0012 (EPA Information
Collection Request [ICR] No.574). The
burden for that ICR is estimated to
average 100 hours per respondent,
including time for reading the
regulations, processing, compiling, and
reviewing the requested data, generating
the request, storing, filing, and
maintaining the data. Under PRA, an
agency may not conduct or sponsor, and
a person is not required to respond to
a collection of information unless it
displays a currently valid OMB control
number, or is otherwise required to
submit the specific information by a
statute. The OMB control numbers for
the EPA regulations that are codified in
40 CFR chapter I, after appearing in the
preamble of the final rule, are further
displayed either by publication in the
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Fmt 4702
Sfmt 4702
Federal Register or by other appropriate
means, such as on the related collection
instrument or form, if applicable. The
display of OMB control numbers for
certain EPA regulations is consolidated
in a list at 40 CFR 9.1.
As indicated previously, this action is
not subject to the notice–and–comment
requirements under the Administrative
Procedure Act (APA) (5 U.S.C. 551 et
seq.) or any other statute. As such, it is
not subject to the provisions of the
Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.). Further, this action
is expected to only have a limited
impact because only entities which are
now manufacturing such a chemical
substance, and which have not already
prepared and submitted a PMN to EPA,
must submit a PMN as a result of this
action if they intend to continue
manufacturing it.
Based on EPA’s experience with
review of PMNs, State, local, and Tribal
governments have not been impacted by
these activities, and EPA does not have
any reason to believe that any State,
local, or Tribal government would be
impacted by this action. As such, this
action will not have substantial direct
effects on the States or 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, entitled
Federalism (64 FR 43255, August 10,
1999). Nor does this action significantly
or uniquely affect the communities of
tribal governments as specified by
Executive Order 13175, entitled
Consultation and Coordination with
Indian Tribal Governments (65 FR
67249, November 9, 2000). In addition,
EPA has determined that this regulatory
action would not impose any
enforceable duty, contain any unfunded
mandate, or otherwise have any affect
on small governments subject to the
requirements of sections 202, 203, 204,
or 205 of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public
Law 104-4).
This action does not involve any
technical standards that require the
Agency’s consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
This action will not have an adverse
impact on the environmental and health
conditions in low-income and minority
communities. Therefore, under
Executive Order 12898, entitled Federal
Actions to Address Environmental
Justice in Minority Populations and
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16JAP1
Federal Register / Vol. 73, No. 11 / Wednesday, January 16, 2008 / Proposed Rules
Low-Income Populations (59 FR 7629,
February 16, 1994), the Agency is not
required to and has not considered
environmental justice-related issues.
List of Subjects
40 CFR Part 704
Environmental protection, Chemicals,
Confidential business information,
Hazardous substances, Imports,
Reporting and recordkeeping
requirements.
40 CFR Part 720
Environmental protection, Chemicals,
Hazardous substances, Imports,
Reporting and recordkeeping
requirements.
40 CFR Part 721
Environmental protection,
Administrative practice and procedure,
Chemicals, Hazardous substances,
Imports, Labeling, Occupational safety
and health, Reporting and
recordkeeping requirements.
40 CFR Part 723
Environmental protection, Chemicals,
Hazardous substances, Photographic
industry, Reporting and recordkeeping
requirements.
Dated: January 10, 2008.
James B. Gulliford,
Assistant Administrator, Office of Prevention,
Pesticides and Toxic Substances.
[FR Doc. E8–681 Filed 1–15–08; 8:45 am]
BILLING CODE 6560–50–S
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
44 CFR Part 67
[Docket No. FEMA–B–7756]
Proposed Flood Elevation
Determinations
Federal Emergency
Management Agency, DHS.
ACTION: Proposed rule.
ebenthall on PRODPC61 with PROPOSALS
AGENCY:
SUMMARY: Comments are requested on
the proposed Base (1 percent annualchance) Flood Elevations (BFEs) and
proposed BFE modifications for the
communities listed in the table below.
The purpose of this notice is to seek
general information and comment
regarding the proposed regulatory flood
elevations for the reach described by the
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15:31 Jan 15, 2008
Jkt 214001
downstream and upstream locations in
the table below. The BFEs and modified
BFEs are a part of the floodplain
management measures that the
community is required either to adopt
or to show evidence of having in effect
in order to qualify or remain qualified
for participation in the National Flood
Insurance Program (NFIP). In addition,
these elevations, once finalized, will be
used by insurance agents, and others to
calculate appropriate flood insurance
premium rates for new buildings and
the contents in those buildings.
DATES: Comments are to be submitted
on or before April 15, 2008.
ADDRESSES: The corresponding
preliminary Flood Insurance Rate Map
(FIRM) for the proposed BFEs for each
community are available for inspection
at the community’s map repository. The
respective addresses are listed in the
table below.
You may submit comments, identified
by Docket No. FEMA–B–7756, to
William R. Blanton, Jr., Chief,
Engineering Management Branch,
Mitigation Directorate, Federal
Emergency Management Agency, 500 C
Street, SW., Washington, DC 20472,
(202) 646–3151, or (e-mail)
bill.blanton@dhs.gov.
FOR FURTHER INFORMATION CONTACT:
William R. Blanton, Jr., Chief,
Engineering Management Branch,
Mitigation Directorate, Federal
Emergency Management Agency, 500 C
Street, SW., Washington, DC 20472,
(202) 646–3151 or (e-mail)
bill.blanton@dhs.gov.
SUPPLEMENTARY INFORMATION: The
Federal Emergency Management Agency
(FEMA) proposes to make
determinations of BFEs and modified
BFEs for each community listed below,
in accordance with section 110 of the
Flood Disaster Protection Act of 1973,
42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed BFEs and modified
BFEs, together with the floodplain
management criteria required by 44 CFR
60.3, are the minimum that are required.
They should not be construed to mean
that the community must change any
existing ordinances that are more
stringent in their floodplain
management requirements. The
community may at any time enact
stricter requirements of its own, or
pursuant to policies established by other
Federal, State, or regional entities.
These proposed elevations are used to
meet the floodplain management
requirements of the NFIP and are also
used to calculate the appropriate flood
insurance premium rates for new
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Fmt 4702
Sfmt 4702
2859
buildings built after these elevations are
made final, and for the contents in these
buildings.
Comments on any aspect of the Flood
Insurance Study and FIRM, other than
the proposed BFEs, will be considered.
A letter acknowledging receipt of any
comments will not be sent.
Administrative Procedure Act
Statement. This matter is not a
rulemaking governed by the
Administrative Procedure Act (APA), 5
U.S.C. 553. FEMA publishes flood
elevation determinations for notice and
comment; however, they are governed
by the Flood Disaster Protection Act of
1973, 42 U.S.C. 4105, and the National
Flood Insurance Act of 1968, 42 U.S.C.
4001, et seq., and do not fall under the
APA.
National Environmental Policy Act.
This proposed rule is categorically
excluded from the requirements of 44
CFR part 10, Environmental
Consideration. An environmental
impact assessment has not been
prepared.
Regulatory Flexibility Act. As flood
elevation determinations are not within
the scope of the Regulatory Flexibility
Act, 5 U.S.C. 601–612, a regulatory
flexibility analysis is not required.
Executive Order 12866, Regulatory
Planning and Review. This proposed
rule is not a significant regulatory action
under the criteria of section 3(f) of
Executive Order 12866, as amended.
Executive Order 13132, Federalism.
This proposed rule involves no policies
that have federalism implications under
Executive Order 13132.
Executive Order 12988, Civil Justice
Reform. This proposed rule meets the
applicable standards of Executive Order
12988.
List of Subjects in 44 CFR Part 67
Administrative practice and
procedure, Flood insurance, Reporting
and recordkeeping requirements.
Accordingly, 44 CFR part 67 is
proposed to be amended as follows:
PART 67—[AMENDED]
1. The authority citation for part 67
continues to read as follows:
Authority: 42 U.S.C. 4001, et seq.;
Reorganization Plan No. 3 of 1978, 3 CFR,
1978 Comp., p. 329; E.O. 12127, 44 FR 19367,
3 CFR, 1979 Comp., p. 376.
§ 67.4
[Amended]
2. The tables published under the
authority of § 67.4 are proposed to be
amended as follows:
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Agencies
[Federal Register Volume 73, Number 11 (Wednesday, January 16, 2008)]
[Proposed Rules]
[Pages 2854-2859]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-681]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 704, 720, 721, and 723
[EPA-HQ-OPPT-2007-0392; FRL-8131-8]
RIN 2070-AJ21
Proposed Clarification for Chemical Identification Describing
Activated Phosphors for TSCA Inventory Purposes
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed clarification.
-----------------------------------------------------------------------
SUMMARY: This document proposes a clarification under which activated
phosphors that are not on the Toxic Substances Control Act (TSCA)
section 8(b) Chemical Substance Inventory (TSCA Inventory) would be
considered to be new chemical substances under TSCA section 5, thus
would be subject to the notification requirements under TSCA section
5(a) new chemical notification requirements. In certain letters and
other interpretations issued by EPA from 1978 to 2003, it appears that
the Agency erroneously indicated that activated phosphors constitute
solid mixtures for purposes of the TSCA Inventory, and thus that they
were not separately reportable as chemical substances under TSCA
section 5(a) new chemical notification requirements. This proposed
clarification is necessary because EPA's interpretations in this area
have not been consistent. Given this past inconsistency, EPA is seeking
comment on its proposed clarfication.
DATES: Comments must be received on or before March 17, 2008.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2007-0392, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
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: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC.
Attention: Docket ID Number EPA-HQ-OPPT-2007-0392. The DCO is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the DCO is (202) 564-8930. Such deliveries are
only accepted during the DCO's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2007-0392. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket
Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, will be publicly available only in hard copy. Publicly
available docket
[[Page 2855]]
materials are available electronically at http://www.regulations.gov,
or, if only available in hard copy, at the OPPT Docket. The OPPT Docket
is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West
Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public
Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding Federal holidays. The telephone number of the
EPA/DC Public Reading Room is (202) 566-1744, and the telephone number
for the OPPT Docket is (202) 566-0280. Docket visitors are required to
show photographic identification, pass through a metal detector, and
sign the EPA visitor log. All visitor bags are processed through an X-
ray machine and subject to search. Visitors will be provided an EPA/DC
badge that must be visible at all times in the building and returned
upon departure.
FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Lintner, Regulatory Coordinator, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: TSCA-
Hotline@epa.gov.
For technical information contact: David Schutz, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (202) 564-9262; e-mail
address: schutz.david@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are, or may in the future
be, a manufacturer or importer of an activated phosphor that requires
submission of a premanufacture notification (PMN) or exemption request
under TSCA section 5. Special procedures would apply to persons who
manufactured these chemicals after the publication of the Initial TSCA
Inventory and before a date 12 months following the publication of a
final chemical identification clarification document in the Federal
Register. Potentially affected entities may include, but are not
limited to:
Chemical manufacturers or importers (NAICS codes 325,
3251), e.g., anyone who manufactures or imports, or who plans to
manufacture or import, an activated phosphor for a non-exempt
commercial purpose.
Electric Lighting Equipment Manufacturing, Electric Lamp
Bulb and Part Manufacturing (NAICS codes 3351, 33511), e.g., anyone who
manufactures or imports, or who plans to manufacture or import,
lighting equipment containing an activated phosphor for a non-exempt
commercial purpose.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the technical person listed under FOR FURTHER
INFORMATION CONTACT.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM
that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and
then identify electronically within the disk or CD-ROM the specific
information that is claimed as CBI. In addition to one complete version
of the comment that includes information claimed as CBI, a copy of the
comment that does not contain the information claimed as CBI must be
submitted for inclusion in the public docket. Information so marked
will not be disclosed except in accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. What Action is the Agency Taking?
This action proposes a clarification in the approach used for the
chemical identification of activated (doped) phosphors for purposes of
listing on the TSCA Inventory. A doped or activated phosphor is a
substance resulting from the chemical combination of a mixture of metal
oxides, carbonates, phosphates or acid phosphates, chlorides, and/or
fluorides, most frequently by sintering, along with a small amount of
one or more dopants. Dopants can include such chemical substances as
antimony, europium, gallium, germanium, magnesium, manganese,
strontium, or yttrium. When this material is electrically excited, it
emits light. The color and electrical efficiency of light emission is a
function of the parent phosphor and of the dopant which is present.
EPA is required under TSCA section 8(b), 15 U.S.C. 2607(b), to
compile and keep current an inventory of chemical substances
manufactured, imported, or processed for commercial purposes in the
United States. This inventory is known as the TSCA Chemical Substances
Inventory (TSCA Inventory). In 1977, EPA promulgated a rule published
in the Federal Register issue of December 23, 1977 (42 FR 64572) under
TSCA section 8(a), 15 U.S.C. 2607(a), to compile an inventory of
chemical substances in commerce at that time. In 1983, and building on
several earlier interim policies, EPA promulgated a rule published in
the Federal Register issue of May 13, 1983 (48 FR 21722) under TSCA
section 5, 15 U.S.C. 2604, to keep the TSCA Inventory up-to-date
through a procedure for the submission, receipt, and health and safety
review of PMNs covering chemical substances not yet in commerce from
their intending manufacturers and importers.
Manufacturing, importing, or processing of a new chemical is
illegal prior to the expiration of the PMN review period. Once EPA
receives a PMN, the Agency has 90 days to review the notice (unless for
good cause EPA extends the review period). During the review period,
EPA may act under TSCA section 5(e) or 5(f) to regulate the
[[Page 2856]]
new chemical substance. If EPA has not prohibited manufacture or import
of the chemical substance during the review period, these activities
may begin subject to any restrictions or testing requirements imposed
upon the submitter during the review period (these restrictions may be
imposed upon others via a Significant New Use Rule (SNUR) and
subsequent action under TSCA section 5(e) or 5(f) taken in follow-up to
a significant new use notification (SNUN)). When manufacture or import
begins, the notice submitter must provide a notice of commencement,
after which EPA adds the chemical substance to the TSCA Inventory. If
the Agency receives a PMN submission for a chemical substance which EPA
determines is excluded from consideration as a chemical substance under
TSCA (generally because it meets the criteria for one of the excepted
categories at TSCA section 3(2)(B), which include mixtures, pesticides,
tobacco, food, drugs, etc.) it will not accept the PMN. A similar
practice was followed as well during the period 1978-1979, when the EPA
was accepting submissions for the Initial TSCA Inventory, and during
1979-1983, prior to promulgation of the May 13, 1983 PMN rule.
Partly as a result of the Agency's incomplete information and
understanding of the chemistry involved in manufacturing activated
phosphors, from 1978 through 2003 EPA has been inconsistent in its
interpretation to potential submitters and in its actions regarding
whether activated phosphors are considered distinct chemical substances
for purposes of the TSCA Inventory. During the period 1978-1979, when
EPA received submissions for the Initial TSCA Inventory, it accepted a
number of doped phosphors for listing, but in other cases it sent
``problem letters'' to the manufacturers of doped phosphors indicating
that they were mixtures.
In October 1979, the Agency wrote to a lighting manufacturer and
stated that such listings could be ``unnecessary'' and that their
continued inclusion on the TSCA Inventory would be ``closely
examined.'' In January 1980, a lighting manufacturer wrote to the
Agency to challenge problem letters it had received. The manufacturer
stated that the materials it manufactured should be excluded from
mixture status because they had characteristic crystal structures and
that volatile reaction products given off during their manufacture
showed that chemical synthesis was occurring. In March 1982, the Agency
wrote to a lighting manufacturer and suggested that activated phosphors
could be regarded either as physically altered chlorophosphates or as
mixtures, thus not subject to PMN. In August 1983, the Agency wrote to
the lighting manufacturer which had challenged the problem letters and
informed it that the materials had, in fact, been placed on the TSCA
Inventory, and in addition that a PMN was appropriate for another
activated phosphor but that ``low levels'' of an activator would not
require separate PMN.
In January 1993, a lighting manufacturer submitted a Low Volume
Exemption (LVE) Application for an activated phosphor with a letter
referencing much of the history as described in this unit and asserting
that, based on Agency positions, no submission should be necessary, but
the Agency did accept the application and granted the LVE. After that
LVE was granted, the manufacturer submitted a letter making the case
that activated phosphors should, in fact, be considered to be mixtures
and requesting that the Agency issue a clarifying statement. In
response, the Agency met with the manufacturer on the issue and
indicated that activated phosphors should be considered chemical
substances instead of mixtures, but did not issue a written
clarification.
In 1995, EPA issued the publication entitled Toxic Substances
Control Act Inventory Representation for Products Containing Two or
More Substances: Formulated and Statutory Mixtures (Formulated and
Statutory Mixtures), available at http://www.epa.gov/opptintr/newchems/
pubs/mixtures.txt), which interpreted the mixture definition given at
40 CFR 710.3(d) and 720.3(u):
Mixture means any combination of two or more chemical substances
if the combination does not occur in nature and is not, in whole or
in part, the result of a chemical reaction; except ``mixture'' does
include (1) any combination which occurs, in whole or in part, as a
result of a chemical reaction if the combination could have been
manufactured for commercial purposes without a chemical reaction at
the time the chemical substances comprising the combination were
combined, and if all of the chemical substances comprising the
combination are not new chemical substances, and (2) hydrates of a
chemical substance or hydrated ions formed by association of a
chemical substance with water, so long as the nonhydrated form is
itself not a new chemical substance.
Formulated and Statutory Mixtures discusses common examples of
mixtures, including paints, blended fuels, and solvent combinations.
``Mixture'' can include, as well, solid solutions--homogeneous
crystalline phases composed of several distinct chemical species.
Alloys are solid solutions, and are considered mixtures. For the
purposes of TSCA, multi-component blends or formulations of chemical
substances, or certain reaction product combinations which can be
completely characterized as consistently formed sets of their
constituent chemical substances, are considered to be mixtures of
chemical substances. Mixtures are not reportable, although their
constituent chemical substances are. Most important in the context of
this clarification, a mixture can often provide its function over some
range of constituent ratios, consequently it is unusual if the ratios
of chemical substances which comprise a mixture are necessarily
definite or stoichiometric, and if the mixture components are
deliberately reacted together to manufacture a chemical substance, this
reaction product cannot be considered a mixture for TSCA purposes
except in very specialized circumstances which are not present in the
case of the activated phosphors.
In June 1998, a lighting manufacturer wrote to the Agency and
stated that, in the absence of any negative response by the Agency
within 60 days of the letter, it intended to rely on the interpretation
in Formulated and Statutory Mixtures, and that it believed that that
interpretation precluded TSCA Inventory listing for activated
phosphors. The Agency did not respond to that letter. Based on a 2003
request from a lighting manufacturer, and cognizant of the history
described in this unit, EPA held a meeting with the manufacturer in
September 2003 and as a result has reexamined some earlier
assumptions--particularly about non-stoichiometry and non-reaction
between chemical substances used to make activated phosphors--which may
have led it to believe that activated phosphors could be considered
mixtures.
The result of this reexamination is this clarification that
individual activated phosphors should be considered to be distinct
chemical substances under TSCA. EPA's clarification on the potential
need to report activated phosphor materials is based on its updated
understanding about reactions and stoichiometry in activated phosphors,
as follows: Activated phosphors are in general synthesized by means of
a solid state reaction at high temperature and using precise quantities
of the precursor chemical substances, both for the base materials and
for the dopants which control the quality of light emitted. Precise
ratios of component materials are used to maintain strict stoichiometry
in the end product, and component
[[Page 2857]]
materials are thoroughly blended before reaction for uniformity of the
product. Heat may be absorbed or released by the reactant mixture at
certain temperatures, typically by the release of water: This is
generally an indication of chemical substance synthesis. During the
manufacture of activated phosphors, other volatile reaction products
are often emitted, another indication that chemical substances are
being formed. The phosphor and the amount of dopant added need to be
controlled with high precision, and during sintering the doped phosphor
undergoes oxidation state changes. Consequently, EPA believes that
activated phosphors cannot be manufactured for commercial purposes
without chemical reaction. Additionally, activated phosphor products
have a different function from the material which would be produced by
the same synthetic process in the absence of dopant, and which would
not emit the characteristic light, which is the primary property
sought. Because dopants provide the primary property sought from these
materials, small or even trace amounts of dopant must be considered to
be reactants which must be included in the chemical identity. These
factors preclude these materials from being considered as ``mixtures.''
B. What is the Agency's Authority for Taking this Action?
Section 5 of TSCA requires any person who intends to manufacture
(defined by statute to include import) a new chemical substance (i.e.,
a chemical substance not on the TSCA Inventory) to notify EPA at least
90 days in advance and comply with the statutory provisions pertaining
to the manufacture of new chemical substances for non-exempt commercial
purposes. Section 8(b) of TSCA requires EPA to compile, keep current,
and publish a list of each chemical substance which is manufactured or
processed in the United States (the TSCA Inventory). This requirement
includes defining the scope of the listings on the TSCA Inventory.
C. Why is this Proposed Chemical Identity Clarification Necessary?
Because activated phosphors are precluded by the factors identified
in the last paragraph of Unit II.A. from being considered to be
formulated or statutory mixtures, some previous EPA interpretations
that such materials need not be reviewed through the new chemicals
process were incorrect. As a result of certain past EPA
interpretations, some manufacturers of activated phosphors have not
submitted new chemical notifications under TSCA section 5 because those
interpretations incorrectly indicated that activated phosphors were
covered for TSCA purposes if the substances used in their manufacture
were already on the TSCA Inventory. Other manufacturers have submitted
notices for these materials, and they have been given TSCA Inventory
listings in some cases. Several industry representatives have asked EPA
to clarify the Agency's chemical identity policy for activated
phosphors. EPA now agrees that it is necessary to add listings to the
TSCA Inventory for activated phosphors which have been manufactured but
not listed, and that it is possible that some existing listings should
be altered to describe certain metal components as dopants. This
document proposes a clarification to previous interpretations on
chemical identity for activated phosphors. With this proposed
clarification, activated phosphors that are not on the TSCA Inventory
would be considered new chemical substances under TSCA section 5.
Because some of the interpretations provided by the agency prior to
2003 led some manufacturers to believe that the products they
manufactured were already on the TSCA Inventory if their precursor
substances were on the TSCA Inventory, some manufacturers of activated
phosphor products have not submitted PMNs required under TSCA section
5. This chemical identification problem is similar to one involving
monomer acid and its derivatives, which was resolved through Agency-
industry dialog and a period for submission of new notices (Correction
to Chemical Nomenclature for Monomer Acid and Derivatives for TSCA
Inventory Purpose published in the Federal Register issue of June 27,
2001 (66 FR 34193) (FRL-6784-6). The Agency is proposing to address
this activated phosphor situation in a similar manner.
III. Proposed TSCA New Chemicals Program Policy for Activated Phosphor
Chemical Identity
EPA is proposing that the portion of EPA's earlier interpretations
indicating that activated phosphors are mixtures rather than chemical
substances in their own right was erroneous, and that TSCA Inventory
listing would be required for these materials. Under this proposal,
PMNs would be required for activated phosphors not on the TSCA
Inventory (and for which a TSCA section 5(h)(4) exemption has not been
granted) and which are manufactured on or after the effective date of
the final clarification. In accordance with TSCA Inventory correction
guidelines published in the Federal Register issue of July 29, 1980 (45
FR 50544), activated phosphors that were never reported for the Initial
TSCA Inventory are not eligible for TSCA Inventory correction as an
alternative to PMN submission.
A. What is the Basis for and Scope of this Proposed Chemical
Identification Clarification?
EPA no longer considers to be valid the chemical identity
interpretation that activated phosphors are mixtures rather than
chemical substances in their own right. Thus listing on the TSCA
Inventory established at TSCA section 8(b) is required for these
chemical substances. The proposed chemical identity clarification would
affect anyone who manufactures or imports, or who plans to manufacture
or import, an activated phosphor not now listed on the TSCA Inventory.
B. What Are the Key Dates and Provisions of this Proposed Chemical
Identification Clarification?
The effective date for this proposed new chemical identity
clarification, described in Unit II.B. would be 12 months following the
date of publication of the final chemical identification clarification
document in the Federal Register. Prior to this effective date,
companies would be allowed to continue commercial production of non-
TSCA Inventory listed activated phosphors under the old, incorrect
chemical identity interpretation. After the effective date, any
manufacturer making non-TSCA Inventory listed activated phosphors for
non-exempt commercial purposes would no longer be in compliance with
TSCA section 5. Therefore, companies would need to submit PMNs or
exemption applications at least 90 days before the effective date to
ensure that Agency review is completed before this chemical
identification clarification takes effect. Continued commercial
production prior to expiration of the applicable review period would be
allowed if it were during the year following the date of publication of
the final chemical identification clarification document in the Federal
Register and applies only to activated phosphor materials already being
made.
EPA will work closely with chemical manufacturers and importers to
resolve chemical identity issues for any specific material for which
the manufacturer believes the incorrect activated phosphor
interpretations may still have applicability.
To facilitate the PMN process for activated phosphors currently
using the incorrect chemical identification, EPA
[[Page 2858]]
would allow an exception to its TSCA new chemicals program policy of a
limit of six chemical substances per consolidation notice for these
chemical substances. However, consistent with the Agency's chemical
identification requirements for consolidated notices, submitters must
use the Chemical Abstracts Service (CAS) Inventory Expert Service to
develop correct Chemical Abstracts (CA) names for all of their reported
chemical substances, in accordance with Method 1 as described in the
Premanufacture Notification regulations, 40 CFR 720.45(a)(3)(i). EPA
encourages persons intending to manufacture activated phosphors to file
PMNs using the proper chemical identity immediately instead of delaying
their submissions to near the effective date of this proposed document.
PMNs filed in response to this chemical identification
clarification should, as specified in 40 CFR 720.50, include all
information normally included with a PMN submission, such as toxicity
data on the PMN chemical substance that are in the possession or
control of the PMN submitter, or known to or reasonably ascertainable
by the PMN submitter.
C. What Are the Consequences of Not Submitting a PMN and Completing PMN
Review on an Activated Phosphor Before the Effective Date of this
Proposed Chemical Identification Clarification?
Starting on the effective date of the final chemical identification
clarification document, anyone manufacturing (includes import) for a
non-exempt commercial purpose an activated phosphor that is not
specifically listed on the TSCA Inventory would be in violation of
TSCA. Penalties of $32,500 per violation per day are possible.
D. Would a PMN Be Required for Persons Who Did Not Submit One Due to an
Incorrect EPA Interpretation, Regardless of Whether They Still
Manufacture the Chemical Substance?
A PMN would have to be submitted by any person who intends to
manufacture or import an activated phosphor not on the TSCA Inventory
for a non-exempt commercial purpose on or after the effective date of
the final chemical identification clarification document. If future
manufacture is not intended, no PMN need be submitted. For example, if
you manufactured such a phosphor in 1986 but are not currently
manufacturing nor intending to resume manufacture, you would not be
required to submit a PMN at this time. However, if you later form an
intention to manufacture the activated phosphor after the effective
date of the final chemical identification clarification document, you
would need to submit a PMN 90 days before commencing manufacture.
IV. Do Certain Statutory and Executive Order Reviews Apply to this
Action?
No. This document presents the Agency's clarification of the TSCA
Inventory chemical identification principles. This action is not a
regulatory action or significant guidance document under Executive
Order 12866, entitled Regulatory Planning and Review (58 FR 51735,
October 4, 1993), as amended by Executive Order 13422 (72 FR 2763,
January 23, 2007). As such, this action does not require review by the
Office of Management and Budget (OMB) under Executive Order 12866. In
addition, Executive Orders 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997) and 13211, entitled Actions Concerning Regulations that
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001), do not apply to this action because it is not
``economically significant'' as defined by section 3(f) of Executive
Order 12866. Nor does this action establish an environmental standard
that may have a negatively disproportionate effect on children, or
otherwise have any significant adverse effect on the supply,
distribution, or use of energy.
This document does not contain any new information collection
requirements that would require additional review and approval by OMB
under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.). The
information collection activities related to the submission of
information pursuant to TSCA section 5 are already approved by OMB
under OMB Control No. 2070-0012 (EPA Information Collection Request
[ICR] No.574). The burden for that ICR is estimated to average 100
hours per respondent, including time for reading the regulations,
processing, compiling, and reviewing the requested data, generating the
request, storing, filing, and maintaining the data. Under PRA, an
agency may not conduct or sponsor, and a person is not required to
respond to a collection of information unless it displays a currently
valid OMB control number, or is otherwise required to submit the
specific information by a statute. The OMB control numbers for the EPA
regulations that are codified in 40 CFR chapter I, after appearing in
the preamble of the final rule, are further displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers for certain EPA regulations is
consolidated in a list at 40 CFR 9.1.
As indicated previously, this action is not subject to the notice-
and-comment requirements under the Administrative Procedure Act (APA)
(5 U.S.C. 551 et seq.) or any other statute. As such, it is not subject
to the provisions of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
et seq.). Further, this action is expected to only have a limited
impact because only entities which are now manufacturing such a
chemical substance, and which have not already prepared and submitted a
PMN to EPA, must submit a PMN as a result of this action if they intend
to continue manufacturing it.
Based on EPA's experience with review of PMNs, State, local, and
Tribal governments have not been impacted by these activities, and EPA
does not have any reason to believe that any State, local, or Tribal
government would be impacted by this action. As such, this action will
not have substantial direct effects on the States or 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, entitled Federalism
(64 FR 43255, August 10, 1999). Nor does this action significantly or
uniquely affect the communities of tribal governments as specified by
Executive Order 13175, entitled Consultation and Coordination with
Indian Tribal Governments (65 FR 67249, November 9, 2000). In addition,
EPA has determined that this regulatory action would not impose any
enforceable duty, contain any unfunded mandate, or otherwise have any
affect on small governments subject to the requirements of sections
202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104-4).
This action does not involve any technical standards that require
the Agency's consideration of voluntary consensus standards pursuant to
section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
This action will not have an adverse impact on the environmental
and health conditions in low-income and minority communities.
Therefore, under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and
[[Page 2859]]
Low-Income Populations (59 FR 7629, February 16, 1994), the Agency is
not required to and has not considered environmental justice-related
issues.
List of Subjects
40 CFR Part 704
Environmental protection, Chemicals, Confidential business
information, Hazardous substances, Imports, Reporting and recordkeeping
requirements.
40 CFR Part 720
Environmental protection, Chemicals, Hazardous substances, Imports,
Reporting and recordkeeping requirements.
40 CFR Part 721
Environmental protection, Administrative practice and procedure,
Chemicals, Hazardous substances, Imports, Labeling, Occupational safety
and health, Reporting and recordkeeping requirements.
40 CFR Part 723
Environmental protection, Chemicals, Hazardous substances,
Photographic industry, Reporting and recordkeeping requirements.
Dated: January 10, 2008.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.
[FR Doc. E8-681 Filed 1-15-08; 8:45 am]
BILLING CODE 6560-50-S